United States General Accounting Office

GAO Report to Congressional Committees

October 1995 MAMMOGRAPHY

SERVICES

Initial Impact of New

Federal Law Has Been

Positive

GAO/HEHS-96-17

GAO United States

General Accounting Office

Washington, D.C. 20548

Health, Education, and

Human Services Division

B-270025 

October 27, 1995

The Honorable Nancy L. Kassebaum

Chairman, Committee on Labor and

 Human Resources

United States Senate

The Honorable Thomas J. Bliley, Jr.

Chairman, Committee on Commerce

House of Representatives

Breast cancer is the second leading cause of cancer mortality among

American women. The American Cancer Society has estimated that, in

1995, 46,000 women will die from breast cancer and an additional 182,000

will be diagnosed with the disease. The probability for survival increases

significantly when the disease is discovered in its early stages. Currently,

the most effective technique for early detection of breast cancer is

mammography, an X-ray procedure that can detect small tumors and

breast abnormalities. Research studies indicate that widespread use of

mammography could reduce breast cancer mortality by one-third,

especially among women aged 50 to 74.

The effectiveness of mammography as a cancer detection technique is

directly related to the quality of mammography procedures. In response to

concerns that many providers were using mammography procedures of

insufficient quality, the Congress enacted the Mammography Quality

Standards Act of 1992 (MQSA). The act established a number of

requirements aimed at strengthening quality, such as certification and

annual inspection of mammography facilities. The act also mandated that

we assess the program established by the Food and Drug Administration

(FDA) to implement these various requirements. We are required to issue

an interim report in 1995 and a final report in 1997. This interim report is

focused on assessing whether FDA’s implementation of the act so far has

had any effect on (1) the quality of mammography services and (2) access

to such services. This interim report is based primarily on our analysis of

outcome data from FDA’s certification and annual inspection programs and

on our interviews with officials from federal, state, and private

organizations involved with the programs. We did our work from

November 1994 through August 1995 in accordance with generally

accepted government auditing standards. Details of our scope and

methodology are presented in appendix I.

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Results in Brief Early indications are that the act has had a positive effect on the quality of

mammography services. A set of uniform standards, substantially the same

as those advocated by the American College of Radiology (ACR), a private,

nonprofit professional association of radiologists, is now required in all

states. Before the act, states varied widely in the standards they imposed,

and only a few states had standards comparable to those established

under MQSA. We also found that these standards are having more than a

symbolic effect, because in order to become fully certified, many facilities

have had to improve their practices. Annual inspections of certified

facilities are helping to ensure that facilities are in compliance with

standards on a day-to-day operating level.

When the act was passed, the Congress was concerned that access to

mammography services might be limited because many providers would

choose to drop mammography services rather than upgrade operations to

comply with the standards. Our work suggests that this does not appear to

be the case. While some facilities have chosen to cease mammography

services rather than comply with higher standards, the number that have

done so is relatively small compared with the total number of facilities

available to provide services. Those facilities that chose to stop delivering

such services were generally small-volume providers located within 25

miles of another certified facility. FDA’s gradual approach to implementing

the act’s requirements appears to have been a factor in minimizing adverse

effects on access. FDA has not closed many facilities that have not met

certification or inspection requirements. Instead, it has given facilities time

and repeated opportunities to meet new quality assurance requirements

and to correct problems found during inspections.

Background An estimated 23.5 million mammograms were performed in the United

States in 1992 at a cost of about $2.5 billion. Both the National Cancer

Institute (NCI) and the American Cancer Society recommend that all

women over the age of 50 have annual screening mammograms, though

the two organizations are not in total agreement on the recommended

frequency of screening mammography for women under the age of 50.

Utilization rates for the technology have continuously increased over the

years. According to the Centers for Disease Control and Prevention, the

percentage of women aged 50 and above who had received mammograms

in the past year increased from 26 percent in 1987 to 54 percent in 1993.

The demand for mammography services has resulted in significant growth

in the number of mammography facilities, currently numbering over 10,000

nationwide.

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Mammography is one of the most technically challenging radiological

procedures, and ensuring the quality of the radiologic image is difficult. If

the image is poor, tumors and abnormalities may go undetected. To

illustrate, two images of the same patient who had a cancerous tumor are

presented in figure 1. The tumor is visible in the picture on the right,

where the image is of higher quality, but it is blurred and indecipherable in

the picture on the left.

