55852 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 900

[Docket No. 95N–0192]

RIN 0910-AA24

Quality Mammography Standards

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations governing mammography.

Amendments are being made to the

requirements for accreditation bodies;

procedures for facility certification; and

quality standards for mammography

personnel, equipment and practices,

including quality assurance. This action

is being taken to provide increased

assurance of adequate and consistent

evaluation of mammography facilities

on a nationwide level and compliance

of the facilities with quality standards.

It also carries out the intent of Congress

that FDA replace the existing interim

rules with more comprehensive final

regulations.

DATES: This regulation is effective April

28, 1999; except §§ 900.12(b)(8),

900.12(e)(4)(iii), 900.12(e)(5)(i),

900.12(e)(5)(iii), and 900.12(e)(5)(x),

which become effective October 28,

2002.

FOR FURTHER INFORMATION CONTACT:

Roger Burkhart, Center for Devices and

Radiological Health (HFZ–240), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20850, 301–594–

3332, FAX 301–594–3306.

SUPPLEMENTARY INFORMATION:

I. Background

The Mammography Quality Standards

Act (the MQSA) (Pub. L. 102–539) was

passed on October 27, 1992, to establish

national quality standards for

mammography. The MQSA required

that, to provide mammography services

legally after October 1, 1994, all

facilities, except facilities of the

Department of Veterans Affairs, shall be

accredited by an approved accreditation

body and certified by the Secretary of

Health and Human Services (the

Secretary). The authority to approve

accreditation bodies and to certify

facilities was delegated by the Secretary

to FDA.

The MQSA was enacted in response

to the growing incidence of breast

cancer and its associated mortality rate.

Breast cancer is now the most common

nonskin cancer and is the second

leading cause of cancer deaths among

women, after lung cancer. Early

detection of breast cancer, typically

involving breast physical examination

and mammography, is the best means of

preventing deaths that can result if the

diagnosis is delayed until the onset of

more advanced symptoms.

Mammograms can reveal breast cancer

up to 2 years before a woman or her

doctor can feel a lump. In addition, over

90 percent of these early stage cancers

can be cured (Ref. 1).

However, according to the General

Accounting Office (GAO), a

mammogram is among the most difficult

radiographic images to read. It must be

of high quality for the image to be

interpreted correctly. If the image

quality is poor, the interpreter may miss

an incipient cancerous lesion. This false

negative diagnosis could delay early

treatment and result in an avoidable

death or increased morbidity. It is

equally true that poor quality images or

faulty interpretations can lead to a false

positive diagnosis when normal tissue is

misread as abnormal. This can lead to

needless anxiety for the patient, costly

additional testing, and painful biopsies.

The Senate Committee on Labor and

Human Resources held hearings on

breast cancer in 1992 and found a wide

range of problems with mammography

practice in the United States including:

(1) Poor quality equipment, (2) a lack of

quality assurance procedures, (3) poorly

trained radiologic technologists and

interpreting physicians, and (4) a lack of

facility inspections or consistent

governmental oversight.

A. Provisions of the MQSA

The MQSA was enacted to address

these deficiencies in mammography

practice. Under the MQSA, Congress

established a comprehensive statutory

scheme for the certification and

inspection of mammography facilities to

ensure that only those facilities that

comply with minimum Federal

standards for safe, high-quality

mammography services would lawfully

continue to operate after October 1,

1994. Operation after that date would be

contingent on receipt of an FDA

certificate attesting that the facility

meets the mammography quality

standards issued under section 354(f) of

the Public Health Services Act (the PHS

Act) (42 U.S.C. 263b(f)).

Specifically, the MQSA required the

following:

(1) Accreditation of mammography

facilities by private, nonprofit

organizations or State agencies that have

been approved by FDA as meeting the

standards established by FDA for

accreditation bodies and that continue

to pass annual FDA reviews of their

activities. The MQSA also requires that,

as part of the overall accreditation

process, actual clinical mammograms

from each facility be evaluated for

quality by the accreditation body.

(2) An annual mammography facility

physics survey, consultation, and

evaluation performed by a qualified

medical physicist.

(3) Annual inspection of

mammography facilities, to be

performed by FDA-certified Federal or

State inspectors. If State inspectors are

used, the MQSA requires a Federal

audit of the State inspection program by

direct Federal inspections of a sample of

State-inspected facilities.

(4) Establishment of initial and

continuing qualification standards for

interpreting physicians, radiologic

technologists, medical physicists, and

mammography facility inspectors.

(5) Specification of boards or

organizations eligible to certify the

adequacy of training and experience of

mammography personnel.

(6) Establishment of quality standards

for mammography equipment and

practices, including quality assurance

and quality control (QC) programs.

(7) Standards governing

recordkeeping for patient files and

requirements for mammography

reporting and patient notification by

physicians.

(8) Establishment by the Secretary of

a National Mammography Quality

Assurance Advisory Committee

(NMQAAC). Among other things,

NMQAAC is required to advise FDA on

appropriate quality standards for

mammography facilities and

accreditation bodies.

The MQSA replaced a patchwork of

Federal, State, and private standards. Its

purpose is to guarantee sufficient

oversight of mammography facilities to

ensure that all women nationwide

receive adequate quality mammography

services.

B. Interim Regulations

On December 14, 1993, the President

signed legislation (H. Rept. 2202)

granting authority to the Secretary (and

by delegation, to FDA) to issue

temporary interim regulations setting

forth standards for approving

accreditation bodies and establishing

quality standards for mammography

facilities. This authorization was

provided in recognition of the fact that

FDA certification of the approximately

10,000 mammography facilities in the

United States could not be

accomplished by the October 1, 1994,

statutory deadline without streamlining
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55853

the rulemaking process for issuing

initial standards. Because of the urgent

public health need for national

mammography standards, Congress

decided to grant this interim rule

authority rather than extend the

deadline to develop standards.

In the Federal Register of December

21, 1993 (58 FR 67558 and 58 FR

67565), FDA issued interim rules

establishing requirements for entities

applying to serve as accreditation bodies

and for facilities applying to obtain FDA

certification in order to continue the

legal provision of mammography

services after October 1, 1994. These

interim rules became effective on

February 22, 1994. They were amended

by another interim rule published in the

Federal Register on September 30, 1994

(59 FR 49808).

C. Accreditation and Certification

Operating under the interim

regulations, FDA approved the

American College of Radiology (the

ACR) and the State of Iowa as

accreditation bodies and issued

certificates to more than 5,000 facilities

accredited by these 2 bodies before the

October 1, 1994, statutory deadline.

Over 4,500 of the remaining facilities

were actively involved in becoming

accredited on that date. In the fall of

1994, FDA also approved the States of

Arkansas and California as accreditation

bodies.

In recognition of the fact that a large

number of facilities were working to

meet accreditation standards at the same

time, and cognizant of the extremely

heavy demands this placed upon the

accreditation bodies, FDA used

authority provided by the MQSA to

issue 6-month provisional certificates

on October 1, 1994, to facilities whose

applications for accreditation were

sufficiently complete for review and

which, on preliminary examination,

appeared reasonably likely to receive

accreditation. This avoided the major

reduction in access to mammography

that would have resulted had several

thousand facilities been forced to close

their doors until the accreditation and

certification process could be

completed.

By March 31, 1995, the expiration

date for the 6-month provisional

certificates issued on October 1, 1994,

over 8,200 facilities had become fully

accredited and certified. Most of the

facilities whose accreditation was still

in progress satisfied the criteria for the

1-time 90-day extension of the

provisional certificate provided by the

MQSA and were granted such

extensions.

By June 30, 1995, approximately

9,400 facilities had become fully

accredited and certified. Several

hundred more, primarily facilities that

had begun operation after October 1,

1994, or facilities that had previously

failed accreditation and were seeking

approval after having taken corrective

actions, were operating under

provisional certificates or 90-day

extensions of these certificates. FDA

estimates that approximately 800

facilities closed between October 1993

and June 1995. The closings were due

to a number of reasons, including failure

to apply for certification, voluntary

closure, and failure to meet the

standards for accreditation, and other

reasons unrelated to the MQSA, such as

retirement.

D. Onsite Inspection of Facilities

At the same time FDA was working

with the four accreditation bodies to

accredit and certify facilities, the agency

was also meeting the MQSA

requirement to establish an annual

onsite inspection program to monitor

facility compliance with the MQSA

standards. The bulk of these inspections

are performed by State inspectors

operating under the contracts that FDA

has with 49 States, Puerto Rico, the

District of Columbia, and New York

City. Federal inspectors inspect Federal

facilities and facilities in the remaining

States and do audits of the State

inspections. FDA has trained and

certified approximately 250 Federal and

State inspectors for this program. All

facilities that completed the certification

process had received their first

inspections by September 1996 and

approximately 70 percent had received

their second inspections by the end of

March 1997. FDA was pleased to find

widespread compliance with the quality

standards during these inspections.

Only 2 percent of the facilities had one

or more of the most serious findings

(referred to by FDA as Level 1 findings)

during the first round of inspections and

that proportion has dropped to less than

1 percent of the facilities inspected so

far in the second round.

E. Development of Proposed Regulations

In granting interim rule authority to

FDA, Congress made clear its intention

that the agency replace the interim

regulations with more comprehensive

regulations as soon as possible. These

more extensive regulations were to be

developed using the normal ‘‘notice and

comment’’ rulemaking process and

consultation with the NMQAAC.

Apart from the strong congressional

encouragement, there were also other

reasons why it was important to replace

the existing interim regulations for

quality mammography with more

comprehensive final regulations. The

interim regulations were based

primarily on the voluntary standards of

the ACR’s Mammography Accreditation

Program (MAP). Utilization of the MAP

standards aided greatly in meeting the

October 1, 1994, deadline for

accreditation and certification of

facilities. The application of these

standards to all facilities, instead of just

those that had sought voluntary

accreditation from the ACR, had a

significant impact on mammography

nationwide. However, the MAP

provisions did not cover all areas that

required standards under the MQSA,

such as mammography of patients with

breast implants and experience

requirements for some personnel of

mammography facilities. Furthermore,

in many situations where MAP

voluntary standards were relevant, their

wording needed to be changed and

clarified for use as part of a regulatory

program.

One especially significant gap was in

the equipment area where the standards

under the interim regulations were

minimal. To provide greater assurances

of quality equipment performance, the

ACR, with the Centers for Disease

Control and Prevention (CDC), had

previously convened expert committees

to develop specifications for

mammography equipment. The reports

of these expert committees were an

important basis for the equipment

provisions of the proposed regulations.

In addition, the interim standards

were required to be issued and

implemented prior to FDA developing

any significant experience regulating

mammography. Because the statute was

new and the regulatory scheme it

established presented a different and

innovative approach, the agency would

inevitably develop ideas for

improvement in quality and efficiency

of implementation as the program

developed.

For all of these reasons, it was

necessary to replace the interim

regulations with more comprehensive

final regulations in order to obtain the

highest quality mammography that is

reasonably achievable. Coincident with

the implementation of the interim rules,

work was proceeding on the

development of final regulations. This

effort was aided by the agency’s ongoing

experience under the interim rules and

the advice of members of the NMQAAC.

The NMQAAC membership includes

health professionals whose work

focuses significantly on mammography

and representatives of consumer groups.

NMQAAC was chartered on July 7,
55854 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

1993. Nominations for members were

accepted until September 7, 1993. The

first meeting of the NMQAAC was held

February 17 through 18, 1994. At that

meeting, and in subsequent meetings in

April, July, and September 1994, the

NMQAAC reviewed and commented on

drafts of portions of the proposed

regulations developed by FDA. At its

January 1995 meeting, the NMQAAC

reviewed the entire body of draft

proposed regulations. Many of the

requirements in the proposed

regulations were based on advice

obtained from the members of

NMQAAC during these meetings.

Another valuable resource utilized by

FDA in the development of the

proposed regulations was the guideline

entitled, Quality Determinants of

Mammography (Ref. 2). This guideline

was developed by the Quality

Determinants of Mammography Panel,

with support from the Agency for

Health Care Policy and Research

(AHCPR), to help eliminate low quality

mammography and, thereby, eliminate

the adverse consequences it causes. The

Panel consisted of a diverse group

representing many medical specialties

and consumer representatives

knowledgeable about mammography.

Proposed regulations were published

in the Federal Register of April 3, 1996

(61 FR 14856). To facilitate review by

the public, they were published in 5

separate documents, as described in the

introduction to section III of this

document.

F. Development of the Final Regulations

A 90-day public comment period

ending July 3, 1996, was provided for

the proposed regulations. During that

time, extensive efforts were made to

encourage public comments.

Approximately 17,000 copies of the

proposed regulations were mailed to the

organizations and individuals on FDA’s

MQSA mailing list, including 1 to every

certified mammography facility. The

availability of the proposal was

announced in Mammography Matters,

the newsletter of FDA’s Division of

Mammography Quality and Radiation

Programs (DMQRP), and in the

newsletters of professional groups.

Copies were also distributed by FDA

personnel at professional meetings. By

the end of the comment period,

approximately 1,900 responses,

containing approximately 8000

individual comments, had been

received from organizations and

individuals. NMQAAC also provided

additional comments on the proposal

during an April 1996 meeting.

Analysis of the many comments began

after the end of the comment period. At

the October 1996 meeting, FDA

consulted the NMQAAC for advice with

respect to some of the more

controversial issues raised by the

comments. During the January 1997

meeting, the Committee reviewed the

entire set of regulations in light of the

comments received. The public

comments and the advice received from

the NMQAAC were used to develop a

draft of final regulations, which the

members of the NMQAAC had an

opportunity to review individually in

March 1997.

The majority of the final regulations

will become effective April 28, 1999.

The interim rules will continue to apply

until that date. Certain equipmentrelated regulations, in § 900.12(b) and

(e), will become effective October 28,

2002. This delay in the effective date for

certain equipment requirements is

intended to minimize the costs

associated with equipment

improvements. The cost savings are

achieved by permitting facilities to

implement the improvements as they

follow their normal equipment

replacement schedule instead of

requiring an immediate purchase of new

equipment or equipment upgrades.

II. Highlights of the Final Rule

This section highlights the major

features of the final regulations, as

compared to the interim and the

proposed regulations, and their

potential for achieving the MQSA goals

of establishing nationwide quality

standards for mammography, while

maintaining a broad patient access to

mammography services. A detailed

discussion of the public comments and

FDA’s response to them is provided

under section III of this document.

These final regulations fulfill FDA’s

responsibility under the MQSA to

establish national quality standards for

mammography services, with extensive

input from NMQAAC. These Federal

regulations will be implemented under

the MQSA framework whereby

mammography facilities are accredited

once every 3 years by FDA-approved

State or private not-for-profit

accreditation bodies, and inspected

once every year by FDA-trained and

certified State (or in some cases Federal)

inspectors. The Federal-State-private

sector partnership provides the

necessary tools to successfully

implement these regulations and realize

the MQSA’s goal of assuring high

quality mammography services for every

American woman.

Accordingly, these regulations

establish rigorous criteria designed to

enhance the quality of mammography

services in a manner that is reasonably

achievable by mammography facilities.

The regulations provide facilities with

flexibility in needed areas to meet the

important public health goals of these

standards. Taken as a whole, the

regulations are expected to provide

substantial consumer benefits in a

reasoned and cost-effective manner.

The final regulations consist of two

subparts. Subpart A is composed

primarily of the requirements to be met

by the accreditation bodies who perform

the crucial initial screening of

mammography facilities for quality,

including clinical image review, subpart

B establishes quality standards to be met

by the mammography facilities and

administrative procedures.

A. Accreditation Body Requirements

The final regulations refine and codify

policies FDA had developed under the

interim regulations for the initial

approval of accreditation bodies by

FDA, and for defining the ongoing

responsibilities of these bodies and the

agency’s oversight of them. The primary

goal of the accreditation body

requirements is to ensure that there is

nationwide consistency, both within

and between accreditation bodies, in the

evaluation of mammography units and

procedures to determine if they meet the

standards for quality mammography.

The major change made from

proposed §§ 900.3 through 900.7 was

the removal of several provisions that

would have assigned compliance

responsibilities to the accreditation

bodies. Removal of these provisions

ensures that the activities of the

accreditation bodies will have their

proper focus, which is to identify

facilities that are not performing

adequate quality mammography and to

advise such facilities on the nature of

their problems and how to correct them.

Compliance activities under the MQSA

are reserved for FDA.

B. Facility Quality Standards

1. Personnel Standards

The personnel standards of

§ 900.12(a) cover interpreting

physicians, radiologic technologists,

and medical physicists who provide

services to mammography facilities. The

goals of the standards are to ensure that

personnel: (1) Have general

qualifications in radiology; (2) possess

specific qualifications in

mammography; and (3) keep their

qualifications up-to-date.

Most of the proposed changes in the

personnel area were intended to clarify

general statements in the interim

regulations that have caused confusion

in interpretation. A major step to

improve quality of personnel
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55855

performance, however, was the

proposed establishment of initial and

continuing experience requirements for

radiologic technologists and medical

physicists. These requirements are

parallel to requirements already in the

interim regulations for physicians and,

like the physician requirements, are

intended to make sure that individuals

have supervised clinical experience

before they begin to provide

mammography services independently,

and that they maintain their skills

through regular performance of their

duties. These new experience

requirements have been codified in the

final rule after some adjustments in the

amount of experience required due to

practical considerations, such as the

difficulties that medical physicists

under contract to one facility would face

in attempting to meet the proposed

requirement to do surveys in several

facilities.

Another significant change from the

proposed personnel standards is that the

final rule ‘‘grand parents’’ technologists

who met the personnel requirements

under the interim regulations. Without

grand parenting technologists already in

the system, there was the possibility

that localized shortages of technologists

would occur, resulting in a serious,

short-term impact on access to

mammography. Because the agency

believes that most technologists

presently providing mammography

services either meet, or have

qualifications comparable to the final

requirements, grand parenting could be

permitted to relieve these concerns

without any significant impact on

quality.

2. Equipment

The equipment standards in

§ 900.12(b) are intended to ensure that

mammography equipment has the

capability of producing quality

mammograms over the full range of

clinical conditions. The equipment area

was addressed only briefly in the

interim regulations. To better define the

equipment capabilities needed for high

quality mammography, equipment

specification standards were proposed

for all equipment components of the

mammography system from the X-ray

generator to the view box. These

proposals relied heavily upon the

recommendations of the equipment

focus groups convened in the early part

of the decade by the ACR, with the

support of CDC.

After reviewing the information

provided in the public comments and

by the NMQAAC, FDA revisited the

question of the proper balance between

the economic impact of new standards

and the associated gains to the public

health. This reconsideration led the

agency to conclude that the expected

benefits from some of the proposed

equipment specifications would not

compensate for the cost to replace or

retrofit mammography systems to meet

them. The agency has concluded that, in

some cases, the same public health goals

could be accomplished through

specified quality assurance procedures.

Accordingly, specifications related to

source-image receptor distance (SID),

focal spot location, filtration, and film

processors have been eliminated and

specifications related to compression

and radiation output are being treated as

performance standards under the

quality assurance section of the

regulations. Similarly, performance

outcome aspects of the requirements for

alignment have been moved to the

quality assurance section. Finally,

requirements related to system

resolution were eliminated as

duplicating performance standards

already in the quality assurance section,

and the requirements related to the

examination of disabled patients were

eliminated in part because of a lack of

consensus about the need for such

requirements.

In an effort to reduce costs, FDA is

phasing in the equipment requirements,

with some becoming effective the same

time (18 months) as the rest of the

regulations and others within 5 years.

However, based on the desire not to

impede technological advances, the

uncertainty in estimating needs further

in the future, and an assessment of the

associated costs, the agency has

eliminated the proposed 10-year phasein requirements and some of the 5-year

phase-in requirements. The agency

intends to reassess the need for the

deleted requirements at a future time.

3. Recordkeeping and Reporting

Requirements

The recordkeeping and reporting

requirements of § 900.12(c) are intended

to: (1) Ensure that all patients and their

referring physicians receive timely and

adequate notification of the results of

examinations, and (2) assist in diagnosis

by ensuring that records of past

examinations, including the original

mammograms, are available when

needed for comparison with the images

produced during new examinations.

With respect to patient notification of

examination results, the final rule

codified this essential reporting

requirement as a performance outcome

standard. The proposed rule would have

required the facilities to have a system

to ensure that all patients received

written notification of their examination

results, and further specified what

should be included in that notification.

The final rule requires that each facility

have a system to ensure that the results

of each mammographic examination are

communicated to the patient in a timely

manner. Thus, the focus is placed on the

desired performance outcome, the

notification of the patient in a timely

manner, and not on the method or

specific conduit of the notification.

Under the final rule, the facility has the

flexibility to use the method of

notification that is most effective in its

situation and to convey the information

to the patient that it deems to be most

important. In the part of the preamble

discussing this provision, FDA

continues to endorse the use of written

notification as the most reliable way to

guarantee that each patient is notified of

results and that any necessary followup

will occur and recommends that

facilities follow the AHCPR guidelines

on direct written notification to all

patients. The agency also describes

other methods that may achieve the

desired outcome equally well in specific

situations.

With respect to providing patients

with original mammograms upon

request, the final rule was modified to

make it clear that the original

mammograms must be made available to

other medical facilities, at the patient’s

request, whether the transfer is

permanent or temporary. It is expected

that this change will end the difficulties

in obtaining previous original

mammograms for comparison with new

mammograms (an essential aid to

diagnosis) that many patients have

experienced under the interim

regulations.

4. Quality Assurance

The goal of the quality assurance

requirements of § 900.12(d), (e), and (f)

are to ensure that equipment and

personnel continue to perform at

adequate levels. Section 900(d) defines

staff responsibilities and recordkeeping

requirements for the quality assurance

program, § 900.12(e) establishes

equipment QC requirements, and

§ 900.12(f) outlines the requirements for

mammography medical outcome audits.

The proposed equipment QC

requirements represented a major

transition towards performance outcome

standards. The interim regulations had

referenced the ACR quality assurance

manuals and thus specified not only the

performance outcomes to be achieved

but the test procedures to be followed.

The proposed rule was intended to

establish the desired performance

outcomes and the required frequency of

testing at levels nearly identical to those

in the interim regulations, but sought to

give the mammography facilities some
55856 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

flexibility in the testing procedures to be

used.

The final rule leaves the testing

frequencies and the performance

outcomes largely unchanged from the

proposal, with the exception that

standards have been added for radiation

output, alignment, and compression,

parameters previously considered under

the equipment specifications. The

provisions related to retesting after

equipment failure and taking equipment

out-of-service until problems are solved

have also been modified to give the

facility more flexibility in determining

when performance is compromised

sufficiently to warrant such actions.

5. Medical Outcomes Audit

A comprehensive mammography

medical outcomes audit program can

ensure that a facility is providing its

patients with accurate mammography

examinations and followup care and has

the potential to provide the basis for

performance outcome standards.

However, the public comments made it

clear that more research is needed

before the state-of-the-art will be

sufficiently advanced to support

regulatory performance outcome

requirements based on audits. FDA did

move a step beyond the interim

requirement that each facility have a

system for reviewing outcome data by

codifying requirements related to the

analysis of the data collected.

6. Consumer Complaint Mechanism

Under the interim regulations,

accreditation bodies have developed

mechanisms for addressing consumer

complaints about the quality of

mammography services received.

Requirements for such mechanisms

have been continued in § 900.4(g) of the

final regulations. FDA recognized,

however, that consumer complaints

usually can be addressed most

effectively at the facility level. For this

reason, FDA proposed to require each

facility to develop a system for

collecting and resolving consumer

complaints, with special emphasis

placed on the resolution of serious

complaints. This requirement has been

codified with little change in

§ 900.12(h). The accreditation body and

FDA retain the responsibility for

addressing complaints that cannot be

resolved at the facility level.

7. Alternative Requirements

The alternative requirements in

§ 900.18 provide a mechanism for

implementing advances in

mammography that meet quality

standards more rapidly than would be

possible through amending the

regulations. This mechanism will be

used only when the potential public

health benefits justify such actions.

This section was incorporated into the

proposed rule from the interim

regulations with little change. Before

codification in the final rule, the section

was modified to give the agency the

authority to allow an approved

alternative to be used by entities other

than the entity that applied for

approval. This change was made in

response to concerns that it would be an

unnecessary duplication of effort for the

agency and for the applicants if multiple

applications were required for the

approval of the same advance in

mammography.

8. Performance Outcomes

FDA’s proposed rule invited

comments on the possibility of taking a

performance outcomes approach to

mammography quality standards.

Suggestions and comments on possible

performance outcome indicators were

also invited. As discussed in more detail

elsewhere in this document, the

consensus of the public comments was

that while the performance outcome

concept was attractive in theory, much

additional research will be needed

before a performance outcome system to

ensure mammography quality can be

issued. The agency agrees with this

consensus but also believes that it is

possible to start moving in that direction

in certain areas as noted in the previous

discussion.

III. Provisions of the Final Rule

The proposed regulations that

published in the Federal Register of

April 3, 1996, consisted of five separate

documents. The first, ‘‘Quality

Mammography Standards; General

Preamble and Proposed Alternative

Approaches’’ (61 FR 14856 (Docket No.

95N–0192)): (1) Surveyed the history of

efforts to implement the MQSA; (2)

summarized FDA’s analysis of the

environmental, economic, and

paperwork impacts of the final

regulations; and (3) set out the agency’s

proposed ‘‘scope’’ and ‘‘definitions’’

sections (§§ 900.1 and 900.2). In that

document, the agency also invited

public comments on the concept of

performance-based outcomes

regulations and the feasibility of

recasting the proposed design and

process requirements into performancebased outcomes requirements.

The second, ‘‘Quality Standards and

Certification Requirements for

Mammography Facilities; General

Facility Requirements’’ (61 FR 14870

(Docket No. 93N–0351)), proposed

regulations covering a variety of areas,

including: (1) Applicability (§ 900.10);

(2) requirements for certification

(§ 900.11); (3) procedures for suspension

or revocation of accreditation; (4)

accreditation body approval; (5) facility

certificates (§§ 900.13 and 900.14); (6)

the process for appealing agency

decisions (§ 900.15); and (7) an

alternative requirement process

(§ 900.18). Some aspects of the facility

standards were also covered. These

included medical records and

recordkeeping (§ 900.12(c)); general

quality assurance requirements

(§ 900.12(d)); mammography medical

outcome audits (§ 900.12(f));

mammography of examinees with breast

implants (§ 900.12(g)); the consumer

complaint process (§ 900.12(h)); and

additional clinical image review and

patient notification (§ 900.12(I)).

The third, ‘‘Proposed Requirements

for Accreditation Bodies of

Mammography Facilities’’ (61 FR 14884

(Docket No. 95N–0192)), covered the

approval, responsibilities, and

withdrawal of approval of accreditation

bodies (§§ 900.3 to 900.7).

The fourth, ‘‘Quality Standards and

Certification Requirements for

Mammography Facilities; Personnel

Requirements’’ (61 FR 14898 (Docket

No. 95N–0215)), proposed standards to

be met by interpreting physicians

(§ 900.12(a)(1)), radiologic technologists

(§ 900.12(a)(2)), and medical physicists

(§ 900.12(a)(3)) working in

mammography facilities.

The fifth, ‘‘Proposed Quality

Standards for Mammography

Equipment Quality Assurance’’ (61 FR

14908 (Docket No. 95N–0195)),

proposed equipment specifications

(§ 900.12(b)) and requirements for the

equipment quality assurance program

(§ 900.12(e)).

The proposed regulations were

published in these five segments to

facilitate review and make it easier for

members of the public to focus on the

sections of most interest to them.

Because the final regulations are being

issued as a single document, the

comments received in response to the

proposed regulations are addressed as

part of this single preamble rather than

in separate documents relating to each

of the five proposal documents. General

comments are treated first, followed by

a discussion of the public response to

the concept of performance outcome

requirements and their feasibility. Then

comments on the individual

components of the final regulations are

discussed in the order that each

component appears in the final

regulations.

Finally, the comments on the FDA’s

analyses of impact are discussed in

sections V of this document, and section

VI covers the Paperwork Reduction Act

of 1995 provisions. Citations for

individual provisions of the regulations
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55857

generally have remained the same; the

preamble clearly notes any instance in

which a provision has been codified

under a new citation.

Each of the five proposed regulations

was preceded by a preamble containing

a wide range of information intended as

background and information for the

final regulations. Comments that the

agency received relating to preamble

discussions have been addressed either

with the general comments or with the

specific regulation sections to which

they are most closely related.

A. General Comments

Many comments received on the

proposed regulations raised issues or

concerns that were broader in scope

than any specific provision. These more

general comments are responded to first,

before turning to the more specific

comments.

1. The Overall Value of the Quality

Standards

(Comment 1). A number of the

comments stated opposing positions on

the overall value of the quality

standards established by these

regulations. Seventeen comments

supported the quality standards with

only minor modifications, noting that

they would strengthen radiology

practices and enhance the quality of

mammography. Twenty-six comments,

on the other hand, opposed the quality

standards in their entirety. Reasons

given included concern about costs and

the resultant impact on access,

opposition to the regulation of

medicine, a characterization of the

standards as unnecessary micromanagement, belief that more stringent

standards were unnecessary or

ineffective in improving quality, and an

opposition to ‘‘international’’

requirements for mammography

practice.

The agency recognizes the need to

balance the benefits to be achieved from

improved quality of mammography with

the cost of those improvements and the

impact such cost might have on access

to mammography. Congress addressed

the concern with that balance in

drafting the MQSA and has guided the

agency in its efforts to implement the

statute. An independent evaluation of

the program performed by GAO

determined that the interim regulations

had a positive effect on the quality of

mammography without a serious

adverse impact on access (Ref. 2).

Although, as previously mentioned, a

number of facilities did close for various

reasons, service from another provider

was generally available within 25 miles.

Newly established facilities have

continued to be certified, further

mitigating any impact on access. Based

upon its experience with the interim

regulations and advice from NMQAAC

members, FDA believes that the

proposed regulations will achieve

further improvements in quality at a

cost that will not impact access

significantly. The public comments on

the proposal led to a further refinement

of the regulations, including removal of

requirements when the comments

persuaded the agency that the

requirement was not essential. These

changes, and the associated reduction in

cost, should provide an even more

favorable ratio of benefit to cost.

In answer to concerns about micromanagement, many of the specific

provisions added in the final regulations

reflect practices and policies that were

developed under the interim

regulations. These policies were

developed in response to requests from

mammography facilities for information

on how to meet the requirements of

interim regulations and are already

being followed by most facilities.

Incorporating these policies into the

final regulations gave interested parties

the opportunity to comment on them. In

response to the comments, requirements

have been refined to achieve the most

favorable balance between benefit and

cost.

Finally, FDA notes that the system for

ensuring quality mammography

established by the MQSA and these

regulations is unique to the United

States and is not a duplicate of, or

related to any international

requirements or systems established in

any other country.

(Comment 2). Two comments, while

apparently not in total opposition to the

regulations, did express their authors’

opinions that the personnel and

recordkeeping and reporting

requirements went ‘‘far beyond FDA’s

medical device mandate.’’

FDA notes that the authors of these

comments have overlooked the fact that

these regulations are issued under the

MQSA, which amended the Public

Health Service Act, not under the

Medical Device Amendments to the

Federal Food, Drug, and Cosmetic Act

(the act). The MQSA specifically

requires the agency to develop

standards for personnel qualifications

and for reporting and recordkeeping (42

U.S.C. 263b(f)).

(Comment 3). Several comments,

while expressing varying degrees of

support or opposition to the

requirements, asked why mammography

has been singled out for such attention.

Some suggested that other diseases were

as serious or more serious than breast

cancer, while one comment pointed out

that the radiation levels in

mammography are quite low.

Although a case might be made for

developing similar programs for

diagnosis of other diseases, Congress

decided that mammography should be

the subject of this legislation. Congress

found the evidence sufficiently

convincing that breast cancer was a

significant public health risk that could

be reduced by improved mammography

and, furthermore, that the performance

of mammography nationwide was in

need of improvement. Congress

responded with the MQSA, and FDA is

carrying out the mandate of that statute.

FDA agrees with the comment that

observed that the radiation levels in

mammography are much lower than

they were 20 years ago (largely as a

result of a cooperative government,

industry, and facility effort) and lower

than those used in many other

examinations. However, the primary

concerns addressed by the MQSA are

not radiation levels but poor image

quality and interpretation.

(Comment 4). One comment criticized

the proposed regulations for not

sufficiently recognizing local facility

condition variations, indicating that

standards appropriate for some facilities

might be unduly burdensome to others.

In contrast, another comment strongly

supported the application of uniform

standards in both rural and nonrural

areas. It stated that this would ensure

that women in rural areas received

optimum care.

FDA believes that all women are

entitled to high quality mammography,

no matter where they live, and so has

not issued lesser standards for rural

areas or any other subset of facilities.

The agency further notes that the fear

that applying uniform minimum

standards would cause an undue burden

to rural facilities is refuted by the

experience of Michigan, where such

uniform standards have been applied to

all facilities in that State since 1989

(Ref. 3), and by experience under the

Federal interim regulations.

(Comment 5). Ten comments stated

that ‘‘the regulations and the complaint

process may confuse the public by

bringing up more issues than it is

necessary for them to be concerned with

and confusing the role of mammography

in the overall diagnosis and treatment of

breast cancer.’’

The purpose of the MQSA is to ensure

adequate quality mammography for all

patients. If this purpose is achieved,

members of the public will be able to

receive mammography at any facility in

the country without having to be

concerned about the issues covered by

the regulations. Thus, public
55858 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

‘‘confusion’’ should decrease rather than

increase as a result of these regulations.

Without additional details, FDA cannot

respond further to the concern

expressed by the comments about

confusion over the role of

mammography. The agency assumes,

however, that any such problems could

be handled through educational efforts.

2. Division of Responsibility

The MQSA established a system of

checks and balances involving the

interaction of several groups, including

FDA, the States, and the accreditation

bodies. A number of comments

expressed varied concerns about the

division of responsibility established by

the proposal.

(Comment 6). One of these comments

stated that oversight and review of

mammography facilities is the backbone

of the MQSA program. Along with a

second comment, it noted that FDA, not

the accreditation bodies, should be

responsible for enforcement actions.

FDA agrees with this comment and

believes that the final regulations clearly

give the agency the primary

responsibility for this function.

However, the regulations also establish

that the accreditation bodies have

responsibility for notifying FDA when

they have information that enforcement

actions may be needed and for assisting

in related investigations.

(Comment 7). Two comments stated

that the regulations should allow States

to eliminate overlapping functions if

they are serving as both accreditation

bodies and inspection agencies. A third

comment stated that more leeway

should be given to State accreditation

bodies, which have enforcement

capability, than to non-State

accreditation bodies. A fourth comment

recommended eliminating some

unspecified requirements if a State

agency holds both accreditation body

status and an inspection contract.

FDA agrees that states that are both

accreditation bodies and inspection

agencies may be able to combine some

functions and, in fact, some steps have

been taken under the interim

regulations. However, it is important

that all facilities meet the same

accreditation and inspection

requirements. The agency believes it is

unlikely that any requirements

pertaining to accreditation bodies or

facility standards can be eliminated

entirely in States with dual status. The

need for consistency also explains why

FDA disagrees with the third comment;

State accreditation bodies may have

enforcement capability under State law

but this capability could vary greatly

from State to State. As the author of the

fourth comment did not give specific

examples of requirements to be

eliminated, the agency cannot respond

further to that comment.

(Comment 8). Three comments

suggested that to reduce costs there

should be one comprehensive system to

accomplish all the necessary

accreditations within any State that

already has in place a mechanism for

accreditation of facilities and licensure

of technologists. The comment observed

that the Federal Government would

have to subsidize States for this work.

States are permitted under the MQSA

to apply to become FDA-approved

accreditation bodies (42 U.S.C.

263b(e)(1)(A)) and three States have

already done so. FDA disagrees that the

agency should merely substitute

existing State accreditation and

licensing systems for the MQSA

standards. States may have widely

different accreditation standards under

their State laws, while the drafters of the

MQSA envisioned a system that would

establish uniform, minimum national

standards for all mammography

facilities. The MQSA, however,

expressly permits State laws relating to

mammography that are more stringent

to be issued or to remain in effect (42

U.S.C. 263b(m)). Furthermore, the

drafters of the MQSA did not provide

for Federal subsidies for any

accreditation body; the statute instead

expects those bodies to be supported by

their accreditation fees.

(Comment 9). One comment

recommended the adoption of only one

set of rules, whether it be established by

the State, ACR, or FDA, to govern

mammography, while a second

recommended combining FDA and ACR

into one ‘‘accreditation body’’ to reduce

the problems of complying with the

requirements of both. Another comment

objected to FDA permitting States to

pass additional laws and regulations

governing mammography in addition to

the MQSA requirements. It stated that

this would prevent the establishment of

consistent nationwide standards.

Another comment objected to the

absence of a preemption clause in the

MQSA, fearing that would lead to

overlapping State and Federal

regulations.

FDA notes that, within the limits of

the authority given to it by the MQSA,

it has worked towards the goal of one

set of rules. The MQSA authorizes FDA

to establish one set of uniform baseline

standards and to require that all

approved accreditation bodies,

including ACR, enforce standards

substantially the same as these. The

agency has taken this step. FDA also

notes that the Health Care Financing

Administration (HCFA) has agreed to

accept the MQSA regulations and

inspections in lieu of the regulations

and inspection system it had previously

established to govern mammography

under Medicare, thus reducing

duplication. The MQSA also requires

State standards to be at least as rigorous

as those of FDA. However, as noted by

the comment that there is no

preemption clause in the statute, the

MQSA explicitly gives States authority

to develop additional regulations

governing mammography, as long as

they are more stringent than the MQSA

requirements (42 U.S.C. 263b(m)). The

intention of the MQSA was to create a

uniform nationwide baseline quality

level for mammography, while

permitting individual States to strive for

higher levels. Only Congress can make

changes in this approach, not FDA.

(Comment 10). One comment

expressed concern that the nature of the

State/Federal agency relationship may

be an impediment to ensuring quality

mammography. The author cited two

GAO reports criticizing the oversight of

State programs by other Federal

agencies. FDA notes that the agency has

a long history of Federal-State

cooperative programs, especially with

respect to educational efforts and

inspections in the medical X-ray area,

and that, in general, these programs

have been very successful. As the

agency moves into new areas of

cooperation with the States, it is

studying the experiences of other

Federal agencies in an effort to avoid

any difficulties they may have

experienced in working with the States.

(Comment 11). One comment

recommended that FDA’s

mammography oversight be limited to

equipment standards and requiring that

facilities be accredited and that

oversight of the accreditation bodies by

FDA be reduced. Another comment

suggested limiting FDA’s oversight only

to ensuring that facilities are accredited

properly by the accreditation bodies.

FDA notes that the MQSA gives FDA

far greater responsibilities than either of

these comments would permit and the

regulations are intended to help the

agency continue to fulfill its obligations

under the statute.

(Comment 12). Similarly, two

comments made the general

recommendation that the accreditation

bodies be given expanded

responsibilities. Other comments had

more specific opinions, for or against,

certain expanded responsibilities for the

accreditation bodies. Two comments

stated that the accreditation body

should be the sole evaluator of the

annual physicist survey, with the

MQSA inspector merely accepting the
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55859

accreditation body’s review. A third

comment argued, however, that valuable

information would be lost if the

inspector accepted the accreditation

body’s review of the report and a fourth

comment agreed that, if duplicate

review is not cost effective, it would be

more appropriate for the inspector to

review the survey than the accreditation

bodies. Three comments stated that the

accreditation body should be

responsible for tracking all personnel

requirements for a facility, while a

fourth would give the accreditation

body responsibility for review of

continuing education credentials.

Similarly, a fifth comment would limit

the inspections to review of the

physicist survey and the QC program,

plus taking a phantom image, leaving

oversight of the other areas to some

unspecified group. Another comment on

the appropriate division of

responsibilities stated that FDA should

not have inspectors performing tests

that have already been conducted by

medical physicists and technologists.

FDA has utilized, and plans to

continue utilizing, the expertise of the

accreditation bodies to the maximum

extent permitted by the statute. The

agency also realizes that the checks and

balances system required by the MQSA

leads to some duplication of effort

between the accreditation body and the

inspectors or the inspectors and the

medical physicists. However, one of the

weaknesses of the pre-MQSA oversight

system for mammography was the lack

of an onsite evaluation of the facility

programs by an individual independent

of the facility. Experience with the

interim regulations has demonstrated

the value of such inspections; the great

majority of findings were for situations

that had not been identified by the

accreditation bodies or the medical

physicists. On the other hand, there is

no doubt that the accreditation bodies

and the medical physicists have

prompted the correction of many

problems before the inspections took

place. These activities and results

demonstrate the strength of the program.

The agency believes that the drafters of

the MQSA were correct in concluding

that a checks and balances system,

involving two or more entities, would

be more effective in ensuring the

continued maintenance of high quality

mammography than the use of only one

entity or the other.

(Comment 13). Two comments

recommended that the information

obtained by either the accreditation

bodies or the inspectors should be

shared with the other groups to cut

down on unnecessary duplication of

information collection activities or

submission requirements for the

facilities.

FDA agrees with this comment and

the statute itself supports elimination of

collection of duplicative information (42

U.S.C. 263b(d)). Under the interim

regulations, the agency has been

working with the accreditation bodies

on the electronic exchange of

information and will continue to do so

under the final regulations.

3. Inspections and Inspectors

A number of the more general

comments addressed various aspects of

the annual and audit inspections.

(Comment 14). Two comments

suggested that the FDA facility

inspections should be reduced or

eliminated in order to reduce the costs

to facilities or because annual

inspections are not needed. A third

comment urged that inspection

frequencies not be included in

regulations.

Annual onsite inspections are

required by the MQSA (42 U.S.C.

263b(g)); that requirement cannot be

changed by the agency, even if it is not

in regulations. The agency is evaluating

alternative ways for conducting

inspections in the hopes of reducing

costs for facilities.

(Comment 15). One comment stated

that it was inconsistent for FDA to

inspect every facility every year while

the accreditation bodies are required to

visit a much smaller number of facilities

annually. The comment further

maintained that the MQSA inspections

duplicated other inspections.

The FDA inspections and the

accreditation body visits serve two

different purposes. The MQSA

inspections, which are required to be

annual, are intended to ensure that all

facilities continue to meet the MQSA

quality standards. The MQSA

requirement that accreditation bodies

visit a sample of their facilities each

year serves an additional purpose,

which is to have accreditation bodies

evaluate their own performance and the

effectiveness of their accreditation

procedures (42 U.S.C. 263b(e)(4)(A)). In

addition, accreditation bodies, at FDA’s

request or on their own authority, will

visit facilities that have been identified

as potential problem facilities for the

purpose of identifying the problems and

assisting the facility in correcting them.

(Comment 16). Eleven comments

suggested that ACR be designated as the

inspection organization in New Mexico.

FDA is unable to consider this

suggestion because the MQSA

specifically limits inspectors to Federal

or State personnel (42 U.S.C. 263b(g)).

(Comment 17). Three comments were

concerned about the standards for FDA

inspectors and two more urged

additional training for inspectors.

Another comment was very

complimentary of inspectors in Iowa.

Fifteen other comments expressed

various concerns about the inspection

fees.

These issues are beyond the scope of

these regulations, which cover

requirements for accreditation bodies

and quality standards for facilities only.

FDA has referred these comments

directly to the components of FDA that

deal with inspector training and

inspection fees.

4. Public Participation in the Process

(Comment 18). Three comments

expressed concern that not enough

public input has been obtained during

the regulation development process and

suggested that facilities, manufacturers,

and personnel should be interviewed.

The NMQAAC is composed of

representatives of the mammography

community and consumer groups and

has been a valuable conduit of public

input during the eight meetings at

which it discussed the final regulations

before and after they were published.

Furthermore, each meeting included an

open session during which members of

the public could make statements and

many individuals took advantage of

these opportunities. Finally, there were

three public comment periods during

the development of the regulations. The

first of these was for comments on the

interim regulations. A great deal of

information was gained for use in the

development of the final regulations

from comments received at this time.

The second was after preliminary drafts

of the equipment and medical physicist

standards were released and again

valuable information was obtained from

the public. The third opportunity to

comment was after the publication of

the proposed regulations and, as

previously discussed, approximately

1,900 responses covering every area of

the regulations were received from a

broad spectrum of organizations and

individuals. FDA believes that the

public has had ample opportunity to

participate in the regulation

development and reiterates that this

public participation had a significant

impact on its final form.

(Comment 19). Another comment

recommended prohibiting NMQAAC

members from also serving on advisory

boards or as consultants to accreditation

bodies in order to avoid the possibility

that a limited number of people will

have disproportionate influence on the

program.

In forming the NMQAAC and its other

advisory panels, FDA has complied

with the Federal Advisory Committee
55860 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

Act (the FACA), the agency’s

implementing regulations at 21 CFR part

14, and the MQSA. The FACA requires

each advisory committee to be fairly

balanced in terms of the points of view

represented and the MQSA expressly

describes the constituent segments of

the affected community that are to have

representatives on the Committee (42

U.S.C. 263b(n)). Because advisory

committees enlist the expertise of

outside consultants to advise the

government, it is frequently the case

that well-qualified members are

nationally recognized experts who are

also called upon to play leadership and

consultant roles for private groups. The

agency does not prohibit such

individuals from providing government

service if the agency determines that

such participation is in the best interest

of the government because the need for

such participation outweighs the

potential conflict of interest. The

existence of any potential conflicts are

stated for the public record at the

beginning of each advisory committee

meeting and panel members who have

conflicts on particular matters may be

prohibited from voting on those issues.

5. Double Reading

In the preamble to the proposed rule

(61 FR 14870 at 14876, April 13, 1996),

FDA noted that one of the comments

received on the interim regulations

suggested that all mammograms be read

a second time by a second qualified

physician. The author of the comment

stated that this would avoid

unnecessary surgery and emotional

stress that can arise from a false positive

reading and the lack of appropriate

followup in the case of a false negative

reading. The agency did not include

such a requirement in the final

regulations but asked for further

comments on the issue.

(Comment 20). Twenty four

comments argued against a double

reading requirement, basing their

opposition on such reasons as the cost,

the difficulty of achieving double

reading, the delays in reporting to the

referring physician leading to patient

dissatisfaction, and the belief that it

would be a meaningless exercise and

only a few abnormalities would be

picked up. Comments asserted that the

burden would be especially great in

rural and isolated areas and could

reduce access to mammography

services. Twelve of these comments also

questioned where the notion of double

reading would lead; and would there be

a press for triple and quadruple reading.

One of these comments urged that the

focus be on training for the first reader

so that double reading is not necessary.

On the other hand, three comments

offered strong support for the use of

double reading and one comment went

so far as to say that all films should be

double read in order to eliminate the

trauma and psychological stress

associated with false positives. One

comment suggested requiring double

reading for all positive mammograms.

FDA has determined not to include a

double reading requirement in the final

regulations. Double or multi-reading (as

it is now called by the agency for

reasons discussed with the comments

on § 900.2) is referenced in the

regulations only as a way for

interpreting physicians at low-workload

facilities to meet their continuing

experience requirements. Although this

practice is not being required, the

regulations do not preclude double

reading. FDA encourages facilities that

believe their services will benefit from

such procedures to establish the

practice as a quality assurance measure.

6. The Organization of the Final

Regulation

(Comment 21). A number of

comments were extremely critical of the

organization of the proposal, finding it

difficult to read and to see the

relationship between the five separate

divisions, each with its own docket

number, preamble, and regulatory

content. Several of these comments

stated that information on the

organization of the proposal should

have been provided, while others made

suggestions for reorganization of the

material when it was published as a

final regulation.

FDA adopted the method of

presentation in the preamble of the

proposals in an effort to make it easier

for readers to focus on the provisions

that were of most concern to them.

Readers interested primarily in the

personnel requirements, for example,

would need consider only the fourth

division, while those whose concerns

were primarily equipment-related,

could focus on the last division.

Although the summary section of each

of the five divisions identified the

material being provided in the other

divisions, it is clear from the comments

that further explanation would have

been helpful.

The final regulations are being

published in a single document. This

single document follows the usual

Federal Register format of a preamble

and a regulation section. The regulation

section combines the regulations from

the five divisions of the proposal in

numerical order from §§ 900.1 to 900.18,

with some sections reserved for later

use. For the convenience of the reader,

a table of contents is provided.

7. Other Comments

(Comment 22). Additional comments

were received on widely varied topics.

One comment noted that mammography

services are provided for men and

women, and suggested that any mention

of ‘‘women’’ should be replaced by

‘‘women and men.’’

FDA agrees that men are also

consumers of mammography services.

However, because breast disease and

diagnosis overwhelmingly affects

women, that word seems more

appropriate. However, the agency notes

that in the regulations themselves and at

many places in the preamble, the term

‘‘patient’’ is used. FDA believes this

terminology addresses the comment’s

concern.

(Comment 23). Four comments took

issue with statements in the preamble to

the proposed regulations concerning the

expected benefits from improved

mammography and the number of

expected deaths from breast cancer.

FDA is aware that several aspects of

these issues are unsettled and that

authorities may draw different

conclusions from the same data.

However, the authors of the comments

did not appear to challenge the statute’s

underlying assumption that

mammography can be valuable in

combating a serious public health

threat, even though they might disagree

on the quantification of that value.

(Comment 24). Three comments urged

FDA to delay the final regulations until

a study of the impact of the interim

regulations could be conducted to

determine what changes were needed or

even if the MQSA itself were necessary.

Congress intended that final regulations

be in place before October 1, 1994, so

that the benefits of improved

mammography could be realized as

soon as possible. Recognizing the

magnitude of the task, Congress

provided FDA with interim rule

authority that would require regulations

to be issued in two steps. The first step

was the interim regulations, which led

to significant benefits. Neither Congress

nor the agency believes that any further

delay in completing the second stage

and achieving the increased benefits of

the final regulations can be justified.

The agency notes, however, that

facilities have been operating under the

interim rules for over 21⁄2 years and

inspections against the interim

regulations have been occurring for over

2 years. This experience with the

interim regulations and the problem

areas that were identified have

contributed significantly to the

provisions of the final regulations.

(Comment 25). One comment asked

the agency to clarify who makes the

decisions about the MQSA regulations.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55861

FDA assumes that the author is

referring to decisions about

interpretations of the regulations,

including decisions about the adequacy

of particular training programs for

mammography personnel. These

decisions are made primarily in FDA’s

DMQRP (address above).

(Comment 26). Four comments

expressed concern that the more unique

mammography regulations become, the

greater the likelihood that generalists

will be forced out of the field.

Many of the personnel requirements,

such as licensing and certification, are

general requirements of the medical

field. In addition, Congress determined,

and FDA agrees, that mammography is

a sufficiently unique and difficult

examination to require specialized

training and experience in the

production and interpretation of the

images and in the testing and

maintenance of the equipment.

However, it does not require a full-time

mammography practice to meet the

experience requirements specific to

mammography and the specific training

requirements are only a fraction of what

is required for other purposes, such as

completing a residency program or

maintaining certification from the

American Registry of Radiologic

Technologists (ARRT). Thus,

individuals will be able to meet the

MQSA requirements without limiting

their activities to mammography and so

there will still be room for generalists.

(Comment 27). A number of

comments expressed a variety of

concerns about matters outside the

scope of these regulations or beyond

FDA’s authority. These concerns

included: (1) Questions about the

appropriate frequency for screening

mammography and the levels of

Medicare reimbursement; (2) a

recommendation that a State advisory

board be created to monitor each State’s

mammography program; and (3) a

concern about the perceived domination

of medicine by big business. Because

these comments are beyond the scope of

these regulations, these comments will

not be addressed.

B. Alternative Approaches to Quality

Mammography

Executive Order 12866 requires

Federal agencies to identify and assess

alternative forms of regulation and,

where feasible, specify performance

objectives (performance or outcomebased standards), rather than specifying

the behavior and manner of compliance

that regulated entities must adopt

(design-specification standards). In

addition, Executive Order 12866

requires each agency to avoid

regulations that duplicate other

regulations. In response to this

Executive Order, under Docket No.

95N–0192, in the Federal Register of

April 3, 1996 (61 FR 14856 at 14859)

FDA invited comments on the feasibility

of developing performance-based

regulations. Although the agency did

not propose specific regulations in this

area, it did suggest several possible

performance measures for

mammography and requested comments

on their value and feasibility. The

agency also invited the public to suggest

other performance outcomes that might

provide a basis for performance-based

standards. FDA also invited comments

on suggestions for other possible

alternative approaches. While the

standards that were proposed were not

designed to be performance-based

standards, there are elements of

performance requirements throughout

the final regulations. For example, most

of the QC standards in the final

regulations are performance based. The

discussion in the proposal was to

consider extending such performance

criteria to areas not now covered by that

type of requirement and to make the

performance standards that had been

proposed more general, thereby possibly

reducing the burden on facilities.

1. General Comments

(Comment 28). Sixteen comments

asserted that the goal of the quality

mammography efforts by FDA should be

to reduce burdens on the medical

community by not requesting comments

and review of additional regulations.

Some of the comments stated that ACR

should be the entity designated to

define performance standards and that

compliance with such standards should

be voluntary. Five additional comments

suggested that it was more appropriate

for ACR and ARRT to oversee and

govern mammography quality.

FDA notes that these comments are in

conflict with the statutory provisions of

the MQSA (42 U.S.C. 263b)), which

mandate that the government have

authority and responsibility to establish

standards for the performance of quality

mammography. However, in carrying

out that mandate, FDA has solicited and

considered comments from the members

of the mammography community,

including comments from ACR, ARRT,

and members of NMQAAC.

(Comment 29). Several individual

comments addressed the general issue

of alternative approaches for quality

mammography. One comment favored

FDA’s role in establishing and

strengthening standards for quality

mammography. Another suggested that

FDA work with volunteers who have an

interest in alternative compliance

options in order to learn what is best.

Although FDA intends to continue to

gather ideas and information from

experts in the field, the agency believes

that the opportunity for public review

and comment on proposed regulations

that will affect members of the

mammography community is the most

equitable approach and will minimize

potential problems of ‘‘standardization

without representation.’’

(Comment 30). Four comments

addressed the issue of FDA establishing

another set of interim rules, to be in

effect while necessary research on

performance outcomes-based standards

was conducted, or simply going forward

with the final regulations as proposed.

These comments supported finalizing

the proposed regulations and suggested

change only if new technologies or

alternative compliance options are

identified at a later time.

Three comments focused on the cost

of changing the regulations and

discouraged change to the final

regulations if any additional costs were

to be borne by the mammography

facilities.

FDA is sensitive to the issue of costs

associated with the regulations and will

keep this issue in mind whenever

considering changes to the regulations.

(Comment 31). Two comments

expressed concerns that the general aim

of alternative approaches to achieve

compliance would result in loopholes

that would allow facilities not

performing at acceptable levels to

continue to perform substandard

mammography.

The agency recognizes the importance

of issuing performance standards that

do not allow loopholes. As with

provisions that specify the manner of

compliance facilities must adopt, FDA

intends to review performance-based

approaches for potential gaps that could

defeat efforts to achieve quality

mammography.

(Comment 32). One comment stated

that the ideas presented in the

alternative approaches section are

unworkable and were not discussed

with the members of NMQAAC.

FDA acknowledges that NMQAAC

did not have the opportunity to discuss

the alternative approaches material

before publication (61 FR 14856).

However, NMQAAC members did have

the opportunity to review this material

and to make comments and

recommendations at two meetings after

the proposal was published.

Generally, the NMQAAC comments

did not support increasing the number

of performance-based standards at this

time. They pointed out that the
55862 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

proposed regulations were actually a

mix of performance- and specificationbased standards. While NMQAAC

agreed that increased reliance on

performance-based standards might

have promise for the future, after further

research is done, there are insufficient

data at this time to base the entire set

of standards on performance criteria.

(Comment 33). One comment stated

that the current tests specified in the

existing regulations are more thorough

and complete than alternative

performance approaches that were

identified in the preamble to the

proposed rules. A similar comment

stated that the current tests should be

used by all facilities, with the exception

of those facilities that might develop

improved, innovative strategies or

methods. The comment recommended

that these facilities apply to FDA for

exemptions to use the innovative

strategies or alternative methods. FDA

notes that a process for accepting and

reviewing such applications is provided

by § 900.18.

An additional comment expressed

support for the intent of Executive

Order 12866, but at the same time

argued that it is in the best interests of

FDA to be more specific in the final

rules about those instances where there

are multiple methods or procedures to

accomplish the same task. The comment

further stated that it was unclear how

the agency decided whether to use a

performance outcome-based or a designbased requirement in a particular

situation. A second comment expressed

a similar opinion.

FDA notes that the comments on

performance outcome-based standards

discussed above and in the following

pages point out many difficulties at the

present time in establishing regulatory

requirements to ensure quality

mammography that are based totally on

performance outcomes. However, the

agency believes that in certain areas, for

example, quality assurance,

performance outcome standards can and

should be established. In developing

standards in a particular area, the

agency first considered whether it was

feasible to ensure quality in that area

with performance-outcome standards. If

it was not possible to issue adequate

performance-outcome standards in that

area, the agency then turned to design

standards. Along those lines, FDA

disagrees with the statement in the

comment that specific-design standards

should always be issued in cases where

there are multiple ways of adequately

achieving a particular task or goal. On

the contrary, the agency believes that

performance-outcome standards should

be strongly considered in such areas in

order to give facilities the flexibility to

chose the method of achieving the goal

that bests fits its particular

circumstances, instead of requiring that

all facilities follow the same path.

One other general comment similar to

those of NMQAAC, asserted that it was

premature to try to identify alternative

performance-based approaches due to

inadequate research and testing of these

alternative methods at this time.

Another comment indicated that FDA

did not comply with Executive Order

12866 because the agency did not make

a real effort to identify alternative

approaches. Similarly, one comment

argued that the FDA regulations ignored

duplication with other regulations,

although no examples were given.

FDA notes that it did include a

number of possible performance

outcomes measures in the proposal.

There may be other possibilities of

which the agency is unaware, but the

fact that no alternatives were suggested

by the author of these comments, or in

any other comment, suggests that few, if

any, other options are currently

available. FDA further notes that the

attempt to elicit public comment,

recommendations, and opinions

concerning performance-based

standards through the proposal will not

end its efforts to identify such

alternatives. FDA is unable to respond

to the criticism that its efforts duplicate

other regulations in the absence of

information on where the author of the

comment believes this has occurred.

However, HCFA has agreed to set aside

its regulations in the mammography

area and to accept FDA-certified

facilities as meeting its requirements for

reimbursement under Medicare and

Medicaid. This eliminated one possible

source of regulation duplication.

FDA strongly supports the use of

performance standards, however, it

recognizes that additional research is

needed in the scientific community

before it can support additional

regulations based on performance

outcomes. FDA encourages continued

research in this area, and will actively

work to develop performance standards

in the future.

2. Performance Standards and Outcomes

Measures Suggested in the Proposal

A large number of comments were

received on the various performance

outcomes measures identified as

possible alternatives by FDA. These are

reviewed in the following narrative in

connection with the identified

alternative.

3. Mammography Medical Outcomes

Audit

(Comment 34). FDA in the preamble

to the proposed rules, FDA suggested

that the results of a mammography

medical outcomes audit might be used

as the basis for a performance-based

standard for each mammography

facility. A significant number of

comments expressed concerns about

one particular aspect of the audit,

namely, requirements for patient

followup that might be necessary to

obtain outcomes data. The major issues

raised were the cost of such followup

and the lack of evidence that feedback

about outcomes improves practitioner

performance. The authors of the 10

comments believed that individual

practitioners would never have

sufficient cases to calculate meaningful

statistical outcomes.

Concerns were also expressed that

there were no protections for the

confidentiality of outcomes data and

that medical outcomes-based standards

could motivate practitioners to avoid

challenging or difficult cases. Eleven

comments expressed objections to any

performance standard that would

require mammography facilities and

interpreting physicians to collect

followup data on films interpreted as

negative or to require the calculation of

statistics relating to sensitivity,

specificity, or minimal cancer detection

rates. One comment objected on the

basis that requiring the collection of

such data would imply that standards

were required to force physicians to do

the best possible job and that this was

necessary because it was the norm for

physicians to cheat or be dishonest. One

comment expressed the view that use of

cancer registries to accumulate data for

monitoring outcomes was clumsy and

expensive.

A related set of comments directed

toward use of the positive predictive

value (PPV) statistic as a measure of

quality mammography performance was

overwhelmingly negative. Nine

comments pointed out that there are

varying definitions of PPV and that this

is not a measure familiar and

understandable to the general public.

The general consensus was that this

statistic was not useful and should not

be required to be published outside the

physician’s practice. Six respondents

argued that it was completely

unacceptable to use the physician’s

outcomes data as a measure of

performance. Two comments expressed

the viewpoint that collection of

information about PPV was not

appropriate because it was affected by

many factors beyond the control of the

facility. Three comments vehemently

opposed the public disclosure of

outcomes data, arguing that there would

be a high likelihood of misinterpretation

by the public and incentives for
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55863

facilities to falsify data. Two comments

stated that data collection and review

alone would not have any significant

influence on radiologists’ behavior, and

consequently, that collection of

statistical data was not worth the effort.

Finally, one comment agreed that it

would be valuable to find valid process

and outcomes measures for

mammography but concluded that it

would be premature to focus on PPV,

which is subject to influence by so

many factors external to the radiologist.

In contrast to these negative

comments on using the results of the

mammography medical outcomes audit

as the basis for performance standards,

one comment strongly supported the

idea of the medical audit as the basis for

a performance standard and argued for

the publication of such findings in order

to ensure that the public had access to

information that would allow them to

select a reputable institution. Another

supportive comment asserted that the

agency should develop performance

standards for medical outcomes audit

statistics, which could then be used to

evaluate physician performance. A third

respondent urged that medical

outcomes could and should be used as

more comprehensive measures of

competence and compliance. Another

comment suggested that standardized

values for sensitivity and specificity

could support a reduction in personnel

requirements for facilities that met the

performance standards for these two

statistics. One final comment applauded

the possibility of change from

specification of the manner of

compliance to specification of

performance objectives.

FDA observes that the majority of the

comments received oppose the use of

the results of the mammography

medical outcomes audit as the basis for

performance-based standards, at least at

this time. The agency recognizes that

the issues of the confidentiality of data

collected and the limitations of PPV as

an indicator of performance, and the

other problems identified in the

comments, are concerns that would

have to be addressed before the audit

could become the basis for performancebased standards. The agency has

concluded that it is premature to

establish performance standards based

upon the mammography medical

outcomes audit, primarily because the

necessary data to establish such

standards and to resolve the concerns

expressed in the comments are not yet

available.

FDA is aware that the National Cancer

Institute’s Breast Cancer Surveillance

Consortium (NCI BCSC) has been

actively engaged in research to

understand the full effect of breast

cancer screening on cancer outcomes

through a collaborative effort with

academic and community-based

mammography facilities. Through

linkages of data from mammography

facilities with pathology data on cancer

outcomes from population-based cancer

registries, outcomes data will be

correlated to interpretation. One of the

goals of this research is to help establish

realistic targets for mammography

performance. FDA participates with the

NCI BCSC and has staff expertise in the

medical outcomes audit area to further

assist standards development of

outcomes measures. FDA will evaluate

results from this research project as well

as other projects to determine the best

approach to promote improved

mammography performance through

performance-based outcome measures.

FDA anticipates issuing regulations in

the future that would have appropriate

medical outcomes-based measures.

To this end, facilities are actively

encouraged to develop their medical

audit programs and pursue outcomesbased measures. Information to assist

facilities in conducting and interpreting

the mammography medical outcomes

audit can be found in the medial

literature. In addition, in 1994 the

Agency for Health Care Policy and

Research published, ‘‘Quality

Mammography: Clinical Practice

Guidelines.’’ This primer has a complete

discussion of issues surrounding the

medical audit and has references to aid

facilities. Meanwhile, the suggestions

contained in the comments to FDA’s

proposed rule supporting the use of the

audit as a basis for performance

standards will be considered by FDA in

further efforts to develop performancebased standards. In addition, FDA

specifically invites comments on this

issue for future consideration. Please

submit comments on this issue to the

contact person listed above.

4. Performance-based or Proficiency

Testing

With respect to personnel, FDA raised

the possibility in the proposal that

standards based on successfully passing

proficiency tests might be the basis for

replacement of design specification

standards requiring certain levels of

training and experience.

(Comment 35). The general consensus

of 34 comments on proficiency testing

was that such requirements would be

excessive, unnecessary, costly,

impractical, and duplicative of

examinations already in place, such as

those administered by the American

Board of Medical Physics, the American

Board of Radiology (ABR), and the

American Board of Health Physics.

Twenty comments criticized the use of

performance-based standards in this

area because they asserted that such

standards are not yet developed to a

level where they can substitute for

current requirements. Two comments

stated that it is better if FDA does not

become involved in personnel

performance-based standards as part of

the MQSA. Rather, continuing medical

education (CME) requirements as they

currently exist should be satisfactory for

this part of the education process. Three

respondents indicated that the term

‘‘performance-based testing’’ is too

vague and could include even such

simple things as the radiologist’s

observation of the technologist

performing an examination.

After reviewing these general

comments and the specific ones that are

discussed later in this document, FDA

has concluded that it would be

premature to establish general

performance standards based on

proficiency testing because there is no

consensus among experts about what

those standards should be or how they

should be measured. The topic of

proficiency testing for specific

professional groups drew a number of

responses varying in their level of

support for such testing. Specific

comments are noted and discussed as

follows:

a. Proficiency testing for radiologists

(Comment 36). Proficiency testing for

radiologists drew divergent responses.

Three comments urged that FDA, in

collaboration with NMQAAC, develop a

proficiency test that physicians must

pass prior to initiating the practice of

mammography interpretation. Four

additional comments favored

proficiency testing for radiologists, but

only as an initial requirement. Thirteen

comments indicated unqualified

support for proficiency testing for

physicians. In contrast, five comments

maintained that board certification

could replace proficiency testing with

intermittent retesting at 5- to 8-year

intervals. Such examinations could be

handled by the accreditation bodies.

Another comment stated that random

clinical image review at the time of the

MQSA annual inspection could

substitute for proficiency testing. Six

comments agreed with the basic premise

that performance evaluation is

important in order to determine

accurate standards but that more time is

required to determine appropriate

testing devices and standards. One

comment stated that training and

experience requirements for interpreting

physicians should be sufficient and

there was no need for periodic testing.

Similarly, one comment stated that the
55864 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

medical audit could function as a

proficiency test for radiologists. Two

comments expressed a total lack of

support for proficiency testing, arguing

that such testing is time consuming,

costly, unnecessary, redundant, and not

done in any other area of medicine. One

comment stated that periodic

proficiency testing is appropriate for

nonradiologists reading mammograms

but not for trained radiologists. In lieu

of proficiency testing, this comment

suggested a special certificate as part of

designated continuing education

courses as a simpler way to establish a

measure of proficiency. One final

comment stated that proficiency testing

would impose undue hardship on the

radiologist whose practice is not

exclusively devoted to mammography.

A total of 79 respondents argued that

the cost of proficiency testing would be

too high and that the additional

expenses would be passed along to

consumers.

FDA observes that support for

proficiency testing for interpreting

physicians is somewhat stronger than

for proficiency testing in general, but

that the majority of respondents still

opposed the idea. Given the diversity of

response to the possible use of

proficiency testing for radiologists, and

the fact that no existing tests were

identified in the comments, FDA has

concluded that it is not in the interest

of quality mammography to mandate

such testing at this time. The agency

believes that proficiency testing for

physicians, if feasible at all, would have

to undergo further development before

it could be the basis of a performance

standard.

b. Proficiency testing for technologists

(Comment 37). Three respondents

stated that proficiency testing every 3 to

5 years would be beneficial to

technologists. One additional comment

concurred, but recommended testing

every 2 years. Overall, however, there

was a general lack of support in the

comments for proficiency testing of

technologists.

Sixty-one comments stated that such

testing for technologists cannot be

conducted objectively and also

indicated that the final requirements

were adequate to ensure the

qualifications of technologists. Ten

additional comments claimed that

proficiency testing for technologists is

impractical because of the lack of

established criteria and the absence of

an appropriate body to administer such

tests. Three respondents argued that the

medical audit served as a proxy

proficiency test for technologists.

Twenty comments stated that the

proposed continuing education

requirements were sufficient and it was

not necessary to administer

recertification examinations. Thirtyseven comments argued that

technologist proficiency testing was

redundant with the other initial and

continuing education requirements.

One comment stated that at one time,

the ARRT had considered adding a

practical exam to its evaluation of

mammography competency but deferred

doing so until credible analyses would

establish that such an examination

would result in improved quality of

performance. Four comments stated that

proficiency testing for technologists

would drive technologists away from

the field of mammography. One

comment expressed the view that

annual testing was unnecessary because

mammography does not change that

rapidly. Another comment stated that a

requirement for proficiency testing for

technologists would have a negative

impact on the availability of

mammography in rural and

mountainous regions. An additional

respondent argued that the annual

requirements for technologists are

already excessive and the addition of

competency or proficiency testing

would simply raise costs or close

mammography facilities. Four other

comments expressed similar sentiments,

stating that technologists already have

to meet sufficient requirements, and the

addition of proficiency testing would be

excessive. Concerns also were raised

about who would administer such

testing and the method of payment. One

comment urged that, if proficiency

testing became a requirement for

recertification, it should be offered at no

cost to the technologist.

One comment argued that

incompetent technologists could pass a

proficiency test and further stated that

proficiency testing was a measure of

test-taking skills, not of mammographic

competency. Two comments expressed

the point of view that proficiency

testing is useless and insulting. Several

comments stated that recertification, if

required in addition to continuing

education, is redundant, timeconsuming, and costly. These comments

asserted that retesting is valuable only

in instances of significant changes in the

mammography modality. One comment

pointed out that the ARDMS (a

sonographer’s organization not further

identified) had tried to offer a practical

examination, but abandoned the project

because it proved too costly. The

remaining comments were all generally

opposed to proficiency testing for

technologists. One comment suggested

that a better way to evaluate

technologists would be to require

performance at a seminar that would

assess their clinical competence.

Another comment concurred with this

viewpoint, saying that a written exam

cannot measure competence in a handson field such as mammography. Finally,

one comment argued that further

examination is not necessary if the

technologist remains active in the field

of mammography and maintains proper

licensure.

The agency is persuaded that

regulations requiring such testing would

be premature. FDA believes some of the

objections raised, as with the objections

to radiologist testing, can be addressed

and overcome; e.g., to the extent

comments argued that proficiency

testing was duplicative of current

training, education, and experience

requirements, FDA could consider

eliminating some of those requirements.

However, the agency agrees with the

general consensus expressed by the

comments and concludes that

proficiency testing for technologists

currently cannot provide the basis for a

performance standard.

c. Proficiency testing for physicists

(Comment 38). The agency received

17 comments about this topic. Of the 17,

3 were in favor of proficiency testing for

physicists, with 1 additional comment

asserting that is would be possible to

conduct such a test, but only at great

cost. Other comments stated that

proficiency testing for physicists was

simply a bad idea. Two comments

argued that the proposed standards of a

written examination and a practical

survey test were sufficient proficiency

measures for physicists. Two comments

stated that a doctorate in physical

science and board certification in an

appropriate medical physics subspecialty provided a better assurance of

professional integrity than written and

practical examinations. Another

comment suggested that it would be

more appropriate for physicists’

accreditation bodies to administer such

tests because FDA lacked the necessary

experience and knowledge in this area.

One comment expressed concern about

the possibility of computer errors if the

examinations relied on computer

programs for test administration and

scoring. One comment recommended

that the idea of a qualifying examination

for physicists should be further

explored, especially because the

proposed regulations do not adequately

address the issue of how detailed an

annual survey should be.

One comment asked whether a

performance-based standard would help

physicists working at small institutions

to meet the training requirements.

Although it is possible that proficiency
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55865

testing could alleviate difficulties

involving access to training for some

physicists, FDA notes that it is not

possible to determine whether such an

approach would permit these physicists

to qualify until such a time as the form

and nature of a possible proficiency test

is better known.

As with proficiency testing for

interpreting physicians and radiologic

technologists, the comments have

persuaded FDA that it would be

premature to require such testing for

physicists as the basis of a performance

standard. The agency, however, will

continue to explore the feasibility of

such testing for radiologists,

technologists, and physicists.

5. Mammography Equipment and QC

The preamble to the proposals (61 FR

14860) suggested possible performancebased substitutes for equipment

specification and QC testing in the

proposed rule. One general comment

recommended that FDA retain the

existing QC tests as proposed to ensure

adequate mammography equipment and

QC. The author was of the opinion that

one or two performance-based criteria

would not be adequate to serve as QC

measures.

a. Phantom image testing

FDA suggested that one possibility

was that a more sophisticated phantom

might be developed for use in a single

QC test that would provide the same

information on equipment performance

as some or all of the separate tests and

specifications. A performance-based

standard predicated on test results using

this phantom and falling within defined

limits might provide the same assurance

of image quality as a number of the

design specifications and, therefore,

could replace the design specifications

in the regulations.

(Comment 39). One comment stated

that it was possible to develop a single

system test with an alternative phantom.

The comment stated that one distinct

advantage of a single system test would

be to replace the present daily processor

quality control (QC) test with

sensitometry based on the actual light

emission of the radiographic screen and

at the same time check the performance

of the rest of the imaging system. The

comment stated that the final

regulations should allow facilities and

accreditation bodies to work together to

adopt a suitable phantom to be used as

a daily total system test. The majority of

the comments received, however, were

opposed to using phantom image testing

as a comprehensive equipment test,

even if such testing would permit

alternative tests to be performed less

frequently. There was strong support for

FDA to implement the mammography

performance and design requirements

described in the proposed rules.

Overall, a total of nine comments

opposed use of the phantom as a daily

test that would replace other QC tests.

It was noted that more frequent use of

the phantom would increase costs,

would not yield an adequate measure of

quality, would be useful only as a

supplement to other QC tests, and

would yield results that were highly

variable. Three comments remarked that

phantom testing is a good measure of

quality but cannot replace all other QC

tests. Finally, it was noted that the STEP

test should be added to the phantom

image analysis.

FDA observes that the general

consensus of these comments is that it

is unlikely that testing with a more

sophisticated phantom, if one is made

available through further research, will

be an adequate substitute for other QC

tests.

b. Repeat rate

Another measure that was suggested

as a possible performance standard was

the facility’s repeat rate. Under the final

regulations, a repeat rate is to be

analyzed every 3 months, and include

up to 250 examinations. In the preamble

to the proposal (61 FR 14860), FDA

asked for comments on the possibility of

using the repeat analysis rate in some

modified form, such as conducting the

test continuously, as the basis for a

performance standard. The agency also

noted that such a use would have to

take into account the possibility that the

repeat rate could be altered through the

acceptance by a mammography facility

of all images of any quality performed.

(Comment 40). Responses to this

possible alternative were generally

negative. Three comments contended

that the repeat rate could not serve as an

alternative to existing equipment and

QC tests. Specifically, it was noted that

ongoing repeat analyses could not

substitute for QC tests. Four comments

raised concerns about the possibilities

for altering or falsifying findings and

lack of consistency within and between

mammography facilities in performing

repeat analyses. A related comment

stated that technologists will not repeat

images that should be redone if they

think the repeated images will affect

their job. This means poorer images may

be submitted to radiologists for

interpretation.

FDA recognizes the validity of the

concerns raised by these comments and

has concluded that a performance

standard based on repeat rate analyses

is not likely to enhance quality

mammography nationwide.

c. Clinical image review

FDA identified clinical image review

as a possible basis for performancebased standards. General comments

regarding clinical image review for this

purpose were largely unfavorable.

(Comment 41). Nine respondents

argued that random selection of images

for review is unnecessary because the

review is conducted by the accreditation

body. It is better therefore, these

comments continued, to select previous

images of the same patients to document

improvements in image quality between

examinations rather than random

selection of images. Thirteen comments

stated that the supervising radiologist

ultimately is responsible for assessment

of clinical image quality. Four

comments questioned who would do

the clinical image reviews for all

facilities and suggested that this would

require a new government agency in a

time when government has been

directed to downsize. Two comments

stated that clinical image review is only

useful as a learning tool in difficult

cases and is not useful as a general test

of proficiency.

Additional comments were received

on the possibility of using clinical image

review to evaluate the performance of

the radiologic technologist. Twelve

comments were openly opposed to

clinical image review for assessment of

technologists, arguing that it would

require a large investment of effort and

financial resources. One comment said

that the radiologist, not the technologist,

is responsible for the quality of images

and, consequently, it would be

inappropriate to use this as a

performance assessment for

technologists. Another comment

expressed the point of view that clinical

image review was unnecessary if

technologists remain active in

performing mammography and also

maintain proper licensure.

The question of who would do the

image reviews drew a number of

comments. One comment said that

clinical image review by technologists

had been tried previously with poor

success, although specifics about the

problems were not mentioned. Nine

comments asserted that clinical image

review to assess technologist

performance should be done under

physician review, rather than by

sending images to an outside

bureaucracy, which would be very

costly for facilities. Cost was raised as

an issue by another respondent who

argued that a facility with many

mammography technologists would

have many images out for review, which

would be both costly and a threat to

patient confidentiality. One comment

suggested that the FDA inspector review
55866 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

clinical images at the time of the annual

MQSA inspection, rather than the

facility submitting the images to some

central point. Under this approach,

technologists and radiologists would

complete critique forms of their images

to explain any difficulties or problems

in taking or reading the films.

On the more positive side, twelve

comments stated that clinical image

review under the MQSA, combined

with additional actions, would ensure

proper mammography performance

sufficient to assess technologists’

clinical skills. The additional action

suggested by 10 of these comments was

yearly attendance at hands-on

workshops, while another comment

suggested periodic recertification

examinations, and the 12th advocated

use of repeat analysis. This last

comment also suggested that such an

evaluation could even substitute for the

practice volume requirement for

technologists in the proposal.

FDA observes that opinion is divided

more evenly on the feasibility of using

clinical image review as a performance

standard for technologists than on the

feasibility of the other possible bases for

performance standards mentioned in the

proposal. The major problem seems to

be how to establish an effective system

at a reasonable cost. Although clinical

image review will not substitute for the

radiologic technologist requirements

being finalized in the regulations, FDA

will continue to evaluate this issue in

collaboration with the members of

NMQAAC and other agencies involved

with mammography QC.

6. General Observations

As discussed above, FDA sought

public comment on the possibility of

taking an alternative approach to

assuring the quality of mammography

nationwide. The alternative approach

would be the greater use of

performance-based standards in place of

the primarily design specification

standards established in the interim

regulations and proposed for the final

regulations. Several possible measures

or mechanisms that could form the basis

for performance-based standards were

identified and the public was invited to

comment on their feasibility and also to

suggest other options. The agency also

asked for comments on how it should

proceed with regulation development if

performance-based standards were

considered feasible. If such standards

could be developed relatively quickly,

FDA could consider maintaining the

interim standards and delaying the

issuance of final regulations until

performance-based standards were

developed. Conversely, if the expected

time for the development of

performance-based standards was

lengthy, in the interest of achieving

additional improvement in

mammography more rapidly, the agency

might appropriately proceed with

finalizing the proposed rules (as

modified in response to public

comment) and replace them at a later

date with performance-based standards

after the necessary research for those

standards was complete.

(Comment 42). Only four comments

addressed these questions directly and,

as noted above, they urged FDA to

proceed with publication of the final

regulations. FDA also notes, as

described above, that the comments on

the possible mechanisms for

performance-based standards identified

by the agency were predominantly

negative. Furthermore, none of the

comments suggested any other

possibilities for performance-based

standards. This would seem to support

the view that performance-based

standards, if feasible, will require

further research. Based on this, FDA

concluded that it should proceed with

the publication of these final

regulations. If further research and

development suggest that performancebased standards can replace these

regulations, FDA will propose

amendments to the MQSA rules.

C. Scope § 900.1

This section briefly summarized the

content of the following regulatory

sections. No comments were received

and it was codified unchanged.

D. Definitions § 900.2

This section defines terms used in the

regulations whose meaning would not

be common knowledge or for which

there exists more than one definition,

making it necessary to specify which is

to be used for the purposes of these

regulations. Comments received on the

definitions in the proposal are discussed

first. This is followed by a consideration

of comments that recommended adding

new definitions or made other more

general comments on the proposed

definitions. Discussed third are

definitions that have been added to, or

changed from, those in the proposal due

to changes in other parts of the

regulations.

1. Comments on the Proposed

Definitions

a. General comments on several

related definitions

The following closely related

definitions were included in the

proposal in order to identify which

consumer complaints must be

considered by the facility and the

accreditation bodies in the complaint

process required by the MQSA:

• Adverse event

• Consumer

• Serious adverse event

• Serious complaint

The purpose of these definitions, as

explained in the preamble to the

proposal (61 FR 14863), is to ensure that

serious complaints about the quality of

the MQSA-related mammography

services are adequately addressed

without placing an undue burden on

facilities and accreditation bodies by

requiring extensive consideration for

relatively minor complaints.

‘‘Adverse event’’ is defined to mean

an undesirable experience associated

with mammography activities within

the scope of 42 U.S.C. 263b. Examples

were included in the definition.

The definition of a ‘‘consumer’’ is

intended to make it clear that a patient

or a representative of the patient (for

example, family members or referring

physicians) can file complaints.

‘‘Serious adverse event’’ is defined to

mean an adverse event that could

significantly compromise clinical

outcomes or for which a facility failed

to take appropriate corrective action in

a timely manner. Finally, ‘‘serious

complaint’’ is defined to mean a report

of a serious adverse event. Facilities,

under § 900.12(h), and accreditation

bodies, under § 900.4(g), are required to

carry out specified activities in response

to serious complaints.

(Comment 43). A number of general

comments were received on these

related definitions. One comment stated

that using the severity levels outlined in

current inspection procedures would be

more applicable for complaint activities

than the proposed definitions.

FDA disagrees with this comment.

The severity levels used for the MQSA

inspection program were developed for

use by inspectors. They are too

technical and not necessarily relevant

for consumer complaint purposes.

(Comment 44). One comment

recommended removing the terms

‘‘adverse event’’ and ‘‘serious adverse

event’’ and the addition of the definition

of ‘‘complaint’’ to mean the report of

any undesirable experience associated

with mammography activities. These

experiences may include poor image

quality, failure to send mammography

reports within 30 days, or the use of

personnel who do not meet regulatory

requirements. Another comment also

suggested adding a definition for

complaint without specifying what it

should be.

FDA believes that the definition

offered by the first comment could

result in complaints unrelated to the
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55867

MQSA (e.g., billing procedures) and

complaints that would not ordinarily be

considered serious by most patients

(e.g., facility temperature) being

forwarded to the accreditation bodies

and FDA when they have the greatest

chance for resolution at the facility. The

final regulations require facilities to

record all serious complaints. The

facility will forward unresolved serious

complaints to the accreditation body

and/or FDA for further action. In

addition, the agency notes that the

definitions of ‘‘adverse event’’ and

‘‘serious adverse event’’ give examples

of the kind of complaints that are within

the parameters of the consumer

complaint mechanism. All of the

examples noted in the comment would

fall within the scope of consumer

complaints subject to further

accreditation body and FDA review.

b. Adverse event

(Comment 45). One comment agreed

that the definition of ‘‘adverse event’’

should include failure to send

mammography reports in a timely

fashion to the referring physician or

self-referred patient, but argued that 30

days is an unreasonably long time for

communication of adverse events. FDA

notes that the 30-day period referenced

in the definition is intended as the

maximum amount of time that may

elapse and that the regulations state that

the results should be communicated as

soon as possible.

This is discussed further in section

III.L.3 of this document, where FDA’s

responses to comments received on

§§ 900.12(c)(2) Communication of

mammography results to the patient,

and 900.12(c)(3) Communication of

mammography results to health care

providers, are given.

(Comment 46). Several comments

requested greater clarity or additional

explanation for the term ‘‘poor image

quality’’ (used in the definition of

adverse event), and FDA’s criteria to

determine when image quality is poor.

The comment observed that the

definition of poor image quality is likely

to be very subjective.

FDA agrees that a single definition for

poor image quality would be subjective

and, therefore, has not included such a

definition in order to give facilities and

accreditation bodies the flexibility to

evaluate such performance in a

particular situation on a case-by-case

basis. However, criteria to be considered

by accreditation bodies in evaluating

acceptable image quality are specified in

§ 900.4(c)(2). Consumers who decide to

complain about poor image quality

would generally have assistance from

health professionals (for example,

referring or consulting physicians, or

accreditation body) in making this

determination. In situations in which

FDA has reason to believe image quality

at a particular facility is poor, FDA may

consult with accreditation bodies for

additional mammography review in

order to determine whether corrective or

enforcement actions are appropriate.

c. Serious adverse event

The regulation defines ‘‘serious

adverse event’’ as ‘‘an adverse event that

may significantly compromise clinical

outcomes, or an adverse event for which

a facility fails to take appropriate

corrective action in a timely manner.’’

(Comment 47). Four comments

recommended that the definition of

‘‘serious adverse event’’ should be

revised. They stated that failure to take

action on a nonserious event should not

turn the event into a serious complaint.

The comments recommended that

‘‘serious complaint’’ should be written

to preclude common and potentially

unavoidable complaints about

mammography (e.g., compression hurts,

room too cold).

FDA disagrees that the definition

should be revised. Failure to take action

on certain nonserious events may

indeed result in a serious adverse event.

For example, it is generally accepted

that most compression complaints are

considered to be minor. However, there

may be instances in which compression

is unusually severe and, therefore, the

complaint would be considered serious.

FDA believes the definition should

remain flexible to allow for this type of

situation.

(Comment 48). One comment

suggested changing ‘‘may significantly

compromise clinical outcomes’’ to ‘‘has

significantly compromised clinical

outcomes.’’

FDA disagrees. A primary goal of the

consumer complaint mechanism is to

improve mammography services by

providing facilities with data and

information they might not otherwise

receive or analyze. It is preferable to

correct a potentially serious situation

before harm occurs, rather than after the

harm has affected the patient.

d. Serious complaint

(Comment 49). A ‘‘serious complaint’’

is defined as ‘‘a report of a serious

adverse event.’’ Two comments

suggested that descriptions of the type

of serious complaints to be reported to

the accreditation body should be

specified.

FDA agrees that additional

descriptions will be helpful and intends

to make such information available

through guidance. The agency believes

that making this information available

in guidance, rather than in regulations,

will give facilities, accreditation bodies,

and FDA the flexibility to determine on

a case-by-case basis whether or not an

event should be classified as serious.

e. Contact hour

‘‘Contact hour’’ was defined in the

proposal as an hour of training received

through direct instruction.

(Comment 50). One comment

recommended that it be defined as 50

minutes.

FDA is aware that in academic

institutions an hour of didactic training

is frequently only 50 minutes long.

However, in clinical and continuing

education situations, an hour of

instruction is usually a full 60 minutes.

Reducing the figure from 60 to 50

minutes would reduce the training

requirements 16 percent. Because those

training requirements were proposed at

what are believed to be the minimum

adequate levels, the agency did not

change the definition.

f. Direct instruction

Direct instruction requires instructorstudent interaction, either face-to-face or

through examination.

(Comment 51). One comment stated

that the definition is too vague,

especially when compared to

mammography equipment evaluation.

FDA disagrees. The agency believes

the definition is sufficiently specific to

give a clear idea of what is required,

while also preserving the flexibility to

accept possible new approaches to

instruction.

g. Direct supervision

The definition of direct supervision

was designed to permit ‘‘trainees’’ to

lawfully obtain the experience in

interpreting or producing mammograms

or surveying mammography units that

they needed to become qualified or

requalified. At the same time, by having

the trainee’s work checked and, if

necessary, corrected before any clinical

care might be jeopardized, the patient’s

right to adequate quality mammography

is protected.

(Comment 52). One comment

supported this definition. A second

comment asked if direct supervision

was needed for ‘‘nonqualified’’ people

doing the QC tests.

In accordance with 42 U.S.C.

263b(f)(1), personnel qualifications were

established only for interpreting

physicians, radiologic technologists,

and medical physicists. As a result, tests

performed by medical physicist

‘‘trainees’’ would have to be done under

this definition of direct supervision,

although tests performed by QC

technologist ‘‘trainees’’ would not.

However, the agency notes that

§ 900.12(d)(1)(iv) makes the QC

technologist responsible for ensuring

the quality of performance of those
55868 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

doing QC tests. The definition of QC

technologist in § 900.2(pp) requires the

QC technologists to meet the

requirements for a radiologic

technologist, including training in

quality assurance/QC. Taken together,

these requirements provide for a level of

supervision similar to that provided

under this definition.

h. Facility

The definition of ‘‘facility’’ is

provided by the law itself in 42 U.S.C.

263b(a)(3). It includes a variety of types

of locations where mammograms are

produced, processed, or interpreted.

(Comment 53). Three comments either

inquired if processing and interpreting

facilities would have to be certified and

inspected or asked that these facilities

be excluded from the requirements. The

law defines locations where

mammograms are processed or

interpreted, and where mammograms

are produced, as facilities (42 U.S.C.

263b(a)(3)). The agency’s approach

under the interim regulations, which is

expected to continue under the final

regulations, has been a systems

approach. The facility producing the

mammograms receives the certificate

and is responsible for ensuring that the

facilities at which their mammograms

are processed and interpreted, if

separate, meet the applicable quality

standards. This is consistent with the

statutory provision that requires the

facility performing the mammography to

be responsible for meeting quality

standards (42 U.S.C. 263b(a)(3)(B)). FDA

has not set up a separate certification

and inspection system for facilities that

process or interpret only. However,

because a certification system for

‘‘partial’’ providers may have some

advantages for such facilities, the

agency may consider such an approach

in the future.

(Comment 54). Two comments

requested that the definition be

expanded to address situations

involving multiple locations under the

same certificate or temporary locations

where a unit (stationary, portable, or

mobile) is used more than a minimum

number of days.

FDA’s experience under the interim

regulations shows there is wide variety

in the locations at which mammography

is performed and in the corporate and

business relationships among these

locations. Presently, such situations are

handled on a case-by-case basis in

consultation with the facilities and

accreditation bodies involved. The

agency believes that it is essential that

this flexibility be maintained and that it

would be unduly restrictive to prescribe

permissible locality arrangements in

regulation.

i. First allowable time

The proposal defined ‘‘first allowable

time’’ as the earliest time a physician is

eligible to take the diagnostic radiology

boards of an eligible certifying body.

Because the ‘‘first allowable time’’ a

resident physician becomes eligible to

take the boards may vary with the

certifying body, the definition cannot be

more specific. If a resident physician

wishes to use the exemption from the

initial experience requirement described

in § 900.12(a)(1)(iii)(B), it is the

physician’s responsibility to ascertain

the requirements of the body by which

he or she wishes to become certified and

to seek that certification as soon as he

or she becomes eligible to do so.

(Comment 55). Three comments

stated that this definition was unclear

and were unsure how or why this

related to resident physicians who

would be interpreting 240 mammograms

during a 6-month period. NMQAAC also

stated that the concept of ‘‘first

allowable time’’ required further

explanation.

This term is used in

§ 900.12(a)(1)(iii)(B). That provision is

an exemption that allows resident

physicians to interpret the 240

mammograms required for initial

experience in any 6-month period

during the last 2 years of their residency

program (rather than during the last 6

months immediately prior to the date

that the physician qualifies as an

interpreting physician as required under

§ 900.12(a)(1)(D)). This exemption is

available as long as these physicians

become board certified the first time

they are eligible. This provision allows

residency programs to be flexible in

scheduling training for their resident

physicians and eliminates the need to

put all senior resident physicians on

their mammography rotation during the

last 6 months of their program.

(Comment 56). Two comments stated

that because the ‘‘first allowable time’’

may vary with the certifying body, a

more uniform standard would be

preferable.

FDA believes that the term ‘‘first

allowable time’’ must be defined as

proposed in order to allow flexibility,

because certifying bodies differ in the

scheduling of their examinations.

Anything more proscriptive could

penalize future resident physicians if

the certifying body wished to change its

examination schedule.

j. Lead interpreting physician

This term was included in the

proposal to identify the interpreting

physician who has the general

responsibility for ensuring that the

facility meets the quality assurance

requirements.

(Comment 57). One comment stated

that the definition was not needed

because this person is easily identified,

while a second comment wanted the

term changed to supervising

interpreting physician.

FDA agrees that in most facilities the

person with this responsibility can be

easily identified, but also believes there

is an advantage in having a term that

can be used to designate and reference

this individual, both for the benefit of

the employee and patients of the

facilities and for the accreditation

bodies and the government regulators.

The possibility of using ‘‘supervising’’

was discussed with NMQAAC but was

rejected out of concern about possible

confusion between this individual and

administrative supervisors who may

have different responsibilities.

k. Mammographic modality

‘‘Modality,’’ as proposed, means a

technology, within the scope of 42

U.S.C. 263b, for radiography of the

breast. Screen-film and

xeromammography were given as

examples of a modality. In fact, at

present, they are the only examples in

general use.

(Comment 58). Two comments stated

that the term modality has other uses in

medicine and that the definition could

be confusing to facilities. Twelve other

comments also found the term unclear.

FDA notes that NMQAAC spent some

time discussing other possible terms

that could be used before concluding

that this was the most appropriate. The

agency is aware that the term modality

is used in different ways in different

areas, which is why a definition of its

meaning with respect to the MQSA is

needed. In an effort to distinguish it

further from the other meanings of

modality, FDA has changed the name of

the term being defined from ‘‘modality’’

to ‘‘mammographic modality.’’ The

definition now appears in the final

regulations at § 900.2(z).

(Comment 59). Two comments

recommended that the term ‘‘modality’’

be replaced with ‘‘specialized

techniques in mammography.’’

FDA did not accept this suggestion

because both ‘‘techniques’’ and

‘‘specialized techniques’’ already have a

variety of meanings in radiology and the

agency concluded that the

recommended change would increase

rather than reduce confusion.

(Comment 60). Nine comments

suggested that the definition be

broadened to include other technology.

Stereotactic, ultrasound, digital, nuclear

medicine, Magnetic Resonance Imaging

(MRI), and CT were all suggested for

addition.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55869

FDA does not believe that the

definition should be broadened. The

definition is intended to clarify training

requirements for personnel providing

mammography services. These

individuals are required to have training

in each mammographic modality with

which they work. Because ultrasound,

nuclear medicine, and MRI fall outside

the statutory definition of

mammography as radiography of the

breast, the agency cannot include

training related to those technologies as

part of the regulatory requirements.

Digital, CT, and stereotactic do fall

under the authority granted by 42 U.S.C.

263b but have been temporarily

exempted from the regulatory

requirements. When and if training and

other requirements related to these

technologies are issued, the proposed

definition will not delay such

requirements from taking effect for those

modalities.

(Comment 61). One comment

recommended that xeromammography

be excluded from the definition because

it produced less than optimal

mammograms at a higher dose.

FDA agrees that there have been

problems with the use of

xeromammography and notes that these

problems have led to its near

disappearance. However, the effect of

removing xeromammography from the

definition would be to exempt those

who use the technology from having to

obtain training. FDA expects such a

change would increase, not decrease,

the problems with the modality.

l. Mammography

This definition incorporates the

definition of mammography as

‘‘radiography of the breast’’ provided by

42 U.S.C. 263b(a)(6), but temporarily

excludes from the quality standards

radiography of the breast performed in

interventional mammography or with an

investigational mammography device

during a scientific study conducted in

accordance with FDA’s investigational

device exemption regulations.

(Comment 62). One comment

suggested that ‘‘for the purposes of these

regulations’’ should be inserted in this

definition.

FDA believes that it is well

understood that all definitions that

appear with any regulation are for the

purposes of those regulations.

(Comment 63). Another comment

suggested expanding the wording of the

definition to specifically mention X-ray

radiation and several types of image

receptors. FDA notes that the term

radiography implies the use of X-rays.

The agency further notes that if the

changes were made, and a new, yet

unimagined type of image receptor was

approved following investigational

device studies, the definition would

have to be amended before the new

device could be put into general use. To

avoid such a delay in the use of an

advance in image receptor technology,

the agency has retained the proposed

general definition.

m. Exclusion of interventional

mammography

In the proposal (61 FR 14862), FDA

temporarily excluded interventional

mammography (radiography performed

during invasive interventions for

localizations or biopsy procedures) from

the definition of mammography. This

had the effect of exempting such

mammography from the requirements of

the regulations. A similar exemption has

been in effect under the September 30,

1994, amendments to the interim

regulations (59 FR 49808–49813). The

basis for the exclusion, as explained in

the preamble to the proposal (61 FR

14862), was the agency’s belief that

science had not advanced to the point

where effective national quality

standards could be developed for these

devices.

(Comment 64). Over 90 comments

supported the exclusion of

interventional mammography. Many of

these agreed that there currently is no

consensus with respect to appropriate

standards for stereotactic units, and

until regulations based on scientific data

can be developed, it is inappropriate to

include interventional procedures

within the scope of the regulations. In

addition, the comments stated that

surgeons have extensive experience in

dealing with breast disease and breast

biopsy and they are best suited to

manage the patient. These comments

noted that many surgeons have had

extensive experience performing

stereotactically guided breast biopsies

and have achieved good results with

this procedure. Others wrote that in this

procedure, the surgeon knows that the

lesion is present and is merely using

stereotactic images to guide the needle

to the proper position for biopsy. Other

comments stated that while radiologists

have only one method to biopsy the

breast, surgeons have several options

and can offer the patient the best biopsy

option for her clinical status. Some

comments stated that surgeons have a

long history of providing followup care

for patients and for many years have

used radiographic equipment in the

operating room and are familiar with its

use. Several comments said that

surgeons have used mammography for

many years in the diagnosis and

treatment planning for breast cancer

patients. Still others said that these

biopsy procedures will evolve into

therapeutic procedures that are best

handled by the surgeon and that

surgeons are best equipped to handle

any followup or complications

associated with these biopsy

procedures.

NMQAAC and over 100 comments

opposed the exclusion of interventional

mammography. Many of these asserted

that it is counterproductive to set

quality standards for mammographic

diagnosis while having none for

mammographically guided invasive

breast procedures and that only

interpreting physicians have the

expertise and experience necessary to

perform this procedure. Authors of

other comments wrote that interpreting

physicians have experience dealing

with the quality assurance and QC

issues necessary to maintain stereotactic

biopsy equipment and that the failure to

regulate this procedure places the

public at risk. Some said that the lack

of adequate mammographic training

could lead to the lesion in question

being missed during tissue sampling

and that the abilities and training

required to localize a small subtle

suspicious area are the same as those for

interpreting a mammogram. Other

comments stated that only interpreting

physicians will be able to interpret the

original mammograms to determine if a

needle biopsy is appropriate.

