[Federal Register: October 28, 1997 (Volume 62, Number 208)]
[Rules and Regulations]
[Page 55851-55901]
From the Federal Register Online via GPO Access

[[Page 55851]]

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Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 16 and 900

Quality Mammography Standards; Final Rule

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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.

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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
Secs. 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

[[Page 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,

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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 equipment-related regulations, in Sec. 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 Secs. 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 Sec. 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

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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 Sec. 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 phase-
in 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 Sec. 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 Sec. 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, Sec. 900.12(e) establishes equipment QC
requirements, and Sec. 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

[[Page 55856]]

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 Sec. 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 Sec. 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 Sec. 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 (Secs. 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 performance-based
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 (Sec. 900.10); (2) requirements for
certification (Sec. 900.11); (3) procedures for suspension or
revocation of accreditation; (4) accreditation body approval; (5)
facility certificates (Secs. 900.13 and 900.14); (6) the process for
appealing agency decisions (Sec. 900.15); and (7) an alternative
requirement process (Sec. 900.18). Some aspects of the facility
standards were also covered. These included medical records and
recordkeeping (Sec. 900.12(c)); general quality assurance requirements
(Sec. 900.12(d)); mammography medical outcome audits (Sec. 900.12(f));
mammography of examinees with breast implants (Sec. 900.12(g)); the
consumer complaint process (Sec. 900.12(h)); and additional clinical
image review and patient notification (Sec. 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 (Secs. 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
(Sec. 900.12(a)(1)), radiologic technologists (Sec. 900.12(a)(2)), and
medical physicists (Sec. 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 (Sec. 900.12(b)) and requirements for the
equipment quality assurance program (Sec. 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

[[Page 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 micro-management, 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 micro-management, 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

[[Page 55858]]

``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

[[Page 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

[[Page 55860]]

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 Sec. 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 Secs. 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 2\1/2\ 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.

[[Page 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 outcome-based 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

[[Page 55862]]

proposed regulations were actually a mix of performance- and
specification-based 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 Sec. 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 design-
based 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

[[Page 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
performance-based 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 outcomes-based 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 performance-based 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

[[Page 55864]]

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. Thirty-
seven 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, time-
consuming, 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 hands-on 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 sub-specialty 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

[[Page 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
performance-based 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
performance-based 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

[[Page 55866]]

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
performance-based standards can replace these regulations, FDA will
propose amendments to the MQSA rules.

C. Scope Sec. 900.1

    This section briefly summarized the content of the following
regulatory sections. No comments were received and it was codified
unchanged.

D. Definitions Sec. 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:
<bullet> Adverse event
<bullet> Consumer
<bullet> Serious adverse event
<bullet> 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 Sec. 900.12(h), and
accreditation bodies, under Sec. 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

[[Page 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 Secs. 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 Sec. 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 instructor-student 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
Sec. 900.12(d)(1)(iv) makes the QC technologist responsible for
ensuring the quality of performance of those

[[Page 55868]]

doing QC tests. The definition of QC technologist in Sec. 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 Sec. 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 Sec. 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
Sec. 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
Sec. 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.

[[Page 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,

[[Page 55870]]

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
Sec. 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 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. 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 Sec. 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. Multi-reading 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

[[Page 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 ``multi-reading'' to include both
independent and consultative reading. If the multi-reading 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 self-referred 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 Sec. 900.12(a)(2) for

[[Page 55872]]

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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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
Sec. 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

[[Page 55873]]

he or she has been assigned responsibility under
Sec. 900.12(d)(1)(iii).
    FDA considered the possibility of adding this definition, but notes
that Sec. 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 Sec. 900.12(e)(7) needs to be performed. Under
Sec. 900.12(e)(7), a mobile unit is one that is used to produce
mammograms at more than one location. The agency believes
Sec. 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 Sec. 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
Sec. 900.12(e)(5)(v). Definitions of ``air kerma'' and ``kerma'' were
also added as Secs. 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
Sec. 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 Sec. 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 Sec. 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
Sec. 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 Sec. 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 Sec. 900.2(uu) in the
final regulations.

[[Page 55874]]

E. The Accreditation Body Application (Sec. 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
(Sec. 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 (Sec. 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 (Sec. 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
Sec. 900.4(c)(5) and for phantom image reviewers under
Sec. 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 (Sec. 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 (Sec. 900.3(b)(3)(xiii))
    This subparagraph requires a prospective accreditation body to
provide any information required by FDA beyond that specifically listed
in Sec. 900.3(b)(3).
    (Comment 100). One comment described this requirement as
exceedingly vague and recommended it be deleted.

