Mammography Services: Impact of Federal Legislation on Quality, Access,
and Health Outcomes (Letter Report, 10/21/97, GAO/HEHS-98-11).

Pursuant to a legislative requirement, GAO reviewed the Mammography
Quality Standards Act of 1992's (MQSA) effect on: (1) the quality of
mammography service detection of breast cancer to save lives; and (3)
women's access to mammography services.

GAO noted that: (1) MQSA has increased mammography facilities' adherence
to accepted quality assurance standards, which has had a positive effect
on mammography services; (2) MQSA established nationwide minimum
standards and required facility accreditation, which resulted in
thousands of facilities' having to improve their quality assurance
processes; (3) the Food and Drug Administration's (FDA) annual
inspections of facilities, now in their third year, continue to show
increasing compliance with these national quality standards; (4) further
evidence of quality improvement can be seen in the quality of the X-ray
images; (5) before the act took effect, 11 percent of facilities tested
were unable to pass image quality tests; now, the nationwide figure is 2
percent; (6) experts agree that improving the quality of mammography
images should lead to more accurate interpretation by physicians and,
therefore, to improved early detection of breast cancer; (7) however,
neither data nor research methodologies are now in place to clearly
establish these links; (8) FDA has established federal qualification
standards for physicians who interpret mammograms but has not
established criteria for measuring interpretation accuracy; (9)
comparable pre- and post-MQSA clinical data for measuring mammography
performance and cancer outcome either do not exist or are too limited to
be useful; (10) FDA's proposed final regulations require each facility
to use its own data to monitor physicians' performance on
interpretation; (11) the National Cancer Institute has established a
Breast Cancer Surveillance Consortium of nine research projects, which
are making progress in both developing a methodology and collecting
clinical data for assessing trends in mammography performance in
detecting breast cancer and reducing mortality; (12) when MQSA was
enacted, concern was expressed that some women might have difficulty
obtaining mammography services if facilities chose to close down rather
than to upgrade their operations to meet the new quality standards; (13)
GAO found no indication that access problems had developed as a result
of MQSA; (14) nationwide, the number of facilities that stopped offering
mammograms was nearly offset by the number of new entrants into the
field; (15) 92 percent of all facilities that closed were within 5 miles
of a facility that remained open, and GAO's discussions with officials
in states with the highest closure rates did not reveal any evidence
that access problems had occurred; and (16) FDA has informed GAO that it
has acted to strengthen the MQSA inspection program.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  HEHS-98-11
     TITLE:  Mammography Services: Impact of Federal Legislation on 
             Quality, Access, and Health Outcomes
      DATE:  10/21/97
   SUBJECT:  Breast cancer
             Cancer research
             Quality assurance
             Institution accreditation
             Laboratories
             Medical equipment
             Disease detection or diagnosis
             Health care services
             Inspection
             Women
IDENTIFIER:  CDC National Breast and Cervical Cancer Early Detection 
             Program
             NCI Surveillance, Epidemiology, and End Results Program
             
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Cover
================================================================ COVER


Report to Congressional Committees

October 1997

MAMMOGRAPHY SERVICES - IMPACT OF
FEDERAL LEGISLATION ON QUALITY,
ACCESS, AND HEALTH OUTCOMES

GAO/HEHS-98-11

Mammography Services

(108310)


Abbreviations
=============================================================== ABBREV

  ACR - American College of Radiology
  CDC - Centers for Disease Control and Prevention
  CIS - carcinoma in situ
  FDA - Food and Drug Administration
  HHS - Department of Health and Human Services
  MQSA - Mammography Quality Standards Act of 1992
  NCI - National Cancer Institute
  NEXT - Nationwide Evaluation of X-ray Trends
  SEER - Surveillance, Epidemiology, and End Results Program

Letter
=============================================================== LETTER


B-276103

October 21, 1997

The Honorable James M.  Jeffords
Chairman
The Honorable Edward M.  Kennedy
Ranking Minority Member
Committee on Labor and Human Resources
United States Senate