FDA agrees with the comments stating

that interventional mammography can

be of great use in the evaluation of

breast disease, but only if optimally

performed. Until recently, the science

had not advanced to the point where

effective national quality standards

could be developed for these

procedures. Since the publication of the

proposed regulations on April 3, 1996,

significant progress has occurred in the

professional community and FDA now

believes that there is enough

information to begin the development of

interventional mammographic

regulations. However, that development

requires a comprehensive and careful

approach that addresses all the factors

involved in such procedures. The

agency has already begun the

development process by bringing this

issue before NMQAAC during its

October 1996 meeting and is continuing

to gather information and data.

Although the agency has concluded that

the final regulations should exclude

coverage of interventional

mammography, FDA expects to propose

regulations covering all aspects of

interventional mammography in the

near future.

n. Exclusion of investigational devices

In the proposal, FDA also excluded

from the definition of mammography,
55870 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

and thus from the regulatory

requirements, investigational

mammography devices that were being

evaluated in accordance with FDA’s

investigational device exemption

regulations in 21 CFR part 812. This

provision extended the exclusion for

investigational devices previously

established under the September 30,

1994, amendments to the interim

regulations. The agency believes that it

is obvious that it would be premature to

establish standards for devices still in

the experimental stage. FDA also

believes that the precautions built into

the agency’s general investigational

device exemption regulations provide

adequate protection for the public

health during the use of these devices.

However, the agency made clear in the

preamble to the proposal (61 FR 14862)

that any conventional mammography

device used during the scientific study

to provide baseline data for evaluating

the safety and efficacy of the

investigational device was not within

the scope of the exclusion and would

have to meet the MQSA requirements.

(Comment 65). Two comments stated

that the wording of this section would

make MRI for mammography

investigations or use of full field digital

mammography illegal, unless they are

performed by a radiologist specializing

in mammography.

MRI is not radiography of the breast

and, therefore, does not come under the

definition of mammography. Similarly,

investigational studies, such as those

involving full field digital

mammography, are specifically

excluded under the definition of

mammography in § 900.2(z)(2) of the

final regulations. FDA concludes,

therefore, that the regulations will not

prevent such research from occurring.

However, any conventional

mammography performed as part of a

study is not excluded and does have to

meet all the requirements of the final

regulations. FDA has modified the

definition to clarify this issue.

o. Mammography medical outcomes

audit

‘‘Mammography medical outcomes

audit’’ means a systematic collection of

mammography results and the

comparison of those results with

outcomes data.

(Comment 66). One comment stated

that the term ‘‘medical audit’’ was selfexplanatory and did not need a

definition.

FDA disagrees. There are many

different working definitions of this

term being used in the professional

community. FDA’s definition of what

minimally constitutes a mammography

medical outcomes audit is for the

purposes of the MQSA requirements

and may be different from

recommended guidelines and

definitions of other organizations.

p. Mammography unit or units

The definition for ‘‘mammography

unit or units’’ is an assemblage of

components for the production of X-rays

for use during mammography. Several

components were listed.

(Comment 67). Two comments

suggested that compression device,

breast support, and components

associated with the image receptor and

grid be added to the list.

These suggestions would not fit the

general criterion of a component for the

production of X-rays and the agency is

not adding them to the list.

q. Mean optical density

‘‘Mean optical density’’ was defined

as the average of the optical densities

measured for phantom thicknesses of 2

to 6 centimeters (cm) using kilovolt

peak (kVp) values clinically appropriate

for the thicknesses.

(Comment 68). Three comments were

received on this definition. One

suggested that the thickness range

should be changed to 3 to 7 cm. A

second also supported a 3 to 7 cm range,

but stated it would be prudent to check

at 2 and 8 cm as well. The third

comment stated that, because the

thicknesses chosen could influence the

result, the definition should specify the

thicknesses to be used. The comment

further suggested that 2, 4, and 6 cm

should be used.

This definition is used in connection

with a QC test of Automatic Exposure

Control performance. The test

procedures recommended by the ACR

manuals and incorporated by reference

into the interim regulations requires the

use of 2, 4, and 6 cm thicknesses. The

agency agrees with the third comment

that it would be of value to add the

exact thicknesses to the definition and

has done so. FDA does not believe there

is justification for changing the range of

thicknesses used in this standard test, as

suggested by the other two comments.

r. Medical physicist

‘‘Medical physicist’’ is defined as a

person trained in evaluating the

performance of mammography

equipment and quality assurance

programs and who meets the

requirements of § 900.12(a)(3).

(Comment 69). One comment stated

that the MQSA does not provide

statutory authority to FDA to define the

profession of medical physicist.

It is not FDA’s intention to define the

profession of medical physicist in

general and the agency also agrees that

it lacks the authority to do so. However,

the MQSA requires that the agency

establish qualifications for those

medical physicists providing

mammography services to

mammography facilities (42 U.S.C.

263b(f)(1)(E) and (F)). This provides

both the authority and responsibility to

define ‘‘medical physicist’’ for the

purpose of these regulations. Again, this

definition applies only to medical

physicists who wish to provide services

to mammography facilities under the

MQSA and not to the profession as a

whole.

s. Multi-reading

‘‘Double reading,’’ defined as two or

more interpreting physicians

interpreting the same clinical image,

was included in the proposal to describe

one of the options that interpreting

physicians can use to meet the

experience requirements.

(Comment 70). Several comments,

including a consensus of NMQAAC,

requested further clarification of this

term. Confusion apparently has arisen

due to the fact that ‘‘double reading’’

commonly is used to describe the

situation where a mammogram is read

by two interpreting physicians in an

attempt to improve the accuracy of the

interpretation. Two comments,

including a consensus comment from

NMQAAC, suggested that another term

be used to describe multiple

interpretation as it applies to the final

regulations.

In response to these comments, FDA

has substituted the term ‘‘multi-read’’ to

describe interpretation of mammograms

by two or more physicians. Multireading can be used by physicians to

meet continuing experience

requirements. Multi-reading can also be

used by physicians to meet initial and/

or requalification requirements if it is

done under direct supervision.

(Comment 71). Some of the comments

incorrectly assumed that FDA was

forcing facilities to have all their

mammograms read by two interpreting

physicians.

While facilities are free to perform

this type of ‘‘multi-reading’’ as a means

to improve accuracy, FDA does not

require that any mammogram be read by

more than one interpreting physician.

(Comment 72). One comment

suggested adding the words ‘‘that has

not been marked as to possible

pathology’’ at the end of the definition

of ‘‘double read’’ (now changed to

multi-read).

FDA disagrees and believes that an

interpreting physician benefits from

reviewing mammograms, even those

that have been marked by another

physician. Requiring the removal of

such marks would be overly

burdensome and might even be
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55871

detrimental to the patient if the original

marks were not put back on the images.

(Comment 73). One comment

requested clarification as to whether

physicians must independently

interpret the same clinical image, or is

it within the intent of the definition to

include two or more physicians in

consultation interpreting the image

together.

FDA intends the concept of ‘‘multireading’’ to include both independent

and consultative reading. If the multireading is done under direct

supervision, there must be a

consultative component to the

supervision.

t. Patient

In the proposal, FDA used

‘‘examinee’’ to refer to any individual

undergoing a mammography

examination. This was a change from

the term ‘‘patient,’’ which was used in

the interim regulations. As explained in

the preamble to the proposal (61 FR

14862), the change was made in

recognition of the fact that most

individuals who undergo

mammography are not ill and do not

have a condition requiring medical care.

(Comment 74). Eighteen comments

stated that it was not necessary to

replace ‘‘patient’’ with ‘‘examinee,’’

because patient is a term used

universally. One comment objected to

the proposed use of ‘‘examinee’’ and

preferred ‘‘patient’’ because ‘‘patient’’

conveys the ethical protections of a

doctor-patient relationship, confers

malpractice protection, and ensures that

third party payers recognize the

examination as required care. One

comment agreed with the definition of

examinee and the inclusion of selfreferred persons.

NMQAAC discussed these comments

and there was general consensus to

recommend that FDA use the term

‘‘patient,’’ provided the definition

would include people who did not have

health care providers and people

without medical symptoms. Finally it

should be noted that the MQSA uses the

term patient. In light of these comments,

FDA has decided to return to the use of

‘‘patient,’’ which is defined in the final

regulations as anyone undergoing a

mammographic procedure.

u. Phantom

‘‘Phantom’’ is defined as a test object

used to simulate radiographic

characteristics of compressed breast

tissue and containing components that

radiographically model aspects of breast

tissue and disease.

(Comment 75). One comment on this

definition requested that FDA specify

the phantom contents and

measurements. A second comment

urged FDA not to change the current

phantom unless the new phantom

decreased the frequency of other testing.

FDA believes that the accreditation

bodies should establish the phantom

specifications and related performance

criteria, rather than the agency

establishing them through regulation.

However, as part of its responsibilities

for accreditation body approval and

oversight, FDA will examine each

body’s phantom specifications and

performance requirements to ensure that

they are substantially the same among

different accreditation bodies.

FDA believes that the second

comment was in response to the

suggestion that a more sophisticated

phantom might facilitate the

establishment of performance outcomes

standards based on the new phantom’s

use that would take the place of several

of the existing tests. This issue was

discussed previously with other

comments on that subject under section

III.B of this document, where the agency

concluded that performance standards

based on a new phantom were not

practical at this time.

v. Physical science

‘‘Physical science’’ means physics,

chemistry, radiation science (including

medical physics and health physics),

and engineering.

(Comment 76). One comment received

on this definition stated that the

engineering part of this definition

should be limited to electrical and

nuclear engineering only, while a

second comment opposed the inclusion

of engineering and chemistry at all.

FDA notes that this term is used to

establish the qualifications to be met by

medical physicists, which include a

degree in the physical sciences on an

appropriate level. The purpose of that

part of the requirements is to ensure that

the individual has a general familiarity

with the scientific concepts,

calculations, and techniques that

provide a basis for understanding and

completing more specialized work in

medical physics, not that he or she has

already achieved the training in medical

physics. The agency further notes that

this general requirement is reinforced

with a more specific requirement for

training in physics. Because meeting

these two requirements provides an

adequate foundation for meeting the

more specialized medical physics

requirements, the agency does not

believe the definition needs to be

narrowed by eliminating the fields

suggested in the comments.

w. Positive mammogram

‘‘Positive mammogram’’ means a

mammogram that has an overall

assessment of findings that are either

‘‘suspicious’’ or ‘‘highly suggestive of

malignancy.’’

(Comment 77). One comment stated

that the term positive mammogram was

self-explanatory and did not need a

definition. FDA disagrees. There are

many different working definitions of

this term being used in the professional

community. Because the final

regulations require all positive

mammograms to be entered into the

facility’s medical audit system, it is

necessary to retain a definition of

‘‘positive mammogram’’ in order to

clarify the scope of the audit.

x. QC technologist

This term was defined to mean the

individual who is responsible for the

segments of the quality assurance

program that are not the responsibility

of the lead interpreting physician or the

medical physicist. In general, this

responsibility consists of the routine QC

testing and some data analysis and

corrective actions related to the results

of that testing.

(Comment 78). One comment stated

that it is not necessary to identify or

define this position because the person

with this responsibility is easily

identified.

FDA does not agree with this

comment for the same reason it

disagreed with the similar comment

about the definition of lead interpreting

physician. In addition, the title of QC

technologist is already widely used in

mammography facilities.

This definition was changed,

however, as a result of discussions at

the January 1997 NMQAAC meeting. It

is often possible for a single individual

to perform the duties of a QC

technologist for an entire radiology

facility. That individual ordinarily is a

technologist, but may not meet the

qualifications to do mammography. At

early meetings, NMQAAC had agreed

that this person should be a qualified

technologist, but did not necessarily

have to be qualified to perform

mammography. This would avoid the

possibility that the mammography

department of a radiology facility might

have to have its own QC technologist,

thus forcing the facility to assign two

persons to meet the responsibilities

previously handled by one. NMQAAC

reconsidered its position at the January

1997 meeting, however, and concluded

that the advantages of having the QC

technologist in the mammography

department be qualified to do

mammography outweighed the possible

extra costs. FDA accepted NMQAAC’s

advice on this matter and changed the

wording in the definition to require the

QC technologist to meet all the

qualifications in § 900.12(a)(2) for
55872 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

radiologic technologists doing

mammography.

(Comment 79). Three comments

disagreed with the proposed definition

because it barred qualified biomedical

engineers, manufacturer’s

representatives, and other individuals

the authors believed were qualified from

serving as QC technologists. Although

NMQAAC has changed its position from

time to time on whether the QC

technologist must be qualified to do

mammography, it has never wavered

from its advice that the individual in

this position should be a radiologic

technologist. FDA concurs with that

view. However, as discussed below in

connection with the quality assurance

requirements under § 900.12(d)(1)(iv),

the final regulations permit

nontechnologists to perform certain QC

tasks as long as the QC technologist

ensures that the performance is

adequate.

y. Traceable to a national standard

Traceability refers to the ability to

show that an instrument has been

calibrated by a process that eventually

led back to a standard established by the

National Institute of Standards and

Technology (NIST).

(Comment 80). A number of

comments requested further

clarification of traceability. A few

comments requested that the

requirement for annual calibration be

changed to every 3 years.

In response to these comments and

after discussion with calibration

experts, FDA has revised the definition

of traceability. The term itself has been

changed to ‘‘traceable to a national

standard’’ to more clearly reflect what is

needed. Other changes have clarified

that the ultimate source of the

calibration may be either NIST or a

calibration facility that participates in a

proficiency program with NIST at least

once every 2 years during which the

calibration facility achieves agreement

within + 3 percent of the NIST standard

at mammography energy levels.

2. New Definitions Suggested by the

Comments

a. Category I

(Comment 81). Several comments

suggested that the meaning of the term

‘‘Category I,’’ as used in the regulations,

was unclear.

In response, FDA has defined

Category I, at § 900.2(g), to mean

medical educational activities that have

been designated as Category I by the

Accreditation Council for Continuing

Medical Education, the American

Osteopathic Association, a State

medical society, or an equivalent

organization.

b. Contact mammography

(Comment 82). One comment

recommended that this term from the

final regulations should be defined.

However, in the revisions of the

regulations following the public

comments, this term has been

eliminated, so a definition is no longer

needed.

c. Continuing education unit

(Comment 83). One comment warned

that it would be difficult to interpret the

personnel training requirements if the

term continuing education unit was not

defined.

FDA agrees with this comment and

has added a new § 900.2(l), which states

that continuing education unit or

continuing education credit means 1

contact hour.

d. Diagnostic and screening

mammography

(Comment 84). Over 30 comments

stated that diagnostic and screening

mammography should be defined and

asserted that vacillation over these

definitions only confuses the public and

those who are to measure outcomes.

As explained in the proposed rule (61

FR 14862), FDA is eliminating these

terms from the definitions section

because differences of opinion within

the professional community regarding

the distinction between these two types

of mammography procedures remain

unresolved. These terms can have

different meanings depending upon

their context. For example, HCFA has

defined screening and diagnostic

mammography for claim processing

purposes. AHCPR has defined these

terms in their guidelines for medical

audits. On the other hand, some

facilities do not distinguish between

screening and diagnostic

mammography. Facilities also differ on

categorizing certain circumstances as

screening or diagnostic, as in the

example of a healthy, asymptomatic

woman with breast implants who has

diagnostic views performed during

‘‘routine screening.’’ The terms

screening and diagnostic

mammography, along with other terms

and definitions associated with the

medical audit, are in the process of

obtaining consensus within the

scientific community. At present, FDA

recommends that each facility choose

and consistently utilize HCFA, AHCPR,

or other definitions in the medical

literature for medical audit purposes.

e. Established operating level

(Comment 85). One comment noted

that this term was used in connection

with a number of QC tests and suggested

that it be defined as ‘‘the single point for

a particular quality assurance parameter

set by the lead interpreting physician.’’

FDA agrees that a definition of

established operating level is needed

and has added, at § 900.2(p), that

‘‘established operating level means the

value of a particular quality assurance

parameter that has been established as

acceptable by the facility’s quality

assurance program.’’ This definition

indicates that the level should not be

merely set but also should be

determined to be acceptable. The

responsibility for making that

determination will belong primarily to

the lead interpreting physician, as the

comment suggested. However, the

definition being issued refers to

acceptance as part of the entire quality

assurance program because additional

facility and FDA personnel also may be

consulted when the level is established.

f. Image receptor

(Comment 86). Two comments

suggested that a definition of image

receptor be included in the final

regulations. FDA notes that there is a

general understanding within the

radiology and general medical

community of what this means and if a

specific definition is needed, one is

already available in 21 CFR 1020.30(b).

The agency does not believe that it

needs to be repeated here.

g. Image receptor support device

(Comment 87). One comment

suggested that a definition of image

receptor support device as that part of

the mammography X-ray unit that is

designed by the manufacturer to hold

the cassette be added to clarify

§ 900.12(b)(5).

FDA agrees that this is a useful

suggestion. However, as a result of other

revisions that have been made to the

proposal, the term ‘‘image receptor

support device’’ is no longer used in the

regulations and, therefore, a definition

is no longer needed.

h. Laterality

(Comment 88). Several comments

found the meaning of the term

‘‘laterality,’’ as used in the regulations,

to be unclear.

In response to these comments, FDA

has defined laterality, at § 900.2(w), to

mean the designation of either the right

or left breast.

i. Mammography equipment

(Comment 89). One comment

suggested that a definition of

‘‘mammography equipment’’ should be

added and further suggested that the

definition include all physical

components of a mammography facility

needed to produce an interpretable film.

The author believed that this would

more clearly define the components that

the physicist would need to include in

the required ‘‘survey’’ of

‘‘mammography equipment’’ for which
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55873

he or she has been assigned

responsibility under § 900.12(d)(1)(iii).

FDA considered the possibility of

adding this definition, but notes that

§ 900.12(e)(9) already establishes the

evaluations that, at a minimum, are to

be included in the survey. Because of

this, the agency decided that an

additional definition was not needed.

j. Mobile unit

(Comment 90). Three comments

suggested that mobile units should be

defined in such a way as to clarify when

mammography units used under a

variety of different circumstances are to

be included in this category.

FDA notes that the term mobile unit

is relevant to compliance with these

regulations only in determining when

the additional testing required by

§ 900.12(e)(7) needs to be performed.

Under § 900.12(e)(7), a mobile unit is

one that is used to produce

mammograms at more than one

location. The agency believes

§ 900.12(e)(7) makes it sufficiently clear

when the additional testing is needed.

k. Quality assurance, quality

assurance program, and QC

(Comment 91). Two comments

recommended that these terms be

defined. FDA notes that one or more of

these terms have been defined in 21

CFR 1000.55, in the ACR Quality

Assurance manuals, or by various other

authorities. While the wording of these

definitions may vary, the basic concepts

are the same and are widely understood.

The agency does not believe that they

need to be defined again.

l. Technique chart

(Comment 92). One comment among

those that suggested that a technique

chart should be part of the quality

assurance manual also noted that this

would require defining technique chart.

The comment also made some

suggestions for the definition.

FDA notes that, as will be discussed

with other comments related to quality

assurance records required under

§ 900.12(d)(2), a technique chart is not

being required to be included in the

facility’s quality assurance manual.

Because the term is not used in the

regulations, a definition is not needed.

m. Other comments on the proposed

definitions

(Comment 93). Thirteen identical

comments wanted the quality assurance

definitions changed, stating that, ‘‘it is

objectionable to have the FDA creating

definitions of medical terms not agreed

on by physicians.’’

Quality assurance is not defined in

the regulations and, as discussed above,

the agency does not believe such a

definition is needed. From other

information in the letters containing the

comments, it appears that they are

actually referring to specific definitions

discussed under the heading of ‘‘Quality

Assurance’’ in the preamble to the

proposal. There were four such

definitions: ‘‘lead interpreting

physician,’’ ‘‘QC technologist,’’ ‘‘time

cycle,’’ and ‘‘traceability.’’

FDA agrees that, to the extent

possible, the agency should adopt

definitions for medical terms that have

widespread agreement among

physicians. In fact, QC technologist, as

discussed above, is already a title

widely used in facilities and in the ACR

manuals. It appears that medical

facilities have already reached

consensus on its use as an

administrative title, although there may

be differences on the necessary

qualifications of such individuals.

The agency does not agree that the

other three terms are medical terms

whose definitions require agreement

among physicians. ‘‘Time cycle’’ and

‘‘traceability’’ are technical terms

related to the film development time

and the calibration of radiation

measuring instruments. These are not

terms that physicians use regularly or

about which they are likely to discuss

and reach consensus. The remaining

term, lead interpreting physician, is an

administrative term, not a medical one.

As discussed previously, this term has

been defined as the designation of an

individual physician at each facility

who has certain responsibilities under

these regulations; that identification

will make it easier for facilities,

accreditation bodies, and government

regulators to ensure and monitor

compliance with the MQSA standards.

3. New or Changed Definitions Made

Necessary by Changes in the

Regulations

a. Air kerma and kerma

The Omnibus Trade and

Competitiveness Act of 1988 amended

the Metric Conversion Act of 1975 to

require each Federal agency to use the

International Systems of Units (SI) in its

activities. The SI is also known as the

metric system although it makes use of

only some of the metric quantities and

units. In accordance with this

requirement, a memorandum dated

March 19, 1990, from FDA’s Associate

Commissioners of Regulatory Affairs

and Public Affairs, established the FDA

policy for the use of SI metric

measurement. Since 1990, FDA has

been undergoing a transition to SI

quantities and units in its regulatory

activities. To this end, air kerma, which

is an SI quantity, has been introduced

as a replacement for the quantity of

exposure previously referenced in

§ 900.12(e)(5)(v). Definitions of ‘‘air

kerma’’ and ‘‘kerma’’ were also added as

§§ 900.2(d) and 900.2(v), respectively, in

the final regulations.

b. Calendar quarter

To give facilities more flexibility in

maintaining their records on personnel

qualifications, changes were made in

several provisions of § 900.12(a). These

changes allow the facility to use a

variety of methods to calculate the time

periods necessary to establish

compliance with personnel

requirements. In calculating these time

periods, the facility may designate any

one of the following as the endpoint for

the period of time used to determine if

their staff met the continuing education

and experience requirements: (1) The

date of the inspection; (2) the last day

of the last calendar quarter before the

inspection; or (3) any date in between

those two. To avoid any

misunderstandings, FDA added a

definition of calendar quarter, under

§ 900.2(f), that establishes the endpoints

of the 4 quarters as March 31, June 30,

September 30, and December 31.

c. Interim regulations

Reference was made to the interim

regulations several times in the final

regulations. For the benefit of those

unfamiliar with those regulations, FDA

defined them by citing, under § 900.2(t)

of the final regulations, the Federal

Register publication of December 21,

1993, as amended on September 30,

1994.

d. Interpreting physician

This definition was modified from the

proposed definition by adding the term

‘‘licensed’’ in order to clarify the intent

of the statute that the physician

maintain a valid State license to practice

medicine.

e. Qualified instructor

During the revisions of the training

requirements for radiologic

technologists, the term ‘‘qualified

individual’’ and its definition in

§ 900.12(a)(2)(ii) were replaced by the

term ‘‘qualified instructor’’ in referring

to the individuals providing the training

and the category of such individuals

was expanded. These changes made it

necessary to add, as § 900.2(oo), a

definition of ‘‘qualified instructor’’ as an

individual whose training and

experience adequately prepares him or

her to carry out specified training

assignments. The new definition also

includes examples.

f. Standard breast

Although the term standard breast

was used and defined at several points

in the proposed regulations, it had not

been included in the definitions section.

It has now been added as § 900.2(uu) in

the final regulations.
55874 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

E. The Accreditation Body Application

(§ 900.3)

In this section, FDA proposed

procedures to be followed by

organizations or agencies applying to

become FDA-approved accreditation

bodies. It also proposed criteria for

evaluation and approval of prospective

accreditation bodies.

1. General Comments on the

Accreditation Process

(Comment 94). Several comments

supported portions of the rule, and the

initial accreditation process in general,

stating that it had elevated the quality

of many facilities under the interim

regulations. Other comments, including

some from members of NMQAAC,

expressed a variety of concerns,

including possible conflict of interest

and lack of uniformity that may result

if States become certifying bodies. One

general comment recommended that

FDA monitor ACR, rather than facilities.

Comments about the States as

certifiers go beyond the scope of this

document and will be addressed in

future proposed regulations covering

States as certifying agents. However, the

agency notes that the MQSA expressly

provides that States may serve as

certifying bodies (42 U.S.C. 263b(q)).

Preparations are under way to draft

proposed regulations that would govern

State agencies that wish to become

certifying bodies. Just as these final

regulations establish standards and

procedures for accreditation bodies,

including State agencies that serve in

that capacity, provisions regulating

States as certifying bodies would

establish standards and procedures that

States must meet to assume that

responsibility. Those standards and

procedures would address uniformity of

standards and include conflict of

interest provisions, as do the regulations

governing accreditation bodies.

Members of the public will have full

opportunity to comment further on

States as certifiers when those

regulations are proposed. In response to

the comment that urged FDA to monitor

ACR rather than facilities, the agency

notes that the statute requires FDA to

monitor both accreditation bodies and

facilities in a variety of ways.

(Comment 95). One comment wanted

FDA to promote multiple accreditation

bodies because of concerns that States

approved as accreditation bodies will

have overly stringent requirements.

States approved as accreditation

bodies are required to accredit facilities

under the MQSA in accordance with

standards that are substantially the same

as those applied by all approved

accreditation bodies. However, the

MQSA does not prohibit State

regulations from being more rigorous

than those of FDA. Although more

stringent State requirements cannot be

used to deny accreditation under the

MQSA, facilities may be required by a

State to meet such additional

requirements in order to practice

mammography in that State.

2. The Clinical and Phantom Image

Review Process (§ 900.3(b)(3)(iii)(A) and

(B))

These provisions require the

prospective accreditation body to

provide information that describes its

clinical and phantom image review

process in its application to FDA.

(Comment 96). One comment

requested that this information also be

provided to all mammography facilities,

stating that it would result in improved

overall image quality and would assist

facilities denied accreditation to prepare

for appeals hearings.

FDA understands that facilities may

believe they could prepare better for

accreditation review if they had details

relating to the procedures the

accreditation bodies would be applying

during clinical and phantom image

review. However, FDA also recognizes

that disclosure of the details of such

procedures may undermine the integrity

of the review process under certain

circumstances. FDA concludes that this

is a matter for accreditation body policy

rather than regulations. The actual

clinical attributes reviewed during

accreditation are described in the final

regulations.

3. Policies and Procedures

(§ 900.3(b)(3)(iii)(J))

This provision requires prospective

accreditation bodies to provide FDA

with information describing policies

and procedures that will ensure timely

processing of facility applications for

accreditation.

(Comment 97). One comment on this

section requested FDA to require

accreditation bodies to respond to

requests for information or to written

communications expressing concerns

from facility personnel or other

interested parties about the

accreditation process. Another comment

suggested including a review of the

consistency of the accreditation body’s

responses to facility and industry

inquiries as part of the annual

evaluation of the accreditation body by

FDA.

FDA agrees that timely processing of

facility accreditation applications is

important to meet statutory certification

deadlines and that good communication

between accreditation bodies and

facilities can improve such timeliness.

However, FDA disagrees that specific

prescriptive regulations are needed

concerning communications between

the accreditation body and facilities.

4. Education and Experience Criteria

(§ 900.3(b)(3)(iv))

(Comment 98). One comment stated

that this subparagraph, requiring that

prospective accreditation bodies

provide information describing

education and experience criteria for its

staff, fails to specify minimum

acceptable values for these criteria. It

also asked for clarification of

‘‘professional staff.’’

By professional staff, FDA means

those persons evaluating and making

decisions on accreditation applications.

FDA has established minimum

requirements for the clinical image

reviewers under § 900.4(c)(5) and for

phantom image reviewers under

§ 900.4(d)(5), but has not issued

minimum requirements for other

accreditation body staff in order to

maintain flexibility for accreditation

bodies and to be able to consider

alternatives on a case by case basis.

FDA’s experience under the interim

regulations is that every professional

member of an accreditation body staff is

qualified to perform his or her assigned

functions.

5. Resources (§ 900.3(b)(3)(vi))

This provision requires prospective

accreditation bodies to provide

information in their application to aid

FDA in determining if the body has

adequate resources to carry out its

responsibilities.

(Comment 99). One comment asked

what constitutes adequate funding, what

specific additional resources are

required and in what amount, and how

FDA expects to evaluate the adequacy of

an application if no minimum

requirements exist for such resources.

Funding and other resource needs,

e.g., personnel and data systems, are a

function of the variable conditions

under which accreditation bodies may

operate and the populations they may

serve.

FDA could not establish rigid funding

or staffing requirements to apply to

every accreditation body applicant. As

issued, the regulations provide FDA

with authority to obtain information to

evaluate the individual circumstances of

each applicant.

6. Other Information (§ 900.3(b)(3)(xiii))

This subparagraph requires a

prospective accreditation body to

provide any information required by

FDA beyond that specifically listed in

§ 900.3(b)(3).

(Comment 100). One comment

described this requirement as

exceedingly vague and recommended it

be deleted.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55875

FDA must reject this suggestion

because the requirements that

accreditation bodies provide FDA with

additional information is in the statute

itself (42 U.S.C. 263b(e)(1)(vii)). The

drafters of the MQSA recognized that it

would be impossible to foresee in

advance when circumstances might

create the need for additional

information.

FDA has added one provision to

§ 900.3(b)(3) to obtain information from

prospective accreditation bodies about

procedures and policies they would

implement to protect confidential

information. This requirement is at

§ 900.3(b)(3)(ix) and its addition has

caused the subsequent sections to be

renumbered.

7. Term of Approval (§ 900.3(g))

(Comment 101). A small number of

comments, both pro and con, were

received concerning the accreditation

body’s term of approval, proposed by

FDA to be 5 years. Some, including

members of NMQAAC, stated that this

term was too short, particularly in light

of FDA’s annual accreditation body

evaluation. These comments also

expressed concern about the amount of

paperwork required for renewal.

In response to these concerns, FDA

has increased the renewal period in the

final regulation to 7 years. Because FDA

shares the concern about the amount of

paperwork required for renewal of

accreditation body approval, the agency

plans to limit the data required to be

submitted to only that information

necessary to justify renewal. FDA will

hold discussions with each

accreditation body prior to renewal to

identify the information that will be

required. Such information may

include, but is not limited to,

information and data pertaining to the

accreditation body’s program not

previously submitted to FDA and all

proposed changes to the accreditation

body’s program or standards.

F. Standards for Accreditation Bodies

(§ 900.4)

Accreditation bodies are responsible

for the initial screening of

mammography facilities. They are to

ensure that the facilities they accredit

meet the quality standards established

by FDA, both initially and on an

ongoing basis. They also have unique

responsibility for conducting reviews of

clinical images from the facilities to

determine if the images meet the image

quality standards established by the

accreditation body with FDA approval.

This section of the regulations outlines

the requirements that FDA-approved

accreditation bodies must meet in

carrying out these responsibilities.

1. General Comments on the Standards

for Accreditation

(Comment 102). One comment

generally supported this section as

written, while a second applauded the

regulations for not requiring specific

measures of interpretive performance.

Other comments encouraged FDA to

add additional requirements and

responsibilities for accreditation bodies,

but did not identify what these should

be. One comment stated that the

proposed rules for accreditation bodies

suffered from a lack of either design or

performance-based criteria, but failed to

suggest any design or performancebased criteria that should be applied.

FDA believes that the final regulations

governing accreditation bodies are

sufficiently detailed without being

overly prescriptive. Although particular

performance-based requirements were

not identified by these comments, FDA

notes that some performance data on

accreditation body activities are

available and are used by FDA in its

annual evaluation of each accreditation

body.

(Comment 103). One comment

recommended that each accreditation

body be required to demonstrate

expertise in recordkeeping and

epidemiology.

FDA believes that its review of the

accreditation body’s application will

provide sufficient information to

establish that the accreditation body has

recordkeeping capability. Although

accreditation bodies may employ

epidemiologists, nothing in the MQSA

suggests that FDA should make this a

requirement.

(Comment 104). One comment stated

that excessive requirements for

accreditation bodies will destroy the

basic concept behind the idea for

accreditation bodies, i.e., significant

involvement of the public and

professional sector. The comment

warned that detailed rules could reduce

the opportunity for creative approaches

and innovative development of new QC

tests and procedures. A second

comment stated that FDA should not

hinder the accreditation bodies from

performing as independent entities.

FDA shares concerns that overly

detailed requirements may limit

professional involvement and useful

innovation. Although it may appear that

the final regulations include many new

requirements for accreditation bodies, to

a large extent the provisions reflect

procedures and criteria that the current

accreditation bodies already are

following under the interim regulations.

In fact, many were first devised by the

accreditation bodies themselves and are

examples of accreditation body

innovation, e.g., development,

submission, evaluation, and monitoring

completion of corrective action plans by

facilities found to have problems

producing quality mammograms. FDA

has taken great care to delete or amend

requirements that might limit creative

approaches and innovation. Because the

comment does not identify specific

rules in the proposal that might cause

such problems, the agency cannot

respond further.

In response to the second comment,

the agency notes that the MQSA

requires FDA to establish standards for,

and to approve accreditation bodies.

Entities that apply to become

accreditation bodies must comply with

those standards. FDA does not believe

that compliance with those standards

will diminish the ability and obligation

of accreditation bodies to make

independent professional judgments.

Those judgments, however, must be

consistent with statutory obligations to

ensure that facilities comply with the

Federal standards and work with FDA

to improve the practice of

mammography. Accreditation bodies are

free to encourage innovation, conduct

research, develop new standards, and

apply for appropriate variances when a

particular practice or procedure

presents an opportunity to enhance

mammography quality.

2. Code of Conduct and General

Responsibilities (§ 900.4(a))

These provisions were intended to

describe the responsibilities of the

accreditation body when there is a

possibility that mammography practice

at an accredited facility poses a risk to

human health. As proposed, those

sections set forth particular actions an

accreditation body would be required to

take in those circumstances.

a. Image quality (§ 900.4(a)(1) and

(a)(2))

(Comment 105). One comment stated

that the accreditation body should have

the discretion to determine the

appropriate review for a given

circumstance and the option to initiate

other actions FDA had not described in

the proposal (e.g., random film checks

followed by a site visit, if necessary).

Three other comments recommended

deletion of these paragraphs and the

substitution of guidance documents that

would give accreditation bodies more

flexibility.

FDA generally agrees with these

comments and has eliminated most of

the detailed provisions of these

paragraphs (including all of proposed

paragraph § 900.4(a)(2)). The final

provisions establish that the

accreditation body has a responsibility

to review clinical images or other
55876 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

aspects of a facility’s practice any time

it obtains or receives information that

suggests a facility is not in compliance

with the MQSA standards, or upon

request from FDA. The accreditation

body also has responsibility to require

and monitor corrective actions or to

suspend or revoke a facility’s

accreditation if the accreditation body’s,

or FDA’s, review confirms that a

problem exists. These responsibilities

are integral to the role accreditation

bodies play under the MQSA to assist

the government in establishing and

monitoring quality standards for

mammography. Nothing in the final

regulations precludes an accreditation

body from initiating investigations on

its own.

b. Equipment or practices that pose a

serious risk (§ 900.4(a)(2))

(Comment 106). Six comments

recommended changing the requirement

that an accreditation body inform FDA

on becoming aware of situations of

potentially serious risk to the public

health from ‘‘within 5 business days’’ to

‘‘the next business day.’’

FDA agrees with concerns raised by

these comments and has changed the

requirement to ‘‘as soon as possible but

in no case later than 2 business days.’’

The standard that triggers such

responses has been amended to those

that ‘‘pose a serious risk to human

health’’ in order to ensure that FDA is

informed of all problems that may

require immediate followup.

c. Conflict of interest (§ 900.4(a)(4))

The goal of this provision was to

ensure that actions of the accreditation

body’s clinical or phantom image

reviewers were not affected by any

conflict of interest, and to ensure that

accreditation bodies avoid the

appearance of such conflicts in order to

establish and maintain confidence in

the accreditation process.

(Comment 107). Four comments

recommended expanding clinical image

reviewer conflict of interest concerns to

include the individual’s family,

corporations, partnerships, and

associations.

FDA disagrees with these comments.

The comments provided no arguments

to support this recommendation and no

evidence to suggest that the present

conflict of interest provision is

inadequate. In addition, FDA believes

limitations suggested by the comment

would eliminate some highly qualified

clinical image reviewers from eligibility

without commensurate benefit to the

system. The agency notes that, if similar

conflict of interest provisions had been

applied to membership on NMQAAC,

many of the members that played a

major role in developing final

regulations would not have been eligible

to serve on the committee.

(Comment 108). One comment

recommended expanding the conflict of

interest provision to specify that clinical

and phantom image reviewers must not

review images from facilities within the

State in which they reside. A second

comment also expressed concern about

clinical image reviewers evaluating

images from their own States or

geographically limited areas. The

comment proposed that FDA require

‘‘blind’’ readings of all images by

reviewers and prohibit review if there is

potential conflict of interest.

FDA disagrees with the suggestion

that reviewers should be barred from

reviewing images from the State in

which the reviewer resides. Such a

requirement would effectively preclude

State accreditation bodies from having

independent clinical image review

programs. All present State

accreditation bodies with independent

clinical image review programs require

and take measures to ensure blind

reading to preclude bias, and FDA

expects that any future State or national

accreditation bodies will have similar

safeguards as part of their QC, clinical

image review, and conflict of interest

standards.

(Comment 109). One comment

recommended that ACR and any other

professional organizations acting as

accreditation bodies randomly select

clinical image reviewers and phantom

image reviewers from a pool to reduce

the possibility of reviewer bias.

FDA agrees in principle that

accreditation body reviews should not

be biased, but finds no compelling

reason to require use of pools and

random selection. Under the MQSA,

FDA has issued minimum requirements

for all interpreting physicians and these

requirements apply to any clinical

image reviewer employed by an

accreditation body. In addition, with

these provisions, FDA is requiring each

accreditation body to establish and

implement procedures to train and

evaluate its reviewers and to avoid

conflict of interest. Within this

framework, FDA concludes that the

assignment of clinical image reviewers

for any applicant facility is best left to

the accreditation body.

d. Equipment performance and design

characteristics (§ 900.4(a)(5))

These provisions are intended to

prevent conflict of interest situations

that could arise if the use of specific

products were required by an

accreditation body as a condition of

accreditation.

(Comment 110). One comment stated

that there may be an appearance of a

conflict of interest by accreditation

bodies in these situations and that

special care must be taken with respect

to the promotion of any product. The

comment expressed the conclusion that

the possibility of conflict is so great that

it should never be acceptable for an

accreditation body to require use of a

particular product. A related comment

stated that the accreditation bodies

should not be able to require use of their

own products by facilities they accredit.

Over 15 additional comments opposed

allowing the accreditation bodies to

require the use of their products as a

condition of accreditation or otherwise

opposed commercial activities that

would create a conflict of interest.

FDA understands the concerns

expressed in these comments and notes

that, in general, the regulation has been

written to preclude accreditation bodies

from requiring use of any specific brand

or product. However, the agency

believes exceptional situations may

develop that warrant use of a particular

product because of the public health

benefits the product provides. The final

regulation, therefore, gives FDA the

flexibility to permit accreditation bodies

to require the use of a specific

commercial product when the agency

has determined that such use is in the

best interest of the public health.

(Comment 111). A few stated that

conflict of interest requirements should

not be an impediment to development

of new technologies and services, nor be

used by other entities to ‘‘harass’’ ACR

and improperly influence FDA.

FDA agrees that conflict of interest

provisions should not impede the

development of new technologies, but

also believes that it would undermine

the integrity of the accreditation process

if accreditation bodies could require

facilities to use products the

accreditation body develops as a

condition of accreditation. FDA believes

that the final regulations strike the

proper balance between these

competing interests.

(Comment 112). Over 150 comments

on identical printed forms stated that

FDA should prohibit conflicts of interest

by accreditation bodies and should

adopt the conflict of interest provision

suggested by a trade association and

included in the preamble to the final

regulations (61 FR 14487).

FDA agrees that conflicts of interest

by accreditation bodies stemming from

accreditation body requirements to use

specific products or services should be

prohibited. However, none of these 150

comments offered arguments to support

adopting the suggested provision or to

explain why the agency’s proposal was

inadequate. FDA’s experience under the
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55877

interim regulations demonstrates that

potential conflicts can be addressed

satisfactorily by the provisions of

§ 900.4(a)(6). The suggested conflict

provision would effectively preclude

development of products and services

by an accreditation body. FDA believes

that because accreditation bodies

possess particular experience and

expertise, such products and services

have the potential to enhance practice

or otherwise be beneficial to public

health. For these reasons, FDA has

concluded that it is unnecessary and

would be inadvisable to adopt the

suggested conflict provision.

(Comment 113). One comment stated

that only FDA, as opposed to

accreditation bodies or other entities,

should be able to require the use of

particular mammography related

products and, if FDA does so, the use of

such products should be required of all

facilities.

FDA agrees with this comment as a

general rule. However, FDA may

approve the imposition of such a

requirement by an accreditation body if

the agency determines that it is in the

best interest of public health to do so.

Such an accreditation requirement

would only apply to facilities accredited

by the accreditation body that requested

the approval unless FDA determined

that adoption of the same requirement

by all accreditation bodies was in the

best interest of quality mammography.

(Comment 114). One comment

requested clarification on the use of the

word ‘‘product,’’ apparently asking

whether the word was intended to apply

to a specific item or a general category

of products.

FDA believes that the word ‘‘product’’

is commonly understood. The conflict

of interest provisions prohibiting an

accreditation body from requiring a

product to be used can apply to several

product categories or to specific brands

or products, depending on the

circumstances.

(Comment 115). Finally, one comment

made several suggestions related to

these provisions. The comment

contained the recommendations that

FDA should require of accreditation

bodies that: (1) Their accreditation and

onsite inspections be managed by

different departments; (2) their clinical

image reviewers not review images from

facilities in their home State to avoid a

range of potential conflicts of interest;

(3) reciprocity agreements between

adjacent States be precluded; and (4)

they meet at least the minimum

standards of operation of the ACR

program.

FDA believes that the internal

division of responsibilities within

accreditation bodies is not appropriate

for regulation; many professional and

government agencies have dual

responsibilities for accreditation and

inspection and are able to carry out

those responsibilities fairly and

effectively without necessarily using

different departments. It was noted

previously that the second suggestion

was not accepted by FDA because it

would effectively preclude State

accreditation bodies from having

independent clinical review programs.

Because the third suggestion does not

identify or otherwise describe the

reciprocity agreements intended to be

prohibited, the agency cannot respond.

In answer to the last suggestion, FDA

notes that all accreditation bodies are

required to meet the final regulations

governing accreditation bodies in order

to become approved and maintain their

accreditation authority. FDA will not

approve any accreditation body that

does not have standards of operation

that ensure the accreditation body can

meet its obligations under the MQSA.

Nothing in the MQSA precludes ACR or

any other accreditation body from

having additional standards for aspects

of mammography that are not within the

scope of the MQSA. Nor does the MQSA

impinge on a State’s ability to enforce

its own standards under State authority

if those standards are at least as

stringent as the MQSA’s.

e. Denial of accreditation to a facility

(§ 900.4(a)(7))

This paragraph was intended to

ensure that no State accreditation body

could bar facilities in that State from

being accredited under the MQSA by

any other FDA-approved accreditation

body.

(Comment 116). Several comments

raised questions that made it evident

that this section was unclear as

proposed. Comments asked whether a

State accreditation body could require

or restrict facilities within that State to

accreditation by the State accreditation

body. Other comments asked whether

facilities could have more than one

accreditation. This section has been

rewritten so that the answers to both

questions should be unambiguous.

As revised, the provision clearly

states that no accreditation body can

require a facility to be accredited by that

accreditation body if more than one

accreditation body is available. Nor can

an accreditation body preclude a facility

from being accredited by any other

available accreditation body.

Consequently, nothing in the final

regulations prevents a facility from

having more than one accreditation.

However, FDA will issue only one

certificate, usually based on the initial

accreditation.

The geographic scope of authority for

an accreditation body will be

established through the accreditation

body approval process. A State certainly

could determine, as all current State

accreditation bodies have, to restrict

accreditation body activities to facilities

within the State. A non-State

accreditation body similarly could

request to be approved to accredit in a

limited geographic area. It would be up

to the applicant to initially identify,

based on its circumstances and

resources, the area it intends to serve. In

addition, FDA could restrict the scope

of an accreditation body’s authority to a

geographical area that is smaller than

that desired by the accreditation body if,

for example, the agency had doubts

about the ability of the accreditation

body to provide adequate service in the

desired area.

(Comment 117). One comment

asserted that a State government cannot

be restricted at any time from requiring

its own accreditation guidelines to be

met by facilities in that State.

FDA agrees that States may require

facilities to meet standards under State

law that are at least as stringent as those

under the MQSA. However, such

standards may not be required as a

condition for accreditation under the

MQSA.

One comment expressed the view that

this provision was unnecessary because

a facility accredited by a State agency

would not voluntarily seek accreditation

elsewhere. FDA disagrees with this

comment. A small number of facilities

have sought and received dual

accreditation. In addition, the main

point of the provision is to ensure that

facilities are able to seek initial and

exclusive accreditation under the

MQSA from another accreditation body,

even if the State acts as an accreditation

body in their geographic area.

f. Changes to standards (§ 900.4(a)(8))

(Comment 118). FDA received two

comments on this section, which

requires an accreditation body to obtain

FDA permission prior to changing any

standards previously accepted by the

agency. Both comments were generally

supportive of the provision. One

comment suggested verifying whether

current technology is capable of meeting

the requirements for any change in

standards before the change is made.

This will serve to minimize costs for

both facilities and industry.

FDA agrees with this comment and

routinely considers the adequacy of

current technology during development

of new standards or evaluation of
55878 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

standards proposed by the accreditation

bodies.

(Comment 119). One comment further

stated that any proposed change to any

standard by an accreditation body

should be supported by scientific data

and that FDA should seek industry

input before authorizing the change.

FDA agrees that changes in standards,

and especially technical standards,

benefit from the application of scientific

data, where possible. The agency further

agrees that industry input is often

useful. However, FDA believes that, in

many circumstances, the information

already available to the agency is

sufficient for a decision and that

additional scientific data and outside

comment will not be necessary.

Therefore, FDA did not make this a

regulatory requirement.

g. Confidential information

(§ 900.4(a)(9))

This paragraph requires the

accreditation bodies to establish

procedures to protect confidential

information.

(Comment 120). Ten comments asked

how FDA will ensure that

confidentiality will be maintained.

The intent of this provision is to

guarantee that each accreditation body

has in place procedures, programs, and

systems that train employees to guard

against unauthorized disclosure of

information. Federal regulations, State

laws, and contractual obligations will

all play a part in determining an

accreditation body’s responsibility in

any particular situation. In general,

however, if FDA shares nonpublic

information with an accreditation body

about a particular facility, the record

containing that information is an agency

record under the control of FDA and the

accreditation body would not be

authorized to disclose that information

without the permission of the agency. If

an accreditation body, in violation of

the final regulations, were to improperly

use or disclose information received

from a facility for purposes of

accreditation, FDA believes the facility

would have a private right of action

against the accreditation body under the

laws of most States. In addition,

unauthorized disclosures of

information, whether received from

FDA or the facility, would be a basis for

FDA to withdraw an accreditation

body’s approval. Nothing in these

regulations, however, is intended to

preclude or hinder the exchange of

information between FDA and

accreditation bodies when that

information is required to be shared in

order for the agency and the

accreditation body to carry out

functions under the statute.

(Comment 121). Three comments

recommended allowing accreditation

bodies to use and disclose information

gathered during the accreditation

process, if the identification of an

individual, facility, or group is not

compromised. Each comment cited the

Freedom of Information Act (FOIA). A

similar comment found this regulation

to be overly restrictive, and stated that

the regulation should allow use of the

data for research purposes, ‘‘so long as

the released data involves only pooled

information that does not allow

identification of an individual, facility,

or group.’’

FDA generally agrees with these

comments. Disclosure of aggregate

information that does not reveal,

directly or indirectly, the identity of

particular facilities or individuals, is

consistent with the FDA’s regulations

implementing the FOIA. However, in

the event of ambiguity, accreditation

bodies would consult with FDA and

obtain clearance before making such

disclosures. FDA does not believe data

obtained from facilities for accreditation

purposes should be used for purposes

that have no relationship to

accreditation body processes or

standards, unless the accreditation body

obtains the consent of the facility. This

would not impede an accreditation body

from using data to review and improve

its internal processes, to educate

personnel to improve accreditation body

efficiency and performance, or to

publicly discuss results of the processes

using aggregate data.

(Comment 122). One comment noted

that all data collected by or emanating

from State agencies may be releasable

under some State laws, and that

nonpublic information is not necessary

for accreditation. The comment also

sought clarification about what would

be deemed nonpublic information. A

second comment stated that, in

Arkansas, all information received by a

publicly funded agency for accreditation

review is releasable under that State’s

Freedom of Information (FOI) laws. A

third comment, which also requested

clarification on public versus nonpublic

information, suggested that public

information be limited to name, address,

phone, and accreditation status. The

comment noted that there have been

complaints from radiologists about the

use of information, including concerns

about selling the MQSA certified facility

address list.

FDA recognizes that people have

varying ideas about what constitutes

nonpublic information. Any information

in the possession of FDA that is

prohibited from disclosure under

various statutes FDA enforces or that is

exempt from mandatory disclosure

under the FOIA is considered nonpublic

information by the agency. Examples of

such nonpublic information include

data about the volume of business

handled by any particular facility, the

name or personal identifier of any

mammography patient, and internal

recommendations for enforcement

action. FDA would not make such

information public in response to a

request for information under the FOIA.

As stated previously, accreditation

bodies that obtain nonpublic

information from FDA will be required

to treat it as an FDA record and protect

it accordingly. If an accreditation body

obtains similar information from other

sources, FDA expects the information

will receive similar protection in the

vast majority of cases. FDA has had

public information regulations in place

implementing the FOIA since 1977.

During those years, FDA has found that

State confidentiality laws are usually

consistent with FDA’s requirements.

Arkansas’ FOI law, e.g., which was cited

by one comment, has provisions for

exceptions to mandatory public

disclosure that are similar to the Federal

FOIA and FDA’s implementing

regulations. In situations where the

accreditation body believes that State

law requires disclosure of information

that would be considered confidential if

it were part of an FDA record, every

effort will be made to consult State

authorities and resolve the apparent

inconsistencies.

In addition, FDA notes that all the

currently approved accreditation bodies

have had experience handling sensitive

nonpublic information. ACR has done

so for many years and, since the

beginning of its voluntary MAP in 1987,

has handled and processed information

very similar to that required under the

MQSA. The State accreditation bodies

also have broad experience processing

and protecting sensitive information

because they have had previous

responsibility regulating facilities under

their own State laws. FDA has no

evidence that any accreditation body

has improperly disclosed information.

With respect to the comment that

complained about the sale of a list of

certified facilities, FDA notes that this

sale was not by an accreditation body,

and that the names and addresses of

certified facilities would not, in any

case, be nonpublic information. The list

is available from NTIS for a nominal

charge to cover the cost of reproduction

and is also available from the Center for

Devices and Radiological Health

Internet site.

(Comment 123). Ten comments stated

that permission to disclose nonpublic
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55879

information should rest with the

facility, not FDA.

The final regulations are consistent

with these comments. An accreditation

body may not disclose to the public any

nonpublic information it has obtained

from a facility without the permission of

that facility. If an accreditation body has

obtained information about a facility

from FDA or its duly designated

representatives, including a State

agency with responsibility for

monitoring mammography facilities, the

accreditation body cannot further

disclose that information without the

written permission of FDA. Because

FDA is obligated to protect nonpublic

information, it would not authorize

release of information about any facility

that was entitled to be protected from

disclosure under the Federal law. FDA

has added references in the final

regulations to information obtained

from or provided to State agencies

because FDA’s experience under the

interim regulations demonstrates the

necessity for sharing information among

accreditation bodies, State authorities,

and FDA in order to ensure quality

mammography.

3. Facility Standards (§ 900.4(b))

This section outlined the

responsibilities accreditation bodies

must meet to ensure that facilities they

accredit meet the FDA quality

standards.

a. General comments on facility

standards

(Comment 124). Seven comments

requested that FDA add an additional

provision to state, ‘‘The accreditation

body shall review previous inspection

reports prior to issuing full

accreditation.’’ Eight additional

comments recommended adding that

sentence, plus the additional words, ‘‘to

previously accredited facilities’’ at the

end.

FDA appreciates the concerns of these

comments that accreditation bodies

have access to complete information

about facilities that are applying for

accreditation for the first time or to

renew their accreditation. FDA

disagrees that accreditation bodies

should be required to review all prior

inspection reports for every application

it receives. Such a requirement could

raise accreditation costs unnecessarily,

and the prior accreditation history that

each facility must submit with its

accreditation application will provide a

summary of significant related

information. However, FDA encourages

accreditation bodies to request

inspection records from FDA whenever

the accreditation body believes that

such records would aid in review of an

accreditation application.

b. Monitoring facility compliance

(§ 900.4(b)(1))

Under this provision, an accreditation

body must require each facility it

accredits to meet quality standards that

are substantially the same as those

required by FDA.

(Comment 125). Six comments

recommended using this provision to

make the accreditation bodies

responsible for reviewing continuing

education and other personnel

requirements, thereby eliminating

verification of these personnel standards

from the annual inspections.

FDA notes that the accreditation

bodies have the responsibility under the

interim regulations to ensure that

personnel qualifications are met before

they accredit a facility and will continue

to have that responsibility under the

final regulations. However, the number

of personnel noncompliances found

during inspections over the last 2 years

illustrates the value of an onsite check

of these qualifications. As experience

with inspection and accreditation

activities develop, FDA is working with

the accreditation bodies to improve and

enhance the role each plays in oversight

of facility compliance with quality

standards.

(Comment 126). One comment

recommended replacing ‘‘substantially

the same’’ with ‘‘the same’’ to ensure

clarity.

FDA disagrees with this comment.

The MQSA does not contemplate that

the standards be identical; the statute

uses the phrase ‘‘equal to’’ (42 U.S.C.

263b(e)(1)(B)(vi)). Using ‘‘the same’’

would unduly restrict accreditation

bodies, and effectively preclude

relatively minor differences that are

necessary or appropriate because of

different or changing circumstances

among accreditation bodies.

c. Facility compliance (§ 900.4(b)(2))

(Comment 127). One comment stated

that accreditation bodies should not be

required to ensure that a facility correct

noncompliances because accreditation

bodies have no authority in these

matters. Instead, the comment suggested

that accreditation bodies be required to

refer enforcement matters to FDA or, in

the future, to a State certifying entity.

As discussed previously, FDA agrees

that enforcement matters are ultimately

the responsibility of the agency. This

provision has been modified

accordingly. As discussed previously

(see section III.F.1 of this document),

accreditation bodies have responsibility

and authority to monitor compliance

with standards and to suspend or revoke

accreditation of facilities that do not

maintain standards.

4. Clinical Image Review (§ 900.4(c))

FDA believes that effective clinical

image review is essential for high

quality mammograms. A primary

purpose of the MQSA is to ensure that

all mammography facilities have the

benefit of such review and that

accreditation bodies are qualified to

perform that function. Accordingly,

FDA proposed more specific

requirements with respect to clinical

image review than were established

under the interim regulations. The

proposed requirements, which were

based on advice from NMQAAC and

public comments, have been codified

without significant changes in the final

rule.

The regulations define three separate

but related types of clinical image

review. They are accreditation and

reaccreditation clinical image review,

random clinical image review, and

additional mammography review. Each

serves a different purpose within the

framework of the MQSA and the

regulations.

Accreditation and reaccreditation

clinical image review is performed for

each facility once every 3 years. Its

purpose is to ensure that each facility is

capable of producing and recognizing

high quality images of fatty and dense

breasts. Section 900.4(c) has been

retitled in the final regulations from the

general title that had been proposed,

‘‘Clinical image review,’’ to ‘‘Clinical

image review for accreditation and

reaccreditation’’ to clarify that the

provisions of this section refer

specifically to clinical image reviews

performed for accreditation and

reaccreditation.

In addition to clinical image review

performed for routine accreditation and

reaccreditation, the MQSA also requires

the accreditation body to conduct

random clinical image review. This type

of review is performed on a selected

sample of the accreditation body’s

facilities and serves three major

purposes. Random clinical image review

is an indicator of the quality of

mammography performed at facilities, a

measure of the performance of the

accreditation body, and a method to

assure the public that facilities continue

to produce high quality images during

the intervals between reaccreditation

reviews. Under the provisions of

§ 900.4(f)(2), FDA is allowing each

accreditation body to develop its own

FDA-approved random clinical image

review process to include at least 3

percent of its accredited facilities each

year. This enables each body to

individualize the review to best evaluate

its facilities and monitor its own

performance. While the accreditation

bodies will be evaluating the same
55880 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

attributes used for accreditation and

reaccreditation clinical image review,

they will have to adjust their scoring

and pass-fail criteria to take into

account that, due to the selection

process, these studies may not be

representative of the best images a

facility can produce.

The third type of review is additional

mammography review. This review is

an evaluation of facilities that FDA has

reason to believe may present a serious

risk to human health due to

compromised mammography quality.

The term ‘‘additional clinical image

review,’’ used in the proposal, was

changed to ‘‘additional mammography

review’’ to indicate that this review of

problem facilities is not necessarily

limited to an evaluation of clinical

images but can involve all aspects of

mammography at the facility. The

requirements for this type of review are

provided in § 900.12(j).

a. Frequency of clinical image review

(§ 900.4(c)(1))

Section 900.4(c)(1) states that clinical

image review for accreditation and

reaccreditation shall be performed at

least once every 3 years. This is in

accordance with the requirements

specified by the MQSA.

b. Attribute requirements

(§ 900.4(c)(2))

Section 900.4(c)(2) lists the eight

attributes to be used for evaluating

clinical images.

(Comment 128). One comment agreed

with the section as proposed, while

another comment thought it was too

proscriptive and did not allow for

changes in technology and assessment.

Two other comments stated that the

attributes were too vague, while another

said that the attributes should be

identical to any existing standards and

definitions currently in use.

FDA notes that the attributes

described in § 900.4(c)(2) were derived

from existing standards that have been

used successfully for mammographic

evaluation for many years.

Accreditation bodies are currently using

these attributes to evaluate clinical

images under the interim regulations.

FDA does not believe the use of these

attributes will limit the introduction of

new technologies because FDA has the

flexibility to modify the attributes for

new mammographic modalities, if

necessary.

(Comment 129). One comment

recommended that the contrast,

sharpness, and noise attributes should

be dropped because all mammograms

contain some blurring and noise.

FDA agrees that some degree of

blurring and noise occur on all films.

However, these attributes should be

evaluated to determine if the blurring or

noise are of such severity as to obscure

anatomical structures.

(Comment 130). Several comments

addressed specific attributes. One

comment stated that the positioning

attribute implies that it is not necessary

to get all the breast tissue on the film.

FDA notes that, due to anatomical and

mammographic limitations, all breast

tissue cannot be imaged on each view.

The requirement was specifically

written by FDA to take this fact into

account.

(Comment 131). Several comments,

including one from NMQAAC, urged

that the word ‘‘tissue’’ be replaced with

‘‘image’’ when referring to exposure and

that ‘‘processing’’ should be added to

the list of ‘‘artifacts.’’

FDA agrees that ‘‘processing’’ should

be added to the list of ‘‘artifacts’’ and

has changed ‘‘tissue exposure’’ to

‘‘exposure level’’ to be more consistent

with existing standards and definitions.

(Comment 132). One comment was

unclear as to whether ‘‘noise’’ was the

same as ‘‘quantum mottle.’’ FDA notes

that ‘‘quantum mottle’’ is a form of

‘‘noise,’’ although it is not the only form

of ‘‘noise.’’

(Comment 133). Several comments

opposed the examination identification

attribute as being too specific and

requiring too much information to be

placed in the small flasher space. Two

comments supported the description of

the attribute as written.

FDA has received a great deal of

advice from NMQAAC regarding the

importance of examination

identification as an attribute of quality

mammography and believes that the

present requirement is in the best

interest of the patient. A facility may

satisfy the requirements for examination

identification through the use of stickon labels so that all the information

does not have to fit within the flasher

space. NMQAAC recommended

specifically adding the name and an

additional identifier to patient

identification. FDA agrees with this

suggestion and has modified this section

accordingly.

(Comment 134). One comment stated

that technical factors such as kVp,

milliamperes (mA’s), and amount of

compression should be required on all

films because this information would

aid in evaluating problems. It noted that

ACR recommends recording these

technical factors.

FDA believes that facilities should

have the option of recording this

information if they believe it beneficial

for their practice. Because many

facilities have indicated that having this

information on all images is not useful,

the agency does not believe it is cost

effective to make this a mandatory

requirement for all facilities.

(Comment 135). Two comments, and

several members of NMQAAC, stated

that FDA must ensure that accreditation

bodies prevent reviewers from knowing

the identity of the facility under review,

especially in the case of local reviewers.

FDA agrees that this is an important

issue and has discussed it in response

to comments on § 900.4(a)(4), which

addresses possible conflicts of interest

by image reviewers.

(Comment 136). One comment asked

if the technologist identification is

meant to be unique for a facility, for a

particular health corporation, or

nationally recognized. The technologist

identification requirement is facilitybased and any system that enables the

facility to determine which technologist

performed the examination should be

acceptable.

(Comment 137). One comment agreed

that mammography unit identification

was important for reproducibility, while

another asked whether it would be

possible to have the unit identification

on the patient’s question and answer

form rather than on the film.

FDA believes that, in cases where

there is more than one unit in the

facility, the unit identification should be

on the film, so that this information may

be obtained without referring to other

sources.

c. Scoring clinical images

(§ 900.4(c)(3))

Section 900.4(c)(3) requires the

accreditation body to establish a system

for scoring clinical images using the

attributes in § 900.4(c)(2) and to develop

pass-fail criteria for these attributes. It

also requires that images be

independently reviewed by two or more

clinical image reviewers. This section

was modified from the proposal to

clarify that each attribute shall be

individually evaluated.

(Comment 138). One comment

warned that perfectly acceptable images

can be rejected by the clinical image

review process if a pass-fail system is

used. The author believed that there

should be some form of grading system

for the evaluation of the films.

FDA agrees that a grading system

should be employed in evaluating the

studies. A requirement for such a

system was in the proposed regulations.

It has been modified in the final

regulations to require that acceptable

and unacceptable results be established

for each of the eight attributes and an

overall pass-fail system. This change

ensures that each facility has the benefit

of an evaluation of each attribute,

providing the facility with the
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55881

information essential to take appropriate

corrective actions when necessary.

FDA’s experience under the interim

regulations indicates that failure by the

clinical image review process of what

are later judged to be acceptable images

is an unusual occurrence. In those rare

cases where the facility disputes an

accreditation body clinical image review

decision, the facility has the option of

appealing this adverse decision to the

accreditation body and then to FDA.

(Comment 139). One comment said

that the specific details of the scoring

process should be made public, utilized

in an identical manner by all

accreditation bodies, be verified, and

result in a numerical score for each set

of films reviewed. FDA notes that the

determinants of high image quality

mammography have already been made

public by accreditation bodies,

professional organizations, and by

clinical authors publishing in peer

review radiology journals. This

information should be incorporated into

each facility’s quality assurance

program and should be used for

selecting the studies that are submitted

to the accreditation body for clinical

image review. FDA believes that the

specific details of the accreditation

body’s scoring procedures should

remain confidential to preserve the

integrity of the process. However, the

details will be reviewed and evaluated

by the agency as part of FDA’s approval

and oversight responsibilities.

d. Selection of clinical images for

review (§ 900.4(c)(4))

Section 900.4(c)(4) describes the

number and types of images that shall

be submitted by the facility for

accreditation and reaccreditation

clinical image review.

(Comment 140). Four comments

stated that accreditation and

reaccreditation clinical image review

should be done on randomly selected

images rather than the ‘‘best’’ images a

facility can produce, arguing that this

would give a better indication of the

quality of mammography being

performed. One comment agreed with

§ 900.4(c)(4) as proposed, but suggested

adding one randomly selected set of

images. One comment mistakenly

believed that FDA was allowing

accreditation bodies to use either

random or nonrandom selection of

clinical images for accreditation or

reaccreditation clinical image review.

FDA has retained the provision that

accreditation and reaccreditation

clinical image review is to be performed

using the ‘‘best’’ images a facility can

produce. Using this criterion for

selection allows the accreditation body

to apply its highest standards to the

scoring of these images. It also serves as

a check on facility personnel to see if

they understand what makes a high

quality image. Random clinical image

review, as required in § 900.4(f), serves

a different purpose than accreditation

and reaccreditation clinical image

review. Although the accreditation body

evaluates the same attributes, the

scoring standards are more flexible to

take into account that these may not be

the ‘‘best’’ images a facility can produce.

(Comment 141). Two comments stated

that clinical image review is extremely

valuable, but that more films should be

reviewed.

FDA disagrees. Requiring review of

additional studies would serve to raise

the cost and complexity of the review

process without a demonstrable increase

in quality. During discussions with

NMQAAC, a majority of the committee

agreed with FDA’s position on this

issue.

(Comment 142). Two comments urged

FDA to replace the term ‘‘view’’ with

‘‘projection.’’

FDA discussed this with NMQAAC,

who agreed with the agency that ‘‘view’’

is the correct term to use in this context.

(Comment 143). Six comments stated

that clinical images for accreditation

and reaccreditation review should be

selected from a specified period of time.

Three comments, including a consensus

of NMQAAC, stated that both the

clinical images and the phantom image

should be from the same 30-day period.

FDA did not set timeframes for

submission of images in the regulations

in order to allow the accreditation

bodies to establish these timeframes

based on their own circumstances and

experience with the review process. The

agency has rejected the suggestion that

phantom and clinical images be from

the same 30-day period because this

could create logistical problems if a

second set of clinical images had to be

submitted.

One comment expressed the author’s

belief that a national accreditation body

should develop materials showing

examples of acceptable dense and fatreplaced breast images. FDA encourages

accreditation bodies to provide such

information and education but does not

believe that this is a matter that should

be addressed in regulation.

(Comment 144). Several comments,

including a consensus of NMQAAC,

stated that it is often difficult to find

images that are totally normal and

suggested that images could be sent

from either negative or benign

assessment categories.

FDA agrees and has modified

§ 900.4(c)(4)(iii) accordingly.

(Comment 145). One comment

suggested that § 900.4(c)(4)(iv) be

revised to allow a facility to submit

alternative mammograms only if the

facility does not have images interpreted

as normal under § 900.4(c))(4)(iii). It

stated that no alternatives should be

accepted for craniocaudal and

mediolateral views required in

§ 900.4(c)(4)(I) or for dense and fatty

breast images required in

§ 900.4(c)(4)(ii). FDA disagrees and

believes that accreditation bodies

should be given the flexibility to deal

with these situations in an appropriate

and individualized manner.

e. Clinical image reviewers

(§ 900.4(c)(5))

Section 900.4(c)(5) requires the

accreditation body to ensure that its

clinical image reviewers are interpreting

physicians, are trained and evaluated in

the clinical image review process,

document their findings and the reasons

for assigning a particular score to any

clinical image, and provide information

to the facility for improving image

quality.

(Comment 146). Several comments,

including some from NMQAAC, stated

that criteria for clinical image reviewers

should be more detailed and that FDA

should specify a minimum training and

evaluation curriculum or other

performance-based measure. One

comment stated that it was essential for

all accreditation body clinical image

reviewers to meet minimum standards

of reliability.

FDA notes that § 900.4(c)(5)

establishes the basic requirements for

clinical image reviewers and serves as

the starting point for the accreditation

bodies to develop their own additional

requirements. Through its oversight

activities, FDA ensures that the different

accreditation programs are internally

and externally consistent. FDA

currently monitors accreditation body

policies to achieve consistency in

critical areas. The agency has worked

and continues to work with the

accreditation bodies to enhance existing

procedures and establish new programs

to monitor inter- and intra-accreditation

body consistency for clinical image

review.

(Comment 147). Five comments

suggested that inspectors be trained to

be clinical image reviewers. These

comments reasoned that such training

would permit a more accurate

evaluation of clinical image quality than

the current practice of letting facilities

pick their best films for accreditation

body evaluation. One of the comments

contended that image quality would

improve overall if a facility knew that
55882 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

any image could be reviewed during

inspections.

The MQSA assigns primary

responsibility for clinical image review

to accreditation bodies. The agency has

established basic standards for clinical

image reviewers, including that they be

interpreting physicians, and will review

and monitor each accreditation body’s

performance of this critical function.

However, FDA believes the actual

evaluation of clinical images should

remain the role of the accreditation

body. At its January 1997 meeting,

NMQAAC discussed the issue of using

the MQSA inspectors for clinical image

review. They concluded, and the agency

agrees, that inspectors do not have, nor

can reasonably be given, the training

and expertise required to perform

clinical image review.

f. Image management (§ 900.4(c)(6))

Section 900.4(c)(6) requires the

accreditation body to establish a

tracking system for clinical images to

ensure their security and return to the

facility within 60 days.

(Comment 148). One comment stated

that the requirement to return all

clinical images within 60 days was too

restrictive, because 60 days would not

be adequate if a third review were

required. This comment recommended

90 days. Another comment stated that

the turnaround time for accreditation

body image review was already too long,

and that such delays limited a facility’s

opportunity to submit a second set of

improved images within the review time

cycle. A third comment stated that films

should be returned to facilities in 45 to

60 days.

With respect to this matter, FDA has

had to balance the needs of the facility

against those of the accreditation body.

Using the experience gained under the

interim regulations, the agency

concludes that the 60-day period is

appropriate.

(Comment 149). One comment stated

that § 900.4(c)(6)(ii) should clearly state

that the accreditation body is obligated

to inform only the facility of any

abnormalities found on clinical images

submitted to the accreditation body

which had been interpreted by the

facility as negative. The comment

explained that this obligation should

not extend to informing either patients

or referring physicians.

FDA believes it is imperative that

patients and referring physicians be

notified of any suspicious abnormality

detected during the clinical image

review process. However, the agency

has concluded that only the facility that

performed the examination has access to

the necessary patient and referring

physician information to allow proper

notification of the affected individuals.

FDA has modified the regulation

accordingly.

(Comment 150). One comment stated

that proposed § 900.4(c)(6) implied that

mammography reports would be sent to

the accreditation body with the films.

The comment asserted that requiring

facilities to submit reports would raise

concerns about patient confidentiality

and establish an additional and new

requirement for facilities.

FDA agrees with this comment and

the regulation has been amended to

delete the reference to mammography

reports.

g. Unsatisfactory image quality

(§ 900.4(c)(7))

Section 900.4(c)(7) describes the

accreditation body’s responsibility

when it determines that clinical images

from a facility that it accredits are

unsatisfactory.

(Comment 151). One comment stated

that the accreditation body has no direct

authority to ‘‘take appropriate action’’ if

corrective measures to address poor

clinical image quality are not

implemented by the facility.

Section 900.4(c)(7) has been modified

from the proposal to address this

comment. As discussed previously, FDA

agrees that responsibility for enforcing

compliance with the MQSA

requirements rests primarily with FDA.

Accreditation bodies, however, can and

are expected to take action to revoke or

suspend the accreditation of facilities

that do not comply with standards

established by the accreditation body,

which include producing high quality

clinical images. This section has been

changed to state that the accreditation

body is responsible for notifying the

facility of the nature of the problem and

its possible causes. The requirements

that have been deleted, to monitor the

progress of the facility and to take

appropriate action if corrections are not

made, are inherent in the accreditation

process and have been stated previously

in § 900.4(a)(1)(ii).

5. Phantom Image Review (§ 900.4(d))

The review of phantom images is an

important part of the evaluation of a

facility for accreditation. The

production and evaluation of phantom

images is also an important part of the

medical physicist survey, of the facility

inspection, and of the facility’s quality

assurance program. However, § 900.4(d)

covers only the requirements that the

accreditation body must meet to ensure

that its phantom image reviews are

performed accurately, in a timely

fashion, and without bias.

a. General comments on phantom

image review

(Comment 152). Two comments stated

that phantom image review by the

accreditation body is unnecessary

because it is performed twice a year,

once by the medical physicists during

annual physics surveys and again by

inspectors during yearly inspections.

FDA notes that, as with clinical image

review, the phantom image review

performed during the accreditation

process and the reviews performed at

other times have different purposes. The

words ‘‘for accreditation and

reaccreditation’’ have been added to the

title of § 900.4(d) to clarify the purpose

of the phantom image review in this

section. During the accreditation

process, phantom images are reviewed

by the accreditation body to determine

if the facility is producing adequate

quality images to permit its

accreditation or reaccreditation. The

phantom image reviews conducted

during a medical physicist survey, an

inspection, or as part of the facility

quality assurance program are intended

to provide some assurance that the

facility continues to produce adequate

quality images during the 3-year interval

between accreditations. Because of these

different objectives, the agency believes

that the multiple phantom image

evaluations are not redundant.

b. Phantom image reviewers

(§ 900.4(d)(5))

This paragraph discussed the

requirements for and the procedures to

be followed by the phantom image

reviewers.

(Comment 153). Two comments stated

that FDA did not provide any specific

qualifications and training requirements

for the accreditation body phantom

image reviewers in the proposed rule.

One comment wanted further

clarification of these qualifications and

the other expressed concern that

accreditation bodies may have widely

different criteria for phantom image

reviewers. A few comments

recommended that only medical

physicists be considered qualified for

phantom image review, but another

comment expressly opposed that

limitation. Six comments supported

§ 900.4(d)(5)(I) as written.

FDA has stated in § 900.4(d)(5)(I) that

the accreditation bodies must ensure

that their phantom image reviewers

meet the requirements specified in

§ 900.12(a)(3) for medical physicists or

alternative requirements established by

the accreditation bodies and approved

by FDA in accordance with § 900.3(d).

The agency believes that this provides

sufficient guidance to accreditation

bodies with respect to qualifications and

training requirements, while permitting

flexibility to accommodate different
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55883

circumstances among the accreditation

bodies.

FDA does not agree with the

comments that only medical physicists

should be allowed to perform phantom

image review, although any medical

physicist who met either the

requirements in § 900.12(a)(3) or FDAapproved alternative requirements

could serve in this capacity. The key

criteria are that the individuals doing

the phantom image review be

adequately trained in the review process

and have sufficient educational

background to understand the concepts

involved. The ability to carry out the

full range of the responsibilities of the

medical physicists under the MQSA is

not required. The agency believes,

therefore, with proper training and

experience, individuals other than

medical physicists can become qualified

to evaluate phantom images.

All phantom image reviewers,

whether or not they are medical

physicists, must comply with the

additional requirements, established by

FDA in § 900.4(d)(5)(ii) and (iii), to be

trained in the review process, to

document scoring, and to provide

feedback to facilities on improvement

measures. If the accreditation bodies

develop their own alternative or

additional requirements for phantom

image reviewers, FDA will ensure

consistency among the accreditation

bodies through its oversight program.

(Comment 154). Eight comments

wanted the agency to require phantom

image review by at least two reviewers.

One comment stated that all facilities

should use the same phantom and the

same scoring procedure.

The agency has no evidence to suggest

that double reviews are necessary for

adequate evaluation and did not make

this a regulatory requirement. However,

FDA notes that it is currently the

common practice of all accreditation

bodies to have all failed phantom

images evaluated by a second reviewer.

FDA disagrees with the comment

regarding the same phantom and scoring

procedures for all facilities. The agency

wants to refrain from specifying either

a phantom type or scoring methodology

in order not to inhibit future

advancements in phantom evaluation

procedures. In addition, experience has

shown that phantom type and scoring

methodology is generally consistent

from facility to facility even without a

regulatory requirement. FDA will

continue to monitor the situation and

will ensure that any different phantoms

or scoring methodology that may be in

use will not compromise the minimum

standards currently approved.

(Comment 155). Two comments on

this provision expressed concerns about

possible conflicts of interest for

reviewers. FDA has addressed this issue

in § 900.4(a)(4), which was discussed

previously.

c. Image management (§ 900.4(d)(6))

As proposed, this paragraph required

the return of the phantom image to the

facility that produced it.

(Comment 156). Three comments

stated that returning phantom images

increases costs without benefit. Another

stated that retaining the images would

allow the accreditation body to compare

past and current images to assess

possible changes in a facility’s QC

program.

FDA believes that phantom images

that result in a failure of accreditation

should be returned to the facility in

order to illustrate the accreditation

body’s assessment of the nature of the

problem and its possible causes. Such

images can be a valuable learning tool

for the facility as it seeks to correct its

problems. To minimize costs, however,

FDA has revised this paragraph to

require the accreditation body to return

only those images that cause a failure.

d. Notification measures for

unsatisfactory image quality

(§ 900.4(d)(7))

As proposed, this paragraph described

a variety of actions that the

accreditation body should take if it finds

a facility’s phantom image is of

insufficient quality to permit

accreditation of the facility. The

provision has been revised, as has the

parallel provision for clinical image

review discussed above, to focus on the

accreditation body’s obligation to notify

the facility of the nature of the problem

identified and of possible solutions.

(Comment 157). Six comments

supported § 900.4(d)(7) as proposed.

The comments stated that this

requirement provides assistance to the

facility and promotes timely correction

of problems. Two comments expressed

concern that the accreditation bodies

could ‘‘close’’ a facility on the basis of

inadequate quality of phantom images

even if the facility had been producing

high quality clinical films. The

comments explained that this could

happen because of the subjective nature

of phantom image review and the fact

that problematic phantom images are

unavoidable, in spite of adequate care.

Because § 900.4(d)(7) requires the

accreditation body to notify the facility

of the nature of the problem and its

possible causes, FDA does not believe

the review process will prevent

accreditation of a facility that is able

and willing to devote resources to

improvements in this area. It is the

policy of the approved accreditation

bodies to offer facilities at least two

chances to improve the quality of failed

images to the satisfactory level. If the

facility uses the information provided

by the accreditation body on the

possible causes of the problem to guide

corrective actions, the agency believes

that a facility producing high quality

work, as the comments described,

should be able to achieve the minimum

phantom image quality required by the

accreditation body.

(Comment 158). One comment stated

that the accreditation body has no direct

authority to ‘‘take appropriate action’’ if

corrective measures are not

implemented.

As discussed previously in

connection with clinical image review,

nothing in the proposed provision

would require the accreditation body to

act beyond its authority, which includes

a responsibility to deny, suspend, or

revoke accreditation of facilities that do

not achieve the accreditation body’s

standards. However, the agency has

reworded the provision to focus on its

primary purpose, which is to ensure

that facilities who fail the phantom

image review are informed of the

causes.

6. Reports of Mammography Equipment

Evaluations, Surveys, and QC

(§ 900.4(e))

This paragraph describes the reports

on the evaluations of their equipment

that the accreditation body must require

from each facility, the reporting

schedule, and the responsibility of the

accreditation body to review the reports

and to use them in accreditation

decisions.

(Comment 159). Several comments

expressed varying viewpoints on the

need for submission of this information

and who should evaluate it. One

comment stated that it is redundant for

facilities to have to submit information

about equipment to the accreditation

body because each facility is inspected

annually, and also may receive an onsite

visit from an accreditation body. This

would result in three reviews annually,

which would be unnecessary and

burdensome to both the facility and the

accreditation body. Three other

comments also stated the position that

the accreditation body should be the

sole evaluator of the annual physicist

survey. One of the three also contended

that the inspector, unless a qualified

mammography medical physicist, is not

qualified to review these reports. This

comment suggested that the inspection

review be eliminated and that the

accreditation body be required to send

a statement to FDA confirming that the

report was received and reviewed.
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On the other hand, one comment

urged that both the accreditation body

and the inspector continue to review the

physicist survey reports. Another

comment stated that, if duplicate review

is not deemed cost effective, then the

inspector should review the survey

rather than the accreditation body.

These two comments agreed that it is

imperative that the facilities both read

the report and correct any deficiencies

that could lead to noncompliance or

degradation of images, but expressed a

concern that facilities would not do so

unless both the accreditation body and

the inspector required such actions. A

third comment agreed that the inspector

should not just accept the accreditation

body’s review of the facility survey.

Valuable information would be lost if

the inspector does not review the

survey.

FDA believes that having both the

accreditation body and the inspector

review the physicist’s report is

consistent with the MQSA’s reliance on

review by different entities and is a

benefit to the public health, especially

during these early years of the MQSA

program. The two checks are different in

nature. The accreditation bodies make a

complete assessment of such surveys as

they are reported annually. Inspectors,

on the other hand, do not evaluate the

surveys the same way. Instead,

inspectors check for completeness and

to determine if the facility has

implemented necessary corrections

identified in the survey. Typically, the

submission of surveys to the

accreditation bodies and the occurrence

of inspections are not coincident.

Having the inspectors do an

independent check may draw attention

sooner to an incomplete survey or a

problem found by the survey that has

not yet been corrected.

(Comment 160). One comment asked

how five facilities became accredited

without physicist reports.

FDA and the accreditation bodies are

unaware of any facilities that have been

accredited without physicist reports.

Because the facilities for which such

accreditation was alleged were not

identified in the comment, it is not

possible to respond further.

(Comment 161). Nine comments

argued, that as proposed, § 900.4(e)(2)(i)

would lead to facilities changing from a

12-month cycle to a 14-month cycle for

the medical physicist survey.

FDA agrees with these comments and

the section has been changed

accordingly.

7. Onsite Visits to Facilities and

Random Clinical Image Reviews

(§ 900.4(f))

The MQSA requires that accreditation

bodies make a ‘‘sufficient number’’ of

onsite visits to the facilities they

accredit ‘‘to allow a reasonable estimate

of the performance’’ of the body (42

U.S.C. 263b(e)(4)(A)). The statute also

requires the accreditation body to

conduct random reviews of clinical

images from the facilities it accredits, in

addition to the clinical image reviews

required for accreditation (42 U.S.C.

263b(e)(1)(B)). Section 900.4(f)

implements these requirements.

a. General comments on onsite visits

(Comment 162). One comment

questioned the cost-effectiveness of

requiring accreditation bodies to

prepare three copies of a summary

report describing all facility assessments

conducted during that year. The

comment asserted that FDA could

review this information during the

annual oversight inspection of the

accreditation body.

Under the statute, FDA is required to

evaluate the performance of each

accreditation body. The summary of

onsite visits provides valuable

information on which to base such

evaluations. FDA, therefore, retained the

requirement that three copies of the

summary be included in the

accreditation body’s annual report to

FDA. Multiple copies will allow

simultaneous review by multiple

reviewers and, in the event that some of

the materials are difficult to reproduce,

will help ensure uniformity and

readability of the materials.

b. Onsite visits (§ 900.4(f)(1))

(Comment 163). Three comments

agreed with the need for onsite visits,

while two comments stated that the

visits were unnecessary. Two comments

recommended that the onsite visit be

combined with the annual inspection,

while two other comments stated that

the onsite visit should not be construed

as a substitute for, or be conducted

during, the annual inspection. One

comment stated that the onsite visit

process does not serve as a check of the

accreditation body’s quality assurance

process.

FDA reiterates that the requirement

for onsite visits by the accreditation

bodies is established by the statute (42

U.S.C. 263b(e)(4)). The purpose of such

visits is to provide a mechanism by

which accreditation bodies can ensure

facility compliance with quality

standards and monitor their own

performance of accreditation functions.

The accreditation body will be able to

compare the consistency of results from

visits to information obtained through

other accreditation body functions.

These onsite visits by the accreditation

bodies are different from and are

intended to be complementary to the

annual inspection of every certified

facility performed by FDA or State

inspectors. Combining the two

evaluations into one review would

likely undermine the effectiveness of

both visits and inspections. This issue

was discussed with NMQAAC and the

agency’s position was supported by a

consensus of the committee.

(Comment 164). One comment

recommended a prior notice of 5 days

for onsite visits so as not to disrupt

patient care. FDA believes that

accreditation bodies will need flexibility

in scheduling onsite visits. In some

cases, particularly if an accreditation

body has serious concerns about a

facility’s ability to meet quality

standards, significant advance notice

would not be appropriate. In general, for

facilities selected randomly for onsite

visits, FDA encourages accreditation

bodies to work with facilities to

schedule visits that minimize patient

inconvenience and disruption to facility

operations. This has been the general

practice of all accreditation bodies.

c. Sample size (§ 900.4(f)(1)(I))

Section 900.4(f)(1)(I) requires

accreditation bodies to select some

facilities for onsite visits on a random

basis and select other facilities based on

specific reasons for concern about those

facilities, such as a previous history of

noncompliance with quality standards.

In general, each accreditation body will

have to visit annually at least 5 percent

of the facilities it accredits, up to a

maximum of 50 facilities, but no less

than 5. The number could exceed 50 if

many facilities need to be visited

because of previously identified

concerns.

(Comment 165). Two comments

agreed with § 900.4(f)(1)(I) as proposed.

However, 14 comments recommended

that the maximum of 50 facilities be

raised to a higher number. Reasons

given for the increase included a belief

that 50 is not statistically significant for

a large accreditation body. Two

comments wanted the number raised

because they had ‘‘seen too many

certified facilities with questionable

compliance.’’ One comment stated that

a national accreditation body should

visit at least one facility from each State

or region.

The agency disagrees with raising the

number of onsite visits. FDA has

discussed with NMQAAC and the

accreditation bodies the issue of the

number of onsite visits that an

accreditation body can reasonably

perform. There was general agreement

among NMQAAC and the accreditation

bodies that the regulation should not be

changed. The agency has had to balance
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55885

the benefits of accreditation body onsite

visits against its monetary cost.

Requiring more than 5 percent or 50

facilities could significantly increase the

cost of accreditation and potentially

reduce the number of accredited

facilities and access to mammography

without commensurate benefit.

d. Visit plan (§ 900.4(f)(1)(ii))

Section 900.4(f)(1)(ii) establishes

baseline standards for the conduct and

content of the onsite visits.

(Comment 166). Four comments,

including a consensus of NMQAAC,

stated that the composition and

qualifications of onsite visit teams

should be specified. One of the

comments recommended that the team

be comprised of a qualified active

clinical image reviewer, a phantom

image reviewer, and an accreditation

body staff member.

The agency believes that the

accreditation body is in the best

position to define the onsite visit team.

This gives the accreditation body the

flexibility to tailor the team to the

specific needs of the facility, thereby

reducing costs while maintaining

quality.

(Comment 167). One comment

believed that the decision to review

clinical images and the selection of

images should be made at the discretion

of the accreditation body at the time of

the visit. It stated that, if the facility has

proper quality assurance procedures in

place, it may not be necessary to review

the clinical images. FDA disagrees. The

agency believes that clinical image

review is one of the most important

aspects of the entire MQSA program and

should be a part of every accreditation

body onsite visit.

(Comment 168). Two comments,

including a consensus of NMQAAC,

recommended that § 900.4(f)(1)(ii)(D) be

amended to require the accreditation

body to ‘‘verify the presence’’ of the

facility’s medical outcomes audit system

during an onsite visit, rather than

‘‘review’’ the system; requiring a review

implies that the visit team is evaluating

the audit against an agreed upon

standard rather than verifying that a

system is in place.

FDA agrees and has modified this

section accordingly.

e. Clinical image review for random

sample of facilities (§ 900.4(f)(2))

This paragraph establishes the

requirements for the clinical image

review for a random sample of facilities.

(Comment 169). Sixteen comments

stated that there appears to be a

contradiction in the preamble to the

proposed regulations because remarks

in one section questioned the

effectiveness of random clinical image

review, but another section stated that

random visits for facilities are effective.

FDA believes that the comments are

comparing the agency’s views of two

different processes. The agency believes

that random clinical image review is a

useful tool in the evaluation of facilities

and accreditation bodies. However, the

agency stated in the proposal’s preamble

(61 FR 14890) that random clinical

image review would not be an effective

use of accreditation body resources if

applied to all facilities. Random onsite

visits to a limited number of facilities

represent a different tool to evaluate

facilities and accreditation bodies and,

as stated in the preamble to the

proposal, are effective in this context.

(Comment 170). One comment stated

that the goals of random clinical image

review should be clearly determined

prior to establishing minimum quality

standards.

As previously stated, the purpose of

random clinical image review is to serve

as an indicator of the quality of

mammography performed at facilities, a

measure of the performance of the

accreditation body, and a method to

assure the public that facilities continue

to produce high quality images during

the intervals between reaccreditation

reviews. In this context, FDA believes

that it is important that the accreditation

bodies be given the flexibility to

develop a process for random clinical

image review that is best suited to meet

their needs and those of their accredited

facilities. However, the agency notes

that § 900.3(b)(3)(iii) requires a

prospective accreditation body, as part

of its application, to give FDA a

description of its procedures for

performing random clinical image

review. In addition, the agency will

monitor the use of random clinical

image review as part of its oversight

responsibilities.

Eight comments stated that the

sample size for random clinical image

review in proposed § 900.4(f)(2)(I)

should be increased. Two of the

comments recommended that all

facilities undergo random clinical image

review in each 3-year period. One of

these comments stated that this is

required by the statute.

FDA addressed this issue in the

preamble to the proposed rule and

believes its interpretation of the statute

is reasonable. FDA’s proposal changed

the interim rule, which required random

clinical image review at every

accredited facility, to a requirement that

the accreditation body select a sample of

facilities for random clinical image

review. The change in the sampling

requirement was based on FDA’s

experience under the interim

regulations. The agency believes that

annual random clinical image review for

every facility, in addition to the clinical

image reviews required for initial

accreditation and reaccreditation, is not

an effective use of accreditation body

resources. FDA does agree that, after

more data are accumulated, the 3

percent sample in the proposal may

prove to be too low. The agency,

therefore, has revised the provision to

state that at least 3 percent of the

facilities be sampled annually, to allow

the agency more flexibility to modify

the sample size if information obtained

in the future justifies such a

modification.

Section 900.4(f)(2)(ii) has also been

revised from the proposal to clarify that

reviewers performing random clinical

image review shall evaluate the same

film attributes used in accreditation and

reaccreditation clinical image review.

(Comment 171). One comment stated

that randomly selected clinical images

should not be evaluated with the same

stringent requirements as those used for

evaluating the ‘‘best’’ clinical images

submitted for initial accreditation or

reaccreditation.

As previously stated, FDA will

require the accreditation body to

evaluate the same attributes in the

random clinical image review as are

evaluated in the accreditation and

reaccreditation clinical image review.

As previously explained, the agency

believes that accreditation bodies will

have to adjust their scoring and pass-fail

criteria to take into account that, due to

the selection process, these

examinations may not be representative

of the best images a facility can produce.

Such adjustments are appropriate and

are permitted under the final

regulations.

Section 900.4(f)(2)(iv) has been added

to the regulations to clarify that the

process for selection of images for

random clinical image review may differ

from the process for selection of images

for accreditation and reaccreditation

clinical image review.

(Comment 172). Two comments noted

that different accreditation bodies

already have instituted different

selection criteria for their random

clinical image review. One comment

suggested that the review should be a

combination of random (selected by the

inspector) and nonrandom (selected by

the facility) studies.

FDA recognizes that, under the

interim regulations, each accreditation

body has developed its own process for

random clinical image review. Each is

designed to best serve the needs of the

accreditation body and its accredited

facilities. The agency believes this
55886 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

flexibility encourages efficient and

effective review and has not changed

the requirement. FDA believes that the

selection of a combination of random

and nonrandom studies would

complicate the review process without a

corresponding benefit. FDA is working

with all of the accreditation bodies to

further refine and improve their

procedures and programs and will

continue to do so. As noted previously,

although each accreditation body can

devise its own process for random

clinical image review, that process must

be reviewed and approved by FDA.

8. Consumer compliant mechanism

(§ 900.4(g))

This paragraph describes the

responsibilities of the accreditation

bodies to ensure that serious consumer

complaints are adequately addressed.

(Comment 173). The comments

received were very similar to those

received on § 900.12(h), which outlines

the responsibilities of the facilities in

this area. The comments on both of

these paragraphs are discussed in

section III.L.8 of this document in

connection with § 900.12(h).

9. Reporting and recordkeeping

(§ 900.4(h))

No comments were received on this

paragraph, which describes the

mechanisms by which the accreditation

bodies provide information to FDA.

Consequently, this section was

codified with only minor editorial

changes.

10. Fees (§ 900.4(I))

This paragraph outlines the

requirements that must be met by

accreditation bodies to ensure that the

accreditation fees are reasonable.

(Comment 174). Eight comments

claimed that any fees are unreasonable,

particularly for small practices, while

another comment requested that multiunit facilities be charged a higher fee.

The MQSA clearly intended that the

accreditation process be supported

through facility fees and that the agency

be assigned the task of ensuring that

such fees are reasonable (42 U.S.C.

263b(e)(1)(B)(iii)). FDA could not

prohibit fees even if another source of

funding were available. In response to

the last comment, the agency notes that

accreditation bodies can and do charge

higher fees to multi-unit facilities.

G. Evaluation (§ 900.5)

This section states that FDA will

evaluate the performance of each

accreditation body annually, as required

under the MQSA, and briefly outlines

information that will be reviewed as

part of the evaluation.

(Comment 175). One comment urged

FDA to establish standard evaluation

criteria and procedures to apply to the

review of all accreditation bodies prior

to establishing final regulations.

FDA agrees with this comment.

Different accreditation bodies have

different operational circumstances, e.g.,

geographic area and facilities served.

Consequently, with FDA approval, they

may have somewhat different programs.

However, despite program differences,

all accreditation bodies have to comply

with the regulations governing

accreditation body activities. Therefore,

FDA has developed standard evaluation

criteria that are being used to evaluate

all accreditation bodies.

H. Withdrawal of Approval (§ 900.6)

This section outlines the enforcement

actions available to FDA, including

withdrawal of approval, if the agency

determines that an approved

accreditation body has not remained in

substantial compliance with the

requirements.

(Comment 176). One comment stated

that ‘‘major accreditation functions,’’

upon which FDA could base a decision

to withdraw an accreditation body

approval, should be clearly identified.

Another asked how FDA would verify

that an accreditation body, whose

approval had been withdrawn, had

notified all of its facilities. Two other

comments protested elimination of the

mandatory schedule for accreditation

bodies to submit corrective action plans

for minor deficiencies.

Based upon its history of regulating

accreditation body activities under the

interim regulations, FDA believes that

withdrawal of approval of an

accreditation body would be rare and, in

any case, would follow notice of

problems and attempts to bring the body

into full compliance. Should such a

withdrawal occur, however, FDA would

closely monitor the entire process of

closing down the accreditation body

operations, including the required

notification of facilities.

FDA finds no basis for imposing

mandatory schedules for correction of

minor accreditation body deficiencies.

Since approval of the first accreditation

body in 1994, FDA has maintained a

close working relationship with all the

MQSA accreditation bodies.

Accreditation body operational

activities that might have been

categorized as ‘‘minor deficiencies’’

have been resolved quickly and

satisfactorily through direct

communication with the accreditation

bodies, rendering specific mandatory

time limits for all such corrections

unnecessary. The regulation continues

to provide FDA with authority to

specify a time period for any particular

corrective action.

I. Hearings (§ 900.7)

This section describes the rights of

accreditation bodies and facilities to

hearings challenging adverse actions.

(Comment 177). Only one comment

was received and it supported this

section as written. Consequently, this

section was codified with only minor

editorial changes.

J. Applicability (§ 900.10)

This section of the proposal stated

that the provisions of subpart B (which

includes the facility quality standards)

apply to all facilities under the

jurisdiction of the United States that

provide mammography services, except

for those of the Department of Veterans

Affairs (VA).

No comments were received directly

on this section, although several

comments on other sections questioned

the exclusion of the facilities of VA.

FDA notes that the wording of this

section, including the exclusion, is

based directly on the statute; the agency

is unable to make any modifications (42

U.S.C. 263b(a)(3)(A)). However, VA is

presently developing, under a separate

legislative mandate, a program to ensure

mammography quality equivalent to

that required by the MQSA.

K. Requirements for Certification

(§ 900.11)

This section establishes the

requirement that mammography

facilities must have an FDA certificate

in order to operate lawfully and

provides details on how to make

application for a certificate and the time

period during which the certificate may

be effective. Only some of the

provisions of this section drew

comments. Discussion of these

comments follows.

1. General (§ 900.11(a))

This paragraph requires

mammography facilities to have

certificates issued by FDA to operate

lawfully. To obtain a certificate,

facilities are required to meet the quality

standards in § 900.12 and to be

accredited by an approved accreditation

body or other entity designated by FDA.

(Comment 178). One comment noted

that FDA proposed to add that a facility

may be accredited by an ‘‘* * * other

entity as designated by the FDA,’’ that

FDA claims to be concerned that at

some time a facility may not have access

to an accreditation body, and therefore

an alternative accreditation body may be

necessary for facilities to operate

lawfully. The comment argued that

there is no statutory basis for FDA to
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55887

appoint another entity and questioned

under what circumstances a facility

might not have access to an

accreditation body. The comment closed

by stating that, unless an urgent need for

this provision can be clearly defined

with limitations in its scope, it should

be deleted from § 900.11 and elsewhere

in the regulation.

The Secretary has discretion under

the statute, both with respect to

approving private nonprofit

organizations and States as accreditation

bodies and with respect to prescribing

proof of accreditation. While the

probability that facilities may not have

access to an accreditation body is at

present remote, there are neither

guarantees nor requirements that any

particular accreditation body will

continue to serve in that capacity

indefinitely. If one or more of the

currently approved accreditation bodies

were to become unable or unwilling to

serve in that capacity, the agency wants

provisions in place that will allow an

alternative accreditation authority to be

designated in order to ensure continuity

and availability of quality

mammography. Nothing in the statute

precludes FDA from providing for this

eventuality in its regulations or from

designating other accreditation routes if

that should ever become necessary to

protect the public health.

(Comment 179). One comment stated

that facility certification should allow

interpreting physicians to work outside

of the certified facility. The comment

interpreted the proposal to treat an

offsite reading room the same as an

offsite mammography clinic and

maintained that requiring the offsite

reading room to be certified is

burdensome and unnecessary.

FDA does not, at this time, intend to

require separate certification of partial

providers, such as an interpreting

physician with an offsite reading room.