Page 3 GAO/HEHS-96-17 Mammography Services
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Figure 1: Example of Low- and High-Quality Mammography Images of the Same Patient

Cancerous

Mass

Tumor Not Visible Tumor Visible

Source: Dr. Carolyn Kimme-Smith, UCLA Department of Radiology, Los Angeles, California.

Accurate interpretation of mammograms is equally as important as image

quality. According to radiological experts, mammograms are the most

Page 4 GAO/HEHS-96-17 Mammography Services
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difficult radiographic images to read. Misreading mammograms can have

considerable consequences. A mammogram that is incorrectly read as

showing an abnormality could cause a woman to go through unnecessary

and costly follow-up procedures, such as ultrasound or biopsies. A

mammogram that is read as normal when an abnormality is actually

present could result in missed diagnosis of early lesions and delayed

treatment, which could cost a woman’s life.

MQSA contains a number of provisions designed to ensure the quality of the

image and its interpretation. Among other things, MQSA requires that

• FDA establish quality standards for mammography equipment, personnel,

and practices;

• all mammography facilities be accredited by an FDA-approved accrediting

body (either a nonprofit organization or a state agency) and obtain a

certificate from FDA in order to legally provide mammography services

after October 1, 1994; and

• all mammography facilities be evaluated annually by a certified medical

physicist and be inspected annually by FDA-approved inspectors.

FDA issued interim regulations in December 1993 that established

requirements for accrediting bodies and quality standards and certification

requirements for mammography facilities. Since early 1994, FDA has been

working with the National Mammography Quality Assurance Advisory

Committee1

 to develop the final regulations. FDA officials estimate that

they will publish the proposed final regulations for public comment in

October 1995 and issue the final regulations in October 1996. As of

October 1, 1994, FDA had approved ACR and the states of California,

Arkansas, and Iowa as official accrediting bodies. Because of ACR’s

pre-MQSA involvement in establishing a voluntary accreditation program, it

serves as the major accrediting body, responsible for over 95 percent of

1

MQSA also required that the Secretary of Health and Human Services establish a National

Mammography Quality Assurance Advisory Committee. The Secretary delegated the responsibility to

FDA. Among other things, the Committee is responsible for advising FDA on the appropriateness of

quality standards for mammography facilities and accrediting bodies and for studying (1) the effect of

MQSA on access to services in rural and health-professional-shortage areas, (2) the costs and benefits

of compliance with MQSA, and (3) the sufficiency of medical physicists after October 1, 1999, to

ensure compliance with MQSA. The Committee was required to report the findings of the first two

studies by October 1993, but as of July 15, 1995, it had not done so.

Page 5 GAO/HEHS-96-17 Mammography Services
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the current MQSA accreditation workload.2 To minimize duplicate

submission of application information to FDA and accrediting bodies,

under FDA’s interim rules facilities need only submit application

information to the accrediting bodies. On the basis of accrediting bodies’

notification, FDA automatically issues certificates to facilities that pass

accreditation review.

Quality of

Mammography

Services Has

Improved

Early indications point to a general improvement in the quality of

mammography services under the act. This improvement is mainly the

result of setting national quality assurance standards and establishing

enforcement mechanisms to ensure that the standards are met by all

mammography providers.

Standards Are Now in

Place

Before MQSA, wide variations existed in oversight provided at the state

level. To provide an indication of these variations, we asked a panel of

experts3

 to develop a list of mammography standards they considered

most important. Eighteen quality assurance requirements were selected

and then used as a benchmark for evaluating state oversight before MQSA

took effect. These requirements, listed in appendix II, include such items

as the quality of clinical image evaluations and the use of equipment

designed especially for mammography. Before MQSA was implemented,

only two states—Michigan and Texas—had enacted legislation and

regulations that included all 18 requirements.4

 Nine states—Alabama,

Connecticut, Kansas, Louisiana, Montana, Nebraska, North Dakota, West

Virginia, and Wyoming—plus the District of Columbia made no mention of

any of these requirements in state laws or regulations. See appendix III for

state-by-state results.

