Mammography Services: Initial Impact of New Federal Law Has Been Positive
(Letter Report, 10/27/95, GAO/HEHS-96-17).
Pursuant to a legislative requirement, GAO examined whether the Food and
Drug Administration's (FDA) implementation of the Mammography Quality
Standards Act has had any effect on the: (1) quality of mammography
services; and (2) access to such services.
GAO found that: (1) the act has had a positive effect on the quality of
mammography services; (2) a uniformed set of standards for mammography
services is required in all states; (3) many facilities have had to
improve their services in order to become fully certified; (4) annual
inspections of mammography facilities help ensure that these facilities
are in compliance with the standards set by the American College of
Radiology; (5) the number of facilities ceasing mammography services
rather than complying with the quality standards is relatively small;
and (6) FDA has not closed many of the facilities unable to meet the new
certification requirements, but it has given them time to comply with
the new quality assurance requirements and to correct the problems found
during inspection.
--------------------------- Indexing Terms -----------------------------
REPORTNUM: HEHS-96-17
TITLE: Mammography Services: Initial Impact of New Federal Law Has
Been Positive
DATE: 10/27/95
SUBJECT: Breast cancer
Cancer research
Women
Inspection
Compliance
Quality assurance
X-ray radiation monitoring
Disease detection or diagnosis
Health services administration
IDENTIFIER: Michigan
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Cover
================================================================ COVER
Report to Congressional Committees
October 1995
MAMMOGRAPHY SERVICES - INITIAL
IMPACT OF NEW FEDERAL LAW HAS BEEN
POSITIVE
GAO/HEHS-96-17
Mammography Services
(108215)
Abbreviations
=============================================================== ABBREV
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
Letter
=============================================================== LETTER
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.
RESULTS IN BRIEF
------------------------------------------------------------ Letter :1
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
------------------------------------------------------------ Letter :2
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.
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.
Figure 1: Example of Low- and
High-Quality Mammography Images
of the Same Patient
(See figure in printed
edition.)
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 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 Committee\1 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 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.
--------------------
\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.
\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.
QUALITY OF MAMMOGRAPHY SERVICES
HAS IMPROVED
------------------------------------------------------------ Letter :3
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
---------------------------------------------------------- Letter :3.1
Before MQSA, wide variations existed in oversight provided at the
state level. To provide an indication of these variations, we asked
a panel of experts\3 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 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 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.
--------------------
\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.
\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.
ACCREDITATION PROCESS HAS
PRODUCED CHANGE AT MANY
FACILITIES
---------------------------------------------------------- Letter :3.2
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, 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.
--------------------
\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.
\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.
INSPECTION PROCESS IS
DESIGNED TO ENFORCE
COMPLIANCE
---------------------------------------------------------- Letter :3.3
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.
Table 1
Number of Facilities With Serious
Noncompliance Violations (as of June
1995)\
Number of
Type of violation facilities
-------------------------------------------- ------------
Medical physicist did not meet MQSA 40
qualification requirements.
Interpreting physician did not meet MQSA 34
qualification requirements.
Radiological technologist did not meet MQSA 19
qualification requirements.
Not all interpreting physicians had a state 16
medical license.
Facility had not been surveyed by medical 12
physicist.
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
------------------------------------------------------------ Letter :4
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
---------------------------------------------------------- Letter :4.1
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 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
Percen Percen Percen
Status Number t Number t Number t
---------- ------ ------ ------ ------ ------ ------
Full 5,338 53 8,421 80 9,406 93
certifica
tion
Provisiona 4,692 47 576 5 522\a 5
l
certifica
tion
90-day 1,557 15 242 2
extension
==========================================================
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.
\a Includes 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 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.
--------------------
\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.
MOST CLOSURES DID NOT LIMIT
ACCESS
---------------------------------------------------------- Letter :4.2
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
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.
--------------------
\10 Screening 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).
\11 On 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.
MICHIGAN'S EXPERIENCE SHOWS
ACCESS UNAFFECTED
---------------------------------------------------------- Letter :4.3
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 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
------------------------------------------------------------ Letter :5
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
------------------------------------------------------------ Letter :6
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.
---------------------------------------------------------- Letter :6.1
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
SCOPE AND METHODOLOGY
=========================================================== Appendix I
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.
--------------------
\12 Lou 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.
MAMMOGRAPHY QUALITY ASSURANCE
REQUIREMENTS USED IN ASSESSING
STATES' PRE-MQSA PROGRAMS
========================================================== Appendix II
Requirement Purpose of requirement
------------------ --------------------------------------
Dedicated To ensure the use of equipment
equipment specifically designed for mammography
Technical exposure To ensure optimal picture quality and
factors 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 To administer the appropriate
control radiation exposure for each woman's
unique breast size
kVp accuracy and To ensure the accuracy and consistency
reproducibility of electrical current
Half-value layer To ensure an accurate picture is
produced at the minimum level of
radiation
Collimation To protect the patient from excess
assessment radiation
Screen-film To ensure a sharp mammography image
contact
Average glandular To ensure the radiation dose to the
dose patient does not exceed government
standards
Phantom image To evaluate the ability of the
review equipment to produce images of
sufficient quality
Processor To ensure the processor is producing
sensitometry and high-quality images
densitometry
Repeat analysis To identify the cause of and
correction for rejected mammograms
Clinical image To identify problems related to
evaluation technique or equipment
Outcome data To evaluate the effectiveness of
mammography in screening and detecting
breast cancer
Mammogram To ensure an adequate period of film
retention retention in case it is necessary to
compare future mammograms
Mammogram report To ensure complete and unambiguous
mammography reports
Personnel To establish minimum qualifications
requirements for education, training, experience,
and professional certification of
mammography personnel
----------------------------------------------------------
KEY MAMMOGRAPHY QUALITY ASSURANCE
REQUIREMENTS, BY STATE, AS OF
DECEMBER 1993
========================================================= Appendix III
(See figure in printed
edition.)
BASIS OF FDA'S CALCULATION OF
FISCAL YEAR 1995 ANNUAL INSPECTION
FEES FOR MAMMOGRAPHY FACILITIES
========================================================== Appendix IV
Breakdown of MQSA inspection First Addition
fee costs Cost unit al unit
---------------------------- ---------- ------ --------
Contracts with states to $10,480,55 $958 $123
conduct inspections 6
FDA personnel to conduct 351,439 32 4
inspections
Equipment, development of 611,199 56 7
calibration procedures, and
instrument calibration
Design, programming, and 566,643 52 7
maintenance of data systems
necessary to schedule
inspections and track
results
Training and certification 894,305 81 10
of inspectors (FDA and
state)
==========================================================
Total FY 95 annual $12,904,14 $1,178 $152\b
inspection costs 2 \b
----------------------------------------------------------
Source: FDA, MQSA inspection fees, November 1994.
\a The 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.
\b Totals do not add due to rounding.
(See figure in printed edition.)Appendix V
COMMENTS FROM THE FOOD AND DRUG
ADMINISTRATION
========================================================== Appendix IV
GAO CONTACTS AND STAFF
ACKNOWLEDGMENTS
========================================================== Appendix VI
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.
*** End of document. ***