The definition of a facility in § 900.2(q)

includes partial providers, and FDA

recognizes that there may be future

advantages to separately certifying

partial providers of mammography

services. For example, it may be

advantageous for a radiological practice

with one or more interpreting

physicians to be certified as a facility.

By doing so, the practice’s interpreting

physicians could interpret

mammograms from any other certified

facility without those other facilities

having to demonstrate the qualifications

of the interpreting physician. At the

present time, however, policies and

procedures have not been established

for accreditation and certification of

partial providers. Consequently, as is

the case under the interim regulations,

an interpreting physician interpreting

mammograms at a remote site will be

included under the certificates of the

mammography facility for which he or

she interprets mammographic images.

The physician will have to provide

information to those facilities

demonstrating that the requirements

regarding his or her qualifications and

any other applicable MQSA standards

are met.

2. Applications (for Certificates and

Provisional Certificates) (§ 900.11(b)(2))

FDA has amended the language in

§ 900.11(b)(1)(ii), (b)(2)(ii), and (b)(3)(iii)

from ‘‘will’’ to ‘‘may’’ in order to

parallel the statutory language that gives

the agency discretion with respect to the

issuance of certificates, provisional

certificates, and extensions of

provisional certificates to practice

mammography. Although the agency

has relied on accreditation body

determinations in making decisions

about whether to issue certificates, and

intends to continue to do so, there may

be situations in which FDA has

additional information not available to

the accreditation body or when the

agency has reason to disagree with the

accreditation body’s evaluation of the

facility as likely to perform quality

mammography. In those circumstances,

the agency retains discretion to deny a

certificate even if the facility has

become accredited. A new provision has

been added at § 900.16 to implement the

agency’s statutory authority to deny

certification to an accredited facility and

to set forth the appeal procedures

available to such facilities. In general,

this paragraph requires that new

facilities apply for accreditation through

an approved accreditation body. Once a

facility’s application is accepted by the

accreditation body, FDA may issue a

provisional certificate that will allow

the facility to perform mammography

for not longer than 6 months in order to

obtain the clinical images necessary for

accreditation. A provisional certificate

may not be renewed, but a facility may

apply for a one time 90-day extension of

the provisional certificate under certain

circumstances.

(Comment 180). One comment

suggested extending the 6-month

provisional certification period for

facilities that failed to be accredited,

and a second comment stated that a

facility should make substantial changes

before being granted a second

provisional certificate. A third comment

recommended that FDA provide for

renewal of provisional certificates at the

discretion of FDA because some

facilities may not complete

accreditation, through no fault of their

own, and may not qualify for a 90-day

extension. A fourth comment

recommended that provisional

certification should be limited to one

time only and described the 90-day

extension as generous, allowing

facilities a 9-month period in which to

achieve full compliance.

In accordance with the MQSA,

provisional certificates may only be

extended for facilities that can

demonstrate that access to

mammography would be significantly

reduced in the geographic area served

by the facility, and only if the facility

reports the steps that will be taken to

qualify the facility for certification. In

response to the first comment, therefore,

FDA notes that there is no statutory

provision for either an additional

extension or the issuance of a second

provisional certificate to the same

facility.

The agency recognizes the dilemma

noted in the comment concerning

facilities that have been unable, perhaps

for reasons beyond their control, to

complete accreditation within the time

period. The final regulations provide for

reinstatement of certain facilities that

failed accreditation or failed to complete

the process during the first 6 months as

new facilities. To qualify for

reinstatement, the facility must submit

and complete a corrective action plan

developed to ensure correction of any

deficiencies that led to failure. That

corrective plan must be approved by the

accreditation body and completed by

the facility before the facility can be

reinstated. On reinstatement, the facility

is treated as a new facility, and issued

a new provisional certificate that will

allow it to produce mammograms for

the clinical image review, which must

be passed to obtain a 3-year

accreditation and certification term.

FDA understands the concern of those

comments that suggested facilities

should not be given additional time or

a second chance to establish that they

are capable of doing quality work. The

agency has had to weigh those concerns

against competing concerns for access

and the statutory emphasis on bringing

facilities into compliance rather than

putting them out of business. FDA

believes that its reinstatement policy

strikes the proper balance.

(Comment 181). Two comments

agreed with § 900.11 as proposed.

Another stated that a better definition is

required to differentiate between those

facilities that fail the second film review

and are later reinstated, and those that

fail and submit a new application under

the pretense of being a new facility.

FDA and the accreditation bodies

recognize the risk that might be created

if a facility that failed accreditation is
55888 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

issued a second provisional certificate

under such pretense. FDA has instituted

a variety of measures under the interim

regulations to avoid such occurances,

including close communication among

accreditation bodies, between

accreditation bodies and FDA, and a

policy that each facility provide a

history of previous accreditation

activities with its application. The

facility history requirement has been

codified in the final regulation to

require all applicant facilities to provide

a complete history of prior accreditation

activities, including a statement that all

information and data submitted in the

application is truthful and accurate, and

that no material fact has been omitted.

FDA expects to continue close

communication among accreditation

bodies and FDA to identify potential

problems with this type of

misrepresentation by facilities applying

for accreditation.

(Comment 182). One comment

recommended that § 900.11 be revised

to include the MQSA provision that

authorizes States to perform

certification duties.

The MQSA does provide that States

may serve as certifying bodies (42 U.S.C.

263b(q)). However, this subject is

beyond the scope of these proposed

regulations. Preparations are under way

to draft regulations that will govern

State agencies that wish to become

certifying bodies, and the public will

have an opportunity to comment on

future proposals.

3. Provisional Certification Extensions

(§ 900.11(b)(3)(i))

This paragraph describes the

information a facility must submit to

apply for a 90-day extension of its

provisional certificate.

(Comment 183). One comment noted

that the statute requires FDA to evaluate

requests for 90-day extensions but that

this provision stipulates that a facility

shall submit its evidence in support of

extensions to its accreditation body. The

comment asked if it is FDA’s intent to

transfer this authority to the

accreditation bodies. If it is not FDA’s

intent to transfer this authority to the

accreditation bodies, the comment

requested that, ‘‘* * * its accreditation

body * * *’’ be changed to ‘‘the FDA.’’

The MQSA gives FDA the authority to

evaluate and determine whether or not

a facility qualifies for a 90-day extension

of its provisional certificate, and FDA

does not intend to transfer this authority

to the accreditation bodies. However,

the agency believes that it is in a better

position to render valid decisions on

requests for 90-day extensions if the

accreditation body first reviews and

makes a recommendation on the request

in light of the accreditation body’s

detailed knowledge of the applicant and

other facilities in the area. Therefore,

the final regulation has been amended

to clarify that the accreditation body

will forward the facility’s request for an

extension, along with the accreditation

body’s recommendation. New

§ 900.11(b)(3)(ii) requires accreditation

bodies to forward both requests and

their recommendations to FDA within 2

business days of receipt of the request.

4. Reinstatement Policy (§ 900.11(c))

This paragraph contains the

requirements and procedures for

reinstatement of certification. Under

this provision, FDA may permit a

previously certified facility that has

allowed its certificate to expire, that has

been refused a renewal of its certificate

by FDA, or that has had its certificate

suspended or revoked by FDA, to apply

to have the certificate reinstated.

(Comment 184). Four comments

expressed concern that reopening a

facility whose accreditation has lapsed

may be difficult and that reinstatement

is necessary so that such facilities may

qualify as new facilities and thereby

qualify for issuance of provisional

certificates.

Reinstatement is the appropriate

procedure for reopening a facility whose

certification has lapsed. The MQSA

only allows a provisional certificate to

be issued to new facilities. As noted in

section III.K.2 of this document, any

facility that seeks reinstatement under

this provision of the regulations will

have to provide sufficient information to

its accreditation body to establish that

any problems in meeting the MQSA

standards have been corrected, and that

circumstances are such that the facility

may qualify as a new facility for

purposes of reinstatement. The decision

about whether to apply for

reinstatement is one that each facility

must make based on its own

circumstances. If the costs associated

with such application are too high for

any particular facility, it will forgo

providing mammography services. On

the other hand, if a facility has

determined that it can improve its

practice sufficiently to warrant

reinstatement, or that it wished to

resume a practice it voluntarily closed,

reinstatement will permit such facilities

to qualify for provisional certification as

new facilities, and produce the clinical

images that are necessary for 3-year

accreditation and certification.

5. Justification for Reinstatement

(§ 900.11(c)(1)(iii))

This paragraph requires a facility

applying for reinstatement to justify its

application.

(Comment 185). A comment asked

how this would cover a facility that

allowed its certificate to expire for

reasons other than failure to comply or

qualify.

FDA notes that a justification is

required for all applications for

reinstatement. A facility whose

certificate has expired but that has had

no deficiencies should submit a

corrective action plan that explains the

reasons for expiration and what it has

done or will do to ensure that the

facility meets the MQSA quality

standards at the time of reinstatement.

6. Provisional Certificates to Reinstated

Facilities (§ 900.11(c)(2) and (c)(3))

(Comment 186). Four comments

raised concerns about the

appropriateness of issuing provisional

certificates to reinstated facilities, as the

agency had proposed.

As a result of these comments, FDA

has modified § 900.11(c) to read,

‘‘Reinstatement policy. A previously

certified facility that has allowed its

certificate to expire, that has been

refused a renewal of its certificate by

FDA, or that has had its certificate

suspended or revoked by FDA, may

apply to have the certificate reinstated

so that the facility may be considered to

be a new facility and thereby be eligible

for a provisional certificate.’’ This

change is intended to make clear the

need for a mechanism so that previously

certified facilities that have instituted

corrective actions or wish to resume

services following voluntary cessation

of mammography may be considered

new facilities for purposes of issuing

provision certificates as noted in section

III.K.4 of this document. The agency has

also changed the language of this

provision from ‘‘will’’ to ‘‘may’’ in

§ 900.11(i)(2) to indicate that the agency

retains discretion to accept facilities for

reinstatement.

7. The 2-Year Waiting Period

(§ 900.11(c)(4))

As proposed, this provision stated

that if a facility’s certificate is revoked,

the facility may not be reinstated for 2

years if owned or operated by any

person who owned or operated the

facility at the time of revocation.

Proposed § 900.11(c)(4) did not

accurately reflect the MQSA

requirement because it imposed the 2-

year waiting period on facilities rather

than on persons. The MQSA requires a

2-year waiting period before persons

who own or operate a mammography

facility at the time an act is committed

that results in revocation of the facility’s

certificate may again own or operate a

mammography facility (42 U.S.C.

263b(I)(3)).
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55889

Section 900.11(c)(4), therefore, has

been changed to read, ‘‘If a facility’s

certificate was revoked on the basis of

an act described in 42 U.S.C. 263b(I)(1),

no person who owned or operated that

facility at the time the act occurred may

own or operate a mammography facility

within 2 years of the date of

revocation.’’

(Comment 187). More than 40

comments expressed concern about how

FDA would apply revocation and about

the 2-year waiting period, which many

comments suggested was excessive.

These and related comments to

§ 900.13 suggest an unwarranted

expectation that suspension and

revocation of certificates will be

common practice in the event of

noncompliance with the regulations. As

noted above, the 2-year waiting period

is mandated by the MQSA in the event

of revocation of a certificate. That

timeframe is not subject to modification

by the agency. However, after more than

2 years of enforcement of the MQSA,

FDA has not revoked any certificates

and has only suspended the certificate

of one operating facility. This should

alleviate concerns that this enforcement

action is one FDA is likely to use

frequently or without cause.

The conditions under which FDA

may suspend or revoke a certificate are

set forth in § 900.14. In most cases, a

suspension would precede a revocation

action. As explained in the preamble to

the proposed rule (61 FR 14878),

suspension of a certificate generally

would occur only when all other efforts

to bring a facility into compliance with

the regulations have failed or if

continued operation of a facility would

present a serious risk to human health.

Suspension allows a facility to complete

corrective action under accreditation

body and FDA monitoring, and

subsequently to be reinstated if those

corrections are adequate. FDA generally

intends to revoke certificates only when

corrective and voluntary measures have

failed and the agency has clear evidence

that a facility cannot or will not practice

quality mammography, or in the event

the facility made false statements to

FDA.

Unless other more serious events, as

indicated above, necessitate otherwise,

FDA will not revoke or suspend a

certificate as a result of a finding that a

facility is correcting, is willing to

correct, or has corrected identified

deficiencies. FDA’s goal is to bring

noncompliant facilities into compliance

with the MQSA standards so that they

can produce quality mammograms,

rather than to close facilities. This goal

reflects the intent of the drafters of the

statute; the legislative history discussing

the sanctions provisions, e.g., states that

‘‘the first priority of the Secretary is to

restore a mammography facility to

compliance * * *’’ S. Rept. 102–448, at

2 (1192).

(Comment 188). Ten additional

comments stated that this section is

frightening to many radiologists and

asked who decides when voluntary

action or lesser sanctions have proven

ineffective, and if any third party

reviews agency decisions. FDA will

determine when voluntary or lesser

sanctions have proven ineffective. The

decision to suspend or revoke a

certificate, however, is subject to

challenge by the facility which is

entitled to an informal hearing under 21

CFR part 16, and ultimately subject to

judicial review.

L. Quality Standards (§ 900.12)

1. Personnel (§ 900.12(a))

This paragraph of the regulations

establishes the training and experience

requirements for physicians who

interpret mammograms, radiologic

technologists who perform

mammography examinations, and

medical physicists who have

responsibility for periodically surveying

the mammography equipment and

overseeing the facility’s equipment

quality assurance program. The

requirements include initial

qualifications that must be met before

an individual can begin independently

providing mammography services to the

facility and continuing qualifications

that must be met on an ongoing basis.

Facility recordkeeping requirements

related to personnel are also discussed.

The final regulations generally retain

the same requirements as were outlined

in the proposal. In response to

comments, however, the amount of

training or experience needed to satisfy

particular requirements has been

adjusted in several places. The final

regulations also establish a ‘‘grand

parenting’’ provision for radiologic

technologists.

a. General comments on personnel

section

(Comment 189). General comments

submitted by the public to FDA on

§ 900.12(a) offered contrasting views on

the value of the personnel standards.

One comment applauded the increased

specificity of the proposal over the

interim rules because the changes

clarified what requirements the facility

personnel had to meet. A second

comment likewise noted that the

requirements were ‘‘well presented’’

and clarified a number of issues. In

contrast, a third comment stated that the

more specific requirements made it

harder for facilities to show that the

requirements were met. A fourth

comment found the requirements too

prescriptive (but offered no suggestions

on what could be deleted as

unnecessary), but a fifth comment asked

for even more specificity.

This variety of opinion illustrates the

difficulty of striking the proper balance

between making regulatory

requirements specific enough so that it

is clearly understood what is required

yet general enough to allow for

appropriate flexibility. FDA believes

that the variety of comments indicates

that significant changes to the general

approach taken by the proposal are not

warranted. However, the question of the

proper balance between specificity and

flexibility was reconsidered in response

to comments on particular

requirements.

(Comment 190). One general comment

asked for clarification on who would be

qualified to teach physicians,

technologists, and physicists to use new

technologies as they develop.

FDA believes that the new definition

of qualified instructor (§ 900.2(oo)),

discussed earlier, provides an adequate

means for identifying qualified

instructors. Under this definition,

representatives of the manufacturers

who develop new technology, along

with the physicians, technologists, and

physicists who worked with the

technology while it was in the

investigational stage, would generally be

accepted as qualified to be the initial

instructors in the use of the new

technology. This approach is consistent

with the general practice in the teaching

of medicine.

(Comment 191). Several of the general

comments on the personnel

requirements were based on a

misinterpretation of the proposed

regulations or of the MQSA itself. Six

identical comments argued for retaining

the interim regulations, not because

they opposed the proposed new

requirements as such, but because they

believed that the choice was between

either the interim regulations or

performance-based outcome measures,

such as proficiency testing.

As explained previously, while

comments were requested on the

concept of performance-based outcome

requirements, new performance-based

requirements are not being proposed at

this time.

(Comment 192). Another comment

mistakenly believed the regulations

made investigational use of MRI

unlawful but, in fact, MRI procedures

are not within the scope of the MQSA

(42 U.S.C. 263b(a)(6)). Similarly, two

general comments recommended

removing of this section entirely,
55890 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

reasoning that because FDA does not

impose training or experience

requirements on users of other medical

devices, there was ‘‘no possible

justification’’ for mammography being

treated differently.

In fact, however, Congress has

directed that mammography be treated

differently and required the government

to establish personnel standards (42

U.S.C. 263b(f)(1)(C), (D), and (E)). The

MQSA embodies Congress’s

determination that such standards

would help ensure that mammography

services are provided only by those

qualified to do so.

b. Comments on interpreting

physicians (§ 900.12(a)(1))

The final regulations for interpreting

physicians establish initial professional,

educational, and training qualifications,

as well as requirements for continuing

experience and education. Although

neither a national standard nor a

continuing performance competency

test for mammography interpretation

currently exists, the requirements of

§ 900.12(a)(1) for interpreting physicians

will provide baseline standards to help

ensure the reliability and accuracy of

interpretation of mammograms for

women throughout the country.

The final regulations are generally the

same as those proposed. In response to

comments, however, some new

provisions have been added and several

others were revised as follows: (1) Sixty

rather than 40 hours of documented

medical education in mammography

must be Category I; (2) a new section

was added to clarify the use of CME

obtained by teaching medical education

courses; (3) the mechanism to document

continuing experience and education

requirements has been revised to reduce

the administrative burden on facilities;

(4) additional pathways for physicians

who need to reestablish their

qualifications have been added; and (5)

the initial qualifications have also been

modified to clarify the conditions for

‘‘grand parenting’’ of interpreting

physicians and the initial experience

requirement for some residents. These

changes from the proposal will be

discussed below in connection with the

appropriate provisions.

(Comment 193). Over 100 comments

stated that only radiologists should be

permitted to work as interpreting

physicians.

After considering these comments,

FDA continues to believe that this

additional limit would not be in the

interest of public health. Currently,

there are some physicians, not formally

trained as radiologists, who have met

the requirements of the interim

regulations and are competently

interpreting mammograms. Therefore,

FDA believes that it would be

unnecessarily restrictive to limit

interpreting physicians to radiologists.

By requiring all physicians wishing to

interpret mammograms to meet the

same baseline quality standards of

training, experience, and continuing

education, the goal of ensuring quality

mammography can be achieved without

arbitrary restrictions relating to the

specialty of the particular physician.

(Comment 194). One comment

suggested that interpreting physicians

who practice at more than one facility

should be required to provide proof of

credentials and qualifications only one

time, rather than providing this material

for each facility with which the

physician is affiliated.

FDA disagrees for a number of

reasons. First, the MQSA requires

mammography facilities to meet certain

requirements, including establishing

that its personnel are qualified under

the statute. Because it is the facility that

is responsible and will be inspected, it

is necessary for that facility to have

documentation for all the interpreting

physicians who work there. In addition,

while several of the initial personnel

requirements do not change over time,

some, such as medical licenses, are time

limited and need to be updated.

Similarly, if the continuing experience

and education requirements are not

updated by the personnel, the facility

can be cited for violations of the MQSA.

(Comment 195). One comment stated

that interpreting physicians should be

required to pass an annual, documented

visual acuity test. In response to this

suggestion, FDA notes that while visual

acuity is important, there are no

standards as to what would constitute

acceptable visual acuity. The agency

does not believe it is necessary to

become involved in those details of

physician fitness that are better handled

by licensing authorities.

(Comment 196). Two comments stated

that training in ultrasound should be

required for interpreting physicians as

part of the accreditation program.

Under the MQSA, FDA’s authority to

regulate mammography is limited to

radiography of the breast. Therefore,

requirements related to ultrasound have

not been included in personnel or other

facility standards.

(Comment 197). Two comments

supported FDA’s position that all

physicians reading mammograms

should be required to meet the same

training standards. The comments stated

that this is particularly important with

regard to locum tenens and that

facilities may need to be reminded that

their locum tenens should provide all

appropriate documentation prior to

beginning independent interpretation.

FDA agrees that all personnel are

required to meet the same standards

regardless of whether they work full or

part-time and facilities must make sure

that all the personnel at their facility

meet the necessary requirements.

The quality standards for interpreting

physicians are divided into four

sections: Initial qualifications;

continuing experience and education;

exemptions; and reestablishing

qualifications.

Under § 900.12(a)(1)(i), the first

qualification for an interpreting

physician is a State license to practice

medicine.

(Comment 198). Over 50 comments

recommended that the proposal be

changed to state that all interpreting

physicians should be licensed in ‘‘the’’

State in which they practice.

FDA does not believe the proposed

regulation should be amended.

Although § 900.12(a)(1)(I)(A) requires

the interpreting physician to have ‘‘a’’

State license to practice medicine, in the

vast majority of cases, State laws require

a physician to be licensed in ‘‘the’’ State

in which he or she is practicing. If the

State in which the mammography

facility is located is different from the

State that issued the license, a physician

may have to meet additional State

requirements in order to practice

medicine lawfully at that facility. With

respect to physicians practicing in

Federal facilities, a valid State license

from any State is sufficient. However,

the Federal employee would be unable

to practice outside the Federal facility

unless the physician also fulfilled the

requirements of that State for the

practice of medicine.

Under § 900.12(a)(1)(I)(B), the second

initial qualification for interpreting

physicians is board certification or 3

months of documented formal training

in interpreting mammograms. The

training is to include radiation physics

(including radiation physics specific to

mammography), radiation effects, and

radiation protection.

(Comment 199). Over 80 comments

stated that all interpreting physicians

should be board certified radiologists.

The comments stated that being board

certified establishes that the person

reading the mammogram understands

all the basic principles of physics and

breast anatomy and that this would

ensure the most accurate readings. In

contrast, four comments disagreed with

the use of specialty board certification

as a measure of qualification. These

comments generally argued that

requiring specialty board certification

will adversely affect patient access to
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55891

medical services. These comments also

stated that many individuals certified by

the ABR did not receive formal training

in current mammography techniques

because their training predated the

development of modern mammography

standards. One comment stated that

individuals certified by ABR before

1989 were not examined in

mammography techniques as part of

their board certification process and that

the oral examination process of ABR

certification is highly subjective and

influenced by personality and

demeanor. The comment also claimed

that ABR has awarded board

certification through the ‘‘Class A’’ rule,

in which favorite candidates were

certified without any examination

process, and that ABR does not adhere

to ‘‘due process’’ by using subjective

oral examinations to certify candidates.

In response to criticism of board

certification as fulfillment of an initial

quality standard, FDA notes that the

statute specifically recognizes board

certification as one of the mechanisms

for meeting a portion of the interpreting

physician requirements (42 U.S.C.

263b(f)(1)(D)(I)(I)). In addition, the

agency continues to believe that board

certification is a valid indication of

overall competency. FDA recognizes

that some earlier board examinations

may not have included testing in

mammography. FDA also recognizes

that board certification that includes

mammography testing cannot ensure the

accuracy of outcomes in clinical

mammography practices; no training or

certification program can guarantee

proficiency in all cases. However, board

certification is evidence that the

physician is knowledgeable in the

basics of diagnostic radiology and can

serve as a foundation for the additional

requirements specific to mammography

that interpreting physicians must meet

under FDA’s regulations. The ‘‘Class A’’

rule referenced in the comments was

used in the mid 1930’s during the

startup phase of the ABR in order to

certify those outstanding physicians

who were experienced in the field of

radiology. This rule has not been used

in over 50 years and, since 1940, all

candidates have had to take

examinations. FDA does not believe that

the ‘‘Class A’’ rule has a significant

bearing on the radiologists practicing

today. While FDA does agree that there

is some subjectivity in all tests, the

agency is satisfied that the accepted

boards represent a valid means of

determining general competency. FDA

disagrees with the assertion that the

boards do not adhere to due process.

Formal appeals processes are available

to those candidates who wish to dispute

a board decision. For all these reasons,

FDA believes that board certification

must remain an acceptable way to meet

a portion of the initial qualifications for

mammography personnel.

In response to comments that

questioned the validity of permitting

physicians who are not board certified

to practice mammography, FDA notes

that Congress directed FDA to establish

an alternative pathway to board

certification (42 U.S.C.

263b(f)(1)(D)(I)(II)). FDA believes that

the 3 months of documented formal

training will ensure that all physicians

interpreting mammograms have

received an adequate amount of

instruction.

(Comment 200). Several comments,

including a consensus of NMQAAC,

stated that the 3-month training

alternative was appropriate, but that the

topics, number of hours for each topic,

and the qualifications for those teaching

these topics should be specified.

NMQAAC and others believed that this

training should be limited to that

obtained in a radiology residency

program. Some, including members of

NMQAAC, said that the physics training

should only be obtained from a medical

physicist. One comment suggested that

FDA require a minimum of 200 hours of

physics training.

After considering all the comments,

FDA has concluded that specifying the

precise number of hours spent on each

topic would be too prescriptive and

would curtail the ability of training

programs to individualize their

curricula. FDA also believes that

restricting training to radiology

residency programs or, in the case of

physics, to training by a medical

physicist, would limit adequate training

opportunities. FDA’s experience under

the interim regulations has led the

agency to conclude that adequate

training opportunities are also available

to physicians who are not involved in

radiology residency programs.

(Comment 201). Several comments

stated that FDA should notify the

certifying boards, residency programs,

facilities, and personnel of the new

requirements so that sufficient training

and proper documentation are given to

all physicians. One comment suggested

phasing in the 3-month training

requirement to allow program directors

the time needed to adjust their

curricula. One comment stated that

physicians should be made aware that it

is their responsibility to keep track of

training and continuing education.

FDA agrees with the general points

being made by these comments. The

agency has and continues to provide the

appropriate boards, programs, facilities,

and personnel with the information they

need to meet and document the

requirements of the MQSA. Programs

should have an adequate amount of time

to adapt to the new requirements, which

will not go into effect until 18 months

after publication of this rule.

(Comment 202). Several comments

suggested that 2 months of documented

formal training in the interpretation of

mammography, the current requirement

under the interim regulations, is more

than sufficient and that the increase to

3 months was excessive. One comment

proposed that the 3 months be reduced

to 2 months for those who have been

reading mammograms consistently for 5

years or more. Another comment

suggested that individuals who have

qualified under the interim regulations

should not be required to reapply or

provide further documentation beyond

that which was previously submitted to

FDA.

FDA has received advice from

NMQAAC, AHCPR, and others that 2

months of training for new physicians is

insufficient to cover all the required

topics. AHCPR has advocated 4 months

of training. FDA believes that the

increase from 2 to 3 months is

appropriate and can be instituted by

residency and other training programs

without undue burden. As explained

below, interpreting physicians who

began independent interpretation under

the interim regulations are considered to

have met the initial qualifications under

the final regulations. There will be no

need for them to reapply or supply

additional documentation to FDA. Also,

because the 3-month requirement

applies only to new interpreting

physicians, anyone with the suggested 5

years of consistent experience should

have qualified previously under the

interim regulations.

(Comment 203). One comment stated

that any physician who is not a

radiologist should be required to

demonstrate competency in

mammography through an examination,

in addition to the training requirements.

FDA declines to accept this

suggestion. The agency has concluded,

as discussed earlier, that adequate

training programs can ensure that an

interpreting physician has skills to

practice mammography, regardless of

his or her initial specialty. In addition,

FDA agrees with the many public

comments the agency received

concerning the difficulties associated

with physician competency testing as a

qualifying method. At the present time,

a suitable test to judge the competency

of interpreting physicians does not

exist. This may become an option in the
55892 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

future, but until it does, training

requirements appear to offer the most

satisfactory method of establishing

quality standards.

(Comment 204). One comment

recommended that all interpreting

physicians be urged to meet exactly the

same criteria without regard to board

status. The comment suggested that the

original alternative pathway established

by the interim regulations, 2 months of

documented training in interpreting

mammograms, 40 hours of CME in

mammography, and 15 hours of

Category I CME per 3-year period,

should be required for all interpreting

physicians, even those who are board

certified.

In response to this comment, FDA

notes that the MQSA establishes an

alternative rather than a cumulative

requirement in this matter. While FDA

always encourages individuals to strive

for excellence by exceeding the

requirements, either of the two

pathways (board certification or 3

months training) will be sufficient

training to meet this portion of the

initial requirement. All interpreting

physicians, including those who are

board certified, are required to comply

with the initial and CME requirements.

This has been true under the interim

regulations and will continue to apply

under the final regulations.

The third initial requirement for

interpreting physicians,

§ 900.12(a)(1)(i)(C), is 60 hours of

documented medical education in

mammography, including instruction in

the interpretation of mammograms and

education in basic breast anatomy,

pathology, physiology, technical aspects

of mammography, and quality assurance

and QC. Unlike the proposed rule, the

final regulation requires that all 60 of

these credits be Category I CME. At least

15 of these 60 Category I CME hours

must have been acquired within the 3

years immediately prior to qualifying as

an interpreting physician. Hours spent

in residency specifically devoted to

mammography will be considered as

equivalent to Category I CME and will

be accepted if documented in writing by

an appropriate representative of the

training institution. The specific

mammographic modality training

requirement that was included in the

proposed rule (61 FR 14907) has been

deleted from this part of the final

regulations because it is duplicated in

§ 900.12(a)(ii)(C).

(Comment 205). Several comments

agreed with § 900.12(a)(1)(I)(C) as

originally proposed, while others,

including NMQAAC, maintained that

all 60 hours of credit should be Category

I in order to provide consistency in the

quality of the training. Several

comments recommended that the

number of hours spent in each subject

be specified. Many comments said that

the 40 hours already required by the

interim regulations are sufficient and

that raising the number to 60 would

have a negative impact on cost and the

availability of mammography services.

Several stated that Category II credit is

just as educational as Category I and

should be allowed. One comment

questioned the value of CME

requirements generally, stating that

most of what is said at conferences and

courses is repetitive.

FDA disagrees with the comment

questioning the usefulness of CME. The

agency believes that 60 hours of training

is in keeping with current trends in

training and the emergence of new

technologies. Because this expanded

requirement will apply only to new

interpreting physicians and time spent

in residency specifically devoted to

mammography will be accepted toward

meeting this requirement, FDA does not

believe that the number of hours

required will have a negative impact on

availability of services. FDA has been

persuaded by the comments and its

experience under the interim

regulations that all 60 hours should be

Category I. Category I CME credits are

generally those that offer more formal

training and provide a solid basis for the

ongoing maintenance and growth of the

interpretive skills of the physician.

While Category II hours may be useful,

the variability of such education and the

difficulty in documenting such training

convinced FDA to strengthen the

requirement by making all 60 hours

Category I. FDA has not specified the

number of hours required to be spent in

each subject because the agency believes

that this would be too restrictive and

would limit the ability of physicians

and programs to individualize training.

(Comment 206). Three comments

recommended that FDA clarify that the

persons providing this training be in

active practice and individually fulfill

these qualifications.

FDA disagrees with these comments.

It is not necessary for all of the persons

providing the training to meet the

qualifications of interpreting physicians.

For example, those teaching basic breast

anatomy, pathology, or physiology do

not have to be interpreting physicians to

provide expert instruction in those

subjects.

(Comment 207). One comment

asserted that 40 or 60 hours of training

does not qualify someone to read a

mammogram.

In response to this comment and

others that questioned the clinical value

of any particular requirement, FDA

agrees that 60 hours of training alone

does not qualify a physician to read a

mammogram. However, this is only one

of a series of requirements; the

combination of requirements relating to

training, experience, and continuing

education is intended to provide

assurance that those interpreting

mammograms meet baseline quality

standards.

The final initial qualification relates

to experience reading mammograms.

Section 900.12(a)(1)(I)(D) requires the

qualifying physician to interpret or

multi-read at least 240 mammographic

examinations within the 6 months

immediately prior to the date that the

physician qualifies as an interpreting

physician. This interpretation or multireading shall be under the direct

supervision of an interpreting

physician. The intent of this

requirement is to demonstrate recent

supervised experience before the

physician begins to interpret

mammograms independently. Although

the language has been clarified, this

requirement is essentially unchanged

from the proposal.

(Comment 208). Several comments

misinterpreted the proposed

requirement to mean that interpreting

physicians would have to interpret 240

studies under direct supervision any

time he or she changed facilities.

That interpretation is incorrect. This

is an initial requirement for the

individual prior to beginning practice as

a new interpreting physician and is

independent of the number of facilities

at which the physician works.

(Comment 209). Two comments

suggested that the requirement to

interpret 240 mammograms under direct

supervision should be revised to be 240

within the last 2 years of training prior

to qualification as an interpreting

physician. The comments stated that the

requirement of 240 mammograms in the

last 6 months of training is virtually

impossible for any residency program

with more than 6 residents in any

postgraduate year.

FDA agrees. Both the proposal and the

final rule include a provision that

allows residents to meet this

requirement in the last 2 years of their

radiology residency programs if they

become appropriately board certified at

the ‘‘first allowable time.’’ See

discussion of § 900.12(a)(1)(iii)(B) that

follows.

(Comment 210). One comment asked

for clarification concerning the 240

mammograms that a physician must

interpret for initial training. The

comment wanted to know if two
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55893

readings of a mammogram can be

counted as two interpretations.

Multi-reading, as defined in

§ 900.2(ff), allows two or more

physicians to read the same

mammogram and each may count it as

one interpretation. However, one

physician may not read the same

mammogram twice and count it as two

separate interpretations.

(Comment 211). Several comments

stated that physicians should be given a

document stating the number of

mammograms read after completing

residency training. This would assist the

facility in making sure physician

requirements are met.

FDA agrees that this is a good idea

and has and will continue to inform

residency programs of the benefits of

such a policy. However, FDA does not

regulate residency programs and cannot

require that such programs provide this

documentation.

(Comment 212). Several comments

recommended that the supervised

interpretation required for initial

qualification be performed under

someone qualified to teach

interpretation. NMQAAC recommended

that this training be obtained in a

radiology residency program.

While the majority of interpreting

physicians will receive this training in

their residency program, FDA believes

that restricting such training to only

those in radiology residency programs

would unnecessarily limit the

availability of adequate training

opportunities. As previously discussed,

FDA’s experience under the interim

regulations has led the agency to

conclude that adequate training

opportunities exist outside of radiology

residency programs.

Section 900.12(a)(1)(ii)(A) is the first

of the requirements established to

ensure that interpreting physicians, who

have met initial requirements, maintain

their qualifications as they practice

mammography. Under this requirement,

in order to continue to qualify under the

MQSA rules, interpreting physicians are

required to have interpreted or multiread at least 960 mammographic studies

in the previous 24 months. Although the

wording has changed somewhat from

the interim and the proposed final rules,

there has not been a substantial change

in this requirement. The proposal has

been amended so that a total of 960

examinations have to be interpreted in

the previous 24 months instead of the

previous formulation of an average of 40

examinations per month over 24

months. This requirement continues to

provide flexibility to physicians who

find they need or want to interrupt their

practice for periods of time for personal

or professional reasons (e.g., maternity,

illness, sabbaticals). The wording has

also been revised to clarify that the 24

months can be measured in any of the

following ways: From the date of the

annual inspection of the facility at

which the interpreting physician works;

from the last day of the calendar quarter

immediately preceding the annual

inspection date; or from any date in

between the two. These options will

ease the paperwork burden on the

facility and allow the facility to gather

and monitor this information in a more

efficient manner. For example, rather

than tabulate daily or monthly totals,

the facility may wish to tabulate this

data only at the end of the quarter prior

to the next expected annual inspection.

FDA strongly recommends that facilities

use the same tabulation method and the

same option for determining the 24-

month period for all of their personnel

for simplicity and to help achieve

consistency within the facility.

However, this is not required.

(Comment 213). Ten comments stated

that diagnostic radiology graduates who

pursue a fellowship in a field other than

mammography face a difficult situation

and will unnecessarily burden

supervising physicians when they

resume mammographic interpretation at

the end of these fellowships. The

comments stated that interpreting

physicians who meet the requirements

for 2 months training during residency

and pass the certifying board exams

have been adequately educated, and

their interpretations do not need to be

supervised when they resume reading

mammograms.

FDA disagrees and has received

advice from many groups, including

NMQAAC, that continuing experience is

a necessary requirement to help ensure

the accuracy of mammographic

interpretation. FDA believes that it is in

the best interest of the patient for

physicians who have not interpreted the

required number of studies in the

previous 24 months to be supervised

prior to independent interpretation.

This requirement applies equally to

radiology fellows who have been

outside the practice of mammography as

well as to interpreting physicians who

stop practicing for a significant period

of time.

(Comment 214). FDA received 17

comments addressing the issue of

interpreting an average of 40

mammographic examinations per

month. Of these, 7 agreed with the

proposal or recommended a higher

number of examinations, while 10

asserted that the requirement was

unnecessary, or that the number was too

high and would adversely effect low

volume or rural facilities.

FDA believes that all women,

including those in rural areas, are

entitled to the same quality of care. The

agency cannot support lower standards

for particular facilities. The agency also

believes that it will not be difficult for

most physicians to meet this continuing

qualification, even for those in rural

areas. The agency also wants to clarify

that this is a physician requirement, not

a facility requirement. Interpreting

physicians who provide services to low

volume facilities can interpret films at

more than one facility to attain the

required number of examinations.

Multi-reading of images previously

interpreted by another physician is also

accepted as a way of meeting this

requirement. However, the physician

may not count interpretation of the

same mammogram more than once.

Currently, under the interim

regulations, multi-reading is being used

successfully by some interpreting

physicians to meet this requirement. For

all of these reasons, the agency believes

this requirement will not cause a

mammography access problem.

FDA recognizes that numbers alone

cannot guarantee competency, but

believes that the experience a

radiologist accumulates through

interpreting a certain minimum number

of studies is a necessary aspect of the

qualification process. In § 900.12(f),

FDA has issued requirements for the

establishment and implementation of a

medical outcomes audit for individual

physicians. When used properly, this

type of monitoring can further improve

the reliability, clarity, and accuracy of

interpretation of mammograms.

(Comment 215). One comment stated

that FDA should not set a maximum

number of films that can be read by an

interpreting physician.

FDA agrees. There is nothing in the

MQSA or the regulations that

establishes such a limit.

Section 900.12(a)(1)(ii)(B) requires

interpreting physicians to further

maintain their skills by teaching or

completing at least 15 Category I CME

credits in mammography in the

previous 36 months. This training must

include at least six Category I

continuing education credits in each

mammographic modality used by the

physician. As with the continuing

experience requirement, FDA has

modified the language of the proposal to

allow facilities greater flexibility and

efficiency in tabulating this data for

interpreting physicians working at the

facility.

(Comment 216). Seventeen comments

raised questions about CME in
55894 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

technologies that do not fall within the

scope of the MQSA, such as ultrasound

or MRI. These comments asked whether

6 hours of CME in each of these breast

imaging applications is required and, if

not, can such continuing education in

these technologies nevertheless be used

to satisfy the CME requirements. Two

comments suggested further

clarification of what activities are

acceptable as CME.

Because these technologies are

outside the scope of the MQSA, there is

no requirement for a physician to have

continuing education in them in order

to qualify under the MQSA. CME in

such technologies may, however, be

applied to fulfill a portion of the

continuing education requirement if

that continuing education is likely to

aid the physician in the understanding

of mammographic breast cancer

detection. CME in ultrasound and MRI

of the breast would fall into this

category and could be used to fulfill a

portion of the continuing education

requirement.

(Comment 217). Several comments

supported the requirement for

interpreting physicians to obtain at least

15 Category I CME every 3 years. Others

asserted that there was no clear basis for

the requirement. One comment stated

that the interim rule requirements

regarding completion of CME are

unnecessarily bureaucratic because

one’s knowledge does not suddenly

expire with an arbitrary deadline. Two

comments maintained that the cost and

number of man-hours required by these

regulations is a serious burden,

particularly considering that there is no

scientific evidence that these efforts will

result in improved medical care.

Another comment indicated that

training in each mammographic

modality is already part of training

programs and, for the vast majority of

individuals, training is unnecessary

because they have been providing

services in these modalities for many

years. This comment and others asserted

that requirements for additional

documentation of continuing education

is unnecessarily burdensome for

physicians who can demonstrate that

they have completed an accredited

program and have appropriate

certification.

FDA has been advised by NMQAAC

and professional organizations, such as

ACR, that continuing education is

necessary in order to maintain skills in

an ever changing field of medicine. The

agency agrees and notes that the statute,

42 U.S.C. 263b(f)(1)(D)(ii), establishes a

general requirement for continuing

education. FDA has required that the

credits be Category I CME in order to

ensure that continuing education is

more formal, can be documented, and

contributes to the development of the

professional skills of the physician. FDA

believes that there are many avenues for

obtaining this education and that the

cost and man-hours required will not be

overly burdensome on physicians. This

requirement, as it relates to timeframes

for monitoring compliance, has been

modified from the proposal in a manner

similar to that for continuing

experience. This change will clarify that

facilities need not update CME for

physicians on a daily or monthly basis.

FDA has evaluated many different

scenarios for use as averaging periods

and reviewed this particular issue with

NMQAAC.

(Comment 218). Several comments

recommended that CME be averaged

over a fixed 3-year period rather than on

any given day. FDA notes that under a

fixed 3-year period, physicians could

acquire CME credits at the beginning of

one period and at the end of the next,

resulting in a span of almost 6 years in

which the physician had not received

any CME.

FDA has concluded that the present

floating 36-month period is more likely

to contribute to quality mammography.

A floating 36-month period eliminates

the possibility that physicians will go

for extended periods of time without

continuing education. At the same time,

it still permits physicians to devote their

time to longer courses, when they are

available, and to update their CME

when the best opportunities for training

arise, regardless of when that offering is

made within the 36-month period.

(Comment 219). One comment

recommended that interpreting

physicians be tested every 2 years to

keep up to date with all changes in the

discipline.

FDA believes that, at the present time,

there is no adequate proficiency test to

judge the continuing competency of

interpreting physicians. For the

foreseeable future, continuing

experience and education requirements

appear to offer the most satisfactory

method for establishing compliance

with these personnel standards.

(Comment 220). One comment

requested stricter control over

acceptable ways for an interpreting

physician to obtain continuing

education units in mammography. The

comment claimed that interpreting

physicians who do not attend actual

view box classes, but get their CME from

a syllabus, have higher call back rates

on films that they interpret. The

comment recommended that all

interpreting physicians be required to

attend actual hands-on training

seminars.

FDA disagrees with this comment.

After discussion with NMQAAC, the

agency believes that limiting continuing

education to hands-on training would

greatly restrict the ability of many

interpreting physicians to obtain such

training, without providing a

documented corresponding benefit.

FDA believes that syllabi and other

types of training can be as beneficial as

hands-on training.

(Comment 221). Several comments,

including some from NMQAAC,

indicated that a better definition of

modality was needed. In order to reduce

any confusion, the term ‘‘modality’’ has

been changed to ‘‘mammographic

modality’’ to emphasize that the term

does not refer to nonmammographic

techniques, such as ultrasound or MRI,

that may be used to examine the breast.

Several comments stated that the

requirement for six Category I CME

credits in each mammographic modality

is impractical and recommended that

the continuing education qualification

be left at 15 Category I credits in breast

imaging, as required under the interim

regulations. The comments went on to

say that radiologists do more than just

breast imaging and that, in any case,

breast imaging courses do not list their

credits by mammographic modality.

FDA believes that the requirement for

six Category I CME credits in each

mammographic modality used by the

interpreting physician is consistent with

the goal of maintaining expertise. At the

present time, there are only two

mammographic modalities available,

film screen and xeromammography.

More than 99.5 percent of facilities are

using only one mammographic

modality, namely film screen. Currently,

because there is only one

mammographic modality generally

used, this requirement would not create

an additional burden for the vast

majority of physicians. When digital

mammography becomes available, those

physicians using both film screen and

digital modalities would have to acquire

at least six category I CME credits in

each of these mammographic modalities

over a 3-year period. If three different

mammographic modalities become

available and all three were used by an

interpreting physician, that physician

would have to accumulate at least 18

Category I credits in the previous 36-

month period, 6 in each mammographic

modality. It is true that designation of

CME credits in mammographic

modalities other than film screen is not

commonplace at the present time.

However, as courses become available

in digital mammography, the number of
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55895

hours devoted to the new

mammographic modality can be

documented by the course sponsors. In

the meantime, keeping a copy of the

program outline listing the lecture titles

will serve as adequate documentation

for the MQSA inspectors.

Section 900.12(a)(1)(ii)(C) requires

that, before using a new mammographic

modality in his or her practice, the

interpreting physician must have at

least 8 hours of training with that

mammographic modality.

(Comment 222). Several comments,

including those from NMQAAC,

supported this requirement, while many

others wanted additional clarification or

stated that 8 hours was excessive

because similar skills are used in all

mammographic modalities. Several

comments asked how this training could

be obtained and documented in light of

the fact that CME courses do not

presently provide such training or give

certificates in such detail.

FDA believes that 8 hours of training

in a new mammographic modality is an

appropriate baseline. FDA agrees that

there is overlap in the skills necessary

to interpret studies done by different

mammographic modalities. However,

there are enough differences to justify

this additional education. Before a

physician begins to interpret images

produced by a particular

mammographic modality, the agency

believes that the physician should have

specific training in the interpretation of

such images. Until new mammographic

modalities become widely available,

there may be a paucity of formal CME

courses giving such instruction. FDA

recognizes this and, therefore, has not

required that this be Category I CME.

This will allow other entities, such as

equipment manufacturers, to supply the

initial training. In this way, physicians

and other personnel will be able to

obtain the required 8 hours of training

from sources intimately associated with

the new equipment they will be using.

Formal category I CME courses will also

be accepted. As mentioned previously,

for those courses that do not list the

CME by mammographic modality, the

program outline can serve as

documentation of how much time was

spent in the new mammographic

modality.

(Comment 223). Many comments

interpreted this requirement to mean

that physicians must receive 8 hours of

CME credit in xeromammography,

which is now used very infrequently.

These comments misinterpreted this

requirement, which applies only when

a physician begins using a

mammographic modality in which he or

she has not been previously trained.

Because xeromammography is seldom

used today, it would be extremely

unlikely for an interpreting physician to

begin using this mammographic

modality for the first time. It would only

be in this unlikely circumstance that the

interpreting physician would have to

obtain 8 hours of xeromammographic

training.

(Comment 224). One comment

suggested that, in addition to this

requirement, the physician should also

be required to interpret a specified

number of mammograms from the new

modality under the supervision of a

qualified interpreting physician before

independent interpretation.

FDA does not support this additional

requirement. While supervised

interpretation might benefit interpreting

physicians who begin using a new

modality, the agency does not believe

this qualification needs to be mandated

for physicians who are already

experienced in interpreting

mammograms through another

mammographic modality. Such a

requirement could hinder the

introduction of new mammographic

modalities by raising the cost of initial

training and significantly reducing

access.

With the concurrence of NMQAAC,

§ 900.12(a)(1)(ii)(D) was added to the

final regulations to clarify that CME

earned by teaching a particular course

could be counted only once towards the

15 credits for an interpreting physician

under § 900.12(a)(1)(ii)(B).

Section 900.12(a)(1)(iii) establishes

exemptions from certain personnel

requirements for interpreting physicians

in specific cases. Section

900.12(a)(1)(iii)(A) exempts physicians

who qualified under the interim

regulations from the new and additional

initial requirements in § 900.12(a)(1)(i):

The additional month of training for

physicians using the alternative

pathway; the additional 20 hours of

CME; and the requirement that 15

Category I CME credits must have been

acquired in the 3 years immediately

before qualifying as an interpreting

physician.gi11(Comment 225). One

comment opposed ‘‘grand parenting’’ of

interpreting physicians who qualified

under the interim regulations because of

the ‘‘minimal standards’’ required under

the interim regulations. Another

comment agreed with the regulation as

written.

In order to ensure continuing and

uninterrupted availability of

mammographic services and because

FDA’s inspections over the past 2 years

do not demonstrate problems with these

physicians, FDA is permitting those

interpreting physicians who qualified

under the interim regulations to

continue to interpret mammograms,

provided that they maintain the

continuing experience and education

requirements in § 900.12(a)(1)(ii). As

discussed in connection with other

personnel requirements, the agency has

determined that qualifying standards

should be raised as new personnel

qualify in the future because of

increasingly complex and changing

technologies. The agency has also

concluded that the need for continued

availability of services, fairness to

practicing personnel, and the

compliance record of facilities with the

MQSA over the past years justify

permitting personnel who qualified

under the interim regulations to

continue to practice. FDA believes the

final rule strikes the proper balance

among these considerations and is in

the best interest of the public health.

Section 900.12(a)(1)(iii)(B) establishes

another exemption in response to

concerns raised by members of

NMQAAC and others that the initial

experience requirement in

§ 900.12(a)(1)(i)(D) may pose a problem

for residency programs that schedule

mammography rotations earlier than the

final 6 months in the residency

program. Instead of requiring the initial

reading experience to be completed in

the last 6 months prior to initial

qualification, this provision has been

amended to permit some residents to

satisfy the requirement by having

interpreted at least 240 mammographic

examinations under the direct

supervision of an interpreting physician

in any 6-month period during the last 2

years of the residency. This exemption

is available only to those residents who

successfully become board certified at

the ‘‘first allowable time,’’ which means

the earliest opportunity provided by an

eligible certifying board. The physician

who qualifies for this exemption would

become responsible for fulfilling the

continuing education and experience

requirements of § 900.12(a)(1)(ii)

beginning on the date of that physician’s

board certification in diagnostic

radiology, provided the other initial

requirements are satisfied. If the

physician does not become board

certified at the first allowable time by

the certifying board, the exemption does

not apply and the physician must

interpret 240 mammographic

examinations under the direct

supervision of an interpreting physician

within a period of 6 months

immediately prior to initial qualification

as an interpreting physician.

(Comment 226). Several comments

said that this exemption was still too

restrictive and recommended that the
55896 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

requirement be expanded to allow

reading at any time during the

residency, rather than within the final 2

years. Some believed the requirement

was too stringent because the exemption

was available only to those residents

who became board certified at the ‘‘first

allowable time.’’ One comment asserted

that residents who did not pass the

boards at the first allowable time were

no less qualified to perform

mammography than the resident who

successfully completed the boards,

unless the physician failed the

mammography section.

After considering these comments,

FDA has concluded that the final

regulations provide sufficient flexibility.

The exemption permits residents to

interpret the required number of

mammograms in any 6-month period

during the last 2 years of their residency

program, as long as they become board

certified the first time they are eligible.

This allows residency programs

flexibility in scheduling their residents

and prevents the scenario of having all

senior residents doing their

mammography rotation during the same

6-month period. FDA believes that

mammography interpretations

performed more than 2 years before

completion of a residency program are

not recent enough to qualify as initial

experience, even in the situation where

residents become board certified at the

first allowable time. FDA expects that

the 2-year time period will allow

participants in virtually all residency

programs to comply with the regulation.

A baseline standard in general radiology

would be ensured by the fact that

residents qualifying for this exemption

would have passed their certification

boards, including the mammography

section. Those residents not

successfully completing their board

certification at the first allowable time

would not be eligible for this

exemption.

(Comment 227). Several comments

stated that this exemption should be

revised to allow an individual

completing a radiology residency

program and progressing on to a 1-year

fellowship to qualify under

§ 900.12(a)(1)(iii)(B).

FDA disagrees and believes that

meeting the initial requirements and

qualifying for this exemption is

independent of any additional training

the individual may obtain. As discussed

previously in connection with

continuing experience requirements,

FDA believes it is in the best interest of

public health that interpreting

physicians, including radiology fellows

who have been outside the field of

mammography, have relatively recent

experience before beginning or

resuming independent interpretation.

Section 900.12(a)(1)(iv) provides a

method for physicians to reestablish

their qualifications as interpreting

physicians in the event they do not

maintain the continuing experience or

education requirements. Section

900.12(a)(1)(iv)(A) requires the

physician who has failed to meet the

continuing experience requirement to

interpret or multi-read either 240

mammographic examinations or enough

mammographic examinations to bring

the physician’s total up to 960 for the

prior 24 months, whichever is less.

These interpretations shall be under the

direct supervision of an interpreting

physician and occur within the 6

months immediately prior to resuming

independent interpretation. This section

was modified from the original proposal

to be consistent with policies that have

been successfully implemented under

the interim regulations to deal with

physicians who need to reestablish their

qualifications.

Section 900.12(a)(1)(iv)(B) requires

physicians who have not maintained the

continuing education requirement to

obtain a sufficient number of Category I

CME credits in mammography to bring

their total up to the required 15 credits

in the previous 36 months. A physician

who fails to maintain continuing

experience or education requirements

may not serve as an interpreting

physician until he or she reestablishes

those qualifications.

(Comment 228). Two comments stated

that there should be a penalty for

physicians who do not meet the

requirements in the appropriate

timeframe.

FDA believes that temporary

disqualification from independent

interpretation is the most effective and

appropriate penalty in these situations.

The purpose of the regulations is to

ensure that personnel meet baseline

standards. Under the final regulations,

physicians who do not maintain the

required number of interpretations or

earn the necessary CME credits must

cease independent interpretation of

mammograms until such time as they

complete a sufficient number of

supervised interpretations or CME to

meet the requirements. This is the best

way to protect the public health. FDA

disagrees with the comment that the

physician should be penalized in some

additional manner for not having

maintained the continuing

requirements.

c. Radiologic technologists

§ 900.12(a)(2)

FDA’s interim and final regulations

for radiologic technologists performing

mammography both seek to ensure that

technologists: (1) Possess adequate

general qualifications for performing

radiologic examinations; (2) possess

adequate specific qualifications for

performing mammography

examinations; and (3) maintain these

qualifications over time. The changes

from the interim regulations to the final

regulations were primarily clarifications

with some additional requirements to

address concerns that became apparent

as the interim regulations were

implemented. In response to comments

on the proposed rule, a number of

changes have been made. A ‘‘grand

parenting’’ provision has been added to

qualify those technologists who met the

interim requirements as fulfilling the

initial training and experience

requirements of the final regulations.

The final regulations also relax the

requirements that had been proposed for

training specific to imaging patients

with implants and reduce the number of

supervised examinations that have to be

performed as part of the initial

requirements and to ‘‘requalify’’ in cases

where the continuing experience

requirement has not been met. The

following changes are discussed in

connection with the specific provisions.

The general issue that drew the most

comments was the question of whether

a ‘‘grand parenting’’ clause should be

added for presently practicing

technologists.

(Comment 229). Over 30 comments

urged that technologists who met the

qualification requirements of the

interim regulations should be deemed to

meet those of the final regulations. An

additional six comments urged that

technologists who have earned the

advanced certificate in mammography

from the American Registry of

Radiologic Technologists (the ARRT(M))

should be accepted as meeting the final

regulations.

(Comment 230). Three comments

recommended that either 40 hours of

training or 20 hours and the ARRT(M)

be the basis for grand parenting, while

another comment urged that ‘‘years of

experience’’ be the basis for grand

parenting. Members of NMQAAC also

recommended the addition of a limited

grand parenting provision. Specifically,

NMQAAC recommended limiting grand

parenting to technologists who met the

initial training requirements of the

interim regulations by receiving 40

hours of training or earning the

ARRT(M) (two of the several options

that FDA had accepted under the

interim regulations) and who had also

performed at least 100 examinations.

Many comments expressed concern

that, without grand parenting of present
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55897

technologists, there would be no one

qualified to practice under the final

regulations without more training. The

comments asserted that these training

demands would be expensive, disrupt

facility routine, and overwhelm the

training resources available to

technologists. Some of the comments

further argued that there would be no

one qualified to provide this training.

The agency has been persuaded by the

comments it received and the advice of

NMQAAC that ‘‘grand parenting’’

provisions should be added to the

technologist requirements. Under the

final regulations technologists who have

met the requirements of § 900.12(a)(2) of

the interim regulations by the effective

date of the final regulations will be

considered to have met the initial

mammography training and experience

requirements in the new regulations.

Section 900.12(a)(2)(ii) of the final

regulations has been revised to reflect

this. This change will achieve

consistency with grand parenting

provisions already existing for the other

personnel groups. Although FDA

believes that there are many

technologists presently practicing who

will meet the requirements of the final

rule, this change will ensure that there

will be an adequate number of qualified

personnel to perform examinations and

teach new technologists after the final

regulations become effective.

FDA did not extend this grand

parenting to the continuing education

and experience requirements of

§ 900.12(a)(2)(iii) and (iv). Because these

are ongoing requirements intended to

ensure that technologists keep their

skills sharp and their knowledge up-todate, past qualifications can not be used

to meet these requirements. Similarly,

FDA did not include the general

licensing or certification requirement

established by § 900.12(a)(2)(i) as a

qualification that could be grand

parented. Because the license or

certificate has to be renewed on a

periodic basis, fulfilling this

requirement in the past cannot justify

exempting technologists from the need

for future renewal.

On the other hand, FDA has declined

to adopt the limitations on grand

parenting proposed by NMQAAC.

Under the interim regulations, FDA has

accepted a number of ways for

technologists to meet the initial

mammography qualifications.

Successful completion of 40 hours of

training or the ARRT(M), the exclusive

methods recommended by NMQAAC,

are only two of these ways. Other ways

technologists have been accepted as

meeting the initial training requirement

include obtaining a mammography

certificate from the States of California,

Arizona, and Nevada and successfully

passing a comprehensive training course

that is less than 40 hours in length but

meets other rigorous criteria. Still other

technologists have been accepted as

qualified after a case-by-case evaluation

of their qualifications. FDA estimates

that as many as several thousand

technologists might be disqualified if

the NMQAAC recommendation was

accepted, creating a potentially serious

impact on access to mammography, and

individual hardship. FDA has no

evidence to indicate that these

technologists as a group are performing

inadequately and, therefore, has

retained them within the scope of the

grand parenting provision.

The requirements of § 900.12(a)(2)(i)

are intended to provide some assurance

that the radiologic technologist is

qualified to perform radiologic

examinations.

(Comment 231). Two comments

supported this requirement as written,

but others suggested various changes.

Over 20 comments stated that

technologists should be required to be

licensed in ‘‘the’’ State in which they

were practicing or, at least, if they met

§ 900.12(a)(2)(i) through a State license,

that it should be a license in ‘‘the’’ State

of practice. A related comment

suggested that FDA require

technologists to meet State requirements

that are as stringent as FDA’s.

FDA has not accepted the suggestions

made by these comments for a number

of reasons. First, the statute provides

that technologists be given a choice

between State licensure or certification

by a professional body (42 U.S.C.

263b(f)(1)(C)(i)) and the law also

requires that the license be from a State,

not ‘‘the’’ State of practice. FDA can not

limit the choices established by the

statute and notes, in addition, that some

States do not have technologist

licensure. FDA also believes it to be

beyond the authority conferred upon it

by the MQSA to stipulate State

licensure requirements.

(Comment 232). One comment

recommended that there should be

national licensing of mammography

technologists.

FDA does not believe that the MQSA

contemplated the establishment of a

national licensing requirement to

replace State standards and procedures.

The statute’s specific reference to State

licensing as an alternative requirement

supports this conclusion (42 U.S.C.

263b(f)(1)(C)(i)(I)).

(Comment 233). With respect to

certification, one comment urged that

the general certification be limited by

regulation to that of ARRT.

FDA agrees that ARRT general

certification meets the requirements of

§ 900.12(a)(2)(I) and, in fact, this is

presently the only certification accepted

by the agency for this purpose.

However, as discussed in the proposal,

FDA does not want to codify a list of

eligible certifying bodies because that

will restrict its ability to add or delete

organizations in a timely manner (See

61 FR 14900).

(Comment 234). Two comments

suggested that FDA require certification

bodies to establish a special

mammography certification program

based upon 6 months of training as an

alternative to the general certification or

licensing requirement.

FDA does not believe that this is

necessary. Certification bodies are free

to establish alternative programs and

expand existing ones and FDA will

evaluate such programs on a case by

case basis. However, the increased level

of training contemplated by this

suggestion may not justify the cost.

Similarly, although FDA believes that

the suggestion in another comment that

technologists be required to watch

radiologists read films 8 hours every 6

months to improve ‘‘rapport’’ may be

useful training, FDA has no evidence

that the expected benefit would warrant

mandating such a requirement.

The provisions of § 900.12(a)(2)(ii) are

intended to provide some assurance that

technologists possess adequate

qualifications specific to mammography

before beginning to perform

mammography examinations.

(Comment 235). One issue related to

these requirements drew several

hundred comments, the largest number

received on any part of the proposed

regulations. This issue was the value of

earning the ARRT(M) in meeting the

specific mammography requirements for

radiologic technologists. Unfortunately,

over 80 percent of these comments,

consisting primarily of multiple copies

of 8 or 10 similar form letters, were

based on a misunderstanding conveyed

by an article in a journal that is widely

distributed to mammography facilities.

Many comments were based on an

impression gained from this article that,

because the ARRT(M) was not

mentioned specifically in the

regulations, it would have no weight in

meeting the requirements. Some

comments even indicated a belief that

FDA would somehow ‘‘take away’’ the

certification that the authors of the

comments had worked so hard to

obtain.

The authors of these comments

unfortunately did not understand that

the ARRT(M) has been given great

weight under the interim regulations as
55898 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

evidence that the technologist is

adequately qualified, even though it is

not mentioned explicitly in those

regulations. In fact, none of the large

number of certificates or training

programs that FDA has accepted to meet

part or all of the personnel training

requirements are mentioned in the

interim regulations. FDA, moreover,

stressed in the proposed regulations that

the agency has ‘‘recognized the value of

training hours required for ARRT

special certification’’ and intends to

continue to do so (61 FR 14094).

Specific mention of a credential in the

regulations is not necessary for

acceptance and, as discussed earlier, the

agency has concluded that codifying

particular organizations or programs

will hamper the agency’s ability to

evaluate training programs on a case-bycase basis and to make timely changes

in the acceptance of such training (61

FR 14900, 14904).

FDA regrets the distress this

misunderstanding has caused many

technologists and has contacted as many

of the authors of these comments as

possible to ease their concerns over the

issue. The agency also has offered to

work with the journal and the author of

the article to ensure greater accuracy in

future articles on the MQSA

requirements. The journal has published

the FDA correction of the article in an

attempt to dispel this misunderstanding.

(Comment 236). Some of the

comments received about the ARRT(M)

made specific suggestions as to what

type of recognition it should receive.

Nearly 150 comments expressed the

opinion that the ARRT(M) should be

required of all technologists doing

mammography, while over 40 more

stated that it should be required in

association with other training.

While FDA recognizes the great value

of the ARRT(M) and intends to continue

to accept it towards meeting the 40-hour

requirement for radiologic technologists,

the agency will not designate that

particular certificate as a required or

exclusive standard. FDA has no basis for

establishing the ARRT(M) as the only

way of demonstrating training in

mammography. Furthermore, before a

technologist can earn the ARRT(M), she

or he must first earn general

certification from the ARRT. The MQSA

establishes that technologists have two

alternative routes for general radiologic

training: Either State licensure or

certification by an approved

professional group (42 U.S.C.

263b(f)(1)(C)(i)). If FDA were to require

the ARRT(M), it would effectively

eliminate the State licensure route to

general qualification, in contradiction to

the statuary provisions.

(Comment 237). Over 50 comments

urged that the ARRT(M) be accepted as

an alternative to the 40 hours of training

required by § 900.12(a)(2)(ii). This also

was the recommendation of NMQAAC

members at the January 1997 meeting,

although at earlier meetings NMQAAC

had recommended that the ARRT(M) be

accepted as equivalent to only 20 hours

of training. One comment questioned

the value of the ARRT(M), based on the

opinion that the examination that must

be passed to receive the ARRT(M) was

not sufficiently specific to

mammography.

FDA will not accept the ARRT(M) in

lieu of the 40 hours of training required

by § 900.12(a)(ii). The ARRT itself has

recognized earning the ARRT(M) as

equivalent to 24 hours of training. FDA

does not have a basis for disagreeing

with this evaluation by the sponsoring

organization and, in most

circumstances, intends to evaluate the

ARRT(M) as equivalent to 24 training

hours. FDA also notes that the

performance of clinical examinations is

a required component of the 40 hours of

training required under § 900.12(a)(2)(ii)

of the final rules. FDA has been

informed by members of NMQAAC and

others that technologists can and do

pass the test for receiving the ARRT(M)

without having performed any

mammography examinations. For these

reasons, although FDA did accept the

ARRT(M) as meeting the interim

regulation requirement to have training

‘‘specific to mammography,’’ and will

continue to do so until the effective date

of the final regulations, the ARRT(M)

will not be considered equivalent to the

final requirement of 40 hours of

training, which must include the

performance of examinations.

(Comment 238). Over 100 comments

urged that the ARRT(M) be accepted as

meeting at least part of the 40-hour

training requirement of

§ 900.12(a)(2)(ii). Another 27 comments

made suggestions for the number of

hours for which it should be accepted,

with the numbers varying from 5 to 30

hours.

FDA agrees that the ARRT(M) is

acceptable for meeting part of the

training requirement. Also, as already

noted, the agency intends to accept the

ARRT’s estimate of the amount of

training represented by its approved

programs, unless there is evidence, now

or in the future, that such acceptance is

not warranted. Thus, the ARRT(M)

ordinarily will be accepted as meeting

24 hours of the 40-hour training

requirement and the agency reiterates

that the fact that the ARRT(M) is not

specifically mentioned in the

regulations does not preclude this

acceptance.

(Comment 239). A number of other

comments addressed whether 40 hours

of training was an adequate and

appropriate amount to provide

reasonable assurance of quality

mammography. Twenty comments

stated that it was a reasonable amount.

Three comments asserted that the

amount of training was excessive or

even that training in mammography was

not needed. An additional comment was

concerned about the impact of the

requirement on small facilities.

In response to these comments, the

agency notes that training for radiologic

technologists specific to mammography

is required by the statute. The agency

also notes that nearly all technologists

who have met the interim regulations,

whether at small or large facilities, have

already obtained 40 hours of training or

close to it without a noticeable adverse

impact on the facilities. Some portion of

these comments, and seven others, may

have been based on the mistaken belief

that the 40 hours was required to be in

addition to any previous training in

mammography. The grand parenting

provision, which provides that meeting

the interim regulations will qualify

individuals as meeting the initial

training requirements under the final

regulations, should alleviate some of

these concerns.

On the other hand, 14 comments

stated that 40 hours of training was

inadequate. Several of these made

suggestions for higher levels of training,

ranging up to 480 hours and including

the performance of 200 examinations.

The preponderance of the comments,

however, seemed to support the figure

of 40 hours of training. This amount was

originally recommended, and is still

supported, by NMQAAC. In the absence

of any current evidence that 40 hours of

training are insufficient, FDA believes

that no change needs to be made in this

number of hours.

(Comment 240). A number of

comments addressed instructor

qualifications. Concerns mentioned

earlier, namely, that there would be no

qualified instructors, have been

addressed in part by the grand parenting

provision. Thirteen other comments

asked for more clarification as to who

would be a qualified instructor or

suggested listing specific categories of

individuals who would be qualified.

FDA believes that the new definition

of qualified instructor in § 900.2(oo) will

address these concerns. Because of the

wide variety of individuals who have

expertise to provide the various

segments of the technologist training,

the agency wrote this definition with
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55899

the goal of describing certain groups

that can be identified as qualified at this

time, while retaining the flexibility to

accept other individuals on a case-bycase basis.

(Comment 241). Three comments

urged that the training be required to be

Category A, but another comment said

that such a requirement would make it

difficult for a facility to find courses to

qualify new technologists.

NMQAAC also did not reach a

consensus on this issue. Although FDA

has decided to accept only Category I

training as meeting the interpreting

physician requirements, the agency does

not believe that a similar step is needed

in the technologist area. In contrast to

the situation with physician Category I

and II training, the distinction between

Category A and B is based upon whether

or not prior approval by a recognized

group has been obtained, not on the

type of training. Thus, the concerns that

led the agency to restrict physician

training to Category I do not apply in

the technologist situation.

Similarly, FDA does not believe that

it is necessary to require the 40 hours of

training to be ‘‘graduate’’ training that is

taken after the technologist meets the

requirements of § 900.12(a)(2)(i), as

suggested by one comment. FDA is

unaware of any reason to believe that

the mammography training received as

part of the technologist’s basic training

curriculum is unacceptable.

(Comment 242). Four comments were

critical of the concept of continuing

education courses, stating that students

‘‘sleep through them’’ and that they are

only ‘‘money-makers’’ for the training

providers.

While abuses of these types may exist,

FDA believes that the great majority of

training providers are sincerely

interested in providing training that will

improve medical care and that the great

majority of students are equally

interested in learning as much as

possible from their training.

(Comment 243). Another large group

of comments addressed the specific

requirements included in

§ 900.12(a)(2)(ii). Nine comments

suggested the addition of more subjects

to those required to be included in the

40 hours of training. Specific

suggestions included technical factors,

film evaluation and critique, pathology,

mammography of disabled women, and

communication with patients. Three

other comments supported the proposed

inclusion of the topics of positioning

and quality assurance.

FDA agrees that the topics suggested,

and probably many others, could be

valuable components of technologist

training. Some, in fact, are subsumed

under the topics proposed and finalized

under § 900.12(a)(2)(ii)(A). However, the

agency’s intention was to limit this list

in the regulation to only the subject

areas most central to the quality

performance of mammography

examinations in order to maximize

flexible and individualized training.

FDA has added only imaging of patients

with breast implants to the list of

required topics, for reasons discussed

below. The final regulation includes the

words ‘‘but not necessarily limited to’’

to clarify that training in other areas also

could be included in the 40 hours as

long as the basic areas are covered. The

agency intends to make additional

information available on training

programs and subjects that can satisfy

this requirement.

At its January 1997 meeting,

NMQAAC reconsidered a

recommendation it made earlier and

advised that FDA amend the proposed

regulations to require the initial

experience requirement of

§ 900.12(a)(2)(ii)(B) to be in addition to

the 40 hours of training instead of part

of the training, as was proposed. FDA

did not receive any other comments

making this recommendation. After

considering the advice of NMQAAC, the

agency has decided to retain the

proposed requirement without

amendment. FDA’s experience in

implementing the MQSA over the past

years has not provided evidence that the

significant increase in the training hours

(approximately 50 percent over the

proposal) that would result from

NMQAAC’s recommendation is

warranted.

(Comment 244). Several other

comments asked for clarification about

whether previous training could be

counted towards the mammography

requirement or expressed concern about

current technologists having to repeat

their training. As explained previously,

under the grand parenting provision

that has been added, radiologic

technologists who have previously

qualified under the interim regulations

will be deemed to have met the initial

personnel requirements and will not

have to repeat training for that purpose.

Section 900.12(a)(2)(ii)(B) requires

that performance of clinical

examinations under direct supervision

of a qualified individual be part of the

initial training. This requirement was

intended to be parallel to the

requirement that existed for interpreting

physicians under the interim

regulations and was continued for them

in the final regulations.

(Comment 245). Eight comments

supported this provision, noting that

competency comes about by combining

didactic training with actual experience

and that such a requirement has worked

well in the State of Iowa for several

years.

A much larger number of comments

opposed such a requirement. Eight of

those opposing the requirement

mistakenly believed that the supervision

would have to be done by a radiologist

and such supervision was not available

in their situation.

Supervision of radiologic technologist

examinations by a physician is not

required; the new definition of a

qualified instructor (§ 900.2(oo)) should

help correct this misunderstanding.

(Comment 246). Twenty comments

expressed concerns about having

qualified supervision, especially in

small and rural facilities. The new grand

parenting provision that has been added

to the final rule for radiologic

technologists should solve this problem

in areas where a shortage might have

occurred.

(Comment 247). Nineteen other

comments raised concerns about

requiring supervised mammography

examinations that related to issues of

cost, liability, and patient privacy.

FDA notes that these are all issues

that have been faced and successfully

resolved by technologist schools

nationwide in connection with the

clinical training that they provide their

students. FDA believes that they are

manageable concerns and that any

difficulties they raise are outweighed by

the benefit of clinical training for

radiologic technologists. The agency

also notes that the addition of the grand

parenting provision will limit this

requirement to new technologists

wishing to enter the field and that the

number of examinations has been

decreased, as discussed below.

(Comment 248). Six comments took

the position that practical training was

not needed. Their authors apparently

believed that technologists could learn

to adequately perform mammography

examinations with only classroom

training.

FDA disagrees. In view of the

difficulty of performing adequate

mammography examination, the agency

believes that some clinical experience is

vital for initial qualification.

(Comment 249). A number of

comments expressed conflicting views

on the appropriate number of

examinations that should be done as

part of the initial training. Twenty-two

of these comments expressed the

opinion that 50 examinations was too

many, due to cost or difficulty of

completing that number, or because of

a belief that fewer examinations would

serve the same purpose. Ten comments,
55900 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

however, suggested higher numbers,

ranging up to 200 examinations.

The question of the number of initial

examinations was raised at the January

1997 NMQAAC meeting, but no

recommendation was made on the issue.

After considering these comments, FDA

concluded that reducing the required

number to 25 examinations would give

the technologist adequate initial

experience, while at the same time ease

burdens relating to cost and availability

of the training.

(Comment 250). A relatively large

number of comments were also received

on the requirements proposed in

§ 900.12(a)(2)(ii)(C). These comments

focused primarily upon the proposal

that all technologists doing

mammography should receive at least 5

hours of training in the imaging of

patients with breast implants as part of

their 40 hours of initial training. Several

different issues were brought up with

respect to this requirement.

The first issue was whether it was at

all necessary to require training in

breast implant imaging. Over 30

comments supported this requirement.

These comments noted that the training

was necessary to perform adequate

examinations of women with implants

and that having the training would

remove the need to have a physician

present during the examination. About

half of these comments recommended

that no specific amount of training be

required. Eighteen comments opposed

any requirement relating to implant

imaging, arguing that technologists were

already obtaining such training as part

of their initial curriculum, that imaging

of women of breast implants did not

require special training, and that their

facilities conducted so few

examinations that such a requirement

would be ‘‘overkill.’’

A second issue was whether the

training should be required of all

technologists, as proposed, or just those

who perform examinations of women

with implants. One comment supported

requiring it of all technologists in order

to ensure that no matter what facility a

woman with breast implants chose for

an examination, she would be examined

by a technologist with this training. The

NMQAAC took this same position for

the same reason. Ten other comments,

however, urged that this requirement be

limited in some way, with suggestions

varying from limiting it to technologists

who perform such examinations, to new

technologists, or to technologists at

facilities that perform a minimum

number of examinations of patients with

implants per year.

A third issue was whether there was

sufficient training available in this area.

Approximately 25 comments stated that

there would not be sufficient training

opportunities available to meet this

requirement. A few of these comments

supported this position with data from

their own experience or surveys of

training providers in their area. This

position is in contrast with the

comments mentioned earlier, which

stated that this requirement was not

needed because training of patients with

breast implants was already routinely

being received. The position is also

somewhat inconsistent with the 15

comments FDA received from

technologists who said that they had

received the required training in the

past, but might have difficulty providing

documentation because their certificates

do not specifically state the content of

the training.

A fourth issue addressed in the

comments was the proper mixture of

classroom, video, and practical training.

Eight comments stated that video

training would have to be permitted

because there would not be enough

patients available to meet this

requirement through clinical training.

An additional 5 comments stated that it

would probably not be possible to

include clinical training. On the other

hand, 20 comments emphasized the

importance of clinical training and

another 12 stated that it should be

possible to receive this training in a

clinical seminar. However, another

comment pointed out that models

would be reluctant to undergo the

compression required by such training.

The final issue was the amount of

training that should be required in

imaging patients with implants. Nearly

30 comments expressed the opinion that

5 hours was too much for reasons that

included cost and the belief that the

necessary knowledge could be conveyed

in less than 5 hours. Over 50 additional

comments suggested specific and lesser

amounts of training. About 80 percent of

these comments supported a

requirement for 2 hours of training,

although some of those supporting 2

hours would also require an additional

number of examinations under direct

supervision. Several comments also

suggested stating the requirement in a

different way, for example, as part of a

larger number of hours devoted to

positioning or in terms of a minimum

number of patients.

There were also a number of

comments based on misunderstandings

of the proposed requirement. Thirteen

comments, for example, urged that the

5 hours be part of the general 40-hour

training requirement, apparently not

realizing that was already proposed.

Seven other comments were based on

the mistaken belief that implant imaging

was a ‘‘mammographic modality’’ and

that training in this area would also be

required as part of their continuing

education.

The training required for imaging

patients with implants is part of, and

not in addition to, the 40 hours of initial

training and that the definition of

mammography modality does not

include breast implants. The agency

expects to issue educational materials to

help interpret the final regulations and

will further clarify these and similar

misunderstandings.

In response to the comments on the

five major issues, FDA first notes that

the statute requires the agency to

establish standards relating to special

techniques for mammography of

patients with implants (42 U.S.C.

263b(f)(1)(H)). Requiring technologists

to be trained in examining such patients

is consistent with the statutory

requirements. In addition, FDA has

received many comments, including

advice from NMQAAC, which

underscore the necessity for performing

such examinations with trained

personnel.

The agency also notes that the grand

parenting requirement will relieve

technologists who met the interim

regulations from the need to obtain

additional training in the imaging of

patients with breast implants. This

should alleviate much of the concern

that was expressed in comments about

availability of training and the

overloading of limited training

resources. The grand parenting

provision also eliminates the possibility

that technologists who have been

performing such examinations

successfully for years but were not

formally trained, or who do not have

documentation of their training, would

have to obtain this training. At the same

time, all technologists newly entering

the field will have to receive training in

imaging of patients with breast

implants. FDA believes this requirement

strikes the proper balance to ensure that

patients are properly examined.

Further, after consultation with

NMQAAC, FDA concluded that this

training should not be established as a

separate requirement, but instead

should be included under

§ 900.12(a)(2)(ii)(A) as one of the topics

required to be covered during the 40

hours of training related to

mammography. By including imaging of

patients with breast implants among

these required subjects, FDA ensures

that all radiologic technologists being

trained for the field of mammography

will receive education in this important

technique, as required by the MQSA. At
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55901

the same time, by eliminating any

particular hourly requirement, the

agency permits maximum flexibility in

the amount and type of training

received, plus some degree of assurance

that the student will be evaluated in this

area as part of the formal training

process. Radiologic technologists who

expect to examine patients with

implants on a more frequent basis or

facilities that have large numbers of

such patients among their clients can

increase the training hours in this

subject. Conversely, radiologic

technologists and facilities with few

such examinations can devote training

hours to other subjects that seem more

beneficial to their practice, as long as

the basics of imaging women with

implants have been covered adequately.

Because the hours devoted to such

training are required to be documented

contact hours under the supervision of

a qualified instructor, a variety of types

of training similar to those suggested in

the comments could be suitable as long

as they meet the criteria of

§ 900.12(a)(2)(ii)(A).

The second part of proposed

§ 900.12(a)(2)(ii)(C), which was that at

least 8 of the 40 hours must be training

with each mammographic modality

used by the technologist, received far

fewer comments.

(Comment 251). Five comments

supported the requirement, although

some concern about problems of

documentation was expressed. Two

comments opposed the requirement,

one due to a mistaken impression about

the number of modalities for which

training would be required, the other

because of a desire to leave the facility

the flexibility to decide how much

training was needed. Fourteen

comments wanted the number of hours

required per mammographic modality to

be reduced.

FDA believes that much of the

opposition to this requirement as

proposed arises from a

misunderstanding of what is meant by

mammographic modality. Presently,

there are only two mammographic

modalities, screen-film and

xeromammography, as defined in the

regulations. Most technologists use only

one or the other and, thus, this

requirement has no great impact on

them. For those technologists who do,

or will, work with more than one

mammographic modality, FDA does not

believe it is excessive to have at least 20

percent of the total amount of initial

training related to each mammographic

modality used. Therefore, this part of

the proposal has been retained in the

final regulations.

The continuing education

requirement, § 900.12(a)(2)(iii), was the

first of two, along with continuing

experience, intended to ensure that the

technologists keep their skills and

knowledge base up-to-date. The basic

requirement proposed was that

radiologic technologists have continuing

education equivalent to 15 continuing

education units in a 3-year period. The

amount proposed was unchanged from

that established under the interim

regulations, but the proposed wording

puts the emphasis on the total to be

earned in a 3-year period instead of a

yearly average.

(Comment 252). Five comments

supported the requirement as being

flexible and adequate to keep

‘‘technologists on top of changes.’’

Three comments opposed it on the

grounds that the continuing education

requirements of the ARRT were

sufficient or that earning the ARRT(M)

should excuse technologists from

earning continuing education credits.

FDA is aware that the ARRT requires

earning 12 credits per year while the

proposed regulations require an average

of only 15 per 3-year period. However,

the 12 per year required by the ARRT

continuing education standards can be

from any area of radiology and will not

necessarily be training in

mammography. If the radiologic

technologist takes mammography

training to fulfill ongoing ARRT

requirements, that training can be

counted towards satisfaction of the

MQSA continuing education standards.

Similarly, while earning the ARRT(M) is

evidence of a high level of knowledge at

the time the test was taken, it does not

ensure that the technologist will keep

up with changes after that date, which

is the primary purpose of continuing

education. Thus, FDA cannot excuse

technologists from this requirement on

the basis that they have met the ARRT

continuing education standard or have

earned the ARRT(M).

Two additional comments supported

the idea of looking back 3 years for the

averaging period. Ten identical

comments suggested changing the

requirement to earning 10 hours every 2

years while two others urged that

technologists be required to earn 5

hours of continuing education credit

each year.

FDA established the longer time

period for averaging continuing

education credits to permit and

encourage the technologists to take

longer and more comprehensive courses

as they became available. The agency

believes such training may be more

valuable than several short

uncoordinated courses. Shortening the

averaging period to 1 or 2 years would

not prevent technologists from taking 15

credit courses, but it might discourage

them from doing so due to a reluctance

to pay for hours of training that would

be beyond those necessary to meet the

requirements. Use of a 3-year averaging

period also provides greater flexibility

in selecting courses that best meet

individual needs and minimizes the

possibility that a technologist will sign

up for a course simply because it was

available and the end of the year was

approaching.

(Comment 253). Two comments urged

that continuing education in implant

imaging be specifically required as part

of the continuing education for

technologists.

In view of the many comments

discussed earlier concerning the

appropriate amount and type of training

needed to successfully image patients

with implants and the availability of

that training, FDA has concluded that

such a specific requirement would be

too restrictive.

(Comment 254). A number of

comments were received about the

number of continuing education units

being required. Eight comments asserted

that the requirement of an average of 5

units per year would be too great a

burden on technologists in rural

facilities. On the other hand, one

comment suggested increasing the

number of credits required to 12 per

year and provided further suggestions

on the type of training, while another

urged the requirement be raised to 10

credits per year.

After considering these comments,

FDA has concluded that the 5 unit per

year average is reasonable. Twelve units

of continuing education per year are

required to maintain the ARRT

credentials and, at this time, the

majority of radiologic technologists

practicing mammography have ARRT

certification. Because the 5 units

required by these regulations can be part

of those 12, the final regulation does not

establish an excessive requirement. The

agency also believes that, in association

with the requirement in

§ 900.12(a)(2)(iii)(D) for extra training if

the technologist begins working with a

new mammographic modality, an

average of 5 credits per year is adequate

to ensure that the technologist keeps upto-date.

(Comment 255). Five comments urged

that only Category A training be

accepted, while a sixth asked for

clarification on that point and a seventh

would restrict the training to certain

types without reference to category.

For the reasons previously discussed,

FDA does not believe that it is necessary
55902 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

to restrict continuing education credits

for radiologic technologists to Category

A courses.

(Comment 256). One comment stated

that a limit should be placed on the

number of times credit could be earned

for teaching the same course. NMQAAC,

when discussing this issue,

recommended that no credit should be

given for teaching. FDA recognizes,

however, that a great amount of study

and learning is required to successfully

teach a course, especially the first time

it is given. The agency will continue to

permit personnel to earn credit towards

the continuing education requirement

by teaching, but has added a new

provision that limits the times a

particular course can be counted

towards this requirement to once in any

3-year period (see § 900.12(a)(2)(iii)(B)).

This is consistent with similar

provisions for interpreting physicians

and medical physicists.

(Comment 257). A number of

comments on this section were based on

misunderstandings. One comment

expressed the belief that this

requirement actually meant that an

individual would have to earn 15 units

every 2 calendar years in order to meet

this requirement. Another comment,

incorrectly assuming that implant

imaging was a mammographic modality,

assumed that 6 hours of implant

imaging training would be required

every 3 years. Other comments

mistakenly concluded that 5 credits on

implant imaging would be required

every year, that the requirement to

average 5 credits a year was being

increased to 6, or that 5 credits were

being required each and every year.

All of these comments opposed the

requirement based on their

misunderstandings. As FDA develops

educational materials to help personnel

understand how they may comply with

the new regulations, special attention

will be focused on correcting such

misunderstandings. Changes in the

wording of § 900.12(a)(2)(iii)(A) from

the proposal are intended to emphasize

that the basic continuing education

requirement is to earn 15 credits over 3

years and to clarify options for

calculating the time period to be used to

demonstrate compliance with that

requirement. The agency hopes that

these changes will eliminate confusion

about whether 5 units must be averaged

per year or earned per year (the unit

requirement is an average) and provide

radiologic technologists and the

facilities that employ them with some

flexibility in maintaining and

documenting compliance with this

requirement. Both of the changes

parallel similar changes made in the

wording to the interpreting physician

and medical physicist requirements.

Only two comments were received on

proposed § 900.12(a)(2)(iii)(B) (now

§ 900.12(a)(2)(iii)(C)), which requires a

technologist to have some continuing

education for all modalities used by that

technologist. One comment stated this

was a ‘‘great revision.’’ The other

expressed concerns about the

availability of the training.

FDA believes that if a new

mammographic modality is introduced,

training will be available initially from

the originators of the mammographic

modality because those originators will

have a high interest in ensuring that the

mammographic modality is used

properly. FDA acknowledges that

training with a disappearing

mammographic modality, like

xeromammography, may be more

difficult to obtain. However, FDA has

concluded that the possibility of

detriment to the public health that

could result from personnel not

maintaining their skills must override

this concern.

(Comment 258). FDA received four

comments on proposed

§ 900.12(a)(2)(iii)(C) (now

§ 900.12(a)(2)(iii)(D)), which describes

requalification procedures for

technologists who failed to meet

continuing education requirements. One

comment agreed with the provision and

two comments went further to suggest

that there should be some sort of

penalty for not meeting the requirement

on time. The authors apparently did not

realize that the penalty was not being

able to perform mammography except

under direct supervision until the

requalification was completed (see

previous discussion related to

interpreting physician). The fourth

comment supported the requirement,

but expressed concern about who would

approve the training and keep the

records of completion.

FDA has found the mechanisms used

under the interim regulations for

approving training, which involve the

participation of professional groups, are

adequate. These same professional

groups ordinarily provide

documentation of completion. Under

the interim regulations, it has been the

responsibility of the facility to obtain

and maintain such records and this will

continue under the final regulations.

(Comment 259). The three comments

received on proposed

§ 900.12(a)(2)(iii)(D) (now

§ 900.12(a)(2)(iii)(E)) opposed the

requirement that a technologist receive

training in use of a mammographic

modality for which she was not

previously trained before using that

modality. One comment stated that the

requirement would be an undue

hardship and two stated that it will be

difficult to obtain the training. FDA

believes that the value of being trained

in the use of a mammographic modality

before beginning to use it on patients

overrides the hardship concern. As

discussed earlier, FDA also believes that

availability of training will not be a

problem and that the definition of

qualified instructor (§ 900.2(oo))

provides for an adequate number of

teachers. The proposed requirement has

been retained unchanged.

Continuing experience is the second

of the general requirements intended to

ensure that the technologists maintain

their skills. As proposed,

§ 900.12(a)(2)(iv) required that

technologists perform a minimum of

100 examinations during a 12-month

period. This requirement was intended

to parallel the continuing experience

requirement for physicians.

(Comment 260). Eight comments

supported a continuing experience

requirement for technologists,

explaining that a technologist’s

positioning skills improve with

additional mammography examinations.

Nine comments opposed the

requirement. Several of these suggested

alternative measures, such as a ‘‘lengthy

appraisal (at least 3 days * * *) * * *’’

by the chief technologist and

radiologists or a certification program

similar to that used by the American

Heart Association for CPR certification.

While these suggestions have merit,

they are a form of proficiency testing

and, as discussed elsewhere, large

numbers of comments provided valid

reasons to conclude that it is premature

to require such testing.

(Comment 261). Another comment

opposed the requirement on the grounds

that ‘‘if you can do a mammogram, you

can do it, period.’’ The author’s basic

assumption seems to be that you never

forget how to perform mammography.

FDA notes that the purpose of

continuing experience requirements is

to ensure that technologist skills are

maintained at a level that is likely to

produce accurate and reliable

mammograms. In view of the

complexity of the examination and

changes in technology, FDA believes

that the optimism expressed by this last

comment is unwarranted.

(Comment 262). Proposed

§ 900.12(a)(2)(iv)(A) set the continuing

experience requirement at the

performance of at least 100

mammography examinations in a 12-

month period. One comment stated that

this was a ‘‘very acceptable

requirement,’’ but two believed that it
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55903

should be higher. One of these

recommended that the number should

be the same as the 480 interpretations a

year required of radiologists. Four

comments supported the level of the

requirement, but asked that the

averaging period be longer than a year

to allow technologists to be absent for

longer periods and still be able to meet

the requirement. Two of these

comments noted that physicians are

allowed a 24-month averaging period for

their continuing experience. Ten other

comments suggested that the number be

lowered, with 50 or 75 a year being the

most common suggestions.

FDA has concluded that the number

of 100 per year, which was first

suggested by NMQAAC in February

1994, and supported by them at their

January 1997 meeting, is the most

reasonable compromise between the

need to establish a requirement

sufficiently high to maintain skills and

the need to avoid disqualifying large

numbers of competent technologists.

The agency notes that as few as two

examinations per week will be sufficient

to meet this requirement.

FDA does agree with the suggestion

that the averaging period be lengthened

to 24 months and the wording of the

regulation has been changed to require

the performance of 200 examinations in

a 24-month period. A clarification of

how to determine the 24-month period

was also added, which parallels similar

provisions for calculating such time

periods for interpreting physicians and

medical physicists.

(Comment 262a). Seventeen

comments identified specific groups

that they believed would have difficulty

meeting this requirement. These

included individuals, such as

mammography supervisors, instructors,

and technologists in sales, who had

made career choices that would make it

difficult for them to meet this

requirement.

FDA understands the desire of these

individuals to keep their options open

in case they wish to return to the

performance of examinations, but the

agency believes that higher priority

must be given to maintaining

technologist proficiency. FDA also

notes, as discussed later, that a

requalification procedure has been

provided for technologists in this

situation.

(Comment 263). A related concern

was expressed in the 13 comments that

indicated technologists in rural

hospitals would have difficulty meeting

this experience requirement. As

explained previously, FDA recognizes

that rural facilities face special

challenges but believes that it would be

contrary to the MQSA goal of assuring

women a uniform minimum level of

quality of mammography nationwide to

establish lesser standards for

technologists practicing in rural areas.

As proposed, § 900.12(a)(2)(iv)(B)

stated that technologists who fail to

meet the continuing experience

requirement can re-establish this

qualification through the performance of

50 mammography examinations under

direct supervision.

(Comment 264). Ten comments stated

that this number of examinations was

too many and suggested that it be

reduced, with 30, 25, and 20

examinations all being proposed.

Another comment urged that there be a

penalty for failing to meet this

requirement, apparently not realizing

that the penalty was not being able to

work independently until

requalification was completed. One

comment urged that proficiency testing

be used instead of an experience

requirement, while another was

concerned about how the performance

of these examinations would be

documented.

As discussed above, FDA has reduced

the number of examinations that have to

be performed under direct supervision

as part of the initial training from 50 to

25. The agency has no reason to require

the requalification figure to be higher

than the number of examinations for

initial qualification. Accordingly, the

agency has similarly reduced the

requalification requirement from 50 to

25 examinations.

d. Medical physicist (§ 900.12(a)(3))

Section 900.12(a)(3) establishes the

requirements that must be met by

medical physicists who conduct surveys

of mammography facilities and provide

oversight of the facility quality

assurance program. Initial

qualifications, alternative initial

qualifications, continuing qualifications,

and the reestablishment of

qualifications are all covered. No major

changes have been made in the final

regulations from what was proposed.

Some changes have been made in the

survey experience requirement and in

the averaging time for the continuing

qualifications requirement. The

comments received on the final

regulations in each of these areas are

discussed in below in connection with

the specific provisions.

(Comment 265). One comment stated

that the proposed rule is very positive,

ensuring that only properly trained and

adequately qualified professionals

perform medical physics surveys.

Another comment concluded that the

medical physicist qualifications were

appropriate and reasonable.

The initial qualification requirements

for medical physicists include board

certifications or State licensure or

approval; masters degree or higher in

physical science with 20 semester hours

in college or graduate level physics; 20

contact hours of training in

mammography; and survey experience.

The proposed initial qualifications

requirements generated a wide spectrum

of comments. Views varied greatly on

the value of State approval or licensure

in ensuring that physicists were

properly qualified to perform

mammography services.

(Comment 266). Ten comments

expressed doubt that State approval/

licensure provided a sound basis for

establishing competence. One comment

recommended that the State approval

option be deleted, while another

suggested that State approval be

accepted only after FDA investigation.

One comment stated that State

approval/licensure should be part of

alternative criteria with additional

appropriate training and experience

requirements. Three comments argued

that State approval or licensure should

be specific to the State where the

professional practice will occur, unless

a State reciprocity mechanism is in

place. One comment stated that the

proposal was unclear as to whether

State approval was sufficient or

additional requirements would need to

be met after October 1997. On the other

hand, seven comments stated that State

approval, like board certification, was

adequate by itself and that additional

requirements were not needed.

Five comments stated that board

certification should be required for all

medical physicists. Several other

comments urged FDA not to accept

board certification without requiring a

special certificate for mammography.

Two comments recommended deleting

the master’s degree requirement and

argued that course work in college level

physics and supervised experience

should be adequate. One comment

contended that the issues of degree,

training, and curricula are unnecessarily

complicated in the proposed regulation.

Another comment stated that the

requirement of board certification or

State licensure unfairly excludes

physicists who are otherwise well

qualified to test mammography

equipment on the basis of their actual

experience in this field. One comment

stated that these requirements are

appropriate.

FDA considered all of the comments

received concerning initial

qualifications requirements for medical

physicists. Because the MQSA expressly

establishes State approval or licensure
55904 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

as an alternative pathway (42 U.S.C.

263b(f)(1)(E)(i)), FDA could not

eliminate this route for initial

qualification, even if the agency

believed it was desirable to do so. The

agency is aware that not all States have

adequate minimum qualifications

standards. Concern has also been

expressed that some board certified

physicists do not have adequate

experience with mammography

equipment. Therefore, as proposed, FDA

added additional educational and

experience requirements for all

physicists, regardless of which initial

route they follow to become qualified

under the MQSA. These additional

requirements are: (1) For initial

qualification, masters degree or higher

in physical science, with a minimum 20

semester hours or equivalent in college

or graduate level physics, 20 contact

hours of training in mammography, and

experience of surveying 1 facility and 10

units; and (2) for alternative initial

qualification, bachelors degree or higher

in physical science, with a minimum 40

semester hours or equivalent in college

or graduate level physics, 40 contact

hours of training in mammography, and

experience of surveying 1 facility and 20

units.

(Comment 267). A number of

comments suggested that additional

subjects, such as mathematics, biology,

nuclear physics, and radiologic

technology should be added as

acceptable fields in which the degree

may be obtained. Some comments

wanted the reference to physical science

to be changed to medical physics. One

comment stated that physicists who are

not board certified should be required to

demonstrate a stronger educational

background than currently required. In

response to the agency’s discussions in

the preamble section of the proposal

about the possibility of requiring all 20

semester hours in imaging physics (61

FR 14905), two comments stated that

such a requirement would not be

appropriate because the mammography

equipment evaluation would require

more than training in imaging and

limiting 20 semester hours to imaging

physics would not provide the physicist

with the education needed to adapt to

constant changes in technology.

The agency has decided to keep the

requirement of physical science as the

field in which the degree must be

obtained and believes that its definition

of physical science (§ 900.2(jj))

sufficiently covers the wide range of

subfields that can provide adequate

initial training to enable an individual

with 20 semester hours of physics to

understand the basics of mammography

physics. The agency believes that this

would not be the case if other fields,

such as biology, were added to the

definition.

(Comment 268). Sixteen comments

stated that board-certified physicists

should not have to demonstrate

compliance with the additional

educational requirements of

§ 900.12(a)(3)(i)(B)(1) in the proposed

regulations, but should demonstrate

experience conducting mammography

surveys. Because the MQSA establishes

board certification and State licensure/

approval as equivalent pathways for

qualifying medical physicists, FDA has

not issued different additional

qualifications for each of these groups.

Accordingly, the agency has retained

this requirement as proposed. However,

if a designated board confirms that its

certification in an accepted speciality

always requires the minimum of a

masters degree in physical science with

at least 20 semester hours in physics,

the agency may not have to verify the

degree and semester hour requirements

during annual inspections for those

physicists certified by that board.

Another initial requirement is that

physicists have 20 contact hours of

documented training in mammography.

Several comments requested further

clarification of contact hours. Some

comments urged FDA to accept self

attestations of contact hours for

experienced physicists who have

worked in the field for a long time but

do not have any documented contact

hours. Ten comments stated that, if the

medical physicist is board certified, the

contact hours requirement should not

apply.

After considering these comments and

consulting with NMQAAC, FDA has

retained contact hour requirements for

all physicists, regardless of which initial

route they followed to become qualified.

FDA will accept self attestation of any

contact hours received before October

1994. The agency has also provided a

more detailed description of contact

hours in § 900.2(m).

Under the proposal, an additional

initial requirement was that medical

physicists shall have the experience of

surveying at least 5 facilities and 10

units.

(Comment 269). About one hundred

comments opposed the requirement for

multiple facility surveys for in-house

physicists and stated that in-house

physicists who are employed by

hospitals and medical schools are often

contractually prohibited from

performing surveys at outside facilities.

Several of these comments suggested

that FDA should instead base its

requirement on number of unit surveys.

In response to these comments, the

agency has revised this requirement so

that physicists qualified under

§ 900.12(a)(3)(I) will be required to have

initial experience of one facility and ten

unit surveys. FDA did not eliminate the

facility requirement entirely because the

agency strongly believes that having

experience with complete surveys of

facilities, including oversight of all QC

records, is necessary. Evaluations of

units only cannot provide a medical

physicist with the same experience and

knowledge as the survey of a facility.