Our interviews with officials from 20 states indicated that the impact of

MQSA on quality of mammography services was greatest in states that had

2

Concerned about the quality of mammography services, ACR began in 1987 a voluntary

mammography accreditation program to provide assurance of quality to patients seeking services at

ACR-accredited facilities. The program involved a number of facility procedures and image quality

requirements, including an evaluation of clinical images produced by each facility. The program did

not include on-site inspections of each facility and, because it was a voluntary program, only facilities

that were seeking accreditation were subjected to ACR review.

3

The experts came from five agencies or organizations: FDA, NCI, ACR, the Conference of Radiation

Control Program Directors, and the Medical Center of the University of California at Los Angeles.

4

Information about state mammography quality assurance requirements was obtained from an NCI

study entitled Legislative and Regulatory Mandates for Mammography Quality Assurance. The study

involved detailed review of state-enacted legislation and regulations on mammography quality

assurance. It did not assess the extent to which states enforce their regulations.

Page 6 GAO/HEHS-96-17 Mammography Services
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no or few pre-MQSA standards. For example, officials from four states that

had no pre-MQSA standards told us that they believed MQSA would greatly

improve the quality of mammography services in their states. Officials

from Michigan, which already had well-developed standards, welcomed

the additional authority and resources that MQSA gave them to enforce the

standards, but said the act’s effect would not be as significant as it would

in states without such standards already in place.

Another measure of variation in quality standards before MQSA was the

level of voluntary participation in mammography quality assurance

activities developed by ACR. ACR has managed a voluntary accreditation

program since 1987, but, according to NCI and ACR records, only between

37 and 44 percent of the nation’s mammography units were accredited by

ACR as of July 1993.

The MQSA standards, as currently prescribed in FDA’s interim regulations,

include all 18 requirements chosen by our panel as well as a number of

other requirements. Thus, the October 1994 implementation of MQSA had a

substantial effect in that all providers, regardless of location or setting,

became responsible for complying with a single, minimum standard of

care. In all, FDA’s interim regulations contain more than 30 requirements

covering such matters as personnel qualification and radiation safety. In

implementing these requirements, FDA adopted the standards that had

been set by ACR in its voluntary compliance program. These standards have

been endorsed by professional organizations as well as industry and

government experts. FDA officials chose these standards because they

believed the standards were based on sound scientific principles and

clinical judgment gained through extensive experience; further, the

legislative history of MQSA indicates that the Congress intended to use the

ACR program as the model for accreditation.5

The current standards include specific requirements to control image

quality, but the requirement for monitoring the accuracy of image

interpretation is less specific. The regulations include a general

requirement that each facility have a system to review outcome data,

including follow-up on positive mammograms (those identified as showing

tumors or abnormalities) and their correlation to biopsy results. However,

the regulations do not include standards for evaluating the outcome data.

How to develop a quality assurance system to monitor the accuracy of

5

Under ACR’s program, facilities are required to have a quality assurance system that includes qualified

personnel (interpreting physician, medical physicist, and radiologic technologist) with adequate

continuing education in mammography, as well as appropriate equipment, quality control, and quality

assurance procedures.

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image interpretation is a controversial issue in the medical community. On

one hand, several academic studies have shown wide variation in the

interpretation of the same films by different radiologists, and some experts

suggest that peer reviews of films or proficiency tests of radiologists are

needed to ensure accuracy. On the other hand, others, including FDA,

believe that those measures are too difficult and costly to implement and

that a system of tracking the mammography outcomes is a better approach

to achieve the goal of quality interpretation.

FDA officials told us that, after consulting with the National Mammography

Quality Assurance Advisory Committee, they are considering expanding

the outcome data requirement in the proposed final regulations. The

option under consideration is for each facility to designate at least one

interpreting physician to review the outcome data at least annually, and

for the facilities to use the data to evaluate the performance of each

interpreting physician and the facility as a whole. FDA officials told us this

option would allow facilities discretion in defining outcome standards.

They said such discretion was needed because no consensus existed on

appropriate outcome measures and because more research was needed

before outcome standards could be prescribed.

Accreditation Process Has

Produced Change at Many

Facilities

MQSA called for facilities to comply with the new standards through an

accreditation process. In adopting ACR standards in its interim regulations,

FDA granted automatic certification to any facility that had already

demonstrated compliance with ACR requirements by being accredited

under ACR’s voluntary program. All other facilities had to apply for

accreditation by completing an application package and submitting

materials for testing to provide evidence of meeting the standards.