[[Page 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 Sec. 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 Sec. 900.3(b)(3)(ix) and its addition has caused the
subsequent sections to be renumbered.
7. Term of Approval (Sec. 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 (Sec. 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 performance-based 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 (Sec. 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 (Sec. 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 Sec. 900.4(a)(2)). The final provisions establish that the
accreditation body has a responsibility to review clinical images or
other

[[Page 55876]]

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
(Sec. 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 (Sec. 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
(Sec. 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

[[Page 55877]]

interim regulations demonstrates that potential conflicts can be
addressed satisfactorily by the provisions of Sec. 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 (Sec. 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 (Sec. 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

[[Page 55878]]

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 (Sec. 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

[[Page 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 (Sec. 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 (Sec. 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 (Sec. 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 (Sec. 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 Sec. 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

[[Page 55880]]

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 Sec. 900.12(j).
    a. Frequency of clinical image review (Sec. 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 (Sec. 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 Sec. 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 stick-on 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 Sec. 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 facility-based 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 (Sec. 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
Sec. 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

[[Page 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 (Sec. 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 Sec. 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 Sec. 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 fat-replaced 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 Sec. 900.4(c)(4)(iii) accordingly.
    (Comment 145). One comment suggested that Sec. 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
Sec. 900.4(c))(4)(iii). It stated that no alternatives should be
accepted for craniocaudal and mediolateral views required in
Sec. 900.4(c)(4)(I) or for dense and fatty breast images required in
Sec. 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 (Sec. 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 Sec. 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

[[Page 55882]]

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 (Sec. 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 Sec. 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 Sec. 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 (Sec. 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 Sec. 900.4(a)(1)(ii).
5. Phantom Image Review (Sec. 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, Sec. 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
Sec. 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 (Sec. 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 Sec. 900.4(d)(5)(I) as written.
    FDA has stated in Sec. 900.4(d)(5)(I) that the accreditation bodies
must ensure that their phantom image reviewers meet the requirements
specified in Sec. 900.12(a)(3) for medical physicists or alternative
requirements established by the accreditation bodies and approved by
FDA in accordance with Sec. 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

[[Page 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 Sec. 900.12(a)(3) or FDA-
approved 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 Sec. 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 Sec. 900.4(a)(4), which was discussed previously.
    c. Image management (Sec. 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
(Sec. 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 Sec. 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 Sec. 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
(Sec. 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.

[[Page 55884]]

    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,
Sec. 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
(Sec. 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 (Sec. 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 (Sec. 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 Sec. 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

[[Page 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 (Sec. 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 Sec. 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
(Sec. 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
Sec. 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 Sec. 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

[[Page 55886]]

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 (Sec. 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 Sec. 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
Sec. 900.12(h).
9. Reporting and recordkeeping (Sec. 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 (Sec. 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 multi-unit 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 (Sec. 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 (Sec. 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 (Sec. 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 (Sec. 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 (Sec. 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 (Sec. 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 Sec. 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

[[Page 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 Sec. 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
Sec. 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)
(Sec. 900.11(b)(2))
    FDA has amended the language in Sec. 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 Sec. 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 Sec. 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

[[Page 55888]]

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 Sec. 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 (Sec. 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
Sec. 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 (Sec. 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 (Sec. 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 (Sec. 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 Sec. 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
Sec. 900.11(i)(2) to indicate that the agency retains discretion to
accept facilities for reinstatement.
7. The 2-Year Waiting Period (Sec. 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 Sec. 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)).

[[Page 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 Sec. 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 Sec. 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 (Sec. 900.12)

1. Personnel (Sec. 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
Sec. 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
(Sec. 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,

[[Page 55890]]

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 (Sec. 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
Sec. 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 Sec. 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 Sec. 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 Sec. 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

[[Page 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

[[Page 55892]]

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,
Sec. 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 Sec. 900.12(a)(ii)(C).
    (Comment 205). Several comments agreed with Sec. 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 multi-reading 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 Sec. 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

[[Page 55893]]

readings of a mammogram can be counted as two interpretations.
    Multi-reading, as defined in Sec. 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 multi-read 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 Sec. 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

[[Page 55894]]

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

[[Page 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, Sec. 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 Sec. 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
Sec. 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
Sec. 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 Sec. 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 Sec. 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

[[Page 55896]]

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
Sec. 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 Sec. 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

[[Page 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 Sec. 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 Sec. 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-to-date, past
qualifications can not be used to meet these requirements. Similarly,
FDA did not include the general licensing or certification requirement
established by Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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

[[Page 55898]]

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-by-case 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
Sec. 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 Sec. 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 Sec. 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
Sec. 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
Sec. 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

[[Page 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-by-case 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 Sec. 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 Sec. 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
Sec. 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 Sec. 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
(Sec. 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,

[[Page 55900]]

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 Sec. 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 Sec. 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

[[Page 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 Sec. 900.12(a)(2)(ii)(A).
    The second part of proposed Sec. 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, Sec. 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 Sec. 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 up-to-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

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