Although the amended regulation does

not mandate survey experience with

more than one facility, the agency

encourages all physicists to perform

additional facility surveys when

possible to expand their experience.

FDA believes that it is also advisable to

gain familiarity with a number of

different mammography units because

much of the educational benefit is lost

if the same unit is surveyed repeatedly

to meet the experience requirement. In

order to address this concern to some

degree, the regulation now provides that

no more than one survey of a specific

unit within a period of 60 days can be

counted towards the total

mammography unit survey requirement.

The initial experience requirement

also stated that, after the effective date

of these regulations, the initial survey

experience must be acquired under the

direct supervision of a qualified medical

physicist.

(Comment 270). One comment stated

that direct supervision would be very

difficult to arrange. Another suggested

requiring two surveys under direct

supervision and the rest under indirect

supervision. The comment stated that

indirect supervision with telephone

consultation and advice is more

valuable than the direct supervision.

FDA has retained this requirement

because the agency and NMQAAC

consider it important that new

physicists entering the field acquire

initial experience in conducting

mammography surveys under the direct

supervision of a qualified medical

physicist, who can correct any mistakes

made during the learning process before

they pose to a threat to patients. Because

this provision does not take effect until

the effective date of the regulations, the

agency believes that it will not disrupt

the availability of experienced medical

physicists.

Alternative initial qualifications were

established in § 900.12(a)(3)(ii) to

provide a way to permit medical

physicists who have been successfully

providing mammography physics

services for some time, but who lack a

masters degree, to continue to practice
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55905

without lowering quality standards in

any manner that would jeopardize

public health. In general, in order to

qualify by this alternative qualification

route, an individual must have qualified

under § 900.12(a)(3) of the interim

regulations and maintained his or her

licensure, approval, or certification

requirement as required under the

interim regulations. The physicist using

this alternative route is also required to

have a bachelors degree or higher in

physical science, with at least 10

semester hours or equivalent in college

level physics, 40 contact hours of

training in mammography, and survey

experience of 10 facilities and 20 units.

(Comment 271). Several comments

opposed the alternative pathway for

initial qualifications and considered the

proposed educational requirements for

these medical physicists to be

inadequate. On the other hand, a larger

number of comments shared FDA’s

concern for existing medical physics

service providers and the facilities they

serve. These comments supported this

alternative qualifications route and

recommended that experienced

individuals who have previously

qualified and who meet continuing

education and experience qualifications

should be allowed to continue to

practice. Five comments stated that the

alternative initial qualifications should

be a permanent option. One comment

claimed that the proposed alternative

qualifications criteria were too

restrictive to permit many State licensed

physicists to qualify.

A number of comments suggested

increasing the requirement of semester

hours of college level physics for this

alternative route from the proposed

number of 10. Some comments

suggested that the credit hours

requirement for this alternative route be

increased from 10 to 15 or 20 hours by

including subjects such as biology,

radiation biology, radiation science, and

chemistry. Other comments expressed

concern that this college level physics

requirement would bar a number of

presently qualified physicists from

continuing to provide mammography

services. Two comments stated that the

requirement for semester hours in

physics should be removed, and that

physicists qualified under the current

interim regulations by the State

licensure or approval process should

not have to meet additional educational

requirements. One comment stated that

10 hours of physics is reasonable.

Another comment stressed that formal

training in physical science is necessary

and stated that this standard should not

be weakened.

In the preamble to the final

regulations, the agency explained its

reasons for proposing the alternative

initial qualifications route for physicists

with bachelors degrees who are

currently performing mammography

physics services under the interim rule

(62 FR 14905). Based upon discussions

with NMQAAC and the Conference of

Radiation Control Program Director’s

Task Force on Medical Physics Criteria,

the agency proposed the requirements

for course work in physics, contact

hours, and experience included in this

alternative route. The agency believes

that the combination of all these

requirements provides adequate

protection for the public health, while

permitting most practicing physicists to

continue to provide mammography

services under the final rule.

Moreover, the agency considered it to

be unfair to individual physicists and

potentially detrimental to facilities and

the public to exclude many currently

practicing physicists by withdrawing

the alternative initial qualifications

route or by increasing the educational

credit hours requirement for these

individuals in the absence of evidence

that such physicists are providing

inadequate services. The agency was

concerned that such an exclusion could

cause a possible shortage in the

availability of physics services for some

period of time.

Several comments supported the

views expressed in the preamble to the

proposed rule. In addition, the agency’s

experience and data gathered from its

inspection data base affirm that many

currently practicing medical physicists

with bachelors degrees, adequate course

work in physics, and substantial

experience are performing quality

medical physics surveys in

mammography facilities with care and

competence.

The agency continues to believe that

it is very important to have at least 10

semester hours in college or graduate

level physics. The other subjects,

suggested by some comments, will not

necessarily provide an individual with

the necessary background and training

to understand the basics of

mammography physics. However,

because at least a bachelors degree in

physical science is also part of the

educational requirement, the credit

hours in other related subjects,

suggested by the comments, may be

associated with fulfilling the degree

requirement. Although the agency

believes that a minimum of 10 hours of

course work in physics is necessary to

gain proper physics background, it also

believes that requiring more credit

hours in physics, as some comments

and some members of NMQAAC

suggested, will exclude individuals

other than physics minors or majors or

those with graduate degrees. For these

reasons and those previously stated in

the proposed rule (61 FR 14905), the

agency has retained, as proposed, the

minimum requirement of a bachelors

degree with no less than 10 semester

hours or equivalent courses in physics

in its final rule on alternative initial

qualifications.

The agency agrees, however, that

enhanced educational qualifications are

necessary in order for physicists

entering the field in the future to have

the required background to understand

the technology of the future as it

becomes increasingly intricate. As

previously proposed, therefore, FDA is

limiting the use of this alternative

pathway to only those physicists who

have met its requirements by the

effective date of the final regulations.

(Comment 272). Several comments

opposed the contact hours requirement,

while some supported it.

The agency has previously stated its

justification for retaining this

requirement for initial qualification

route. For the same reason, the agency

will retain the requirement for the

alternative route.

(Comment 272a). A large number of

comments stated that the proposed

initial experience requirement of 10

facilities and 20 unit surveys for the

alternative route in

§ 900.12(a)(3)(ii)(B)(3) would be

impossible to achieve for many in-house

physicists and suggested eliminating the

reference to the number of facilities.

In order to be consistent with the

initial requirements for physicists under

§ 900.12(a)(3)(i)(B)(3), the agency has

revised § 900.12(a)(3)(ii)(B)(3) to change

the required initial experience from

conducting surveys of at least 10

mammography facilities and 20 units to

conducting one facility and 20 unit

surveys. Again, no more than one

survey of a specific unit within a period

of 60 days can be counted towards the

total mammography unit survey

requirement.

(Comment 272b). Two comments

stated that the experience component

under the alternative initial requirement

should have to be fulfilled under the

direct supervision of a qualified medical

physicist, as required under

§ 900.12(a)(3)(i)(B)(3). Another comment

suggested changing the effective date of

this regulation to the effective date of

this section because there is more than

one effective date in these regulations.

The agency points out that

§ 900.12(a)(3)(i)(B)(3), which will take

effect 18 months after these regulations
55906 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

are published, will affect only new

medical physicists entering the field.

Because § 900.12(a)(3)(ii)(B) establishes

that the alternative pathway is only

available until the effective date of the

final rules, the direct supervision

requirement does not apply to the

individuals qualified through the

alternative pathway, because no one

will enter the field through that

pathway following the effective date of

the rules. In response to the comments

about varying effective dates in the

proposed rule, FDA points out that,

except for some of the equipment

standards and equipment QC tests, all

sections of the final rule will be

effective 18 months after publication.

This is clearly stated in the final rule.

The continuing qualifications

requirements for medical physicists

have two components:

§ 900.12(a)(3)(iii)(A) continuing

education, which requires the physicist

to earn 15 units over 3 years; and

§ 900.12(a)(3)(iii)(B) continuing

experience, which requires the physicist

to survey 2 facilities and 6 units over 24

months.

(Comment 273). One comment

questioned FDA’s authority to require

continuing education at all.

In response, FDA observes that the

MQSA is designed to provide the

government with authority to issue and

enforce standards to ensure safety and

accuracy of mammography in the

United States. The section of the statute

relating to quality standards lists a

variety of requirements for each group

of personnel associated with

mammography practice. Although only

the requirements relating to interpreting

physicians expressly includes a

reference to continuing education, these

requirements are not an exclusive or

limited list of standards to be

established by the agency. They

represent only the minimum

requirements that Congress mandated

that the Secretary must ‘‘include’’

among those issued to ensure safety and

effectiveness of mammography (42

U.S.C. 263b(f)(1)). Just as FDA has

determined that continuing education is

necessary to maintain the skills and

expertise of radiological technologists,

the agency has concluded that

continuing education requirements are

also essential for medical physicists,

who play a critical role in guaranteeing

the safe operation of equipment and

effective quality assurance systems.

(Comment 274). One comment stated

that these requirements are appropriate.

Two comments asserted that self

training by reading and studying should

qualify. Other comments asked that

continuing education units be better

defined. Another comment stated that

the language was too prescriptive. One

comment stated that most medical

physicists would have completed rather

than taught continuing education units

and another opposed giving repeated

credit for a course taught several times.

One comment maintained that no CME

has been available for those who have

tested Xerox systems for the last 5 years,

and that such courses are unlikely to be

available in the future.

FDA notes that the final rule

establishes that the units earned through

teaching of a specific course can only be

counted once towards the 15 education

units requirement. A new definition for

continuing education unit or credit has

been added in § 900.2(l). The agency

will accept only the continuing

education credits offered by

professional organizations whose

training is shown to be relevant and

acceptable for medical physicists.

Language clarifying the options for

calculating the 3-year period has also

been added. The agency understands

that sufficient training opportunities

may not be available in

xeroxmammography. However, because

only 0.5 percent or less of the facilities

use xeromammography, the agency

believes that the majority of physicists,

if not all, will need only continuing

education related to screen-film

mammography. When other

mammographic modalities, such as

digital mammography, become

available, medical physicists will need

continuing education in those areas.

The agency believes that such training

will be increasingly more available as

the technologies develop. The agency

advises the facilities that use

xeromammography to contact the

manufacturer of this system to provide

or arrange for training in

xeromammography.

(Comment 275). One comment

recommended that the second and

subsequent 3-year periods begin to run

from the original date that the physicist

was required to meet the continuing

experience qualification.

FDA decided to use a floating 3-year

period for all mammography personnel,

instead of a fixed 3-year period as

suggested by the comment, for two

reasons. First, as explained previously,

a fixed period actually allows an

individual to go much longer without

continuing education than the length of

the period itself. With a 3-year fixed

period, for example, if an individual

received training near the beginning of

one period and near the end of the next

period, he or she would go nearly 6

years without continuing education,

which is entirely too long in a changing

field such as mammography. Second,

because inspections are annual, if an

inspector found that an individual had

not met the continuing education

requirement during the previous fixed

period, that individual might have

provided services to the facility for

almost a year before the failure was

discovered. Depending upon the

circumstances, the actions needed to

correct the consequences of using the

services of a noncompliant individual

could require a considerable amount of

time and money on the part of the

facility.

(Comment 276). Two comments stated

that persons providing continuing

education should meet the

qualifications of a medical physicist as

described in the proposed regulations

and that the instructors should be in

active practice.

FDA disagrees. The agency believes

that many scientists, university

professors, and equipment

manufacturers can provide training in

different aspects of mammography

physics.

(Comment 277). Another comment

claimed that it is excessively

bureaucratic to require that a physicist

send a copy of his or her CME to

include in the operating manuals, as

was insisted upon by an inspector at

their facility.

FDA believes that the author of the

comment misunderstood the reason

why the information on CME was

required to be sent to the facility. The

reason was not for inclusion in the

facility’s operating manual but to enable

the facility to demonstrate that its

medical physicist met the continuing

education requirement. All interpreting

physicians, radiologic technologists,

and medical physicists providing

services to mammography facilities have

to document that they meet the

continuing education requirement.

(Comment 278). One comment stated

that there should be some penalty for

failing to meet the continuing education

requirements.

The consequences of failure to

maintain these requirements is the

inability to work independently as a

medical physicist. As stated with

respect to other mammography

personnel, the agency believes this

penalty is the most effective means to

guarantee that physicists maintain

qualifications and to protect the public

health.

Under the proposal, FDA would

require medical physicists to maintain

their skills through the survey of at least

3 mammography facilities a year.

(Comment 279). More than 50

comments opposed this requirement. As
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55907

expressed in related comments, inhouse physicists may be contractually

prohibited from surveying outside

facilities. Many of these comments

suggested deleting the reference to the

number of facilities.

In response to these comments and in

order to establish consistency with

revisions to the initial experience

requirement discussed above, FDA has

revised the proposed continuing

experience requirement. The

requirement will be for surveys of two

facilities and six units in a 24-month

period. The same facility can be

surveyed twice. However, as with the

initial experience requirement, no more

than one evaluation of a specific unit

within a period of 60 days may be

counted towards the requirement. In

addition, while the same facility may be

surveyed twice within this 24-month

period by an individual physicist in

order to meet this requirement, the two

surveys by this physicist must be at

least 10 months apart. This restriction

does not prohibit the facility from

having surveys more frequently than

once every 10 months, if it wishes to do

so out of quality concerns or for other

reasons. The restriction only limits the

number of surveys of that facility that an

individual physicist can use to meet his

or her continuing experience

requirement. The reduction in the

number of facilities will address the

concerns that were raised about inhouse physicists.

In order to be consistent with the

equivalent physician and technologist

requirements, the continuing experience

requirement for physicists is now based

upon a 24-month period. This will now

make it more feasible for physicists who

are out of the field for a time, e.g., on

maternity or sabbatical leave, to

maintain their qualifications. The

requirement has also been amended to

explain options for identifying the 24

months that will be used to determine

compliance. This change parallels

similar changes in the requirements for

radiological technologists and

interpreting physicians and is intended

to provide personnel and facilities with

additional flexibility for monitoring

compliance with these standards.

Section 900.12(a)(3)(iii)(C) requires

physicists to be trained to do surveys of

a mammographic modality for which

they have not previously received

training before independently doing

surveys of such units.

(Comment 280). A number of

comments correctly pointed out that the

reference to mammographic

‘‘examinations’’ should actually be to

mammographic ‘‘surveys’’ or

‘‘evaluations.’’

FDA has corrected this error by

replacing the word examination with

survey.

(Comment 281). Several comments

opposed the requirement for 8 hours of

training in a new mammographic

modality prior to doing a survey of such

a modality. One comment expressed

concern that this will keep physicists

from surveying new modalities. Another

comment suggested that length and

degree of training be commensurate

with the specifics of the new modality.

Two comments stated that the

requirement overestimated the

complexity of new modalities and

undervalues the physicist’s capability of

adapting to new modalities in medical

imaging. One comment stated that this

rule is unnecessary because a qualified

physicist will be able follow guidelines

developed by ACR and AAPM when a

new modality, such as digital

mammography, begins to be used by the

facilities. One comment stated that 8

hours of training in a nonscreen-film

modality would be difficult to complete,

while another comment stated that only

expert instrument manufacturers would

be qualified to provide such training.

The agency continues to believe that

the proposed requirement of 8 hours of

training in a new mammographic

modality before a medical physicist may

begin performing surveys independently

in that type of modality is reasonable

and necessary. Training prior to practice

using a new mammographic modality is

required for all critical personnel

(interpreting physicians, radiologic

technologists, and medical physicists)

because FDA has determined that the

benefits to patients from such prior

training outweighs the cost to

individuals and facilities. The agency

recognizes that training in a new

modality may not be widely available

and agrees with comments that have

observed that equipment manufacturers

would and should be able provide such

training. The agency will encourage

manufacturers of a new mammographic

modality, such as digital

mammography, to provide or arrange for

such training when the modality is

commercially marketed.

Section 900.12(a)(3)(iv) describes

measures medical physicists may take to

reestablish their qualifications if they

have failed to meet their continuing

qualifications requirements.

(Comment 282). Two comments stated

that the surveys of facilities and units

required for reestablishing qualifications

should be consistent with the

experience requirement for initial

qualifications. The authors believed

that, if a medical physicist is not

actively involved in mammography

facility surveys for an extended period

of time, performing the proposed three

surveys may not be enough to regain the

required expertise. They recommended

that the requirement for requalifying be

increased to five supervised surveys.

One comment supported the

qualification’s supervision

requirements. Another comment

questioned why physicists are not

allowed to perform surveys without the

supervision of a qualified physicist,

while such supervision is not required

for physicians and technologists.

The agency notes that this provision

has been amended to be consistent with

similar provisions relating to physicians

and technologists. In order to reestablish

qualifications, physicists must perform

facility and unit surveys to bring their

total up to the required survey of 2

facilities and 6 units in the previous 2

years. This change also makes the

requirements for continuing experience

qualification more consistent with the

experience requirements for initial

qualification, as suggested by some

comments. Any survey performed by a

physicist to bring his or her total up to

the requirement must be under the

direct supervision of a qualified medical

physicist. Contrary to the assumption in

one of the comments, physicians and

technologists who fail to meet their

continuing experience requirement are

also required to reestablish their

qualifications under direct supervision

and cannot resume working

independently until the requalification

is complete.

e. Retention of personnel records

(§ 900.12(a)(4))

The provision on retention of

personnel records § 900.12(a)(4) is

intended to describe the personnel

records that must be kept by the facility

to establish that their personnel meet

the MQSA requirements and to indicate

how long such records should be kept.

(Comment 283). Ten comments

disagreed with the proposal by FDA to

allow records to be discarded following

the next annual inspection and the

resolution of any personnel problems

discovered during that inspection.

These comments urged that records be

required to be kept for longer periods,

with ‘‘as long as the person is employed

at the facility’’ being the maximum

suggestion. Four more comments

suggested that FDA also establish

requirements for how long records of

staff members who have left the facility

should be kept. One comment noted

that the list of the people for whom

records were required in the proposal

included darkroom personnel and

pointed out there were no specified

qualifications for such individuals. Two
55908 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

comments suggested that, if

mammography is performed at various

sites under the same ownership, the

records be kept only at one site and be

sent to the separate facilities as needed.

Finally, one comment expressed the

opinion that keeping personnel records

was an unnecessary burden, but made

no suggestions as to how personnel

qualifications could be verified without

documentation.

FDA has made a number of changes

in this requirement in response to the

comments. First, to address the concern

about inclusion of darkroom personnel,

the list of activities performed at a

facility has been replaced with a

reference to those personnel for whom

quality standards have been issued. The

wording was further changed to clarify

that, as long as an individual is

employed at a facility in one of these

capacities, records must be available to

show that the individual meets all

qualifications. Records for individuals

who have left the facility may be

discarded after the next inspection has

occurred and FDA has determined if the

individual met the requirements.

Although nothing in the MQSA or these

final regulations precludes the facility

from retaining these records for longer

periods of time, FDA does not expect to

have further need to review such

records following the subsequent

inspection. In response to comments

suggesting that multi-site facilities

retain personnel records in a central

location, FDA notes that such a practice

would be permitted but is not required

under the final rule. Because the MQSA

inspections are typically announced in

advance, a facility could store its

records at one site and bring them to the

other sites as needed for review during

the inspections there.

2. Equipment (§ 900.12(b))

The requirements were intended to

establish specifications to ensure that

each facility would have equipment that

is capable of producing quality

mammograms. FDA made a number of

significant changes in the equipment

requirements that were proposed. These

changes include removing several of the

requirements proposed for phase-in 5

and 10 years after the publication of the

final rule and moving several

requirements from § 900.12(b) to the

quality assurance paragraph in

§ 900.12(e). Most of the test procedures

that would have been required under

the proposal have also been deleted.

Each of these changes will be discussed

below.

a. General comments on equipment

(Comment 284). A number of

comments raised issues that did not

address specific provisions proposed

under § 900.12(b), but were directed

generally toward the entire package of

regulations governing equipment. These

included two comments that expressed

a blanket support for the regulations

proposed under § 900.12(b).

One comment stated that it would be

useful to have a better delineation of

responsibility for ensuring that units

meet particular standards under the

MQSA. The comment recommended

that the facility medical physicist be

designated as the individual responsible

to ensure that a facility’s equipment is

in compliance.

FDA believes responsibility for

compliance with all the MQSA

requirements rests ultimately with the

facility. Within the scope of each

facility’s individual operations,

responsibility can be apportioned as the

facility wishes, so long as this is

consistent with the regulations. The

suggestion made by the comment is not

inconsistent with the regulations. Under

§ 900.12(d)(1)(iv), the medical physicist

is designated as the individual

responsible to oversee the QC

requirements, though no provisions

specifically require routine QC testing to

be performed by the medical physicist.

(Comment 285). Three comments

suggested that FDA cannot anticipate

future changes in mammographic

equipment technology sufficiently well

to be able to determine all appropriate

requirements in this area over this

extended timeframe. One of these

recommended that FDA review the

equipment requirements on a

continuing basis to recommend and

propose modifications that are

recognized to promote quality

mammography. One comment suggested

that FDA simply require all

mammography X-ray units to be

replaced every 8 to 10 years in order to

keep facilities upgraded with

standardized equipment.

FDA agrees that it cannot anticipate

all changes in mammography

equipment over the next 10 years and

has not attempted to do so. In the

proposed regulations, FDA simply

incorporated specifications of current

equipment that experts had deemed

desirable for quality mammography

systems. The goal of the proposal was to

ensure that, 10 years in the future, each

facility would be using equipment that

was considered state-of-the-art in

today’s market. FDA approached this

goal by phasing-in the requirements

over various time periods. Equipment

requirements considered most

fundamental to the delivery of quality

mammography would be required first,

followed by those specifications

considered useful but which, because of

cost impact, could be delayed for a

period of 5 years. The third phase under

the proposal included ‘‘nice to have’’

features that are not absolutely

necessary to the production of quality

mammograms and would not be

required until the end of a 10-year

period. However, based on the

uncertainty surrounding the need for

the phase three requirements,

consultation with NMQAAC and

industry representatives, assessment of

the costs associated with some of the

proposed 5-year phase-in requirements,

and consideration of the public

comments, FDA has determined that

this goal is inconsistent with efforts to

keep the costs associated with the

delivery of mammography services at a

manageable level. The agency has,

therefore, decided to eliminate many of

the requirements that had been

proposed for both 5- and 10-year phasein. FDA has previously stated that it

plans to periodically review the

regulations for necessary revisions in

response to new technology and

remains committed to that effort. The

agency intends to and will revisit these

areas in the future to reassess the need

for additional regulations.

Although the revised equipment

standards do not mandate that each

facility have all the equipment features

the agency originally had proposed,

FDA believes the final regulations

establish basic requirements that ensure

that every facility meets the baseline

equipment standards necessary to

perform safe and accurate

mammography. In response to the

comment that recommended requiring

new equipment every 8 to 10 years, FDA

does not believe that the costs

associated with the arbitrary

replacement of mammography

equipment every 8 years to 10 years is

justifiable. In addition, the agency notes,

too, that the alternate standards

provisions, included in the regulations

under § 900.18, provide the flexibility

needed to ensure that new and

innovative advancements reach the

market without unnecessary delay.

(Comment 286). Two comments

recommended that all detailed testing

procedures be eliminated from

§ 900.12(b) to allow flexibility for

qualified medical physicists to

determine the appropriate testing

methodology.

FDA has, in large part, adopted this

approach in the final regulations. In

doing so, the agency has placed

responsibility on the medical physicists

to be able to justify the procedures that

they utilize to perform testing of

equipment in any particular facility.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55909

(Comment 287). One comment

suggested that the X-ray tube companies

are ‘‘planning for early tube retirement

so they can replace the tubes frequently

at high cost to the facilities.’’ The

comment asked FDA to address this

issue immediately in an effort to keep

mammography costs down.

FDA does not control the pricing of

equipment in the marketplace. The

agency is, however, interested in

equipment problems that may indicate a

unit does not meet its specifications

and/or aspects of compliance that it is

certified as meeting. Specific

information about manufacturers should

be submitted to the Office of

Compliance in FDA’s Center for Devices

and Radiological Health, 2094 Gaither

Rd., Rockville, MD 20850.

(Comment 288). One comment

suggested that there should be a lockout and/or alarm mechanism preventing

a mammography technologist from

exposing the patient to radiation

without placing film in the equipment.

Another comment suggested a

requirement for an interlock to prevent

a second exposure until the cassette is

changed, and two more comments

recommended a requirement for an

interlock to ensure the presence of a

cassette in the bucky/film holder. These

comments noted that such incidents

have occurred, needlessly exposing

patients to radiation multiple times

because the technologist forgot to insert

or change the film.

Although FDA is aware that some

manufacturers include interlocks that

ensure the presence of a cassette or that

cassettes are changed after each

exposure on their equipment, FDA is

not considering such requirements at

this time. FDA believes that, unlike

equipment performance, this is an

aspect of the mammography process

that is within the complete control of

the technologist and that the

technologist must assume responsibility

for preparing the system for each

exposure. In facilities where more than

one technologist uses the equipment, a

check list of items should be followed

and this should most certainly be one of

the items on the list. If the technologists

adequately follow standard procedures,

incidents such as those described in the

comments can be prevented without

incurring the considerable expense

involved in requiring the suggested

interlocks.

(Comment 289). One comment asked

the agency to consider requiring special

grounding devices to protect operators

and patients. The comment also

suggested a prohibition against

carpeting in the mammography room,

and a requirement for the use of static

mats around the mammography

machine.

Although these items might be

desirable they do not impact the quality

of the mammography image and are

beyond the scope of these regulations.

(Comment 290). One comment

suggested that a requirement

establishing a maximum distance from

the surface of the patient support to the

sensitive part of the image receptor

should be incorporated in § 900.12(b).

FDA is not aware, and the comment

did not offer evidence to show, that this

represents a problem for current

mammography systems. Accordingly,

the agency is not planning to regulate

this aspect of equipment performance.

(Comment 291). One comment

suggested that the maximum allowable

photo-timed exposure for

mammography applications should be

specified. The comment stated that the

backup limit of 2,000 mA’s (from 21

CFR 1020.31(a)(3)(iii) in the

Performance Standards for Diagnostic

X-ray systems and their major

components) was clearly selected based

on prior technology, i.e., much slower

screen-film systems or, perhaps,

industrial X-ray film where exposures

were typically on the order of 5,000

milli Roentgen (mR) for an average

breast.

FDA notes that the regulations under

21 CFR 1020.31 presently set a limit of

2,000 mA’s for automatic exposure

control equipment when operating with

a peak tube potential under 51 kVp.

This regulation is not specific to

mammography, but applies to any

diagnostic X-ray equipment operating

with a peak tube potential under 51

kVp. In previous draft regulations

presented to NMQAAC, a lower value of

600 mA’s was proposed for

mammography systems. The committee

was of the opinion that 600 mA’s was

too low and FDA planned to increase

the value to 800 mA’s. In the meantime,

FDA received comments from industry

pointing out that some systems have

variable SID capability. This variability

in current equipment undermines an

approach that relies on the maximum

mA’s concept because the mA’s

required at a longer SID may be

significantly greater than that required

at a shorter SID, although the dose

delivered might remain constant.

Because FDA was faced with setting

dose limits for the termination of the

exposure or unnecessarily limiting

equipment SID, the agency decided that

the maximum allowable photo-timed

exposure should not be prescribed in

the regulations at this time. This

decision was presented to NMQAAC,

which had no comment. FDA may

revisit this area in future proposals.

(Comment 292). One comment noted

that the time between exposure of the

film and photographic processing is

critical because the latent image on all

film decays with time.

FDA had considered this aspect of the

imaging process for regulation but,

based on comments from the public and

NMQAAC, decided not to propose

requirements at this time. This area may

be revisited in the future when more is

understood about the requirements and

practices in the mobile mammography

community, where film processing often

must be delayed for a significant period

of time after exposure.

(Comment 293). Several comments

recommended that FDA set standards

for batch variability of film, stating that

this variability is often greater than that

proposed for the equipment standards.

FDA recognizes that the variability of

film may be a potential problem but

believes that facilities can control this,

to a significant degree, through their

purchasing specifications and selection

of suppliers. FDA will monitor this

problem closely to determine if future

regulation is required.

(Comment 294). Twenty-five

comments recommended that FDA

include requirements for the viewbox

and/or the viewing conditions for the

physician and technologist.

FDA agrees such standards would be

beneficial, but does not believe that

enough is known, at this time, to set

appropriate specifications for viewing

conditions. The guidelines

recommended by ACR are excellent and

the agency encourages facilities to

follow them. FDA will consider this

subject for future regulation and all

relevant comments will be reconsidered

at that time.

(Comment 295). Thirty-nine

comments expressed concern that the

cost of some or all of the equipment

regulations would cause facilities to

close and thereby restrict access for

patients. Many of these comments urged

that the equipment requirements should

be made to apply to manufacturers of

equipment for items manufactured after

the specified effective date of the

regulations. A related comment

suggested that the current interim rule,

which requires only that equipment be

specifically designed for mammography,

is working well and that further

regulation proposed under § 900.12(b)

will serve only to stifle invention, add

cost, and ‘‘overly rigidify’’ this

important aspect of providing the

highest quality mammography services

at the lowest cost to the public.
55910 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

FDA can understand why the last

comment believes the interim

regulations are far less extensive than

what was proposed. The interim

regulations address the equipment

aspect of mammography quality directly

by listing four criteria that all X-ray

systems used for mammography must

satisfy: (1) The X-ray equipment must be

specifically designed for mammography;

(2) it must be certified to meet the

performance standards in 21 CFR

1020.30; (3) it must have a removable

grid; and (4) it must have a compression

device. In addition, however, the

interim regulations required each

facility to undergo an annual survey in

accordance with the standards specified

in the 1992 or 1994 ACR QC manuals

(see § 900.12(d) and (e) of the interim

regulations). These manuals outline

extensive requirements for the

equipment associated with the

mammography process. In the final

regulations, FDA has not referenced

these manuals although NMQAAC

strongly advised their continued use

and has instead included specific

requirements that were part of the ACR

standards under final regulations at

§ 900.12(b) and (e). Although they

appear as new regulations, many of

these new provisions merely restate

requirements that previously had been

referenced through the ACR manuals

but are now reformatted as regulation.

FDA is also concerned about all costs

associated with the regulations under

the MQSA, including those incurred by

the purchase, upgrade, and repair of

equipment. However, FDA’s authority

under the MQSA relates to the user of

the equipment rather than the

manufacturer. Under authority granted

to FDA by provisions of the act (which

incorporates the Radiation Control for

Health and Safety Act of 1968), FDA is

pursuing a parallel path to generate

standards for new equipment under

§ 1020.30. This process will take some

time and regulations on new equipment

only gradually affect the installed base.

The agency concluded that regulations

directed at new equipment only, and

not the installed base, would have

inappropriately delayed the benefits of

the improvements provided by the new

equipment for millions of women for a

number of years.

For these reasons, FDA determined

that equipment standards implementing

the MQSA should be directed to the

installed base to ensure that all women,

not just those that utilize facilities with

new equipment, receive an adequate

and equal baseline of care. Based on

facility inspection experience with the

interim regulations, FDA does not

expect a large reduction in providers

and anticipates no access problems

solely as a result of the equipment

regulations. In addition, FDA has

provided mechanisms for alternate

standards in § 900.18 to allow for

innovation and flexibility under the

final rule. The agency has no reason to

believe that the regulations will cause

stagnation in the market for new and

useful equipment.

(Comment 296). One comment asked

if it was necessary to attempt to codify

and regulate equipment standards that,

in the respondent’s opinion, will evolve

anyway through competition in the

market.

Again, the agency responds that the

introduction of new products into the

market place can be a slow process and

waiting for manufacturers to

manufacture and market and for users to

purchase would not produce the change

in minimum national standards that

FDA perceives is needed. Additionally,

in FDA’s experience, certain segments

of any market are often driven by price

concerns rather than features or

performance. FDA believes that

regulations are the only mechanism that

will provide the impetus to achieve the

desired baseline of care in a reasonable

time.

(Comment 297). One comment

supported phasing in the equipment

standards over the next 1 to 10 years, as

discussed in the preamble to the

proposal (61 FR 14909). Two comments

stated that 5 years is not a sufficient

amount of time to require the

purchasing of new equipment and

maintained that it would be more

appropriate to allow a longer phase-in

period, for example, 10 years.

Five comments offered a contrary

point of view, suggesting that the

majority of the mammography

equipment presently in use meets most

of the proposed standards in § 900.12(b)

and that many of the timeframes

proposed in § 900.12(b) are excessively

long. One of these comments expressed

concern that there are some facilities

where the machine limits the ability to

do adequate imaging and the facility

will not get newer equipment if not

forced by law to do so.

FDA appreciates these comments and

recognizes that some facilities will not

upgrade their equipment until the last

possible moment, thereby using

equipment that has become inadequate

by current standards. The agency must

balance these concerns with cost

concerns that facilities, patients, and

FDA all share. The decision to require

certain equipment standards to be

phased in relatively quickly and

postpone others represents the agency’s

efforts to balance these competing

concerns.

(Comment 298). One comment

suggested that there should be

regulations for needle biopsy systems in

§ 900.12, including provisions that

address misalignment of the biopsy

cross-hair. The comment stated that the

cross-hair assembly, if not accurately

aligned, may lead to inaccurate

localization of lesions during needle

localization, increasing the possibility of

morbidity. FDA recognizes the need for

regulation in this area and has raised the

issue with NMQAAC in the past. As a

result of discussions with NMQAAC

and opinions offered by the ACR, the

decision was made to delay regulations

for this aspect of breast radiography

until community consensus can be

reached on all aspects of the process. As

discussed earlier, FDA is currently

working internally on possible

regulations for interventional

mammography, while awaiting the

results of collaborative efforts between

the ACR and the American College of

Surgeons to reach consensus on

recommendations for standards in this

area.

(Comment 299). One comment

recommended that the equipment

specifications proposed under

§ 900.12(b) should not be included in

the final regulations and that the entire

section should be issued as guidance

rather than a binding regulation.

FDA has considered this approach,

but has determined that, because the

guidelines would not have the force of

law, they would not achieve the

widespread results necessary to meet

the goals of the MQSA.

(Comment 300). Nine comments

expressed concern that the proposed

regulations under § 900.12(b) were not

specific as to whether all equipment in

a facility must comply and one of these

comments questioned if existing

mammography units must be redesigned

and/or upgraded to all the standards by

the effective dates.

FDA intends that all facilities

performing mammography shall meet

each of the final regulations by the

effective date of each requirement. In

the case of equipment, all equipment

used for covered mammography

procedures must meet the requirements

in effect at any given time. If equipment

must be repaired, replaced, or upgraded

to achieve this result, then such actions

must be completed by the effective date

or the facility must discontinue offering

mammography services with the

nonconforming equipment until

compliance is achieved.

(Comment 301). One comment stated

that the equipment standards sometimes
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55911

give very specific descriptions of testing

equipment and procedures. For

example, in proposed § 900.12(b)(4)(iv),

FDA specifically described a 12 cm

diameter acrylic disc 1.5 cm thick. The

respondent was unsure why 12 cm was

specified instead of 10, and why 1.5 cm

was specified instead of 1 or 2.

FDA notes that in each case where

test procedures and/or test objects are

specified in these final regulations, the

objects or procedures are usually based

on established test protocols. In some

cases where the test object itself could

be variable, the specifications are

identical to an object used in another

required test in order to reduce the

number of items required for the entire

survey or inspection. In cases where the

test or the test object is new, the details

of its design are beyond the scope of this

document. FDA intends, whenever

possible, to issue guidance documents

that will address the use of such new

procedures and equipment. The

particular example cited in the

comment has been deleted from the

final regulations.

(Comment 302). One comment stated

that the proposed rules are not entirely

consistent with the guidance document

developed by ACR and CDC. The

comment recommended that every effort

should be made to ensure consistency

with the ACR guidance document.

FDA is, of course, aware of the ACR/

CDC document and, in fact, adopted

many of its requirements for these final

regulations. However, the ACR/CDC

document was written as a guideline for

new equipment and not as a regulation

for installed equipment. As a guideline,

its wording would not readily transfer to

regulation and, as a specification for

new equipment, its scope was not

sufficiently broad to address the range

of the installed base or the cost concerns

associated with upgrade and

replacement of equipment. The agency

also notes that the recommendations in

the ACR/CDC guidance represent an

attempt to describe an optimal system.

NMQAAC and members of the public

have stated that some of the features,

while desirable, would generate costs

not justified by the expected benefit,

especially when applied to the installed

base. In those cases where the agency

believes the benefit does not warrant the

cost, FDA has not made particular

features regulatory requirements. Within

these limitations, FDA has generally

made efforts to remain consistent with

the ACR/CDC guidance where doing so

is appropriate.

(Comment 303). One comment

suggested that a section in § 900.12(b) or

(e) should address the issue of screen

placement in the cassette. The comment

noted that, because the screen is

sometimes not positioned with its edge

in contact with the inside wall of the

cassette at the chest wall, the film edge

is underexposed or unexposed. The

comment suggested that ‘‘such cassettes

should be rejected and the screens

remounted.’’

FDA agrees that such conditions

should not exist, but believes the annual

survey and normal QC procedures will

identify and correct such problems and

is not considering regulations to address

this concern at this time.

(Comment 304). One comment

recommended that the proposed

equipment regulations in § 900.12(b) be

rewritten to correspond more closely

with existing international standards.

In certain aspects of equipment

related requirements, FDA has

attempted to conform to both national

and international precedent. However,

in some cases, those guidelines are

inappropriate or do not address the

specific concern being considered under

the MQSA.

(Comment 305). One comment

suggested that the proposed

requirements of § 900.12(b)(17) through

(21), which do not relate to X-ray

equipment or film processors, should be

included as part of the annual physics

survey and need not be specified by

regulation. FDA believes that this

respondent misunderstood these

provisions because the core of the

annual physics survey is, in fact, set

forth in these regulations. Some of these

regulations have been modified and/or

transferred to the quality assurance

section of the final regulations, while

others have been deleted. The remaining

requirements may be checked as survey

or inspection items, verified by

documentation provided by the

manufacturers, or established through

normal QC procedures performed by the

facility. Although the agency has not

expressly prescribed how these

requirements should be met in all cases,

FDA has determined that the facility is

responsible for establishing compliance

with these standards rather than trusting

that they would be included in all

medical physicists routine surveys.

b. Prohibited equipment

(§ 900.12(b)(1))

This paragraph prohibited the use for

mammography of general purpose

equipment or equipment designed for

special nonmammography procedures.

(Comment 306). Seven respondents

recommended that the use of

xeromammographic equipment should

be prohibited or phased out.

FDA considered taking this action but

believes that the unique characteristics

of the xeroradiographic process may

provide a valuable tool in the diagnosis

of some cases. Records obtained during

the first year of facility inspections

under the interim regulations indicate

that there are an extremely small

number of these units in service and it

is believed that the number will

continue to decrease as their use falls

out of favor with the community. FDA

has concluded, therefore, not to ban

their use.

c. General (§ 900.12(b)(2))

This paragraph, as proposed, required

that all equipment be designed for

mammography and certified under

§ 1020.30.

(Comment 307). One respondent

suggested that a definition of

‘‘specifically designed for

mammography’’ be included because

some units may be used for imaging of

extremities.

FDA does not believe that this is

necessary because the manufacturer’s

labeling, along with the FDA device

approval process, ensures that the

design is appropriate for mammography.

FDA recognizes the fact that the

characteristics of mammography

radiographic equipment make it useful

for other radiological examinations and

does not intend to restrict such

applications if the product has also been

approved for that use.

d. Motion of the tube-image receptor

assembly (§ 900.12(b)(3))

This paragraph proposed that the

gantry be capable of specific rotation,

that the angle of the gantry be indicated,

and that the tube-image receptor

assembly remain rigidly fixed in any

position where it was designed to

operate.

(Comment 308). Two comments noted

a citation error in the proposed

regulations. One comment

recommended the deletion of the entire

section, with the possible exception of

requiring the system to remain fixed

when placed in an operating position.

Three other comments supported the

proposed requirements, although one

suggested that only one unit at each

facility need meet the requirements.

NMQAAC supported the proposed

requirements, with the recommendation

that they be applicable only to

equipment acquired 5 or more years

after the publication of the final

regulations.

FDA has determined that NMQAAC’s

recommendation to require compliance

only on equipment acquired 5 or more

years after publication of the final

regulations presents major problems

with respect to enforcement. Such an

approach would produce a situation

where two distinct levels of quality

would be in place for different facilities
55912 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

and often within the same facility, based

on when equipment was acquired. After

reviewing the public comments and

assessing the possible cost impact of the

requirements, FDA decided to remove

the provisions detailing the range of

gantry motion and angle indication. If

this area is considered for future

regulation, all comments submitted on

these sections will be reconsidered in

the process. FDA has reworded the

provision that requires the tube-image

receptor assembly to remain fixed in its

designed operating positions and this

requirement remains under

§ 900.12(b)(3) in the final regulations.

The citation error has been corrected.

e. Image receptor sizes (§ 900.12(b)(4))

This paragraph requires that all

mammography systems have, at a

minimum, both a 18 X 24 cm and 24 X

30 cm screen-film receptor and

matching grids, and that the grids

should be removable. This section also

proposed that grid motion should not be

impeded when a breast is subjected to

compression in the system.

(Comment 309). Seven comments

supported the proposal regarding the

image receptor sizes and matching grid

requirements proposed in

§ 900.12(b)(4)(i). Two comments

opposed the specification requiring both

a large and a small image receptor

system in the regulations. One of these

misread the proposal as being

applicable to xeromammographic

equipment and suggested that the

regulation might prohibit the use of

such equipment because such systems

may not provide multiple image

receptor sizes. The other comment

supported the concept of requiring a

large and small image receptor

combination, but opposed a provision

specifying the actual dimensions of

these receptors. A related comment,

while not actually opposing the

proposal, expressed concern that

requiring multiple image receptor sizes

for screen-film systems might establish

difficult precedents for future

technology.

FDA believes that, for the present and

foreseeable future, the dominant film

sizes used in screen-film mammography

will remain 18 X 24 and 24 X 30 cm and

has not been persuaded to revise the

provision that requires systems to have

both sizes with corresponding grids.

The agency believes that the last

comment is concerned with digital

systems currently under development

and the concern that large or multiple

sized image receptors would be

prohibitively expensive with such

systems. FDA has not formulated an

opinion in this area and will wait to see

what final technology and

configurations evolve for digital systems

before addressing this issue in

regulation.

(Comment 310). One comment, while

neither agreeing nor disagreeing with

the requirement for multiple size image

receptors, stated that the use of smaller

image receptors, even on large breasts,

results in clearer, sharper images and

noted that larger areas compressed all at

once do not provide the sharpness and

detail needed to pick up very small

cancers. The comment stated that, even

though more films are taken when a

smaller film size is used to image a large

breast, the benefits of finding a lifethreatening cancer far outweigh the

minimal increase in radiation exposure

to the patient.

FDA recognizes this practice as

essentially the ‘‘spot compression’’ of

the entire breast in multiple exposures.

Although ‘‘spot compression’’ can yield

improved images, it is not a recognized

or accepted procedure in screening

mammography. Interpreting physicians

who deem such studies necessary will

order them to be performed, but it is not

standard practice for routine screening.

The agency also notes that the

regulation merely requires that the twoimage receptor sizes be available; their

use in any particular case is left to the

judgment of the mammography

personnel involved.

(Comment 311). One comment

proposed that the requirement for

multiple image receptor sizes be

restated to require at least one unit at

the facility to provide the multiple sizes,

rather than requiring each unit to have

both receptors. Experts on NMQAAC

recommended that the requirements of

§ 900.12(b)(4)(i) not be weakened by

permitting a facility to satisfy this

equipment standard by having only one

system with the multiple cassette sizes.

The rest of the committee agreed. FDA

has accepted this advice and retained

this requirement under § 900.12(b)(4)(i).

Section 900.12(b)(4)(ii) requires

facilities to have systems with moving

grids matched to all image receptor sizes

provided.

(Comment 312). One comment

commended FDA for requiring both an

18 x 24 and a 24 x 30 bucky for each

unit. Another recommended that the

regulation read: ‘‘Systems using screenfilm image receptors shall be equipped

with separate moving grids matched to

all image receptor sizes provided.’’ FDA

does not believe that the suggestion was

a significant improvement and did not

make the change.

(Comment 313). One comment

recommended the inclusion of a

requirement in § 900.12(b) that specifies

the image receptor support device shall

match the cassette size.

The agency does not believe this

additional requirement is necessary. By

requiring the system to have both a large

and small image receptor and

corresponding sized grid assemblies,

FDA is confident that most

technologists will select the appropriate

receptor and cassette size for each

patient.

Section 900.12(b)(4)(iii) requires the

grid to be removable for systems used

for magnification.

(Comment 314). Three comments

requested clarification regarding

applicability and intent of this

provision.

FDA notes that the final regulation

was drafted to clarify the interim rule.

Section 900.12(b)(4)(iii) simply states

that the system must be operable with

the grid removed from between the

source and the image receptor when the

technologist is performing magnification

procedures. This could be accomplished

in various ways, including actually

removing the grid mechanism,

substituting a nongrid film holder for

the grid film holder assembly, or any

other mechanism that ensures that the

grid does not interfere with the image or

the automatic exposure control, if one is

used.

Under § 900.12(b)(4)(iv), FDA

proposed that the grid motion not be

impeded when the breast is compressed

and also proposed detailed

requirements for verifying compliance.

(Comment 315). Seven comments

supported the proposed requirements

for assessment of grid related artifacts,

while 14 comments supported the

concept of evaluating grid related

artifacts, but opposed both listing the

requirement in regulation and the test

procedure outlined in the proposal on

the basis that the test method was

unproven and objective standards for

evaluation of the seriousness of the

problem were lacking. In April 1996,

and again in January 1997, NMQAAC

recommended removing

§ 900.12(b)(4)(iv) regarding the grid

related artifacts.

FDA has accepted NMQAAC’s

recommendation and removed this

paragraph.

(Comment 316). Twelve comments

requested justification, clarification, or

suggested modifications for the test

procedure proposed under

§ 900.12(b)(iv). If the issue is revisited

for future regulation, the comments to

this section will be reconsidered at that

time.

f. Beam limitation and light fields

(§ 900.12(b)(5))
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55913

This paragraph covers devices for

limitation of the X-ray field and

specifies light localizer characteristics.

Under § 900.12(b)(5)(i), FDA proposed

that all systems ensure that the X-ray

field can extend to or beyond the chest

wall edge of the image receptor.

(Comment 317). Two comments

interpreted this as a requirement that

the collimator must provide separate

adjustability on the chest wall edge and

suggested that such adjustability is

unnecessary.

FDA accepted these comments and

reworded § 900.12(b)(5)(i) to clarify that

the intent is not that the collimator be

adjustable, but that the collimator allow

complete coverage of the image receptor

at the chest wall edge unless it is the

intent of the operator to not do so. This

requirement has been moved to the

quality assurance section and appears in

§ 900.12(e)(5)(vii).

Section 900.12(b)(5)(ii) proposed that

any system with a light field that

appears to approximate the X-ray field

must approximate the X-ray field to a

specified tolerance and that the light

must produce a minimum specified

brightness. Four comments supported

the alignment recommendations with

the observation that, in the respondents’

opinions, the alignment was more

important on the chest wall edge.

(Comment 318). Two comments

expressed disagreement with this

requirement. In § 900.12(b)(5)(ii), FDA

also proposed a definition for the

mammographic source to image receptor

distance (SID) that was changed slightly

from the definition used for more

general purpose radiographic systems in

order to be more consistent with the

actual usage in mammography. Two

comments supported this change, two

opposed it, and one respondent

expressed concern that the definition of

SID in this section might be confusing.

After reviewing the comments, FDA

has determined that the requirements

for the alignment of the light field and

X-ray field and the definition of SID are

adequately addressed by existing

regulations in § 1020.31, and has

deleted the proposed requirements from

this standard. A QC test to verify

alignment now appears in the quality

assurance section at § 900.12(e)(5)(vii).

With respect to the proposal that the

light provide a minimum illuminance,

two comments supported the

requirement and four comments

opposed it.

FDA notes that this proposed

requirement is the same as that

currently required for general purpose

systems covered by § 1020.31. Thus, it

already applies to such collimators

using such light localizers on

mammography systems. FDA has

chosen to restate the specification here

to eliminate any confusion and to clarify

that the general requirement also

applies to mammography equipment.

The restatement now appears under

§ 900.12(b)(5)(ii) in the final regulations.

Under § 900.12(b)(5)(iii), (iv), and (v),

FDA proposed a phase-in of additional

requirements. The first stage required all

mammography systems to incorporate

such a light localizer 5 years after

publication. The second stage required

that 10 years after publication, all

mammography systems were to prevent

X-ray production unless the correct

combinations of field size and image

receptor were selected and to prevent

any exposure with an X-ray field

exceeding the size of the image receptor

support device.

(Comment 319). Three comments

supported the requirement for the light

field as proposed, with one of these

urging that it be instituted at the earliest

date the regulations become effective.

One comment agreed that a light field,

as proposed, may be a desirable feature

but thought properly trained personnel

are able to position the breast correctly

without a light and suggested that the

requirement should be deleted because,

in the respondent’s opinion, the cost

would be too high to justify. NMQAAC

supported the requirement for a light

field, as proposed. Four comments

supported the proposed requirements in

§ 900.12(b)(5)(iv) and (v) but one of

these suggested that a means to override

the interlocks should be provided. One

comment opposed both proposals.

FDA has reevaluated these proposals

and concluded that they raise safety

concerns related to X-ray systems in

general rather than image quality

concerns. For this reason, and the cost

concerns discussed previously, the

agency has decided to delete both

§ 900.12(b)(5)(iv) and (v) from these

regulations and to develop such

requirements under the authority

provided in the act for regulatory

products subject to the Radiation

Control for Health and Safety Act of

1968. Accordingly, FDA is discussing

relevant changes to part 1020 with its

Technical Electronic Product Radiation

Safety Standards Committee.

After the revisions to the proposal

were completed, there remained only

two paragraphs in this provision:

§ 900.12(b)(5)(i), requiring beam limiting

devices that allow the useful beam to

extend to or beyond the chest wall edge

of the image receptor; and

§ 900.12(b)(5)(ii), which establishes the

illuminance requirement.

g. Source-image receptor distance

(SID) (proposed § 900.12(b)(6))

FDA proposed requirements for a

minimum SID for mammography

systems and specified that the SID must

be displayed. The agency also proposed

an accuracy specification for that

display. In § 900.12(b)(6)(i), FDA

proposed that all mammography

systems have a minimum SID of at least

55 cm.

(Comment 320). One comment

recommended that FDA include a

definition of ‘‘contact mammography’’

as used in § 900.12(b)(6)(i) to eliminate

confusion about its meaning. Another

comment supported the minimum SID

as proposed, and six comments

supported the concept but

recommended that the minimum SID be

reduced to 50 cm; NMQAAC supported

the proposal as published.

In considering these comments and

other more general comments relating to

avoidance of unnecessary specifications

that may limit future technology, FDA

has decided that other requirements in

the final regulations (dose, resolution/

focal spot condition, and system output)

make issuing this requirement

unnecessary. Therefore, the limitation

on the SID has been removed from the

final regulations. In the future, if the

agency determines that regulations

covering this area are required, all

relevant comments will be reconsidered

at that time.

In § 900.12(b)(6)(ii), FDA proposed

that each system should provide a

visual indication of the SID, accurate to

within 2 percent.

(Comment 321). One comment stated

that the actual SID needs definition or

that there should be specification of an

acceptable method of verifying the SID

or location of the focal spot. Other

comments were concerned with

uncertainties in determining the end

points of the SID. One comment noted

that the indication of the SID proposed

in § 900.12(b)(6)(ii) might differ between

systems because of differences in

interpretation of the location of the

image receptor. Conversely, another

comment suggested that the concept of

an indication of the SID, as proposed in

§ 900.12(b)(6)(ii), is ambiguous for those

systems having multiple focal spots and

anode tracks because all focal spots are

not at the same location on the anode.

The comment further suggested that the

‘‘source’’ be defined as the average

location of all focal spots.

Another comment noted that the

standards in IEC 601–1–3(point

29.203.2) specify a tolerance of 5

percent for the SID indicator and

requested that FDA consider adopting

that specification rather than the 2

percent proposed. One comment

suggested that FDA might wish to
55914 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

consider recasting the proposal of

§ 900.12(b)(6) as an outcomes

specification. Another comment

recommended that the proposed

requirement in § 900.12(b)(6)(ii) for

indication of SID be restated to require

the indication only for variable SID

units. NMQAAC recommended that the

section be deleted because they believed

that it would add to the equipment costs

with little benefit to the quality of

mammography.

FDA has accepted the NMQAAC

recommendation and deleted

§ 900.12(b)(6)(ii). If this issue is

revisited, all comments will be

reconsidered at that time.

h. Magnification (§ 900.12(b)(6)

(proposed § 900.12(b)(7)))

As proposed, this paragraph required

that systems used for procedures

beyond basic screening mammography

have magnification capability available

to the user.

(Comment 322). One comment

suggested that the proposal was unclear

as to the intent of ‘‘available to the

user.’’ One comment incorrectly

assumed that, because there was no

implementation date for the

requirement, all diagnostic equipment

installed presently have magnification

capability and will meet the

requirement. One comment expressed

concern that this requirement made his

facility’s equipment obsolete and stated

that most diagnostic mammography

does not require magnification.

The radiologists on NMQAAC stated

that magnification is needed for

noninterventional problem solving

mammography. The committee debated

whether to recommend to delete or

change these provisions and decided

not to recommend such actions.

FDA has retained the provision, but

reworded parts of the proposal to clarify

the intent. The changes include

replacing the term ‘‘diagnostic

mammography’’ with

‘‘noninterventional problem solving

mammography.’’ This change was

necessary because there is no general

consensus as to the definition of

‘‘diagnostic mammography.’’ ‘‘Problem

solving mammography’’ refers to

mammography requiring techniques

beyond those utilized in standard

mammography of asymptomatic

patients and ‘‘noninterventional’’

indicates that the procedures are

noninvasive in nature. The term

‘‘available to the user’’ simply means

that any attachments or accessories

necessary to allow the X-ray system to

perform magnification procedures must

be present with the system and available

to the technologist to encourage and

facilitate the use of the feature.

(Comment 323). Four comments

recommended that the specification be

reworded to require the facility to have

the capability to provide magnification

instead of requiring that each system

provide the feature. However, the

experts on NMQAAC stressed the

importance of requiring the feature in

each system used for such procedures

and FDA has retained the requirement.

In § 900.12(b)(7)(ii) of the proposal,

FDA specified that at least one

magnification setting should be in the

range of 1.4 to 2.0. One comment

suggested that the use of magnification

greater than 1.5 is questionable and that

limits for the image quality and average

glandular dose should be set for these

conditions.

FDA agrees, in principle, with this

comment. Generally, magnification for

these procedures is accepted within the

range specified by the requirement and

most sources seem to agree that

magnification at approximately 1.5 is

optimal. FDA believes that by requiring

the equipment to provide magnification

in the optimum range the facility will

then be able to adequately perform the

procedure. Some systems currently used

for magnification will not meet this

standard. This will not, in itself,

however, force the replacement of the

equipment because the unit may still be

used for the general population

‘‘screening’’ of asymptomatic patients so

long as it meets the other requirements.

(Comment 324). One comment noted

that ‘‘magnification setting’’ as used in

the proposal was not defined. Another

comment stated that the method of

determining the magnification, along

with acceptable limits, should be

specified or referenced. FDA has

removed the word ‘‘settings’’ from the

requirement because it might be

confusing but has not added a definition

of ‘‘magnification’’ to § 900.2; FDA

believes that the term is generally

understood to be the ratio of the sourceto-image receptor distance to the sourceto-object distance.

Because the proposed SID

requirements were moved, proposed

§ 900.12(b)(7) Magnification has been

codified as § 900.12(b)(6).

i. System resolution (proposed

§ 900.12(b)(8))

This paragraph proposed

requirements for the system resolution

for both contact mode and magnification

mode mammography.

(Comment 325). Nine comments

requested that a test procedure be

specified for the contact mode

requirement proposed in

§ 900.12(b)(8)(i). One comment

suggested that a specification of the

appropriate resolution target should be

included along with a specification of

its position in the test plane, and a

requirement for an absorber in the beam

to lengthen the exposure times, because

very short exposures may introduce

interference from gridlines.

FDA agrees with these comments and

has included a description of the test

conditions in the final regulations.

(Comment 326). One comment

correctly noted that the requirements in

proposed § 900.12(b)(8)(i) and (ii)

attribute failure to meet resolution

requirement to problems with the focal

spot when, in fact, the cause of observed

low resolution values may be some

other component in the imaging chain.

FDA agrees with this comment and

has rephrased the requirement.

Based on recommendations from

NMQAAC, FDA has removed this

requirement from the equipment

standard and established a QC

requirement for system resolution that is

codified under § 900.12(e)(5)(iii).

In § 900.12(b)(8)(ii), FDA proposed

regulating the system resolution in the

magnification mode. Based on guidance

received from NMQAAC, FDA has

moved this requirement to the quality

assurance provisions in

§ 900.12(e)(5)(iii), and has designated it

for phase-in after 5 years. If, in that

time, other values are determined to be

more appropriate, the regulations will

be modified accordingly.

Thus, proposed § 900.12(b)(8) System

resolution, no longer appears among the

equipment requirements.

j. Focal spot selection (§ 900.12(b)(7)

(proposed § 900.12(b)(9)))

As proposed, this provision included

several requirements for indication of

the focal spot selected for use in

examinations, interlocking of the focal

spot with selected kVp, and alignment

of the focal spot with the image

receptor. FDA also proposed that the

system indicate which focal spot and,

where applicable, which focal spot

material is selected prior to exposure.

The proposal also recognized that some

systems may automatically select the

focal spot during the exposure and

required a post exposure indication of

the focal spot used during such

exposures.

(Comment 327). Three comments,

including that of NMQAAC,

recommended that the requirements

proposed in § 900.12(b)(9)(ii) and (iii),

concerning indication of the target

material, be linked with an ‘‘or.’’

FDA did not accept this

recommendation because it would

essentially eliminate the requirement for

post-exposure indication of the machine

selected focal spot. The agency believes

that the change would modify the
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55915

requirement in a way the agency does

not intend or desire because it would

permit the equipment to display only

the initial preselected focal spot and

never indicate the actual focal spot

used.

(Comment 328). Two comments

supported the proposal in

§ 900.12(b)(9)(iv) that the system be

interlocked to prevent exposure with

improper or incompatible combinations

of kVp and target material. One

comment opposed this requirement, two

requested clarification, and one

requested a test procedure. NMQAAC

recommended that the initial clause in

the proposal be deleted.

After further consideration of this

requirement, FDA concluded that the

requirement was already adequately

covered by requirements relating to

diagnostic X-ray systems in

§ 1020.30(m) and has deleted proposed

§ 900.12(b)(9)(iv).

k. Focal spot location (proposed

§ 900.12(b)(10))

This paragraph proposed a

requirement that the focal spot be

located in a specific geometric

relationship to the image receptor.

(Comment 329). One comment

supported the requirement, five

(including NMQAAC) opposed it,

believing that it was unnecessary, three

requested clarification on its testing,

and one, recognizing its relationship to

the compression paddle alignment,

recommended that the provision be

moved to the section on compression

paddle alignment.

FDA accepted the NMQAAC

recommendation and deleted this

requirement from the final rule.

l. Filtration (proposed § 900.12(b)(11))

This proposed paragraph contained a

statement requiring mammography

systems to comply with the beam

quality standards for half-value-layer

(HVL) codified at § 1020.30(m)(1).

NMQAAC recommended that the

section specifying the HVL

requirements should be moved to the

QC section. FDA accepted this

recommendation and codified the

requirements for filtration under

§ 900.12(e)(5)(iv).

(Comment 330). One comment

suggested that the proposed rule in

§ 900.12(b)(11)(i) was too vague and

subject to arbitrary interpretations.

Another comment recommended that

more precise rules be used to determine

the required HVL and suggested that

existing dose tables could be used to

determine the desired limits. The

respondent based this position on the

fact that § 1020.30(m)(1) requires the

interpolation or extrapolation of HVL

values in the mammographic range. One

comment noted that filtration is not the

same as HVL; the HVL measure

indicates the filtration that is in the Xray system, but it is not an actual

measurement of filtration. Two

comments noted that the proposed

regulations refer to § 1020.30(m)(1) for

the minimum filtration requirement and

incorrectly interpreted this as a lack of

specification for kVp’s not listed. They

asked what FDA is planning to do

concerning the perceived lack of

regulation of filtration for kVp’s below

30 kV since the table of HVL

specifications does not list any values

below 30 kV. One comment stated that

some realistic values for expected HVL

at ranges of 25 to 30 kVp should be

given. One comment stated that

§ 900.12(b)(11)(i) seems less specific

than current requirements for filtration

and another comment suggested that the

requirement in § 900.12(b)(11)(i) should

be referenced to the most recent ACR

physics manual instead of

§ 1020.30(m)(1).

FDA believes that the comments

indicate that relationship between

filtration and half-value-layer (HVL) in

the mammographic energy range and

the concept of mathematical

extrapolation and interpolation may not

be fully understood by some members of

the mammography community. It is

generally understood that the first HVL

is an indirect measurement of the

filtration in the X-ray beam. In the kVp

range up to 50 kVp, the values specified

in § 1020.30(m)(1) represent a beam

with an inherent filtration equivalent to

0.5 mm of type 1100 aluminum. FDA

notes that, although the standard relates

the HVL in terms of type 1100

aluminum, it does not specify that the

same alloy be used to measure the HVL.

Therefore, the measurement of the first

HVL and the comparison of the result to

the specification indicate whether the

system has sufficient filtration in the

beam; if the first HVL is less than the

number specified in the table, there is

insufficient filtration because the HVL is

a function of the filtration and the

energy of the X-ray beam (kVp).

In response to the comments, FDA has

provided a table of the extrapolated

values of HVL in the mammography

kVp range under the quality assurance

provisions in § 900.12(e)(5)(iv). Values

not shown may be derived by

interpolation. FDA believes that

providing these values, which are

derived from the Federal performance

standard at 21 CFR 1020.30(m)(1) and

are serendipitiously identical to the

ACR recommended values when the

paddle is not in the beam, makes it

unnecessary to reference the ACR

manuals or any other external source of

HVL values.

(Comment 331). Five comments

supported a specification of a maximum

filtration requirement in

§ 900.12(b)(11)(i) and another comment

recommended that a maximum HVL,

specified as a function of kVp, be added

for each known combination of anode

and filter materials. One comment noted

and agreed with the deletion of the

upper limits for HVL that had been

proposed in previous drafts of the

proposed regulations.

FDA deleted those upper limits

because it had concluded that other

aspects of performance and image

acceptability will serve to limit the

maximum filtration. Comments to the

proposal have not persuaded the agency

to reverse that position.

(Comment 332). One comment noted

that § 900.12(b)(11)(i) references

§ 1020.30 and questioned the need to

repeat the requirement. The comment

also found the proposal ‘‘redundant

with § 900.12(b)(2),’’ which requires

equipment to be specifically designed

for mammography. FDA does not agree

that the references are redundant and

has concluded that the restatement in

this regulation serves to clarify and

reinforce the § 1020.30 specification.

One comment suggested that the

regulation be recast in terms of desired

outcomes and offered this example:

‘‘The type and quantity of filtration

interposed between the source and the

breast entrance surface shall be such as

to provide the maximum subject and

image contrast consistent with

limitations on dose (§ 900.12(c) of the

interim regulations) and minimum halfvalue layer (§ 1020.30(m)(1)).’’

FDA believes this suggestion would

introduce an unacceptable level of

subjectivity into the evaluation process

without eliminating the need to

reference the specification in

§ 1020.30(m)(1).

FDA also reconsidered the

requirements in § 900.12(b)(11)(ii) for

variable filtration systems, which

proposed interlocking the filtration with

the target material. Upon further review,

the agency concludes that requiring

equipment to meet standards that

ensure that the minimum filtration

required in § 1020.30(m)(1) is in the

beam during each exposure is sufficient

to ensure proper filtration and has

deleted § 900.12(b)(11)(ii) from the final

regulation.

m. Compression (§ 900.12(b)(8)

(proposed § 900.12(b)(12)))

This paragraph proposed a number of

requirements concerning the application

of compression. The basic proposal was
55916 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

that each mammography unit should

have a compression device.

(Comment 333). Five comments and

several members of NMQAAC

supported the proposed requirement.

One comment suggested that FDA

should go further and require the use of

the compression device.

If the compression device is present,

most technologists will use it

responsibly and also recognizes that the

use of an item is difficult to enforce.

FDA, therefore, has rejected this

suggestion.

Under § 900.12(b)(12)(i) FDA

proposed that, 5 years after publication,

each system would be required to be

equipped with an initial, foot

controlled, power driven compression

and also be required to allow the user

to control additional ‘‘fine adjustment’’

of the compression. The proposal

required that both controls be operable

from each side of the patient.

(Comment 334). Two comments stated

that power-driven compression by foot

control is unreasonable or unnecessary.

One comment stated that FDA should

delete the requirement for fine

adjustment controls and the

specifications on how the compression

controls should operate because they

will increase the cost of new equipment

while providing little benefit. Another

comment stated that no requirement

beyond one that the system ‘‘be capable

of maintaining a force of 25 pounds for

15 seconds and have a maximum force

no greater than 40 pounds when used in

automatic or power driven mode’’ is

necessary.

In contrast, twenty-eight comments

agreed that ‘‘automatic’’ power driven

compression should be required of all

facilities but stated that it should be put

in effect immediately, not 5 years from

now, as proposed. Several of these

comments expressed the opinion that

the technologist needs to have both

hands free to optimize the breast

position. Five comments stated that

manual and power compression

controls, as called for, are essential for

quality mammography. The comments

further noted that manual controls are

needed for finer adjustment and that the

two controls complement each other,

although one comment expressed the

respondent’s belief that the fine

adjustment should be a manual control

because that type of control was

reassuring to some patients. One

comment recommended that the

reference to ‘‘foot controls’’ be deleted

since the goal of ‘‘hands-free’’

application of compression may be

achievable by some mechanism other

than a foot operated control.

FDA has accepted the last comment

and modified the requirement

accordingly. However, FDA believes

that this ‘‘hands free’’ application of

power compression and the fine

adjustment control are basic to the

delivery of quality mammography care

and is retaining the requirements in the

final regulations. FDA appreciates that

this will have a cost impact on the

installed base; however, the agency

believes that the benefit to public health

outweighs this cost and also notes that

most of the current equipment can be

brought into compliance with

modifications that are far less costly

than total replacement.

(Comment 335). One comment

suggested that FDA might wish to recast

the proposal in terms of the desired

outcomes, for example:

Means of applying compression to the

breast shall be provided that; (i) allow the

technologist to use both hands to position the

breast while applying compression, (ii)

facilitate positioning from both sides of the

patient without removing hands from the

patient, (and) (iii) allow a slow, final

adjustment of compression.

While FDA appreciates this

suggestion, the agency believes that

such terms as ‘‘allow’’ and ‘‘facilitate’’

require too much subjective evaluation

in the interpretation of compliance.

Under some design and use conditions,

certain technologists may be able to

demonstrate that the equipment meets

these requirements, while others may

not. FDA believes that establishing

reasonable standards for the equipment

allows the majority of technologist the

greatest opportunity to achieve optimal

positioning for even the most

challenging patients.

(Comment 336). One comment stated

that a number of different types of

mammography systems in use either do

not offer automatic compression or have

only automatic compression with no

manual compression knob. The

comment suggested it would be

worthwhile to retain maximum

flexibility in the final regulation to

allow evaluation of this type of retrofit

system, so long as the intent and

specifications of the final regulations

were met. A second comment stated that

the ‘‘fine adjustment compression,’’ as

proposed, would place a costly burden

on some facilities that do not have

manual compression. Another comment

indicated that when requiring all units

to have a power driven compression

paddle activated by foot controls, as

proposed, it is also necessary to have a

manual compression mode as well. One

comment suggested that final

compression should always be done

using a hand control knob, which the

technologist can easily control with

direct tactile feedback. One comment

agreed that it is necessary to have power

driven compression, as proposed, but

noted that it was not necessary that the

fine adjustment control be power

driven. One comment noted that the

proposed requirements do not preclude

the equipment from having a manual

compression provision.

Many of these comments resulted

from misreading the proposed

regulations. The proposal does not

require the fine adjustment compression

be a manual operation. The fine

adjustment is usually a ‘‘manual’’

adjustment in that it is applied by a

hand operated (‘‘manually operated’’)

control. This does not imply or require

the provision of a direct linked drive

dependent only on the input force

provided by the operator. Many of the

‘‘manual’’ knobs are actually servodriven power compression devices that

are under a more closely controlled

incremental advance than that provided

by the foot control and, in these cases,

the ‘‘tactile’’ feed-back sensed by the

technologist is not necessarily related to

the force applied to the patient. As the

regulations are written, the design of the

equipment can provide a truly

‘‘manual’’ control for the fine

adjustment, or can provide a slower

power driven application that may be

adjusted by a hand control or other

suitable means. FDA believes that most

equipment with power-driven

compression already provides a fine

adjustment control and that the cost

impact on those facilities not presently

meeting this requirement will be

outweighed by the advantages to

positioning and improved image

quality.

(Comment 337). Five comments

suggested that a requirement for

maintaining compression for a specified

period of time should be added and one

suggested that this specification should

be established for both automatic and

fine adjustment compression.

FDA proposed the criteria for

application of compression without

stating a specified time for maintaining

the compression. This means that FDA

expects the compression to meet the

criteria in the regulations until the

compression is terminated, either by an

automatic release at the end of the

exposure or by operator intervention

during or after the exposure. Therefore,

it is not necessary to expressly establish

a time limit for maintenance of

compression.

NMQAAC discussed these provisions

at some length and several committee

members spoke about the importance of

compression to the overall quality of
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55917

mammography. The committee

recommended that the requirements for

power driven and fine adjustment

compression become effective

immediately but that the requirements

for the maximum force in the initial

power drive remain a 5-year phase-in

requirement. The agency considered the

recommendation to move forward the

effective date for the power driven and

fine adjustment controls, but has

determined that the cost considerations

associated with accelerating the

implementation of these requirements

cannot be justified based on the

expected improvements. Therefore, FDA

has reworded these requirements to

address some of the above comments,

and has retained the effective date that

was proposed.

Section 900.12(b)(12(i)(C) proposed

limits on the compression force required

for the automatic power compression

mode.

(Comment 338). Two comments stated

that the proposed requirement for 25 to

40 pounds under power driven

compression was excessive and may

result in patient injury.

Based on input from NMQAAC, ACR,

and the general comments provided by

manufacturers, FDA believes that 25 to

45 pounds is an appropriate range and

presents little risk of injury to patients

when applied by trained technologists.

(Comment 339). One comment

observed that the proposal only limits

the compression under power driven

control and recommended that an upper

limit be set for the maximum

compression under manual control.

Although FDA had considered such

an upper limit, the idea was opposed by

NMQAAC because they felt that it was

unnecessary. FDA is not proposing such

a limit at this time.

(Comment 340). One respondent was

concerned that there may be units

designed to achieve the proposed

compression forces but that have user

adjustable controls that allow

adjustment to values below the

minimum proposed specification.

FDA agrees that such equipment may

exist or be introduced into the market

place. The agency notes that under the

regulations, as codified, the requirement

is for values attainable by the user. If the

user has direct control over any such

system adjustment, then this adjustment

must be used in testing the system. If

such adjustment is only available

through service or installation

configuration, then the unit should be

tested only to the limits adjustable by

the operator. Under these

circumstances, the respondent’s

concerns are adequately addressed

because any user adjustable controls

must be utilized in determining the

compliance of the system with the

standards. FDA has moved the

requirement for the range of acceptable

power driven compression to the quality

assurance section under

§ 900.12(e)(4)(iii).

Under § 900.12(b)(12(ii)(B), FDA

proposed that each system have a means

for manual compression release in the

event of failure of other decompression

mechanisms.

(Comment 341). One comment

questioned if the wording meant that

compression must be maintained in the

event of power failure and, if so, must

the required display of override status

also be maintained after power failure.

FDA intends that the compression be

maintained after a power interruption.

However, the display of override need

not continue in such circumstance

because the fact that the patient is still

under compression would serve as

adequate indication that manual release

is required.

(Comment 342). One comment noted

that there were many designs currently

on the market that allowed for the

manual release of the compression

without the presence of a specific

device as called for in

§ 900.12(b)(12)(ii)(B). The comment

requested that the proposal be reworded

to emphasize the desired outcomes

rather than a specific means of obtaining

those outcomes.

FDA believes that the wording in the

proposal does address outcomes and

does not intend the provision to require

any specific release design. Any

mechanism that allows the manual

release of compression would meet the

requirement. The requirements for the

compression forces and decompression

have been moved, as recommended by

NMQAAC, to the quality assurance

section of the regulations and are

addressed in § 900.12(e)(4)(iii) and

(e)(5)(xi).

In § 900.12(b)(12)(iii)(A), FDA

proposed that systems be equipped with

different sized compression paddles

matching the sizes of all full-sized

image receptors provided and that

compression paddles for special

purposes, including those smaller than

the full size of the image receptor (for

’spot compression’) could be provided.

FDA did not require that these special

paddles be provided but included the

reference to clarify that these paddles

could be included in the system and are

exempt from certain parts of the

requirements applicable to the full size

paddles.

(Comment 343). Three comments

supported the requirement in

§ 900.12(b)(12)(iii)(A) as written. One

comment recommended that the

proposed requirement be expanded to

require that facilities have the ‘‘spot

compression paddles’’ available.

NMQAAC supported the proposal as

published.

FDA has done some minor rewording

in this paragraph and renumbered it in

the final regulations under

§ 900.12(b)(8)(ii)(A).

In § 900.12(b)(12)(iii)(B), FDA

proposed that the compression paddle

be flat and parallel to the patient

support and not deflect from parallel by

more than 1.0 cm at any point when

under compression.

(Comment 344). Nine comments

opposed the proposed requirement.

Three of these suggested that this is not

the best way to compress the breast

because it ignores the anterior tissues

and the often thicker tail of the breast.

One comment stated that nonparallel

paddles are useful for compression of

very large breasts in the MLO view.

Another comment noted that one

manufacturer’s equipment does not

meet the proposed requirement,

suggested that the subject does not need

regulation, and recommended that the

section be deleted. This comment

maintained that the exemptions

available for alternate devices would be

‘‘much too difficult to use to allow

possible improvements.’’ One comment

responded to FDA’s request for

comments on the nonparallel ‘‘alternate

design’’ compression paddle by

supporting the concept of allowing such

a configuration under the proposed

regulations. The comment further noted

that some manufacturers are

investigating the use of compression

paddles that apply compression in

nonparallel geometry and that these

paddles would have difficulty

complying with the regulation as

proposed. One comment suggested that

the proposed requirement was too

restrictive, stating that several

manufacturers have measured the

paddle deflection on their units and

found that the requirement may be

difficult to meet on the 24 x 30 cm

paddles. One comment suggested that

the proposed specification could be

improved if the tolerance were

loosened, if the measured compression

force were reduced, or if the allowable

flex were expressed as a function of the

applied force.

Two comments asserted that the

proposed regulation in

§ 900.12(b)(12)(iii)(B) places too great an

emphasis on the position of the

compression paddle, but does not

address the position of the film in the

patient support. These comments

recommended that the regulations
55918 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

address the film location with respect to

the edge of the patient support and relax

the requirements for the compression

plate. Three comments suggested that

the description of the test method as

proposed in § 900.12(b)(12(iii)(B) should

be deleted and that testing procedures

should be left to the medical physicist

to determine, or be included in a

companion manual prepared by FDA.

Fifteen comments neither supported nor

objected to the proposed requirement,

but were concerned with the test

procedure as proposed and suggested

modifications or requested clarification

of the procedure.

NMQAAC discussed this section at

some length. Some members and

consultants were concerned that the

specifications in the proposal would

limit the introduction of new equipment

and, even though the regulations

provide procedures for obtaining

approval for alternate standards, wanted

to modify the requirement. Experts on

the committee stressed that the purpose

of this regulation was to eliminate those

worn and faulty compression devices

that were intended to be flat and

parallel by design but which, through

use, now flex unacceptably. After

consideration, the committee

recommended that the requirement

remain but that a new provision be

added that addressed those paddles that

by design were not intended to remain

straight and parallel under compression.

They also recommended that the test

procedure described in this section be

deleted as a requirement because it

could be determined by the physicist

during the survey.

In response to the public comments

and NMQAAC recommendations, FDA

has made changes as outlined below.

FDA is deleting the provision that

established a test procedure for this

section. The requirements have been

modified and renumbered as

§ 900.12(b)(8)(ii)(B) and a new

§ 900.12(b)(8)(ii)(C) requires that all

paddles intended by the manufacturer’s

design not to be flat and parallel under

compression must meet the

manufacturer’s design specification and

maintenance requirements. The agency

will revisit and modify its proposal for

the test procedure for this section in the

future and all comments regarding the

procedure will be considered again in

that process.

Under § 900.12(b)(12)(iii)(C) and (D),

FDA proposed that the chest wall edge

of the compression paddle should be

straight and parallel to the edge of the

image receptor and that the chest wall

edge of the compression paddle should

not interfere with the chest wall edge of

the image.

(Comment 345). Two comments

requested clarification on how straight

and how parallel the requirement

intended the chest wall edge of the

paddle to be. One comment agreed with

the intent of the proposed regulation,

but expressed concern that varying

interpretations of the written regulation

will lead to confusion in enforcement.

This comment recommended that, if

such specifications are included in the

final regulations, there should be some

tolerance specified that is both

affordable and effective in the

improvement of mammography.

FDA notes that the intent of this

section is to eliminate the older style

compression paddle that had a curved

chest wall edge. The agency believes

that the words straight and parallel are

well understood but will address

concerns raised by the comments

through issuance of a guidance on this

paragraph that contains a test procedure

facilities may utilize. The description of

this procedure should also clarify any

confusion regarding FDA’s

interpretation of the regulation.

In § 900.12(b)(12)(iii)(D), FDA had

proposed that the chest wall edge of the

compression paddle should be bent

upward.

(Comment 346). One comment

recommended that the proposed

regulation include a requirement that

the chest wall edge of the paddle be

perpendicular to the surface of the

compression plate. Another comment

stated that the use of ‘‘should’’ in

§ 900.12(b)(12(iii)(D) has little meaning

and is unenforceable.

NMQAAC discussed both paragraphs

and did not recommend any changes.

FDA notes that this provision was not

intended to establish a mandatory

requirement but to clarify that such a

design, intended to enhance patient

comfort, was permissible. This

requirement has been codified under

§ 900.12(b)(8)(ii)(E) in the final

regulations. The word ‘‘should’’ has

been replaced with ‘‘may’’ in the final

rule. FDA does not agree that it is

advisable to require the chest wall edge

to be perpendicular to the surface of the

compression paddle since this could

lead to sharp edges that might cause

patient discomfort.

Under § 900.12(b)(12)(iv)(A), FDA

proposed that, 5 years after the

publication date of the final regulations,

the edge of the compression paddle

shall align with the chest wall edge of

the image receptor to within 1 percent.

Proposed § 900.12(b)(12)(iv)(B) further

restricted the alignment to within 2

millimeters 10 years after publication

and § 900.12(b)(12)(iv)(C) proposed a

test procedure for the requirement.

NMQAAC recommended that the

§ 900.12(e)(12)(iv)(A) be moved to the

QC section of the final regulations and

that the requirements should go into

effect at the earliest opportunity.

NMQAAC also recommended that the

requirement under § 900.12(b)(12)(iv)(B)

and (C) be deleted because the

committee believed the proposed 2-

millimeter requirement was too

stringent. The proposed 2-millimeter

requirement and the test procedure have

been deleted and the final regulation

regarding compression paddle-image

receptor alignment was moved to the

quality assurance section and is codified

under § 900.12(e)(5)(vii)(C) where it will

become effective at the earliest effective

date.

(Comment 347). One comment

recommended caution in specifying

these alignment requirements because

they might limit design in some areas of

new technology. The comment

recognized that these proposed

specifications are only applicable to

film-screen systems, but expressed

concern that the concepts might carry

over into new technology areas.

FDA assumes that this comment was

directed toward the issue of image

receptor size for digital systems, but

does not anticipate any conflict.

(Comment 348). Eleven comments

agreed with tightening the tolerance for

alignment as proposed in

§ 900.12(b)(12)(iv) but suggested that

only a positive misalignment should be

allowed.

FDA agrees and accepts these

comments.

(Comment 349). Eight comments

noted a typographical error in

§ 900.12(b)(12)(iv)(A). FDA has

corrected this.

(Comment 350). Three comments

recommended that the ‘‘October 1,

2000’’ effective date be deleted and that

the requirement go into effect in the

earliest phase because, in the

respondents’ opinions, the vast majority

of systems already meet this

requirement.

FDA agrees with these comments and

has accepted this recommendation to

move the effective date forward.

(Comment 351). Six comments

expressed concern regarding the test for

this paragraph.

These comments will be reconsidered

when FDA publishes its guidelines for

the QC test.

Under § 900.12(b)(12)(iv)(D), FDA

proposed that the alignment criteria for

the contact mode should also be

applicable to the magnification mode 10

years after the publication of the final

regulations and proposed a test

procedure.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55919

(Comment 352). Five comments

suggested that the requirement was

unnecessarily restrictive and should be

dropped. Four comments supported the

proposed requirement, believing it

serves to ensure the accuracy of the

alignment of the edge of the

compression paddle with the edge of the

image receptor. One comment

recommended a rewording for the

requirement. Two respondents

expressed concern regarding the test

procedure. NMQAAC suggested that the

requirement in the magnification mode

was unnecessary and should be deleted.

After reviewing the comments, FDA

has accepted the NMQAAC

recommendation and deleted the

requirement for paddle alignment in the

magnification mode.

Under § 900.12(b)(12)(v), FDA

proposed that, 5 years after publication

of the final regulations, all systems

should display the compressed breast

thickness. The proposal also established

a test procedure for the requirement.

(Comment 353). One comment

pointed out that current indicators of

compressed breast thickness are grossly

inaccurate for a number of reasons,

including paddle and compression arm

flex, lack of uniformity across the breast,

and differences in the location at which

various manufacturers determine the

breast thickness (since there is no

agreement where the breast thickness is

to be measured). Two comments

recommended that the word ‘‘correct’’

be inserted between ‘‘the’’ and

‘‘compressed’’ in § 900.12(b)(12)(v). One

manufacturer requested an exception for

its product because the measured breast

thickness read out could be off by 0.6

to 1.0 cm for their paddle. One comment

expressed concern that there was no

clear specification to the accuracy of the

indicated value proposed in

§ 900.12(b)(12)(v)(A). NMQAAC

discussed this provision at its April

1996 meeting and recommended that

the requirement for a display remain but

that no accuracy specification be

associated with the display. NMQAAC

revisited the issue at its January 1997

meeting but did not change its

recommendation. Another comment

suggested that the proposed requirement

should apply only to equipment that

uses the compressed breast thickness in

an algorithm to determine technique

factors. One comment supported the

proposed requirement in

§ 900.12(b)(12)(v)(A) because it is

especially important for implant

patients, but recommended that it go

into effect 5 years after the effective date

of the regulations rather than 10 years

after, as proposed.

FDA has reviewed the comments and

reassessed the need for this

requirement. The practical application

of the information provided by the

display to the mammography process

appears to be questionable and the

concept of having a display that has no

associated accuracy is of debatable

value. FDA has decided to remove

§ 900.12(b)(12)(v) from the final

regulations in accordance with the

agency’s desire to minimize costs, as

discussed previously. All comments

requesting clarification or suggesting

modification to the test procedure will

be considered again if FDA revisits this

requirement.

The portions of proposed

§ 900.12(b)(12) that have been retained

in the equipment provisions were

codified under § 900.12(b)(8).

n. Technique factor selection and

display (§ 900.12(b)(9) (proposed

§ 900.12(b)(13)))

In this paragraph, FDA proposed

requirements for the selection and

display of technique factors.

FDA proposed in § 900.12(b)(13)(i)

that every system shall have the

capability for manual selection of mA’s

or, at least, of mA or time. No public

comments addressed this issue.

NMQAAC discussed the proposal at

both the April 1996 and the January

1997 meeting and supported the

proposal. FDA reworded the

requirement slightly before codification

to clarify its intent. Because of the

deletion of paragraphs listed earlier in

the proposal, paragraph § 900.12(b)(13)

has been codified as § 900.12(b)(9), and

this paragraph became § 900.12(b)(9)(i)

in the final rule.

Under § 900.12(b)(13)(ii), FDA

proposed that all technique factors be

clearly displayed at the control panel

prior to exposure. At § 900.12(b)(13)(iii),

the agency proposed that such factors be

preindicated in the AEC mode.

(Comment 354). One comment

recommended FDA clarify that the

specification in § 900.12(b)(13)(ii)

applies only to the manual mode of

operation. A comment on

§ 900.12(b)(13)(iii) requested

clarification of which technique factors

were intended to be covered by this

requirement. At its April 1996 meeting,

NMQAAC also expressed some

confusion regarding the same issue.

Another comment recommended that

the requirements of § 900.12(b)(13)(iii)

and (iv) be combined.

FDA believes that requirements for

preindication and postindication of the

technique factors should be presented

under separate paragraphs and has not

accepted this last comment. FDA did

clarify § 900.12(b)(13)(ii) and (iii) and

combined them into a single provision

at § 900.12(b)(9)(ii).

Under § 900.12(b)(13)(iv), FDA

proposed that, after AEC exposure, the

system should indicate the actual kV

and mA’s used during the exposure.

(Comment 355). Two comments

recommended that this requirement be

deleted or its implementation date be

delayed because the replacement or

retrofit of many older units might be

costly. Another comment stated that a

mA’s readout, as proposed in

§ 900.12(b)(13)(iv), has not been proven

necessary. NMQAAC discussed this

issue and the cost concerns related to

retrofits to provide the postexposure

mA’s indication. The committee

supported the requirement but

requested some wording changes to

clarify the meaning of mA’s indication.

FDA has retained this provision

because it concluded that the costs

associated with the possible retrofits are

not significant enough to outweigh the

benefits and has included it in the final

regulations under § 900.12(b)(9)(iii).

Under § 900.12(b)(13)(v), FDA had

proposed that each unit provide an

indication of kVp that was accurate to

within + 5.0 percent of the actual kVp.

(Comment 356). Five comments

agreed with the proposed five percent

accuracy specification, but another

comment suggested that the requirement

for kVp accuracy of + 5.0 percent was

not justified because there was no

definition of what kVp really means and

no calibration available for kVp meters.

Another comment stated that ‘‘5 percent

of the actual kVp as proposed in

(b)(13)(v), is a very large discrepancy,’’

noting that 5 percent of 30 kVp allows

31.5 kVp, which, in the respondent’s

opinion, presently is considered to be

unacceptable. The comment further

suggested that § 900.12(b)(13)(v) be

changed to read: ‘‘All indications of kVp

shall be within 1 kV of the actual kVp.’’

In § 1020.30 FDA defines kVp to mean

the maximum value of the potential

difference across the X-ray tube during

an exposure. FDA agrees with the

comment that the + 5.0 percent accuracy

is a large discrepancy and notes that it

is the same specification currently

established by the most recent revision

of the ACR manuals. The agency intends

to provide additional information

regarding compliance with this

requirement.

(Comment 357). Three comments,

including one from NMQAAC, noted

that there was a conflict between the

kVp accuracy specification at

§ 900.12(b)(13)(v) and at

§ 900.12(e)(5)(ii)(A). NMQAAC also

recommended that the requirement be

moved to the quality assurance section
55920 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

and that the + 5.0 percent accuracy

specification be retained. FDA has

accepted these recommendation and the

requirement now appears in the final

regulations under § 900.12(e)(5)(ii) and

includes the + 5 percent accuracy

specification.

In § 900.12(b)(13)(vi), FDA proposed

that, 10 years after the publication of the

final regulations, each X-ray unit used

for mammography would be required to

have a specific range of kVp and mA’s

selection and that adjacent selections of

the kV selection and adjacent selections

of the mA’s should not vary by more

than a prescribed amount. The public

comments regarding this section were

overwhelmingly against including these

proposals in the final regulations.

NMQAAC supported the proposals but

only marginally so, with many opposing

opinions. FDA has reconsidered the

advisability of including these

specifications in the final regulations,

based in part on the public comments

and in part on the difficulty in

predicting the necessity for these

limitations 10 years in the future and

has deleted all requirements proposed

under § 900.12(b)(13)(vi) from the final

regulations.

o. Radiation output (proposed

§ 900.12(b)(14))

This paragraph proposed setting a

minimum value for radiation output per

second of mammography X-ray

equipment, with an increase in that

minimum value to occur 5 years after

publication. This section has been

codified in the quality assurance section

of the final regulations.

(Comment 358). Two comments

agreed with the requirement proposed

in § 900.12(b)(14)(i), with one urging

that the requirement be fully

implemented at the earliest possible

date rather than being phased-in. One

comment suggested that the proposed

requirements in § 900.12(b)(14)(i) and

(ii) might actually be in conflict with

each other. FDA reviewed these

provisions and does not see a conflict

because clause (i) specified an exposure

rate and (ii) specified a time over which

that rate must be met. However, in

response to other concerns, as outlined

in the preamble to the quality assurance

section, FDA has modified the

requirement to clarify that the

specification is to be an average over

three seconds and not an instantaneous

rate measurement.

(Comment 359). One comment

suggested that the proposed requirement

in paragraph (b)(14)(i) be replaced by

the equivalent air kerma expressed in

milligray (mGy). The guidelines

followed by FDA in the writing of

regulations specify that all numerical

limits, where applicable, be expressed

in terms of the International System (SI)

of Units, the internationally accepted

standard, followed by the more common

equivalent in parentheses.

In the proposed regulations, FDA had

represented radiation limits in terms of

exposure expressed in the SI unit of

coulomb per kilogram (C/kg). Although

C/kg is the correct SI unit for exposure,

it is an awkward unit for the actual

operating ranges of exposure (10–4 C/

kg) of mammography systems. FDA

believes now that it would be more

advantageous to specify radiation limits

in terms of the alternate quantity air

kerma expressed in the SI base unit of

gray (Gy). Air kerma, which is defined

at § 900.2(d), is the sum (per unit mass

of air) of the initial kinetic energies of

all the charged ionizing particles

liberated by the X-rays. At the X-ray

energies typically used in diagnostic

radiology and mammography, values for

air kerma are practically

indistinguishable from values of

absorbed dose in air. Air kerma is

increasingly accepted in the

international community as the quantity

preferred in the specification of

radiation delivered, and it is being

proposed to replace exposure in

amendments in 21 CFR part 1020.

Because amendments to those standards

are not final, the units were not used in

the proposal. However, FDA is replacing

the quantity exposure with the quantity

air kerma in these final MQSA

regulations because it anticipates that

parallel changes will be made in the

international standards and part 1020.

(Comment 360). One comment

suggested that FDA recast proposed

§ 900.12(b)(14)(i) as a performance

objective, such as: ‘‘The radiation

output, in terms of exposure rate, at

clinically useful kVp’s shall be

sufficiently high to avoid exposure

times of such duration that loss of

resolution due to motion or excessive

dose due to film reciprocity failure is

expected to occur.’’

FDA appreciates the benefits of

adopting performance standards when

appropriate but believes that in this case

the suggested wording introduces an

unacceptable level of subjectivity into

determining compliance.

(Comment 361). One comment

recommended that the test procedure

proposed to measure radiation output in

§ 900.12(b)(14)(iii) specify the position

of the compression paddle during the

measurement.

FDA assumes this comment is

expressing concern regarding the scatter

contribution to the reading and its

variability depending on the distance

the paddle is located from the detector.

FDA recognizes the possible effects of

scatter on this measurement but does

not believe the contribution is of

sufficient concern to warrant the

prescription of paddle position relative

to the detector. In clinical use, the

paddle is obviously in contact with the

breast. If a facility wishes to test with

the paddle in a similar position, FDA

has no objection. Similarly, if the

paddle is moved nearer to the focal spot,

FDA would find this acceptable. FDA

does, however, require the compression

paddle to be in the X-ray beam between

the source and the detector as was

specified in § 900.12(b)(14)(iii).

(Comment 362). One comment

suggested that FDA require that

compliance with § 900.12(b)(14) be

determined ‘‘with the phantom in the

beam and that the exposure be

completed within 2.5 seconds.’’

FDA believes that placing any

phantom in the beam during this test

would not improve this test and that the

three second exposure proposed is both

reasonable and appropriate for this

requirement.

(Comment 363). Two comments

suggested that compliance with

§ 900.12(b)(14)(i) should be determined

at a routine clinical kVp instead of the

proposed 28 kVp. FDA notes that 28

kVp is used clinically for

mammography, although not as

frequently as other kVp values. It was

selected first by the American

Association of Physicists in Medicine

and then by the ACR/CDC Imaging

System Focus Group as the standard

kVp to be used in association with their

radiation output specifications. These

specifications were utilized by FDA in

establishing this radiation output

requirement. If a different kVp were

selected, the radiation output would

likely have to be modified; however,

professional consensus on what

modifications would be appropriate is

presently lacking. The agency, therefore,

does not accept these comments.

(Comment 364). One comment

recommended that the proposed

requirements under § 900.12(b)(14)

should be made part of § 1020.31 so that

uniform requirements would be ensured

nationwide. FDA reiterates its previous

position that this would not achieve the

desired impact on the installed base of

mammography equipment. FDA

believes that most modern

mammography systems can meet this

requirement. However, the agency is

considering parallel requirements under

§ 1020.31 to ensure that future

production is compliant.

(Comment 365). One comment

supported the test procedure specified

in § 900.12(b)(14)(iii) as being an
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55921

improvement over the current

specification. Another comment

suggested that the requirement in

§ 900.12(b)(14)(i), as written, should

only apply to a molybdenum/

molybdenum Mo/Mo anode/filter

combination because other target-filter

combinations may not need to meet the

requirement to deliver adequate

imaging.

NMQAAC supported the proposed

requirements, but suggested that the

specifications should be limited to Mo/

Mo target-filter units only. They also

recommended that all of § 900.12(b)(14)

be moved to the quality assurance

section.

FDA has accepted NMQAAC

recommendations to limit the

requirements to Mo/Mo target-filter

units and to codify the requirement with

the QC requirements.

(Comment 366). One comment noted

that xeromammography equipment

might not meet these proposed

requirements.

FDA believes that xeromammography

units should be able to meet the

requirement, as proposed, but with the

acceptance of the Mo/Mo limitation

discussed above, the requirement would

no longer be applicable to xerox

systems, which incorporate tungsten

targets.

(Comment 367). One comment

suggested that the proposed

requirements of § 900.12(b)(14)(i) and

(iii) need to be linked in order to

explain where the output is to be

measured.

FDA does not agree with this

comment although it has reworded the

proposed § 900.12(b)(14) for

clarification. The provision has been

codified as § 900.12(e)(5)(x).

p. Automatic exposure control

(§ 900.12(b)(10) (proposed

§ 900.12(b)(15)))

As proposed, this paragraph required

that each mammography system have an

automatic exposure control (AEC) for

mA’s, established a specification for the

AEC reproducibility, and set

requirements for the indication of the

AEC detector positions and selected

location.

(Comment 368). One comment

suggested that the requirements

proposed in § 900.12(b)(15) should be

prefaced with a statement that they are

intended to apply only to film-screen

modalities. A related comment reported

that xeromammography systems do not

have AEC controls as required in

§ 900.12(b)(15) and that this would bar

their use.

FDA agrees with these comments and

has rewritten this requirement to limit

it to screen-film mammography systems.

Under § 900.12(b)(15)(i), the proposal

required all AEC devices to be operable

in each equipment configuration

provided and gave examples of common

configurations.

(Comment 369). Several comments

sought to limit the applicability of this

requirement in different ways. One

comment supported the proposed

requirements in § 900.12(b)(15)(iv)(A)

and (B) as a means to ensure appropriate

detector location and thereby avoid

repeat exposures and reduce patient

dose. One respondent did not believe

that the automatic exposure control

photo-timing proposed in

§ 900.12(b)(15)(i) is significant in

obtaining satisfactory diagnostic

mammograms. Three comments

recommended modifying

§ 900.12(b)(15)(i) by replacing ‘‘of

equipment configuration provided’’

with ‘‘where applicable.’’ The

comments further suggested that the

examples of equipment configurations

in § 900.12(b)(15)(i) be deleted. One

comment agreed with the April 1996

NMQAAC recommendation that the

requirements proposed in

§ 900.12(b)(15)(i) should be limited to

clinically used configurations.

FDA remains convinced that the use

of AEC devices on mammography

equipment is an aid to quality

mammography and believes that

requiring it for ‘‘all combinations of

equipment configuration provided’’ is

appropriate and necessary. The agency

notes that the requirement applies to the

configuration of the individual unit. For

example, if the unit is not provided with

magnification capability, then it would

not be required to have a functioning

AEC in a nonexistent magnification

mode. The agency also notes that

NMQAAC reversed its April 1996

position during its January 1997

meeting and concurred with the

requirement as proposed.

Under § 900.12(b)(15)(ii), FDA

proposed that the AEC be capable of

providing automatic mA’s selection.

(Comment 370). One comment

recommended deleting this

requirement, stating ‘‘that it is the

purpose of AEC to provide automatic

mA’s selection’’ and, therefore, the

requirement was redundant. One

comment requested clarification of the

phrase ‘‘automatic mA’s selection.’’

Another comment asked whether

§ 900.12(b)(15)(ii) required automatic

termination of exposure or automatic

display of mA’s and questioned why the

AEC should be able to automatically

select mA’s.

FDA defines an automatic exposure

control as a device that automatically

controls one or more technique factors

in order to obtain a desired quantity of

radiation at a preselected location. Such

a device would automatically terminate

the exposure when the selected quantity

of radiation had been delivered. This

definition does not restrict the

technique factor(s) that may be selected;

the control of target material, focal spot,

filtration, time, mA, and/or kVp are all

viable options for such a device.