Accreditation was performed by one of the FDA-approved accrediting

bodies. While the accreditation procedures established by Arkansas,

California, and Iowa are somewhat different from ACR’s,6

 the four

accrediting bodies enforce the same FDA standards. Because ACR accounts

for more than 95 percent of the current MQSA accreditation workload, we

focused our review on ACR’s accreditation process.

When MQSA initially took effect, many mammography units did not meet its

mammography standards. According to ACR records, between October 1,

6

For example, ACR allows facilities to submit materials for review only twice and will deny

accreditation to facilities that fail the second review. Arkansas and Iowa, on the other hand, allow

facilities to resubmit materials three times and, instead of denying accreditation if a facility fails the

second review, continue to work with the facility to bring it into compliance with accreditation

requirements.

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1994, and August 1, 1995, 7,525 different mammography units from

approximately 5,510 facilities went through ACR’s first review for

accreditation, and 2,598 units (35 percent) from roughly 1,900 facilities

failed to meet the accreditation requirements.7

 After a second review

process, ACR found about two-thirds of these units to be in compliance and

granted them full accreditation.8

 Of those that were denied accreditation

after failing the second review, 277 facilities have since taken sufficient

corrective actions to qualify for reinstatement. These data suggest that the

accreditation process has resulted in improvement at these facilities.

Inspection Process Is

Designed to Enforce

Compliance

MQSA inspection authority provides FDA with another means to ensure that

facilities comply with standards on a day-to-day operating level. While

accreditation is a mail-in process that involves the submission and review

of application materials, inspections are conducted on site, allowing

inspectors to verify information provided during the accreditation process.

Actual inspections began somewhat later than initially planned. FDA

entered into agreements with states to train state inspectors for annual

inspections and reimburse states for their inspection costs. FDA had

planned to have 200 inspectors trained by June 1995, but only 159

inspectors were trained by that date. Because of these delays in training,

annual inspections did not begin until January 1995, although they had

been planned to start in October 1994.

Early results from annual inspections indicated that many facilities fell

short of full compliance with MQSA requirements. As of June 9, 1995,

inspectors had inspected 1,843 facilities and found that 601—or

33 percent—had deficiencies that needed to be corrected. Of these, 119

facilities were considered to be in serious noncompliance with MQSA

standards. As table 1 shows, the most common violations noted in the

serious noncompliance group involved the facilities’ use of personnel who

did not meet FDA’s qualification requirements.

7

ACR uses mammography units rather than facility counts to compute these percentages. In reviewing

a facility’s application for accreditation, ACR requires facilities to submit materials for each

mammography unit and reviews each unit separately to determine if it meets accreditation

requirements. Thus, a facility that has more than one mammography unit could have some of its units

pass and some of its units fail.

8

ACR’s accreditation process allows facilities to go through two reviews. Facilities that fail the first

accreditation review can correct deficiencies and resubmit the materials for a second review. If a

facility fails the second review, ACR denies accreditation.

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Table 1: Number of Facilities With

Serious Noncompliance Violations (as

of June 1995) Type of violation

Number of

facilities

Medical physicist did not meet MQSA qualification requirements. 40

Interpreting physician did not meet MQSA qualification requirements. 34

Radiological technologist did not meet MQSA qualification

requirements. 19

Not all interpreting physicians had a state medical license. 16

Facility had not been surveyed by medical physicist. 12

Other 8

Note: Total number of facilities shown exceeds 119 because some facilities had more than one

serious violation.

Under the current inspection program, FDA issues a warning letter to

facilities in serious noncompliance, such as those listed above. Facilities

are required to respond in writing within 15 days, listing specific steps they

plan to take to correct violations. Failure to promptly correct the

deficiencies could result in regulatory action by FDA, such as fines,

suspension or revocation of the facility’s certificate, or a court injunction

prohibiting the facility from performing mammography.

Early Indications

Show No Significant

Adverse Impact on

Access to Services

While many facilities had problems meeting FDA’s quality standards and

deadlines for compliance, FDA and the accrediting bodies made significant

efforts to work with facilities to avoid large-scale facility closures or

discontinuance of services. As a result, although some facilities have

discontinued services, so far the number of closures is relatively small and

access to services has not been significantly affected.