Because the mA’s is the product of time

(in seconds) and mA, the control of time

and/or mA represents control of the

mA’s; therefore, AEC’s generally

function by controlling mA’s and/or

kVp. FDA was initially concerned that

an AEC that controlled kVp alone,

without capability to control mA’s,

could not adequately ensure the small

incremental changes in radiation that

are often necessary in mammography.

FDA has reconsidered this position

because it has concluded that any such

device that reaches the marketplace

would provide the necessary ranges of

adjustment in order to have been

approved under the FDCA’s

requirements for safety and efficacy of

new devices. Therefore, FDA is

removing the requirement proposed in

§ 900.12(b)(15)(ii) that all AEC devices

provide automatic mA’s selection.

Under § 900.12(b)(15)(iii), FDA

proposed a limit on the reproducibility

of the AEC.

(Comment 371). One comment

suggested the wording be changed to

include ‘‘for each target/filter

combination.’’

FDA believes the change is not

needed; because no target-filter

combinations were specified in the

regulation, all combinations are subject

to the requirement.

NMQAAC recommended that this

requirement be moved to the quality

assurance section. FDA has accepted

this recommendation and the

specification for the evaluation of the

AEC reproducibility is codified in

§ 900.12(e)(5)(i).

Under § 900.12(b)(15)(iv), FDA

proposed requirements regarding the

positioning flexibility of the AEC

detector, visual location of the available

detector positions, and indication of

which AEC detector location was

selected.

(Comment 372). Two comments

recommended that the proposal be

expanded to require increased flexibility

in placement of the AEC detector. One

comment commended the proposed

requirement for AEC positions to be

indicated at the input surface of the

breast compression paddle. The

comment believed that this requirement

would improve the quality of imaging

and prevent repeat images. Two
55922 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

comments suggested that FDA add a

requirement specifying the necessary

accuracy of the indication of both the

size and available position of the AEC

detectors. The respondents’ suggested

the indication might depend on

magnification of the indication resulting

from various breast thicknesses.

FDA interprets these comments to

mean that a projected indication on the

input surface of the breast might vary in

size and location depending on the

magnification induced by the

displacement of the input surface

caused by various breast thicknesses.

FDA agrees that this might occur and

notes that such a system would be a

design that might not be able to meet the

requirements.

FDA intends the indications of the

size and location represented on the

compression paddle to be representative

of the actual size and location of the

detectors as they would appear if

marked on the breast support device.

The agency anticipates no confusion

will be caused by varying displacement

of the paddle from the patient support

since the indication of size and position

will remain constant.

(Comment 373). One comment

suggested that the indicators should not

‘‘give rise to artifacts in the image.’’

FDA believes that any such artifacts

will be detected and corrected during

the normal QC process and, therefore,

modification of this requirement is

unnecessary.

(Comment 374). One comment stated

that this requirement leaves too much

room for interpretation and would be

very difficult to inspect against. The

comment suggested one could argue that

merely knowing the position via the

handle that moves the detector would

be adequate for proper detector

positioning. The comment further stated

that all current units do provide clear

indication of detector position, which is

visible from both sides of the patient,

and that the requirement should be

removed.

FDA does not agree that the

requirement is subject to conflicting

interpretation or would be difficult to

inspect, but does agree that the location

of the position selector would be an

adequate indication of which detector

position had been selected (although it

would not indicate the detector position

itself). FDA also does not agree that the

installed base of systems all provide

such flexibility or indications and

remains persuaded that the requirement

will provide useful tools for the

technologist.

NMQAAC recommended that FDA

delete the proposal that the selected

detector position be visible from both

sides of the patient because they did not

consider it of sufficient importance to

require in the regulations. FDA has

adopted this recommendation and the

requirement has been amended

accordingly.

Under § 900.12(b)(15)(v), FDA

proposed that the operator be able to

vary the optical density from the normal

density setting. No specific comments

were received on this proposal and FDA

codified this requirement without

change.

Under § 900.12(b)(15)(vi), FDA

proposed that, 10 years after the

publication of the final regulations, each

unit would be required to provide four

steps above and four steps below the

normal optical density setting and

proposed limits for the acceptable

variability between adjacent settings on

this control.

(Comment 375). FDA received a large

number of comments on this section.

The overwhelming majority were

opposed to the requirement because of

concerns regarding the wording of the

provision, the perceived cost to

facilities, the range of control to be

provided, the incremental difference

between adjacent settings, and the

necessity for the requirement. In

response to these comments and

because of agency concerns regarding

costs, FDA concluded that the proposal

should be deleted from the final

regulations and that further study

should be undertaken to determine if

future requirements in this area are

warranted. If regulations or guidelines

are proposed later, the individual

comments will be reconsidered at that

time.

Under § 900.12(b)(15)(vii), FDA

proposed requirements for the optical

density variation permitted with a

screen-film mammography system

under AEC.

(Comment 376). Three comments

supported the proposed requirement in

paragraph (b)(15)(vii) because it

evaluates the equipment performance

when used on breasts of various size

and density. Two comments indicated

that § 900.12(b)(15)(vii) was not

stringent enough and one of these

recommended that an initial value of

0.15 OD should be specified.

FDA disagrees with this comment

because it believes that the initial value

should remain the same as that used in

the interim regulations. NMQAAC

recommended that these requirements

be moved to the quality assurance

section and FDA agreed. The

requirements have been codified under

§ 900.12(e)(5)(i).

In the proposal, FDA had specified

that the system meet the requirements

for AEC reproducibility at each

available detector position.

(Comment 377). Three comments

suggested that the test under

§ 900.12(b)(15)(vii) is necessary for only

one detector position because the

detector and associated electronics do

not change.

FDA disagrees with these comments

because some AEC detectors utilize

individual detectors that are

permanently fixed in position. The

switching of position is actually a

change in contact points or system logic

to read the selected position. In such

cases, the testing of one position

provides no indication of the function at

other locations.

(Comment 378). One comment

suggested that the testing of photo-timer

tracking with dosimeter positioning is

usually not necessary unless multiple

detectors are used.

The agency believes that when the

process is accomplished by the

relocation of the same detector to

different positions, the functioning of

the detector at each detector location is

not guaranteed by testing at only one

position. This could be influenced by

broken wires, poor connections, or dirty

contacts in the system.

(Comment 379). One comment stated

that testing of the AEC at all detector

positions will be dependent on the

dimensions of the phantom. The

respondent stated that the commonly

used 10 cm x 10 cm phantom may not

be large enough for all positions and

that this will drastically increase the

time required to perform this test.

FDA does not agree with this

comment. The phantom could be placed

near the focal spot and thereby cover all

available detector positions without

being repositioned.

(Comment 380). One comment

suggested that with multiple detectors it

is not necessary to test the tracking over

the entire range of phantom thicknesses.

FDA interprets this comment to mean

that, once the detector reproducibility at

each position has been established, the

testing of reproducibility for additional

thickness need be performed at only one

position. FDA does not agree with this

comment; it does agree, however, that

when one detector is used and moved

from position to position, once it is

established that the detector is

reproducible over the entire range of

thicknesses at one position, it is only

necessary to establish the correct

functioning for one thickness at each

other position. In response to these

comments and in recognition of the

costs associated with testing

reproducibility at multiple positions,

FDA has deleted the specification for
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55923

testing at each detector position.

Because the agency remains convinced

that the best way to ensure that the

detector(s) functions properly at each

position is to test it/them at each

position. FDA encourages facilities and

the medical physicists to include such

testing as a routine part of the annual

survey. The remaining provisions of

proposed § 900.12(b)(15) are codified as

§ 900.12(b)(10).

q. Disabled examinees (proposed

§ 900.12(b)(16))

In this paragraph, FDA proposed that

each facility choosing to schedule

disabled patients have equipment and

protocols in place to ensure that the

facility could adequately accommodate

such disabled patients. This proposal

did not require each facility to accept

disabled patients, but did require those

doing so to be capable of performing the

service.

(Comment 381–382). Many comments

expressed the mistaken belief that FDA

was seeking enforcement powers under

the American with Disabilities Act

(ADA) or to duplicate the ADA.

Other comments on this section

ranged from calling the requirement too

lenient to calling it unnecessarily

intrusive. The majority of the

comments, although not opposed to

accommodating disabled patients, were

concerned that the screening of patients

prior to their examination would be

difficult or impossible because many

appointments are not made by the

patient. Comments also expressed

concern that accepting disabled patients

under this requirement would obligate

facilities to be able to accommodate all

disabled patients. Some comments also

questioned whether there was

equipment available that could offer this

range of use.

Another area of concern was related

to mobile units and facilities which,

because of their size and stand-alone

nature, would be difficult to adapt to

accommodate the range of disabilities

the facilities might encounter.

NMQAAC consumer representatives

supported this section and urged FDA to

require facilities to either serve disabled

patients or refer them to a facility that

can. Other comments questioned the

value of referrals, citing lack of

knowledge regarding other facilities’

equipment, staff, and ability to deliver

the services necessary.

Because of the lack of consensus on

the need for this requirement and the

concerns raised in the comments, FDA

has decided to delete the proposed

requirement and revisit it at a future

date if a problem is perceived. FDA

strongly urges facilities to voluntarily

institute procedures that will direct

patients with disabilities to facilities

that are capable of serving this

population. The agency believes that

local consumer groups and all

accreditation bodies can pool

information and educate the public and

the mammography community about

the availability and locations of such

services.

r. X-ray film (§ 900.12(b)(11)

(proposed § 900.12(b)(17)))

In this paragraph, FDA proposed a

requirement that X-ray film used for

mammography must be designated for

such use by the film manufacturer.

(Comment 383). One comment

supported the proposed requirement.

Three comments suggested that it was

too vague, one comment questioned

how one would know if a

manufacturer’s designated

mammography film is adequate for

doing quality mammography under the

requirements, and another suggested the

adoption of the storage

recommendations from ACR’s

Recommended Specifications for New

Mammography Equipment. NMQAAC

supported this requirement as proposed.

FDA has not proposed regulations

governing film storage because it

believes that each facility should follow

the manufacturer’s instructions for the

particular film being used. The goal of

this requirement is to ensure that the

film used by the facility is considered,

at least by the manufacturer, as being

suitable for mammographic use. The

regulation is not intended to establish

standards for film; the only requirement

placed on the facility is to check that the

film it uses has been designated by the

manufacturer for mammography. The

requirement is not vague once its

limited scope is understood. FDA

codified this requirement, without

change, in § 900.12(b)(11).

s. Intensifying screens (§ 900.12(b)(12)

(proposed § 900.12(b)(18)))

FDA proposed in this paragraph that

only intensifying screens that have been

specified by the manufacturer as

appropriate for mammography may be

used for mammography.

(Comment 384). One comment

supported the proposed requirement.

Again, one comment questioned how a

facility would know if a manufacturer’s

designated mammography screens are

adequate for doing quality

mammography under the proposal.

Another comment stated that

xeromammography systems do not use

intensifying screens and that

§ 900.12(b)(18) would serve to ban their

use.

FDA does not intend a specification

about screen requirements to apply to

any modality that does not use screens

in the production of its images.

Therefore, the agency sees no impact of

this requirement on xeromammography.

Although NMQAAC supported the

requirement, one member expressed

concern that the wording of the

proposal implied that the facility was

responsible for matching the spectral

sensitivity of the film and the screen. As

explained in connection with the

mammography film specification above,

the intent of the requirement is not to

address the quality of the product, but

rather to ensure that it is one intended

by the manufacturer to apply to

mammography. In general, the facility is

responsible for matching the spectral

sensitivities of the screen with the film.

However, the facility is expected to use

the information provided by the

manufacturers and not to derive the

information independently. FDA has

reworded the requirement to clarify this

point and codified it as § 900.12(b)(12).

t. Film processing solutions

(§ 900.12(b)(13) (proposed

§ 900.12(b)(19)))

In this paragraph, FDA proposed that

facilities use film processing solutions

capable of developing films in a manner

equivalent to the film manufacturer’s

minimum specifications.

(Comment 385). Three comments

supported this proposed requirement

and requested that guidance documents

be established for this area. Six

comments suggested that the word

‘‘minimum’’ be deleted because, in the

respondents’ opinions, most facilities

generally comply with the regulatory

requirement and the regulation should

encourage them to meet more than the

minimum. FDA appreciates these

comments and notes that facilities are

free to exceed this minimum; the

requirement, however, is intended only

to establish that facilities comply with

the manufacturers’ minimum standards.

(Comment 386). Three comments

questioned how a facility could

demonstrate equivalence under

§ 900.12(b)(19) because some

manufacturers of film processing

chemicals refuse to acknowledge that

other vendors’ chemicals produce

‘‘equivalent’’ results. The comments

requested that the wording be changed

to clarify compliance.

FDA believes these comments are

similar to the ones regarding quality of

the film and screens used in

mammography. It is not the intent of the

requirement that the facility

experimentally determine the

compatibility of various solutions with

the film, but only that the facility obtain

documentation from the suppliers

showing that their products are

intended to be used for processing the
55924 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

particular film used by the facility and

that they provide results consistent with

the film manufacturer’s specifications.

The facility would only be required to

establish the equivalence independently

if no documentation, in the form of

labeling or specifications, were available

from the chemical or film supplier.

(Comment 387). One comment

questioned how the requirement can be

met when the film manufacturer does

not manufacture chemicals for film

processing.

FDA notes that, in such cases, it

would likely be easier to establish

equivalence because the film

manufacturer would specify the

requirements for the processing as

opposed to a manufacturer that supplies

both film and chemicals and is likely to

specify solutions only by name rather

than characteristics.

(Comment 388). One comment

recommended that FDA allow

accreditation bodies to review and

monitor the use of chemicals for film

processing and eliminate the

requirement from the regulations.

Although the agency is continually

working with the accreditation bodies to

divide responsibilities when such

division is useful and possible, FDA did

not adopt the recommendation. The

MQSA requirements, even when

administered by the accreditation

bodies, are implemented through

Federal standards. FDA may consider

requiring accreditation bodies to collect

and monitor information about

chemicals used for film processing in

the future. NMQAAC agreed with the

requirement as proposed. FDA has

codified the requirement in the final

regulations under § 900.12(b)(13).

u. Lighting (§ 900.12(b)(14) (proposed

§ 900.12(b)(20)))

In this paragraph, FDA proposed a

requirement that facilities provide

special lights for use during

interpretation with variable luminance

capable of producing light levels greater

than that provided by the viewbox.

(Comment 389). Four comments

supported the proposal. One stated that

‘‘it might reduce the number of retakes,

and provide better detail to the

interpreting physician.’’ Two comments

noted that the light should be required

wherever the interpreting physician is

reading films, but that it may not be

necessary at all locations where images

are taken. One comment noted that the

proposed requirement in § 900.12(b)(20)

was for a ‘‘bright light’’ or ‘‘hot lamp’’

for viewing dense areas of films. The

comment suggested that the purpose of

the lamp should be included and that it

should only be required for facilities

that use the screen-film modality.

FDA agrees that the light is only

required where mammograms are

interpreted but recommends that it may

be useful to the technologist in

evaluating the quality of the films. FDA

also agrees that facilities not

interpreting screen-film mammograms,

or not reviewing previous screen-film

mammograms for reference, do not need

these special lights.

(Comment 390). Two comments stated

that a fixed output lamp may give the

same information as the variable output

‘‘hot lamp’’ proposed. NMQAAC

supported the requirement, but

recommended that the word ‘‘variable’’

be removed because it is the increased

intensity and masking provided by the

light rather than any variability in

output that actually enhance the reading

of the image.

FDA has accepted these suggestion

and has reworded the final requirement

accordingly.

(Comment 391). One comment

expressed difficulty imagining the

benefits of this requirement to the

patient.

FDA believes the usefulness of this

device is well established, especially in

view of the trend toward denser films in

mammography; by optimizing

interpreting conditions for physicians,

the regulation increases the likelihood

that the patient’s mammogram will be

accurately interpreted.

(Comment 392). One comment

recommended that FDA allow

accreditation bodies to review and

govern the proposed requirement in

§ 900.12(b)(20), and eliminate it from

the regulations. As indicated above in

response to a similar comment by the

same individual.

FDA has not adopted the

recommendation, although it may

consider requiring such action by the

accreditation bodies in the future.

(Comment 393). Four comments

suggested that the proposed requirement

was too vague. One comment suggested

that the requirement be reworded to

specify that a ‘‘spot lighting’’ device be

provided.

FDA agrees with these comments and

amended the final requirement to clarify

this point.

(Comment 394). A number of

comments chose this section to offer

suggestions regarding requirements for

the viewbox or the viewing conditions.

FDA has discussed those comments in

the general equipment section above.

Because of the deletion or movement

of other paragraphs in the equipment

portion of the proposed regulations, the

reworded § 900.12(b)(20) was codified

as § 900.12(b)(14).

v. Film masking devices

(§ 900.12(b)(15) (proposed

§ 900.12(b)(21)))

In this paragraph, FDA proposed that

all facilities ensure the presence of film

masking devices that are capable of

limiting the illuminated area of the

viewbox to the exposed or smaller area

of the film, that facilities using

nonrectangular collimation ensure

suitable masking, and that such devices

be available to the interpreting

physicians.

(Comment 395). Six comments

supported the requirement. Two of

these comments further suggested that

the requirement be modified to clarify

that any effective means of masking,

including ‘‘black film or manual or

automatic masking devices,’’ would be

acceptable. One comment questioned

how effective the film masking devices

must be because the respondent

believed that many presently in use do

a poor job of blocking the unnecessary

light. FDA has not attempted to specify

particular mechanisms for masking,

only that provisions for masking be

available. Any device that blocks

viewbox light not required for viewing

and interpreting the image would meet

the intent of this requirement. The level

of ‘‘blocking’’ was not addressed, but

with the light levels under

consideration, the agency believes that

the elimination of any noticeable

transmission through the masking is

easily achievable. The device need not

be an expensive or elaborate system, but

it must be capable of eliminating

extraneous viewbox light.

(Comment 396). Two comments

supported the proposed requirement to

provide appropriate masking for

nonrectangular images as a means to

further promote the correct masking of

all shape images, but another comment

stated that the nonrectangular

collimation referenced should be

eliminated because ‘‘there is no need for

it and it causes significant problems in

the masking of the films for proper

viewing conditions.’’ NMQAAC

suggested that the requirement

regarding nonrectangular masking was

redundant and recommended that it be

removed from the final regulation.

FDA does not intend to express a

preference for rectangular or

nonrectangular collimation. This section

was included in the proposal to

reinforce the point that, in all cases, the

masking should be appropriate to the

image. FDA is accepting the NMQAAC

recommendation and deleting the

provision relating to nonrectangular

collimation from the final regulations;

FDA agrees with NMQAAC that the
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55925

general masking specification covers all

sizes and shapes of images.

(Comment 397). One comment

questioned how much limitation of the

exposed image the proposal intended

the masking to provide and one

comment proposed that the masking

requirement be expanded to require

limitation of ‘‘the illuminated area to a

region or regions substantially smaller

than the exposed portion of the film.’’

FDA has not accepted this

recommendation because it may not be

desirable, in all cases, to limit the view

to an area ‘‘substantially smaller than

the exposed portion of the film.’’ The

intent of the section is that masking be

as close to the full darkened film area

as possible. The masking can certainly

be variable, so that the darkened area

can be reduced to a specific area of

interest. This is not required, however.

Discussions with interpreting

physicians have led FDA to conclude

that it is often desirable to visualize the

entire image to establish a ‘‘gestalt’’

impression before further interpretation

of the film. A masking system that

prevented such a practice, therefore,

may be undesirable and is not being

required.

(Comment 398). One comment

questioned to what extent the film

masking devices were required to be

available. The comment asked if all

mammograms were required to be read

on viewboxes equipped with masking

devices or if the facility need only

require adequate masking for one

viewbox, even if multiple reviewers

were reading film at the same time on

different viewboxes.

In response to this comment, FDA has

modified the final regulation to indicate

that such devices should be available in

sufficient numbers to allow each

physician requiring one to have access

to one. NMQAAC recommended that

the requirement that the devices be

available to physicians should be

deleted, stating that any physician who

desired to use masking could provide

their own at little or no expense and

that the facility need not provide such

devices for them. FDA partially agrees

with this assessment but has not

accepted this recommendation because

it has concerns about facilities that

require significant numbers of films to

be read daily and where the interpreting

physician simply does not have time to

individually mask images. Placing

responsibility with the facility will

ensure that masking devices are

provided in such cases.

(Comment 399). Two comments

recommended that the regulation

mandate the use of film masking devices

by the physician, and one of these

suggested that masking should be used

by the technologists in their film

critique area. While FDA certainly

agrees that both interpreting physicians

and technologists should utilize

masking, the agency believes that, if the

devices are available, most individuals

will use them and that requiring their

use would be difficult to enforce.

(Comment 400). One comment stated

that film masking devices may be

expensive to obtain and cumbersome to

use. This comment maintained that,

although film interpretation may be

improved by using these devices,

requiring that facilities provide such

devices appears to be excessive

regulation and this requirement should

be deleted.

FDA notes that the goal of the MQSA

is to provide a consistent baseline of

quality mammography services to all

patients. If an item that is consistent

with that goal is identified as having a

positive impact on the diagnostic

process, FDA believes it is important to

assure women that facilities at least

have these devices available for use on

their behalf. FDA also notes that

masking devices do not ordinarily entail

significant expense. FDA has codified

the requirement for availability of

masking in the final regulations under

§ 900.12(b)(15).

w. Film processors (§ 900.12(b)(22)

(proposed § 900.12(b)(22)))

In this paragraph, FDA proposed a

number of requirements for the film

processors used to develop

mammograms. As proposed,

§ 900.12(b)(22)(i), covering processor

setup and maintenance, would go into

effect 1 year after final publication;

§ 900.12(b)(22)(ii) and (iii), requiring

display of the time cycle and

maintenance of the developer

temperature, would be phased-in after 5

years; and § 900.12(b)(22)(iv) and (v),

requiring the display of the developer

temperature and for variable cycle

processors to be interlocked to prevent

new film being accepted by the

processor until cycle parameters are

stabilized, would be phased-in after 10

years.

Section 900.12(b)(22)(i) proposed that

all such processors be set up and

maintained at the technical

development specifications for the film

used for mammography at the facility.

(Comment 401). One comment

requested a definition of technical

development specifications, as used in

the proposed regulations. Another

comment stated that, if it is going to be

mandatory to meet film manufacturers

technical requirements, then

manufacturers should be required to

make written guidelines available as to

what factors are needed to achieve the

maximum result from the film.

FDA coined the phrase ‘‘technical

development specifications’’ to

represent a listing of the technical

aspects of correct processing as

provided by the film manufacturer. This

would be expected to include such

items as correct solutions, proper

temperatures, applicable immersion

times, replenishment rates, and any

other instructions the manufacturer

deemed appropriate and critical to the

processing of its film. FDA believes that

many manufacturers do provide such

information and that the market

advantage these manufacturers will

enjoy will encourage all manufacturers

to do so. The NMQAAC recommended

that this section be moved to the quality

assurance provisions and FDA has

followed that advice.

The agency has reconsidered the

proposed requirements in

§ 900.12(b)(22)(ii), (iii), (iv), and (v).

FDA received a number of comments

both supporting and opposing these

proposals. However, based on the

anticipated costs associated with these

proposals compared with the marginal

benefits they would provide, FDA has

decided to delete them from the final

regulations. If the agency proposes

future regulations for these areas, all

related comments will be reconsidered.

3. Medical Records and Mammography

Reports (§ 900.12(c))

This section establishes quality

standards for medical records and

mammography reports as required by

the MQSA under 42 U.S.C.

263b(f)(1)(G). The regulation provides,

in general, that facilities prepare written

reports of mammography examinations,

that results be communicated to the

patient or provider, and that films be

maintained for a reasonable period of

time or transferred to the patient.

(Comment 402). Public comments

were received on § 900.12(c). The most

controversial areas were specific

provisions in the proposal for use of

standardized assessment categories in

the mammography report, written

notification of all mammography

results, and for original mammograms to

be transferred to other facilities or

entities upon patient request. Each of

these areas will be discussed below in

connection with those specific

provisions.

a. General comments

As an initial matter, FDA disagrees

with four comments that asked FDA to

delete the entire regulation on medical

records and reports because it was an

intrusion of FDA into the practice of

medicine and abridged the rights of
55926 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

radiologists. The agency’s authority and

responsibility to regulate these medical

records, mammography reports, and

communication of results was

established by Congress through specific

provisions of the MQSA. The agency

could not eliminate the entire

regulation, even if it believed such

action was appropriate. Discussions

with NMQAAC clearly indicated the

committee’s support for regulations in

this area as well.

b. Contents and terminology

(§ 900.12(c)(1))

The proposal established

standardized assessment categories for

interpreting physicians to use to

evaluate mammograms, ranging from

‘‘negative’’ to ‘‘highly suggestive of

malignancy.’’ In addition, the regulation

requires the interpreting physician to

address clinical questions, if possible,

and include recommendations, if any, in

the report.

(Comment 403). Comments in support

of the proposed standardized

assessment categories stated that such

categories: would ensure that a

definitive result for each mammogram is

reached; would establish consistency

across facilities; are a valuable tool to

assist consumers and clinicians in

understanding results; should also be

used in the written notification to

patients; and permit efficient and

uniform analysis of outcomes in

medical audits. One comment in

support of this section suggested that

the title be changed to ‘‘Contents,

terminology and timeframes.’’

Fourteen comments stated that it is

inappropriate for the Federal

government to establish medical terms

for classification of mammography

results through regulation. Other

comments opposing the establishment

of standard assessment categories stated

that: Such categories would prevent any

particular facility from continuing to

use its customary terminology and,

thereby, cause confusion to its referring

physicians; the message, rather than the

exact words, are important and

resources would be wasted in

monitoring the correct use of particular

phrases; and that establishing standard

classifications would reduce flexibility

for the reporting physicians.

Some comments objected to the

details of a particular classification

category, rather than to the idea of

standard classifications. One comment

stated that a ‘‘negative’’ report may

mislead a referring physician about the

existence of breast cancer because

mammography cannot detect all breast

cancers, while another comment

concluded that the term ‘‘suspicious’’

inherently suggests that the lesion is

malignant, and proposed

‘‘indeterminate’’ as a substitute

category.

After considering all these comments,

FDA has decided to keep the proposed

categories in order to promote

consistency and clarity in

mammography interpretations. In

discussions with NMQAAC, the use of

final assessment categories was

supported because they promote

consistency in communication of results

among medical care providers and

standard categories are necessary in the

medical audit of mammography

interpretation. These particular

categories are based on similar

categories developed by ACR. The ACR

Breast Imaging Reporting and Data

System categories are: Assessment Is

Incomplete-Need Additional Imaging

Evaluation; 1-Negative; 2-Benign

Finding; 3-Probably Benign Finding—

Short Interval FollowUp Suggested; 4-

Suspicious Abnormality—Biopsy

Should Be Considered; and 5-Highly

Suggestive of Malignancy—Appropriate

Action Should be Taken.

FDA believes that the medical

community is familiar with these

categories and the assessment

classifications established under the

final regulations (‘‘negative,’’ ‘‘benign,’’

‘‘probably benign,’’ ‘‘suspicious,’’

‘‘highly suggestive of malignancy’’) are

equivalent to the ACR system. The

medical community has already

affirmed their usefulness and value

through widespread use of the ACR

system. Accordingly, the agency

concludes that requiring these

classification terms in mammography

reports will not be burdensome, given

their current level of use and

acceptance.

FDA has made minor changes in

particular assessment categories in

response to comments. Two comments

requested FDA to delete the word

‘‘imaging’’ from the proposed

assessment category of ‘‘needs

additional imaging evaluation’’ and

substitute the ACR category of ‘‘needs

additional evaluation’’ because physical

examination may be part of further

evaluation. In fact, the ACR category is

‘‘Need Additional Imaging Evaluation,’’

with ‘‘incomplete’’ as its descriptor.

Accordingly, FDA is adding the word

‘‘incomplete’’ to the description of this

category, which will now read:

‘‘Incomplete: needs additional imaging

evaluation.’’ The mammographic result

should be categorized into this or one of

the other assessment categories. The

agency notes that, if the result is

‘‘negative’’ or ‘‘probably benign’’ based

on the mammogram, but physical

examination is recommended, the

recommendation for clinical followup,

surgical consultation, biopsy, or other

action should be stated in the

recommendations section of the report.

The agency also is aware that there are

screening mammography practices that

do not issue a final assessment until

followup diagnostic mammography has

been scheduled and performed. These

facilities, and others, can continue their

policy of not issuing an assessment, and

can use this category of ‘‘Incomplete:

needs additional imaging evaluation.’’

FDA’s proposed language for the

‘‘negative’’ category stated that if the

interpreting physician is aware of

clinical findings or symptoms, these

should be explained. One comment

asked if this explanation must be

written into the report or could be

attached as a symptom in-take form. The

agency believes that the

recommendations section of the report

is the most effective way to direct

referring health care providers to further

work-up based on physical findings or

symptoms, despite negative

mammographic results.

(Comment 404). One comment stated

that it would be hard to determine

compliance with the proposed

requirement that clinical questions

raised by the referring health care

provider be addressed in the

recommendation section of the report.

FDA responds that it can determine

compliance with a regulation in a

variety of ways, including review during

an inspection of a facility’s standard

operating procedures. FDA inspectors

can be trained to verify that each facility

has in place a system that requires its

interpreting physicians to address the

concerns of referring health care

providers in the recommendations

section of the mammography report.

FDA agrees with comments that

suggested that the recommendation

section of the report remain separate

and unstructured; the agency has not

proposed specific categories or language

for this portion of the report in order to

provide maximum flexibility for clinical

management recommendations.

(Comment 405). One comment stated

that there should be a unique patient

identifier to distinguish between two

patients with the same first and last

name. NMQAAC also agreed, stating

that the medical report and the

mammography films should have a

patient identifier in addition to the

name. FDA agrees that an additional

patient identifier in addition to the

name will improve the accuracy and

clarity of the results and subsequent

followup and the proposal has been

amended to require reports to have this

additional identifier. However, the
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55927

choice of the additional identifier, such

as the date of birth or hospital number,

is left up to the facility because each

individual practice has a better

understanding of its particular needs in

this matter.

(Comment 406). Two comments asked

if a radiologist who did not read the film

or dictate the report can sign a report if

the radiologist who did perform the

interpretation is unavailable and

concurs with this practice. Another

comment stated that FDA should allow

signatures that are authenticated

through computers, which are normally

accepted in a court of law. A third

comment stated that signatures should

be evident on the report filed in the

patient’s permanent file.

FDA interprets the MQSA’s

requirement that each mammography

report be ‘‘signed’’ by the interpreting

physician to mean that each report must

identify who interpreted the

mammogram and rendered the reading

on the written report. The final

regulations state that the name of the

interpreting physician must be on the

mammography medical report. This

name may be handwritten, typed,

stamped, written electronically, or

recorded in any other manner. However,

with respect to ‘‘signatures’’ that are

used to proof-read reports or to ‘‘sign’’

them out for purposes of authenticating

such reports or releasing them to other

parties or institutions, FDA believes that

each facility is in the best position to

devise its own procedures to ensure

accuracy of reports and integrity of the

system without the MQSA regulations

in this area.

(Comment 407). One comment

recommended that there be a

requirement for facilities to maintain

records that include the signature of the

qualified radiologic technologist who

performed or supervised the

examination and the signature of any

individual who conducted all or part of

the examination under supervision of a

qualified radiologic technologist.

FDA disagrees with this comment.

The MQSA does not have a signature

requirement for the technologist. The

final regulations require ‘‘technologist

identification’’ on each film image

(§ 900.4(c)(viii)(E)) and the agency

believes each facility can adopt its own

system to identify technologists without

having the agency mandate such

procedures.

(Comment 408). One comment

suggested that the term ‘‘health care

provider’’ should be replaced with

‘‘referring physician.’’ FDA disagrees

because patients are referred for

mammograms by nonphysicians, such

as physician’s assistants, nurse

practitioners, and other health care

workers.

c. Communication of mammography

results to patients (§ 900.12(c)(2))

This provision requires that: (1) Each

facility establish a system to ensure that

results are communicated to patients;

(2) patients without health care

providers receive medical reports and

lay summaries of their mammography

results; (3) each facility establish a

referral system for patients without

health care providers, if necessary; and

(4) results that are ‘‘suspicious’’ or

‘‘highly suggestive of malignancy’’ be

communicated as soon as possible.

(Comment 409). FDA received

hundreds of comments on the proposal

that all patients receive written results

of their mammography examination.

Comments that objected to this proposal

generally focused on disruption of

doctor-patient relationships, confusion

for patients, and additional expense to

facilities without commensurate patient

benefit. Ninety comments stated that the

referring health care provider is

responsible for communicating results

to patients and is best able to convey

such results and answer patient

questions. Other comments that raised

concerns about disrupting the referring

doctor-patient relationship stated that

written notification from the facility

would allow patients to bypass a

referring physician and never get a

physical breast examination. Many

comments stated that written

notification to every patient would

cause confusion for the patients.

Twenty-three comments said confusion

would arise if patients were notified

about results before such results were

reviewed by their referring physicians;

twenty-one comments stated that many

patients would misinterpret their

reports; ten comments stated that the

difference between the information

provided in a lay notification and the

information contained in a copy of the

actual written report would confuse

patients who received both.

Seventy-two comments stated that the

additional cost associated with written

communication to every patient would

cause financial hardship for

mammography facilities. In general,

these comments and others argued that

the cost of providing or ensuring written

notification in every case outweighs any

patient benefit that might result. Ten

comments stated that radiologists would

have to police referring physicians who

agreed to provide patient notifications

and followup. Other comments stated

that: (1) Small or rural facilities would

be burdened by patient notification

requirements, especially those without a

computerized system; (2) producing

patient notification reports is timeconsuming and hinders the

accomplishment of daily operations,

and would not directly improve patient

care; (3) developing a notification

document that could explain every

possible scenario involving diagnostic

findings is virtually impossible; and (4)

radiologists and providers of

mammography would become more

frequent targets of litigation because of

this reporting requirement. Thirty-seven

comments stated that it is unrealistic to

expect radiologists, who may never see

patients, to determine the literacy level,

ethnic, cultural, and social sensibilities

of those patients in order to tailor an

appropriate written notification. Fifteen

comments stated that the requirement

would create excessive waste paper for

the environment. Some comments

found the proposal for written

notification unnecessary in light of

other reporting and followup

requirements, the individual patient’s

responsibility to communicate with her

physician, and the belief that patients

are always informed of results by their

physicians. Two comments asserted that

written notification for all patients was

not authorized by the MQSA.

FDA also received 66 comments that

supported the proposal for all patients

to receive written notification of

mammography results including

comments offering strong support from

national breast cancer patient groups.

These comments generally focused on

the fact that women otherwise were not

assured of timely and accurate

information about their mammography

examinations and that such written

notification could save lives by

encouraging initiation of necessary

followup.

It was also noted that the experience

of facilities that instituted such

notification was positive. Comments in

support of written patient notification

stated that such notification was

appropriate because patients are entitled

to know the results of their exams, it is

the facility’s responsibility to inform

patients of results, and there is a public

health need for written notification

because not all referring physicians

discuss results with their patients.

(Comment 410). Comments described

written notification as an important

addition to quality mammography

practice, a crucial component to

ensuring reliable mammography and

consistency across the country, and a

major step toward fostering better

communication between doctors and

their patients. One comment supported

the proposed system to ensure that

patients and referring physicians receive

reports, and that all patients receive a
55928 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

report in lay terms, but also stated that

the referring physician should continue

to be responsible for patient followup.

Another comment stated that FDA

should not allow any party, other than

the facility, to distribute these written

notifications.

Many comments asserted that written

notification for each patient may

ultimately reduce health care costs and

extend lives because of earlier

treatment. Five comments stated that

written notification empowers the

medical consumer and minimizes the

possibility of tragic error when

abnormal results slip through the cracks

of the referring physician systems.

Comments asserted that referring

physicians do not always communicate

results to patients, even when the

results are abnormal. Several breast

cancer survivors commented positively

on this proposed requirement and one

author stated that such written

notification saved her life. Seven

comments stated written notification

has reduced medical liability of

facilities, but that costs should be offset

with increased reimbursement.

Comments from State health officials

and some facilities having experience

with written patient notification

reported that the experience had been

positive. Facilities that have instituted

written notification stated that the

practice is appreciated by patients and

does not cause the facility any particular

hardship. Massachusetts has required

such written notification since 1994.

The comment from a State official stated

that, although initially resisted, the

procedure is now accepted by

physicians throughout the State;

facilities in Massachusetts receive

positive feedback from patients and no

facility has closed in that State because

of this additional requirement.

Some comments recommended that

the notification include additional

information. Twelve comments asked

that the written notification also include

information about the location of the

films, directions about how a woman

could obtain them, and the facility

contact person for questions concerning

the result. Another comment said the

notification should include information

about the importance of clinical breast

examinations by a qualified physician,

monthly self-breast examinations, and

mammograms at appropriate times,

especially for patients without

physicians. Some comments wanted

facilities to be required to provide

written notification to referring

physicians and patients.

Many comments suggested

alternatives that were variations to the

proposed requirement for written

patient notification. Ten comments

supported the current interim

regulations, which require written

notification from the facility only to

those patients who do not have a health

care provider or referring physician.

Thirteen comments stated that, for

referred patients, the required

notification should simply state that the

mammogram report has been mailed to

the physician and the examinee should

contact that physician. Twelve

comments stated that only those

patients who request a written report

should be sent one.

Other comments agreed that patient

notification of results by the facility was

appropriate, but preferred to leave the

method of communication up to the

facility, which could tailor notification

procedures to its practices and the

circumstances of particular patients.

Comments observed that in some

screening cases, where the radiologist

never speaks to the patient, written

notification of results makes sense;

however, where there is extensive

interaction and verbal communication

with the examinee onsite, written

notification can be redundant,

expensive, and wasteful of paper. Five

comments stated that patients should be

verbally told at the time of the

examination to contact her physician’s

office and not to assume that ‘‘no news

is good news.’’ Other alternatives

suggested by comments included

several that were in direct contradiction

to each other: (1) Require written

notification only to those patients who

have not received the final report

verbally at the facility or, if findings are

negative, by telephone; (2) encourage

notification of patients with abnormal

studies; (3) require patient notification

in lay terms only if the results are

negative and notify referring physicians,

including followup notes, when there

are abnormal results; (4) send referring

physicians lists of patients who had

mammography at a facility with positive

studies highlighted; (5) require

notification of patients who request

results after a specified time period has

passed in order to allow communication

between the patient and the referring

physician and to prevent duplication

and failure to inform; and (6) require

that every patient receive a copy of her

mammography report, if desired, or by

default if her preference is not stated.

After reviewing and considering the

hundreds of comments FDA received

concerning patient notification, the

agency concluded that these many

comments all share the common goal of

providing an effective mechanism for

communicating mammography results

to patients, but that the comments

clearly advocate different approaches to

achieving this goal. FDA agrees with

consumer groups that written

notification of mammographic results

represents ‘‘best practices’’ in ensuring

that each and every woman is clearly

and effectively notified of the results of

her mammogram. These ‘‘best practices’’

are outlined clearly in a series of

recommendations published by AHCPR

in Chapter 4 of the 1994 guidelines

entitled, ‘‘Quality Determinants of

Mammography’’ (Ref. 2). In these

guidelines AHCPR strongly

recommends that mammography facility

personnel provide each patient with

written notification of the results of her

mammography examination either

onsite or by mail. Studies cited by

AHCPR have shown that direct

communication with patients, which is

in addition to written communication to

health care providers, dramatically

increases compliance with followup

recommendations. However, FDA also

recognizes that many in the health care

community have strong reservations, for

the many reasons cited above, about

making written notification to all

patients a Federal requirement. Finally,

FDA notes that although the MQSA

requires mammography facilities to

notify patients’ referring physicians, in

writing, of the examination results, the

statute requires those facilities to notify

patients directly in writing, only in

those instances where the patient has no

referring physician. FDA believes that

the best way to reconcile the many

different points of view on this

subject—and achieve the goal of

effective patient notification consistent

with the statute—is to issue a general

rule requiring patient notification,

together with a recommendation that

facilities follow the AHCPR guidelines

regarding written notifications to

patients. The relevant portions of the

AHCPR guidelines have been printed as

an appendix to the preamble of this

document for ease of reference.

Accordingly, the agency has revised

the final rule to eliminate the

requirement for written notification to

every patient and has substituted a

performance-based regulation that

requires each facility to ensure that the

results of each mammographic

examination are communicated to the

patient. Under the final rule, each

facility will be responsible for

establishing a system of notification,

through its own efforts or in cooperation

with third parties, that guarantees that

patients are informed of the results of

their examinations in a timely manner.

The system must also ensure that

women who do not have health care
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55929

providers receive written notification,

along with the mammography medical

report, no later than 30 days following

an examination and that each facility

communicate abnormal results as soon

as possible.

As noted above, FDA continues to

believe that written notification of

mammographic results is the most

reliable way to guarantee that each

patient is notified of results and that any

necessary followup will occur.

Comments from consumer groups and

breast cancer survivors about the

importance of early and accurate

communication to patients supports the

public health need for systems that

ensure patient notification. Written

notification to a patient of results can

permit that patient to make informed

medical decisions at critical times. One

cancer survivor informed the agency

that having the actual results of an

abnormal study in hand allowed her to

pursue treatment options that saved her

life. Furthermore, the agency disagrees

with comments that assume all patients

are notified of their mammographic

results; many referring health care

providers do not communicate results of

mammograms to patients and the adage

‘‘no news is good news’’ still rings true

for many patients. During the MQSA

inspections, FDA has uncovered a

handful of facilities that do not even

issue written mammography reports to

referring physicians. Accordingly, the

agency is continuing to require each

facility to establish systems that will

ensure that patients are notified of the

results of their mammograms.

FDA believes that high quality

mammography extends from the

production of high quality

mammographic images to the

communication of results to the patient.

Ensuring that patients get their results is

the responsibility of all participants in

the mammography imaging chain: The

patient, the facility, and the referring

health care provider. The final

regulations fully charge facilities to

meet their responsibility.

At its January 1997 meeting,

NMQAAC recommended that all

facilities should not be required to

provide written notification. While

some concern was voiced about

difficulties in directly notifying all

patients who underwent diagnostic

mammography, many members advised

FDA to require some type of direct

notification of all patients and that this

notification be documented. Although

the agency continues to support written

notification to all patients as the

optimum practice under most

circumstances, the final regulation does

not prescribe any particular form of

notification. Comments from facilities

and physicians indicate that facilities

have devised a variety of systems of

communication to notify patients of

mammography results. These include

verbal conversations at the time of the

examination, telephone communication

after the examination, cooperative

arrangements with referring physicians

who convey the results verbally to their

own patients, and written

communications that are either directly

issued from the facility and convey

results or instruct the referring

physicians to issue these reports. The

AHCPR guidelines recommending direct

written communication to all patients

also provided examples and suggestions

about the other types of communication.

Under the final regulation, in the case

where a facility decides to rely on a

third party to communicate results

(either written or verbally), there should

be a documented agreement between the

facility and the third party that

establishes this cooperative

responsibility. This documentation may

be in the form of attestation by the third

party or letters of agreement signed by

the third party. In addition, the agency

reserves the right during inspections to

confirm not only the presence of such

documentation, but also to ask for

further documentation from the facility

to verify that patients were indeed

notified. Further documentation can

include copies of referring physician

medical records documenting that

results were discussed or sent to the

patient. These descriptions of systems

and documentation are intended to be

examples; others may also be

acceptable. However, if third parties do

not provide the mammography facility

with further documentation when

requested during inspections, the

mammography facility is subject to

regulatory enforcement action under the

MQSA for failing to document that

results were provided to patients. Thus,

for facilities that choose to rely on third

parties for communicating results,

whether they be referring physicians or

communication consultants or other

parties, the facility still has ultimate

responsibility to meet the patient

notification requirements of the final

regulations.

The agency also believes that the

approach taken in the final regulation

will address the concerns about

communication and cost that were

raised by so many of the comments. The

flexibility that has been built into the

final regulation will permit facilities to

tailor notification systems to the

particular needs of the general patient

population and individual patients they

serve. At the same time, requiring each

facility to establish and document the

existence and operation of such systems

achieves the primary goal of ensuring

that patients receive the results of their

mammograms.

In addition, the agency notes that the

requirement for reasonable attempts at

immediate communication when results

of an examination are ‘‘suspicious’’ or

‘‘highly suggestive of malignancy’’ has

been retained in the final regulation.

Potential delays in diagnosing and

treating breast cancer are reduced with

this requirement that facilities directly

notify patients who have no health care

provider of abnormal results as soon as

possible. (The same requirement for

immediate communication in the case

of ‘‘suspicious’’ or ‘‘highly suggestive of

malignancy’’ findings applies to the

facility’s communication with the

referring physicians of those women

who have identified health care

providers). The agency concludes,

therefore, that the most significant

public health risk that may result from

failure to communicate results is

addressed in the final regulation.

The final regulation continues to

require written notification by facilities

to patients who do not have referring

physicians, as specified in the MQSA.

The statute also sets forth, and the

regulation incorporates, the requirement

that such self-referred patients receive a

copy of the actual mammography report

that would be prepared and sent to the

referring physician, if there were one. In

response to comments that questioned

the agency’s authority to require patient

notification, FDA notes that the

language of the MQSA is very explicit

with respect to patient notification of

test results and the form that

notification must take in these

particular circumstances (see 42 U.S.C.

263b(f)(1)(G)).

(Comment 411). Many comments

urged FDA to require referring

physicians to be responsible for the

communication and followup of results

of mammography examinations. FDA

agrees that a physician with knowledge

of a particular patient’s entire medical

history is often the best source of

communication and followup of results.

However, FDA’s primary jurisdiction

under the MQSA is related to

mammography facilities and not

individual practices of referring health

care providers.

One comment suggested an

arrangement whereby facilities and each

provider of care enter into a written

agreement that the referring physician

assumes responsibility and liability for

informing his or her patients of

mammography results, and the

mammography facility would be
55930 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

allowed to breach this contract at any

time when a patient requests the results

in writing. FDA agrees that this

arrangement would meet the

requirements of the final regulations.

However, if referring physicians fail to

communicate results to patients despite

their agreement to do so, the

mammography facility is responsible

under the MQSA for failing to ensure

communication of results and is subject

to regulatory action by FDA.

FDA intends to look for

documentation during inspections to

establish that patient notification

systems are in place and operational.

For example, if a verbal communication

system is used to tell patients of results,

this communication should be

documented in the patient’s medical

record and should be capable of

verification by the MQSA inspectors. If

a facility sends letters to patients,

records of that correspondence, or

standard operating procedures

describing this correspondence, must be

available for inspection. In

circumstances where a facility relies on

referring physicians or other third

parties to communicate results to

patients, the facility must provide

documentation of these arrangement

and their implementation, as described

above. In those cases where the

mammography facility is the primary

breast care provider for the patient,

there must be documentation of results

being conveyed to the patients. By

allowing a variety of notification

systems, the agency has attempted to

ensure that communication of results

will be accomplished effectively, but

without undue burden on

mammography practices or unnecessary

increases in the cost of mammography

services. Finally, the agency notes that

the regulations being issued to require

facilities to establish and maintain

systems that ensure patient notification

of results does not preclude any patient

from requesting additional reports or

records from the facility. Nothing in the

record and report section of the MQSA

should be construed to limit a patient’s

access to the patient’s medical records

(42 U.S.C. 263b(f)(1)).

(Comment 412). One comment stated

that FDA’s intention to inspect and

monitor systems established by facilities

to verify that patients receive

notification of results in lay language is

unrealistic and that facilities should not

be required to establish such systems.

FDA disagrees. FDA has issued

interim regulations, as required by the

MQSA, that required notices in lay

language to be issued, along with the

actual report when patients do not have

a referring health care provider (42

U.S.C. 263b(f)(1)(G)(ii)(IV)). This is a

current requirement for all facilities and

is already subject to inspection and

verification.

(Comment 413). One comment stated

that complex situations, such as when a

mammogram is assessed as negative, but

the patient has clinical findings, need

careful explanation to patients so that

the importance of the situation and

recommendation for followup will be

understood. This comment

recommended that the mammography

facility be responsible for patient care if

it is accepting women who have no

physicians.

FDA believes this practice standard is

largely being adopted by the

mammography community and

supports this. Under the final

regulations, each facility is required to

maintain a system for referring patients

to health care providers when clinical

followup is recommended and the

patient has no physician.

(Comment 414). One comment stated

that followup reminder letters are

critical and should be mandated.

FDA disagrees that these should be

mandated. Rather, each practice should

be allowed to determine if such letters

or other forms of reminders are needed.

(Comment 415). One comment

reflected confusion about the immediate

followup call to patients required under

§ 900.12(c)(2), which is in addition to

the notification requirements. Although

notification is required for all patients

under the system established by the

facility to ensure such communication,

FDA believes that special efforts at

communication are required when there

are abnormal results and the patient

does not have a referring physician. In

these cases, the facility is expected to

contact the patient who has no health

care provider as soon as possible and

the 30-day timeframe for sending

reports and long summaries is

superseded. Under the final regulations,

this immediate communication is

required only in situations where the

probability of cancer is high

(mammograms assessed as ‘‘suspicious’’

or ‘‘highly suggestive of malignancy’’).

In cases where such immediate

notification is required, the facility

remains obligated to also provide the

necessary written notifications within

30 days as followup.

(Comment 416). One comment

supported the requirement that, when

an examination shows suspicious

findings, a facility should directly

communicate with a nonreferred

patient. This provides patents the

assurance that they will receive the care

they need.

FDA agrees and the final regulations

contain this requirement.

(Comment 417). One comment stated

that, in cases where assessments are

‘‘suspicious’’ or ‘‘highly suggestive of

malignancy’’ and results must be

‘‘immediately’’ communicated to the

examinee or physician, FDA should

define what ‘‘immediately’’ means.

Another comment suggested

‘‘immediately’’ be defined as 24 hours.

FDA believes that the variety of

circumstances that may arise when

followup is required make a rigid

definition of ‘‘immediate’’ unreasonable.

Because there are circumstances when

immediate communication is not

possible, FDA has revised the

requirement to communicate abnormal

results from ‘‘immediately’’ to ‘‘as soon

as possible.’’ Health care professionals

understand the importance of

accomplishing such notification when

there are suspicious or highly suggestive

findings. Although it is impossible to

establish a precise timeframe, FDA

expects such communication ordinarily

can be accomplished within 48 to 72

hours and not later than a week

following the examination.

(Comment 418). One comment stated

that 30 days is an unreasonably long

window in which to notify patients of

results. Three other comments agreed

with FDA that 30 days was reasonable.

Another comment stated that reports

and notification should not be sent out

for at least 5 days in order to wait for

outside comparison films; otherwise,

addenda lay notification and reports

would confuse patients and physicians.

Another comment recommended that

notification to patients should wait until

all mammography imaging work up has

been completed.

FDA believes that issuing medical

reports to health care providers (or to

patients with no health care providers

along with lay summaries) within 30

days is a reasonable standard. This does

not mean facilities must wait 30 days,

as the first comment suggests, but rather

that 30 days is the outside limit. FDA

disagrees that notification of results

should be delayed until the total

imaging work-up is completed because

situations arise when imaging work-ups

can extend over more than 1 month.

Therefore, FDA is requiring a report of

the medical finding for each

mammogram to be generated within 30

days. Under the final regulations,

facilities must also ensure that patients

have their results communicated to

them within that time. Many facilities

may notify patients or have other parties

notify patients after written medical

reports are provided to physicians; other

facilities may choose to communicate
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55931

results to patients prior to the issuance

of the medical report to the referring

provider by means such as providing

verbal results at the time of the

mammography examination. As

discussed above, a variety of systems

will be acceptable as long as they ensure

that results are communicated to

patients and that communication is

timely.

(Comment 419). Eight comments

stated that patients without health care

providers should not get the actual

medical report along with the lay

notification. These comments claimed

that the terminology in the medical

reports would confuse patients and

either generate more inquiries or keep

them from understanding that further

studies are needed. They recommended

instead, that patients can request the

report be sent to a physician if further

medical advice is desired. One comment

also stated that, while it is critical to

include the patient in the information

loop for the results of her mammogram,

it is poor medicine to send the patient

who is self-referred the copy of the

mammogram report that is intended for

the physician.

FDA disagrees. The MQSA expressly

requires facilities to provide patients

without referring physicians both the

medical report and the lay summary (42

U.S.C. 263b(f)(1)(G)(ii)). This

requirement allows the patient to

provide her mammography report

immediately to a subsequent health care

provider, if needed.

(Comment 420). Two comments asked

what is meant by ‘‘reasonable attempts’’

to communicate results of suspicious

studies to patients without referring

physicians as soon as possible. The

comments asked whether a certain

number of phone calls or a registered

letter would be acceptable.

FDA does not intend to mandate

procedures for communication with

patients in these circumstances because

different methods are likely to be more

or less effective with different facilities

and patient populations. Telephone

calls and registered mail are examples of

attempts at communication that may

work. Verification that contact has been

made is the goal. Each facility can

consult with its risk management

director to establish procedures to

convey results and document attempts

at communication that are ‘‘reasonable.’’

FDA recommends that mammography

facilities utilize the AHCPR’s guidelines

in ‘‘Quality Determinants of

Mammography’’ that address the

effective communication of

mammography results to patients and

follow those guidelines with respect to

written notification to patients. That

document includes excellent sample lay

notices that facilities could adopt. As

noted previously, information from

Chapter 4 of these guidelines has been

reprinted as an appendix to the

preamble of this document for ease of

reference.

d. Communication of mammography

results to health care providers

(§ 900.12(c)(3))

The final regulation requires each

facility to provide the mammography

report to a referring or named health

provider within 30 days of the date of

the examination. The regulation also

requires a facility to make reasonable

attempts to communicate with the

health care provider or the provider’s

designee as soon as possible when an

examination reveals suspicious results.

These requirements paralleled those for

communication of suspicious results to

patients without identified health care

providers.

(Comment 421). Five comments

requested guidance in defining who is a

responsible designee of the health care

provider.

In response, the agency notes that

when referring health care providers are

not available, they ordinarily have

responsible designees, such as medical

coverage services or partners, to assume

medical responsibilities for the

unavailable provider’s patients. These

requirements parallel and complement

those related to patient notification.

(Comment 422). Twenty-nine

comments stated that 30 days is a

reasonable time period for getting

reports out (unless there are delays in

obtaining comparison studies). Three

comments asked FDA to define the

timeframe required for ‘‘immediately’’

communicating the results of suspicious

or highly suggestive mammograms to

health care providers. One comment

expressed concern that the requirement

to attempt to communicate ‘‘suspicious’’

or ‘‘highly suspicious of malignancy’’

findings to health care providers

immediately will impose an

unmanageable burden on understaffed

facilities.

FDA disagrees with this last comment

but, as with the provision relating to

communication with patients, the

agency has changed the language from

‘‘immediate’’ to ‘‘as soon as possible’’

because immediate communication may

not be possible given the variety of

circumstances that may be associated

with communication of suspicious

results to a particular provider. FDA

believes health professionals

understand the urgency of the situation

when a patient has a suspicious or

highly suggestive mammogram and they

are mandated to communicate this

result to the referring health care

provider in an attempt to expedite

diagnosis or treatment. Again, although

it is not realistic to mandate a rigid

schedule, the agency expects that such

communication ordinarily can occur

within 48–72 hours, and not later than

a week following the evaluation of the

examination. NMQAAC discussed this

section and supported the regulations as

revised.

(Comment 423). One comment

questioned the ability of physicians who

read only twice a week to comply with

the requirement to communicate with

health care providers within the

mandated timeframes. FDA believes

timeframes and procedures are

sufficiently flexible to balance the need

to protect patient health with the

realities of good mammography

practices. Reading twice a week does

not preclude a physician or the facility

that employs that physician from

complying with the requirements.

(Comment 424). Another comment

recommended that radiological reports

transmitted to the referring physician be

acknowledged by electronic signature,

which should be kept in the electronic

file indefinitely. As stated previously,

with respect to proof-reading reports

and ‘‘signing’’ them out (for

authentification or release), FDA

assumes that facilities are able to devise

their own procedures to ensure accuracy

of reports and integrity of the system

without the MQSA regulations at this

time.

e. Recordkeeping (§ 900.12(c)(4))

FDA’s final regulation implementing

recordkeeping standards for facilities

requires each facility to maintain films

and reports at least 5 years or until the

patient requests them or requests their

transfer. If the film and report represent

the only mammogram for that patient,

the facility must retain them for 10 years

or for any longer period of time that is

required by State law or until the

patient requests them or requests their

transfer.

FDA received numerous comments

supporting its proposal to require

transfer of the original mammogram

upon the request of the patient.

(Comment 425). Fourteen comments

stated that original films should be

transferred because copies are

frequently poor quality and jeopardize

successful followup. Four comments

stated that the request for transfer

should be in writing and that the

regulation should state ‘‘temporary or

permanent transfer.’’

FDA believes each facility should be

free to establish its own procedures for

transfer of films and may wish to

consult its risk management director for
55932 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

guidance. FDA agrees in part with the

last comment and has modified the final

regulation to clarify that a patient may

request that the transfer of the original

films be temporary or permanent. FDA

will leave it to the facility to decide

whether the request for transfer should

be in writing or may take some other

form. NMQAAC also supported the

addition of this language to the final

regulation.

The agency has also amended the

language of the provision to clarify that

a request for a transfer supersedes a

facility’s responsibility to maintain the

films for a particular length of time and

that the request may be made by an

individual on behalf of the patient as,

for example, might be necessary in cases

where the patient is incapacitated or has

a legal guardian.

(Comment 426). Two comments

agreed that original mammograms

should be sent for comparison to other

facilities. However, these comments

stated that FDA’s suggestion in the

preamble to the proposal that facilities

make a copy is very difficult and

expensive. Another comment stated that

copying originals to retain in the record

when transfer is requested should not be

required because this would increase

costs, would not be adequate for

comparisons, and would delay sending

films out in the timely manner.

In response to these comments, the

agency notes that there are no

requirements for facilities to make

copies of films they are requested to

transfer. If this suggestion to make and

keep a copy of the mammograms is not

practical or useful to a facility, it need

not be followed.

(Comment 427). Three comments

supported the transfer of original films,

but would require their return within 30

days in cases of temporary transfer.

FDA does not intend to establish a

time limit on transfer of films at the

request of patients. Even in cases where

the transfer is temporary, the originals

may be used during clinical procedures

that may not be completed in 30 days.

However, FDA does support the return

of films in a timely manner and expects

facilities that transfer and receive films

under such circumstances to cooperate

in the interest of the patient’s treatment.

(Comment 428). FDA also received

many comments expressing concerns

about original film transfers. Twenty-six

comments stated that transferring

original films is problematic because the

films may be lost, their transfer may

breach confidentiality, the originating

institution will not be able to make

comparisons, and patient may be denied

access to films at a later date. One

comment stated that FDA should clarify

if the transfer of original films conflicts

with State or locals laws and how

facilities should proceed if that is the

case. Four comments urged FDA to

delete the proposal because the films

themselves are historically the property

of the physician or institution which

generated them and their absence would

disadvantage those physicians or

institutions in defending against claims

asserted against them. Fourteen

comments asked if FDA will indemnify

the radiologist for not having original

films in the event of a malpractice

action. One comment stated that there is

no enforcement provision against those

facilities who refuse to release original

mammography studies on the grounds

of ownership or the potential for legal

action.

FDA understands that the transfer of

original films has not been a universal

practice among facilities and that

physicians may have concerns about the

consequences of loss or misplacement.

Nevertheless, the agency has concluded

that the overwhelming benefit to

patients from access to original films by

other facilities or physicians providing

followup for patients justifies the need

for this provision in the final rule.

All expert comments FDA received on

this matter, including advice from

NMQAAC, emphasized the value of

having original films for comparison to

subsequent studies or followup clinical

procedures. There was general

agreement that copies of mammograms

could not adequately substitute for

originals when difficult diagnoses or

additional procedures were required,

and that clinical decisions, such as

whether to do surgery, require review of

original films. The agency notes that

even those practitioners who criticized

the proposal agreed that the transfer of

films was likely to enhance patient care.

Those who objected did so on grounds

that were unrelated to patient care,

namely potential for liability and

difficulty in defending malpractice

actions.

FDA has not been persuaded that

these concerns are insurmountable or

that they are sufficient to override the

public health benefits associated with

the provision.

Many facilities do routinely transfer

films upon the request of patients and

have established procedures and

systems to implement that process.

Those procedures may include written

requests from patients, release forms

that establish transfer of responsibility

for the films, and agreements with

receiving institutions for subsequent

return. In some cases, facilities that

transfer films do make and retain copies

for their own files; other facilities have

determined that the expense of copying

is not warranted. Loss of films will not

be indemnified by FDA.

With respect to facility concerns

about defense of malpractice claims,

FDA notes that rules of evidence,

including civil discovery, establish

judicial procedures that are designed to

protect each party’s ability to develop

its case. Judges have authority and

discretion to craft remedies in situations

where a patient has lost, withheld, or is

resisting production or examination of a

necessary original record.

FDA is not aware of any State laws

that conflict with the requirement that

original films be transferred upon the

patient’s request. State laws governing

the management and retention of

medical records appear to be silent

about the transfer of original films.

Rather, they are likely to state that

patients are entitled to copies of their

records or that doctors are required to

maintain records. This was the case

with the Florida and New York laws

that were brought to the attention of the

agency.

Were a State to enact a law that

conflicts with this regulation or if,

contrary to FDA’s understanding, such

laws currently do exist, those State laws

would be preempted. The agency

disagrees with comments that have

inferred such laws would be permissible

under the provision of the MQSA that

allows States to establish more stringent

requirements relating to mammography

(42 U.S.C. 263b(m)). The public policy

considerations underlying any State

laws that would restrict a patient’s

access to original films and the quality

data that may only be available from

these original studies would not be

related to the public health objectives of

the MQSA. Accordingly, such State

laws could not be characterized as more

stringent than the MQSA or this

regulation. The agency also notes that

the records provision of the MQSA that

is being implemented by this regulation

explicitly states that nothing in that

provision shall be construed to limit a

patient’s access to that patient’s medical

records (42 U.S.C. 263b(f)(1)(G)).

(Comment 429). One comment

recommended that FDA add that, upon

receipt of authorization to release

mammography film, the mammography

facility must forward the films to the

requestor in a reasonable timeframe to

minimize reporting delays. Another

comment suggested that each facility be

required to provide original films and

copies of reports within 10 working

days of receipt of a written request.

FDA does not believe it is necessary

or useful to mandate the details of such

transfers. The agency believes that each
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55933

facility will develop standard operating

procedures to implement this standard

and that those procedures will reflect

the controls required by risk

management and acceptable practice

standards.

(Comment 430). Six comments

suggested that the facility that took the

most recent mammogram should

maintain ownership of all the originals

because this practice would make it

easier to keep the films available for

future comparisons. FDA’s final

regulations do not preclude this

arrangement if the patient requests

transfer of previous films to the current

facility.

(Comment 431). Twenty-four

comments asked who should bear the

cost of copying films when the original

is released. One comment stated that

facilities should only be able to charge

a nominal fee for transfer of films and

reports. Another comment believed that

the fees must be closely monitored; the

comment noted that reports have been

received in the past from facilities

charging unreasonably high fees for

sending reports and copies of

mammography films. A third comment

stated that FDA should develop fee

guidelines for charges for copying film

and postage to prevent some institutions

from charging high fees.

FDA generally agrees with these

comments and its final regulations limit

charges to the documented cost of the

transfer, so as to not deter patients from

requesting transfers when necessary.

The agency notes that nothing in the

regulations requires facilities to charge

fees for transfer of records. If copies are

made as part of the facility’s standard

transfer process, then the cost of copies

may be documented and included in the

transfer fee charged by the facility.

(Comment 432). One comment asked

if the fee can include a storage charge

or is it for medical records transfer only.

The regulations clearly state that any

fee is for services provided under

§ 900.12(c)(4)(ii), which is the transfer of

films and reports.

(Comment 433). Twelve comments

stated that the proposal that fees

charged for transfer of films and records

not exceed costs appears to be price

controls, if not price fixing.

The agency does not agree that it has

taken any action to establish prices.

FDA is responding to complaints that

fees charged for transfers of records

have been unreasonable. This practice

prevents consumers from making such

transfers and obtaining medical care

with the best quality medical data. The

regulation does intend to control such

charges in order to ensure access by

patients to their films but the final rule

does not require facilities to absorb

additional expenses. Instead, each

facility that decides to charge

consumers for this service must limit its

charges to documented costs.

(Comment 434). Nine comments

stated that original mammograms

should be provided by other facilities

for comparison purposes free of charge

as a courtesy among institutions.

FDA supports this process; the final

regulations do not mandate a charge.

However, if any fee is established,

FDA’s regulation requires that it not

exceed costs of transfers of such records.

(Comment 435). Two comments

suggested that FDA’s regulations should

consider future technology, which may

include the electronic transfer of films.

FDA regulations are for screen-film

and xeromammography. As other

technology is approved for medical use,

alternative standards under the MQSA

will be issued.

(Comment 436). One comment asked

if a facility must retain a series of

mammography records for 10 years and

discard them as each record is 10 years

old, or discard them when the oldest

record is 10 years old. FDA interprets

the provision in the MQSA to mean

that, if there is a series of mammograms

for a patient, the oldest mammogram of

the series can be 5 years old. If there is

only one mammogram for a patient, it

must be kept 10 years unless a transfer

is requested. One comment stated that

mammograms should be maintained for

longer than 10 years if mandated by

State or local law. In fact, the MQSA

mandates this and FDA has written its

regulations to conform to this provision.

(Comment 437). Two comments

recommended that mammograms be

kept indefinitely in order to spare a

patient an unnecessary biopsy and

another comment recommended that

FDA establish a standard retention

period of 5 to 7 years.

The final regulations do not preclude

facilities from keeping mammograms

longer than what is required by the

statute as a minimum. However, the

agency rejects the 5 to 7 year standard

because the timeframes set forth in the

regulation are prescribed by the statute.

(Comment 438). One comment

recommended that FDA reinstate a

HCFA requirement that previous

mammograms be obtained for

comparison with present films.

FDA believes that this is good medical

practice, but it is not an appropriate

focus for FDA regulations under the

MQSA.

f. Mammographic image identification

(§ 900.12(c)(5))

This provision describes the elements

that must be included on any

mammography film to identify the

image. They are: patient identifier, date

of examination, view, laterality, facility

identification, technologist

identification, cassette/screen

identification, and unit identification, if

the facility has more than one unit.

The NMQAAC advised FDA that

these elements need to be present on all

mammogram films to ensure proper

patient care. FDA agrees. These are the

same elements as those established by

§ 900.4(c)(2)(viii) to identify films

submitted to accreditation bodies for

clinical image review. Comments

received from the public relating to

these elements for film identification are

addressed in that section of the

preamble that discusses

§ 900.4(c)(2)(viii).

4. Quality Assurance—General

(§ 900.12(d))

This paragraph was intended to

identify the individuals responsible for

the actions required by § 900.12(e) and

(f), including those intended to ensure

that safe radiation dose levels were

used. With one or two exceptions, the

requirements of this paragraph were

included in the ACR quality assurance

manuals that were made part of the

interim regulations by reference. The

ACR manuals are not referenced in the

final regulations. However, certain

significant aspects of those manuals,

such as the requirements in this section,

were incorporated into the proposal

because there is broad agreement that

these principles are basic to a good

quality assurance program.

a. General comments on quality

assurance

(Comment 439). Two comments stated

that all facilities should follow the same

set of universal guidelines to maintain

the same quality of results.

FDA notes that the MQSA and the

implementing regulations are designed

to require that facilities meet universal

minimum standards. Nothing in the

statute or regulations is intended to

prevent a facility from applying

additional, more stringent standards or

procedures that strengthen QC at that

facility.

(Comment 440). One comment stated

that FDA should eliminate this entire

paragraph except for a single provision

that would require each facility to have

a quality assurance manual and to

verify, through the signature of a

responsible official, that the manual is

followed.

FDA does not believe that the general

requirement suggested by the comment

would effectively establish minimum

levels of quality assurance at all

facilities.
55934 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

b. Responsible individuals

(§ 900.12(d)(1))

This paragraph identified the

responsibilities of the individuals

associated with the quality assurance

program.

(Comment 441). Two comments

recommended that FDA be more

specific about what responsibilities

should be listed and to whom they

should be assigned.

FDA does not believe that additional

detail will be useful in these provisions.

Greater specificity would limit the

facility’s flexibility to design a quality

assurance program that best meets its

individual needs and to quickly change

its program in response to changes in

circumstances or technology.

(Comment 442). One comment

expressed the author’s disappointment

that this section and the rest of the

regulations failed to allot any

responsibility to administrators and

Chief Executive Officers (CEO’s), who

have the authority to make the decisions

that control quality but seem to be more

motivated by financial concerns.

FDA agrees that administrators,

CEO’s, owners, and operators of

facilities share responsibility for the

quality of mammography at their

facilities. However, individuals working

more directly in and with the

mammography facility on a daily basis

often are better able to determine when

quality problems exist and how to

correct them. The agency recognizes

that it is sometimes difficult for the staff

to obtain the administrator’s support for

necessary actions. Nevertheless, if

necessary actions are not taken to

correct quality assurance defects, the

result could be sanctions against the

facility by FDA. Because such sanctions

can affect the reputation and

profitability of any facility, FDA

believes that administrators and CEO’s

will cooperate to support actions to

improve or maintain mammography

quality.

c. Lead interpreting physician

(§ 900.12(d)(1)(i))

This provision requires facilities to

identify a lead interpreting physician to

have the general responsibility for

ensuring that the quality assurance

requirements of § 900.12(d) through (f)

are met. This is a change from the

interim regulations, which assigned this

responsibility to a mammography

medical physicist. This change drew a

number of almost evenly divided

comments.

(Comment 443). Eleven comments

plus NMQAAC supported the change.

Various comments pointed out that the

medical physicist often does not have

the authority to implement needed

actions, especially if he or she is a

contract physicist who is rarely at the

facility, and the medical physicist

usually does not have the expertise to

deal with nonequipment issues. One

comment noted that Massachusetts’

regulations have a similar provision to

the proposal and it had been found to

improve the quality assurance programs.

Eleven other comments opposed the

change. Some of these comments stated

the belief that interpreting physicians

did not have sufficient knowledge of or

interest in quality assurance to properly

handle this responsibility. Others said

that, in modern medicine, the

physicians also lack authority to

implement necessary changes and

pointed out that interpreting physicians

may also be contract employees and not

actually at the facility. A related

comment warned that, if the

interpreting physician is to be given

responsibility for oversight, he or she

must also have authority to institute

necessary changes. One comment stated

that while it is important to have an

interpreting physician in this role, it is

more important to assign this

responsibility to someone at the facility,

even if it means involving a

nonphysician. Another comment

questioned the basis for designating a

lead interpreting physician if he or she

can assign their responsibilities to other

people. Two comments suggested that

wording be changed to allow each

individual facility to decide who would

be most appropriate for this

responsibility. Finally, one comment

stated that the MQSA specifically said

that the medical physicist was to have

responsibility for the quality assurance

program.

After considering all these comments,

FDA has decided to leave this

responsibility in the hands of an

interpreting physician, as proposed.

Because the interpreting physician is

the final arbiter of the quality of a

mammogram, it is logical that the

responsibility for the quality assurance

program rest with an interpreting

physician. The agency recognizes that

interpreting physicians in some

facilities face the same limitations on

their authority as medical physicists.

However, FDA believes that an

interpreting physician is more likely to

have adequate authority, or the ability to

influence those that do, than a medical

physicist. The agency also recognizes

that the interpreting physicians may not

be located at the facility itself. Even in

those circumstances, interpreting

physicians have more regular

interaction with the facility through

their mammography interpretations

than do contract medical physicists

conducting annual surveys. Again, the

agency realizes that interpreting

physicians may not have the knowledge

to carry out all aspects of the program

themselves, but notes that this is likely

to be true of any other individual in this

position. For this reason, the final

regulations do not require the lead

interpreting physician to perform all of

the duties personally, but rather to see

that they are carried out in such a way

as to meet the requirements. The basic

responsibility remains with the

interpreting physician, even if some or

all individual duties are delegated to

people with specific training to carry

them out. Contrary to the opinion

expressed in one comment, identifying

a lead interpreting physician is valuable

because it assigns this basic

responsibility and establishes

accountability even when tasks are

delegated.

Many important duties will be

delegated to the medical physicist. FDA

is aware, as one comment noted, of the

MQSA provision that requires the

medical physicist to ‘‘survey

mammography equipment and oversee

quality assurance practices at each

facility’’ (42 U.S.C. 263b(f)(1)(F)). As

noted above, the interim regulations did

assign to the medical physicist the

overall responsibility for quality

assurance. FDA’s experience under the

interim regulations, however,

established that the interpreting

physician, who ordinarily has more

interaction with the facility and is more

likely to be onsite, also has an important

role in the oversight of quality

assurance. As discussed, members of

NMQAAC and public comments

pointed out problems with the medical

physicist having the primary

responsibility for all quality assurance

at the facility. After evaluating its

experience and the comments, the

agency proposed, and now intends, to

shift overall responsibility for the

quality assurance program to the lead

interpreting physician. The medical

physicist will continue to do the annual

survey and oversee quality assurance

practices, especially those related to the

equipment, as required by the MQSA

and the agency expects that the

physicist’s expertise will inform all final

decisions that are made on quality

assurance issues. The final regulation,

however, requires additional oversight

through the lead interpreting physician.

FDA believes this change from the

interim regulations is in accordance

with its general authority to require the

facility to establish an effective quality

assurance program (42 U.S.C.

263b(f)(1)(A)).
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55935

Section 900.12(d)(1)(i) requires the

lead interpreting physician to determine

whether individuals assigned to quality

assurance responsibilities are qualified

to carry them out. FDA agrees with the

comment that urged that the lead

interpreting physician also be given

authority to make needed changes

because effective quality assurance will

require facilities to respond

appropriately to situations that need

improvement or correction. Internal

administrative and budgetary decisions,

however, are beyond FDA’s authority

and the agency cannot control the

business and management relationships

that will affect any lead interpreting

physician’s ability to institute change.

d. Interpreting physicians

(§ 900.12(d)(1)(ii))

This paragraph was intended to

emphasize the role that all interpreting

physicians should play in establishing

and maintaining quality mammography

at a facility. As previously mentioned,

the interpreting physicians are the final

arbiters of the quality of mammography

images. It is important that they

communicate their satisfaction or

dissatisfaction with the quality of the

images they are provided to interpret to

the technologists who produced them.

Such communication is the crucial first

step in the identification of problems

and the initiation of corrective actions.

FDA is aware that this communication

has not always occurred in the past,

especially if the interpreting physicians

are not located at the facility. Media

investigations and many anecdotal

accounts have illustrated this failure in

communication.

None of the 17 comments on this

provision disagreed with the basic

premise that interpreting physicians

should provide feedback to facility staff

producing the mammograms. However,

there were some misunderstandings as

to just what was required.

(Comment 444). In particular, 13

comments mistakingly assumed that

each interpreting physician was

required to contact every technologist

about the quality of each film taken.

These comments requested that the

requirement be limited to reporting

technically inadequate mammograms to

the QC technologist. Another comment

pronounced the requirement as

excellent, but asked whether a report

was required on the technologist’s

performance for every film or if a

summary of each technologist’s

performance was sufficient. Another

comment suggested that feedback be

given to the lead interpreting physician

or, in his or her absence, to the QC

technologist. One comment requested

that this provision be more specific, and

another recommended that all

interpreting physicians be required to

have training in the technical aspects of

mammography, quality assurance, and

QC.

FDA drafted the proposed regulation

to be general in order to give each

facility the flexibility to design a

feedback system that best fits its own

situation. The agency believes this

flexibility should be retained in the final

regulations. In response to the

comments, however, FDA has clarified

that followup activities by interpreting

physicians are required only when the

image is of poor quality. FDA

recommends, however, that positive

feedback also be given when warranted

because such feedback is an effective

incentive for maintaining quality

performance.

e. Medical physicists

(§ 900.12(d)(1)(iii))

This paragraph summarizes the role of

the medical physicist in establishing

and maintaining quality mammography.

(Comment 445). Eleven of the

comments received on this provision

suggested various wording changes.

Seven of these supported changes that

would state that the physicist is to

evaluate the equipment and to survey it.

An eighth comment wanted to amend

the language to give the medical

physicist authority to take necessary

steps to ensure quality in his or her area

of responsibility. Two comments

suggested changes that would limit the

physicist’s responsibilities to overseeing

the equipment-related quality assurance

practices. These comments further

suggested limiting the physicist’s review

of the QC technologist’s work to

verifying that it is performed and not to

include providing advice on tests or

suggestions for corrective measures.

Another comment, however, clearly

disagreed with this point of view and

stated that the medical physicists

should be required to oversee the

facility’s entire quality assurance

program.

FDA agrees that the physicist should

be involved in equipment evaluation

and the annual survey and notes that

changes made elsewhere, in the survey

definition and in § 900.12(e), will

achieve this goal. FDA cannot require

that the medical physicist be given

authority to initiate changes at the

facility to improve quality for the same

reasons that it did not issue regulations

giving the lead interpreting physician

similar administrative and budgeting

authority. The agency does agrees that

the physicist’s oversight responsibility

should be focused primarily on the

equipment-related areas. The definition

of the position of lead interpreting

physician in § 900.12(d)(1)(i), as

discussed previously, should clarify that

general overall responsibility rests with

that physician while responsibility for

equipment-related matters resides with

the physicist. FDA does not agree with

the suggestion that would limit the

medical physicist’s role in the oversight

of the QC program to merely verifying

that the technologist’s work was done.

The agency believes that, as the

equipment and imaging physics expert,

the physicist’s role must be more active

and that ensuring an adequate QC

program clearly should be part of the

medical physicist’s duties. The medical

physicist should not stop with verifying

that the QC tests were performed but

should also ensure that they were

performed properly, that the results

were analyzed, and that any problems

detected by the analysis were corrected.

(Comment 446). A final comment on

this paragraph suggested that a new

intermediate position be created at a

level between the QC technologist and

the physicist. The comment

recommended that the person in this

position could do tests that do not

require a physicist but are beyond a

technologist’s training, and noted that

such a position has been quite useful in

the respondent’s facility.

Provisions of § 900.12(e) require that

surveys and mammography equipment

evaluations be performed by medical

physicists. Under the interim or final

regulations, a facility is free to create an

intermediate position for personnel to

perform other testing during the time

periods between the surveys and

evaluations, including performance of

the tests normally done during surveys.

However, the agency does not have

sufficient evidence to demonstrate that

it would be beneficial to make this a

general requirement and believes each

facility is in the best position to decide

whether such a position would be of

value in its situation.

f. QC technologist (§ 900.12(d)(1)(iv))

This provision describes the QC

technologist’s responsibility to perform

all quality assurance duties not assigned

to the lead interpreting physician or the

mammography medical physicist. The

main issue raised by the comments on

this provision was about the

qualifications of the individual holding

this position.

(Comment 447). Eighteen comments

expressed the opinion that the person

doing these tests should be a radiologic

technologist who meets all of the

requirements necessary to perform

mammography examinations. Seven

additional comments stated that the QC

technologist should be a technologist

but, to increase flexibility for the
55936 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

facility, should not necessarily have to

be qualified to do mammography

examinations. One of these seven

recommended that the QC technologist

should have some training in

mammography. Ten comments argued

that the individual performing at least

some of the tests did not even have to

be a technologist, as long as that person

had training in the test performance.

Some of these pointed out that requiring

a technologist to do the tests would

increase facility costs without an

equivalent increase in the quality of

mammography.

After considering the comments, FDA

has revised the proposal to permit

nontechnologists to perform tasks for

which they were trained, as long as their

work is supervised by a QC technologist

who meets the requirements to do

mammography examinations. FDA

believes this change strikes the proper

balance between the need for expert

oversight and the need to reduce

unnecessary costs for facilities.

NMQAAC discussed this issue at

several meetings and, at different times,

expressed varying points of view.

However, after its own review of the

public comments, NMQAAC supported

the approach FDA has taken in the final

rule.

(Comment 448). Twelve comments

suggested changes, primarily to allow or

prohibit the facility from having more

than one QC technologist.

FDA agrees that there are advantages

to the consistency that can be achieved

if there is only one QC technologist. The

agency also recognizes that the facility

may find it useful and necessary to have

more than one QC technologist, e.g., to

ensure coverage when one QC

technologist is ill or on leave. The

agency notes that facilities also have the

option of having the lead interpreting

physician or medical physicist fill in for

the QC technologist, assuming they have

the necessary qualifications, by

temporarily ‘‘reassigning’’ the

technologist’s duties.

(Comment 449). Another comment

suggested that the QC technologist

should report directly to the lead

interpreting physician rather than to the

medical physicist.

FDA notes that the regulations permit

the facility to decide for itself what lines

of communication to the lead

interpreting physician should be

established. The agency believes that

this flexibility should be retained.

(Comment 450). Another comment

suggested that all mammographers

should be trained in all QC tests and

procedures.

From the context of the comment, it

was clear that the author was using the

term ‘‘mammographer’’ to refer to

technologists doing mammography, and

not, as is becoming increasingly

common, to interpreting physicians

interpreting mammography. Section

900.12(a)(2)(ii)(A) does require such

training as part of initial training for

technologists who will begin performing

mammography after the final

regulations become effective. Training

in these areas could also be used to

fulfill initial requirements under the

interim regulations, so many

technologists presently doing

mammography will have had this

training. Although FDA encourages all

radiologic technologists currently

practicing to include such training as

part of their continuing education, the

agency does not believe that the benefits

of retroactively requiring all present

technologists to receive this training

would outweigh the costs.

(Comment 451). A final comment

suggested that adequate time should be

allotted for the quality assurance/QC

duties.

FDA fully agrees with this comment

but does not believe that this kind of

commitment can be codified through a

regulation. The agency also notes that

the amount of time needed will vary

significantly, in view of the different

situations in different facilities and the

differing abilities of the individual QC

technologists. As discussed in

connection with earlier sections, FDA

believes that owners, operators, and

managers will have new incentives to

ensure that quality assurance programs

are properly implemented and that

these programs meet the Federal

standards with which all facilities must

comply.

g. Quality assurance records

(§ 900.12(d)(2))

The provisions of this paragraph have

been significantly changed from the

proposal. The proposal required that the

facility have a quality assurance manual

covering the procedures to be used in

meeting the requirements of § 900.12(e)

and (f). The manual was to be readily

available to all staff members and

documentation that it was read and

approved by the lead interpreting

physician and the medical physicist was

required. A list of individuals assigned

quality assurance responsibilities and

details of their assignments was also to

be available to all staff members.

Records were to be kept showing that

these individuals were qualified for

their assigned duties. Records were also

to be kept showing the data obtained

during monitoring of the facility

performance, the analysis of the

monitoring data, the problems detected

and corrective actions carried out, and

the effectiveness of the corrective

actions in resolving the problems. The

records were to be kept for each test for

a minimum of 1 year or until the test

had been performed two additional

times at the required frequency,

whichever was longer.

In response to comments received, as

summarized below, and in keeping with

the FDA’s goal of less prescriptive and

more flexible regulations, this paragraph

has been greatly simplified. The final

regulations do not require any

description of the procedures to be

followed in performing the QC tests or

a list of the individuals with quality

assurance responsibilities and their

responsibilities. The proposal requiring

records documenting the qualifications

of these individuals to perform their

duties is changed to simply require that

records be kept concerning employee

qualifications. No review, revision, or

sign-off of the manual is required at any

frequency but there is a general

requirement that the lead interpreting

physician, a QC technologist, and a

medical physicist are to ensure that

records are maintained and updated.

The time that the records of testing and

followup actions must be kept has been

clarified but remains essentially the

same.

The proposal divided the provisions

of § 900.12(d)(2) into four paragraphs, (i)

through (iv). As a result of these

changes, paragraphs are no longer

needed but the comments received on

the proposed four paragraphs will be

discussed, following the general

comments.

h. General comments on quality

assurance records

(Comment 452). One comment

asserted that keeping quality assurance

records was an unnecessary burden but

did not suggest an alternative means by

which a facility could demonstrate that

it had carried out the quality assurance

tests and all necessary followup

activities. A second comment

recommended that mammography

facilities be required to retain written

specifications in a standardized format

from the processor manufacturer.

FDA cannot accept the first of these

comments without an adequate

alternative to keeping records. FDA

agrees there would be value in processor

manufacturers providing specifications

in a standardized format but believes it

would be premature to make this a

requirement. The agency’s previous

attempts to encourage the provision of

processor operating characteristics for

different types of film showed that there

are significant problems to be solved,

among them the very large number of
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55937

possible combinations of film,

chemistry, and processors.

i. Records to be kept (proposed

§ 900.12(d)(2)(i), (ii), and (iii))

(Comment 453). A few comments

were received on the records to be kept.

Three comments opposed the change

from requiring the use of the ACR

manual to allowing the use of whatever

manual best fits the facility’s needs.

FDA believes that the increased

flexibility provided by allowing the use

of manuals other than the ACR manuals

is desirable because it permits facilities

to more rapidly adjust their programs to

incorporate improvements in quality

assurance procedures or new techniques

for new technology. When a manual is

specified in regulations, the regulations

may have to be amended to facilitate use

of even a new edition of that manual, let

alone an improved manual from another

source. To increase flexibility even

further, in the final rule FDA has

dropped the use of the word ‘‘manual’’

altogether because it seemed to imply a

certain format. Facilities will now be

able to keep the required records in any

suitable format.

(Comment 454). A number of

comments recommended addition of

items to the list of those required to be

kept. Six comments suggested adding

technique charts to the required records,

while a seventh suggested adding

documents related to the medical

outcomes audit program. Another

comment stated that documentation for

darkroom cleaning, screens, and view

boxes should not be eliminated.

NMQAAC members pointed out that

there was already a requirement in the

ACR manuals, which were incorporated

into the interim regulations by

reference, that a technique chart be

available. Although there was some

difference of opinion, NMQAAC seemed

to support retaining a requirement for

keeping a technique chart with the

equipment but not necessarily in the

manual. With respect to the quality

assurance manual in general, the view

of NMQAAC seemed to be that elements

required in the final regulations were

‘‘key’’ or ‘‘basic’’ to the success of a

quality assurance program. At least one

NMQAAC member expressed

reservations about the detail required

and would have preferred to limit the

regulation to a general requirement that

there be a quality assurance manual.

However, both this member and a

second member recognized that

enforcement by inspectors would be

difficult without more detailed

requirements.

FDA notes that documentation of

facility cleanliness activities is required

in § 900.12(e)(11). The list of other

records that must be kept, although not

necessarily in a ‘‘manual,’’ has been

revised as discussed previously.

(Comment 455). Other issues that

drew a number of comments were who

should sign off on the manual and how

often should review, revision, and signoff take place. Nine comments

supported having the QC technologist

sign-off in addition to the lead

interpreting physician and

mammography medical physicist. A

tenth comment would limit the

physicist sign-off to only those items

related to his or her responsibility.

Three comments stated that the review,

revision, and sign-off should occur at

least annually. NMQAAC supported

both adding the QC technologist to the

sign-off list and the annual review,

revision, and sign-off.

FDA has replaced the requirement for

a formal sign-off with a general

statement that the lead interpreting

physician, QC technologist, and medical

physician should ensure that the

specified records are kept.

(Comment 456). Another comment

stated that qualifications of the

individuals assigned responsibilities in

the QC program should be kept on

record only if those individuals are not

listed in the facility’s application

(presumably for accreditation).

FDA disagrees with this comment.

The accreditation bodies do not check

the qualifications of personnel to

perform quality assurance tasks during

the accreditation process.

Proposed § 900.12(d)(2)(ii), which

required that a list be kept of the

individuals with quality assurance

assignments and their assignments,

drew only one comment. The comment

supported the list but urged that the

requirement be clarified so it was not

construed to mean that only the listed

individuals could carry out the duties.

As discussed above, FDA has eliminated

this proposed requirement.

The only comment on the proposal for

keeping records of qualifications of

quality assurance personnel,

§ 900.12(d)(2)(iii), suggested that those

records should be kept indefinitely. As

discussed above, FDA has reworded the

requirement slightly. Requirements for

record retention are discussed below.

j. Monitoring performance (proposed

§ 900.12(d)(2)(iv))

As proposed, this provision would

have required facilities to maintain

records related to monitoring of their

facility’s performance for 1 year or until

the tests has been performed two

additional times at the required

frequency, whichever was longer.

(Comment 457). One comment stated

that the words ‘‘for a minimum of 1

year’’ should be replaced with ‘‘from

inspection-to-inspection’’ because

inspections may not occur precisely at

annual intervals. FDA has changed the

wording to ‘‘until the next annual

inspection has been completed and FDA

has determined the facility is in

compliance with the quality assurance

requirements.’’ This change addresses

concerns raised by this comment and

clarifies that an inspection includes the

followup and the actual visit to the

facility.

5. Quality Assurance—Equipment

(§ 900.12(e))

The primary purpose of the

equipment aspects of the quality

assurance program is to prevent

problems with equipment or detect and

correct problems before they can have a

significant effect on clinical image

quality. In order to achieve this

objective, the performance parameters of

the equipment must be tested at

appropriate frequencies, the test results

must be analyzed promptly to determine

if the performance of the equipment is

satisfactory, and any identified problem

must be corrected as soon as possible.

Followup tests must also be conducted

to determine whether the corrective

actions were effective and adequate.

Requirements for the types of

equipment tests to be performed and for

the necessary followup actions were

proposed in § 900.12(e). These

requirements have generally been

retained in the final rule. However, on

the basis of a number of valuable

comments the agency received in

response to its proposals, some

revisions to the proposal have been

made. Many of the revisions have been

made after discussions with NMQAAC.

In addition, tests for radiation output

and decompression have been added to

the annual QC tests as § 900.12(e)(5)(x)

and (xi). The action limits for these tests

were proposed as equipment

specifications in § 900.12(b).

a. General comments on equipment

quality assurance

In the preamble to the proposal (61 FR

14912), FDA specifically requested

comments on the value of a simple daily

total system test based upon the

evaluation of the optical density and

artifacts on an image of a uniform

phantom. The agency believed that the

total system test, when performed in

conjunction with the processor

performance test set forth in

§ 900.12(e)(1), would ensure the overall

quality of X-ray machine and processor

performance and of the films produced.

This test would only takes a few

minutes to perform and records of the

test would enable a medical physicist to
55938 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

quickly detect the source of a problem

when it occurs.

(Comment 458). A large number of

comments opposed the idea of such a

test. Several of these comments,

however, confused this test with the

alternative phantom testing identified

earlier as a possible basis for

performance-based standards (See 61 FR

14860). Some members of NMQAAC

also opposed this test. The agency also

received a number of comments

supporting this test. Several comments

agreed that more frequent phantom

testing in conjunction with daily

processor testing is important.

In view of the mixed comments, FDA

concluded that it should not require the

test until it gathers additional data on its

usefulness. However, FDA strongly

encourages facilities to test their

machines as frequently as possible,

either by a phantom evaluation or by the

total system test.

A number of comments requested that

FDA provide a detailed description of

all QC test procedures. Several

comments wanted FDA to reference

ACR QC manual, while some comments

considered the proposed Quality

Assurance-Equipment requirements to

be appropriate.

FDA notes that § 900.12(e)(1) through

(e)(5) lists the minimum performance

tests to be conducted on screen-film

systems and their required frequency.

Action limits for the tests are also

specified. The agency has refrained from

providing extensive detailed

requirements or prescriptive

descriptions of test procedures, as some

comments recommended, in order to

provide facilities with the flexibility to

use their own judgment as to what

testing methods best enable them to

meet the required criteria. FDA has also

decided not to base its QC requirements

on a single manual and, therefore, no

such manual has been referenced. In

addition, NMQAAC has advised FDA

that the ACR manuals were intended to

be used as guidelines, not in a

prescriptive manner. A facility may

consult any appropriate manual on

agency guidance to meet the

requirements in § 900.12(e)(1) through

(e)(5).

(Comment 459). One comment stated

that some of the tests should be more

rigorous. The comment further

questioned why a monthly visual

checklist was not included.

While conducting regular visual

checks of the equipment is a desirable

practice, it is not an action that can be

confirmed from test data. Therefore, the

agency has decided to encourage this

and similar desirable practices through

educational means instead of making

them regulatory requirements.

(Comment 460). Another comment

stated that FDA should only issue more

stringent requirements if their benefits

clearly exceed their costs.

FDA agrees with this comment and

believes that the tests it has required

meet this criterion.

(Comment 461). One comment stated

that numerous paragraphs refer to films,

optical densities, and processors,

without limiting the requirements to

any specific modality.

FDA notes that the initial words in

each paragraph from § 900.12(e)(1) to

(e)(5) are ‘‘Facilities with screen-films

shall * * *,’’ making it clear what

modality is referred to.

(Comment 462). Another comment

maintained that FDA should require

proper QC tests for stereotactic units.

One comment stated that the quality

assurance standards should include a

requirement to use a digital

mammography evaluation phantom

developed by the author’s company that

has been designed specifically for QC of

digital machines for stereotactic biopsy.

Interventional mammography is

presently exempt from the MQSA

requirements for reasons discussed in

response to the comments on the

definition of mammography in

§ 900.2(y). The agency is in the process

of developing quality standards for

interventional mammography and these

will include QC tests. QC tests for other

mammographic modalities have been

addressed in § 900.12(e)(6).

(Comment 463). Another comment

stated that FDA should provide its

inspectors with more latitude to accept

variations from regular inspection

procedures, if the physicist can

adequately explain the rationale for the

deviations and demonstrate how the

standard is met. From the context, the

agency assumes that the author of the

comment is actually referring to survey

procedures rather than inspection

procedures.

FDA has instructed inspectors to

discuss variations with QC personnel or

medical physicists available in the

facility during inspection. In some

cases, the inspectors, after receiving

satisfactory explanations for variances

in test procedures, have refrained from

giving citations or withdrawn citations

initially given to the facility during

inspection. However, because it is

essential that the evaluations of facility

conformance with the quality standards

be consistent nationwide, the latitude

provided to inspectors necessarily has

to be limited. Moreover, those wishing

to use alternatives to the requirements

of the regulations who can demonstrate

that their alternative provides assurance

of quality mammography equal to the

regulatory requirement, may do so in

accordance with § 900.18.

(Comment 464). A few comments

urged FDA to require testing with all

cassettes wherever that is appropriate.

In the proposed regulations, the

agency proposed that screen speed

uniformity of all cassettes in the facility

be tested. In the final regulations, FDA

added that artifact evaluations should

be performed with all cassettes in the

facility. The agency also considered

requiring performance of the phantom

image quality test with all sizes of image

receptors. However, when FDA staff

members carried out phantom image

evaluations using two different image

receptor and cassette sizes with five

different mammography machines, no

difference was seen in the phantom

image scores when results with larger

image receptors were compared to those

with smaller. NMQAAC strongly

advided FDA not to require weekly

phantom testing for all image receptor

sizes because the members do not

believe that phantom image quality is

affected by receptor size. NMQAAC

pointed out that the ACR manual did

not recommend phantom image

evaluation with large image receptor

sizes. Based on all this information, the

agency concluded that facilities should

not be required to conduct phantom

image quality tests with all available

sizes of image receptors.

b. Daily QC tests—screen-film system

(§ 900.12(e)(1))

The only daily tests required under

the final regulations are those that

ensure adequate processor performance

by assessing base plus fog density, mid

density, and density difference, using

mammography films used clinically at

the facility.

(Comment 465). Five comments stated

that there should be a maximum limit

between time of exposure and time of

processing. NMQAAC discussed this

issue in connection with requirements

for mobile units, for which image

degradation due to delayed processing

is a particular concern. The committee

concluded that, in general, this was not

a significant enough problem to require

a regulatory requirement and FDA

accepted this position.

(Comment 466). Ten comments

suggested the word ‘‘examinations’’

should be replaced with ‘‘films’’ and the

word ‘‘performed’’ with ‘‘processed.’’

The agency agrees with these comments

and has made such changes in the final

regulations.

One comment suggested adding the

words ‘‘and evaluate’’ after ‘‘shall

perform.’’
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55939

FDA notes that § 900.12(e)(8)

generally defines tests for which the

evaluation of test results (and corrective

actions) must be performed before

further examinations are conducted.

The processor tests are among them.

(Comment 467). Several comments

suggested that the last few words in

§ 900.12(e)(8)(ii), ‘‘of no less * * * 1.2

OD, [optical density]’’ should be

deleted. These comments stated that in

some cases, the step averages may turn

out to be lower, for example 1.05, and

that should be acceptable if the next

higher step shows a substantially higher

OD, such as 1.4. Another comment

offered a similar argument, noting that

the proposed rules would not allow the

use of modern high gradient

mammography films where the change

in optical density between adjacent

steps in this density range can be as

high as 0.7.

FDA agrees with these comments and

has deleted ‘‘of no less * * * 1.2 OD’’

in § 900.12(e)(8)(ii).

(Comment 468). One comment stated

that QC measures should be in place for

densitometry and sensitometry

equipment.

FDA requires all sensitometers and

densitometers its inspectors use to be

properly calibrated. If FDA inspectors

detect problems in the processor

performance, the facility will have to

identify the cause. If the cause turns out

to be related to inadequate performance

of the facility’s sensitometry or

densitometry equipment, the effort

required to determine the nature of the

problem will give the facility sufficient

incentive to take actions to avoid a

recurrence without the need for a

regulatory requirement.

(Comment 469). Three comments

asserted that the ± 0.15 OD action limits

for mid-density and density difference

were too restrictive as proposed and

requested changing this limit to allow a

wider range.

Under the interim regulations,

facilities have been required to comply

with this limit and the inspection data

reveal that most facilities are able to do

so. The agency does not find that there

is adequate reason for changing this

limit in the final regulation.

(Comment 470). One comment stated

that a guidance document should be

published to provide a clear explanation

of the scientific basis for establishing an

H&D curve and the importance of

parameters taken from this curve to

monitor trends in processor QC.

FDA believes that this is a widely

accepted practice and the most effective

procedure that is currently available.

Sufficient materials providing the type

of guidance requested already exist.

c. Weekly QC tests—screen-film

system (§ 900.12(e)(2))

In the proposal, the image quality test

using a phantom approved by FDA,

which was required monthly by the

interim regulations, was made a weekly

test.

(Comment 471). Twenty comments

opposed changing the phantom testing

from monthly to weekly, arguing that

the additional cost of performing

phantom image evaluation weekly

would be burdensome to many

facilities. However, a larger number of

comments supported this change, many

indicating that their facility already

performs phantom tests weekly.

FDA is convinced by the experience

of the facilities that have been

performing phantom image evaluation

at a higher frequency that the test

should be performed weekly. The

agency believes that the benefit

outweighs a slight increase in costs. As

noted in the preamble to the proposal,

if the daily total system test had been

required, returning the required

frequency of the image quality test to

monthly could have been justified.

However, because FDA is not mandating

the total system test at this time, it is

essential that all facilities perform

weekly phantom image evaluation as an

overall assessment of all aspects of the

imaging chain.

(Comment 472). Some comments

suggested changing ‘‘image contrast’’ to

‘‘density difference’’ and ‘‘assess density

difference’’ to ‘‘assess image contrast’’ in

§ 900.12(e)(2)(iv).

The agency agrees with these

comments and has revised the wording.

(Comment 473). One comment stated

that the density difference between the

background and the test object needs to

be defined. The comment further stated

that there is presently confusion over

the ACR recommendation for a density

difference of 0.40 at 28 kVp.

FDA notes that, with the changes

made as suggested by the previous

comments, it is clear that the density

difference is measured between the

background and a test object added to

the phantom to assess the image

contrast. The agency has determined

that the regulations should not specify

a number for the operating level for this

density difference, specify the test

objects, or prescribe any technique

factors to achieve the desired operating

level, because all these variables may

change with future changes in

technology. However, FDA considers it

important that facilities make sure that

the measured density does not vary by

more than ± 0.05 from the established

operating level.

(Comment 474). Several comments

considered the requirement of a

minimum 1.20 optical density (OD) at

the center of a phantom image to be

high and believed that many facilities

will not be able to meet that standard.

One comment stated that higher OD is

achieved at the expense of patient dose.

Some comments considered 1.20 OD too

low. One comment recommended that

there be an upper limit of OD. Another

comment stated that OD within ± 0.20

is reasonable if the film manufacturer’s

tolerance is better than 0.3 OD from

batch to batch.

FDA believes that proper OD is vital

to the early detection of micro

calcifications and, with the advent of

new mammography screen-film

systems, an OD of 1.2 with a variation

of no more than 15 percent can be

achieved if the processors and the units

perform properly. NMQAAC also

advised FDA to require that the film OD

at the center of the phantom image be

no less than 1.2 for the purposes of this

test. The agency, however, believes that

a requirement for an upper limit on OD

may hinder any future development of

mammography screen-film systems.

Therefore, the agency will retain

§ 900.12(e)(2)(i) and (ii) as proposed.

(Comment 475). One comment stated

that the point of the image quality test

is to determine constancy; therefore, it

was unnecessary to mandate the

measuring position of optical density as

the center of the image, as long as the

same location is measured each time.

The intention of this requirement is

that the OD be measured at the same

location of the phantom image each

time, as the comment suggested. The

agency believes that the center of the

phantom image is a reasonable and easy

place to locate such measurements.

Further, it is not advisable to measure

OD too far away from the center towards

the anode side of the phantom image in

order to avoid a decrease in density due

to the heel effect. This could lead to a

failure to meet the ≥ 1.2 OD requirement

when it might have been met if

measured at the center of the same

phantom image.

(Comment 476). One comment

recommended that § 900.12(e)(2)(iv), the

phantom image contrast requirement, be

deleted because daily film sensitometry

already measures this parameter.

FDA disagrees. The daily

sensitometry test only uses light that

simulates the screen phosphor

luminescence. However, emitted light

due to X-ray induced fluorescence from

the screen phosphors is different both in

spectral dependance and in intensity

from the light output from the currently

available sensitometry equipment. It is
55940 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

very important that contrast is evaluated

when the film is exposed by the emitted

light from the actual screen phosphors,

induced by the X-ray beam. For this

reason, the daily film sensitometry test

cannot replace this test of image

contrast.

(Comment 477). Several comments

noted that the current phantoms are not

tissue equivalent and recommended that

FDA specify only one type of phantom

and minimum acceptable performance

criteria. A related comment urged FDA

to provide guidance to establish the

adequacy of image quality. Another

comment requested specification of the

test object and measurement conditions

for phantom evaluation.

FDA has refrained from specifying

phantom or test object type,

performance criteria, or scoring

methodology in order not to inhibit

future advances in phantom technology.

The agency continues to believe that

accreditation bodies should establish

phantom specifications and related

performance criteria. However, as part

of its responsibilities for accreditation

body approval and oversight, FDA will

examine each body’s phantom

specification and performance

requirements, which will have to be

substantially the same among the

different accreditation bodies.

d. Quarterly QC tests (§ 900.12(e)(3))

Two QC tests were required to be

performed quarterly in the proposal.

These were a test of the fixer retention

in film and the repeat analysis.

e. Fixer retention in film

(§ 900.12(e)(3)(i))

This test determines the quantity of

residual fixer in processed film, which

is an indicator of insufficient washing.

Insufficient washing may have a

considerable adverse effect on image

quality.

(Comment 478). One comment

believed that the fixer retention test

should be a semiannual test.

FDA notes that quarterly performance

was recommended by the ACR manuals

and required under the interim

regulations. The agency believes that it

is generally accepted that facilities

should perform this test quarterly and

has retained the frequency requirement

of this test as proposed.

f. Repeat analysis (§ 900.12(e)(3)(ii))

Facilities must perform this test

quarterly with repeated and rejected

films. If the repeat or reject rate,

calculated as a percentage of the total

films included in the analysis, changes

by more than 2 percentage points from

the rate determined the previous

quarter, the cause of the change must be

identified. (For example, if the repeat

rate the previous quarter was 4 percent

and this quarter it is 7 percent, the cause

of the change must be identified. If the

repeat rate this quarter is 6 percent, no

further action is needed.)

(Comment 479). A few comments

suggested changing ‘‘repeat’’ to ‘‘reject.’’

One comment stated that it might be

more appropriate to simply refer to

repeat rate change, rather than repeat or

reject rate change.

FDA believes that while the repeat

rate is perhaps the better indicator of

unnecessary radiation exposure in the

facility, the reject rate gives a better

picture of the image quality situation.

Both rates give useful information and

should be calculated.

(Comment 480). Some comments

recommended that FDA define repeat

and reject to ensure that all but

nonclinical films are analyzed. Several

comments requested FDA to clarify that

films repeated to correct positioning

should be included in the repeat

analysis. FDA believes that it is current

practice that all repeated films are

included in the repeat analysis,

regardless of the cause of such repeats,

and so a regulation mandating this

practice is not needed.

Other comments expressed opinions

on the most desirable frequency of the

repeat analysis. One comment suggested

that all repeats be evaluated and

corrective action be taken when

possible. Several comments

recommended monthly repeat analysis

and stated that this test would be less

useful if it were done quarterly. Another

comment urged monthly repeat analysis

with 400 films. Another stated that the

current method of repeat analysis every

3 months was sufficient.

FDA believes that low volume

facilities would not have sufficient

numbers to conduct a meaningful

analysis if the required frequency is

increased. Similarly, if the minimum

number of films is set too high, the time

period required to collect them in a low

volume facility will be so great that

problems could go undetected for a

significant period of time. FDA,

therefore, has left the required

frequency as quarterly and has not

specified a minimum number of films to

be included in the analysis. The agency

notes that nothing in the regulations

would preclude a high volume facility

from performing the analysis at an

increased frequency and with as many

films as it wished.

(Comment 481). Several comments

urged FDA to include an acceptable

limit of repeat rate in the regulations,

some suggesting that it be 2 to 5 percent.

Two comments wanted FDA to require

corrective action to lower the observed

repeat rate.

FDA again notes that, while most of

these comments referred to ‘‘repeat’’

analysis, an analysis of both the

repeated and the rejected films is

required. In response to these

comments, FDA observes that it has

long been recognized that the parameter

with the greatest impact on the repeat or

reject rate is the subjective opinion of

the physicians doing the interpreting as

to what is acceptable. As noted in the

preamble to the proposal (see 61 FR

14860), the repeat or reject rate could be

reduced by a facility through acceptance

of lower quality films. Any range or

maximum value for repeat or reject rate

that was established as acceptable

through a regulation thus could quickly

be rendered meaningless as an indicator

of acceptable facility performance by

such action. Consequently, the agency

believes that, while it is important to

keep the repeat or reject rate low, it is

more important and useful to assess the

cause of any change (increase or

decrease) in the repeat or reject rate

from the previously determined value.

Therefore, the agency has retained the

proposed requirement that the cause of

a variance of more than 2 percent from

the value previously determined must

be properly assessed and recorded.

In looking for the cause of the change,

the agency strongly advises facilities to

assess all the factors that can affect

repeat or reject rate. These can include

personnel ability and preferences,

changes in personnel, or variance in

machines, processors, films, or

chemistry performance.

(Comment 482). Some comments

asked why a decrease of 2 percent

requires action.

FDA notes, that while it may appear

that a decrease in repeat or reject rate is

a desired goal and should not require

further assessments of the results, this is

not necessarily so. For example, if a

facility added a mobile unit to its

operations, the interpreting physician

might feel a subtle pressure to interpret

films taken with that unit that he or she

might normally reject because of the

greater difficulty in scheduling repeat

examinations at mobile units. This

practice could lead to a reduction in the

repeat or reject rate that does not

necessarily indicate an improvement in

quality. Therefore, the agency believes

that the cause of either an increase or a

decrease of more than 2 percent from

the value previously calculated must be

determined and any corrective actions

should be recorded and assessed.

(Comment 483). A few comments

stated that repeat analysis for each

technologist should be evaluated and

followup studies should be

standardized. One comment wanted
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55941

such analysis performed for each

machine used in the facility.

The agency supports the idea that

analysis of the repeat rate for each

technologist, radiologist, and/or

machine can be valuable. However,

many facilities with a sufficient volume

for a meaningful analysis of their total

operation would not have a sufficient

volume for meaningful analysis of each

technologist, interpreting physician, or

machine. For this reason, FDA does not

believe that a separate analysis for each

technologist, interpreting physician, and

machine should be a regulatory

requirement. However, the agency

recommends that each facility consider

whether such analysis would be useful

in its particular situation.

(Comment 484). One comment urged

FDA to provide more guidance, either in

a guidance document or by reference to

the ACR QC Manuals, as to criteria for

repeat and reject rate evaluation and

corrective action. Another comment

stated that this section needs to be

elaborated to specify the frequency at

which this test needs to be performed

both for large and small volume

facilities, guidelines about whether the

analysis should be site- or technologistspecific, and acceptable repeat or reject

rates. FDA notes that it has provided

guidance for establishing an effective

repeat and reject analysis program in the

past and may provide additional

information in the future. However, the

agency believes that, as repeat or retake

analysis has been an established

procedure in radiology for 20 years or

more, abundant guidance is also

available from other sources. As stated

previously, the agency in the final

regulation will not reference any

manual in order to provide the QC

technologists and the medical physicists

with flexibility to design their own

analysis, recording, and corrective

action procedures.

g. Semi-annual QC tests

(§ 900.12(e)(4))

The proposal included requirements

for semiannual tests of darkroom fog,

screen-film contact, and compression.

The test of darkroom fog in

§ 900.12(e)(4)(i) is intended to be

performed to identify light sources in

the darkroom that can cause significant

mammographic film fogging.

(Comment 485). One comment

supported § 900.12(e)(4)(i) as written.

The comment further stated that

retaining the paragraph as proposed

would eliminate variables for inspectors

when performing this test. Several

comments urged that certain test

conditions be required, such as: ‘‘Carry

out the test under clinical conditions,

with or without the safelight;’’ ‘‘use

previously sensitized film;’’ or ‘‘place

the test film on the counter top or on the

processor feed tray (if not covered),

whichever is closer to a safe light that

remains on when the film enters the

processor.’’ Several other comments

recommended adding words such as

‘‘emulsion side up’’ or ‘‘where the

mammography film is usually handled’’

at specified points in the requirement.

After discussions with NMQAAC,

FDA concluded that the comments did

not provide a basis for amending the

provision. The agency has retained

§ 900.12(e)(4)(i) as proposed, except that

the words ‘‘emulsion side up’’ have

been added for clarification. The agency

will provide information on test

procedures, as some comments

requested, separately. Each facility can

design its own procedures to meet the

generally accepted features of an

adequate darkroom fog test.

(Comment 486). A number of

comments suggested requiring the

darkroom fog test after any change in

the darkroom that could result in an

increase in the amount of fog.

FDA agrees that many changes in the

darkroom could produce darkroom fog

but it also believes that it is difficult to

specify which changes will lead to

increased film fogging. The agency has

left it to the judgment of the facility as

to which changes may lead to increased

film fogging and thus warrant an

additional darkroom fog test.

(Comment 487). One comment

recommended that the acceptable value

of darkroom fog be raised to 0.10 OD

and believed that 60 percent of facilities

will not be able to pass the test as

written.

FDA does not agree that the majority

of facilities will not be able to meet the

required acceptable level of dark room

fogging within 0.05 OD. This

requirement is currently in effect under

the interim regulations and the agency’s

inspection data indicate that most

facilities are in compliance with this

requirement.

(Comment 488). One comment urged

FDA to require a clearly written

procedure that ensures that the

darkroom tests are performed using

mammography films.

The agency considers this a good

practice and recommends that facilities

adopt such procedures. However, FDA

does not believe that this requires a

regulation.

The screen-film contact test in

§ 900.12(e)(4)(ii) is intended to ensure

that proper contact is maintained

between the screen and film in each

cassette used in the facility for

mammography.

(Comment 489). Several comments

noted that the material of the 40 mesh

screen used for the test was not

specified and suggested that it be copper

or a material with an atomic number

similar to copper.

FDA agrees with these comments and

has specified the requirement of 40

mesh copper screen in the final

regulation. It has also clarified that all

cassettes used in the facility for

mammography must be tested.

(Comment 490). Two comments

asserted that a minimum background

density needs to be specified for the

screen-film contact test, with one of

these stating that it should be 0.60 to

0.85 so that the films are not

underexposed leading to false readings.

One comment wanted acceptance levels

to be prescribed in some detail, while

another comment stated that additional

information was needed as to what

constitutes an adequate screen-film

contact test result. Two comments

suggested the following criterion:

‘‘Areas greater than 1 cm are not

acceptable, five or more areas less than

1 cm are acceptable.’’

FDA considers this test very

important. A 40 mesh copper screen

provides adequate resolution and

contrast with a mammography film

when exposed to a proper density.

However, evaluations of these test

results can be subjective and cannot be

verified against a quantified acceptance

level. Therefore, the agency cannot

prescribe a numerical value of

acceptance level in the regulation, as

some comments suggested, because it

would not be readily enforceable. FDA

notes, however, that it does not agree

with the comment that stated that five

or more areas of poor contact with a size

smaller than 1 cm are acceptable. The

agency intends to provide further

information on this test. The agency also

notes that advice is also available in

most QC manuals.

Compression testing is required to

ensure that a mammographic system

provides adequate compression and, at

the same time that the equipment does

not allow dangerous levels of

compression to be applied. In the

proposal, FDA required the compression

device to meet specifications described

in § 900.12(b)(12)(i) and, in accordance

with § 900.12(e)(4)(iii), to be tested

semi-annually to see if the

specifications continue to be met. After

further consideration, the agency

determined that in the final rule it

would be more appropriate to treat the

compression forces as performance

outcomes rather than equipment

specifications. As a result, the standards

for the amount of the compression force
55942 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

have been transferred from § 900.12(b)

to § 900.12(e)(4)(iii). The comments

received on this aspect of proposed

§ 900.12(b)(12)(i) are discussed at this

point with the related comments

received on § 900.12(e)(4)(iii).

(Comment 491). A number of

comments stated that some of the

characteristics of the compression

system described in § 900.12(b)(12)(i)

did not need semiannual QC testing.

FDA agrees with these comments and,

in the final regulation under

§ 900.12(e)(4)(iii), has required that only

the compression force be tested.

Under § 900.12(b)(12)(i)(c) FDA

proposed that, 5 years after publication,

the compression device shall provide a

maximum compression from the power

drive between 111 newtons (25 pounds)

and 200 newtons (45 pounds).

(Comment 492). Several comments

urged FDA to make the compression

force requirement in the power drive

mode effective immediately, not 5 years

from publication as proposed. On the

other hand, one comment disagreed

with the April 1996, recommendation of

NMQAAC that the proposed

requirements be implemented 1 year

after the publication of the final rules.

One manufacturer stated that this

requirement would affect approximately

2,000 of their units in the field and

noted that it would be impossible to

upgrade many of these units to the full

25 pounds. Additionally, the retrofit kit

is likely to be very expensive and not

welcomed by users who find a

precompression force of 17 pounds

adequate when accompanied with

appropriate manual compression.

Although NMQAAC did recommend

making the requirement effective 1 year

after publication at its April 1996

meeting, they reversed that position in

January 1997 after considering the

possible cost of the action. The agency

has thus retained in the final rule at

§ 900.12(e)(4)(iii), the requirement of

compression force in power drive mode

5 years from the date of publication, as

proposed in § 900.12(b)(12)(i)(c).

FDA, however, also considers it

important that all mammography

machines used currently provide

adequate compression force. Under the

interim regulations, facilities are

required to use equipment that provides

a minimum compression of 111

newtons. The agency is continuing to

require this minimum compression

force. In case of machines where such

force is not available in power drive

mode, the facilities may use the manual

compression to attain this minimum

compression requirement. However, 5

years after the publication of the final

rule, all machines must provide a

maximum compression force in power

drive mode of between 111 newtons (25

pounds) and 200 newtons (45 pounds).

h. Annual QC tests (§ 900.12(e)(5))

Section 900.12(e)(5)(i) through (xi)

lists a number of tests a facility must

perform annually. Action limits for the

test results are specified, except for the

system artifacts (§ 900.12(e)(5)(ix)) and

decompression (§ 900.12(e)(5)(xi)) tests;

the nature of these do not allow the

agency to provide any quantified

acceptance level. The tests described in

§ 900.12(e)(5)(i) through (ix) were

proposed as QC tests. The tests in

§ 900.12(e)(5)(i)(x) and (xi) have been

moved from § 900.12(b) of the proposal

after FDA concluded that they are more

performance than specification oriented

and, therefore, are more appropriately

located in § 900.12(e) in the equipment

quality assurance section of the final

regulation.

(Comment 493). One comment stated

that the regulation should require these

tests to be done by a qualified medical

physicist. FDA notes that this

requirement already appears at

§ 900.12(e)(9), which requires that these

tests be done as part of the facility

survey and further requires that the

survey be performed by a qualified

medical physicist.

Two comments questioned why the

proposed requirements under

§ 900.12(e)(5) established testing limits

different from those used by the

accreditation body. The comments

claimed that these ‘‘discrepancies’’ will

hinder compliance. FDA believes that

the authors of these comments are

mistaken. The agency assumes that by

‘‘testing limits,’’ the comments are

referring to action limits. FDA notes that

the action limits of § 900.12(e)(5) are the

same as those in the ACR manuals, and

thus, the same as those the facilities and

the accreditation bodies are using under

the interim regulations.

The automatic exposure control (AEC)

test in § 900.12(e)(5)(i) measures several

parameters of the AEC system.

The first action limit specified for the

AEC is that it shall be capable of

maintaining the film optical density

within ± 0.30 of the mean optical

density as the phantom thickness and

kVp are varied in § 900.12(e)(5)(i)(A).

(Comment 494). Some comments

wanted a definition of ‘‘Mean Optical

Density.’’

FDA notes that such a definition was

provided in § 900.2(w) of the proposal,

now § 900.2(ee) in the final regulation.

(Comment 495). Other comments

asked FDA to specify the type of

phantom needed for this test or asked if

the same phantom used for the image

quality test is required. A related

comment stated that the test blocks used

by the physicists should be specified to

be 15 x 15 mm homogeneous material,

in order to ensure an even scatter

pattern or distribution that would not be

affected by the position of the AEC and

inhomogeneous scatter. The comment

suggested that phantoms made up of

either acrylic or BR12 can be used.

Another comment wanted the test

details and acceptance levels to be

prescribed.

The agency requires the thickness of

the phantom to be varied from 2 to 6

cm. These thicknesses are currently

required under the interim regulation

and the facilities may use any

homogeneous material of appropriate

thicknesses that will provide a film OD

of no less than 1.2 at the center of the

image. The agency has previously

discussed its rationale for not providing

detailed test procedures.

(Comment 496). One comment

requested FDA to clarify whether testing

is required with all available

thicknesses and kVp’s. FDA has

changed the wording in the final

regulation to clarify that AEC tracking is

required only for phantom thickness

varied over a range of 2 to 6 cm and for

kVp’s varied appropriately for such

thicknesses over the kVp range used

clinically.

Proposed § 900.12(e)(5)(i)(C)

established an alternative to proposed

§ 900.12(e)(5)(i)(A) by allowing the

development of a technique chart of

kVp and density control settings to

ensure that the film optical density

requirements of § 900.12(e)(5)(i)(A)

would be met in cases where it could

not be done directly by AEC.

(Comment 497). Two comments stated

that a technique chart should be

required for all machines under all

situations. Two others stated that the

proposal created a loophole for the AEC

equipment specification requirements

proposed in § 900.12(b)(15)(vii)(A). One

comment asked if a technique chart

would be acceptable in the year 2000

when all machines are expected to meet

the ± 0.3 OD variance requirement. One

comment suggested eliminating the

option of using a technique chart.

The agency has combined the

provision permitting the use of a

technique chart with § 900.12(e)(5)(i)(A)

in the final rule. After consideration of

the comments, FDA has decided to

permit the use of a technique chart to

meet the ± 0.3 OD variance requirement

only for 5 years after the publication of

the final regulation. After 5 years, the

AEC equipment must meet the ± 0.30

OD variance requirement directly.

FDA has moved a provision proposed

as an equipment requirement in
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55943

§ 900.12(b)(15)(vii)(B) to the quality

assurance paragraph as

§ 900.12(e)(5)(i)(B). As explained earlier,

the move was made because this

provision was more appropriately

located with the QC performance tests

than with the equipment specifications.

This provision requires, effective 5 years

from the publication of this regulation,

that the film optical density be

maintained within ± 0.15 of the mean

optical density at the appropriate kVpthickness combination. Use of the

technique chart to compensate for

inadequacies in the AEC will no longer

be permitted after that date.

(Comment 498). In response to the

original proposal in

§ 900.12(b)(15)(vii)(B), one comment

requested that FDA clarify whether

compensation steps using a technique

chart will be allowed. The comment

also stated that ± 0.15 OD criteria can

not be met if the film manufacturers

allow 0.3 OD variation from one film

batch no another.

As noted in the previous paragraph,

FDA will permit the use of a technique

chart to compensate for inadequacies in

the AEC for 5 years after the publication

of the final rule; after that time the

technique chart can no longer be used

as an aid in maintaining the film optical

density within ± 0.15 of the mean

optical density at the appropriate kVpthickness combination. The agency also

advises facilities to use films from the

same batch so that film variability, if

any, is not introduced while testing AEC

performance. Because film variability

can be eliminated as a source of bias in

the AEC performance test, there is no

justification for increasing the AEC

actions limit to ± 0.30 OD because that

would simply mean that the facility

would have to contend with variability

of ± 0.30 from the film and another ±

0.30 from the AEC.

(Comment 499). Two comments stated

that the proposed requirement was too

lenient, while two others believed that

it was too restrictive. Three comments

supported the proposed requirement.

FDA believes, after discussion with

NMQAAC, that it is reasonable to

require that the ± 0.15 OD limit be met

by all units 5 years after publication of

the final rule. The agency believes that

the cost to meet this requirement will be

minimized by the fact that, by the end

of this period, many of the units unable

to meet the ± 0.15 OD requirement will

have been replaced by facilities on their

normal replacement schedules. The

agency does not believe it has any basis

to require a tighter limit than ± 0.15 OD.

Section 900.12(e)(5)(i)(C) (proposed

§ 900.12(e)(5)(i)(B)) proposed that the

operating OD be no less than 1.20.

(Comment 500). Several comments

suggested deleting the word

‘‘operating.’’ One comment requested

the definition of ‘‘Operating OD.’’

FDA agrees that the word operating

should be deleted. This requirement is

now moved to § 900.12(e)(5)(i)(C) in the

final rule.

One comment urged FDA to require a

mean optical density of at least 1.3 OD.

FDA notes that the regulation allows

facilities to use a higher film OD if they

believe that will make the test a better

indicator of the ability to detect microcalcifications and will aid in improving

image quality. However, the agency

does not consider it necessary at this

time to require any higher OD. The

agency also notes that NMQAAC

advised FDA to retain the 1.2 OD

requirement as proposed.

The annual test in § 900.12(e)(5)(ii)

tracks the kilovoltage accuracy and

reproducibility.

(Comment 501). A large number of

comments stated that kVp accuracy

should be within 5 percent instead of

the proposed ± 10 percent.

The agency is persuaded by these

comments and has made the change in

the final regulation.

(Comment 502). One comment

questioned the justification of a very

tight coefficient of variation for the kVp

reproducibility.

FDA believes that the coefficient of

variation of a given set of kilovoltage

measurements should be less than 0.02,

as was proposed. This is the standard

presently required under the interim

regulations and most facilities are

currently in compliance with it; there is

no justification for relaxing the

standard, either from the point of view

of public health or a cost consideration.

(Comment 503). Several public

comments and a member of NMQAAC

expressed concern that one widely used

kVp testing instrument does not read

below 23 kV, while kilovoltage settings

as low as 21 or 22 kVp are sometime

used. A few comments suggested

requiring kVp testing at two clinical

setting values. One comment stated that

§ 900.12(e)(5)(ii)(B), as written, could be

interpreted to mean kVp reproducibility

should be measured from 25 to 30 kVp

in 0.5 kVp increments. Another

comment stated that it should be

acceptable to test kVp reproducibility in

just one setting within the clinical

range.

In response to these comments, FDA

has revised the final regulation to

require that the lowest kVp at which

accuracy be tested is the lowest clinical

used kVp that can be measured by a kVp

test device. The agency, however,

disagrees with the comments that

recommend testing kVp at one or two

clinical settings only. FDA considers it

important to test kVp accuracy at least

at the highest and lowest measurable

clinically used values, and at the

facility’s most commonly used clinical

kVp. The agency, however, has

modified the regulation to require that

the coefficient of variation of

reproducibility be determined at the

most commonly used kVp only.

One comment claimed that the kVp

accuracy requirement should be

checked with all focal spots. The agency

has no reason to believe this is

necessary.

The focal spot condition (proposed as

system resolution) test in

§ 900.12(e)(5)(iii) was proposed to

evaluate the performance of the

mammography unit by assessing the

resolution capability of the system.

(Comment 504–505). A few comments

stated that some mammography

machines could not meet the proposed

resolution requirement even though the

focal spot size was adequate. One

comment maintained that the line pair

resolution requirement was too

restrictive. A member of NMQAAC

stated that, in magnification

mammography, the resolution

requirement would be difficult to meet.

These comments suggested that the

focal spot size measurement be added as

an alternative requirement, as is the

current practice under the interim

regulation. Two other comments also

urged FDA to continue to permit focal

spot dimension measurements as part of

acceptance tests for mammography

equipment evaluation. One comment

supported replacing focal spot

measurement with performance related

specifications of system resolution.

FDA considered the immediate

economic impact on facilities of meeting

the resolution requirement as proposed

and decided to permit continued use of

the focal spot size measurement as an

alternative to the measurement of

system resolution for a period of 5 years

from the publication of the final

regulation. During this period, facilities

may evaluate the condition of the

mammography unit by determining

either the system resolution, proposed

as § 900.12(e)(5)(iii) (new

§ 900.12(e)(iii)(5)(A)), or the focal spot

dimensions as described in

§ 900.12(e)(5)(iii)(B). The agency

believes that by the end of this period,

when the regulation will require the

evaluation of system resolution only,

many of the units unable to pass the

system resolution test will have been

replaced by the facility on its normal

replacement schedule.
55944 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

The agency believes the benefits of

assessing overall performance of the

system through use of the system

resolution test justify their transition.

NMQAAC also advised FDA to require

the system resolution test.

(Comment 506). One comment

suggested that FDA should only require

that the resolution shall be sufficient so

that the system can detect microcalcifications of 300 μm and greater

sizes.

FDA notes that available scientific

data indicate that 50 μm resolution is

necessary in mammography imaging for

early and proper detection of microcalcifications. This is equivalent to

about 10 cycles (lp)/mm resolution

when the bar pattern is used. The

agency believes that all new equipment

meets this requirement as proposed.

Under the interim regulation, this

criterion is already being met by the

facilities which chose to evaluate focal

spots by assessing system resolution.

Further, NMQAAC advised FDA to

adopt such a requirement in the final

regulation. For these reasons, the agency

did not accept the comment.

(Comment 507). A member of

NMQAAC advised FDA that the units

should be specified in SI units and

suggested using ‘‘ycles/mm’’ in place of

‘‘ine pairs/mm.’’ One comment stated

that the height of the line-pair test

pattern above the image receptor must

be specified in association with the

resolution limits and suggested that the

height should be 4.5 cm. Other

comments requested clarification of

‘‘parallel’’ and ‘‘perpendicular’’ to the

axis in terms of the bars of a test pattern

whose orientation was being described.

Three comments urged that test

specifications be included in the

regulations.

In response to these comments, FDA

has added a new § 900.12(e)(5)(iii)(A) to

specify that the high contrast resolution

bar patterns must be placed 4.5 cm

above the breast support surface and be

oriented parallel and perpendicular to

the anode-cathode axis. FDA has also

introduced cycles/mm as the primary

unit.

(Comment 508). One comment asked

at what magnification the system is

required to resolve 11 and 13 lp/mm.

Another comment suggested that the

tests should be performed at all

magnifications used. Two comments

urged FDA to require focal spot

assessment for all focal spot sizes. One

comment suggested that the system

resolution should be tested with the grid

in use. One comment suggested that the

grid should not be in the imaging chain

during magnification.

FDA reiterates that 5 years from the

date of publication of the final rule, all

facilities must perform the system

resolution test annually and must meet

the requirements specified in

§ 900.12(e)(5)(iii)(A)(1), both in contact

mode and in all magnification

mammography modes used in the

facility. The agency believes that if a

machine can meet the requirements

using the large focal spot size used in

contact mode, it will meet the

requirements using the small focal spot

size also. The agency also believes that

the resolution test must be conducted

under the normal operating condition,

that is, for contact mammography the

resolution assessment must be

performed with the grid in place

whereas for magnification

mammography, the grids should be

removed. The agency intends to provide

more discussion about these procedures

in educational documents.

(Comment 509). Two comments stated

that the line-pair minimum should be

increased.

FDA believes that the present values

are generally accepted as representing

the best cost/benefit compromise.

(Comment 510). One comment

recommended requiring a monthly

phantom test with indicators of what

should be expected in resolution

capabilities at a given magnification to

ensure adequate performance between

physicist surveys. The comment also

recommended that the system

resolution in magnification mode be

monitored to determine whether it

diminishes with time.

Although it encourages facilities to

carry out this type of performance-based

study, FDA does not believe there is

adequate evidence to show that these

additional tests would produce benefits

that outweigh the costs facilities would

incur in performing them. Therefore, at

this time, the agency is not including

them in the regulation.

The beam quality and half-value layer

(HVL) paragraph as proposed in

§ 900.12(e)(5)(iv), required the HVL to

meet the specifications provided in

§ 900.12(b)(11). Two comments stated

that the exact specifications should be

included under § 900.12(e)(5)(iv), rather

than merely by reference. Two

comments suggested that the upper HVL

limits described in the 1994 ACR QC

Manual should also be included and

that HVL limits should be specified for

other target filter combinations.

In the final rule, FDA has specified

HVL requirements only in

§ 900.12(e)(5)(iv). The specifications for

kVp’s in the mammographic range are

provided in a tabulated form. Values not

shown in the table may be determined

by linear interpolation or extrapolation.

NMQAAC members were unable to

reach a consensus on the value of

having an upper limit of HVL or on

what the upper limit should be. FDA

views this as an indication that there is

a general lack of consensus on this topic

in the mammography community and,

therefore, the agency has decided not to

include any upper limit in the

regulation.

The breast entrance exposure and

AEC reproducibility paragraph, as

proposed in § 900.12(e)(5)(v),

established the action limit for the

coefficient of variation of these two

variables at 0.05.

(Comment 511). Three comments

suggested deleting the breast entrance

exposure requirement, while another

considered it to be an equipment

standard. This last comment further

stated that lack of AEC reproducibility

will be identified by other QC tests and

the phantom image. Another comment

inquired whether it was the intent of the

provision to require facilities to

calculate exposure reproducibility for

data points consisting of mR divided by

mAs, or to separately measure the

reproducibility of exposure and mAs.

FDA believes that this test must be

performed at least annually and that the

coefficient of variation must be

calculated for both exposure and mAs.

If a unit does not indicate a postexposure mAs value, then mAs should

be obtained by a secondary method. In

accordance with the movement towards

the use of SI units discussed in

connection with the new definition of

air kerma (§ 900.2(d)), the agency has

also introduced air kerma as the primary

quantity to be measured in this test.

Breast entrance exposure remains as an

alternative quantity.

The dosimetry test in

§ 900.12(e)(5)(vi) determines the mean

glandular dose delivered during a single

cranio-caudal view using an FDA

approved phantom simulating a

standard breast. When the mean

glandular dose exceeds 3.0 mGy,

corrective action is required.

(Comment 512). A number of

comments were received on the

specifications for the phantom to be

used in performing this test. Some

comments stated that most facilities are

using phantoms simulating a 4.5 cm

breast and it would not be cost effective

to change to phantoms simulating a 4.2

cm breast. One comment suggested that

FDA should recognize that most

technique charts are set using whole

number thicknesses, arguing that 4.0 cm

is probably the most reasonable. One

comment stated that ACR phantoms are

not tissue equivalent phantoms.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55945

Another comment stated that, to date,

most dose data had been set using the

RMI accreditation phantom. The

comment questioned its actual tissue

equivalence and further stated that dose

standards should be set using a

phantom that correlates as closely as

possible to actual thickness.

In the preamble to the proposal (61 FR

14912), FDA solicited comments about

actual thickness that the existing

phantoms simulate. FDA did not receive

enough evidence in response to this

question to convince the agency that the

existing phantoms simulate a 4.0 cm

compressed breast more closely than

they simulate a 4.2 cm compressed

breast, which is the figure currently

used. The agency, therefore, continues

to require that the dose should be

determined under the assumption that

the phantom simulates a 4.2 cm

compressed breast and that the

technique factors should be chosen

accordingly. FDA did not propose, nor

has it required in the final rules, any

change in the phantoms currently being

used. As stated earlier, the agency

believes that accreditation bodies

should establish phantom specifications

and related performance criteria. In the

future, if better tissue equivalent

phantoms are available to simulate a

different compressed breast thickness

that can change dose calculations

significantly, the agency will revise the

thickness requirement for average dose

calculation. FDA also notes that a

change from 4.2 cm to 4.0 in thickness

does not result in a significant change

in the calculated dose.

(Comment 513). One comment stated

that calculation of the entrance dose to

the phantom is not necessary if kVp,

HVL, and mAs for the exposure are

within limits. Another comment stated

that, because the existing image quality

phantom simulates a 4.2 cm compressed

breast, not 4.5 cm, the dose limit could

be lowered. One comment stated that

the regulations should not allow any

dose less than 0.8 mGy, while another

comment stated that there is no reason

for accepting 300 mrad as a maximum

mean glandular dose because, even at 25

kVp, the typical mean glandular dose is

120–150 mrad (1.2–1.5 mGy). This

comment recommended setting the dose

limit at 250 mrad (2.5 mGy). Another

comment recommended that FDA

consider lowering the patient dose

requirements to that of the State of

California requirement.

FDA strongly believes that a proper

dose calculation at least once a year for

each unit is critical for public health

and safety. FDA further believes that the

present dose limit of 3.0 mGy provides

adequate protection from unnecessary

radiation and does not want to change

the dose limit to 2.5 mGy or establish

a lower limit of 0.8 mGy, in order to

avoid the possibility of inhibiting future

advances in imaging technology, as

discussed in the preamble to the

proposal (61 FR 14912).

(Comment 514). One comment

suggested that the phantom kVp and

mAs must be compared to the average

of 20 or more 4.2 cm clinical breast

mammograms to ensure that the

measured glandular dose is consistent

with patient radiation doses.

In response to this comment, the

agency notes that the dose must be

determined with technique factors and

conditions used clinically for a standard

breast. The agency understands that, for

some facilities, commonly used

technique factors may be slightly

different from what would be technique

factors for a standard size breast and

therefore different from what would be

used for the available phantom, which

simulates a standard breast. However,

the agency does not believe that dose

will vary so significantly that it will

exceed the required limit of 0.3 mGy in

cases of patients with non standard

breast size, as long as the mammography

unit is capable of meeting the dose

requirement using a phantom

simulating a standard breast.

(Comment 515). Two comments urged

FDA to require that the time of exposure

be less than or equal to 2.5 seconds.

FDA did not accept this comment

because the agency believes that it does

not have enough evidence to confirm

that 2.5 seconds is the absolute

maximum exposure time needed to

cover all patient sizes. The agency

recommends that facilities determine

the proper exposure time for their needs

through consultation with the medical

physicists and the equipment

manufacturers.

The requirements for X-ray field/light

field/image receptor/compression

paddle alignment in § 900.12(e)(5)(vii)

are intended to ensure that: (1) All

systems have beam limitation devices

that prevent the patients from receiving

unnecessary radiation dose, permit

imaging of the critical breast tissue near

the chest wall, and avoid white borders

on the film; (2) if a light field is

provided, the congruence of the light

field with the X-ray field should be such

that the sum of misalignments on

opposite sides between X-ray field and

light field is within 2 percent of the SID;

and (3) the alignment of the edge of the

compression paddle with the chest wall

edge of the image receptor is sufficient

to permit pulling the breast tissue away

from the chest wall for imaging and to

keep the shadow of the vertical edge of

the paddle from being visible on the

image. The test also ensures that the

extension of the edge of the paddle is

within 1 percent of the SID so that the

patient’s chest is not pushed away from

the breast support surface.

(Comment 516). One comment stated

that § 900.12(e)(5)(vii) should include

exact specifications rather than just a

reference to those specifications in

§ 900.12(b)(5). One comment argued that

confinement of the X-ray field within

the image receptor cuts off useful film

area and misses some of the breast

tissue. The comment further suggested

that this requirement should be changed

so that the X-ray field can extend

slightly beyond the edges of the image

receptor in order to make full use of the

film area and not potentially miss any

breast tissue that is overlying the image

receptor, and to blacken what would be

an otherwise clear border.

In the final regulation, FDA has

moved the X-ray field/light field/image

receptor/compression paddle alignment

specifications to § 900.12(e)(5)(vii). FDA

notes that § 1020.31(f)(3), which the

agency referenced in the proposal,

allows extension beyond the chest wall

edge of the image receptor by as much

as 2 percent of the SID so as to properly

image breast tissue on the chest wall

side. In the final rule, the agency allows

extension of the X-ray field beyond all

edges of the image receptor but limits

this extension to within 2 percent of the

SID.

(Comment 517). Two comments

suggested that the term ‘‘image

receptor’’ should be defined. In the

agency’s earlier discussion of the

definitions, the agency has referenced

§ 1020.31 as providing a definition of

image receptor.

(Comment 518). One comment stated

that the requirement for a light field in

this section imposes an unwarranted

expense.

FDA notes that a light field is not

required but if one is present, it must

meet the light field-X-ray field

alignment requirement.

(Comment 519). One comment urged

FDA to consider relaxing the

requirement for the alignment of the

compression paddle and the breast

support surface. One comment

questioned whether limiting the

extension of the compression paddle

beyond the image receptor to within 1

percent of SID is achievable in all units.

Another comment suggested that this

requirement be written to more

accurately reflect the need to extend

past the edge of the image receptor,

although by no more than 1 percent of

the SID. Three comments stated that it

appeared from the proposed regulation
55946 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

that it was permissible for the

compression paddle to be visualized on

the mammography film.

FDA believes that the one percent

extension limitation can be achieved

and notes that the current requirement

under the interim regulations is one

percent. The agency has also clarified

the final rule to emphasize that the

shadow of the compression paddle shall

not be visible on the image.

(Comment 520). One comment

requested clarification on whether the

reference was intended to be with

respect to a vertical line or with respect

to a line connecting the focal spot and

edge of the image receptor when the

requirement that the chest wall edge of

the compression paddle not extend

beyond the chest wall edge of the image

receptor by more than one percent of

SID is being met.

(Comment 521). One comment

suggested that FDA specify whether this

requirement is with respect to the

interior surface of the paddle or the

exterior surface. The comment,

however, acknowledged that this is not

an important issue with a 1 or 2 mm

paddle thickness.

FDA disagrees with comments that

suggest including all these details in the

regulation. However, the agency wishes

to clarify that the reference is the

vertical line and the requirement refers

to the interior surface of the paddle.

One comment stated that this

requirement should be met with all

image receptors. FDA notes that the

regulation as written requires this test to

be performed for all full-field aperture

sizes used for beam limitation in the

facility; this will ensure that all image

receptors meet the requirement.

The screen speed uniformity test, as

proposed in § 900.12(e)(5)(viii), requires

that at least once a year, each facility

must ensure the consistency of the

screen speed among all cassettes used in

the facility for mammography. The same

test is required currently at the same

frequency under the interim regulation.

(Comment 522). One comment stated

that § 900.12(e)(5)(viii) did not allow for

slow and fast screen variations due to

large and small screens having different

relative speeds. Another comment

suggested that the maximum optical

density difference should be reduced to

0.15.

FDA believes that the difference

between the screen speeds of all

cassettes, small or large, should be such

that the OD variation is within 0.3 OD.

The agency, however, does not believe

that tightening the restriction on density

difference to 0.15 is justified. Members

of NMQAAC supported this view.

One comment requested FDA to

describe the test procedure to be used.

As discussed earlier, FDA made a

general decision to refrain from

describing specific test procedures for

QC tests in the regulations. The agency

will include a more detailed description

of some tests in its guidance document.

System artifacts in § 900.12(e)(5)(ix)

mean artifacts produced by any part of

the mammographic system, including

the X-ray machine, screen-film system,

and/or processors. This subparagraph

requires the facility to determine the

level and possible adverse effects of

artifacts produced by its systems. These

artifacts should be distinguished from

the patient related artifacts.

(Comment 523). One comment stated

that the evaluation should be done for

all full-field image receptor sizes.

FDA agrees and has added this

requirement to the final regulation.

(Comment 524). One comment

recommended elimination of this test

because the physicists always watch for

artifacts whenever a film is taken.

FDA strongly believes that a separate

test solely meant for artifact evaluation

is necessary. Further, this test should

also evaluate the whole imaging chain

for the source of any artifacts detected.

(Comment 525). One comment stated

that the test can also be done with a

smaller phantom positioned closer to

the collimator. As advised by

NMQAAC, FDA proposed that artifacts

should be evaluated through the use of

a test object of high grade defect-free

material that is large enough to cover

the mammography cassette.

FDA notes the intent in requiring an

object of this size is to capture and

identify artifacts that are caused

anywhere in the cassette and its screenfilm combination. In this way, the

quality of the entire film can be better

assured. FDA understands that there

may be other ways of accomplishing

this goal, such as the method suggested

in the comment, but the agency lacks

data to confirm that the suggested

procedure will produce equivalent

results. The agency notes that the

alternative requirement mechanism of

§ 900.18 provides a way by which

alternatives to the requirements can be

evaluated, and possibly accepted, by

FDA.

(Comment 526). One comment stated

that more guidance should be provided

on evaluating artifacts. One comment

wanted the test details and acceptance

levels prescribed.

Again, FDA has decided that test

details are subjects more appropriately

addressed separately from the

regulations. The agency also notes that

the acceptance level for artifacts is at

present a subjective assessment and not

amenable to the establishment of

specific numerical standards.

(Comment 527). One respondent

believed that testing X-ray systems for

artifacts does not require the use of a

test object. Another comment stated that

use of a thick (4 cm) acrylic test object

will harden the beam to the point that

it will mask grid and/or carbon fiber

cover artifacts and may even mask grid

lines.

FDA disagrees. The agency believes

that an exposure time sufficient to

image appreciable artifacts may not be

achieved if a test object is not used,

while these artifacts would be visible

during a normal patient exposure.

FDA has moved the radiation output

requirement from § 900.12(b)(15) to

§ 900.12(e)(5)(x) because it concluded

that it was more appropriate to treat this

test as an annual QC test rather than an

equipment specification. This test is

intended to determine if the

mammographic system is capable of

producing a minimum required output.

Five years from the publication of the

final rule, the requirement will change

to require a higher output from each

system.

(Comment 528). Two members of

NMQAAC opposed this requirement as

an annual test. One member stated that

a 3-second field test of the unit may

cause damage to the tube. The same

NMQAAC member further stated that

averaging the results over a 3-second

exposure time would not reveal whether

the output rate dropped unacceptably

low at any time during the exposure.

FDA does not have evidence

indicating that any significant

fluctuation in exposure takes place

within an exposure time of the order of

3 seconds. However, the agency has

revised this requirement in

§ 900.12(e)(5)(x)(B) from that originally

proposed in § 900.12(b)(14) to clarify

that no instantaneous radiation output

requirement is intended; instead, the

requirement is the output averaged over

a 3-second period. Also, because the

exposure times can be lengthy for some

patients, the agency does not consider 3-

second exposure time unreasonable.

The agency also considers a yearly

check of radiation output important and

reasonable.

i. QC tests—other modalities

(§ 900.12(e)(6))

This provision requires facilities

using image receptor modalities other

than screen-film to establish a quality

assurance program that is substantially

the same as that recommended by the

image receptor manufacturer, except

that the maximum allowable dose is not

allowed to exceed that established in
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55947

§ 900.12(e)(5)(vi) for screen-film

systems.

No public comments were received on

this paragraph and it has been codified

as proposed.

j. Mobile units (§ 900.12(e)(7))

This provision requires

mammography units used at more than

one location to meet all of the quality

assurance requirements established in

§ 900.12(e)(1) through (e)(5). In addition,

at each visit at each examination

location, before any additional

examinations are conducted, the facility

is required to verify the performance of

such units using an adequate test

method.

(Comment 529). Three comments

supported the additional testing of

mobile units. One of these noted that

the many environments in which the

units operate made the testing

necessary. Six comments opposed the

additional testing. The most common

reasons given for the opposition was

concern about being able to process the

test images before mammography is

performed and that the additional

testing was unnecessary because moving

the unit did not create any problems.

When the need for additional testing

of mobile units was discussed at the

NMQAAC meeting of September 1994,

it was noted that a recent ACR survey

of facilities operating mobile units had

found that about one in seven facilities

reported quality problems with their

mobile units at least weekly. Largely

based on this information, NMQAAC

recommended that postmove,

preexamination testing of mobile units

be included in the final regulations.

NMQAAC continued to support this

proposed requirement at its January

1997 meeting.

FDA agrees that no change should be

made to the proposal. The agency

further notes that several of the

opposing comments based their concern

upon the difficulty of processing

phantom images at the mobile site.

However, the final regulation does not

require the use of any specific test, only

that the test method be able to verify

that adequate image quality is being

produced by the unit. This gives the

facility the option of using other tests

that do not require processing of images

before examinations are conducted, as

long as the test can demonstrate that

adequate image quality is likely to be

achieved. One such test, based on the

consistency of mAs readings, was

described by a speaker at the September

1994 NMQAAC meeting.

(Comment 530). Five comments

expressed concern about the fact that

acceptable testing methods were not

specified in the regulations. Three of

these comments asked who a facility

should consult to determine if its test

method would be considered adequate

by FDA. Related comments on this issue

asked how inspectors would determine

adequacy without guidance and noted

that the State of Massachusetts left it to

the medical physicist to determine what

test method should be used. One

comment urged that a test based on the

mAs reading be considered acceptable,

while another stated the performance

test required by the State of Illinois

should be recognized by FDA.

FDA plans to issue information

describing test methods that it is likely

to consider acceptable for verification of

performance of mobile units after a

move and before examinations are

conducted. It is expected that at least

one of these methods will not require

the processing of images before the

examinations begin. Because these

methods will not be regulatory

requirements, FDA may accept other

test methods proposed by facilities,

medical physicists, or other interested

parties. Facilities are always free to

discuss any particular method with FDA

prior to establishing its use.

(Comment 531). One comment

opposed allowing central film

processing for mobile services out of

concern for degradation of the latent

image during the time between exposure

and development.

This issue was discussed at some

length at two NMQAAC meetings and

the conclusion was that this degradation

would not be significant during the

typical times between exposure and

development of mobile facility images.

FDA, therefore, has not prohibited

central processing.

(Comment 532). One comment stated

that if diagnostic imaging is done at a

mobile facility, a radiologist should be

present. Practice of medicine issues

have made it difficult to define the

distinction between screening and

diagnostic mammography. Because of

this difficulty, FDA has issued the final

regulations to apply to all

mammography, rather than addressing

specific requirements to one area or the

other.

k. Use of test results (§ 900.12(e)(8))

The provisions of this proposed

paragraph were intended to ensure that

the facility did not stop with the

performance of the quality assurance

tests but analyzed the results of the tests

to determine if problems existed and

took necessary actions to correct those

problems. Ongoing anecdotal evidence

and the MQSA inspection data indicate

that, even 20 years after the introduction

of the concepts of quality assurance,

some facilities are still neglecting to take

the important final steps in the process.

Section 900.12(e)(8)(i), as proposed,

requires facilities to compare the results

of their quality assurance tests with

action limits specified in § 900.12(e)(1)

through (e)(6) and, if their results fall

outside the action limits, to repeat the

tests immediately to verify that the

testing process was not responsible for

the result.

(Comment 533). Thirteen comments

opposed, at least in part, the

requirement to repeat the tests

immediately. Some of these comments

urged that it be applied only to the

processor QC, screen-film contact, and

average glandular dose tests. Two

comments supported exempting annual

tests. Four of the comments stated that

the decision about what tests should be

repeated should be left to the medical

physicist. NMQAAC recommended

complete deletion of the proposed

requirement that the tests be repeated

immediately. One comment took the

opposite view, stating that this

requirement helps facilities identify

trends.

FDA notes that this requirement was

originally added to ensure that the

facility confirmed whether the problem

was due to the equipment rather than an

improperly performed test before it

went to the trouble and expense of

taking corrective actions. However, the

agency has been persuaded that a

facility that goes to unnecessary expense

to correct an equipment problem that

was actually a testing problem is likely

to take steps on its own to avoid

repetition of such a situation. In view of

that conclusion, and the public

comments, the requirement to repeat the

test has been deleted from the final

regulations.

Section 900.12(e)(8)(ii), as proposed,

stated that if the repeated tests continue

to produce unacceptable results, the

problem shall be identified and

corrected before any further

examinations are performed.

(Comment 534). Seven comments

stated that this provision, as proposed,

was too broad and that at least in some

cases it would not be necessary to shut

down the entire facility until the

problem was solved. Other comments

gave the views of their authors as to

which tests, if failed, indicated

problems serious enough to require the

facility to stop doing mammography

until the problem was solved. The most

frequently mentioned tests in this

category were the processor QC tests of

§ 900.12(e)(1) and the average glandular

dose test of § 900.12(e)(5)(vi), each of

which was listed by 13 comments.
55948 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

(Comment 535). Seven comments

included the image quality test of

§ 900.12(e)(2) and six each, the screenfilm contact test of § 900.12(e)(4)(ii), the

compression test of § 900.12(e)(4)(iii),

the tests for modalities that did not use

screen-film of § 900.12(e)(6), and the

additional test for mobile units of

§ 900.12(7) on their lists of tests

important enough that their failure

required problem detection and

correction before mammography

continued. The system resolution test of

§ 900.12(e)(5)(iii) was listed in five

comments. One comment each also

would include the artifact test of

§ 900.12(e)(5)(ix) (if there were

‘‘serious’’ artifacts), the kVp test of

§ 900.12(e)(5)(ii), and tests of output and

the phototimer (if the errors were

‘‘large’’) on the list.

NMQAAC as a group supported the

requirement that the problem must be

corrected before mammography

continues only in the cases of the

processor QC tests, the average

glandular dose test, and the screen-film

contact test. However, the medical

physicists serving as committee

members and consultants for NMQAAC,

when discussing specific tests in their

individual comments, presented

somewhat different and conflicting

views. They agreed that the processor

QC and the average glandular dose tests

were of sufficient importance that, if

they were failed, the facility should

cease doing mammography until the

problem was corrected. They also

supported adding the image quality test

to that list. Opinions of these physicists

were split on whether the screen-film

contact test, the automatic exposure

control tests of § 900.12(e)(5)(i), the

breast entrance exposure and AEC

reproducibility test of § 900.12(e)(5)(v),

the tests for modalities other than

screen-film, and the additional test for

mobile units should be considered

important enough that their failure

would require problem correction before

mammography continued.

After consideration of the comments,

FDA agrees that not all test failures are

serious enough to require the facility to

cease doing mammography until the

source of the problem is corrected. The

agency also agrees with two additional

comments that stated that, even if the

test failure does indicate a problem that

requires immediate correction, it may

not be necessary to shut down the entire

facility. For example, if the processor

QC tests are failed, it may be possible

to continue to perform mammography,

but to delay processing the films until

the processor problem is corrected, as

long as the anticipated processing delay

is not of such duration that image

degradation becomes a concern.

Similarly, if the facility has more than

one mammography unit, the failure of

one unit would not be a reason for

stopping the use of another unit that did

pass the tests.

In response to these considerations,

FDA has revised § 900.12(e)(8)(ii) by

dividing the tests into two groups.

Those tests listed in § 900.12(e)(8)(ii)(A)

are those whose failure requires

immediate problem evaluation and

correction. However, the wording has

been changed to state that the corrective

actions must be taken ‘‘before any

further examinations are performed or

any films are processed using the

component of the mammography system

that failed the test’’ (emphasis added). If

the failure is related to a component for

which there is no alternative, for

example, a failure of the facility’s only

mammography unit, then the facility

will still have to cease doing

mammography until the problem is

corrected. However, if there is another

unit or processor that has passed the

tests, the facility will be able to continue

producing and processing mammograms

with that equipment while the problem

with the first unit is corrected.

Included in § 900.12(e)(8)(ii)(A) are

the processor QC tests (§ 900.12(e)(1))

and the average glandular dose test

(§ 900.12(e)(5)(vi), both of which

everyone who commented on this

paragraph agreed were important

enough that their failure required

evaluation and correction of the

problem before the piece of equipment

was used for further mammography.

FDA has also included the image quality

test (§ 900.12(e)(2)) in this group, even

though it was mentioned in fewer

comments. The importance of this test

is underscored by the fact that the

primary goal of the MQSA is to ensure

adequate quality mammography for all

women. The agency has also included

the additional test for mobile units

(§ 900.12(e)(7)) because it is a test that

directly evaluates image quality.

FDA has also included the tests for

nonscreen-film modalities

(§ 900.12(e)(6)) on this list. This

particular provision was intended to

facilitate the introduction of new

modalities because it ensures that

facilities using the new modality will

have an adequate quality assurance

program, while at the same time not

requiring amendment of the

requirements of § 900.12(e) before the

new modality can be used. Because it is

not possible to predict in advance what

new modalities may appear and what

QC tests may be required for them, FDA

believes they must be placed in

§ 900.12(e)(8)(ii)(A) to adequately

protect the public. Should it prove to be

the case that some or all of the tests that

are applicable to the new modality

might more appropriately be placed in

§ 900.12(e)(8)(ii)(B), regulatory relief can

be provided through the alternative

requirements mechanism of § 900.18

until § 900.12(e)(8)(ii) can be amended.

FDA has also agreed with comments

urging that the screen-film contact test

(§ 900.12(e)(4)(ii)) and the compression

test (§ 900.12(e)(4)(iii)) be placed on the

list of those tests whose failure should

require taking a piece of equipment out

of service until the problem is detected

and corrected. The agency notes that the

new wording referred to above means

that failure of the first of these tests only

requires taking the cassette in question

out of service and, as one comment

pointed out, the corrective action most

likely will simply be replacement of the

cassette. The compression test is

included out of concerns raised by both

anecdotal accounts and reports to FDA’s

Medical Device Reporting System of

injuries resulting from excessive

compression and the knowledge that

inadequate compression can lead to

poor quality images.

Finally, FDA retained the darkroom

fog test (§ 900.12(e)(4)(i)) on this list,

even though it was not mentioned by

any of the comments. FDA has

concluded from studies, such as the

Nationwide Evaluation of X-ray Trends

program of the Conference of Radiation

Control Program Directors, that

excessive darkroom fog is more

pervasive and has a greater impact on

image quality than is commonly

realized. The agency also notes that the

detection and correction of the problems

contributing to darkroom fog is a

relatively uncomplicated process and

can be carried out relatively rapidly.

Often the problem is associated with the

safelight and simply discontinuing use

of the safelight until it can be replaced

or repaired may provide a temporary

correction that would permit returning

the darkroom to service.

FDA has placed all other tests under

§ 900.12(e)(8)(ii)(B). These are tests

whose failure indicates that there are

problems that must be corrected, but, for

various reasons are not considered to

present a health hazard serious enough

to require taking a piece of equipment

out of use until the problem is

corrected. Retake analysis is included in

this group (§ 900.12(e)(3)(ii)). In this

case, mammography must be allowed to

continue to determine if the corrective

action has indeed had the desired effect

on retake rate. Also in this group are

tests such as kVp accuracy

(§ 900.12(e)(5)(ii)) and alignment

(§ 900.12(e)(5)(vii)), for which, as one of
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55949

the NMQAAC physicists argued, there

are compensation methods that can be

used as temporary corrective actions

until the problem can be given a more

permanent correction. Other tests

included in this group, such as the

system resolution test

(§ 900.12(e)(5)(iii)—called the focal spot

condition test in the final regulations)

are early warning tests that give an

indication of possible approaching

problems. In the case of the system

resolution test, FDA has accepted the

argument of the NMQAAC physicist

who believed that, unless the system

resolution was so poor as to lead to

failure also of the image quality test,

some time could be permitted for the

correction of the resolution problem. Of

course, if the image quality test is failed,

the piece of equipment will be taken out

of service until the problem is corrected.

Finally, this group includes the artifact

test (§ 900.12(e)(xi)), for which there are

no objective action limits against which

to compare the test results.

Although problems revealed by the

tests in the second group are not

considered serious enough to take a

piece of equipment out of service until

corrected, FDA believes that they must

not be allowed to exist indefinitely.

Therefore, § 900.12(e)(8)(ii)(B) requires

that when tests in this group are failed,

the problems must be evaluated and

corrected within 30 days.

l. Surveys (§ 900.12(e)(9))

This paragraph required that a facility

survey be performed by a medical

physicist no less often than once a year.

The tests and reviews that, at a

minimum, were to be included in the

survey were specified along with

requirements that the medical physicist

provide a survey report to the facility

within 30 days of the survey.

Identification of those who performed

the survey was to be provided in the

report.

(Comment 536). Two comments were

received on § 900.12(e)(9)(i), which

specified that the surveys should be

conducted annually. One comment

indicated confusion about the

requirement by stating that an annual

FDA inspection was not needed if a

certified physicist conducted biannual

surveys. The other comment asked that

the requirement be modified to allow

the annual surveys to take place in a

year plus or minus a reasonable period.

FDA notes that an inspection is not a

survey but rather is a check by an

independent authority on how well the

facility is meeting the requirements. An

inspection and a survey serve different

functions and are both required under

the MQSA. Furthermore, the inspection

does not duplicate the physicist’s work.

The inspection involves conducting

only the tests that provide the most

general picture of the equipment

performance but also includes review of

other aspects of the facilities

performance such as personnel

qualifications and reporting and

recordkeeping practices, which are not

considered by the physicist during the

survey. Recognizing the unique

characteristics of both the survey and

the inspection, and the benefits of

multiple oversight mechanisms,

Congress required that each be

conducted annually. Performance of

more frequent surveys, semi-annually,

e.g., does not eliminate the need for

inspections. FDA has retained the

requirement for an annual survey in

accordance with 42 U.S.C.

263b(e)(1)(B)(iv). This requirement does

not prohibit the facility from having a

survey more frequently if it wishes. In

response to the second comment, FDA

notes that it has exercised its

enforcement discretion under the

interim regulations, and intends to

continue to do so under the final

regulations, to permit short periods of

additional time beyond 12 months for

the facility to obtain a survey under

certain circumstances. The agency has

done so in recognition of the difficulty

that facilities that rely on contract

physicists have in scheduling surveys.

However, this exercise of enforcement

discretion in a particular year is not

intended to set a pattern that will permit

facilities to impemissibly lengthen the

timeframes between surveys to longer

than annually.

(Comment 537). Several comments

were received on the survey report

required under § 900.12(e)(9)(iii). One

comment recommended that a standard

physicist report format should be

required to facilitate review. Another

stated that there should be provision for

identification of units if the facility has

more than one unit or has installed a

new unit in an old room. A third

comment stated that the report should

include the calibration dates of the

exposure measuring instruments.

FDA recognizes the advantages of a

standardized report and in the past has

encouraged the use of the report format

recommended in the ACR quality

assurance manuals. This format

includes provision for identification of

the unit being evaluated; such

information has been and will continue

to be implicitly required, because

without it, the facility is unable to prove

that a particular unit was included in

the survey. FDA also believes that there

has been a move towards

standardization under the interim

regulations because reports that

inadequately provide the information

needed during inspections have created

extra work for facilities and physicists

who must provide the information. This

has led to improvements in later reports.

However, while there are advantages to

a standardized report, FDA also

recognizes the need to allow flexibility

in this respect to cover special

situations and to permit the use of

individual initiative in developing

improved formats. The agency

concludes, therefore, that it is both

unnecessary and needlessly restrictive

to require a specific report format by

regulation.

Because the calibration requirement

for exposure measuring instruments

(§ 900.12(e)(12)) is a new requirement,

this information has not been checked

during inspections under the interim

regulations. Because it is now a

requirement under the final regulations,

FDA expects that, in most cases, this

information will be included in the

survey report and that there is no need

for a specific regulation requiring it to

be there. However, if the facility wishes

to provide the information in some

other format, it will have the flexibility

to do so.

(Comment 538). Four comments were

related to the requirement of

§ 900.12(e)(9)(iv) that the report be

provided to the facility within 30 days

of the survey. One comment suggested

shortening the interval to 2 weeks.

Another stated that Massachusetts had

found that a requirement that the

facility’s lead interpreting physician

sign the report within 30 days had been

effective in ensuring that the findings of

the medical physicist were

implemented. A third comment

proposed that the deficiencies noted by

the medical physicist be corrected

within 1 month. The fourth comment

urged that if the report is not received

within 30 days, the facility be required

to take the equipment out of service.

This, it was believed, would stimulate

the physicist to be timely.

FDA believes that a shorter time

period would be unreasonable in

situations where contract physicists

might do several surveys in a several

day trip before returning to his or her

office to complete the reports. The

agency also believes that it is common

practice that before leaving the facility,

the physicist gives a preliminary report

to the facility staff, which would

include identifying conditions that

require prompt action. The new

provisions of § 900.12(e)(8), which

require correction of certain serious test

failures before the failed equipment is

used for further examinations, will

further stimulate the provision of
55950 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

preliminary reports. The agency

continues to believe, therefore, that the

30-day timeframe is reasonable. With

respect to the second and third

comments, the agency believes that the

new § 900.12(e)(8) adequately ensures

that the more serious failures are

corrected before the equipment is used

again and that all identified problems

are corrected within 30 days. A separate

requirement is not needed here. With

respect to the fourth comment, FDA

believes that there is already sufficient

incentive for the facility to make sure it

receives its report within the 30 days

without need for the drastic action

suggested.

(Comment 539). The last comment on

this paragraph endorsed the

requirement in § 900.12(e)(v), that not

only the physicist, but anyone who is

performing part of the survey under the

physicist’s direct supervision be

identified.

FDA retained this requirement when

the regulations were codified.

m. Mammography equipment

evaluations (§ 900.12(e)(10))

FDA proposed this provision to

resolve several somewhat conflicting

concerns. The basic goal was to ensure

that newly installed equipment or

equipment that had undergone major

changes is tested for adequate

performance by a qualified person

before the equipment is used for

examinations. However, this goal had to

be achieved within the statutory

limitations that provide for the issuance

of provisional certificates prior to the

completion of the survey and that

require review of QC data as part of the

survey. Such data cannot be generated

unless the unit is in clinical use (42

U.S.C. 263b(c)(2)). The agency was also

concerned about the costs that might be

incurred by a facility that required two

visits by the physicist, one visit for the

original equipment check and the

second for the full survey. There was

also concern about the possibility of

reduced access attributable to delays in

putting the equipment into use due to

inability to arrange for a visit by a

physicist for some period of time.

Proposed § 900.12(e)(10) was an

attempt to balance these conflicting

concerns by requiring a mammography

equipment evaluation of units or

processors that were either new or had

undergone major changes before those

units were put to use in performing

examinations. The evaluations were to

be done by a qualified person, who

could be a physicist or could be another

individual, such as an installer or

manufacturer’s representative, and any

problems found were to be corrected

before the equipment was used

clinically.

(Comment 540). One comment

supported this paragraph as written, but

27 comments opposed allowing anyone

but a medical physicist who met the

requirements of § 900.12(a)(3) to

perform the mammography equipment

evaluation. NMQAAC also supported

requiring that the physicist perform this

evaluation.

In view of these comments, FDA has

changed the wording to limit the

performance of the mammography

equipment evaluation to a medical

physicist or someone under the direct

supervision of a medical physicist. As

noted above, this may mean a delay of

some weeks in the use of the equipment

at some facilities until a medical

physicist can be scheduled for the

evaluation. However, the agency has

been persuaded by the unanimity of the

public comments and the advice of

NMQAAC that the benefits of having a

medical physicist perform the

evaluation outweighs the disadvantage

of a possible delay. The agency also

notes that by planning ahead, the

facility may be able to minimize this

delay.

(Comment 541). Several comments

addressed the issue of the content of the

mammography equipment evaluation.

Two comments urged that this be a

complete survey but a third noted that

the equipment would have to be in use

for a period of time before the complete

evaluation could be done. Four other

comments suggested some specific tests

to be included in the evaluation, but

two more comments recommended

leaving the decision about necessary

testing to the person doing the testing.

As noted above, the MQSA provisions

relating to provisional certificates and

the physical impossibility of checking

QC data before the equipment is put

into use preclude the possibility that the

mammography equipment evaluation

can be the full survey required by the

statute. Although the agency agrees that

it may be beneficial to do a variety of

tests at the time of the equipment

evaluation, it does not intend to

designate particular tests in the

regulations. The revised provision

simply requires that the evaluations

determine if the new or changed

equipment meets the applicable

requirements of § 900.12(b) and (e),

thereby focusing on the primary public

health concern, which is to establish

that units are not put into clinical use

without proper testing. This more

general wording, the agency believes,

also eliminates the need to consider

processors and mammography units

separately with respect to this

evaluation, as suggested by six

comments.

Related to the content of the

mammography equipment evaluation is

FDA’s concern, mentioned earlier, about

the expense to the facility if two

physicist visits are required, one for a

mammography equipment evaluation

and another, later, for the survey. The

agency’s original efforts to reduce costs

was its proposal to permit the

mammography equipment evaluation to

be performed by qualified individuals

other than physicists. The revised final

regulations eliminate this possibility. In

a different approach to limiting costs to

the facility, FDA plans to permit the

initial survey of the new or changed

equipment to be done in two stages. The

first stage, the mammography

equipment evaluation, will obviously

require a facility visit by the physicist.

If the facility and physicist can

cooperate to produce adequate

documents, FDA will permit the second

stage, the review of the QC data after it

is available, to be done by mail.

Presumably, this will cost the facility

less than two onsite visits to the facility

by the physicist. The agency stresses

that this two-stage process is intended

to help contain costs associated with a

facility’s initial survey of new or

changed equipment and is entirely

optional and within the discretion of the

facility and its physicist. The agency

will require subsequent annual surveys

of that equipment to be done at one time

through an onsite visit.

The proposal required a

mammography equipment evaluation

for new equipment and also after major

components of the equipment were

changed. FDA specifically asked for

comments on what should be

considered to be ‘‘major components’’

but received relatively few responses.

(Comment 542). One comment

suggested processor rollers in the case of

the processor. For the X-ray unit, two

comments suggested the X-ray tube and

one of these went on to add the bucky,

the screen-film system, and the phototiming system. Two comments also

suggested changes in the ventilation

system because such changes can cause

major artifact problems. Another

comment simply suggested that repairs

by service personnel should require

testing.

FDA found these suggestions useful

and will take them into account in

determining what constitutes a major

component. With respect to the

regulations themselves, in view of the

limited number of comments, the

agency decided to continue to keep the

wording general.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55951

(Comment 543). One comment

opposed the entire idea of a

mammography equipment evaluation

before the equipment was put into use,

stating that it would only increase the

cost of installation. Another comment,

however, strongly supported the

correction of all problems before any

equipment was put into use. FDA agrees

that there will be some cost associated

with mammography equipment

evaluations, but believes that the

dangers inherit in permitting the use of

untested equipment in patient

examinations more than justifies this

requirement. Therefore, the agency has

retained the requirement in the final

rules and clarified that the evaluation is

also required for new and reassembled

equipment, or whenever a major

component is changed or repaired.

n. Facility cleanliness (§ 900.12(e)(11))

This proposed paragraph required the

facility to establish and implement

protocols for maintaining darkroom,

screen, and view box cleanliness and to

document that the protocols were

followed.

(Comment 544). Six comments

stressed the importance of darkroom,

screen, and view box cleanliness,

primarily because of the likelihood that

dirty conditions will lead to artifacts.

Three comments took the opposite

position, stating that the section should

be deleted due to lack of evidence of a

hazard. Seven comments urged FDA to

go further and establish protocols for

cleaning in the regulations. On the other

hand, 13 identical comments questioned

whether it would be possible for FDA to

establish regulations on cleanliness.

FDA believes that proper standards of

cleanliness contribute to quality

mammography; e.g., they do reduce

undesirable effects associated with

artifacts. However, as the agency stated

in the preamble to the proposed

regulations, there are a variety of

cleaning protocols and a variety of

circumstances affecting the cleaning

needs of a facility. FDA continues to

believe that facilities must be given the

flexibility to establish cleaning

protocols that best fit their needs. The

presence and use of such protocols can

easily be determined during inspections

and their effectiveness, or lack thereof,

will be demonstrated by the results of

the QC tests, such as the artifact test.

(Comment 545). Six comments stated

that FDA was paying attention to

disinfecting the equipment but not to

screen cleanliness, apparently a

reference to § 900.12(e)(13), discussed

below.

FDA disagrees with these comments

and believes that adequate attention has

been paid to both areas. The agency also

notes that the infection control

requirements will also address the

concerns raised by the comment, which

stated that cleanliness requirements for

bucky and compression paddle and

examination room cleanliness should be

added.

o. Calibration of air kerma (exposure)

measuring instruments (§ 900.12(e)(12))

This paragraph, as proposed, required

calibration of the instruments used by

medical physicists in their annual

surveys to measure exposure, at least

annually. Ten years after publication of

the regulation, additional requirements

would have to be met by those doing the

calibration.

(Comment 546). Numerous comments

urged FDA to change the required

frequency of calibration to once every 2

years. A few comments opposed the

requirement entirely, while others

suggested calibration more frequently

than annually. In response to these

comments, FDA changed the required

frequency to once every 2 years as a

normal practice, but also retained the

requirement for calibration after a repair

of the instrument.

As discussed in connection with the

definitions of kerma and air kerma, the

agency has also introduced the quantity

of air kerma into this rule in accordance

with the move towards use of SI units.

Also in accordance with the agency cost

concerns discussed earlier, the

requirements proposed in

§ 900.12(e)(12)(ii) to be phased-in over

10 years have been eliminated.

p. Infection control (§ 900.12(e)(13))

This paragraph was proposed in

recognition of the fact that, while

transfer of disease caused by blood

borne pathogens during mammography

has never been reported, it is

theoretically possible. Therefore, the

agency concluded that appropriate

precautions should be taken. Because

FDA believes that this concern is not

unique to mammography, it did not

propose specific requirements for

mammography equipment but stated

instead that the facility should follow

the general requirements for infection

control related to medical devices.

(Comment 547). Seven comments

opposed this requirement. Reasons

given included that it was redundant,

unnecessary, and time-consuming;

would create needless paperwork; and

did not deal with a radiation control

problem. Two comments, however,

urged additional measures, such as

requiring informed consent and the use

of protective covers. Another comment

warned that any material placed

between the breast and the image

receptor would cause increased dose

and degradation of image quality.

FDA believes that the comments do

not provide convincing arguments for a

change in the agency’s position in either

direction. The agency continues to

believe that at least a theoretical

concern about disease transmission

exists and that the best way to deal with

this concern is to address it as part of

infection control procedures to be

followed during the use of medical

devices in general.

6. Quality Assurance-Mammography

Medical Outcomes Audit (§ 900.12(f))

This paragraph requires that every

mammography facility establish and

maintain a mammography medical

outcomes audit program for followup on

mammographic assessments and

correlation of pathology results with the

interpreting physician’s

recommendations. This program should

be designed to ensure the reliability,

validity, and accuracy of interpretation

of mammograms.

a. General comments on medical

outcomes audit

(Comment 548). A single comment

was received on the general difficulty in

conducting a medical outcomes audit

faced by facilities that rely on contract

interpreting physicians. Specifically, the

comment noted that there would be a

higher potential for bias in medical

outcomes audits conducted for small

facilities that employed a relatively

greater number of interpreting

physicians.

FDA disagrees that the use of a

number of contract interpreting

radiologists will necessarily result in

biases in medical outcomes data. Data

should be calculated both for the

aggregate facility data base of patients

and again for each interpreting

physician. Because the data are to be

calculated for individual physicians,

any particular set of data that represents

unusual or anomalous results will be

readily identified and additional

calculations can be performed by the

facility to project average outcomes

without that outlying data. The benefit

of tracking these results, therefore,

includes the ability to identify problems

and find trends. The facility will be

required to designate a reviewing

interpreting physician to review these

data and to notify all interpreting

physicians, including contract

interpreting radiologists, of both

aggregate and individual results. Such

analyses may require followup actions,

which are to be documented by the

reviewing interpreting physician.

b. Confidentiality

The issue of maintaining

confidentiality of medical outcomes

audit information collected by the
55952 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

facility during its mammography

medical outcomes audit was a highly

controversial area and generated a

diverse number of comments. Five

comments stated that FDA should

collect audit results and publish the

information in aggregate form for the

public’s information. Two additional

comments argued that interpreting

physician performance data should be

made available to any third party or

examinee.

On the other hand, 25 comments

urged that FDA ensure confidentiality of

medical outcomes audit data either

through Federal legislation or under the

MQSA. Thirteen comments sought to

protect the data by making it available

only for internal purposes and

restricting its submission to FDA and

other agencies. One respondent

expressed concerns relating to the use of

data by third parties, such as facilities,

radiologists, and patients. The comment

went on to say that, in the instance of

a law suit, all such information would

be subpoenaed. Five comments stated

that due to lack of common definitions

and public understanding of the

statistics most likely to be captured in

the medical outcomes audit, such data

should not be made available to any

person not affiliated with the facility.

Nine other comments agreed that

medical audit data should not be shared

with others outside the facility, even

though they agreed that valuable use

can be made of the medical audit within

the facility in assessing the accuracy of

interpretations. Two comments argued

that, unless false negative cases are

required to be included in the medical

outcomes audit and also protected from

discovery, there will be incentives to

conduct poor quality audits. Finally,

one comment stated that medical

outcomes audit requirements inevitably

will increase third-party requests for

medical audit data in order to select

providers.

FDA recognizes the very sensitive

nature of the issue of confidentiality of

mammography medical outcomes audit

data. Under the final regulations, there

are no requirements for dissemination

or reporting of the data to public bodies

or other agencies, including FDA. There

is, however, a requirement that each

facility establish and maintain a system

to conduct followup and make that

system available for review by the

inspector. Followup is required for all

positive mammograms and for those

patients who are known to have

developed breast cancer after having

had a mammogram at the facility. There

is also a requirement for internal facility

review of these data. FDA believes these

regulations ensure the establishment

and use of medical outcomes audit data

to help protect the public health

without necessarily jeopardizing the

confidentiality of such data or the

incentives facilities and practitioners

have to use these data to improve

performance. Future regulations are

possible in this area.

(Comment 549). Fifteen comments

wondered if radiologists could refuse to

allow an inspector to copy audit data in

addition to visually reviewing it. As

discussed previously, FDA does not

intend to have inspectors obtain

photocopies of medical outcomes audit

information. The agency is requiring

inspectors only to verify that systems

are in place for the facility’s use as part

of a quality assurance program (see

earlier discussion in the preamble to the

proposal at 61 FR 14875).

c. General requirements

(§ 900.12(f)(1))

This paragraph requires facilities to

establish and maintain a system for

collection and review of outcome data

and correlation of pathology results

with initial mammographic results. The

active collection and followup of data

are to focus on positive mammograms

with correlation between pathology

results and interpreting physician’s

initial mammographic interpretation.

(Comment 550). Overall the

comments about this paragraph were

generally positive. Eight comments

stated that the requirement would be

beneficial to mammography facilities

and staff. A small number of comments

advocated that followup data be

collected for all abnormal

mammograms, including those requiring

additional imaging before a final

mammographic interpretation can be

made.

FDA notes that the current language

of the final regulations states that a

system is to be in place to collect and

review outcome data for all

mammograms with required followup

for positive mammograms. Although

followup is required only for positive

mammograms, facilities that wish to

follow all their cases are encouraged to

do so. Future MQSA regulations may

include such a requirement for broader

followup, including for those

mammograms requiring additional

imaging before determination of a final

mammographic result.

Followup for patients with abnormal

mammographic results has been

conducted successfully by several

different groups, including the National

Cancer Institute Breast Cancer

Surveillance Consortium, CDC,

individual groups of radiologists, and

on a statewide basis in Colorado.

Followup for all patients with abnormal

mammographic results, or symptomatic

for breast cancer, or requiring additional

imaging studies was successfully

accomplished in Colorado through the

Colorado Mammography Advocacy

Project (CMAP).

As mentioned previously under the

discussion on the use of the

mammography medical outcomes audit

as an alternative approach to design and

process-based regulations, the National

Cancer Institute’s Breast Cancer

Surveillance Consortium has also

established a major research project to

understand the full effect of breast

cancer screening on cancer outcomes.

Data on breast cancer screening

practices from nine sites across the

country are being linked to populationbased cancer registries. By 2000, the

database will contain information on

nearly 3.2 million mammographic

examinations and over 24, 000 cases of

breast cancer. Standardized procedures

and tools were created and are being

tested by the surveillance consortium

that will assist mammography facilities

in data collection and auditing. Results

and outcomes of the consortium will

help establish performance standards

for mammography and FDA will

evaluate these for appropriateness for

future standards under MQSA.

CMAP is a centralized data

management system that conducted

followup for all women with abnormal

mammograms and women with

symptoms of breast changes. CMAP also

prompts return for regular rescreening

through a series of reminder letters to

women and their physicians. This

system involves voluntary participation

of mammography centers, with most

facilities in the greater Denver

metropolitan area participating. CMAP

services were also offered to some or all

patients outside of the metropolitan

region. The same tracking and followup

and screening reminder methods were

used at these facilities as for those in the

Denver metropolitan area. Data

collection for individual patients,

facilities, radiologists, surgeons, and

referring physicians is governed by

stringent standards for confidentiality.

During the 8 years of operation of

CMAP, the Program ensured that there

were no breaches in confidentiality

protocols. Followup includes collection

of all information about diagnostic

procedures performed to evaluate

mammographic abnormalities.

Currently, CMAP is tracking more than

200,000 women and more than 300,000

mammograms with approximately 3

percent falling into the ‘‘positive’’

category based on radiologists’

mammographic interpretation. The

system has documented screening
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55953

compliance rates in excess of 85 percent

and improved outcomes associated with

the diagnosis of breast cancer.

Specifically, women tracked by CMAP

and diagnosed with breast cancer had

smaller tumor sizes and earlier stages at

detection when compared to a cohort of

women with breast cancer who had not

received the level of tracking and

followup performed by CMAP.

(Comment 551). Twelve respondents

supported the FDA requirement for

collection of outcomes data, but

requested that FDA establish guidelines

for the content of the audit and the audit

process in order to ensure comparability

of medical outcomes data. In contrast,

three comments supported the current

FDA position to establish only very

general requirements for the medical

outcomes audit.

In the absence of any consensus

standards for either mammography

outcomes or data collection methods,

FDA has chosen to defer proposing

these parameters and methods until

more research has been completed and

clear guidelines can be formulated for

mammography centers.

Despite the general support for the

medical outcomes audit, 28 comments

expressed concerns that there is no

consensus on measures of

mammographic efficacy. As discussed

above, FDA acknowledges the lack of

substantive research on appropriate and

accurate measures to assess accuracy of

mammographic interpretation and,

therefore, has not required specific data

to be collected for the medical outcomes

audit. Instead, the agency has

established a general requirement that

mammography facilities have a system

in place to collect and review outcome

data for all mammograms. Followup is

mandatory only for positive

mammograms and for patients who

were previously screened at a facility

and were subsequently found by that

facility to be diagnosed with breast

cancer.

In addition, the same 28 comments

maintained that there was no evidence

that performance feedback about

mammography outcomes affected the

quality of care. In fact, however, the

agency notes that there are several

articles in peer-reviewed journals

indicating that performance feedback is

an effective strategy to issue positive

behavior change (Ref. 3).

(Comment 552). Many comments

expressed concern about the impact on

audit results of serving diverse

populations of patients. It was

recommended that FDA keep such

variations in mind when more clearly

defined medical outcome standards are

established in the future.

FDA acknowledges the importance of

this point and will take population

diversity into account in the future

development of more specific audit

parameters.

(Comment 553). Three comments

stated that the medical outcomes audit

requirement emphasized detection of

false positives and expressed the

opinion that this was a meaningless

outcome. Three more stated that the

most important measure was the rate of

false negatives.

FDA notes that the final regulations

do not require reporting of either false

negatives or false positives. The

emphasis is on collecting followup data

for all patients with positive

mammographic findings and for

patients who received mammography at

a facility and were later determined to

have breast cancer. Such followup may

yield a number of statistics, including

false negatives and false positives.

NMQAAC has suggested that FDA

provide reference articles to which

facilities could refer if they wanted to

compare their own statistics with those

of other practices. FDA supports this

type of educational outreach and

intends to list such references in

Mammography Matters as they become

available. NMQAAC also noted that

future revisions of the regulations may

require specific performance standards

to be issued for mammography once

scientific evidence supports such

performance standards. The agency

agrees that such future developments

are possible. However, the current

regulation requires followup only for

patients with positive mammograms as

defined by the assessment categories of

‘‘suspicious’’ and ‘‘highly suggestive of

malignancy’’ and for patients who

received mammography at a facility and

were later determined to have breast

cancer.

(Comment 554). Twenty-seven

comments expressed concerns about

burdens imposed by the FDA

requirement for medical outcomes

audit. The burdens included both

financial costs of conducting the audit

and concerns about staff time to collect

the outcomes data. A subset of these

comments specifically cited costs

associated with the need for

sophisticated computerized systems and

an increase in clerical staff in order to

accomplish the amount of followup

required by the regulation.

FDA notes that the number of patients

requiring followup (i.e., those

mammograms assessed as ‘‘highly

suggestive of malignancy’’ or

‘‘suspicious’’) should be relatively small

compared to the general population of

women screened at a given

mammography facility. In fact, data

from CMAP and the other programs

cited above suggests that an average of

3.0 percent to 5.0 percent of the total

population of patients receiving

mammograms at a facility will require

active followup. While FDA recognizes

that there may be some increase in costs

associated with staff time to conduct

such followup for all positive

mammograms and patients

subsequently diagnosed with breast

cancer, the benefits of followup are

considered to outweigh the costs. In

addition, the small number of patients

requiring intense followup will not

place an undue burden on an individual

mammography facility when it is

measured against the education and

experience acquired by facility

personnel. The information gained by

staff has been shown to have a positive

impact on interpretation skill. Feedback

about patients with positive

mammograms is extremely important

information for both radiologists and

technologists. Finally, it was the general

consensus of the members of NMQAAC

that the benefits of medical outcomes

outweighed the costs, especially when

one considers the small number of cases

the current regulations will affect and

data from centralized mammography

tracking systems, such as the CMAP,

which indicated that costs of followup

can be minimized. One Committee

member also noted that such followup

actions could reduce costs associated

with medical liability actions.

(Comment 555). Sixteen comments

assumed that the medical outcomes

audit would require computerized

systems and more clerical help, thereby

resulting in increased costs.

FDA notes that a computerized

tracking system is not required by the

final regulations. In fact, many facilities

rely on a manual notecard tickler file to

ensure appropriate and timely followup

for eligible patients. Some facilities have

joined a consortium of mammography

centers where followup can be

accomplished by a centralized data

collection effort. Centralization of

followup was designed and

implemented very successfully for

CMAP, with significant economic

benefits and opportunities for data

comparisons between one facility and

the aggregate of all participating

facilities. Utilization of unique

identification numbers for patient,

facility, referring physician, radiologist,

and surgeon preserved confidentiality.

Information on the type of data to

collect and methods of data collection

and interpretation will be forthcoming

from FDA.
55954 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

(Comment 556). Three comments

asserted that the responsibility for

followup should remain with the

surgeon and/or referring physician.

FDA agrees that followup by the

referring physician or surgeon may well

be the most effective way to

communicate with patients and collect

outcome data. However, the agency’s

authority under the MQSA is focused on

mammography facilities. FDA cannot

establish audit or followup

requirements for physicians who do not

work as interpreting physicians in

mammography facilities.

(Comment 557). One comment

suggested that certified facilities be

required to share patient outcome data

with other certified facilities, especially

if that information is necessary in order

to complete the medical outcomes audit.

FDA has no evidence at this time that

facilities are unwilling to share

followup information with other

facilities that have treated their patients.

Upon implementation of the final

regulations, FDA will monitor this

cooperation and determine if there is a

need for such a requirement in

subsequent regulations.

It was requested that FDA define

’correlation’ of mammographic results

with pathology results. FDA has

addressed this in the comments on

§ 900.2(bb) of the final regulations.

d. Data collection (§ 900.12(f)(2))

(Comment 558). This provision

requires that data be collected on an

ongoing basis for at least all patients

with positive mammograms. The

majority of the comments related to this

paragraph suggested that the regulations

require surgeons, referring physicians,

and/or pathology laboratories to submit

outcomes data to the mammography

facility rather than requiring proactive

followup by the facility for all positive

mammograms.

FDA agrees that such reporting would

facilitate the efficient collection of

accurate outcomes data. FDA has taken

actions to encourage other medical

entities to voluntarily provide this data

(Journal of the American Medical

Association, 1995), but as noted above,

FDA’s authority under the MQSA

focuses on mammography facilities.

FDA cannot require other entities or

health care practitioners to collect data

and forward it to mammography

facilities.

(Comment 559). One comment stated

that it ‘‘was not right to force a

physician to file statistics with FDA just

for statistics sake.’’

FDA believes that it is important to

point out that the final regulations do

not require reporting of any medical

outcomes audit statistics to FDA. If such

requirements are established in the

future, it would only be because it was

justified by public health benefits and

not ‘‘just for statistics sake.’’

(Comment 560). A number of

comments raised concerns about the

medical-legal implications of collecting

outcomes data and some of these urged

FDA to mandate audit protection for

every facility in every state. Concerns

were raised that the data could be

subject to subpoena, used against

facilities in malpractice claims, or

evaluated by third-party payers to award

contracts. Discussion among members of

NMQAAC, on the other hand, indicated

that collection and review of data does

result in improved breast cancer

detection outcomes and can also serve

to protect a facility in the instance of a

legal claim.

Although State laws on protection of

medical audit data do vary, FDA

believes such information is protected

from use against facilities or physicians

in the majority of cases. The Committee

supported the regulations as they are

currently written. As stated previously,

the regulations only require that a

system be in place to conduct followup

and that such followup would be

required for all positive mammograms.

The regulations do not require

disclosure of any outcomes data to FDA

or any other entity outside the facility.

The agency has concluded that the final

regulations strike the proper balance

because the benefit of audits in

improving accuracy of interpretation

outweigh concerns about forced

disclosure to third parties.

e. Frequency of audit analysis

(§ 900.12(f)(3))

This paragraph establishes guidelines

for the frequency of the medical

outcomes audit.

(Comment 561). The majority of

comments relevant to this point

supported an annual audit of medical

outcomes, but also recommended that

the audit period end 6 to 12 months

prior to the date of the audit in order to

ensure collection of complete patient

information. FDA recognizes the need

for adequate time to elapse in order to

collect all relevant data. In response to

the comments, the provision was

amended to clarify that the audit

analysis may be completed up to 12

months following the close of the audit

period. This additional time for

completion of followup was supported

by NMQAAC. However, because the

requirement is to do an annual audit, a

subsequent audit period will be in effect

during the time the facility completes

followup for the previous medical

outcomes audit period.

Comments also recommended

requiring quarterly review of audit data

by interpreting physicians. FDA

established the requirement for annual

review of these data in order to

maximize the number of cases eligible

for followup and data analysis.

Facilities are free to review their audit

data at more frequent intervals if that is

useful or desirable for that practice.

FDA notes, however, that quarterly

audit review may not yield sufficient

numbers of cases for performance of

valid statistical analyses.

Finally, one comment asked what was

meant by individually and collectively’

for review of medical outcomes audit

data. FDA has revised the provision to

clarify that the medical outcomes audit

data is to be evaluated by the reviewing

interpreting physician for the entire

facility and for each individual

radiologist reading mammograms for the

facility.

f. Reviewing interpreting physician

(§ 900.12(f)(4))

This paragraph requires that each

mammography facility designate at least

one interpreting physician to review

medical outcomes audit data at least

annually. This individual will also be

responsible for analyzing results and

identifying issues based on these results

and recording any followup actions.

(Comment 562). Eight comments

expressed concerns about the utility and

feasibility of conducting medical

outcomes audit reviews for individual

physicians. These comments reasoned

that the numbers would be so small that

findings would not be of practical or

statistical significance, and that such

analyses would also be resource

intensive.

FDA acknowledges these concerns,

but expects that, over time, adequate

data will be available for individual

interpreting physicians that will become

meaningful and will allow tests of

statistical significance.

(Comment 563). Five comments

supported the proposal to include

’taking corrective action and

documenting such actions’ in the

requirement, while two others argued

that this would not always be possible.

Review of these comments and

discussions with NMQAAC prompted

FDA to change the wording to recognize

that the reviewing interpreting

physician may not always have

authority to institute corrective actions.

As revised, the proposed regulation

requires the reviewing interpreting

physician to document what, if any,

followup actions were taken following

review of the individual and aggregate

medical outcomes audit data.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55955

(Comment 564). Nine comments

noted that facility performance

monitoring and corrective actions were

not defined in the regulations and,

therefore, this provision is unclear.

FDA agrees and has deleted these

terms in revising the language of this

provision.

(Comment 565). Finally, one comment

recommended that the reviewing

interpreting physician should also be

the individual responsible for overall

facility quality assurance.

FDA does not believe that this dual

role is necessary or beneficial for every

facility, e.g., a physician who is best

suited for responsibility over audits may

not be onsite sufficiently often to also be

responsible for overall quality

assurance. Although the final rule

would permit a facility to designate the

same person for both responsibilities, it

is not required.

7. Mammographic Procedure and

Techniques for Mammography of

Patients With Breast Implants

(§ 900.12(g))

This paragraph implements the

MQSA provisions that require FDA to

establish ‘‘standards related to special

techniques for mammography of

patients with breast implants’’ (42

U.S.C. 263b(f)(1)(H)).

a. Breast implant inquiries

(§ 900.12(g)(1))

As proposed, this paragraph required

each facility to have in place a

procedure to inquire if an examinee has

a breast implant at the time of

mammography scheduling.

(Comment 566). More than 110

comments opposed making this inquiry

at the time of scheduling. Reasons for

the opposition included: privacy

concerns of the patient, the fact that the

patient may not be the person

scheduling the examination, and the

belief that the best way to obtain this

information is by having the

technologist question the patient at the

time of the examination. Eleven

comments supported this requirement,

reasoning that this would aid in

efficient scheduling and urged FDA to

publicize the need for implant patients

to inform the facility of their situation

at the time of making an appointment.

After reviewing all comments and

discussing this issue with NMQAAC,

FDA has revised § 900.12(g)(1) to

require all facilities to have a procedure

to inquire whether or not the patient has

breast implants prior to the actual

mammographic examination, but not

necessarily at the time of scheduling.

Those facilities that believe it is

important to identify breast implant

patients at the time of scheduling, in

order for the facility to allot the correct

amount of time for the study, are free to

do so. The comments indicate that many

facilities will choose to use the patient

questionnaire to obtain this information

or have the technologist question the

patient prior to the examination.

(Comment 567). Several comments

stated that facilities should have the

option of referring breast implant

patients to facilities where such

examinations are done regularly.

FDA agrees with these comments and

notes that there are no regulations

requiring facilities to perform studies on

patients with implants. For those

facilities electing not to perform

mammography on patients with breast

implants, FDA strongly recommends

that they develop a mechanism to

inform referring physicians and patients

of this fact. This will decrease the

chances of such patients arriving at a

facility that does not ordinarily perform

breast implant studies.

(Comment 568). Two comments

suggested establishing a minimum

volume for these types of examinations

in order to concentrate them at facilities

that are the best for this purpose.

FDA recognizes that increased

experience with imaging patients with

breast implants is likely to develop

expertise. However, the agency believes

that it is in the best interest of all

concerned to have high quality

mammography performed in as many

facilities as possible. It is possible that

one technologist at a particular facility

may have had additional training in

techniques for imaging such patients

and be able to do excellent

examinations despite relatively low

numbers of such patients. It is not the

intent of the MQSA to arbitrarily restrict

access to mammography services.

b. Maximizing the visualization of

breast tissue for patients with implants

(§ 900.12(g)(2))

This paragraph requires that patients

with breast implants undergoing

mammography have mammographic

views to maximize the visualization of

breast tissue, except where

contraindicated or modified by a

physician’s directions.

(Comment 569). Nine comments

stated that it is important to take

additional and specialized views of the

implanted breast in order to achieve

maximum visualization of tissue. The

authors asserted that a minimum

standard, such as requiring Eklund

views, should be set. One contradictory

comment stated that requiring

mandatory views would cause

unnecessary irradiation because not

every implant can be displaced as in the

Eklund procedure.

FDA and NMQAAC agree that,

currently, the Eklund procedures,

including appropriate individualized

views, provide the best mammographic

means to visualize breast tissue for most

women with implants. The agency and

the committee also recognize that other

methods may exist that would be

preferable in particular cases. Because

breast implant imaging is evolving, the

agency believes that it would be

premature to limit, by regulation, this

imaging to only one technique. FDA

does not believe that this regulation, as

written, will result in unnecessary

irradiation of patients because it allows

facilities to customize the study to the

individual patient.

NMQAAC recommended deleting the

phrase ‘‘and optimize breast cancer

detection’’ as being redundant. FDA

agrees and has deleted the phrase from

the final provision.

c. Onsite supervision of mammograms

of patients with breast implants

(§ 900.12(g)(3))

FDA received almost 300 comments

opposing this proposal, which would

have required that mammograms of

patients with breast implants be

supervised by an onsite interpreting

physician. Reasons for the opposition

included: Severe scheduling and access

problems if an interpreting physician

had to be present, no demonstrated

medical need for an onsite physician,

and the belief that technologists are

capable of performing implant

examinations without the supervision of

an interpreting physician. Four

comments supported the section as

proposed, stating that it was important

to have an interpreting physician onsite

to check the quality of the images.

FDA has been persuaded by the

comments and subsequent discussions

with NMQAAC that requiring an onsite

interpreting physician would result in a

decrease in access to high quality

mammography services for women with

breast implants without a significant

improvement in the quality of care.

Therefore, FDA has deleted this

provision.

8. Consumer Complaint Mechanism—

Facility Standard (§ 900.12(h)) and

Accreditation Body Standard

(§ 900.4(g))

These paragraphs, as proposed,

establish a process for facilities and

accreditation bodies to collect and

resolve serious consumer complaints. It

provides patients with a mechanism to

report what they believe to be seriously

deficient mammography services and

gives them the opportunity to have their

complaints heard, investigated, and

resolved.
55956 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

Section 900.12(h), under facility

standards, establishes requirements for

facilities with respect to collecting and

resolving serious consumer complaints,

while § 900.4(g), under accreditation

body standards, establishes

requirements for actions that

accreditation bodies must take to

resolve consumer complaints referred to

them.

Many of those who commented on the

proposed regulations seemed unaware

that different aspects of the complaint

mechanism were addressed in these two

separate paragraphs, and unaware that

both sections should be read with

reference to the definitions section of

the regulations at § 900.2. Because the

comments on these separate provisions

tended to be similar, and in order to

help illustrate the connection between

them, FDA concluded that it would be

most efficient to address public

comments on the complaint mechanism

sections of the proposed regulations as

a group.

As the consumer representatives on

NMQAAC noted, of all of the comments

on the complaint mechanism, only two

were from consumers. Almost all of the

comments were from representatives of

mammography facilities.

(Comment 570). Several comments

agreed with FDA that facilities should

have the flexibility to develop their own

complaint mechanism and institute

their own procedures for response and

resolution. One comment supported the

requirement that facilities develop a

system for collecting and resolving

serious complaints about mammography

services and the proposed definition of

serious complaints. Two comments,

including one from a breast cancer

advocacy organization, expressed

support for the consumer complaint

provision that FDA proposed.

One comment noted concern that

there is no rule requiring feedback by

facilities to FDA about an accreditation

body. The comment suggested that FDA

implement a communication

mechanism for facilities to register

complaints/comments with FDA about

the accreditation body. The comment

recommended that the mechanism

guarantee followup, similar to the

provision establishing a consumer

complaint mechanism.

FDA believes mechanisms for facility

feedback to FDA already exist. Facilities

that wish to comment about

accreditation bodies may contact FDA’s

DMQRP (address above) and will

receive a response. In addition, the

statutory requirement for FDA to audit

the performance of accreditation bodies

through inspections of selected facilities

establishes additional opportunities for

review and feedback.