FDA Has Taken a Gradual

Approach to Bringing

Facilities Into Compliance

To prevent widespread facility closures, FDA has been working with

facilities to bring them into compliance with MQSA. From the start, FDA was

concerned that many facilities would need time to upgrade their practices.

To provide facilities lead time for preparation, FDA issued its interim

regulations in December 1993, more than 10 months before the

certification deadline of October 1, 1994, and began to send quarterly

newsletters to facilities informing them about MQSA requirements.

Even with advance notice, however, almost 4,700 of the more than 10,000

mammography facilities nationwide failed to complete the accreditation

process in time to receive full certification by the October 1 deadline. The

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two main reasons for this outcome, according to ACR officials, were the

failure of facilities to submit materials in a timely manner and the

submission of applications that did not meet the accreditation

requirements. Using the maximum time allowed by MQSA, FDA issued

provisional certificates to these facilities, giving them 6-month extensions.

FDA also granted 90-day extensions for facilities whose provisional

certificates expired before accreditation requirements could be met. In

April, more than 1,500 90-day extensions were granted. On July 17, 1995,

242 facilities were still in the 90-day extension status, indicating that they

still had problems satisfying all accreditation requirements (see table 2).

Table 2: Status of Facility Certification

10/1/94 4/12/95 7/17/95

Status Number Percent Number Percent Number Percent

Full certification 5,338 53 8,421 80 9,406 93

Provisional

certification 4,692 47 576 5 522a 5

90-day extension 1,557 15 242 2

Total 10,030 100 10,554 100 10,170 100

Note: The total number of facilities changed because (1) many facilities did not send in their

accreditation applications until the final week before the October 1, 1994, deadline and, thus, did

not receive their provisional certificates until some time after October 1, 1994, and (2) some

facilities were decertified as a result of withdrawal or failing the accreditation process after

April 1995.

aIncludes 279 facilities that have been provisionally reinstated.

To minimize the need for shutting down facilities permanently, in

February 1995, FDA established a reinstatement process. This process

allows a facility that has had to stop performing mammography because it

has failed to meet accreditation requirements to apply for reinstatement by

submitting a corrective action plan and applying for accreditation as a new

facility.9

 As of July 17, 1995, 279 facilities have been granted such

reinstatement, which has allowed them to resume mammography services

while pursuing accreditation under a new provisional certificate.

As a result of FDA’s approach, although some facilities did have to cease

performing mammography for some period of time, many of them have

9

To be eligible for reinstatement, a facility must submit to its accreditation body a corrective action

plan that details how the facility has corrected or intends to correct deficiencies. If the accreditation

body and FDA approve the plan, the facility becomes eligible for a new provisional certificate, which

allows it to operate legally for 6 months while pursuing full accreditation. In June 1995, FDA worked

with ACR to revise its reinstatement protocol to allow both failing facilities and those that did not

complete the accreditation process when their 90-day extension expired to apply for reinstatement.

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been able to reopen. According to ACR records, between October 1, 1994,

and August 1, 1995, a total of 488 facilities were denied accreditation (for

failing to pass the second review or to complete submission requirements)

and had to suspend mammography services. As of August 1, 1995, 301 of

these had either passed accreditation on appeal or had been reinstated.

For these facilities, the average time from notification of denial until

reinstatement was about 15 days. Only six of these denied facilities had

notified ACR that they did not intend to resume providing mammography

services. ACR officials said that most of the remaining facilities are in the

process of evaluating the causes of their deficiencies and assessing the

costs of correcting them. ACR officials expected that a substantial majority

would apply for reinstatement within 30 days.

FDA has adopted a similarly gradual approach to resolving deficiencies

identified in annual inspections. As a result, as of July 26, 1995, FDA had not

closed any facilities for noncompliance found during inspections.