(Comment 571). Two comments

discussed the manner in which

accreditation bodies might implement

the complaint resolution process. One

suggested that serious consumer

complaints should be handled by an

ACR Peer Review process. Another

suggested that accreditation bodies

could form boards to receive unresolved

serious complaints.

FDA notes that the final regulations

prescribe no particular method for

accreditation bodies to use, believing

that flexibility will permit each

accreditation body to establish a system

that works best for the facilities it

accredits and the patients they serve.

Establishing specific groups to review

unresolved complaints is one acceptable

method for fulfilling this requirement.

(Comment 572). One comment

recommended that, because

accreditation bodies have no

enforcement authority other than to

revoke or deny accreditation, FDA or

the State certifying entity should retain

authority to investigate consumer

complaints.

In response, FDA notes that nothing

in the MQSA or the regulations

precludes FDA or a State from

investigating complaints. However, the

agency believes consumer complaints

will be addressed most effectively and

efficiently by a three-tiered approach.

First, the complaint should be registered

at the facility, where there is the greatest

chance for resolution. Second, serious

complaints that have not been resolved

at the facility should be directed to the

accreditation body. And, third, the

accreditation body can forward serious

complaints to FDA. Although

consumers may choose to complain to

the facility, the accreditation body, or

FDA, the intent of these mechanisms is

to resolve difficulties quickly at the

level closest to the consumer.

(Comment 573). One comment

suggested a name change for the

consumer complaint mechanism. The

author supported the proposed

requirement, but preferred the use of

either ‘‘consumer comment

mechanism,’’ or ‘‘consumer feedback

mechanism’’ to encourage feedback on

positive mammography experience(s).

FDA and members of NMQAAC agree

that the term ‘‘complaint’’ has negative

connotations and may not encourage

well-deserved positive comments. The

statute, however, requires FDA and

NMQAAC to develop a mechanism for

the investigation of ‘‘consumer

complaints.’’ Consequently, FDA

adhered to the terminology in the

statute.

(Comment 574). FDA received seven

comments requesting additional

guidance and detail about consumer

complaint procedures. Five comments

suggested that guidance documents be

made available for facilities to follow in

generating their system for collecting

and resolving complaints, including

directions for consumers who wish to

file a complaint with the facility’s

accreditation body. One comment

suggested that FDA develop a

standardized plan, with appropriate

forms to review and evaluate each

facility’s consumer complaints. One

comment supported the proposed

definition of a serious complaint, but

noted that most complaints deal with

Medicare and insurance

reimbursements, or lack thereof.

FDA agrees that additional

information will be helpful and

members of NMQAAC have also

strongly recommended that guidance be

developed. The agency plans to develop

such documents for facilities and

consumers.

In reference to discussions in the

proposal about cultural considerations,

one comment noted that facilities

cannot reasonably be expected to

develop complaint procedures for all

possible language, ethnic, and literacy

backgrounds. FDA agrees that to require

facilities to make such provisions would

pose an undue burden. However, the

agency encourages facilities to design

their complaint mechanism procedures

to be responsive to the particular needs

of consumers they serve.

(Comment 575). Fourteen comments

stated that the required consumer

complaint mechanism increases costs.

FDA believes that the requirements

for the complaint mechanism are

minimal. Preliminary estimates indicate

that the costs for establishing and

implementing a system are not

significant and that many facilities

already have such systems in place. In

addition, costs of establishing and

implementing such systems are likely to

be outweighed by the benefits to the

facility resulting from better patient

relations, enhanced reputation, and

avoidance of costs related to unresolved

complaints that may lead to litigation.

(Comment 576). Several comments

expressed concern that some consumer

complaints could unfairly jeopardize

facilities and particular employees.

These comments hypothesized a variety

of situations: A facility’s certification

could be threatened by an examinee

bent on vengeance (for example, if a

false negative mammogram and an error

in interpretation constitute serious

complaints); certain employees could be

singled out any time a complaint is
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55957

referred to a higher authority (the

accreditation body); the technologist

could be falsely accused of a myriad of

issues pertaining to patient care.

Another comment interpreted the

proposed regulation to mean that

patients with complaints must be

contacted for their opinion on whether

the facility’s solutions are acceptable to

them.

FDA foresees some situations in

which a facility’s certification may be

threatened as a result of consumer

complaints. For example, if serious

complaints have been continuously

ignored or left unresolved by the

accreditation body or the facility,

subsequent FDA investigations may

demonstrate that the facility is unable or

unwilling to comply with the MQSA

standards. The agency is confident,

however, that most facilities will make

a sincere and effective effort to respond

to valid complaints and does not expect

that it will be necessary to consider

suspending or revoking certificates for

this reason, except in rare cases. In

reference to concerns about personnel

being unjustly accused, FDA notes that

technologists are not ordinarily

designated as the individuals

responsible for the facility’s

management and operation. To the

extent consumer complaints lead to

improvement in performance of

individual personnel, the quality of

mammography is improved at that

facility. With respect to the need to

contact consumers about resolution of

complaints, the agency believes such

communication is a necessary part of

resolving a complaint. If consumers

believe the facility’s solutions are

unacceptable, they may contact the

accreditation body or FDA, who will try

to resolve the issue on a case-by-case

basis.

(Comment 577). Seven comments

noted their objection to additional

policies and procedures for a consumer

complaint mechanism. One comment

noted that a mandatory facility

complaint mechanism is superfluous

because effective resolution of patients’

complaints is already a component of

proper patient care. Another comment

noted that each facility can develop its

own consumer complaint plan without

any guidelines from the MQSA.

Fourteen comments suggested that FDA

simply accept the policies and

procedures for mammography consumer

complaints that are currently in use at

each facility. If no policy and

procedures are in place, the facility

should establish one.

FDA agrees that, for the majority of

facilities, effective resolution of patient

complaints is already a component of

proper patient care. In fact, under the

interim rules, facilities are required to

post an address where complaints can

be filed with accreditation bodies, and

maintain records of all complaints

registered at the facilities. The

requirements in the final regulations,

therefore, should present little

additional burden. Those facilities that

already have procedures in place are

unlikely to have to make any significant

changes. Only facilities that do not have

a system in place will be required to

make any significant investment of

resources. As discussed above,

procedures are likely to benefit both the

public health and the individual

facility.

(Comment 578). One comment

suggested that the facility should have

the option to ignore a consumer

complaint. This comment stated that

facilities should be encouraged to

handle complaints, but not required to

do so.

Under the final regulations, a facility

must establish a written and

documented system for collecting and

resolving consumer complaints. That

system may include varying degrees of

responsiveness to different kinds of

complaints. A complaint about the

temperature of the waiting room may be

handled differently than a complaint

about failure to receive notification of

examination results. There may be

certain types of complaints under its

system that a facility decides do not

merit additional resources beyond a

verbal acknowledgment or response.

However, the system must include a

mechanism to provide consumers with

a way to register serious complaints

with the accreditation body. The

consumer can use that information to

take serious complaints to the

accreditation body and inform the

accreditation body that the facility made

no attempt to resolve the complaint.

(Comment 579). One comment

applauded the consumer complaint

mechanism in theory, but questioned

the wisdom of permitting the facility to

determine whether the complaint is

serious. The comment stated that

facilities should be required to record

all complaints and provide all

consumers with directions for filing

complaints with the facility’s

accrediting and/or licensing body. FDA

does not believe that the facility

independently determines whether the

complaint is serious because the

definitions of ‘‘serious complaint,’’

‘‘serious adverse event,’’ and ‘‘adverse

event’’ (see § 900.2) are the basis for

such decisionmaking. Also, if

consumers are not satisfied with the

complaint resolution, they may

complain directly to the accreditation

body. A facility’s system may require

that records be kept for all complaints

and that consumers be provided with

directions for filing all complaints with

the accreditation body if they choose to

do so. However, tracking and providing

the consumer with instructions about

how to file a complaint with the

accreditation body are required under

the regulations only for serious

complaints.

Nine comments recommended that all

complaints should be handled on an

individual basis at each facility, and

that recordkeeping should be based on

the protocol for that facility. Two

comments noted the additional amount

of paperwork the consumer complaint

mechanism would generate, and one of

these noted the possibility that facilities

would be open to liability because of

this mechanism.

FDA agrees that all complaints should

be handled at the facility if possible,

and that recordkeeping procedures can

vary with each facility and each

complaint, so long as tracking and

accreditation body notification are

established for serious complaints. If

satisfactory resolution of the complaint

cannot be achieved at the facility level,

however, the consumer must have the

option of taking the complaint to

another level. In response to the concern

about generation of paperwork, FDA

notes that the requirement to track

complaints has been in effect under the

interim regulations since 1993 without

any feedback indicating excessive

paperwork. As to concerns for

additional liability, the agency and

members of NMQAAC have both noted

that records that are required to be

tracked are more likely to help facilities

document that they responded to and

resolved complaints. In addition,

effective consumer complaint

mechanisms allow facilities to identify

problems and improve the quality of

their services.

(Comment 580). One comment

advocated that some safeguard

addressing confidentially should be

implemented before this and similar

recordkeeping requirements are retained

in the final regulations. FDA notes that

consumer complaints are part of patient

records and will be handled by facilities

with the same care as other records

relative to patients. Accreditation bodies

are required to protect nonpublic

information they receive from facilities

and will not further disclose such

information. FDA’s public information

regulations prohibit disclosure of

patient records or information that

would identify individual patients.
55958 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

(Comment 581). FDA did not propose

a requirement that facilities post a sign

that explains how to file consumer

complaints, although NMQAAC

members supported such a requirement.

Nevertheless, the agency received 28

comments, all on a form letter, opposing

any requirement for posting of the

complaint process, particularly with

respect to addressing complaints to the

accreditation body. These comments

argued that such a notice will confuse

patients and send mixed messages (e.g.,

this is a certified facility, but here’s how

to complain). One comment noted that

the consumer complaint mechanism

needs to be more clearly articulated in

order to determine a mechanism for

posting. The comment expressed

concerns about promoting

dissatisfaction with the screening

experience.

FDA notes that facilities can develop

their own posting mechanism if they

chose to do so. In these cases, the

facility could use messages such as:

‘‘We care about our patients. If you have

comments and/or concerns, please

direct them to (the name of the person

in the facility who is responsible for

complaints).’’ FDA notes that the name

of the accreditation body is listed on the

facility certificate, which the facility is

required by statute to post prominently

within view of patients.

9. Clinical Image Quality (§ 900.12(i))

This paragraph establishes that

clinical images produced by any

certified facility must continue to

comply with the standards for clinical

image quality established by the

facility’s accreditation body.

This requirement did not appear as a

separate provision in the proposal but

was added to the final regulations to

emphasize that adequate clinical image

quality is to be maintained by the

facility on an ongoing basis and is not

something to be achieved only at the

time of accreditation. FDA recognizes

that this requirement may appear

unnecessary or redundant. The stated

purpose of the MQSA, to establish

national uniform minimum quality

standards for mammography facilities,

presumes that all facilities will produce

adequate mammograms on a regular

basis. Specific statutory provisions,

such as those requiring random clinical

image review by accreditation bodies

and the establishment of quality

assurance programs at each facility to

ensure clarity of images, reflect the

drafters’ intent to ensure quality

mammograms for every patient. In

addition, the interim regulations issued

by FDA and these final regulations

establish and support the need for

maintenance of adequate clinical image

quality at all times. However, FDA’s

experience with implementation of the

interim regulations, and the impression

the agency has received from some of

the public comments, suggests that

some facilities may view clinical image

quality as important only or primarily in

connection with the accreditation

process. The agency has concluded that

this critical standard for quality

mammography should be stated

explicitly in order to emphasize its

critical importance and eliminate any

chance of misunderstanding.

10. Additional Mammography Review

and Patient Notification (Proposed

§ 900.12(i) (Final § 900.12(j)))

This paragraph requires a facility to

cooperate with FDA in the investigation

of concerns about the quality of the

mammography performed by that

facility and in notification of patients or

the public, should the investigation

justify such notification. As the result of

the addition of the new § 900.12(i),

Clinical image quality, this paragraph is

now § 900.12(j) in the final regulations.

The provision has been modified from

the original proposal to clarify that this

type of review is different from those

performed either for accreditation,

reaccreditation, or for random clinical

image review. Additional

mammography review is to be used in

those cases where FDA has reason to

believe that mammography quality has

been compromised and may present a

serious risk to human health. Depending

on the individual circumstances, this

review may be an onsite evaluation or

may be performed through the mail.

Procedures for performing additional

mammography review will be

developed by the accreditation bodies

and approved by FDA.

If the agency determines that any

activity related to the provision of

mammography at a facility presents a

serious risk to human health,

§ 900.12(j)(2) requires a facility to notify

patients, their designees, their

physicians, or the public of actions that

may be necessary to minimize the risk.

Such notification may be warranted,

e.g., in cases where diagnoses of

possible malignancy may have been

missed due to grossly inadequate

performance on the part of the facility.

Patients, their designees, health care

professionals, or the public may have to

be notified so that they may take

appropriate remedial action. For

example, affected patients may wish to

repeat examinations at another facility

or a member of the public may be able

to contact an otherwise unreachable

patient.

(Comment 582). While seven

comments supported these requirements

as originally proposed, the authors of 26

other comments were concerned about

possible abuse of the provisions. These

comments requested more information

and clear guidelines on how ‘‘serious

risk to human health’’ would be

determined and how the regulation

would be implemented. One comment

stated that the entire section was not

needed and should be deleted. The

authors of 25 comments stated that this

section sounded like a consent decree

without an appeals process. The

comments also stated that the intent of

this section was unclear.

FDA notes that even comments that

expressed concern generally supported

the need to investigate and to take

appropriate action at facilities where

there is a serious risk to human health.

In response to specific comments, the

agency first notes that patient

notification will not always be an

appropriate corrective action, even in

cases where mammography services

have been inadequate. In some cases,

patient notification could result in

unnecessary patient anxiety, without

providing the patient with any plan of

action that the patient could take to

minimize her risk. The agency

recognizes the important consequences

to the patients, the public, and the

facility of pursuing patient notification

and would not initiate such action

without full consultation with the

accreditation body and the facility and

only following review of the additional

mammography review performed by the

accreditation body.

Although NMQAAC agreed that the

agency should exercise this authority

with respect to facilities that are

performing poorly, members of

NMQAAC were unable to reach a

consensus on guidelines for initiating

patient notification. FDA’s experience

under the interim regulations may

reassure facilities and the public that

patient notification is not requested

unless FDA has evidence, including

review of clinical images by the

facility’s accreditation body, that

indicates there is a strong likelihood

that a significant number of

mammograms taken by the facility were

inadequate. In any given situation,

notification will only be appropriate

where the benefits of providing notice to

women, who may wish to repeat the

exam, outweigh any resultant risks,

such as patient anxiety or the possible

disincentive for future mammography

screening. Because of the number of

variables involved in any particular

situation, FDA believes that the decision

as to when a facility has sufficiently
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55959

serious problems to warrant patient

notification is best made on a case-bycase basis. In the past 21⁄2 years, two

facilities have instituted limited patient

notification after an investigation by the

accreditation body and FDA.

The intent of this section is to assure

the public that in those cases of

suspected compromised mammography

quality, an investigation is performed,

and depending on the results of that

investigation, appropriate corrective

action is taken. If patient notification is

the corrective action recommended by

the accreditation body and required by

FDA, the facility will have every

opportunity to participate in designing

and implementing that notification. As

with any adverse accreditation body or

FDA action, the facility has the right to

have a determination about patient

notification reviewed and appealed

within the agency. If the facility does

not voluntarily come into compliance or

take steps the agency has determined

are necessary to ensure quality

mammography at that facility, FDA can

initiate suspension or revocation of the

facility’s certificate. In those

circumstances, the facility is entitled to

a hearing under part 16 of the agency’s

regulations (see § 900.14) and hearing

decisions are subject to judicial review.

Contrary to the opinion of many

respondents, therefore, FDA’s

determination that patient notification

is necessary is subject to review and

appeal.

(Comment 583). One comment

opposed this section, asserting that FDA

already performs clinical image reviews

by randomly notifying the facility that

they have so many days to send in

certain mammograms.

FDA notes that the author of this

comment mistakenly believed that

random clinical image review and

additional mammography review were

the same. As previously stated, these

two reviews are performed differently

and address different issues and

problems. Random clinical image

review is performed as an evaluation

tool by accreditation bodies in an effort

to audit their own performance, and the

performance of facilities they accredit.

Additional mammography review is to

be performed only in those cases where

FDA believes there has been a

compromise of quality sufficient to pose

a serious risk to human health.

(Comment 584). Two comments stated

that FDA should ask the accreditation

body to investigate questionable

facilities, but that the type of evaluation

and the final decision should be left up

to the accreditation body.

FDA continues to work closely with

the accreditation bodies to coordinate

all activities, especially those related to

image review and mammography

quality. Accreditation bodies are critical

in establishing processes and

parameters for additional

mammography review at any particular

facility and may be the first entity to

discover information that indicates such

a review is necessary. Nevertheless,

decisions about whether additional

mammography review or patient

notification are necessary ultimately

must rest with the agency.

(Comment 585). One comment

questioned why FDA would not start

this process as soon as a facility fails

accreditation due to clinical image

review.

FDA responds that accreditation

clinical image review is an evaluation of

the ‘‘best’’ images that a facility can

produce and is scored against the

accreditation body’s highest standard.

Failure to achieve the high quality

standard does not necessarily mean that

the facility’s average images are of a

quality likely to result in the

misdiagnosis of significant

abnormalities.

It is FDA’s view that failure of

accreditation or reaccreditation clinical

image review does not automatically

indicate that the facility’s overall quality

level has been compromised to such an

extent that there is a serious risk to

human health. Unless there is other

information indicating such a risk, the

agency does not intend to apply

§ 900.12(j) to this circumstance. The

initiation of additional mammography

review under this section is primarily

intended to protect the public in

circumstances where there is reason to

believe an accredited facility is

practicing in a way that may cause

serious harm.

M. Revocation of Accreditation, and

Revocation of Accreditation Body

Approval (§ 900.13)

This provision describes the

procedures that FDA will follow in the

event a facility’s accreditation is

revoked by its accreditation body

(§ 900.13(a)). It also outlines the

facility’s responsibility if FDA

withdraws approval of its accreditation

body (§ 900.13(b)). No comments were

received on § 900.13(b).

(Comment 586). One comment

supported § 900.13(a) as written while

another comment stated that this section

is unclear, and asked whether a facility

is allowed to conduct mammography

without accreditation. Another

comment suggested that no FDA

certification should continue in force

after an accreditation body has revoked

the accreditation of a facility.

FDA issues certificates, and only FDA

can determine when a certificate is no

longer in effect. Loss of accreditation

does not automatically mean the loss of

certification. In certain unique

circumstances, a facility may remain

certified though it lacks accreditation.

For example, a facility may be certified

through a provisional certificate to

perform mammography before it is

accredited (42 U.S.C. 263b(c)(2)) or

retain its certification for some period of

time following FDA withdrawal of its

accreditation body’s approval (42 U.S.C.

263b(e)(2)). Under the MQSA, if an

accreditation body revokes the

accreditation of a facility, the certificate

remains in effect until such time as may

be determined by FDA (42 U.S.C.

263b(e)(5)). FDA interprets the statute to

give the agency discretion to find that

the certificate should no longer be in

effect once accreditation has been lost or

to permit the facility to continue to

perform mammography for some period

of time following loss of accreditation.

The language in the final regulation has

been amended to reflect this discretion.

After revocation of a facility’s

accreditation, FDA may conduct an

investigation into the reasons for the

revocation. Following the investigation,

the agency may take whatever action or

combination of actions will best protect

the public health, including the

establishment and implementation of a

corrective plan that may permit the

certificate to remain in effect while the

facility seeks reaccreditation. (In the

event that the investigation convinced

the agency that revocation of

accreditation was not justified, FDA

would have discretion to continue the

certificate in effect while the original

accreditation body reinstated the facility

or another entity provided

accreditation). Anytime FDA determines

that the revocation was justified and the

certificate should not continue in effect,

the facility that has lost its accreditation

may no longer perform mammography.

The final regulation has been amended

to clarify that a facility whose certificate

is no longer in effect must cease to

practice mammography.

(Comment 587). Three comments

concerning this provision appear to

have confused revocation of

accreditation with revocation of

certification. One suggested making the

accreditation bodies responsible for

appeals of revoked certificates, and two

described facilities that purportedly

were unable to operate for 2 years as the

result of revocation of their certificate

due to a single flawed image or the

recommendation of the facility’s

accreditation body.
55960 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

FDA does not have enough

information about the specific cases

referenced in the last comments to

respond, except to note that an

accreditation body does not have

authority to revoke a certificate. In

response to the first comment, the

agency reiterates that suspension or

revocation of accreditation is the

responsibility of the accreditation body,

and each accreditation body is required

to have internal appeals procedures

available to all the facilities it serves.

Suspension of revocation of an MQSA

certificate, however, is the

responsibility of FDA. Such suspensions

and revocations are governed by 42

U.S.C. 263b(i) and the regulation

implementing that section in § 900.14.

An accredited facility whose certificate

FDA is seeking to suspend or revoke is

generally entitled to a hearing before

that action is taken in accordance with

42 U.S.C. 263b(i) and § 900.14. The

agency wants to take this opportunity to

clarify, however, that a facility whose

certificate FDA determines to be no

longer in effect because its accreditation

has been revoked is not governed by 42

U.S.C. 263b(i) or § 900.14. In accordance

with 42 U.S.C. 263b(e)(5), the certificate

of a facility whose accreditation has

been revoked remains in effect only

until such time as determined by FDA.

Although such a facility will be entitled

to an opportunity for a timely hearing

following a determination by FDA that

the certificate is no longer in effect, it

may not continue to practice

mammography in the interim.

N. Suspension or Revocation of

Certificates (§ 900.14)

This section sets forth the conditions

under which FDA may suspend or

revoke a facility’s certificate.

(Comment 588). One comment

supported this section as written, while

another recommended that this section

be revised to include the MQSA

provision which authorizes States to

conduct certification duties.

As noted earlier in this preamble, the

subject of States as certifying bodies is

beyond the scope of these regulations.

Preparations are under way to draft

regulations that will govern State

agencies that wish to become certifying

bodies.

(Comment 589). One comment

recommended changing the word

‘‘determines’’ to ‘‘believes.’’

Suspension or revocation of a

facility’s certificate is an action against

the facility that should be based on

more than ‘‘belief.’’ FDA does not

intend to take such action without

making a determination that it is

warranted.

Because there were so few comments

on this section, it has been codified

basically as proposed. The discussion in

the preamble to the proposal at 61 FR

14877 through 14878 describes the

provisions of this section in detail. FDA

has added failure to provide

information, reports, or records ‘‘to the

accreditation body’’ as an additional

grounds for suspension or revocation in

§ 900.14(a)(3). The agency has made this

change to ensure that accreditation

bodies have access to records, including

clinical images, that are necessary for

review. In many circumstances, the

accreditation body’s access to records is

essential for it to fulfill its obligations

under the statute and to advise FDA

with respect to potential enforcement

actons. A facility that refuses to supply

such records makes it difficult, if not

impossible, for the accreditation bodies

and FDA to efficiently investigate or

monitor mammography practices at that

facility.

O. Appeals of Adverse Accreditation

Decisions that Preclude Certification or

Recertification (§ 900.15)

The title of this provision has been

changed to better reflect the fact that it

describes the procedures for appealing

adverse accreditation decisions that

preclude a facility from becoming

certified or recertified.

(Comment 590). One comment

supported this section as written, and

another comment questioned whether a

facility can submit additional

information in its appeal to FDA, noting

that ACR does not consider any

additional information from a facility

and bases its appeal findings on

rereview of the films from the facility

that were originally evaluated.

When appealing an adverse

accreditation decision, FDA will

consider and evaluate any information

provided by the appealing facility that

may bear on the outcome of the appeal,

in accordance with the governing

regulations identified in the next

paragraph.

(Comment 591). One comment

suggested adding ‘‘or reaccredited’’ in

addition to, ‘‘has failed to become

accredited.’’

FDA agrees that the addition of

‘‘reaccredited’’ would add clarity.

Another comment recommended that

there be a timeframe for appeals. The

MQSA establishes that the procedures

in 42 CFR part 498 are to be followed

by FDA for appeals. These regulations

contain the timeframes to be followed

for appeals under the MQSA.

P. Appeals of Denials of Certification

(§ 900.16)

The comments that requested

clarification about the relationship

between revoked accreditation and

continued certification encouraged the

agency to explicity address the issue of

facilities that have received

accreditation but are denied a

certificate. FDA has added a new

provision to clarify that the statute

provides the agency with discretion to

deny certification to a facility that has

been accredited. As discussed

previously in connection with the

section on reviewing applications for

certificates, FDA ordinarily will issue a

certificate to a facility that has proof of

accreditation by an approved

accreditation body. This has been the

agency’s practice in the past and the

agency intends to continue its reliance

on the professional bodies that are

expert in these reviews.

However, there may be situations

when the agency has access to

information that was not available to the

accreditation body or when the agency

has other reasons to disagree with that

body’s determination that the facility

applying for a certificate will practice

quality mammography. In these unusual

circumstances, FDA has authority to

deny a certificate. The new provision

sets forth the grounds that FDA will use

as the bases for such denials: A finding

that the facility is not likely to comply

with the quality standards; a finding

that the facility is not likely to permit

inspections or provide access to records

and information in a timely fashion; or

a finding that the facility was guilty of

misrepresentation in obtaining

accreditation. These grounds are

parallel to those that are the statutory

bases for suspension or revocation of a

certificate. FDA believes that it is in the

interest of public health to ensure that

such facilities are not permitted to begin

practicing mammography rather than

automatically granting a certificate that

the agency must later seek to revoke.

The new provision also provides

appeal rights for facilities that are

denied a certificate. These procedures

are the same as those set forth for

reconsideration and appeal of an

adverse accreditation decision in

§ 900.15. The procedures are mandated

by the statute under 42 U.S.C.

263b(d)(2) and include the right to

request a formal hearing from the

Departmental Appeals Board of the

Department of Health and Human

Services.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55961

Q. Alternative Requirements (§ 900.18)

Section 900.18 establishes procedures

for approval, extension, and withdrawal

of alternatives to the quality standards

of § 900.12. Such alternatives can be

approved if, among other things, the

alternatives provide at least as great an

assurance of quality mammography as

the original standards. The alternative

requirement procedure allows the

agency to permit the practice of

mammography to benefit rapidly from

improvements and advancements

without the need to first go through the

often lengthy process of amending the

regulations. When added to the interim

requirements through the amendments

of September 30, 1994 (59 FR 49808), no

public comments were received. This

section was incorporated into the final

regulations with only minor changes. A

few comments were received.

1. General Comments on Alternative

Requirements

(Comment 592). Two comments

supported this section, one referring to

it as a ‘‘most sensible approach,’’ but

urged monitoring of the use of the

alternatives after approval. A third

comment suggested that manufacturers

be required to provide documentation of

approved alternatives to potential

purchasers and that copies be available

at the facility for review by the physicist

and the inspector. A fourth comment

urged removal of this section, stating

that no variation in meeting the

requirements should be allowed.

FDA believes that this process is

needed to avoid the danger of

discouraging advances in

mammography and freezing technology

at the present level. If the standards had

to be amended to permit use of an

advance in methods, training, or

technology, the time required for the

amendment might well discourage

members of the public from attempting

improvements. The agency does not

believe that it is necessary to make the

third comment a regulatory

requirement. Manufacturers will find it

difficult, if not impossible, to sell

equipment that does not meet the

requirements or an approved

alternative. Because facilities will

demand such documentation and will

be required to produce it to pass surveys

or inspections, FDA concludes there

will be sufficient incentive to provide

documentation without issuance of a

regulation. The agency also notes that

copies of applications, amendments,

and extensions of alternative standards

will be available to the public in the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. The Dockets

Management Branch is open to the

public between 9 a.m. and 4 p.m.,

Monday through Friday.

2. Approved Requests for Alternative

Standard Notification (§ 900.18(d)(2)(ii))

(Comment 593). One comment

recommended that the justification level

for an alternative requirement in this

paragraph should be changed from the

benefit being so great that the time

required (typically more than 1 year) for

an amendment would be ‘‘an

unjustifiable risk to human health’’ to a

standard that established that the

alternative requirement ‘‘provides a

benefit to human health.’’

FDA believes that the criterion

suggested by the comment could be too

low for some ‘‘benefits,’’ and has

retained the provision as proposed.

3. Summaries (§ 900.18(d)(3))

(Comment 594). One comment stated

that the requirement for providing

summaries of alternative standards to

NMQAAC should be deleted because

NMQAAC does not have authority to

approve or reject actions of FDA in such

matters.

FDA agrees that NMQAAC does not

have approval authority in such matters,

but it does have the responsibility to

advise FDA on matters related to FDA’s

development and implementation of

standards. Because the agency cannot

gain the benefit of this advice on

alternative requirements without

informing NMQAAC about the

alternatives, FDA does not accept this

comment.

4. Applicability (§ 900.18(f))

This paragraph describes the

applicability of an alternative

requirement. The proposal limited the

use of the alternative to the applicant,

with the exception of alternative

requirements approved for

manufacturers of equipment, which

would apply to all users of the

equipment. Under the proposal, others

desiring to make use of other alternative

requirements would have to apply

separately.

(Comment 595). Four comments

stated that FDA should reserve the

authority to extend any approval

beyond the applicant. A fifth comment

went further and advocated automatic

extension of an approved alternative

requirement to all interested parties.

FDA originally placed the limitation on

the approval of alternative requirements

in order to assure itself that the

conditions that prompted the approval

of the original application also applied

for other applicants.

In light of these comments and after

further consideration, the agency has

concluded that the limitation would

impose an unnecessary resource burden

on applicants and FDA. Such a burden

is not warranted by the low probability

that an approved alternative

requirement should not be extended to

other interested and similarly situated

parties. However, because the program

is relatively new and the circumstances

that may trigger requests for alternatives

are so varied, FDA has concluded that

it should review the appropriateness of

each possible extension instead of

making it automatically approved as

suggested in the fifth comment.

Accordingly, § 900.18(f) has been

revised to permit expansion of the

approval of the alternative requirement

to other entities, but only after FDA has

determined that this would be an

effective means of promoting the

acceptance of measures to improve the

quality of mammography.

5. Other Changes

FDA has also made a change in the

administrative procedures included in

§ 900.18, realizing that the level of

delegation of authority to approve

alternative requirements may vary with

time or organizational changes. Thus,

the specific references to approval by

the Director of DMQRP have been

replaced by general references to

approval by FDA.

R. Conforming Amendments

Conforming amendments were made

to 21 CFR 16.1 to add §§ 900.7 and

900.14 to the list of provisions under

which regulatory hearings are available.

IV. Environmental Impact

The agency had determined under 21

CFR 25.34(c) that this action as

proposed is of a type that does not

individually or cumulatively have a

significant effect on the human

environment. Therefore, neither an

environmental assessment nor an

environmental impact statement is

required.

V. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866,

under the Regulatory Flexibility Act (5

U.S.C. 601–612), and under the

Unfunded Mandates Reform Act (Pub.

L. 104–4). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits
55962 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

(including potential economic,

environmental, public health and safety,

and other advantages, distributive

impacts, and equity). The Regulatory

Flexibility Act requires agencies to

analyze regulatory options that would

minimize any significant impact of a

rule on small entities. The Unfunded

Mandates Reform Act requires (in

Section 202) that agencies prepare an

assessment of anticipated costs and

benefits before enacting any rule that

may result in an expenditure in any 1

year by State, local, and tribal

governments, in the aggregate, or by the

private sector, of $100,000,000 (adjusted

annually for inflation).

The agency has conducted analyses of

the final rule, and has determined that

the rule is consistent with the principles

set forth in the Executive Order and in

these statutes. FDA’s analysis, as

summarized in the remainder of this

section, demonstrates that the final rule

constitutes an economically significant

rule, as described in Executive Order

12866. The agency has further

determined that the final rule may have

a significant economic impact on a

substantial number of small entities.

This discussion, therefore, along with

the other relevant sections of this

preamble and the agency’s final

Economic Impact Analysis (available at

the agency’s Dockets Management

Branch), constitute the agency’s final

regulatory flexibility analysis as

required under the Regulatory

Flexibility Act. Similarly, because this

rule is expected to result in

expenditures that exceed $100,000,000

in at least 1 year, these documents also

comprise the agency’s assessment of

anticipated costs and benefits under the

Unfunded Mandates Reform Act. The

final economic impact analysis also

includes all references.

FDA presented a summary of its

preliminary economic analysis in the

preamble to the proposed rule (61 FR

14856). That summary discussed the

potential costs and benefits of the

proposed rule and described the

findings of a more detailed industry

analysis conducted by FDA’s contractor,

the Eastern Research Group (ERG). In

response, the agency received numerous

comments that addressed economic

issues. FDA has examined and

evaluated the reasoning and data

presented in these comments and has

incorporated many of them into its

revised analysis of the final rule. The

following discussion provides a

summary of these impacts and presents

the agency’s responses to the relevant

public comments.

A. Incremental Costs

For its analysis of the incremental

costs of the proposed regulation (‘‘Cost

and Benefit Analysis of Regulations

Under the Mammography Quality

Standards Act of 1992’’; preliminary

final; March 14, 1996), FDA relied on

agency experts and technical

consultants to develop a broad profile of

mammography facilities and to identify

the type and cost of the additional

equipment and procedures that would

be needed to bring the affected facilities

into compliance. That analysis found

that the proposed rule would impose

annualized industry costs of

approximately $61.4 million. Upon

review of the resulting public

comments, FDA has maintained the

basic methodology for these estimates,

but updated or otherwise revised a

number of the input variables.

The full details of the cost estimates

for these final regulations are presented

in the agency’s final Economic Impact

Analysis, which is available for review

at the Dockets Management Branch and

at FDA’s home page on the World Wide

Web (www.fda.gov) the analysis

addresses only those costs that would

not have occurred in the absence of

these final regulations. The estimates

assume that at a minimum

mammography facilities are already

complying with the agency’s current

interim regulations and that a typical

facility will comply with each

requirement of the final regulation by

selecting the least costly method of

compliance. Current facility compliance

levels for the industry were derived for

early provisions of the final regulations

from published data services or

interviews with experts in

mammography. The cost estimates are

based on a facility cost model that

analyzes the inputs to a mammographic

examination (e.g., professional time,

amortization of fixed equipment costs,

variable costs of supplies) and derives

the contribution of each activity to the

average cost of conducting a

mammographic screen. The required

capital costs were developed from an

industry wide inventory of existing

equipment stock, which allowed FDA to

estimate the percentage of equipment

that will need to be modified or

replaced. The compliance cost

attributable to equipment requirements

was calculated by including the value

that this equipment will lose (based on

years of remaining asset life) and the

cost of retrofitting, if possible. The

aggregate costs were modeled over a 10-

year analysis period and allocated

among the industry sectors based on

facility screening volumes. This method

allowed FDA to analyze the effect of

compliance costs on small volume and

large volume facilities.

The analysis projects that yearly

expenditures for compliance by

mammography facilities will range from

a high of $156.2 million during the

second year of implementation to $9.5

million during the tenth year, with the

variation reflecting the phased

implementation dates for the individual

requirements. On an annualized basis

(over the 10-year period at a 7 percent

discount rate), the yearly costs will

equal about $38.2 million. Over the full

10-year period, the combined

expenditures and lost resources for the

largest cost element (replacement of

mammography units with units meeting

technical or quality assurance

standards) will total more than $241

million and contribute approximately

$28.5 million in average annual costs

(75 percent of the total average annual

costs). The other major annual cost

components include medical records

and reports, $4.6 million; quality

assurance systems, $3.4 million;

personnel qualifications, $1.6 million;

and consumer complaint mechanisms,

$0.1 million.

B. Incremental Benefits

The benefits of the final regulations

will result from improvements in

mammography quality and include: (1)

Additional life-years (or quality

adjusted life-years (QALY’s)) and

reduced costs of cancer treatment

gained by earlier stage identification of

breast cancers, and (2) less anxiety and

stress and reduced cost of followup

diagnostic mammographic screens and

other diagnostic procedures gained by

fewer false abnormal screens. While

data limitations preclude FDA from

developing a precise estimate of the

magnitude of these benefits, the agency

has constructed an impact model that

projects the expected health and cost

outcomes under various scenarios of

plausible mammography quality levels.

This model, which forecasts breast

cancer outcomes based on tumor stages

at time of initial identification, is

summarized below and fully described

in the agency’s aforementioned final

Economic Impact Analysis.

1. Baseline Estimates

The patient population affected by the

regulation includes all 79.3 million

women age 30 or older. Applying agespecific cancer incidence rates to the

number of women in each 10-year age

cohort projects approximately 180,600

new breast cancer cases annually, of

which about one-quarter may ultimately

prove fatal.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55963

About 90 percent of the 25 million

mammography procedures performed

each year are for screening procedures

in asymptomatic patients. Thus, FDA’s

impact model assumes a base of 22.5

million annual screens and 2.5 million

annual diagnostic (or subsequent)

mammograms in symptomatic patients.

Of the 22.5 million screens,

approximately 5 million (22 percent) are

for women over the age of 65 and 2.7

million (12 percent) are for women

younger than 40. The remaining 14.8

million annual screens are distributed

by size of each 10-year age category. The

age-specific cancer incidence rates

within each age cohort indicate that

about 56,900 of the 22,500,000 annual

screens are for women with breast

cancer and 22,443,100 are for women

without breast cancer.

Although the benefits of the rule

derive from increases in the quality of

mammography, the quality dimensions

are very difficult to measure. Each

mammogram is unique because each

patient is unique and many factors

contribute to quality, including those

that are not affected by these

regulations. While other measures have

been suggested (e.g., cancer yield and

PPV), FDA’s impact model relies on a

combination of sensitivity and

specificity levels to represent average

mammography quality. The sensitivity

of any diagnostic test is the proportion

of the tested, diseased population that is

correctly identified as diseased. Thus,

test sensitivity addresses the problem of

false negatives. The specificity of a test

measures the proportion of nondiseased

patients who are correctly identified as

not having the disease. Thus, test

specificity addresses the problem of

false positives.

If both sensitivity and specificity

improve toward 100 percent, the

proportion of ‘‘incorrect’’ mammograms

decreases. Although improvements in

one measure may come at the expense

of decreases in the other, as certain

technical changes can tradeoff

sensitivity for specificity, FDA finds

that the input changes required by this

regulation will raise the national

average of both measures. Thus, the

agency’s impact model measures quality

improvement as the percent decrease

(expressed as a percentage over the

current level) in the number of incorrect

diagnoses, both false positives and false

negatives.

Estimates of the current national

average levels of mammography

sensitivity and specificity are

approximate representations, because

they reflect literature examinations

based on different patient populations,

time periods, and definitions. Current

sensitivity measures in community

settings have ranged from 53 percent to

as high as 90 percent and specificity

measures have reached as high as 99

percent. However, several studies

indicate that mammography facilities in

research/academic settings have

sensitivity and specificity measures that

exceed most ‘‘typical, community

facilities’’ by 7 to 13 percent. Based on

these studies, FDA’s baseline estimates

assume that current national levels of

sensitivity and specificity average 80

percent and 90 percent, respectively.

The calculations use age-specific rates,

because breast tissue density varies by

age of patient.

The estimated 80 percent sensitivity

rate implies that while 45,400 of the

estimated 56,900 annually screened

women with breast cancer currently

receive a true positive result, 11,500

receive a false negative result. Thus,

FDA estimates that each year,

mammography fails to identify breast

cancers in an estimated 11,500 screened

women. The agency’s impact model,

which relies on a distribution of

identified cancers by development stage

and SEER incidence rates for both

screened and nonscreened populations,

predicts that about 4,300 of these 11,500

women will die of breast cancer within

20 years. The model implies that perfect

mammography would prevent about

1,200 of these fatalities. FDA recognizes

that perfect mammographic screening is

not yet technologically achievable, but

the agency is convinced that

mammography sensitivity rates can be

significantly improved, thereby

avoiding a substantial number of these

premature deaths.

Economic literature includes many

attempts to place a dollar value on

mortality avoidance for the purpose of

conducting cost/benefit analysis. A

common methodology estimates

society’s willingness to pay to avoid the

risk of a statistical death as evidenced

by wage premiums necessary to attract

employees to riskier occupations. These

data contain considerable variability,

but appear to average about $5 million

per death avoided. Thus, for illustrative

purposes, FDA’s analysis assumes a $5

million value to represent the societal

benefit of preventing a premature death.

The value of a life-year was estimated at

$368,000 and the value of a qualityadjusted life-year at $373,000.

FDA also believes that the improved

mammography quality gained by the

final regulations will significantly

reduce the rate of false positive results.

The above methodology indicates that

22,443,100 women without breast

cancer are screened annually.

Consequently, a baseline specificity

measure of 90 percent implies that

20,184,600 will receive true negative

results, but 2,258,500 others will receive

false positive results. FDA estimated the

cost of the anxiety and increased stress

associated with these false positive

screening results by assessing the

contribution of psychological well-being

to the overall quality of life.

The time between a patient

notification of a positive screen result

and the subsequent identification

through a followup diagnostic

mammogram was assumed to take about

1 month. The cost of enduring this

anxiety was assumed to detract from the

value of a quality-adjusted month value

of $31,100, i.e., $373,000 ÷ 12. Research

indicates that mental focus and

psychological well-being affected by a

major life crisis can contribute

approximately 8 percent to the overall

quality of life. Worries about health,

illness, and well-being may account for

approximately one-sixth of the stress

that would constitute a major life crisis.

To assess the potential effect, FDA’s

impact model assumes that 25 percent

of those patients who receive false

positive results would be willing to pay

about $415 ($31,100 x .08 x .167) to

avoid the stress and anxiety of a false

positive mammogram.

FDA also found that cancer treatment

costs vary by stage of detection, from

annual costs of $18,900 for the earliest

stage to $50,000 for the latest stage.

Other components of FDA’s model

address patient noncompliance with

screening results due to fear or denial.

Diagnostic mammography readings were

assumed to follow positive initial

screens, and additional followup

diagnostic procedures were assumed to

follow positive diagnostic results and to

identify lesions that were present

without screening. Based on limited

data, FDA’s model assumes that a small

number of those patients with positive

screens do not seek further treatment.

Figure 1 illustrates the model

components and baseline estimates.

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Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55965

2. Regulatory Impacts

The agency also finds that the impact

of these regulations could affect the

demand for mammography. One study

found a price elasticity of approximately

-0.2 for outpatient well care. As the

rules will likely raise mammography

prices as well as costs, FDA

incorporated this price elasticity into its

impact model. On the other hand,

improved mammography quality will

have a positive effect on mammography

demand. Assuming that the demand for

mammography for a subset of potential

patients exhibits a unitary elasticity

with respect to quality, FDA’s impact

model finds that a 5 percent increase in

mammography quality would roughly

offset the above price-induced decline

in demand, with the net change less

than .03 percent.

Because of the difficulty in assessing

the impact of the regulations on

mammography quality, no public

comments attempted to quantify the

likely health outcomes. Similarly, FDA

cannot predict the precise magnitude of

the quality improvement that will be

generated by these final regulations.

FDA believes, however, that the

mammography quality improvements

will be substantial and that gains as

small as 5 percent (i.e., reducing the

proportion of incorrect procedures by 5

percent by increasing average sensitivity

levels from 80 percent to 81 percent,

and specificity levels from 90 to 90.5

percent) would produce substantial net

benefits. The results of this analysis are

shown in figure 2. For example, when

compared to the baseline data (figure 1),

the number of earlier cancers detected

due to a 5 percent improvement in

mammography sensitivity would

prevent about 75 women per year from

dying of breast cancer within a 20-year

period. At $5 million per life saved, the

discounted value of this outcome is

about $234 million per year.

Alternatively, the model shows that a 5

percent quality improvement would

bring an annual increase of about 410

discounted QALY’s valued at $153

million. Thus, FDA estimates the benefit

of avoiding these premature mortalities

as ranging from $153 to $233 million

per year.

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Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55967

A 5 percent quality improvement

would also decrease cancer treatment

costs by about $1.9 million. In addition,

the reduction in false positives would

produce less anxiety and stress valued

at $12.7 million, and reduced diagnostic

costs of $14.5 million. In total, quality

improvements of 5 percent would

generate annual benefits of from $182 to

$263 million, far exceeding the expected

annual compliance costs of $38.2

million. From a cost-effectiveness

perspective, the cost per QALY would

amount to about $20,000. Even if the

overall quality improvement were only

2 percent, the estimated annual benefits

of the final regulation exceed the

estimated annual compliance costs.

C. Small Business Impact

According to the Small Business

Administration, any doctor’s office,

clinic, or hospital with $5 million or

less in revenue is considered small. In

addition, any not-for-profit enterprise

that is independently owned and

operated and not dominant in its field

is considered small. On this basis,

mammography is offered in about 4,800

small doctor’s offices or clinics and

5,000 small hospitals, comprising up to

98 percent of all mammography

facilities.

FDA recognizes that the nature of

these regulations may have a

disproportionate effect on very small

volume mammography facilities, as

fixed costs of compliance for equipment

improvements are likely to increase the

cost per mammogram for low volume

facilities relatively more than for high

volume facilities. The cost of a

mammogram is expected to increase by

3.4 percent in an average facility and by

4.2 percent in the smallest 10 percent of

facilities. However, total revenues are

also likely to increase. Overall, the

annual net revenues attributable to

mammography (gross revenues minus

gross costs) are estimated to decline by

approximately $1,000 in the smallest 10

percent of facilities, whereas the larger

facilities may experience net revenue

gains. ERG judged that these smallest

facilities would have an increased

vulnerability for closure. These results

are fully described in the agency’s final

Economic Impact Analysis.

FDA also examined the effect on

small businesses of alternative

implementation schedules for this

proposal. For example, one alternative

would have required an even more

elaborate equipment upgrade, effective

immediately upon issuance of the

regulations. The agency rejected this

alternative becauseit would have placed

an unnecessary burden on the industry,

costing more than $120 million

annually. By eliminating some

specifications that were marginal to

ensuring mammography quality, and

phasing in certain requirements to allow

for normal replacement of current

equipment, the agency substantially

reduced the cost of compliance. FDA

also considered postponing the

implementation of the final equipment

requirements by an additional year. This

alternative would have reduced the

annual compliance costs by $7.1

million, but delay the impact on quality

improvements. The final

implementation schedule was selected

as a reasonable balance between

compliance costs and quality

improvements. FDA also considered

providing an exemption for small

facilities in shortage areas, but

concluded that the importance of

mammography quality made this

tradeoff unacceptable, and that a

primary objective of MQSA was to

ensure quality for all patients. The

agency’s final Economic Impact

Analysis includes a discussion of

several additional alternatives.

D. Total Impact of the MQSA

The total compliance costs for all of

the regulations implementing the MQSA

are the sum of the costs for the interim

rules already in place, as well as for the

final regulations as estimated above.

Thus, to assess the total costs of the

MQSA, FDA also estimated the costs of

complying with the interim regulations.

Interim regulations implementing the

MQSA required facilities to be

accredited by an FDA-approved body as

a first step towards receiving a

certificate. FDA approved the ACR and

the States of Iowa, Arkansas, and

California to accredit facilities. The

standards used by these bodies to

accredit facilities were developed by

FDA, but are largely based on the

standards previously used by the ACR

in their voluntary accreditation

program. Because the ACR was the only

national accreditation body and had

already accredited approximately half of

the mammography facilities in the

country in its voluntary program, the

majority of unaccredited facilities

applied to the ACR for accreditation in

order to continue to provide

mammography services. On being

notified by the ACR or one of the State

bodies that a facility was accredited,

FDA issued a certificate to the facility.

Approximately 5,500 facilities had

not fully completed the accreditation

and certification process by October 1,

1994 and approximately 1,000

accredited facilities were assumed to

incur low levels of compliance cost.

FDA estimated the costs of compliance

with the interim rule by dividing these

6,500 facilities (5,500 unaccredited and

1,000 accredited) into groups with low,

moderate, and high levels of

noncompliance. Approximately 4,500 of

these facilities had completed the

accreditation and certification process

by the end of the 6-month period of the

provisional certificates or required

minor improvements to achieve

accreditation. These facilities were

assumed to have low levels on

noncompliance. Approximately 1,500

were able to complete the accreditation

and certification process by the end of

a 90-day extension of their 6-month

provisional certificate. These facilities

were assumed to have a moderate level

of noncompliance. The remaining

approximately 500 facilities were

assumed to have a high level of

noncompliance.

Discussions with expert consultants

and operators of mammography

facilities indicated that a low level of

noncompliance would typically include

minor recordkeeping and personnel

training deficiencies. A moderate

noncompliance level would typically

include (beyond the low level) some

quality assurance deficiencies and

equipment requiring retrofit. Finally,

facilities with high levels of

noncompliance would incur costs for

replacement of a mammography unit (in

addition to ‘‘moderate’’ costs less

retrofit). Based on this methodology,

FDA estimates the annual costs of the

interim rule at about $23.4 million.

Adding the additional $38.2 million

cost attributable to the final rules

indicates that the total annual

compliance costs of the MQSA are about

$61.6 million.

The benefits of the interim rules result

from their impact on mammography

quality. A poll of industry experts

indicated that the interim rules may

have improved mammography quality

by between 2 and 10 percent. Other

reports have estimated that based on

1992 levels of quality, typical

community quality levels may have

been as much as 13 percent below the

quality levels found in academic or

research centers. FDA agrees that postinterim levels of quality may be

approximately 10 percent lower than

those found in typical academic

settings, which implies a relative quality

gain of 3 percent due to the interim

regulations. FDA also found that, given

average annual compliance costs of

$23.4 million for the interim

regulations, a 3.1 percent quality

improvement would account for the

current level of mammography use (all

else being equal). Thus, FDA estimates

that the interim regulations have
55968 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

resulted in an approximate 3 percent

increase in mammography quality. With

this assumption, FDA’s impact model

calculates that the overall annual

benefits of the interim rule range from

$108 to $155 million, including the

annual gain of about 44 lives and 242

discounted QALY’s.

E. Conclusions

In summary, the final regulations will

generate mammography quality

increases above those already achieved

by the interim regulations. As shown in

the summary table, the annual costs of

compliance with these final regulations

are estimated at $38.2 million. Expected

benefits will accrue as a result of fewer

breast cancer fatalities due to the earlier

detection of lesions and the avoidance

of unnecessary surgery. While the

magnitude of the expected quality

increases are uncertain, an improvement

of 5 percent in mammography

sensitivity and specificity would result

in annual benefits valued at from $178

to $257 million. With respect to all of

the MQSA requirements, the annual

compliance costs of the combined

interim and final regulations equal

about $61.5 million, and the annual

benefits (assuming total quality

increases of 8 percent) range from $284

to $408 million.

TABLE 1.—SUMMARY OF ECONOMIC IMPACTS (MILLION $)

Interim Rule1 Final Rule2 Total3

Compliance Costs 23.4 38.2 61.6

Benefits 108.2–153.8 181.7–262.7 289.9–416.5

Diagnostic Cost Decreases 9.0 14.5 23.5

Treatment Cost Decreases 1.1 1.9 3.0

Anxiety Cost Decreases 7.8 12.7 20.5

Value of Lives Extended 90.3–135.9 152.6–233.6 242.9–369.5

1Assumes 3 percent increase in mammography quality

2Assumes 5 percent increase in mammography quality

3Assumes 8 percent increase in mammography quality

F. Responses to Comments on the

Impact Analysis of the Proposed

Regulation

1. Cost Analysis

FDA published a preliminary impact

analysis in association with the final

regulations on April 3, 1996. Public

comments were invited on the

methodology and projections included

in that analysis.

One comment disagreed with the costbenefit analysis and stated that the

imposition of additional costs would

adversely affect public health because

fewer women will be able to receive the

benefits of mammography.

FDA agrees that additional costs with

no concurrent quality improvement may

adversely affect mammography access.

FDA also recognizes that access without

quality is of no public benefit. FDA

believes, however, that the assurance of

quality resulting from these regulations

will overcome any possible negative

impacts. This belief is supported by a

CDC study on mammography utilization

that showed a continued increase in

screening mammography examinations

under the MQSA interim rules (Ref. 4).

One comment stated that most CEU

classes for technologists cost between

$75.00 and $100.00 for 6 to 8 credits,

and require additional travel expenses.

FDA agrees with the estimate provided

by this comment. FDA estimated that

the cost per hour of technologist’s CEU

would cost approximately $16.00 per

credit hour and used this estimate in its

impact analysis. This estimate was

based on input from consultants and is

within the range presented by this

comment.

Numerous comments stated that the

Federal Register notice for the proposed

rule lacked sufficient methodological

detail and should have included the

cost of each requirement and the per

facility or per procedure cost.

FDA agrees that the summary of

impacts included in the Federal

Register did not include detailed

methodologies, discussions of

assumptions, and sources of data.

Nevertheless, as is required, FDA had

provided a clear explanation of the

calculations used for the cost/benefit

analysis in the Full Regulatory Impact

Analysis which was available for review

at the Dockets Management Branch.

Similarly, the agency’s final Economic

Impact Analysis, which provides

substantial detail on the cost estimates

is available at the same location that

document can also be retrieved from

FDA’s home page on the World Wide

Web (www.fda.gov).

A number of comments asserted that

the equipment requirements would

mandate the replacement of most

mammography units and would

increase the cost of these replacement

units and that these costs were

underestimated by FDA. One comment

calculated the cost of replacing 15,000

mammography units, priced at $70,000,

at more than $1 billion. The comment

also calculated the cost of replacing

5,000 processors (1⁄2 of total), priced at

$15,000, at $75 million.

FDA disagrees with the assumption

that all mammography units in the

country (which actually number about

12,000 instead of 15,000) or even most

units will have to be replaced in order

to meet the final rules. The Economic

Impact Analysis that accompanies this

final rule includes a detailed discussion

on the estimation of the replacement

costs. FDA has estimated the costs of the

equipment requirements of the

proposed rule by estimating

replacement and retrofit costs through

contacts with mammography equipment

manufacturers. For replacements, the

analysis considers the lost useful life of

the machine. FDA also solicited input

on compliance costs from

mammography unit manufacturers and

project consultants. These

manufacturers indicated that not all

mammography units would require

replacement or retrofit and that prices

for the new units would be identical to

current prices. Based upon these

sources of information, FDA estimated

the total costs related to the equipment

requirements of the proposed

regulations to be approximately $270

million or $35 million in average annual

costs (over the 10-year analysis period at

a 7 percent discount rate). The agency

notes that, after consideration of the

public comments and other information,

a number of equipment requirements,

including those related to processors,

were deleted before these regulations

were issued. The impact of those

deletions was to reduce the total

estimated expenditure of meeting the

equipment requirements in lost

resources to $241 million and the

average annual costs over the 10-year

analysis period to $28.5 million.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55969

One comment stated that phasing in

equipment requirements 5 and 10 years

after the effective date of the regulations

would significantly increase costs if

facilities are required to replace the unit

in 5 years and then again in 10 years.

FDA believes that this comment stems

from a misinterpretation of the proposal.

FDA did not expect facilities to replace

units every 5 years. Input on the

equipment requirements from

manufacturers indicated units would be

available almost immediately after the

regulations were published that would

be able to meet the 5- and 10-year

requirements. Thus, if a unit had to be

replaced to meet an immediate

requirement, a new unit could be

selected that would meet the 5- and 10-

year requirements as well. The facility

would not need to purchase additional

replacement units ‘‘every 5 years.’’

FDA’s purpose in phasing in some

requirements 5 and 10 years in the

future was to provide time for facilities

whose units met the immediate

requirements but not the 5- or 10-year

requirements to replace those units on

their regular replacement schedule. This

would decrease the burden by allowing

machines to be replaced as they reach

the end of their useful life. However, for

reasons discussed in the responses to

the comments on the equipment

requirements, most of the 5-year

requirements and all of the 10-year

requirements were removed before these

final regulations were issued.

Two comments expressed concern

that the cost requirements for training

every technologist to perform weekly or

daily phantom checks were not

considered in the impact analysis of the

proposed regulations. Another comment

estimated that the cost of performing the

daily phantom tests for 240 days per

year at $0.80 per sheet of film would be

an additional $192.00 per unit. Using

the estimated 10,800 certified units this

would mean an additional cost of

$2,073,600 per year.

FDA notes that the weekly phantom

tests are identical to those currently

being performed monthly under the

interim regulations. No additional

training costs will be incurred beyond

those already included in the cost

estimates of the interim regulations.

FDA did not include any cost

requirements for training to perform the

daily phantom checks or for

performance of the test because the

agency did not propose such a test but

merely requested public comment on its

possible value. As previously discussed,

FDA concluded from the public

comments that further studies would be

needed to confirm the value of such a

test before it was made a regulatory

requirement. Because it was not made a

regulatory requirement, no costs either

for training in its performance or

performing the test needed to be

included in these cost estimates.

A number of comments stated that

FDA underestimated costs by not

considering all of the factors that will

contribute to increased provider and

consumer cost.

FDA’s Economic Impact Analysis has

attempted to consider all of the factors

that will contribute to increased costs

from compliance with the final rule.

This analysis is available through the

Dockets Management Office, as well as

the World Wide Web. As these

comments did not identify the factors

believed to have been overlooked, the

agency is unable to give a more specific

response.

Numerous comments asserted that the

cost of lay notification would

significantly increase the costs of

mammography. These comments

estimated that the cost ranged from

$0.78 to $15.00 per notification.

For the proposed rule, FDA used a

methodology to estimate the cost of

patient notification that is similar to that

described in the comments. The

Economic Impact Analysis presented an

estimate of $0.94 per written

notification including 2.5 minutes of an

office staff worker’s time and cost of

postage. However, this proposed

requirement was removed from the final

rule before it was codified, so these

estimated costs will not occur.

A number of comments stated that the

increased costs to comply with the final

rule will result in facility closings

(especially for small-volume facilities

and rural facilities) and loss of access.

One comment also stated that FDA has

not adequately justified the cost of the

regulation in the face of reducing access

to low income populations.

FDA agrees that it is possible that

increased costs of conducting

mammography due to these regulations

may cause some facilities to close if

those facilities are currently not offering

high quality mammography. However,

FDA disagrees that such an impact has

not been adequately explored. FDA has

attempted to identify areas of potential

access problems and believes that very

few patients would be adversely

affected if, as is anticipated, few, if any,

facilities close as a result of the burdens

of the final regulations. When facilities

do close, alternate facilities are usually

expected to be available within a

reasonable distance. The agency also

notes that the GAO study cited earlier

found that the interim regulations,

which had a similar cost impact, had

little impact on access. FDA agrees that

access for low income women is a

potential problem, but does not believe

that these regulations will greatly

increase this problem. Nevertheless,

FDA will monitor this potential

outcome to ensure that any adverse

impact on underserved populations is

minimized.

One comment stated that costs were

underestimated because only the

incremental costs of nonvoluntary

compliance were identified.

FDA disagrees with this comment.

The quality standards contained in

these regulations reflect standards of

good practice, so it would not be

surprising to find that many facilities

were already complying with them

before the regulations went into effect.

Where voluntary compliance with

regulatory requirements existed prior to

implementation of the rule, costs were

not included in the agency’s Economic

Impact Analysis because they are due to

the facility’s own desire to achieve

quality mammography and not to the

regulations. FDA agrees that if

compliance costs occur only as a result

of or in anticipation of a regulation and

would be discontinued in its absence,

such costs should be considered.

However, FDA believes that most

mammography facilities did not

anticipate the specific regulatory

requirements of this rule, and so any

past actions to improve quality at their

facilities were independent actions on

their part.

Several comments noted that the

proposal included only costs associated

with the proposed regulations and not

the interim rule. They stated that the

costs and benefits of the entire MQSA

should be estimated.

FDA agrees with these comments and

has included estimates of the interim

impacts for these final regulations.

One comment noted that costs may be

understated because FDA assumed the

lowest compliance cost. This comment

stated that because some facilities

would incur higher costs, the overall

costs were underestimated.

FDA disagrees with this comment.

The agency assumed that each facility

would adopt a least-cost compliance

strategy, which is standard economic

methodology for analysis of regulations

as required by Executive Order 12866.

While some facilities would have higher

costs, other facilities would have lower

(or no) costs. Thus, the least-cost

method of compliance for the average

facility is a reasonable method of

estimating industry wide costs. It is

possible that this comment

misunderstood the methodology used to

estimate costs.
55970 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

One comment stated that FDA has not

adequately accounted for decreases in

mammography usage due to expected

cost increases.

FDA has attempted to address this

issue for the final regulations. FDA

agrees that cost increases are likely to

decrease mammography use, all else

being equal, but that perceived increases

in mammography quality are likely to

offset any negative impact. This issue is

discussed above in B.2 and in the

Economic Impact Analysis that

accompanies the final rule.

One comment asserted that FDA’s

costs were ‘‘unrealistic,’’ rely only on

consultant opinion and are, therefore,

unreliable.

FDA disagrees with this comment.

Cost estimates were derived from an

extensive process of site-visits and

expert input and no alternative data

were included with this comment. The

agency’s cost methodology is fully

detailed in the Economic Impact

Analysis.

Several comments noted that specific

activities were underestimated. FDA

cannot respond to these comments

because no supporting data were

supplied.

2. Benefits Analysis

A number of comments maintained

that FDA overstated the expected

improvement in avoiding cancer deaths

from the final regulation and that the

benefit estimates should be based on

scientific literature.

FDA believes that quality

improvements in mammography will

result in health gains, of which

reductions in breast cancer mortality are

a major contributor. FDA has attempted

to assess the potential quality gains from

the requirement of the final rule by

reviewing relevant literature and

through contact with experts in

mammography quality. The Economic

Impact Analysis that accompanied the

proposed regulations included a

detailed and referenced description of

the benefits estimate. Similarly, the

analysis of impacts for the final

regulations include, a comprehensive

description of the methodology.

One comment maintained that the

final rule was a waste of money because

the ACR program has already

accomplished a goal of ‘‘reasonably

achievable mammographic quality.’’

FDA disagrees with this comment.

While voluntary accreditation by ACR

did much to improve quality in

participating facilities, the agency notes

that, at the time of passage of the

MQSA, less than half of the

mammography facilities in the country

had sought voluntary accreditation. The

MQSA and its implementing regulations

have led to the establishment of a

uniform minimum set of quality

standards to be met by all

mammography facilities, including

standards in areas not previously

covered by the ACR program, and have

provided increased assurance that these

standards continue to be met between

the times of accreditation. As shown in

the above impact analysis, the agency

believes that the benefits achieved more

than compensate for the additional

costs.

One comment stated that there has

been a significant improvement in the

quality of mammography performed

under the interim regulations and

further maintained that this quality

improvement will continue under the

final regulations.

FDA agrees with this comment.

Quality improvements attributable to

the interim regulations are estimated in

conjunction with those attributable to

the final regulations.

Several comments stated that because

sensitivity is defined as the number of

true positives divided by the number of

true positives plus false negatives, a

gain in sensitivity rate would have no

effect on the false positive rate.

FDA agrees with these comments.

FDA believes that both false negatives

and false positives would be reduced by

the quality improvements expected from

these regulations. Thus, FDA believes

that expected quality improvements

would be likely to improve both

sensitivity and specificity of screening

mammography examinations. FDA

notes that a typographical error in the

analysis of impacts accompanying the

proposed regulations may have

contributed to these comments.

One comment stated that the

discussion on sensitivity confuses the

notion that there are inherent tradeoffs

between sensitivity and specificity with

the mathematical reality that this is not

necessarily the case. The respondent

believed also that this error may be due

to confusing sensitivity with PPV.

FDA recognizes that the sensitivity

and the PPV of a diagnostic test are not

identical. Nonetheless, FDA believes

that sensitivity and specificity provide

reasonable quality measures for

evaluating these final regulations.

Several comments stated that there is

an error in the benefits analysis where

it states, ‘‘a five percent gain in

sensitivity measurements of 80 percent

would indicate a revised sensitivity

level of 81 percent (a reduction of the

rate of false positives from 20 to 19

percent).’’ The comments stated that 5

percent gain to 80 is 84 not 81.

FDA agrees that the description of the

impact was not well stated. A 5 percent

quality improvement is defined in

FDA’s analysis as a 5 percent reduction

in inaccurate testing results. Thus, if 20

percent of the diseased, screened

population are currently not identified,

a 5 percent quality improvement would

see 19 percent not identified. The 5

percent is actually a 5 percent reduction

in the complement of sensitivity.

Numerous comments asserted that the

estimated willingness to pay to avoid a

statistical loss of life of $5 million was

too high and was unsupported.

FDA disagrees with these comments.

For illustrative purposes, FDA has

quantified the decreased breast cancer

mortality potentially resulting from the

rule using an average value of $5.0

million per each avoided death. This

value is the implied value of society’s

willingness to pay to avoid the

likelihood of an additional death as

derived from economic literature, as

referenced in the full Economic Impact

Analysis. The methodology used to

estimate this value is based on wagepremiums necessary to induce workers

to accept riskier occupations and is a

commonly used approach for estimating

the value that society appears to be

willing to pay to avoid a statistical

death.

Several comments questioned the

probability of expected benefits

accruing from improvements in

specificity. The comments identified

this as the area where the greatest cost

savings could be realized, and

underlined this area as one which

should be a target for improvement by

the MQSA. Relatively small

improvements in specificity could

markedly reduce the numbers of false

positive results nationwide, resulting in

less diagnostic testing.

FDA agrees with these comments.

These cost savings were addressed for

the proposed regulations and are

addressed for these final regulations.

One comment stated that raising the

sensitivity of a test results in an increase

in the false positives rather than a

decrease.

FDA disagrees. The agency finds that

quality improvements made to comply

with the final rule are likely to improve

sensitivity and/or specificity by raising

the typical community receiver

operating characteristic curve toward

the optimum level. That is, quality

improvements due to these regulations

would change the entire relationship

between sensitivity and specificity by

improving the production function of

mammography. As a result, both

measures would be improved by these

regulations.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55971

One comment questioned the use of

identified cancer stages used in the

benefit analysis and noted that there is

controversy associated with the impact

of ductal carcinoma in situ on health

outcomes.

FDA agrees with this comment and

adjusted the benefit analysis for the

final regulations. One comment asserted that benefits

were overstated because the general

trend in mammography was toward

higher quality even in the absence of the

regulations. FDA disagrees that the beneficial

impact of these regulations has been

overstated. Current trends in

mammography quality are accounted for

in baseline conditions.

Several comments noted areas of

potential benefit that were not

accounted for in the analysis that

accompanied the proposal. These areas

include the benefit of increased

assurance to patients, the benefits of

increased diagnostic quality, and

reductions in treatment costs for

identified cancers.

FDA agrees with these comments and

has included these categories in this

final analysis. One comment stated that references

for the benefit analysis were not

available. FDA notes that references

were included with the Economic

Impact Analysis that accompanied the

proposed regulations. One comment noted that the affected

population would change over time and

that FDA has assumed a static

population. FDA agrees with this comment. FDA

notes, however, that forecasting changes

in future populations would likely

increase the expected benefits because

of the age distribution changes expected

as the baby boom generation moves into

ages of greater risk from breast cancer.

Several comments questioned the

assumptions used in FDA’s benefit

estimation model.

FDA agrees that several of the key

assumptions are uncertain.

Nevertheless, the agency believes that

the absence of scientific certainty does

not preclude the development of

preamble projections based on

reasonably supported amplifying

assumptions. The Economic Impact

Analysis for these final rules provides

sensitivity analyses that demonstrate the

effects of modifying a number of these

variables.

VI. Paperwork Reduction Act of 1995

A. Information Collection Provisions in

the Final Rule

This final rule contains information

collection provisions that are subject to

review by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The following title, description,

and respondent description of the

information collection provisions are

shown with an estimate of the annual

reporting and recordkeeping burden.

Included in the estimate is the time for

reviewing instructions, searching

existing data sources, gathering and

maintaining the data needed, and

completing and reviewing each

collection of information.

Title: Reporting and Recordkeeping

Requirements for Mammography

Facilities.

Description: The final rule collects

information from accrediting bodies and

mammography facilities. Under the final

rule, each accreditation body is required

to submit applications and establish a

quality assurance program. Each

mammography facility is required to

establish and maintain a medical

reporting and recordkeeping system, a

medical outcomes audit program, a

consumer complaint mechanism, and

records documenting personnel

qualifications.

These information collection

requirements apply to accreditation

bodies and to mammography facilities.

In order to be an approved accreditation

body, private nonprofit organizations or

State agencies must submit an

application to FDA and establish

procedures and a quality assurance

program. Mammography facilities must

obtain and prominently display an FDAissued certificate or provisional

certificate; have a medical reporting and

recordkeeping program, a medical

outcomes audit program, and a

consumer complaint mechanism; and

maintain records documenting

personnel qualifications. These actions

are being taken to ensure safe, accurate,

and reliable mammography on a

nationwide basis.

Respondent Description: Businesses

and other for-profit organizations,

nonprofit organizations, Federal, State,

and local governments.

FDA estimates the burden of this

collection of information as follows:

Requirements for Accreditation Bodies of Mammography Facilities and Quality Standards and Certification Requirements

for Mammography Facilities; General Facility Requirements

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours Total CapitalCosts

Total Operating

& Maintenance

Costs

900.3 6 1 6 60 360

900.3(b)(3) 10 1 10 60 600 $50

900.3(c) 4 0.14 0.56 15 8.4

900.3(e) 1 0.2 0.2 1 0.2

900.3(f)(2) 1 0.2 0.2 200 40

900.4(c) and

(d)1 834 1 834 1 834

900.4(e)2 10,000 1 10,000 8 80,000

900.4(f)3 1,000 1 1,000 14.5 14,500

900.4(h)4 6 1 750 6 4,500

900.4(i)(2) 1 1 1 1 1

900.6(c)(1) 1 1 1 1 1

900.11(b)(2) 25 1 25 2 50

900.11(b)(3) 5 1 5 .5 2.5

900.11(c) 10,000 0.0050 50 20 1,000 $1,000

900.12(c)(2) 100 1 100 5 500

900.12(j)(1) 10 1 10 1 10

900.12(j)(2) 1 1 1 50 50

900.15(d)(3)(ii) 10,000 0.0020 20 2 40 $100

900.18(c) 10,000 0.0005 6 2 12 $60
55972 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN—Continued

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours Total CapitalCosts

Total Operating

& Maintenance

Costs

900.18(e) 10 0.1000 1 1 1 $10

TOTAL 102,510 $50 $1,170

1Formerly § 900.4(b) under the interim rule. 2Formerly § 900.4(d) under the interim rule. 3Formerly § 900.4(e) under the interim rule. 4Formerly § 900.4(g) under the interim rule.

Requirements for Accreditation Bodies of Mammography Facilities and Quality Standards and Certification Requirements

for Mammography Facility Requirements; General Facility Requirements and Personnel Requirements

TABLE 3.—ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

Total Operating

& Maintenance

Costs

900.3(f)(1) 10 130 1,300 200 2,000

900.4(g)1 10,000 1 10,000 1 10,000

900.11(b)(1)2 1,000 1 1,000 1 1,000

900.12(c)(4)3 10,000 1 10,000 1 10,000

900.12(e)(13) 6,000 52 312,000 0.125 39,000

900.12(f) 10,000 1 10,000 1 10,000

900.12(h) 10,000 2 20,000 0.5 10,000 $20,000

TOTAL 82,000 $20,000

1Formerly § 900.4(f) under the interim rule. 2Formerly § 900.11(c)(1) under the interim rule. 3Formerly § 900.12(e)(1) under the interim rule.

Most of this burden is not new, but

rather results from requirements

continued from the interim rule. FDA

estimated the annual burden for

reporting and recordkeeping

requirements under the interim rule to

be 120,944 hours (58 FR 67562 and

67569). The additional requirements

contained in these final rules will add

63,566 burden hours to this estimate,

resulting in an estimated total annual

burden of 184,510 hours.

The burden estimate for this final rule

differs from the proposed rule in several

respects (see 61 FR 14865 to 14868).

First, FDA revised § 900.12(c)(2), which

proposed written notification of

examination results to all

mammography patients. The final rule

requires that each facility maintain a

system to ensure that the results of each

mammographic examination are

communicated to the patient in a timely

manner. This revision resulted in the

removal of proposed § 900.12(c)(2)(i)

from the paperwork burden estimates.

Second, FDA revised § 900.12(d)(2),

which proposed the specific

documentation to be maintained by

each facility as part of its quality

assurance program. This revision

included removing §§ 900.12(d)(2)(i),

900.12(d)(2)(ii) and 900.12(d)(2)(iii)

from the final rule and combining

§§ 900.12(d)(2) and 900.12(d)(2)(iv) from

the proposed rule into § 900.12(d)(2) for

the final rule. This revision is reflected

in these estimates of the recordkeeping

burden. Third, FDA added several

reporting and recordkeeping burden

estimates that are not new to the final

rule, but whose impact was overlooked

in the burden estimate for the proposed

rule. Also, FDA renumbered some of the

provisions for the final rule, due to

removal or additions of other

provisions; these revisions had no effect

on the paperwork burden estimates. The

following sections concerning

paperwork burden were renumbered:

§ 900.4(a)(7) in the proposed rule is

§ 900.4(a)(6) in the final rule, and

§§ 900.12(f)(2) and 900.12(f)(4) in the

proposed rule are §§ 900.12(f)(1) and

900.12(f)(3) in the final rule,

respectively.

B. Comments on the Paperwork

Reduction Act Statement

As required by section 3506(c)(2)(B)

of the Paperwork Reduction Act, FDA

provided an opportunity for public

comment on the information collection

provisions of the proposed rule (April 3,

1996). A small number of comments

addressed FDA’s Paperwork Reduction

Act statement. In general, these

comments asserted that FDA had

underestimated burden or had not

considered all of the reporting and

recordkeeping requirements.

One comment stated that FDA’s

Paperwork Reduction Act statement

underestimated the time burden on

mammography facilities for

recordkeeping and reporting. The

comment further stated that FDA’s

estimate of 23,553 hours, which

translated into less than 2.5 hours per

facility (based on an estimated 10,000

mammography facilities in the United

States), was low. The comment asserted

that FDA underestimated or ignored the

incremental burden on facilities from

the interim rule to the final rule. The

comment further stated that at least one

person at each mammography facility
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55973

must understand the final rule. The

author of the comment estimated this

task at 10 hours per person at each of

the estimated 10,000 mammography

facilities.

FDA disagrees with this statement in

general, but upon review of the burden

estimates under the proposed rule FDA

has revised some of the time estimates.

For example, FDA has added hours to

cover § 900.12(e)(3)(13), infection

control, because its burden was

overlooked under the paperwork burden

analysis of the proposed rule.

FDA also agrees that someone in the

mammography facility will have to

understand the final rule and that it will

take some time to develop this

understanding. The agency believes,

however, that the time estimate

suggested by the comment is far too

high. This belief is based upon three

considerations. First, the basic

framework of the requirements has not

significantly changed from the interim

rule. Many of the additional details in

the final rule are taken from policies

developed under the interim rule, with

which the facilities are already familiar.

Because of this overlap, the time

required to understand the final rule is

less than it would be if they were

entirely new. Second, the recordkeeping

and reporting burdens are estimated on

an annual basis; therefore, each estimate

is stated as an average time per year.

Whatever burden there would be in

understanding the new regulations

would be primarily a one-time burden.

If an individual spends x hours the first

year developing an understanding of the

regulations, the time required in the

second and subsequent years will be

much less than x because the person

will already be familiar with them. The

average time per year for understanding

the regulations thus would be only a

small fraction of x. Third, in compliance

with the Paperwork Reduction Act, it is

the time burden for reporting and

recordkeeping that is being estimated.

Thus, only the time required to

understand the new reporting and

recordkeeping requirements, not to

understand the total requirements,

would properly be included in these

estimates. The combined effect of these

three factors, the agency believes,

reduces the time burden for

understanding the requirements that

should be included in these estimates

significantly. The burden for

understanding each requirement has

been included in the individual burden

estimates for that requirement.

One comment stated that FDA had not

estimated any burden for compliance

with proposed § 900.12(f), which

requires each facility to implement a

medical outcomes audit. The author of

the comment estimated that the burden

of such a requirement would require at

least 10 hours of an interpreting

physician’s time at each of the estimated

10,000 mammography facilities. Several

other comments also stated that

proposed § 900.12(f) was an undue

burden on freestanding facilities. The

comments discussed the difficulty in

tracking down and obtaining all biopsy

and consultation outcomes. One

comment noted the lack of evidence that

outcome measurement contributes to

improved care.

FDA understands the difficulty with

tracking outcomes data but such data

are critical in assessing the quality of

mammography at facilities. FDA also

notes that most of the requirements in

§ 900.12(f) do not require any additional

reporting or recordkeeping burden

beyond what was required under the

interim rule.

One comment also asserted that FDA

had failed to include the time burden

for proposed § 900.12(g), which adds

requirements for mammography of

patients with breast implants. The

comment stated that FDA should have

estimated the time burden related to

scheduling patients with implants,

documenting patients with implants,

and requiring the presence of an

appropriately trained interpreting

physician onsite during mammography

of women with implants. The author of

the comment estimated that the above

would require an additional 10 to 20

hours of reporting and recordkeeping at

each mammography facility.

As discussed previously, FDA has

changed the proposed requirement that

each facility should inquire whether a

patient has an implant at the time of

scheduling to a requirement in the final

rule that each facility shall inquire as to

whether the woman has an implant

prior to the examination. The final rule

also eliminated the requirement that an

interpreting physician be present. Even

under the proposal, the additional

recordkeeping time would have been

minimal and the revision in the final

rule gives the facility flexibility in

determining when and how the

information is collected for the patient’s

record. All facilities maintain patient

records with information such as

address, telephone number, insurance

information, and medical history. The

additional time to ask a yes or no

question on implants and record the

answer is negligible.

Another comment stated that FDA

had failed to estimate the additional

requirements and documentation

associated with personnel requirements

in proposed § 900.12(a). The comment

estimated that additional

documentation requirements would

necessitate at least 5 hours of additional

time for approximately 1,000 medical

physicists, and approximately 1⁄4 hour

for each mammography facility.

FDA acknowledges that § 900.12(a)

contains some increases in the required

level of personnel training and

experience from the interim rule.

However, FDA did not include any

recordkeeping burden estimates for the

personnel requirements under either the

interim or final rules because the agency

believes that it is usual and customary

practice for mammography facilities to

keep records of the qualifications of

their employees.

Although this position makes moot

the question of the amount of time

required for recordkeeping related to

these requirements, FDA would like to

note that there are factors that the

author of the comment may not have

been aware of that make the estimates

in the comment excessive. Most changes

in the personnel qualifications are only

increases in the amounts of the interim

requirements. In such cases there is no

additional recordkeeping burden. It

requires no more effort, for example,

under the final rule, to keep a letter in

a doctor’s records indicating that he or

she had 3 months of training in

mammography during residency that it

did, under the interim rule, to keep a

letter indicating he or she had 2 months

of such training.

For most of the new personnel

requirements in the final rule, such as

the continuing experience requirements

for technologists and physicists, the

information that bears on whether these

requirements are met often already

exists in the form of various work

records. All that is needed is to place a

copy or summary in each person’s file.

The remaining new standard

establishes an initial requirement of a

minimum level of education and

training for medical physicists. FDA

believes that the majority of physicists

providing services to mammography

facilities will have exceeded this level

in meeting the requirement that the

medical physicist be board-certified,

State licensed, or State approved, which

was retained from the interim rule. In

such cases, the agency intends to

minimize the burden by accepting the

documentation of board approval, State

licensure, or State approval (in States

whose standards for approval exceed

the minimum level) as adequate

evidence that the second requirement is

also met.

Physicists approved by States that

require a level of qualification for

approval lower than that in the second
55974 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

requirement will have to provide

additional documentation but the time

required is likely to be significantly less

than the 5 hours estimated in the

comment. More importantly, as this is

an initial requirement, it will be a one

time burden. To be compared with the

other burden estimates, it must be

averaged over the physicists’s entire

career, which could be 30 years or

longer.

Again, because keeping records of

personnel qualifications is usual and

customary practice, FDA has not

included this in the burden estimates.

The agency notes, however, for the

reasons discussed above, that the

comment greatly overestimates the time

required for the new recordkeeping.

One comment stated that virtually all

of the requirements in the proposed rule

duplicate requirements of accreditation

bodies and noted that FDA inspectors

require much of the same personnel

documentation required by the ACR.

FDA notes that the author of the

comment has misunderstood the nature

of the accreditation system required

under the MQSA. The requirements of

the FDA-approved accreditation bodies

are not established by those bodies but

rather are FDA-established quality

standards that the accreditation bodies,

as a condition of their approval, must

ensure are met by the facilities they

accredit. Thus, there is only one set of

requirements, not two or more duplicate

sets, and the actions identified in the

comment are mandated by the

legislation in order to increase the

likelihood that quality mammography

will be consistently achieved.

Several comments asserted that the

proposed rule would create an

unnecessary amount of paperwork that

would ultimately take away from time

with patients. One comment asserted

that the reporting requirements would

necessitate a computer system and

additional clerical support.

FDA has attempted to limit the

paperwork burden to only those

recordkeeping and reporting

requirements necessary to ensure that

facilities meet minimum quality

standards. As discussed above, FDA has

also reduced the paperwork burden of

the final rule by removing several

reporting and recordkeeping

requirements from the final rule. The

agency believes that the paperwork

impact, as estimated in Tables 1 and 2,

is not unreasonable in view of the

benefits to be gained from the quality

standards that made the recordkeeping

and reporting necessary.

A number of comments asserted that

proposed § 900.12(c)(2), which would

have required written notification of

mammographic examination results to

all mammography patients, would cost

time and postage expenses and would

generate much paperwork. Some

comments asserted that this practice

would be redundant for patients with

referring physicians who could explain

the results.

FDA has revised § 900.12(c)(2) to

require that each facility shall maintain

a system to ensure that the results of

each mammographic examination are

communicated to the patient in a timely

manner. FDA has allowed for increased

flexibility in the notification of patients

by allowing written or other notification

by either the mammography facility or

the referring physician. FDA believes

that some form of patient notification is

a standard of good practice that is

currently followed voluntarily by

virtually all mammography facilities, so

the burden of this requirement will fall

only on those few facilities who are not

currently meeting such a standard. The

flexibility of notification method

allowed under the revision of

§ 900.12(c)(2) will make the burden

minimal even for these facilities.

Several comments asserted that

proposed § 900.12(h), which requires

the development of a consumer

complaint mechanism, was

unnecessary. The comments stated that

all complaints should be handled on an

individual basis at each facility

according to the protocol of that facility.

One comment asserted that the

proposed rule would be very costly in

terms of staff time and materials.

This comment has misinterpreted the

requirements of § 900.12(h), which gives

facilities the flexibility to develop their

own consumer complaint mechanism in

the manner they feel most appropriate.

The requirement that each facility must

maintain records of each serious

complaint over the last 3 years should

be of minimal burden to facilities and

would only necessitate a file including

the appropriate correspondence by the

complainant, facility, and accrediting

body. Many facilities already have some

form of consumer complaint mechanism

and would not incur significant

additional burden by meeting the

requirements of the final rule.

One comment agreed with proposed

§ 900.12(c)(4)(ii), which states that

facilities must transfer mammographic

films and records to other facilities or

the patient at the patient’s request, but

stated that it was not economical or

practical to copy films for the sake of

keeping them in the patient’s medical

record.

FDA notes that § 900.12(c)(4)(ii) does

not require that a facility maintain

copies of a patient’s medical records if

the patient has asked to have them

transferred elsewhere. The facility is

free to determine for itself whether it is

desirable to copy films for its own

records.

Several comments stated that

proposed § 900.4(c), which requires

clinical image review as part of the

accreditation and reaccreditation

process, would be extremely costly and

time-consuming. This burden includes

the time and expense of choosing the

images and having them copied and

mailed. Another comment supported

clinical image review as the best

approach for a performance-based

standard, but also stated that it would

be costly and time-consuming.

FDA notes that Congress specifically

required clinical image review as part of

the accreditation and reaccreditation

process (42 U.S.C. 263b((e)(1)(B)(i)),

because clinical image review is

necessary to ensure high quality

mammography. While it may appear

that the complexity of the process, and

thus of the burden, has increased due to

the increased detail in the final rule,

these details are presently being

followed as policy by the accreditation

bodies so, in fact, there is no additional

burden. The agency further notes that

facilities are not required to copy the

films before sending them for review.

Only original films are reviewed and

these are returned to the facility after

the review is complete.

Several comments stated that

§ 900.12(e)(13), requiring facilities to

establish an infection control procedure

including documentation after each

cleaning, would create needless

paperwork and would not affect quality

assurance.

FDA has included an additional

paperwork burden estimate for this

requirement in the final rule. Under

§ 900.12(e)(13), facilities are required to

establish and comply with a system for

cleaning and disinfecting equipment as

needed. Although there is no evidence

that blood-borne pathogens have been

transmitted from patient to patient

during mammography, there is a

theoretical possibility of such a

transmission. That agency believes the

time required is justified to ease

concerns about such a possibility,

concerns that in some cases may cause

patients to refuse to undergo

mammography examinations and thus

possibly lose the life-saving benefit of

early detection of breast cancer.

The information collection provisions

of this final rule have been submitted to

OMB for review. Prior to the effective

date of this rule, FDA will publish a

notice in the Federal Register

announcing OMB’s decision to approve,
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55975

modify, or disapprove the information

collection provisions in this final rule.

An agency may not conduct or sponsor,

and a person is not required to respond

to, a collection of information unless it

displays a currently valid OMB control

number.

Appendix

Excerpts from Chapter 4 of AHCPR’s

‘‘Quality Determinants of

Mammography;’’ Guidelines for

Communicating Test Results

As noted previously, FDA

recommends that mammography

facilities utilize the AHCPR’S guidelines

in ‘‘Quality Determinants of

Mammography’’ with respect to written

notification of results to patients. The

pertinent information from Chapter 4 of

those guidelines is reprinted here for

ease of reference. The symbol [R]

indicates that the AHCPR document

provides an additional reference or

references at that point.

COMMUNICATING RESULTS

RECOMMENDATION: The referring health

care provider and the interpreting physician

should be sensitive, supportive, and

appropriate in communicating results, as

well as prompt and accurate. (B)

STRONG RECOMMENDATION: An

appropriate professional at the

mammography facility, usually an

interpreting physician, should send the

woman’s health care provider a written

report documenting the specific findings,

follow up recommendations, and the name of

the interpreting physician. The facility

should directly telephone the referring

provider if the result is suspicious for cancer.

(B)

STRONG RECOMMENDATION: The

mammography facility personnel should give

the woman written notification of the results

of her mammography and other breast

imaging, either on site or by mail. The results

should be in simple language, document the

name of the interpreting physician, be given

in a timely fashion, and include further steps

to be taken. (B)

RECOMMENDATION: If a facility accepts

women who have no health care provider,

facility personnel should give the woman a

list of qualified providers who are willing to

provide care. The name, address, and phone

number of the provider chosen should be

recorded, if possible (C).

STRONG RECOMMENDATION: The

facility personnel should directly telephone

the woman who has no health care provider

if the result is suspicious for cancer (B).

Many women believe that mammography

results are normal if they are not contacted

after their examination. This impression that

‘‘no news is good news’’ can have serious

adverse consequences for women with an

abnormal examination. The interpreting

physician, the referring health care provider,

and the woman are all responsible for

ensuring that mammography results are

communicated in an effective and timely

manner and that recommendations are

carried out. Timely communication is

necessary whether results are normal or

abnormal (Table 3).

An increasing number of mammography

facilities have begun to report both normal

and abnormal results directly to the woman.

This can be accomplished without disrupting

the woman’s relationship with her referring

provider. Studies have shown that direct

communication of results to the woman by

the mammography facility produces a

dramatic improvement in compliance with

follow recommendations [R]. Traditional

communication procedures, where the

facility communicates only with the referring

provider, result in inadequate compliance

with follow up recommendations [R].

Problems in communicating abnormal

results have included confusion concerning

the appropriate steps to be taken;

inappropriate or insensitive communication,

resulting in avoidable anxiety and confusion;

delay in receipt of results; and failure to

communicate results to the woman at all—for

example, when reports are misfiled or filed

unread. These problems have caused delays

in diagnosis and treatment, with

consequences that include limited treatment

options and death [R]. Providing results

directly to the woman is a sound riskmanagement procedure, reducing the

prospect of medicolegal complications for

both the interpreting physician and the

referring health care provider [R].

TABLE 3.—REPORTING OF RESULTS BY MAMMOGRAPHY FACILITY

Outcome of Mammography

Examination and Recommendation for Followup

Communication to

Women—Oral (Onsite or

by Telephone)

Communication to

Women—Write (Onsite or

Sent by Mail)

Phone Communication to

Health Care Provider in

Addition to Standard Report

Always Necessary Written

Report to Health Care Provider

Normal Optional Strongly Recommended None Strongly Recommended

Abnormal: schedule additional imaging and/or

ultrasonography

a) On line1

b) Off line1

Recommended2

Optional2

Strongly recommended2

Strongly recommended2

Recommended3

Recommended3

Strongly recommended

Strongly recommended

Abnormal: short-interval

followup

Optional Strongly recommended Optional Strongly recommended

Abnormal: Biopsy Optional strongly recommended for self-referred womenStrongly recommended4 Strongly recommended Strongly recommended

1For an online study, the interpreting physician is present and reads the mammogram while the patient is there. For an offline study, the mammogram may be read after the woman leaves so the interpreting physician does not have to be present. 2For any patient for whom additional views or ultrasonography are recommended, a telephone call or discussion onsite with the patient may

precede the written letter when the studies are to be performed immediately or within 2 days at that mammography facility. However, the results

of the original and additional studies must be provided to the woman in writing. 3A telephone call from the mammography facility to the woman’s designated physician or other health care provider is recommended. For selfreferred patients, the telephone call should be made to the woman herself. 4For any patient without a direct referral, the mammography facility may wish to send the letter via registered or certified mail.

NOTE: Strong recommendations deal with elements of mammography that the panel considers essential to good practice. Recommendations

deal with elements of mammography that the panel considers attainable in most but not all cases. Options are statements of a less compelling

nature that cannot be justified as recommendations.

Communicating normal results directly to

the woman as soon as possible eliminates

anxiety, reinforces the woman’s role as a

responsible participant in the process,

reminds the woman of the importance of

regular screening, and is a quality assurance

safeguard. Effective communication is most

crucial when results are abnormal and

additional imaging or other follow up is

required. If findings are abnormal, the

written results should detail steps the woman

should take next.

Any written communication must have

language that is carefully constructed to

impart results without causing undue

anxiety, to promote a relationship between

the woman and a health care provider, and

to encourage the woman to take the next step.

[Note—the AHCPR publication provides

several examples of letters for

communicating results directly to women.]
55976 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

Mammography facilities may accept selfrequesting and self-referred women for

mammography. Interpreting physicians have

additional responsibilities for ensuring the

effective communication of results for these

women.

• Self-requesting woman. This woman

comes for mammography on her own

initiative but is able to name a personal

physician or health care provider. Whether

the woman is having screening or diagnostic

mammography, the interpreting physician

should document that the designated

provider accepts responsibility for the

woman’s breast care before sending out the

mammography report. In cases where the

provider declines to accept the

mammography report from the

mammography facility, the facility should

treat the woman as if she were self-referred.

• Self-referred woman. This is a woman

who comes for mammography but has no

personal health care provider or for whom

the provider declines responsibility. Whether

the woman is having screening or diagnostic

mammography, the interpreting physician

assumes responsibility for the woman’s

breast care, including education, physical

examination, and communication of

mammography results directly to the patient

in understandable language. Mammography

facility personnel should give the woman a

list of qualified providers. If the woman

chooses a provider from a list provided by

the mammography facility, the interpreting

physician should ensure that the chosen

clinician will assume responsibility for the

woman’s breast care. Although self-referral

has improved access to mammography, it has

increased the responsibilities of the

interpreting physician and created more

possibilities for failure to communicate

abnormal results.

STRONG RECOMMENDATION: At the

time of the examination, mammography

facility personnel should inform all women

of the time period in which they will receive

their results and of the possibility that prior

films may need to be obtained. The woman

should also be instructed to call the

mammography facility or her health care

provider if she does not receive her results

within the stated time period. The facility

should report results to the woman’s

provider and to the woman within the

shortest practical time period. (B)

RECOMMENDATION: The facility should

use its best efforts to send a report to the

referring health care provider and to send

results to the woman as soon as possible,

usually within 10 business days. The

reporting period should not exceed 30 days.

(B)

STRONG RECOMMENDATION: The

interpreting physician or designee should

telephone the results of an abnormal

examination that requires needle or open

biopsy to the referring (or designated) health

care provider’s office in a timely manner. (B)

RECOMMENDATION: The interpreting

physician or designee should telephone the

results of an abnormal examination that

requires additional views and/or

ultrasonography in a timely manner to the

referring (or designated) health care

provider’s office. (B)

OPTIONAL: The interpreting physician or

the referring (or designated) health care

provider may telephone the woman directly

to explain abnormal findings, their

significance, and recommended next steps.

(B)

Mammography facility personnel should

telephone the referring or designated health

care provider because the written report may

not reach the provider or may not arrive in

time for the provider to respond to questions

from the patient. A telephone call also

enables the provider to ask questions about

the report and to discuss follow up options

with the interpreting physician [R].

When mammography results are abnormal,

a telephone call to the woman’s designated

health care provider before a report is sent

may identify and resolve any vagueness in

the provider-patient status. For a selfrequesting woman with an abnormal finding,

this call will significantly reduce the chance

that she will slip through the cracks.

If the woman does not have a provider or

if the provider declines to accept the report,

the interpreting physician or designee should

call the woman directly to explain the result

and the recommended next steps. This

telephone communication is in addition to

the written report and should offer the option

to have the results explained in person.

Information should not be left on an

answering machine or given to another

individual without the woman’s express

prior permission. Particularly for the woman

without a referring provider, the

mammography facility may choose to send

written notification of abnormal results by

certified mail or with return receipt

requested. Mammography facility personnel

should document the communication to the

referring provider or the woman in the

woman’s medical record. Recommended

reporting is outlined on Table 3.‘‘

Chapter 6 of the AHCPR document also

provides more information on the

communication responsibilities of the

interpreting physician.

VII. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Ries, L. A. G., B. A. Miller, and B. F.

Hankey, et al. (Eds.), ‘‘SEER Cancer Statistics

Review, 1973–1991,’’ National Cancer

Institute, NIH Pub. No. 94–2789, Bethesda,

MD, 1994.

2. AHCPR, ‘‘Quality Determinants of

Mammography,’’ AHCPR Pub. No. 95–0632,

October, 1994.

3. U.S. GAO, ‘‘Mammography Services

Initial Impact of New Federal Law Has Been

Positive,’’ GAO/HEHS–96–17, October, 1995.

4. Linver, M. N., J. R. Osuch, R. J. Brenner,

and R. A. Smith, ‘‘The Mammography Audit:

A Primer for the Mammography Quality

Standards Act (MQSA),’’ American Journal of

Radiology, 1995; 165:19–25.

5. CDC, ‘‘Use of Mammography Services by

Women Aged ≤ 65 Years Enrolled in

Medicare—United States, 1995–1993,’’ 1995;

44:777–781.

List of Subjects

21 CFR Part 16

Administrative practice and

procedure.

21 CFR Part 900

Electronic products, Health facilities,

Mammography, Medical devices,

Radiation protection, Reporting and

recordkeeping requirements, X-rays.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR parts 16 and

900 are amended as follows:

PART 16—REGULATORY HEARINGS

BEFORE THE FOOD AND DRUG

ADMINISTRATION

1. The authority citation for 21 CFR

part 16 is revised to read as follows:

Authority: 21 U.S.C. 41–40, 141–149, 321–

394, 467f, 679, 821, 1034; 42 U.S.C. 201–262,

263b, 364; 15 U.S.C. 1451–1461, 28 U.S.C.

2112.

2. Section 16.1 is amended in

paragraph (b)(2) by numerically adding

entries for §§ 900.7 and 900.14 to read

as follows:

§ 716.1 Scope.

* * * * *

(b) * * *

(2) Regulatory provisions:

* * * * *

§ 900.7, relating to approval, reapproval, or

withdrawal of approval of mammography

accreditation bodies or rejection of a

proposed fee for accreditation.

§ 900.14, relating to suspension or

revocation of a mammography certificate.

* * * * *

3. 21 CFR Part 900 is revised to read

as follows:

PART 900—MAMMOGRAPHY

Subpart A—Accreditation

Sec.

900.1 Scope.

900.2 Definitions.

900.3 Application for approval as an

accreditation body.

900.4 Standards for accreditation bodies.

900.5 Evaluation.

900.6 Withdrawal of approval.

900.7 Hearings.

900.8–900.9 [Reserved]

Subpart B—Quality Standards and

Certification

900.10 Applicability.

900.11 Requirements for certification.

900.12 Quality standards.

900.13 Revocation of accreditation and

revocation of accreditation body

approval.

900.14 Suspension or revocation of

certificates.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55977

900.15 Appeals of adverse accreditation or

reaccreditation decisions that preclude

certification or recertification.

900.16 Appeals of denials of certification.

900.17 [Reserved]

900.18 Alternative requirements for

§ 900.12 quality standards.

Authority: 21 U.S.C. 360i, 360nn, 374(e);

42 U.S.C. 263b.

Subpart A—Accreditation

§ 900.1 Scope.

The regulations set forth in this part

implement the Mammography Quality

Standards Act (MQSA) (42 U.S.C. 263b).

Subpart A of this part establishes

procedures whereby an entity can apply

to become a Food and Drug

Administration (FDA)-approved

accreditation body to accredit facilities

to be eligible to perform screening or

diagnostic mammography services.

Subpart A further establishes

requirements and standards for

accreditation bodies to ensure that all

mammography facilities under the

jurisdiction of the United States are

adequately and consistently evaluated

for compliance with national quality

standards for mammography. Subpart B

of this part establishes minimum

national quality standards for

mammography facilities to ensure safe,

reliable, and accurate mammography.

The regulations set forth in this part do

not apply to facilities of the Department

of Veterans Affairs.

§ 900.2 Definitions.

The following definitions apply to

subparts A and B of this part:

(a) Accreditation body or body means

an entity that has been approved by

FDA under § 900.3(d) to accredit

mammography facilities.