Most Closures Did Not

Limit Access

Facility closures, both in anticipation of the act and since the act took

effect, appear to have had a limited effect on access to mammography

services. Of the 10,000-plus facilities that were providing mammography

services before MQSA, FDA identified 404 facilities, or about 4 percent, that

had ceased to provide mammography services between October 1993 and

October 1994, when MQSA became effective. FDA contracted with a private

research firm to study the impact of these closures on access to

mammography services. The study found that about 97 percent of the

closed facilities were within 25 miles of a certified facility; 62 percent were

within 1 mile of such a facility. In May 1995, FDA asked the contractor to

update the study by adding into the closure population those facilities that

had been denied accreditation or had voluntarily withdrawn from the

process since the act took effect. The update, which covered about 350

such facilities, showed almost identical results.

In addition, officials in the eight states (plus Puerto Rico) that had at least

10 percent of their facilities identified as closed consistently told us that

the closures did not adversely affect access to quality mammography

services in their states. This lack of negative impact may be related to the

fact that most of the closed facilities were low-volume operations in

independent doctors’ offices: we have previously documented that quality

assurance is more difficult to maintain in low-volume facilities.10

10Screening Mammography: Low-Cost Services Do Not Compromise Quality (GAO/HRD-90-32, Jan. 10,

1990), and Screening Mammography: Federal Quality Standards Are Needed (GAO/T-HRD-92-39,

June 5, 1992).

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Several of these state officials also told us that the main reason that many

low-volume providers in their states ceased to perform mammography was

that their volume could not support the costs for system upgrades

necessary to meet MQSA standards. The costs associated with a system

upgrade vary depending on the type and the extent of changes that are

required. For example, FDA estimated that, for facilities that have to

upgrade or replace equipment, the average cost would be about $50,000.

FDA does not have reliable data on costs and has not been able to assess

the economic impact of its interim regulations on facilities. It has

contracted with a private research group to develop an industry profile

and a cost model. FDA officials told us that they plan to assess the total

cost impact of MQSA when the final regulations are issued.

Besides the cost of upgrades, facilities also have to pay accreditation fees

and annual inspection fees. To obtain ACR accreditation, a facility has to

pay a fee of $700 for the first mammography unit and $600 for each

additional unit. In addition, facilities must pay inspection fees, and MQSA

requires that such fees entirely cover inspection costs. For fiscal year

1995, FDA established a fee schedule of $1,178 for the first unit and $152 for

each additional unit for annual inspection; follow-up inspections cost $670

each. The inspection fee assessment is based on FDA’s calculation of the

amount needed to cover the costs of inspections.11 See appendix IV for

more information on total and per-inspection costs.

Michigan’s Experience

Shows Access Unaffected

To provide an additional perspective on how regulations might affect

access, we examined whether any studies had been conducted in states

where mammography standards had been strengthened before MQSA. One

unpublished study by NCI staff had looked at Michigan, which enacted

stringent quality standards almost 5 years before the implementation of

MQSA. According to the principal researcher, access to mammography

services in Michigan was not adversely affected by the tighter standards.

NCI staff analyzed the number of mammography facilities and machines in

Michigan between 1989 and 1994 and found that while the stringent

standards had caused some facilities to discontinue mammography, there

were still sufficient facilities in the state to provide services. In addition,

longitudinal mammography utilization data examined through 1994

11On March 17, 1995, FDA issued a notice in the Federal Register announcing the inspection fee

assessment of fiscal year 1995. In calculating the fee assessment, FDA included specific costs, such as

the cost of contracts with states to conduct annual inspections and FDA personnel and equipment

costs associated with the inspections. Of the total costs included in the 1995 fee assessment, over

80 percent came from the costs of state contracts. In this interim report, we did not determine the

reasonableness of these costs and the fee assessment.

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indicated that Michigan was outperforming most of the country in

mammography usage and was among the very few states with the best

rates of mammography screening compliance. NCI staff also concluded

that, after the implementation of the Michigan standards, the technical

quality of mammograms in Michigan improved in comparison with that of

other states.

Conclusion To date, MQSA’s effects appear generally positive. Mammography quality

standards are now in place in all states, and these standards do not appear

to have had a negative effect on access to services. However, to avoid

large-scale closures of facilities, FDA settled on an approach that allowed

some delay in meeting the certification requirements. For this and other

reasons, such as the availability of outcome data, more time will be needed

before MQSA’s full impact can be determined. MQSA mandates that we assess

the effects of MQSA again in 2 years and issue a report in 1997.