(b) Action limits or action levels

means the minimum and maximum

values of a quality assurance

measurement that can be interpreted as

representing acceptable performance

with respect to the parameter being

tested. Values less than the minimum or

greater than the maximum action limit

or level indicate that corrective action

must be taken by the facility. Action

limits or levels are also sometimes

called control limits or levels.

(c) Adverse event means an

undesirable experience associated with

mammography activities within the

scope of 42 U.S.C. 263b. Adverse events

include but are not limited to:

(1) Poor image quality;

(2) Failure to send mammography

reports within 30 days to the referring

physician or in a timely manner to the

self-referred patient; and

(3) Use of personnel that do not meet

the applicable requirements of

§ 900.12(a).

(d) Air kerma means kerma in a given

mass of air. The unit used to measure

the quantity of air kerma is the Gray

(Gy). For X-rays with energies less than

300 kiloelectronvolts (keV), 1 Gy = 100

radian (rad) = 114 roentgens (R) of

exposure.

(e) Breast implant means a prosthetic

device implanted in the breast.

(f) Calendar quarter means any one of

the following time periods during a

given year: January 1 through March 31,

April 1 through June 30, July 1 through

September 30, or October 1 through

December 31.

(g) Category I means medical

educational activities that have been

designated as Category I by the

Accreditation Council for Continuing

Medical Education (ACCME), the

American Osteopathic Association

(AOA), a state medical society, or an

equivalent organization.

(h) Certificate means the certificate

described in § 900.11(a).

(i) Certification means the process of

approval of a facility by FDA to provide

mammography services.

(j) Clinical image means a

mammogram.

(k) Consumer means an individual

who chooses to comment or complain in

reference to a mammography

examination, including the patient or

representative of the patient (e.g., family

member or referring physician).

(l) Continuing education unit or

continuing education credit means one

contact hour of training.

(m) Contact hour means an hour of

training received through direct

instruction.

(n) Direct instruction means:

(1) Face-to-face interaction between

instructor(s) and student(s), as when the

instructor provides a lecture, conducts

demonstrations, or reviews student

performance; or

(2) The administration and correction

of student examinations by an

instructor(s) with subsequent feedback

to the student(s).

(o) Direct supervision means that:

(1) During joint interpretation of

mammograms, the supervising

interpreting physician reviews,

discusses, and confirms the diagnosis of

the physician being supervised and

signs the resulting report before it is

entered into the patient’s records; or

(2) During the performance of a

mammography examination or survey of

the facility’s equipment and quality

assurance program, the supervisor is

present to observe and correct, as

needed, the performance of the

individual being supervised who is

performing the examination or

conducting the survey.

(p) Established operating level means

the value of a particular quality

assurance parameter that has been

established as an acceptable normal

level by the facility’s quality assurance

program.

(q) Facility means a hospital,

outpatient department, clinic, radiology

practice, mobile unit, office of a

physician, or other facility that conducts

mammography activities, including the

following: Operation of equipment to

produce a mammogram, processing of

the mammogram, initial interpretation

of the mammogram, and maintaining

viewing conditions for that

interpretation. This term does not

include a facility of the Department of

Veterans Affairs.

(r) First allowable time means the

earliest time a resident physician is

eligible to take the diagnostic radiology

boards from an FDA-designated

certifying body. The ‘‘first allowable

time’’ may vary with the certifying

body.

(s) FDA means the Food and Drug

Administration.

(t) Interim regulations means the

regulations entitled ‘‘Requirements for

Accrediting Bodies of Mammography

Facilities’’ (58 FR 67558–67565) and

‘‘Quality Standards and Certification

Requirements for Mammography

Facilities’’ (58 FR 67565–67572),

published by FDA on December 21,

1993, and amended on September 30,

1994 (59 FR 49808–49813). These

regulations established the standards

that had to be met by mammography

facilities in order to lawfully operate

between October 1, 1994, and April 28,

1999.

(u) Interpreting physician means a

licensed physician who interprets

mammograms and who meets the

requirements set forth in § 900.12(a)(1).

(v) Kerma means the sum of the initial

energies of all the charged particles

liberated by uncharged ionizing

particles in a material of given mass.

(w) Laterality means the designation

of either the right or left breast.

(x) Lead interpreting physician means

the interpreting physician assigned the

general responsibility for ensuring that

a facility’s quality assurance program

meets all of the requirements of

§ 900.12(d) through (f). The

administrative title and other

supervisory responsibilities of the

individual, if any, are left to the

discretion of the facility.

(y) Mammogram means a

radiographic image produced through

mammography.
55978 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

(z) Mammographic Modality means a

technology, within the scope of 42

U.S.C. 263b, for radiography of the

breast. Examples are screen-film

mammography and xeromammography.

(aa) Mammography means

radiography of the breast, but, for the

purposes of this part, does not include:

(1) Radiography of the breast

performed during invasive interventions

for localization or biopsy procedures; or

(2) Radiography of the breast

performed with an investigational

mammography device as part of a

scientific study conducted in

accordance with FDA’s investigational

device exemption regulations in part

812 of this chapter.

(bb) Mammography equipment

evaluation means an onsite assessment

of mammography unit or image

processor performance by a medical

physicist for the purpose of making a

preliminary determination as to whether

the equipment meets all of the

applicable standards in § 900.12(b) and

(e).

(cc) Mammography medical outcomes

audit means a systematic collection of

mammography results and the

comparison of those results with

outcomes data.

(dd) Mammography unit or units

means an assemblage of components for

the production of X-rays for use during

mammography, including, at a

minimum: An X-ray generator, an X-ray

control, a tube housing assembly, a

beam limiting device, and the

supporting structures for these

components.

(ee) Mean optical density means the

average of the optical densities

measured using phantom thicknesses of

2, 4, and 6 centimeters with values of

kilovolt peak (kVp) clinically

appropriate for those thicknesses.

(ff) Medical physicist means a person

trained in evaluating the performance of

mammography equipment and facility

quality assurance programs and who

meets the qualifications for a medical

physicist set forth in § 900.12(a)(3).

(gg) MQSA means the Mammography

Quality Standards Act.

(hh) Multi-reading means two or more

physicians, at least one of whom is an

interpreting physician, interpreting the

same mammogram.

(ii) Patient means any individual who

undergoes a mammography evaluation

in a facility, regardless of whether the

person is referred by a physician or is

self-referred.

(jj) Phantom means a test object used

to simulate radiographic characteristics

of compressed breast tissue and

containing components that

radiographically model aspects of breast

disease and cancer.

(kk) Phantom image means a

radiographic image of a phantom.

(ll) Physical science means physics,

chemistry, radiation science (including

medical physics and health physics),

and engineering.

(mm) Positive mammogram means a

mammogram that has an overall

assessment of findings that are either

‘‘suspicious’’ or ‘‘highly suggestive of

malignancy.’’

(nn) Provisional certificate means the

provisional certificate described in

§ 900.11(b)(2).

(oo) Qualified instructor means an

individual whose training and

experience adequately prepares him or

her to carry out specified training

assignments. Interpreting physicians,

radiologic technologists, or medical

physicists who meet the requirements of

§ 900.12(a) would be considered

qualified instructors in their respective

areas of mammography. Other examples

of individuals who may be qualified

instructors for the purpose of providing

training to meet the regulations of this

part include, but are not limited to,

instructors in a post-high school

training institution and manufacturer’s

representatives.

(pp) Quality control technologist

means an individual meeting the

requirements of § 900.12(a)(2) who is

responsible for those quality assurance

responsibilities not assigned to the lead

interpreting physician or to the medical

physicist.

(qq) Radiographic equipment means

X-ray equipment used for the

production of static X-ray images.

(rr) Radiologic technologist means an

individual specifically trained in the

use of radiographic equipment and the

positioning of patients for radiographic

examinations and who meets the

requirements set forth in § 900.12(a)(2).

(ss) Serious adverse event means an

adverse advent that may significantly

compromise clinical outcomes, or an

adverse event for which a facility fails

to take appropriate corrective action in

a timely manner.

(tt) Serious complaint means a report

of a serious adverse event.

(uu) Standard breast means a 4.2

centimeter (cm) thick compressed breast

consisting of 50 percent glandular and

50 percent adipose tissue.

(vv) Survey means an onsite physics

consultation and evaluation of a facility

quality assurance program performed by

a medical physicist.

(ww) Time cycle means the film

development time.

(xx) Traceable to a national standard

means an instrument is calibrated at

either the National Institute of

Standards and Technology (NIST) or at

a calibration laboratory that participates

in a proficiency program with NIST at

least once every 2 years and the results

of the proficiency test conducted within

24 months of calibration show

agreement within ± 3 percent of the

national standard in the mammography

energy range.

§ 900.3 Application for approval as an

accreditation body.

(a) Eligibility. Private nonprofit

organizations or State agencies capable

of meeting the requirements of this

subpart A may apply for approval as

accreditation bodies.

(b) Application for initial approval.

(1) An applicant seeking initial FDA

approval as an accreditation body shall

inform the Division of Mammography

Quality and Radiation Programs

(DMQRP), Center for Devices and

Radiology Health (HFZ–240), Food and

Drug Administration, 1350 Piccard Dr.,

Rockville, MD 20850, marked Attn:

Mammography Standards Branch, of its

desire to be approved as an

accreditation body and of its requested

scope of authority.

(2) Following receipt of the request,

FDA will provide the applicant with

additional information to aid in

submission of an application for

approval as an accreditation body.

(3) The applicant shall furnish to

FDA, at the address in § 900.3(b)(1),

three copies of an application

containing the following information,

materials, and supporting

documentation:

(i) Name, address, and phone number

of the applicant and, if the applicant is

not a State agency, evidence of

nonprofit status (i.e., of fulfilling

Internal Revenue Service requirements

as a nonprofit organization);

(ii) Detailed description of the

accreditation standards the applicant

will require facilities to meet and a

discussion substantiating their

equivalence to FDA standards required

under § 900.12;

(iii) Detailed description of the

applicant’s accreditation review and

decisionmaking process, including:

(A) Procedures for performing

accreditation and reaccreditation

clinical image review in accordance

with § 900.4(c), random clinical image

reviews in accordance with § 900.4(f),

and additional mammography review in

accordance with § 900.12(j);

(B) Procedures for performing

phantom image review;

(C) Procedures for assessing

mammography equipment evaluations

and surveys;
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55979

(D) Procedures for initiating and

performing onsite visits to facilities;

(E) Procedures for assessing facility

personnel qualifications;

(F) Copies of the accreditation

application forms, guidelines,

instructions, and other materials the

applicant will send to facilities during

the accreditation process, including an

accreditation history form that requires

each facility to provide a complete

history of prior accreditation activities

and a statement that all information and

data submitted in the application is true

and accurate, and that no material fact

has been omitted;

(G) Policies and procedures for

notifying facilities of deficiencies;

(H) Procedures for monitoring

corrections of deficiencies by facilities;

(I) Policies and procedures for

suspending or revoking a facility’s

accreditation;

(J) Policies and procedures that will

ensure processing of accreditation

applications and renewals within a

timeframe approved by FDA and

assurances that the body will adhere to

such policies and procedures; and

(K) A description of the applicant’s

appeals process for facilities contesting

adverse accreditation status decisions.

(iv) Education, experience, and

training requirements for the applicant’s

professional staff, including reviewers

of clinical or phantom images;

(v) Description of the applicant’s

electronic data management and

analysis system with respect to

accreditation review and decision

processes and the applicant’s ability to

provide electronic data in a format

compatible with FDA data systems;

(vi) Resource analysis that

demonstrates that the applicant’s

staffing, funding, and other resources

are adequate to perform the required

accreditation activities;

(vii) Fee schedules with supporting

cost data;

(viii) Statement of policies and

procedures established to avoid

conflicts of interest or the appearance of

conflicts of interest by the applicant’s

board members, commissioners,

professional personnel (including

reviewers of clinical and phantom

images), consultants, administrative

personnel, and other representatives of

the applicant;

(ix) Statement of policies and

procedures established to protect

confidential information the applicant

will collect or receive in its role as an

accreditation body;

(x) Disclosure of any specific brand of

imaging system or component,

measuring device, software package, or

other commercial product used in

mammography that the applicant

develops, sells, or distributes;

(xi) Description of the applicant’s

consumer complaint mechanism;

(xii) Satisfactory assurances that the

applicant shall comply with the

requirements of § 900.4; and

(xiii) Any other information as may be

required by FDA.

(c) Application for renewal of

approval. An approved accreditation

body that intends to continue to serve

as an accreditation body beyond its

current term shall apply to FDA for

renewal or notify FDA of its plans not

to apply for renewal in accordance with

the following procedures and schedule:

(1) At least 9 months before the date

of expiration of a body’s approval, the

body shall inform FDA, at the address

given in § 900.3(b)(1), of its intent to

seek renewal.

(2) FDA will notify the applicant of

the relevant information, materials, and

supporting documentation required

under § 900.3(b)(3) that the applicant

shall submit as part of the renewal

procedure.

(3) At least 6 months before the date

of expiration of a body’s approval, the

applicant shall furnish to FDA, at the

address in § 900.3(b)(1), three copies of

a renewal application containing the

information, materials, and supporting

documentation requested by FDA in

accordance with § 900.3(c)(2).

(4) No later than July 28, 1998 any

accreditation body approved under the

interim regulations published in the

Federal Register of December 21, 1993

(58 FR 67558), that desires to continue

to serve as an accreditation body under

the final regulations shall apply for

renewal of approval in accordance with

the procedures set forth in paragraphs

(c)(1) through (c)(3) of this section.

(5) Any accreditation body that does

not plan to renew its approval shall so

notify FDA at the address given in

paragraph (b)(1) of this section at least

9 months before the expiration of the

body’s term of approval.

(d) Rulings on applications for initial

and renewed approval. (1) FDA will

conduct a review and evaluation to

determine whether the applicant

substantially meets the applicable

requirements of this subpart and

whether the accreditation standards the

applicant will require facilities to meet

are substantially the same as the quality

standards published under subpart B of

this part.

(2) FDA will notify the applicant of

any deficiencies in the application and

request that those deficiencies be

rectified within a specified time period.

If the deficiencies are not rectified to

FDA’s satisfaction within the specified

time period, the application for

approval as an accreditation body may

be rejected.

(3) FDA shall notify the applicant

whether the application has been

approved or denied. That notification

shall list any conditions associated with

approval or state the bases for any

denial.

(4) The review of any application may

include a meeting between FDA and

representatives of the applicant at a time

and location mutually acceptable to

FDA and the applicant.

(5) FDA will advise the applicant of

the circumstances under which a denied

application may be resubmitted.

(6) If FDA does not reach a final

decision on a renewal application in

accordance with this paragraph before

the expiration of an accreditation body’s

current term of approval, the approval

will be deemed extended until the

agency reaches a final decision on the

application, unless an accreditation

body does not rectify deficiencies in the

application within the specified time

period, as required in paragraph (d)(2)

of this section.

(e) Relinquishment of authority. An

accreditation body that decides to

relinquish its accreditation authority

before expiration of the body’s term of

approval shall submit a letter of such

intent to FDA, at the address in

§ 900.3(b)(1), at least 9 months before

relinquishing such authority.

(f) Transfer of records. An

accreditation body that does not apply

for renewal of accreditation body

approval, is denied such approval by

FDA, or relinquishes its accreditation

authority and duties before expiration of

its term of approval, shall:

(1) Transfer facility records and other

related information as required by FDA

to a location and according to a

schedule approved by FDA.

(2) Notify, in a manner and time

period approved by FDA, all facilities

accredited or seeking accreditation by

the body that the body will no longer

have accreditation authority.

(g) Scope of authority. An

accreditation body’s term of approval is

for a period not to exceed 7 years. FDA

may limit the scope of accreditation

authority.

§ 900.4 Standards for accreditation bodies.

(a) Code of conduct and general

responsibilities. The accreditation body

shall accept the following

responsibilities in order to ensure safe

and accurate mammography at the

facilities it accredits and shall perform

these responsibilities in a manner that

ensures the integrity and impartiality of

accreditation body actions.
55980 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

(1)(i) When an accreditation body

receives or discovers information that

suggests inadequate image quality, or

upon request by FDA, the accreditation

body shall review a facility’s clinical

images or other aspects of a facility’s

practice to assist FDA in determining

whether or not the facility’s practice

poses a serious risk to human health.

Such reviews are in addition to the

evaluation an accreditation body

performs as part of the initial

accreditation or renewal process for

facilities.

(ii) If review by the accreditation body

demonstrates that a problem does exist

with respect to image quality or other

aspects of a facility’s compliance with

quality standards, or upon request by

FDA, the accreditation body shall

require or monitor corrective actions, or

suspend or revoke accreditation of the

facility.

(2) The accreditation body shall

inform FDA as soon as possible but in

no case longer than 2 business days after

becoming aware of equipment or

practices that pose a serious risk to

human health.

(3) The accreditation body shall

establish and administer a quality

assurance (QA) program that has been

approved by FDA in accordance with

§ 900.3(d) or paragraph (a)(8) of this

section. Such quality assurance program

shall:

(i) Include requirements for clinical

image review and phantom image

review;

(ii) Ensure that clinical and phantom

images are evaluated consistently and

accurately; and

(iii) Specify the methods and

frequency of training and evaluation for

clinical and phantom image reviewers,

and the bases and procedures for

removal of such reviewers.

(4) The accreditation body shall

establish measures that FDA has

approved in accordance with § 900.3(d)

or paragraph (a)(8) of this section to

reduce the possibility of conflict of

interest or facility bias on the part of

individuals acting on the body’s behalf.

Such individuals who review clinical or

phantom images under the provisions of

paragraphs (c) and (d) of this section or

who visit facilities under the provisions

of paragraph (f) of this section shall not

review clinical or phantom images from

or visit a facility with which such

individuals maintain a financial

relationship, or when it would

otherwise be a conflict of interest for

them to do so, or when they have a bias

in favor of or against the facility.

(5) The accreditation body may

require specific equipment performance

or design characteristics that FDA has

approved. However, no accreditation

body shall require, either explicitly or

implicitly, the use of any specific brand

of imaging system or component,

measuring device, software package, or

other commercial product as a condition

for accreditation by the body, unless

FDA determines that it is in the best

interest of public health to do so.

(i) Any representation, actual or

implied, either orally, in sales literature,

or in any other form of representation,

that the purchase or use of a particular

product brand is required in order for

any facility to be accredited or certified

under § 900.11(b), is prohibited, unless

FDA approves such representation.

(ii) Unless FDA has approved the

exclusive use and promotion of a

particular commercial product in

accordance with this section, all

products produced, distributed, or sold

by an accreditation body or an

organization that has a financial or other

relationship with the accreditation body

that may be a conflict of interest or have

the appearance of a conflict of interest

with the body’s accreditation functions,

shall bear a disclaimer stating that the

purchase or use of such products is not

required for accreditation or

certification of any facility under

§ 900.11(b). Any representations about

such products shall include a similar

disclaimer.

(6) When an accreditation body

denies accreditation to a facility, the

accreditation body shall notify the

facility in writing and explain the bases

for its decision. The notification shall

also describe the appeals process

available from the accreditation body for

the facility to contest the decision.

(7) No accreditation body may

establish requirements that preclude

facilities from being accredited under

§ 900.11(b) by any other accreditation

body, or require accreditation by itself

under MQSA if another accreditation

body is available to a facility.

(8) The accreditation body shall

obtain FDA authorization for any

changes it proposes to make in any

standards that FDA has previously

accepted under § 900.3(d).

(9) An accreditation body shall

establish procedures to protect

confidential information it collects or

receives in its role as an accreditation

body.

(i) Nonpublic information collected

from facilities for the purpose of

carrying out accreditation body

responsibilities shall not be used for any

other purpose or disclosed, other than to

FDA or its duly designated

representatives, including State

agencies, without the consent of the

facility;

(ii) Nonpublic information that FDA

or its duly designated representatives,

including State agencies, share with the

accreditation body concerning a facility

that is accredited or undergoing

accreditation by that body shall not be

further disclosed except with the

written permission of FDA.

(b) Monitoring facility compliance

with quality standards. (1) The

accreditation body shall require that

each facility it accredits meet standards

for the performance of quality

mammography that are substantially the

same as those in this subpart and in

subpart B of this part.

(2) The accreditation body shall notify

a facility regarding equipment,

personnel, and other aspects of the

facility’s practice that do not meet such

standards and advise the facility that

such equipment, personnel, or other

aspects of the practice should not be

used by the facility for activities within

the scope of part 900.

(3) The accreditation body shall

specify the actions that facilities shall

take to correct deficiencies in

equipment, personnel, and other aspects

of the practice to ensure facility

compliance with applicable standards.

(4) If deficiencies cannot be corrected

to ensure compliance with standards or

if a facility is unwilling to take

corrective actions, the accreditation

body shall immediately so notify FDA,

and shall suspend or revoke the

facility’s accreditation in accordance

with the policies and procedures

described under § 900.3(b)(3)(iii)(I).

(c) Clinical image review for

accreditation and reaccreditation. (1)

Frequency of review. The accreditation

body shall review clinical images from

each facility accredited by the body at

least once every 3 years.

(2) Requirements for clinical image

attributes. The accreditation body shall

use the following attributes for all

clinical image reviews, unless FDA has

approved other attributes:

(i) Positioning. Sufficient breast tissue

shall be imaged to ensure that cancers

are not likely to be missed because of

inadequate positioning.

(ii) Compression. Compression shall

be applied in a manner that minimizes

the potential obscuring effect of

overlying breast tissue and motion

artifact.

(iii) Exposure level. Exposure level

shall be adequate to visualize breast

structures. Images shall be neither

underexposed nor overexposed.

(iv) Contrast. Image contrast shall

permit differentiation of subtle tissue

density differences.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55981

(v) Sharpness. Margins of normal

breast structures shall be distinct and

not blurred.

(vi) Noise. Noise in the image shall

not obscure breast structures or suggest

the appearance of structures not actually

present.

(vii) Artifacts. Artifacts due to lint,

processing, scratches, and other factors

external to the breast shall not obscure

breast structures or suggest the

appearance of structures not actually

present.

(viii) Examination identification. Each

image shall have the following

information indicated on it in a

permanent, legible, and unambiguous

manner and placed so as not to obscure

anatomic structures:

(A) Name of the patient and an

additional patient identifier.

(B) Date of examination.

(C) View and laterality. This

information shall be placed on the

image in a position near the axilla.

Standardized codes specified by the

accreditation body and approved by

FDA in accordance with § 900.3(d) or

paragraph (a)(8) of this section shall be

used to identify view and laterality.

(D) Facility name and location. At a

minimum, the location shall include the

city, State, and zip code of the facility.

(E) Technologist identification.

(F) Cassette/screen identification.

(G) Mammography unit identification,

if there is more than one unit in the

facility.

(3) Scoring of clinical images.

Accreditation bodies shall establish and

administer a system for scoring clinical

images using all attributes specified in

paragraphs (c)(2)(i) through (c)(2)(viii) of

this section or an alternative system that

FDA has approved in accordance with

§ 900.3(d) or paragraph (a)(8) of this

section. The scoring system shall

include an evaluation for each attribute.

(i) The accreditation body shall

establish and employ criteria for

acceptable and nonacceptable results for

each of the 8 attributes as well as an

overall pass-fail system for clinical

image review that has been approved by

FDA in accordance with § 900.3(d) or

paragraph (a)(8) of this section.

(ii) All clinical images submitted by a

facility to the accreditation body shall

be reviewed independently by two or

more clinical image reviewers.

(4) Selection of clinical images for

review. Unless otherwise specified by

FDA, the accreditation body shall

require that for each mammography unit

in the facility:

(i) The facility shall submit

craniocaudal (CC) and mediolateral

oblique (MLO) views from two

mammographic examinations that the

facility produced during a time period

specified by the accreditation body;

(ii) Clinical images submitted from

one such mammographic examination

for each unit shall be of dense breasts

(predominance of glandular tissue) and

the other shall be of fat-replaced breasts

(predominance of adipose tissue);

(iii) All clinical images submitted

shall be images that the facility’s

interpreting physician(s) interpreted as

negative or benign.

(iv) If the facility has no clinical

images meeting the requirements in

paragraphs (c)(4)(i) through (c)(4)(iii) of

this section, it shall so notify the

accreditation body, which shall specify

alternative clinical image selection

methods that do not compromise care of

the patient.

(5) Clinical image reviewers.

Accreditation bodies shall ensure that

all of their clinical image reviewers:

(i) Meet the interpreting physician

requirements specified in § 900.12(a)(1);

(ii) Are trained and evaluated in the

clinical image review process, for the

types of clinical images to be evaluated

by a clinical image reviewer, by the

accreditation body before designation as

clinical image reviewers and

periodically thereafter; and

(iii) Clearly document their findings

and reasons for assigning a particular

score to any clinical image and provide

information to the facility for use in

improving the attributes for which

significant deficiencies were identified.

(6) Image management. The

accreditation body’s QA program shall

include a tracking system to ensure the

security and return to the facility of all

clinical images received and to ensure

completion of all clinical image reviews

by the body in a timely manner. The

accreditation body shall return all

clinical images to the facility within 60

days of their receipt by the body, with

the following exceptions:

(i) If the clinical images are needed

earlier by the facility for clinical

purposes, the accreditation body shall

cooperate with the facility to

accommodate such needs.

(ii) If a clinical image reviewer

identifies a suspicious abnormality on

an image submitted for clinical image

review, the accreditation body shall

ensure that this information is provided

to the facility and that the clinical

images are returned to the facility. Both

shall occur no later than 10 business

days after identification of the suspected

abnormality.

(7) Notification of unsatisfactory

image quality. If the accreditation body

determines that the clinical images

received from a facility are of

unsatisfactory quality, the body shall

notify the facility of the nature of the

problem and its possible causes.

(d) Phantom image review for

accreditation and reaccreditation. (1)

Frequency of review. The accreditation

body shall review phantom images from

each facility accredited by the body at

least once every 3 years.

(2) Requirements for the phantom

used. The accreditation body shall

require that each facility submit for

review phantom images that the facility

produced using a phantom and methods

of use specified by the body and

approved by FDA in accordance with

§ 900.3(d) or paragraph (a)(8) of this

section.

(3) Scoring phantom images. The

accreditation body shall use a system for

scoring phantom images that has been

approved by FDA in accordance with

§ 900.3(b) and (d) or paragraph (a)(8) of

this section.

(4) Phantom images selected for

review. For each mammography unit in

the facility, the accreditation body shall

require the facility to submit phantom

images that the facility produced during

a time period specified by the body.

(5) Phantom image reviewers.

Accreditation bodies shall ensure that

all of their phantom image reviewers:

(i) Meet the requirements specified in

§ 900.12(a)(3) or alternative

requirements established by the

accreditation body and approved by

FDA in accordance with § 900.3 or

paragraph (a)(8) of this section;

(ii) Are trained and evaluated in the

phantom image review process, for the

types of phantom images to be evaluated

by a phantom image reviewer, by the

accreditation body before designation as

phantom image reviewers and

periodically thereafter; and

(iii) Clearly document their findings

and reasons for assigning a particular

score to any phantom image and

provide information to the facility for

use in improving its phantom image

quality with regard to the significant

deficiencies identified.

(6) Image management. The

accreditation body’s QA program shall

include a tracking system to ensure the

security of all phantom images received

and to ensure completion of all

phantom image reviews by the body in

a timely manner. All phantom images

that result in a failure of accreditation

shall be returned to the facility.

(7) Notification measures for

unsatisfactory image quality. If the

accreditation body determines that the

phantom images received from a facility

are of unsatisfactory quality, the body

shall notify the facility of the nature of

the problem and its possible causes.
55982 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

(e) Reports of mammography

equipment evaluation, surveys, and

quality control. The following

requirements apply to all facility

equipment covered by the provisions of

subparts A and B:

(1) The accreditation body shall

require every facility applying for

accreditation to submit:

(i) With its initial accreditation

application, a mammography equipment

evaluation that was performed by a

medical physicist no earlier than 6

months before the date of application

for accreditation by the facility. Such

evaluation shall demonstrate

compliance of the facility’s equipment

with the requirements in § 900.12(e).

(ii) Prior to accreditation, a survey

that was performed no earlier than 6

months before the date of application

for accreditation by the facility. Such

survey shall assess the facility’s

compliance with the facility standards

referenced in paragraph (b) of this

section.

(2) The accreditation body shall

require that all facilities undergo an

annual survey to ensure continued

compliance with the standards

referenced in paragraph (b) of this

section and to provide continued

oversight of facilities’ quality control

programs as they relate to such

standards. The accreditation body shall

require for all facilities that:

(i) Such surveys be conducted

annually;

(ii) Facilities take reasonable steps to

ensure that they receive reports of such

surveys within 30 days of survey

completion; and

(iii) Facilities submit the results of

such surveys and any other information

that the body may require to the body

at least annually.

(3) The accreditation body shall

review and analyze the information

required in this section and use it to

identify necessary corrective measures

for facilities and to determine whether

facilities should remain accredited by

the body.

(f) Accreditation Body Onsite Visits

and Random Clinical Image Reviews.

The accreditation body shall conduct

onsite visits and random clinical image

reviews of a sample of facilities to

monitor and assess their compliance

with standards established by the body

for accreditation. The accreditation

body shall submit annually to FDA, at

the address given in § 900.3(b)(1), 3

copies of a summary report describing

all facility assessments the body

conducted under the provisions of this

section for the year being reported.

(1) Onsite visits. (i) Sample size.

Annually, each accreditation body shall

visit at least 5 percent of the facilities it

accredits. However, a minimum of 5

facilities shall be visited, and visits to

no more than 50 facilities are required,

unless problems identified in paragraph

(f)(1)(i)(B) of this section indicate a need

to visit more than 50 facilities.

(A) At least 50 percent of the facilities

visited shall be selected randomly.

(B) Other facilities visited shall be

selected based on problems identified

through State or FDA inspections,

serious complaints received from

consumers or others, a previous history

of noncompliance, or any other

information in the possession of the

accreditation body, inspectors, or FDA.

(C) Before, during, or after any facility

visit, the accreditation body may require

that the facility submit to the body for

review clinical images, phantom images,

or any other information relevant to

applicable standards in this subpart and

in subpart B of this part.

(ii) Visit plan. The accreditation body

shall conduct facility onsite visits

according to a visit plan that has been

approved by FDA in accordance with

§ 900.3(d) or paragraph (a)(8) of this

section, unless otherwise directed by

FDA in particular circumstances. At a

minimum, such a plan shall provide for:

(A) Assessment of overall clinical

image QA activities of the facility;

(B) Review of facility documentation

to determine if appropriate

mammography reports are sent to

patients and physicians as required;

(C) Selection of a sample of clinical

images for clinical image review by the

accreditation body. Clinical images shall

be selected in a manner specified by the

accreditation body and approved by

FDA that does not compromise care of

the patient as a result of the absence of

the selected images from the facility;

(D) Verification that the facility has a

medical audit system in place and is

correlating films and pathology reports

for positive cases;

(E) Verification that personnel

specified by the facility are the ones

actually performing designated

personnel functions;

(F) Verification that equipment

specified by the facility is the

equipment that is actually being used to

perform designated equipment

functions;

(G) Verification that a consumer

complaint mechanism is in place and

that the facility is following its

procedures; and

(H) Review of all factors related to

previously identified concerns or

concerns identified during that visit.

(2) Clinical image review for random

sample of facilities. (i) Sample size. In

addition to conducting clinical image

reviews for accreditation and

reaccreditation for all facilities, the

accreditation body shall conduct

clinical image reviews annually for a

randomly selected sample as specified

by FDA, but to include at least 3 percent

of the facilities the body accredits.

Accreditation bodies may count toward

this random sample requirement all

facilities selected randomly for the

onsite visits described in paragraph

(f)(1)(i)(A) of this section. Accreditation

bodies shall not count toward the

random sample requirement any

facilities described in paragraph

(f)(1)(i)(B) of this section that were

selected for a visit because of previously

identified concerns.

(ii) Random clinical image review. In

performing clinical image reviews of the

random sample of facilities,

accreditation bodies shall evaluate the

same attributes as those in paragraph (c)

of this section for review of clinical

images for accreditation and

reaccreditation.

(iii) Accreditation bodies should not

schedule random clinical image reviews

at facilities that have received

notification of the need to begin the

accreditation renewal process or that

have completed the accreditation

renewal process within the previous 6

months.

(iv) Selection of the random sample of

clinical images for clinical image review

by the accreditation body. Clinical

images shall be selected in a manner,

specified by the accreditation body and

approved by FDA under § 900.3(d) or

paragraph (a)(8) of this section, that

does not compromise care of the patient

as a result of the absence of the selected

images from the facility.

(g) Consumer complaint mechanism.

The accreditation body shall develop

and administer a written and

documented system, including

timeframes, for collecting and resolving

serious consumer complaints that could

not be resolved at a facility. Such

system shall have been approved by

FDA in accordance with§ 900.3(d) or

paragraph (a)(8) of this section.

Accordingly, all accreditation bodies

shall:

(1) Provide a mechanism for all

facilities it accredits to file serious

unresolved complaints with the

accreditation body;

(2) Maintain a record of every serious

unresolved complaint received by the

body on all facilities it accredits for a

period of at least 3 years from the date

of receipt of each such complaint;

(h) Reporting and recordkeeping. All

reports to FDA specified in paragraphs

(h)(1) through (h)(4) of this section shall

be prepared and submitted in a format
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55983

and medium prescribed by FDA and

shall be submitted to a location and

according to a schedule specified by

FDA. The accreditation body shall:

(1) Collect and submit to FDA the

information required by 42 U.S.C.

263b(d) for each facility when the

facility is initially accredited and at

least annually when updated, in a

manner and at a time specified by FDA.

(2) Accept applications containing the

information required in 42 U.S.C.

263b(c)(2) for provisional certificates

and in § 900.11(b)(3) for extension of

provisional certificates, on behalf of

FDA, and notify FDA of the receipt of

such information;

(3) Submit to FDA the name,

identifying information, and other

information relevant to 42 U.S.C. 263b

and specified by FDA for any facility for

which the accreditation body denies,

suspends, or revokes accreditation, and

the reason(s) for such action;

(4) Submit to FDA an annual report

summarizing all serious complaints

received during the previous calendar

year, their resolution status, and any

actions taken in response to them;

(5) Provide to FDA other information

relevant to 42 U.S.C. 263b and required

by FDA about any facility accredited or

undergoing accreditation by the body.

(i) Fees. Fees charged to facilities for

accreditation shall be reasonable. Costs

of accreditation body activities that are

not related to accreditation functions

under 42 U.S.C. 263b are not

recoverable through fees established for

accreditation.

(1) The accreditation body shall make

public its fee structure, including those

factors, if any, contributing to variations

in fees for different facilities.

(2) At FDA’s request, accreditation

bodies shall provide financial records or

other material to assist FDA in assessing

the reasonableness of accreditation body

fees. Such material shall be provided to

FDA in a manner and time period

specified by the agency.

§ 900.5 Evaluation.

FDA shall evaluate annually the

performance of each accreditation body.

Such evaluation shall include an

assessment of the reports of FDA or

State inspections of facilities accredited

by the body as well as any additional

information deemed relevant by FDA

that has been provided by the

accreditation body or other sources or

has been required by FDA as part of its

oversight initiatives. The evaluation

shall include a determination of

whether there are major deficiencies in

the accreditation body’s performance

that, if not corrected, would warrant

withdrawal of the approval of the

accreditation body under the provisions

of § 900.6.

§ 900.6 Withdrawal of approval.

If FDA determines, through the

evaluation activities of § 900.5, or

through other means, that an

accreditation body is not in substantial

compliance with this subpart, FDA may

initiate the following actions:

(a) Major deficiencies. If FDA

determines that an accreditation body

has failed to perform a major

accreditation function satisfactorily, has

demonstrated willful disregard for

public health, has violated the code of

conduct, has committed fraud, or has

submitted material false statements to

the agency, FDA may withdraw its

approval of that accreditation body.

(1) FDA shall notify the accreditation

body of the agency’s action and the

grounds on which the approval was

withdrawn.

(2) An accreditation body that has lost

its approval shall notify facilities

accredited or seeking accreditation by it

that its approval has been withdrawn.

Such notification shall be made within

a time period and in a manner approved

by FDA.

(b) Minor deficiencies. If FDA

determines that an accreditation body

has demonstrated deficiencies in

performing accreditation functions and

responsibilities that are less serious or

more limited than the deficiencies in

paragraph (a) of this section, FDA shall

notify the body that it has a specified

period of time to take particular

corrective measures directed by FDA or

to submit to FDA for approval the

body’s own plan of corrective action

addressing the minor deficiencies. FDA

may place the body on probationary

status for a period of time determined

by FDA, or may withdraw approval of

the body as an accreditation body if

corrective action is not taken.

(1) If FDA places an accreditation

body on probationary status, the body

shall notify all facilities accredited or

seeking accreditation by it of its

probationary status within a time period

and in a manner approved by FDA.

(2) Probationary status shall remain in

effect until such time as the body can

demonstrate to the satisfaction of FDA

that it has successfully implemented or

is implementing the corrective action

plan within the established schedule,

and that the corrective actions have

substantially eliminated all identified

problems.

(3) If FDA determines that an

accreditation body that has been placed

on probationary status is not

implementing corrective actions

satisfactorily or within the established

schedule, FDA may withdraw approval

of the accreditation body. The

accreditation body shall notify all

facilities accredited or seeking

accreditation by it of its loss of FDA

approval, within a time period and in a

manner approved by FDA.

(c) Reapplication by accreditation

bodies that have had their approval

withdrawn. (1) A former accreditation

body that has had its approval

withdrawn may submit a new

application for approval if the body can

provide information to FDA to establish

that the problems that were grounds for

withdrawal of approval have been

resolved.

(2) If FDA determines that the new

application demonstrates that the body

satisfactorily has addressed the causes

of its previous unacceptable

performance, FDA may reinstate

approval of the accreditation body.

(3) FDA may request additional

information or establish additional

conditions that must be met by a former

accreditation body before FDA approves

the reapplication.

(4) FDA may refuse to accept an

application from a former accreditation

body whose approval was withdrawn

because of fraud or willful disregard of

public health.

§ 900.7 Hearings.

(a) Opportunities to challenge final

adverse actions taken by FDA regarding

approval or reapproval of accreditation

bodies, withdrawal of approval of

accreditation bodies, or rejection of a

proposed fee for accreditation shall be

communicated through notices of

opportunity for informal hearings in

accordance with part 16 of this chapter.

(b) A facility that has been denied

accreditation is entitled to an appeals

process from the accreditation body.

The appeals process shall be specified

in writing by the accreditation body and

shall have been approved by FDA in

accordance with § 900.3(d) or

§ 900.4(a)(8).

(c) A facility that cannot achieve

satisfactory resolution of an adverse

accreditation decision through the

accreditation body’s appeals process

may appeal to FDA for reconsideration

in accordance with § 900.15.

§§ 900.8–900.9 [Reserved]

Subpart B—Quality Standards and

Certification

§ 900.10 Applicability.

The provisions of subpart B are

applicable to all facilities under the

regulatory jurisdiction of the United

States that provide mammography
55984 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

services, with the exception of the

Department of Veterans Affairs.

§ 900.11 Requirements for certification.

(a) General. After October 1, 1994, a

certificate issued by FDA is required for

lawful operation of all mammography

facilities subject to the provisions of this

subpart. To obtain a certificate from

FDA, facilities are required to meet the

quality standards in § 900.12 and to be

accredited by an approved accreditation

body or other entity as designated by

FDA.

(b) Application. (1) Certificates. (i) In

order to qualify for a certificate, a

facility must apply to an FDA-approved

accreditation body, or to another entity

designated by FDA. The facility shall

submit to such body or entity the

information required in 42 U.S.C.

263b(d)(1).

(ii) Following the agency’s receipt of

the accreditation body’s decision to

accredit a facility, or an equivalent

decision by another entity designated by

FDA, the agency may issue a certificate

to the facility, or renew an existing

certificate, if the agency determines that

the facility has satisfied the

requirements for certification or

recertification.

(2) Provisional certificates. (i) A new

facility beginning operation after

October 1, 1994, is eligible to apply for

a provisional certificate. The provisional

certificate will enable the facility to

perform mammography and to obtain

the clinical images needed to complete

the accreditation process. To apply for

and receive a provisional certificate, a

facility must meet the requirements of

42 U.S.C. 263b(c)(2) and submit the

necessary information to an approved

accreditation body or other entity

designated by FDA.

(ii) Following the agency’s receipt of

the accreditation body’s decision that a

facility has submitted the required

information, FDA may issue a

provisional certificate to a facility upon

determination that the facility has

satisfied the requirements of

§ 900.11(b)(2)(i). A provisional

certificate shall be effective for up to 6

months from the date of issuance. A

provisional certificate cannot be

renewed, but a facility may apply for a

90-day extension of the provisional

certificate.

(3) Extension of provisional

certificate. (i) To apply for a 90-day

extension to a provisional certificate, a

facility shall submit to its accreditation

body, or other entity designated by FDA,

a statement of what the facility is doing

to obtain certification and evidence that

there would be a significant adverse

impact on access to mammography in

the geographic area served if such

facility did not obtain an extension.

(ii) The accreditation body shall

forward the request, with its

recommendation, to FDA within 2

business days after receipt.

(iii) FDA may issue a 90-day

extension for a provisional certificate

upon determination that the extension

meets the criteria set forth in 42 U.S.C.

263b(c)(2).

(iv) There can be no renewal of a

provisional certificate beyond the 90-

day extension.

(c) Reinstatement policy. A previously

certified facility that has allowed its

certificate to expire, that has been

refused a renewal of its certificate by

FDA, or that has had its certificate

suspended or revoked by FDA, may

apply to have the certificate reinstated

so that the facility may be considered to

be a new facility and thereby be eligible

for a provisional certificate.

(1) Unless prohibited from

reinstatement under § 900.11(c)(4), a

facility applying for reinstatement shall:

(i) Contact an FDA-approved

accreditation body or other entity

designated by FDA to determine the

requirements for reapplication for

accreditation;

(ii) Fully document its history as a

previously provisionally certified or

certified mammography facility,

including the following information:

(A) Name and address of the facility

under which it was previously

provisionally certified or certified;

(B) Name of previous owner/lessor;

(C) FDA facility identification number

assigned to the facility under its

previous certification; and

(D) Expiration date of the most recent

FDA provisional certificate or

certificate; and

(iii) Justify application for

reinstatement of accreditation by

submitting to the accreditation body or

other entity designated by FDA, a

corrective action plan that details how

the facility has corrected deficiencies

that contributed to the lapse of, denial

of renewal, or revocation of its

certificate.

(2) FDA may issue a provisional

certificate to the facility if:

(i) The accreditation body or other

entity designated by FDA notifies the

agency that the facility has adequately

corrected, or is in the process of

correcting, pertinent deficiencies; and

(ii) FDA determines that the facility

has taken sufficient corrective action

since the lapse of, denial of renewal, or

revocation of its previous certificate.

(3) After receiving the provisional

certificate, the facility may lawfully

resume performing mammography

services while completing the

requirements for certification.

(4) If a facility’s certificate was

revoked on the basis of an act described

in 41 U.S.C. 263b(i)(1), no person who

owned or operated that facility at the

time the act occurred may own or

operate a mammography facility within

2 years of the date of revocation.

§ 900.12 Quality standards.

(a) Personnel. The following

requirements apply to all personnel

involved in any aspect of

mammography, including the

production, processing, and

interpretation of mammograms and

related quality assurance activities:

(1) Interpreting physicians. All

physicians interpreting mammograms

shall meet the following qualifications:

(i) Initial qualifications. Unless the

exemption in paragraph (a)(1)(iii)(A) of

this section applies, before beginning to

interpret mammograms independently,

the interpreting physician shall:

(A) Be licensed to practice medicine

in a State;

(B)(1) Be certified in an appropriate

specialty area by a body determined by

FDA to have procedures and

requirements adequate to ensure that

physicians certified by the body are

competent to interpret radiological

procedures, including mammography;

or

(2) Have had at least 3 months of

documented formal training in the

interpretation of mammograms and in

topics related to mammography. The

training shall include instruction in

radiation physics, including radiation

physics specific to mammography,

radiation effects, and radiation

protection. The mammographic

interpretation component shall be under

the direct supervision of a physician

who meets the requirements of

paragraph (a)(1) of this section;

(C) Have a minimum of 60 hours of

documented medical education in

mammography, which shall include:

Instruction in the interpretation of

mammograms and education in basic

breast anatomy, pathology, physiology,

technical aspects of mammography, and

quality assurance and quality control in

mammography. All 60 of these hours

shall be category I and at least 15 of the

category I hours shall have been

acquired within the 3 years immediately

prior to the date that the physician

qualifies as an interpreting physician.

Hours spent in residency specifically

devoted to mammography will be

considered as equivalent to Category I

continuing medical education credits

and will be accepted if documented in

writing by the appropriate
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55985

representative of the training institution;

and

(D) Unless the exemption in

paragraph (a)(1)(iii)(B) of this section

applies, have interpreted or multi-read

at least 240 mammographic

examinations within the 6-month period

immediately prior to the date that the

physician qualifies as an interpreting

physician. This interpretation or multireading shall be under the direct

supervision of an interpreting

physician.

(ii) Continuing experience and

education. All interpreting physicians

shall maintain their qualifications by

meeting the following requirements:

(A) Following the second anniversary

date of the end of the calendar quarter

in which the requirements of paragraph

(a)(1)(i) of this section were completed,

the interpreting physician shall have

interpreted or multi-read at least 960

mammographic examinations during the

24 months immediately preceding the

date of the facility’s annual MQSA

inspection or the last day of the

calendar quarter preceding the

inspection or any date in-between the

two. The facility will choose one of

these dates to determine the 24-month

period.

(B) Following the third anniversary

date of the end of the calendar quarter

in which the requirements of paragraph

(a)(1)(i) of this section were completed,

the interpreting physician shall have

taught or completed at least 15 category

I continuing medical education units in

mammography during the 36 months

immediately preceding the date of the

facility’s annual MQSA inspection or

the last day of the calendar quarter

preceding the inspection or any date in

between the two. The facility will

choose one of these dates to determine

the 36-month period. This training shall

include at least six category I continuing

medical education credits in each

mammographic modality used by the

interpreting physician in his or her

practice; and

(C) Before an interpreting physician

may begin independently interpreting

mammograms produced by a new

mammographic modality, that is, a

mammographic modality in which the

physician has not previously been

trained, the interpreting physician shall

have at least 8 hours of training in the

new mammographic modality.

(D) Units earned through teaching a

specific course can be counted only

once towards the 15 required by

paragraph (a)(1)(ii)(B) of this section,

even if the course is taught multiple

times during the previous 36 months.

(iii) Exemptions. (A) Those physicians

who qualified as interpreting physicians

under paragraph (a)(1) of this section of

FDA’s interim regulations prior to April

28, 1999 are considered to have met the

initial requirements of paragraph

(a)(1)(i) of this section. They may

continue to interpret mammograms

provided they continue to meet the

licensure requirement of paragraph

(a)(1)(i)(A) of this section and the

continuing experience and education

requirements of paragraph (a)(1)(ii) of

this section.

(B) Physicians who have interpreted

or multi-read at least 240

mammographic examinations under the

direct supervision of an interpreting

physician in any 6-month period during

the last 2 years of a diagnostic radiology

residency and who become

appropriately board certified at the first

allowable time, as defined by an eligible

certifying body, are otherwise exempt

from paragraph (a)(1)(i)(D) of this

section.

(iv) Reestablishing qualifications.

Interpreting physicians who fail to

maintain the required continuing

experience or continuing education

requirements shall reestablish their

qualifications before resuming the

independent interpretation of

mammograms, as follows:

(A) Interpreting physicians who fail to

meet the continuing experience

requirements of paragraph (a)(1)(ii)(A)

of this section shall:

(1) Interpret or multi-read at least 240

mammographic examinations under the

direct supervision of an interpreting

physician, or

(2) Interpret or multi-read a sufficient

number of mammographic

examinations, under the direct

supervision of an interpreting

physician, to bring the physician’s total

up to 960 examinations for the prior 24

months, whichever is less.

(3) The interpretations required under

paragraph (a)(1)(iv)(A)(1) or

(a)(1)(iv)(A)(2) of this section shall be

done within the 6 months immediately

prior to resuming independent

interpretation.

(B) Interpreting physicians who fail to

meet the continuing education

requirements of paragraph (a)(1)(ii)(B) of

this section shall obtain a sufficient

number of additional category I

continuing medical education credits in

mammography to bring their total up to

the required 15 credits in the previous

36 months before resuming independent

interpretation.

(2) Radiologic technologists. All

mammographic examinations shall be

performed by radiologic technologists

who meet the following general

requirements, mammography

requirements, and continuing education

and experience requirements:

(i) General requirements. (A) Be

licensed to perform general radiographic

procedures in a State; or

(B) Have general certification from

one of the bodies determined by FDA to

have procedures and requirements

adequate to ensure that radiologic

technologists certified by the body are

competent to perform radiologic

examinations; and

(ii) Mammography requirements.

Have, prior to April 28, 1999 qualified

as a radiologic technologist under

paragraph (a)(2) of this section or

completed at least 40 contact hours of

documented training specific to

mammography under the supervision of

a qualified instructor. The hours of

documented training shall include, but

not necessarily be limited to:

(A) Training in breast anatomy and

physiology, positioning and

compression, quality assurance/quality

control techniques, imaging of patients

with breast implants;

(B) The performance of a minimum of

25 examinations under the direct

supervision of an individual qualified

under paragraph (a)(2) of this section;

and

(C) At least 8 hours of training in each

mammography modality to be used by

the technologist in performing

mammography exams; and

(iii) Continuing education

requirements. (A) Following the third

anniversary date of the end of the

calendar quarter in which the

requirements of paragraphs (a)(2)(i) and

(a)(2)(ii) of this section were completed,

the radiologic technologist shall have

taught or completed at least 15

continuing education units in

mammography during the 36 months

immediately preceding the date of the

facility’s annual MQSA inspection or

the last day of the calendar quarter

preceding the inspection or any date in

between the two. The facility will

choose one of these dates to determine

the 36-month period.

(B) Units earned through teaching a

specific course can be counted only

once towards the 15 required in

paragraph (a)(2)(iii)(A) of this section,

even if the course is taught multiple

times during the previous 36 months.

(C) At least six of the continuing

education units required in paragraph

(a)(2)(iii)(A) of this section shall be

related to each mammographic modality

used by the technologist.

(D) Requalification. Radiologic

technologists who fail to meet the

continuing education requirements of

paragraph (a)(2)(iii)(A) of this section

shall obtain a sufficient number of
55986 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

continuing education units in

mammography to bring their total up to

at least 15 in the previous 3 years, at

least 6 of which shall be related to each

modality used by the technologist in

mammography. The technologist may

not resume performing unsupervised

mammography examinations until the

continuing education requirements are

completed.

(E) Before a radiologic technologist

may begin independently performing

mammographic examinations using a

mammographic modality other than one

of those for which the technologist

received training under paragraph

(a)(2)(ii)(C) of this section, the

technologist shall have at least 8 hours

of continuing education units in the

new modality.

(iv) Continuing experience

requirements. (A) Following the second

anniversary date of the end of the

calendar quarter in which the

requirements of paragraphs (a)(2)(i) and

(a)(2)(ii) of this section were completed

or of October 28, 1997 whichever is

later, the radiologic technologist shall

have performed a minimum of 200

mammography examinations during the

24 months immediately preceding the

date of the facility’s annual MQSA

inspection or the last day of the

calendar quarter or any date in between

the two. The facility will choose one of

these dates to determine the 24-month

period.

(B) Requalification. Radiologic

technologists who fail to meet the

continuing experience requirements of

paragraph (a)(2)(iv)(A) of this section

shall perform a minimum of 25

mammography examinations under the

direct supervision of a qualified

radiologic technologist, before resuming

the performance of unsupervised

mammography examinations.

(3) Medical physicists. All medical

physicists conducting surveys of

mammography facilities and providing

oversight of the facility quality

assurance program under paragraph (e)

of this section shall meet the following:

(i) Initial qualifications. (A) Be State

licensed or approved or have

certification in an appropriate specialty

area by one of the bodies determined by

FDA to have procedures and

requirements to ensure that medical

physicists certified by the body are

competent to perform physics survey;

and

(B)(1) Have a masters degree or higher

in a physical science from an accredited

institution, with no less than 20

semester hours or equivalent (e.g., 30

quarter hours) of college undergraduate

or graduate level physics;

(2) Have 20 contact hours of

documented specialized training in

conducting surveys of mammography

facilities; and

(3) Have the experience of conducting

surveys of at least 1 mammography

facility and a total of at least 10

mammography units. No more than one

survey of a specific unit within a period

of 60 days can be counted towards the

total mammography unit survey

requirement. After April 28, 1999

experience conducting surveys must be

acquired under the direct supervision of

a medical physicist who meets all the

requirements of paragraphs (a)(3)(i) and

(a)(3)(iii) of this section; or

(ii) Alternative initial qualifications.

(A) Have qualified as a medical

physicist under paragraph (a)(3) of this

section of FDA’s interim regulations and

retained that qualification by

maintenance of the active status of any

licensure, approval, or certification

required under the interim regulations;

and

(B) Prior to the April 28, 1999 have:

(1) A bachelor’s degree or higher in a

physical science from an accredited

institution with no less than 10 semester

hours or equivalent of college

undergraduate or graduate level physics,

(2) Forty contact hours of documented

specialized training in conducting

surveys of mammography facilities and,

(3) Have the experience of conducting

surveys of at least 1 mammography

facility and a total of at least 20

mammography units. No more than one

survey of a specific unit within a period

of 60 days can be counted towards the

total mammography unit survey

requirement. The training and

experience requirements must be met

after fulfilling the degree requirement.

(iii) Continuing qualifications. (A)

Continuing education. Following the

third anniversary date of the end of the

calendar quarter in which the

requirements of paragraph (a)(3)(i) or

(a)(3)(ii) of this section were completed,

the medical physicist shall have taught

or completed at least 15 continuing

education units in mammography

during the 36 months immediately

preceding the date of the facility’s

annual inspection or the last day of the

calendar quarter preceding the

inspection or any date in between the

two. The facility shall choose one of

these dates to determine the 36-month

period. This continuing education shall

include hours of training appropriate to

each mammographic modality evaluated

by the medical physicist during his or

her surveys or oversight of quality

assurance programs. Units earned

through teaching a specific course can

be counted only once towards the

required 15 units in a 36-month period,

even if the course is taught multiple

times during the 36 months.

(B) Continuing experience. Following

the second anniversary date of the end

of the calendar quarter in which the

requirements of paragraph (a)(3)(i) or

(a)(3)(ii) of this section were completed

or of October 28, 1997 whichever is

later, the medical physicist shall have

surveyed at least two mammography

facilities and a total of at least six

mammography units during the 24

months immediately preceding the date

of the facility’s annual MQSA

inspection or the last day of the

calendar quarter or any date in-between

the two. The facility shall choose one of

these dates to determine the 24-month

period. No more than one survey of a

specific facility within a 10-month

period on a specific unit within a period

of 60 days can be counted towards the

total mammography unit survey

requirement.

(C) Before a medical physicist may

begin independently performing

mammographic surveys of a new

mammographic modality, that is, a

mammographic modality other than one

for which the physicist received training

to qualify under paragraph (a)(3)(i) or

(a)(3)(ii) of this section, the physicist

must receive at least 8 hours of training

in surveying units of the new

mammographic modality.

(iv) Reestablishing qualifications.

Medical physicists who fail to maintain

the required continuing qualifications of

paragraph (a)(3)(iii) of this section may

not perform the MQSA surveys without

the supervision of a qualified medical

physicist. Before independently

surveying another facility, medical

physicists must reestablish their

qualifications, as follows:

(A) Medical physicists who fail to

meet the continuing educational

requirements of paragraph (a)(3)(iii)(A)

of this section shall obtain a sufficient

number of continuing education units to

bring their total units up to the required

15 in the previous 3 years.

(B) Medical physicists who fail to

meet the continuing experience

requirement of paragraph (a)(3)(iii)(B) of

this section shall complete a sufficient

number of surveys under the direct

supervision of a medical physicist who

meets the qualifications of paragraphs

(a)(3)(i) and (a)(3)(iii) of this section to

bring their total surveys up to the

required two facilities and six units in

the previous 24 months. No more than

one survey of a specific unit within a

period of 60 days can be counted

towards the total mammography unit

survey requirement.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55987

(4) Retention of personnel records.

Facilities shall maintain records to

document the qualifications of all

personnel who worked at the facility as

interpreting physicians, radiologic

technologists, or medical physicists.

These records must be available for

review by the MQSA inspectors.

Records of personnel no longer

employed by the facility should not be

discarded until the next annual

inspection has been completed and FDA

has determined that the facility is in

compliance with the MQSA personnel

requirements.

(b) Equipment. Regulations published

under §§ 1020.30, 1020.31, and

900.12(e) of this chapter that are

relevant to equipment performance

should also be consulted for a more

complete understanding of the

equipment performance requirements.

(1) Prohibited equipment.

Radiographic equipment designed for

general purpose or special

nonmammography procedures shall not

be used for mammography. This

prohibition includes systems that have

been modified or equipped with special

attachments for mammography. This

requirement supersedes the implied

acceptance of such systems in

§ 1020.31(f)(3) of this chapter.

(2) General. All radiographic

equipment used for mammography shall

be specifically designed for

mammography and shall be certified

pursuant to § 1010.2 of this chapter as

meeting the applicable requirements of

§§ 1020.30 and 1020.31 of this chapter

in effect at the date of manufacture.

(3) Motion of tube-image receptor

assembly. (i) The assembly shall be

capable of being fixed in any position

where it is designed to operate. Once

fixed in any such position, it shall not

undergo unintended motion.

(ii) The mechanism ensuring

compliance with paragraph (b)(3)(i) of

this section shall not fail in the event of

power interruption.

(4) Image receptor sizes. (i) Systems

using screen-film image receptors shall

provide, at a minimum, for operation

with image receptors of 18 x 24

centimeters (cm) and 24 x 30 cm.

(ii) Systems using screen-film image

receptors shall be equipped with

moving grids matched to all image

receptor sizes provided.

(iii) Systems used for magnification

procedures shall be capable of operation

with the grid removed from between the

source and image receptor.

(5) Beam limitation and light fields. (i)

All systems shall have beam-limiting

devices that allow the useful beam to

extend to or beyond the chest wall edge

of the image receptor.

(ii) For any mammography system

with a light beam that passes through

the X-ray beam-limiting device, the light

shall provide an average illumination of

not less than 160 lux (15 foot candles)

at 100 cm or the maximum source-image

receptor distance (SID), whichever is

less.

(6) Magnification. (i) Systems used to

perform noninterventional problem

solving procedures shall have

radiographic magnification capability

available for use by the operator.

(ii) Systems used for magnification

procedures shall provide, at a

minimum, at least one magnification

valve within the range of 1.4 to 2.0.

(7) Focal spot selection. (i) When

more than one focal spot is provided,

the system shall indicate, prior to

exposure, which focal spot is selected.

(ii) When more than one target

material is provided, the system shall

indicate, prior to exposure, the

preselected target material.

(iii) When the target material and/or

focal spot is selected by a system

algorithm that is based on the exposure

or on a test exposure, the system shall

display, after the exposure, the target

material and/or focal spot actually used

during the exposure.

(8) Compression. All mammography

systems shall incorporate a compression

device.

(i) Application of compression.

Effective October 28, 1999 each system

shall provide:

(A) An initial power-driven

compression activated by hands-free

controls operable from both sides of the

patient; and

(B) Fine adjustment compression

controls operable from both sides of the

patient.

(ii) Compression paddle. (A) Systems

shall be equipped with different sized

compression paddles that match the

sizes of all full-field image receptors

provided for the system. Compression

paddles for special purposes, including

those smaller than the full size of the

image receptor (for ‘‘spot compression’’)

may be provided. Such compression

paddles for special purposes are not

subject to the requirements of

paragraphs (b)(8)(ii)(D) and (b)(8)(ii)(E)

of this section.

(B) Except as provided in paragraph

(b)(8)(ii)(C) of this section, the

compression paddle shall be flat and

parallel to the breast support table and

shall not deflect from parallel by more

than 1.0 cm at any point on the surface

of the compression paddle when

compression is applied.

(C) Equipment intended by the

manufacturer’s design to not be flat and

parallel to the breast support table

during compression shall meet the

manufacturer’s design specifications

and maintenance requirements.

(D) The chest wall edge of the

compression paddle shall be straight

and parallel to the edge of the image

receptor.

(E) The chest wall edge may be bent

upward to allow for patient comfort but

shall not appear on the image.

(9) Technique factor selection and

display. (i) Manual selection of

milliampere seconds (mAs) or at least

one of its component parts (milliapere

(mA) and/or time) shall be available.

(ii) The technique factors (peak tube

potential in kilovolt (kV) and either tube

current in mA and exposure time in

seconds or the product of tube current

and exposure time in mAs) to be used

during an exposure shall be indicated

before the exposure begins, except when

automatic exposure controls (AEC) are

used, in which case the technique

factors that are set prior to the exposure

shall be indicated.

(iii) Following AEC mode use, the

system shall indicate the actual

kilovoltage peak (kVp) and mAs used

during the exposure. The mAs may be

displayed as mA and time.

(10) Automatic exposure control. (i)

Each screen-film system shall provide

an AEC mode that is operable in all

combinations of equipment

configuration provided, e.g., grid,

nongrid; magnification,

nonmagnification; and various targetfilter combinations.

(ii) The positioning or selection of the

detector shall permit flexibility in the

placement of the detector under the

target tissue.

(A) The size and available positions of

the detector shall be clearly indicated at

the X-ray input surface of the breast

compression paddle.

(B) The selected position of the

detector shall be clearly indicated.

(iii) The system shall provide means

for the operator to vary the selected

optical density from the normal (zero)

setting.

(11) X-ray film. The facility shall use

X-ray film for mammography that has

been designated by the film

manufacturer as appropriate for

mammography.

(12) Intensifying screens. The facility

shall use intensifying screens for

mammography that have been

designated by the screen manufacturer

as appropriate for mammography and

shall use film that is matched to the

screen’s spectral output as specified by

the manufacturer.

(13) Film processing solutions. For

processing mammography films, the

facility shall use chemical solutions that
55988 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

are capable of developing the films used

by the facility in a manner equivalent to

the minimum requirements specified by

the film manufacturer.

(14) Lighting. The facility shall make

special lights for film illumination, i.e.,

hot-lights, capable of producing light

levels greater than that provided by the

view box, available to the interpreting

physicians.

(15) Film masking devices. Facilities

shall ensure that film masking devices

that can limit the illuminated area to a

region equal to or smaller than the

exposed portion of the film are available

to all interpreting physicians

interpreting for the facility.

(c) Medical records and

mammography reports—(1) Contents

and terminology. Each facility shall

prepare a written report of the results of

each mammography examination

performed under its certificate. The

mammography report shall include the

following information:

(i) The name of the patient and an

additional patient identifier;

(ii) Date of examination;

(iii) The name of the interpreting

physician who interpreted the

mammogram;

(iv) Overall final assessment of

findings, classified in one of the

following categories:

(A) ‘‘Negative:’’ Nothing to comment

upon (if the interpreting physician is

aware of clinical findings or symptoms,

despite the negative assessment, these

shall be explained);

(B) ‘‘Benign:’’ Also a negative

assessment;

(C) ‘‘Probably Benign:’’ Finding(s) has

a high probability of being benign;

(D) ‘‘Suspicious:’’ Finding(s) without

all the characteristic morphology of

breast cancer but indicating a definite

probability of being malignant;

(E) ‘‘Highly suggestive of

malignancy:’’ Finding(s) has a high

probability of being malignant;

(v) In cases where no final assessment

category can be assigned due to

incomplete work-up, ‘‘Incomplete: Need

additional imaging evaluation’’ shall be

assigned as an assessment and reasons

why no assessment can be made shall be

stated by the interpreting physician; and

(vi) Recommendations made to the

health care provider about what

additional actions, if any, should be

taken. All clinical questions raised by

the referring health care provider shall

be addressed in the report to the extent

possible, even if the assessment is

negative or benign.

(2) Communication of mammography

results to the patient. Each facility shall

maintain a system to ensure that the

results of each mammographic

examination are communicated to the

patient in a timely manner. If

assessments are ‘‘Suspicious’’ or

‘‘Highly suggestive of malignancy’’ and

the patient has not named a health care

provider, the facility shall make

reasonable attempts to ensure that the

results are communicated to the patient

as soon as possible. (i) As soon as possible, but no later

than 30 days from the date of the

mammography examination, patients

who do not name a health care provider

to receive the mammography report

shall be sent the report described in

paragraph (c)(1) of this section, in

addition to a written notification of

results in lay terms. (ii) Each facility that accepts patients

who do not have a primary care

provider shall maintain a system for

referring such patients to a health care

provider when clinically indicated. (3) Communication of mammography

results to health care providers. When

the patient has a referring health care

provider or the patient has named a

health care provider, the facility shall: (i) Provide a written report of the

mammography examination, including

the items listed in paragraph (c)(1) of

this section, to that health care provider

as soon as possible, but no later than 30

days from the date of the mammography

examination; and

(ii) If the assessment is ‘‘Suspicious’’

or ‘‘Highly suggestive of malignancy,’’

make reasonable attempts to

communicate with the health care

provider as soon as possible, or if the

health care provider is unavailable, to a

responsible designee of the health care

provider. (4) Recordkeeping. Each facility that

performs mammograms: (i) Shall (except as provided in

paragraph (c)(3)(ii) of this section)

maintain mammography films and

reports in a permanent medical record

of the patient for a period of not less

than 5 years, or not less than 10 years

if no additional mammograms of the

patient are performed at the facility, or

a longer period if mandated by State or

local law; and

(ii) Shall upon request or on behalf of,

by the patient, permanently or

temporarily transfer the original

mammograms and copies of the

patient’s reports to a medical

institution, or to a physician or health

care provider of the patient, or to the

patient directly; (iii) Any fee charged to the patients

for providing the services in paragraph

(c)(4)(ii) of this section shall not exceed

the documented costs associated with

this service.

(5) Mammographic image

identification. Each mammographic

image shall have the following

information indicated on it in a

permanent, legible, and unambiguous

manner and placed so as not to obscure

anatomic structures:

(i) Name of patient and an additional

patient identifier.

(ii) Date of examination.

(iii) View and laterality. This

information shall be placed on the

image in a position near the axilla.

Standardized codes specified by the

accreditation body and approved by

FDA in accordance with § 900.3(b) or

§ 900.4(a)(8) shall be used to identify

view and laterality.

(iv) Facility name and location. At a

minimum, the location shall include the

city, State, and zip code of the facility.

(v) Technologist identification.

(vi) Cassette/screen identification.

(vii) Mammography unit

identification, if there is more than one

unit in the facility.

(d) Quality assurance—general. Each

facility shall establish and maintain a

quality assurance program to ensure the

safety, reliability, clarity, and accuracy

of mammography services performed at

the facility.

(1) Responsible individuals.

Responsibility for the quality assurance

program and for each of its elements

shall be assigned to individuals who are

qualified for their assignments and who

shall be allowed adequate time to

perform these duties.

(i) Lead interpreting physician. The

facility shall identify a lead interpreting

physician who shall have the general

responsibility of ensuring that the

quality assurance program meets all

requirements of paragraphs (d) through

(f) of this section. No other individual

shall be assigned or shall retain

responsibility for quality assurance

tasks unless the lead interpreting

physician has determined that the

individual’s qualifications for, and

performance of, the assignment are

adequate.

(ii) Interpreting physicians. All

interpreting physicians interpreting

mammograms for the facility shall:

(A) Follow the facility procedures for

corrective action when the images they

are asked to interpret are of poor

quality, and

(B) Participate in the facility’s medical

outcomes audit program.

(iii) Medical physicist. Each facility

shall have the services of a medical

physicist available to survey

mammography equipment and oversee

the equipment-related quality assurance

practices of the facility. At a minimum,

the medical physicist(s) shall be

responsible for performing the surveys

and mammography equipment
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55989

evaluations and providing the facility

with the reports described in paragraphs

(e)(9) and (e)(10) of this section.

(iv) Quality control technologist.

Responsibility for all individual tasks

within the quality assurance program

not assigned to the lead interpreting

physician or the medical physicist shall

be assigned to a quality control

technologist(s). The tasks are to be

performed by the quality control

technologist or by other personnel

qualified to perform the tasks. When

other personnel are utilized for these

tasks, the quality control technologist

shall ensure that the tasks are completed

in such a way as to meet the

requirements of paragraph (e) of this

section.

(2) Quality assurance records. The

lead interpreting physician, quality

control technologist, and medical

physicist shall ensure that records

concerning employee qualifications to

meet assigned quality assurance tasks,

mammography technique and

procedures, quality control (including

monitoring data, problems detected by

analysis of that data, corrective actions,

and the effectiveness of the corrective

actions), safety, and protection are

properly maintained and updated.

These quality control records shall be

kept for each test specified in

paragraphs (e) and (f) of this section

until the next annual inspection has

been completed and FDA has

determined that the facility is in

compliance with the quality assurance

requirements or until the test has been

performed two additional times at the

required frequency, whichever is longer.

(e) Quality assurance—equipment—

(1) Daily quality control tests. Film

processors used to develop

mammograms shall be adjusted and

maintained to meet the technical

development specifications for the

mammography film in use. A processor

performance test shall be performed on

each day that examinations are

performed before any clinical films are

processed that day. The test shall

include an assessment of base plus fog

density, mid-density, and density

difference, using the mammography

film used clinically at the facility.

(i) The base plus fog density shall be

within + 0.03 of the established

operating level.

(ii) The mid-density shall be within +

0.15 of the established operating level.

(iii) The density difference shall be

within + 0.15 of the established

operating level.

(2) Weekly quality control tests.

Facilities with screen-film systems shall

perform an image quality evaluation

test, using an FDA-approved phantom,

at least weekly.

(i) The optical density of the film at

the center of an image of a standard

FDA-accepted phantom shall be at least

1.20 when exposed under a typical

clinical condition.

(ii) The optical density of the film at

the center of the phantom image shall

not change by more than + 0.20 from the

established operating level.

(iii) The phantom image shall achieve

at least the minimum score established

by the accreditation body and accepted

by FDA in accordance with § 900.3(d) or

§ 900.4(a)(8).

(iv) The density difference between

the background of the phantom and an

added test object, used to assess image

contrast, shall be measured and shall

not vary by more than ± 0.05 from the

established operating level.

(3) Quarterly quality control tests.

Facilities with screen-film systems shall

perform the following quality control

tests at least quarterly:

(i) Fixer retention in film. The

residual fixer shall be no more than 5

micrograms per square cm.

(ii) Repeat analysis. If the total repeat

or reject rate changes from the

previously determined rate by more

than 2.0 percent of the total films

included in the analysis, the reason(s)

for the change shall be determined. Any

corrective actions shall be recorded and

the results of these corrective actions

shall be assessed.

(4) Semiannual quality control tests.

Facilities with screen-film systems shall

perform the following quality control

tests at least semiannually:

(i) Darkroom fog. The optical density

attributable to darkroom fog shall not

exceed 0.05 when a mammography film

of the type used in the facility, which

has a mid-density of no less than 1.2

OD, is exposed to typical darkroom

conditions for 2 minutes while such

film is placed on the counter top

emulsion side up. If the darkroom has

a safelight used for mammography film,

it shall be on during this test.

(ii) Screen-film contact. Testing for

screen-film contact shall be conducted

using 40 mesh copper screen. All

cassettes used in the facility for

mammography shall be tested.

(iii) Compression device performance.

(A) A compression force of at least 111

newtons (25 pounds) shall be provided.

(B) Effective October 28, 1999 the

maximum compression force for the

initial power drive shall be between 111

newtons (25 pounds) and 209 newtons

(47 pounds).

(5) Annual quality control tests.

Facilities with screen-film systems shall

perform the following quality control

tests at least annually:

(i) Automatic exposure control

performance. (A) The AEC shall be

capable of maintaining film optical

density within ± 0.30 of the mean

optical density when thickness of a

homogeneous material is varied over a

range of 2 to 6 cm and the kVp is varied

appropriately for such thicknesses over

the kVp range used clinically in the

facility. If this requirement cannot be

met, a technique chart shall be

developed showing appropriate

techniques (kVp and density control

settings) for different breast thicknesses

and compositions that must be used so

that optical densities within ± 0.30 of

the average under phototimed

conditions can be produced.

(B) After October 28, 1999 the AEC

shall be capable of maintaining film

optical density (OD) within ± 0.15 of the

mean optical density when thickness of

a homogeneous material is varied over

a range of 2 to 6 cm and the kVp is

varied appropriately for such

thicknesses over the kVp range used

clinically in the facility.

(C) The optical density of the film in

the center of the phantom image shall

not be less than 1.20.

(ii) Kilovoltage peak (kVp) accuracy

and reproducibility. (A) The kVp shall

be accurate within + 5 percent of the

indicated or selected kVp at:

(1) The lowest clinical kVp that can

be measured by a kVp test device;

(2) The most commonly used clinical

kVp;

(3) The highest available clinical kVp,

and

(B) At the most commonly used

clinical settings of kVp, the coefficient

of variation of reproducibility of the

kVp shall be equal to or less than 0.02.

(iii) Focal spot condition. Until

October 28, 1999 focal spot condition

shall be evaluated either by determining

system resolution or by measuring focal

spot dimensions. After October 28, 1999

facilities shall evaluate focal spot

condition only by determining the

system resolution.

(A) System Resolution. (1) Each X-ray

system used for mammography, in

combination with the mammography

screen-film combination used in the

facility, shall provide a minimum

resolution of 11 Cycles/millimeters

(mm) (line-pairs/mm) when a high

contrast resolution bar test pattern is

oriented with the bars perpendicular to

the anode-cathode axis, and a minimum

resolution of 13 line-pairs/mm when the

bars are parallel to that axis.

(2) The bar pattern shall be placed 4.5

cm above the breast support surface,

centered with respect to the chest wall
55990 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

edge of the image receptor, and with the

edge of the pattern within 1 cm of the

chest wall edge of the image receptor.

(3) When more than one target

material is provided, the measurement

in paragraph (e)(5)(iii)(A) of this section

shall be made using the appropriate

focal spot for each target material.

(4) When more than one SID is

provided, the test shall be performed at

SID most commonly used clinically.

(5) Test kVp shall be set at the value

used clinically by the facility for a

standard breast and shall be performed

in the AEC mode, if available. If

necessary, a suitable absorber may be

placed in the beam to increase exposure

times. The screen-film cassette

combination used by the facility shall be

used to test for this requirement and

shall be placed in the normal location

used for clinical procedures.

(B) Focal spot dimensions. Measured

values of the focal spot length

(dimension parallel to the anode

cathode axis) and width (dimension

perpendicular to the anode cathode

axis) shall be within the tolerance limits

specified in Table 1.

TABLE 1

Focal Spot Tolerance Limit

Nominal Focal Spot Size (mm)

Maximum Measured Dimensions

Width(mm) Length(mm)

0.10 0.15 0.15

0.15 0.23 0.23

0.20 0.30 0.30

0.30 0.45 0.65

0.40 0.60 0.85

0.60 0.90 1.30

(iv) Beam quality and half-value layer

(HVL). The HVL shall meet the

specifications of § 1020.30(m)(1) of this

chapter for the minimum HVL. These

values, extrapolated to the

mammographic range, are shown in

Table 2. Values not shown in Table 2

may be determined by linear

interpolation or extrapolation.

TABLE 2

X-ray Tube Voltage (kilovolt peak) and Minimum HVL

Designed Operating Range (kV) Measured Operating

Voltage (kV)

Minimum HVL (millimeters of aluminum)

Below 50 20 0.20

25 0.25

30 0.30

(v) Breast entrance air kerma and AEC

reproducibility. The coefficient of

variation for both air kerma and mAs

shall not exceed 0.05.

(vi) Dosimetry. The average glandular

dose delivered during a single craniocaudal view of an FDA-accepted

phantom simulating a standard breast

shall not exceed 3.0 milligray (mGy) (0.3

rad) per exposure. The dose shall be

determined with technique factors and

conditions used clinically for a standard

breast.

(vii) X-ray field/light field/image

receptor/compression paddle alignment.

(A) All systems shall have beamlimiting devices that allow the useful Xray beam to extend to or beyond the

edges of the image receptor but by no

more than 2 percent of the SID at the

chest wall side.

(B) If a light field that passes through

the X-ray beam limitation device is

provided, it shall be aligned with the Xray field so that the total of any

misalignment of the edges of the light

field and the X-ray field along either the

length or the width of the visually

defined field at the plane of the breast

support surface shall not exceed 2

percent of the SID.

(C) The chest wall edge of the

compression paddle shall not extend

beyond the chest wall edge of the image

receptor by more than one percent of the

SID when tested with the compression

paddle placed above the breast support

surface at a distance equivalent to

standard breast thickness. The shadow

of the vertical edge of the compression

paddle shall not be visible on the image.

(viii) Uniformity of screen speed.

Uniformity of screen speed of all the

cassettes in the facility shall be tested

and the difference between the

maximum and minimum optical

densities shall not exceed 0.30. Screen

artifacts shall also be evaluated during

this test.

(ix) System artifacts. System artifacts

shall be evaluated with a high-grade,

defect-free sheet of homogeneous

material large enough to cover the

mammography cassette and shall be

performed for all cassette sizes used in

the facility using a grid appropriate for

the cassette size being tested. System

artifacts shall also be evaluated for all

available focal spot sizes and target filter

combinations used clinically.

(x) Radiation output. (A) The system

shall be capable of producing a

minimum output of 4.5 mGy air kerma

per second (513 milli Roentgen (mR) per

second) when operating at 28 kVp in the

standard mammography (moly/moly)

mode at any SID where the system is

designed to operate and when measured

by a detector with its center located 4.5

cm above the breast support surface

with the compression paddle in place

between the source and the detector.

After October 28, 1999 the system,

under the same measuring conditions

shall be capable of producing a

minimum output of 7.0 mGy air kerma

per second (800 mR per second) when

operating at 28 kVp in the standard

(moly/moly) mammography mode at

any SID where the system is designed to

operate.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55991

(B) The system shall be capable of

maintaining the required minimum

radiation output averaged over a 3.0

second period.

(xi) Decompression. If the system is

equipped with a provision for automatic

decompression after completion of an

exposure or interruption of power to the

system, the system shall be tested to

confirm that it provides:

(A) An override capability to allow

maintenance of compression;

(B) A continuous display of the

override status; and

(C) A manual emergency compression

release that can be activated in the event

of power or automatic release failure.

(6) Quality control tests—other

modalities. For systems with image

receptor modalities other than screenfilm, the quality assurance program

shall be substantially the same as the

quality assurance program

recommended by the image receptor

manufacturer, except that the maximum

allowable dose shall not exceed the

maximum allowable dose for screenfilm systems in paragraph (e)(5)(vi) of

this section.

(7) Mobile Units. The facility shall

verify that mammography units used to

produce mammograms at more than one

location meet the requirements in

paragraphs (e)(1) through (e)(6) of this

section. In addition, at each

examination location, before any

examinations are conducted, the facility

shall verify satisfactory performance of

such units using a test method that

establishes the adequacy of the image

quality produced by the unit.

(8) Use of test results. (i) After

completion of the tests specified in

paragraphs (e)(1) through (e)(7) of this

section, the facility shall compare the

test results to the corresponding

specified action limits; or, for

nonscreen-film modalities, to the

manufacturer’s recommended action

limits; or, for post-move,

preexamination testing of mobile units,

to the limits established in the test

method used by the facility.

(ii) If the test results fall outside of the

action limits, the source of the problem

shall be identified and corrective

actions shall be taken:

(A) Before any further examinations

are performed or any films are

processed using the component of the

mammography system that failed the

test, if the failed test was that described

in paragraphs (e)(1), (e)(2), (e)(4)(ii),

(e)(4)(iii), (e)(5)(i), (e)(5)(iii), (e)(5)(v),

(e)(5)(vi), (e)(6), or (e)(7) of this section;

(B) Within 30 days of the test date for

all other tests described in paragraph (e)

of this section.

(9) Surveys. (i) At least once a year,

each facility shall undergo a survey by

a medical physicist or by an individual

under the direct supervision of a

medical physicist. At a minimum, this

survey shall include the performance of

tests to ensure that the facility meets the

quality assurance requirements of the

annual tests described in paragraphs

(e)(5) and (e)(6) of this section and the

weekly phantom image quality test

described in paragraph (e)(2) of this

section.

(ii) The results of all tests conducted

by the facility in accordance with

paragraphs (e)(1) through (e)(7) of this

section, as well as written

documentation of any corrective actions

taken and their results, shall be

evaluated for adequacy by the medical

physicist performing the survey.

(iii) The medical physicist shall

prepare a survey report that includes a

summary of this review and

recommendations for necessary

improvements.

(iv) The survey report shall be sent to

the facility within 30 days of the date of

the survey.

(v) The survey report shall be dated

and signed by the medical physicist

performing or supervising the survey. If

the survey was performed entirely or in

part by another individual under the

direct supervision of the medical

physicist, that individual and the part of

the survey that individual performed

shall also be identified in the survey

report.

(10) Mammography equipment

evaluations. Additional evaluations of

mammography units or image

processors shall be conducted whenever

a new unit or processor is installed, a

unit or processor is dissembled and

reassembled at the same or a new

location, or major components of a

mammography unit or processor

equipment are changed or repaired.

These evaluations shall be used to

determine whether the new or changed

equipment meets the requirements of

applicable standards in paragraphs (b)

and (e) of this section. All problems

shall be corrected before the new or

changed equipment is put into service

for examinations or film processing. The

mammography equipment evaluation

shall be performed by a medical

physicist or by an individual under the

direct supervision of a medical

physicist.

(11) Facility cleanliness. (i) The

facility shall establish and implement

adequate protocols for maintaining

darkroom, screen, and view box

cleanliness.

(ii) The facility shall document that

all cleaning procedures are performed at

the frequencies specified in the

protocols.

(12) Calibration of air kerma

measuring instruments. Instruments

used by medical physicists in their

annual survey to measure the air kerma

or air kerma rate from a mammography

unit shall be calibrated at least once

every 2 years and each time the

instrument is repaired. The instrument

calibration must be traceable to a

national standard and calibrated with an

accuracy of + 6 percent (95 percent

confidence level) in the mammography

energy range.

(13) Infection control. Facilities shall

establish and comply with a system

specifying procedures to be followed by

the facility for cleaning and disinfecting

mammography equipment after contact

with blood or other potentially

infectious materials. This system shall

specify the methods for documenting

facility compliance with the infection

control procedures established and

shall:

(i) Comply with all applicable

Federal, State, and local regulations

pertaining to infection control; and

(ii) Comply with the manufacturer’s

recommended procedures for the

cleaning and disinfection of the

mammography equipment used in the

facility; or

(iii) If adequate manufacturer’s

recommendations are not available,

comply with generally accepted

guidance on infection control, until

such recommendations become

available.

(f) Quality assurance-mammography

medical outcomes audit. Each facility

shall establish and maintain a

mammography medical outcomes audit

program to followup positive

mammographic assessments and to

correlate pathology results with the

interpreting physician’s findings. This

program shall be designed to ensure the

reliability, clarity, and accuracy of the

interpretation of mammograms.

(1) General requirements. Each facility

shall establish a system to collect and

review outcome data for all

mammograms performed, including

followup on the disposition of all

positive mammograms and correlation

of pathology results with the

interpreting physician’s mammography

report. Analysis of these outcome data

shall be made individually and

collectively for all interpreting

physicians at the facility. In addition,

any cases of breast cancer among

women imaged at the facility that

subsequently become known to the

facility shall prompt the facility to

initiate followup on surgical and/or

pathology results and review of the
55992 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

mammograms taken prior to the

diagnosis of a malignancy.

(2) Frequency of audit analysis. The

facility’s first audit analysis shall be

initiated no later than 12 months after

the date the facility becomes certified,

or 12 months after April 28, 1999

whichever date is the latest. This audit

analysis shall be completed within an

additional 12 months to permit

completion of diagnostic procedures

and data collection. Subsequent audit

analyses will be conducted at least once

every 12 months.

(3) Reviewing interpreting physician.

Each facility shall designate at least one

interpreting physician to review the

medical outcomes audit data at least

once every 12 months. This individual

shall record the dates of the audit

period(s) and shall be responsible for

analyzing results based on this audit.

This individual shall also be responsible

for documenting the results, notifying

other interpreting physicians of their

results and the facility aggregate results.

If followup actions are taken, the

reviewing interpreting physician shall

also be responsible for documenting the

nature of the followup.

(g) Mammographic procedure and

techniques for mammography of

patients with breast implants. (1) Each

facility shall have a procedure to inquire

whether or not the patient has breast

implants prior to the actual

mammographic exam.

(2) Except where contraindicated, or

unless modified by a physician’s

directions, patients with breast implants

undergoing mammography shall have

mammographic views to maximize the

visualization of breast tissue.

(h) Consumer compliant mechanism.

Each facility shall:

(1) Establish a written and

documented system for collecting and

resolving consumer complaints;

(2) Maintain a record of each serious

complaint received by the facility for at

least 3 years from the date the complaint

was received;

(3) Provide the consumer with

adequate directions for filing serious

complaints with the facility’s

accreditation body if the facility is

unable to resolve a serious complaint to

the consumer’s satisfaction;

(4) Report unresolved serious

complaints to the accreditation body in

a manner and timeframe specified by

the accreditation body.

(i) Clinical image quality. Clinical

images produced by any certified

facility must continue to comply with

the standards for clinical image quality

established by that facility’s

accreditation body.

(j) Additional mammography review

and patient notification. (1) If FDA

believes that mammography quality at a

facility has been compromised and may

present a serious risk to human health,

the facility shall provide clinical images

and other relevant information, as

specified by FDA, for review by the

accreditation body or other entity

designated by FDA. This additional

mammography review will help the

agency to determine whether the facility

is in compliance with this section and,

if not, whether there is a need to notify

affected patients, their physicians, or

the public that the reliability, clarity,

and accuracy of interpretation of

mammograms has been compromised.

(2) If FDA determines that any activity

related to the provision of

mammography at a facility may present

a serious risk to human health such that

patient notification is necessary, the

facility shall notify patients or their

designees, their physicians, or the

public of action that may be taken to

minimize the effects of the risk. Such

notification shall occur within a

timeframe and in a manner specified by

FDA.

§ 900.13 Revocation of accreditation and

revocation ofaccreditation body approval.

(a) FDA action following revocation of

accreditation. If a facility’s accreditation

is revoked by an accreditation body, the

agency may conduct an investigation

into the reasons for the revocation.

Following such investigation, the

agency may determine that the facility’s

certificate shall no longer be in effect or

the agency may take whatever other

action or combination of actions will

best protect the public health, including

the establishment and implementation

of a corrective plan of action that will

permit the certificate to continue in

effect while the facility seeks

reaccreditation. A facility whose

certificate is no longer in effect because

it has lost its accreditation may not

practice mammography.

(b) Withdrawal of FDA approval of an

accreditation body. (1) If FDA

withdraws approval of an accreditation

body under § 900.6, the certificates of

facilities previously accredited by such

body shall remain in effect for up to 1

year from the date of the withdrawal of

approval, unless FDA determines, in

order to protect human health or

because the accreditation body

fraudulently accredited facilities, that

the certificates of some or all of the

facilities should be revoked or

suspended or that a shorter time period

should be established for the certificates

to remain in effect.

(2) After 1 year from the date of

withdrawal of approval of an

accreditation body, or within any

shorter period of time established by the

agency, the affected facilities must

obtain accreditation from another

accreditation body, or from another

entity designated by FDA.

§ 900.14 Suspension or revocation of

certificates.

(a) Except as provided in paragraph

(b) of this section, FDA may suspend or

revoke a certificate if FDA finds, after

providing the owner or operator of the

facility with notice and opportunity for

an informal hearing in accordance with

part 16 of this chapter, that the owner,

operator, or any employee of the facility:

(1) Has been guilty of

misrepresentation in obtaining the

certificate;

(2) Has failed to comply with the

standards of § 900.12;

(3) Has failed to comply with

reasonable requests of the agency or the

accreditation body for records,

information, reports, or materials that

FDA believes are necessary to determine

the continued eligibility of the facility

for a certificate or continued compliance

with the standards of § 900.12;

(4) Has refused a reasonable request of

a duly designated FDA inspector, State

inspector, or accreditation body

representative for permission to inspect

the facility or the operations and

pertinent records of the facility;

(5) Has violated or aided and abetted

in the violation of any provision of or

regulation promulgated pursuant to 42

U.S.C. 263b; or

(6) Has failed to comply with prior

sanctions imposed by the agency under

42 U.S.C. 263b(h).

(b) FDA may suspend the certificate of

a facility before holding a hearing if

FDA makes a finding described in

paragraph (a) of this section and also

determines that;

(1) The failure to comply with

required standards presents a serious

risk to human health;

(2) The refusal to permit inspection

makes immediate suspension necessary;

or

(3) There is reason to believe that the

violation or aiding and abetting of the

violation was intentional or associated

with fraud.

(c) If FDA suspends a certificate in

accordance with paragraph (b) of this

section:

(1) The agency shall provide the

facility with an opportunity for an

informal hearing under part 16 of this

chapter not later than 60 days from the

effective date of this suspension;

(2) The suspension shall remain in

effect until the agency determines that:
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations 55993

(i) Allegations of violations or

misconduct were not substantiated;

(ii) Violations of required standards

have been corrected to the agency’s

satisfaction; or

(iii) The facility’s certificate is

revoked in accordance with paragraph

(d) of this section;

(d) After providing a hearing in

accordance with paragraph (c)(1) of this

section, the agency may revoke the

facility’s certificate if the agency

determines that the facility:

(1) Is unwilling or unable to correct

violations that were the basis for

suspension; or

(2) Has engaged in fraudulent activity

to obtain or continue certification.

§ 900.15 Appeals of adverse accreditation

or reaccreditation decisions that preclude

certification or recertification.

(a) The appeals procedures described

in this section are available only for

adverse accreditation or reaccreditation

decisions that preclude certification or

recertification by FDA. Agency

decisions to suspend or revoke

certificates that are already in effect will

be handled in accordance with § 900.14.

(b) Upon learning that a facility has

failed to become accredited or

reaccredited, FDA will notify the facility

that the agency is unable to certify that

facility without proof of accreditation.

(c) A facility that has been denied

accreditation or reaccreditation is

entitled to an appeals process from the

accreditation body, in accordance with

§ 900.7. A facility must avail itself of the

accreditation body’s appeal process

before requesting reconsideration from

FDA.

(d) A facility that cannot achieve

satisfactory resolution of an adverse

accreditation decision through the

accreditation body’s appeal process is

entitled to further appeal in accordance

with procedures set forth in this section

and in regulations published in 42 CFR

part 498.

(1) References to the Health Care

Financing Administration (HCFA) in 42

CFR part 498 should be read as the

Division of Mammography Quality and

Radiation Programs (DMQRP), Center

for Devices and Radiological Health,

Food and Drug Administration.

(2) References to the Appeals Council

of the Social Security Administration in

42 CFR part 498 should be read as

references to the Departmental Appeals

Board.

(3) In accordance with the procedures

set forth in subpart B of 42 CFR part

498, a facility that has been denied

accreditation following appeal to the

accreditation body may request

reconsideration of that adverse decision

from DMQRP.

(i) A facility must request

reconsideration by DMQRP within 60

days of the accreditation body’s adverse

appeals decision, at the following

address: Division of Mammography

Quality and Radiation Programs (HFZ–

240), Center for Devices and

Radiological Health, Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850, Attn: Facility

Accreditation Review Committee.

(ii) The request for reconsideration

shall include three copies of the

following records:

(A) The accreditation body’s original

denial of accreditation.

(B) All information the facility

submitted to the accreditation body as

part of the appeals process;

(C) A copy of the accreditation body’s

adverse appeals decision; and

(D) A statement of the basis for the

facility’s disagreement with the

accreditation body’s decision.

(iii) DMQRP will conduct its

reconsideration in accordance with the

procedures set forth in subpart B of 42

CFR part 498.

(4) A facility that is dissatisfied with

DMQRP’s decision following

reconsideration is entitled to a formal

hearing in accordance with procedures

set forth in subpart D of 42 CFR part

498.

(5) Either the facility or FDA may

request review of the hearing officer’s

decision. Such review will be

conducted by the Departmental Appeals

Board in accordance with subpart E of

42 CFR part 498.

(6) A facility cannot perform

mammography services while an

adverse accreditation decision is being

appealed.

§ 900.16 Appeals of denials of

certification.

(a) The appeals procedures described

in this section are available only to

facilities that are denied certification by

FDA after they have been accredited by

an approved accreditation body.

Appeals for facilities that have failed to

become accredited are governed by the

procedures set forth in § 900.15.

(b) FDA may deny the application if

the agency has reason to believe that:

(1) The facility will not be operated in

accordance with standards established

under § 900.12;

(2) The facility will not permit

inspections or provide access to records

or information in a timely fashion; or

(3) The facility has been guilty of

misrepresentation in obtaining the

accreditation.

(c)(1) If FDA denies an application for

certification by a faciity that has

received accreditation from an approved

accreditation body, FDA shall provide

the facility with a statement of the

grounds on which the denial is based.

(2) A facility that has been denied

accreditation may request

reconsideration and appeal of FDA’s

determination in accordance with the

applicable provisions of § 900.15(d).

§ 900.17 [Reserved]

§ 900.18 Alternative requirements for

§ 900.12 quality standards.

(a) Criteria for approval of alternative

standards. Upon application by a

qualified party as defined in paragraph

(b) of this section, FDA may approve an

alternative to a quality standard under

§ 900.12, when the agency determines

that:

(1) The proposed alternative standard

will be at least as effective in assuing

quality mammography as the standard it

proposes to replace, and

(2) The proposed alternative:

(i) Is too limited in its applicability to

justify an amendment to the standard; or

(ii) Offers an expected benefit to

human health that is so great that the

time required for amending the standard

would present an unjustifiable risk to

the human health; and

(3) The granting of the alternative is

in keeping with the purposes of 42

U.S.C. 263b.

(b) Applicants for alternatives. (1)

Mammography facilities and

accreditation bodies may apply for

alternatives to the quality standards of

§ 900.12.

(2) Federal agencies and State

governments that are not accreditation

bodies may apply for alternatives to the

standards of § 900.12(a).

(3) Manufacturers and assemblers of

equipment used for mammography may

apply for alternatives to the standards of

§ 900.12(b) and (e).

(c) Applications for approval of an

alternative standard. An application for

approval of an alternative standard or

for an amendment or extension of the

alternative standard shall be submitted

in an original and two copies to the

Director, Division of Mammography

Quality and Radiation Programs (HFZ–

240), Center for Devices and

Radiological Health, Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850. The application

for approval of an alternative standard

shall include the following information:

(1) Identification of the original

standard for which the alternative

standard is being proposed and an

explanation of why the applicant is

proposing the alternative;

(2) A description of the manner in

which the alternative is proposed to

deviate from the original standard;
55994 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Rules and Regulations

(3) A description, supported by data,

of the advantages to be derived from

such deviation;

(4) An explanation, supported by

data, of how such a deviation would

ensure equal or greater quality of

production, processing, or interpretation

of mammograms than the original

standard;

(5) The suggested period of time that

the proposed alternative standard would

be in effect; and

(6) Such other information required

by the Director to evaluate and act on

the application.

(d) Ruling on applications. (1) FDA

may approve or deny, in whole or in

part, a request for approval of an

alternative standard or any amendment

or extension thereof, and shall inform

the applicant in writing of this action.

The written notice shall state the

manner in which the requested

alternative standard differs from the

agency standard and a summary of the

reasons for approval or denial of the

request. If the request is approved, the

written notice shall also include the

effective date and the termination date

of the approval and a summary of the

limitations and conditions attached to

the approval and any other information

that may be relevant to the approved

request. Each approved alternative

standard shall be assigned an

identifying number.

(2) Notice of an approved request for

an alternative standard or any

amendment or extension thereof shall

be placed in the public docket file in the

Dockets Management Branch and may

also be in the form of a notice published

in the Federal Register. The notice shall

state the name of the applicant, a

description of the published agency

standard, and a description of the

approved alternative standard,

including limitations and conditions

attached to the approval of the

alternative standard.

(3) Summaries of the approval of

alternative standards, including

information on their nature and number,

shall be provided to the National

Mammography Quality Assurance

Advisory Committee.

(4) All applications for approval of

alternative standards and for

amendments and extensions thereof and

all correspondence (including written

notices of approval) on these

applications shall be available for public

disclosure in the Dockets Management

Branch, excluding patient identifiers

and confidential commercial

information.

(e) Amendment or extension of an

alternative standard. An application for

amending or extending approval of an

alternative standard shall include the

following information:

(1) The approval number and the

expiration date of the alternative

standard;

(2) The amendment or extension

requested and the basis for the

amendment or extension; and

(3) An explanation, supported by

data, of how such an amendment or

extension would ensure equal or greater

quality of production, processing, or

interpretation of mammograms than the

original standard.

(f) Applicability of the alternative

standards. (1) Except as provided in

paragraphs (f)(2) and (f)(3) of this

section, any approval of an alternative

standard, amendment, or extension may

be implemented only by the entity to

which it was granted and under the

terms under which it was granted. Other

entities interested in similar or identical

approvals must file their own

application following the procedures of

paragraph (c) of this section.

(2) When an alternative standard is

approved for a manufacturer of

equipment, any facility using that

equipment will also be covered by the

alternative standard.

(3) The agency may extend the

alternative standard to other entities

when FDA determines that expansion of

the approval of the alternative standard

would be an effective means of

promoting the acceptance of measures

to improve the quality of

mammography. All such determinations

will be publicized by appropriate

means.

(g) Withdrawal of approval of

alternative requirements. FDA shall

amend or withdraw approval of an

alternative standard whenever the

agency determines that this action is

necessary to protect the human health

or otherwise is justified by § 900.12.

Such action will become effective on the

date specified in the written notice of

the action sent to the applicant, except

that it will become effective

immediately upon notification of the

applicant when FDA determines that

such action is necessary to prevent an

imminent health hazard.

Dated: September 25, 1997.

Michael A. Friedman,

Lead Deputy Commissioner for the Food and

Drug Administration.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 97–26351 Filed 10–27–97; 8:45 am]

BILLING CODE 4160–01–F