Agency Comments We provided FDA and ACR officials with a draft copy of the report for

review and comment. FDA responded that the draft was accurate and

reflective of the program. While ACR did not provide formal comments,

officials provided some technical comments, which we incorporated as

appropriate. Appendix V contains FDA’s written response.

We will send copies of this report to the Secretary of Health and Human

Services, the Commissioner of FDA, the Director of NCI, the Director of the

Office of Management and Budget, and other interested parties. We will

also make copies available to others on request.

Please contact me at (202) 512-7119 if you or your staff have any questions.

Major contributors to this report are listed in appendix VI.

Mark V. Nadel

Associate Director, National

 and Public Health Issues

Page 14 GAO/HEHS-96-17 Mammography Services
Page 15 GAO/HEHS-96-17 Mammography Services
Contents

Letter 1

Appendix I 

Scope and

Methodology

18

Appendix II 

Mammography

Quality Assurance

Requirements Used in

Assessing States’

Pre-MQSA Programs

19

Appendix III 

Key Mammography

Quality Assurance

Requirements, by

State, as of December

1993

20

Appendix IV 

Basis of FDA’s

Calculation of Fiscal

Year 1995 Annual

Inspection Fees for

Mammography

Facilities

21

Page 16 GAO/HEHS-96-17 Mammography Services
Contents

Appendix V 

Comments From the

Food and Drug

Administration

22

Appendix VI 

GAO Contacts and

Staff

Acknowledgments

23

Tables Table 1: Number of Facilities With Serious Noncompliance

Violations

10

Table 2: Status of Facility Certification 11

Figure Figure 1: Example of Low- and High-Quality Mammography

Images of the Same Patient

4

Abbreviations

ACR American College of Radiology

FDA Food and Drug Administration

GAO U.S. General Accounting Office

MQSA Mammography Quality Standards Act of 1992

NCI National Cancer Institute

Page 17 GAO/HEHS-96-17 Mammography Services
Appendix I 

Scope and Methodology

To develop general information about how FDA has implemented MQSA, we

analyzed data from FDA’s certification and annual inspection programs and

from ACR’s accreditation program. To specifically address our objective of

assessing the initial effect of MQSA on the quality of mammography

services, we relied on two analyses: a comparison of MQSA standards with

existing state standards and an outcome analysis of ACR’s accreditation

and FDA’s inspection results. Because FDA’s inspection program was just

getting under way at the time of our review, our analysis of FDA inspection

results was limited to summary data provided by FDA from its first 4

months of inspection. The analysis of state standards was primarily based

on data from an NCI study of state mammography legislation.12 Although

we did not directly measure the quality of mammography images, the

accreditation process does involve an evaluation of a facility’s quality

assurance system, including a review of clinical images.

To address our objective of assessing MQSA’s effect on accessibility, we

examined an FDA contractor’s study on facility closures and an

unpublished study by NCI staff of Michigan’s experience in implementing

stringent quality standards prior to MQSA. We supplemented this work by

interviewing 6 members of FDA’s National Quality Assurance Advisory

Committee and 32 officials from 20 states and Puerto Rico to obtain their

views on the initial impact of MQSA on quality and accessibility of

mammography services. We did our work from November 1994 through

August 1995 in accordance with generally accepted government auditing

standards.

12Lou Fintor, Marianne Haenlein-Alciati, and Ruth Fischer, “Legislative and Regulatory Mandates for

Mammography Quality Assurance,” Journal of Public Health Policy, Vol. 16, No. 1, Spring 1995.

Page 18 GAO/HEHS-96-17 Mammography Services
Appendix II 

Mammography Quality Assurance

Requirements Used in Assessing States’

Pre-MQSA Programs

Requirement Purpose of requirement

Dedicated equipment To ensure the use of equipment specifically designed for

mammography

Technical exposure factors To ensure optimal picture quality and radiation control

Compression device To uniformly reduce the thickness of the breast so that it

is evenly penetrated by the X ray for the best image of all

breast tissue

Grid capability To control scatter radiation

Automatic exposure control To administer the appropriate radiation exposure for each

woman’s unique breast size

kVp accuracy and

reproducibility

To ensure the accuracy and consistency of electrical

current

Half-value layer To ensure an accurate picture is produced at the

minimum level of radiation

Collimation assessment To protect the patient from excess radiation

Screen-film contact To ensure a sharp mammography image

Average glandular dose To ensure the radiation dose to the patient does not

exceed government standards

Phantom image review To evaluate the ability of the equipment to produce

images of sufficient quality

Processor sensitometry and

densitometry

To ensure the processor is producing high-quality images

Repeat analysis To identify the cause of and correction for rejected

mammograms

Clinical image evaluation To identify problems related to technique or equipment

Outcome data To evaluate the effectiveness of mammography in

screening and detecting breast cancer

Mammogram retention To ensure an adequate period of film retention in case it is

necessary to compare future mammograms

Mammogram report To ensure complete and unambiguous mammography

reports

Personnel requirements To establish minimum qualifications for education,

training, experience, and professional certification of

mammography personnel

Page 19 GAO/HEHS-96-17 Mammography Services
Appendix III 

Key Mammography Quality Assurance

Requirements, by State, as of December

1993

Michigan

Texas

Rhode Island

Massachusetts

Indiana

Mississippi

Iowa

Missouri

Nevada

Arkansas

California

Pennsylvania

Colorado

New Jersey

Washington

Idaho

Utah

New York

Maine

South Carolina

Illinois

Florida

Minnesota

Kentucky

Vermont

Maryland

Ohio

Georgia

New Mexico

Delaware

Oklahoma

North Carolina

Virginia

South Dakota

Oregon

Arizona

Wisconsin

New Hampshire

Hawaii

Alaska

Tennessee

Alabama

Connecticut

District of Columbia

Kansas

Louisiana

Montana

Nebraska

North Dakota

West Virginia

Wyoming

A B C DEF G H I K L MN J O P Q R

Legend

G = Half-Value Layer

H = Collimation Assessment

I = Screen-Film Contact

J = Average Glandular Dose

K = Phantom Image Review

L = Processor Sensitometry and Densitometry

M = Repeat Analysis

N = Clinical Image Evaluation

O = Outcome Data

P = Mammogram Retention

Q = Mammogram Report

R = Personnel Requirements

Equipment

Mammography Develop.

Records

and Tracking

Image

Analysis Pers.

A = Dedicated Equipment

B = Technical: KV, MA, Exposure, Compression Device

C = Compression Device

D = Grid Capability

E = Automatic Exposure Control Performance Capability

F = kVp Accuracy and Reproducibility

Page 20 GAO/HEHS-96-17 Mammography Services
Appendix IV 

Basis of FDA’s Calculation of Fiscal Year

1995 Annual Inspection Fees for

Mammography Facilities

Cost per unita

Breakdown of MQSA inspection fee costs Cost First unit

Additional

unit

Contracts with states to conduct inspections $10,480,556 $958 $123

FDA personnel to conduct inspections 351,439 32 4

Equipment, development of calibration

procedures, and instrument calibration 611,199 56 7

Design, programming, and maintenance of

data systems necessary to schedule

inspections and track results 566,643 52 7

Training and certification of inspectors (FDA

and state) 894,305 81 10

Total FY 95 annual inspection costs $12,904,142 $1,178b $152b

Source: FDA, MQSA inspection fees, November 1994.

aThe unit cost is based on the following assumptions: (1) the total number of mammography units

subject to inspection in 1995 was 10,666; (2) on average, each facility had 1.24 mammography

units; (3) 7.76 hours are required for an annual inspection of a facility with a single mammography

unit; and (4) each additional unit adds one hour to the annual inspection.

bTotals do not add due to rounding.

Page 21 GAO/HEHS-96-17 Mammography Services
Appendix V 

Comments From the Food and Drug

Administration

Page 22 GAO/HEHS-96-17 Mammography Services
Appendix VI 

GAO Contacts and Staff Acknowledgments

GAO Contacts Frank Pasquier, Assistant Director, (206) 287-4861

Sophia Ku, Evaluator-in-Charge, (206) 287-4888

Margaret Buddeke, Evaluator, (206) 287-4804

Staff

Acknowledgments

In addition to those named above, the following individuals made

important contributions to this report: Stan Stenersen, Evaluator; Susan

Lawes, Technical Advisor; Helene Toiv, Advisor; Julie Rachiele, Technical

Information Specialist; and Jennifer Vieten, Intern.

(108215) Page 23 GAO/HEHS-96-17 Mammography Services
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