The Honorable Thomas J.  Bliley, Jr.
Chairman
The Honorable John D.  Dingell
Ranking Minority Member
Committee on Commerce
House of Representatives

Breast cancer is the most commonly diagnosed nonskin cancer and the
second leading cause of cancer deaths among American women.  Experts
estimate that during the 1990s as many as 1.8 million women will be
diagnosed with breast cancer, and 500,000 will die from it.  The
probability of survival increases significantly, however, when the
disease is discovered in its early stages.  Currently, the most
effective technique for early detection of breast cancer is screening
mammography, an X-ray procedure that can detect small tumors and
breast abnormalities up to 2 years before they can be detected by
touch.  The use of mammography as a tool for detecting early cancer
continues to increase.  The proportion of women aged 50 and older who
had received mammograms in the past year increased from 26 percent in
1987 to 57 percent in 1995, according to the Centers for Disease
Control and Prevention (CDC).\1

The effectiveness of mammography as a cancer detection technique is
directly related to the quality of mammography procedures.  To
address concerns about variations in the quality of mammography
services provided by about 10,000 facilities throughout the United
States and its territories, the Congress passed the Mammography
Quality Standards Act of 1992 (MQSA).  This act established a number
of requirements aimed at strengthening mammography quality, including
requiring accreditation and annual inspection of mammography
facilities.  The act is currently under congressional consideration
for reauthorization. 

The act also mandated that we assess and report on the program
established by the Food and Drug Administration (FDA) to implement
these requirements.  We issued two interim reports, the first
focusing on the act's initial impact on access to and quality of
mammography services, and the second focusing on FDA's annual
inspection program.\2 As required by the act, this final report
focuses on assessing the act's effect on (1) the quality of
mammography services, (2) early detection of breast cancer to save
lives, and (3) women's access to mammography services.  We also
followed up on the status of our previous recommendations to FDA (see
app.  II). 

This report is based primarily on our analysis of data obtained from
FDA's certification and annual inspection programs, as well as on
research we reviewed regarding mammography's effectiveness in cancer
detection.  We also consulted with many mammography and cancer
experts during the course of our review.  Details of our scope and
methodology are presented in appendix I.  Our work was done between
January and August 1997 in accordance with generally accepted
government auditing standards. 


--------------------
\1 The proportion of women 40 to 49 who had received mammograms in
the past 2 years also increased:  from 59 percent in 1990 to 66
percent in 1995. 

\2 Mammography Services:  Initial Impact of New Federal Law Has Been
Positive (GAO/HEHS-96-17, Oct.  27, 1995) and FDA's Mammography
Inspections:  While Some Problems Need Attention, Facility Compliance
Is Growing (GAO/HEHS-97-25, Jan.  27, 1997). 


   RESULTS IN BRIEF
------------------------------------------------------------ Letter :1

MQSA has increased mammography facilities' adherence to accepted
quality assurance standards, which has, in turn, had a positive
effect on mammography services.  MQSA established nationwide minimum
standards and required facility accreditation, which resulted in
thousands of facilities' having to improve their quality assurance
processes.  FDA's annual inspections of facilities, now in their
third year, continue to show increasing compliance with these
national quality standards.  Further evidence of quality improvement
can be seen in the quality of the X-ray images.  Before the act took
effect, 11 percent of facilities tested were unable to pass image
quality tests; now, the nationwide figure is 2 percent. 

Experts agree that improving the quality of mammography images should
lead to more accurate interpretation by physicians and, therefore, to
improved early detection of breast cancer.  However, neither data nor
research methodologies are now in place to clearly establish these
links.  FDA has established federal qualification requirements for
physicians who interpret mammograms but has not established criteria
for measuring interpretation accuracy.  Furthermore, comparable pre-
and post-MQSA clinical data for measuring mammography performance and
cancer outcome either do not exist or, for a number of reasons, are
too limited to be useful.  Some steps are being taken to address
interpretation accuracy and outcome measurement issues.  FDA's
proposed final regulations require each facility to use its own data
to monitor physicians' performance on interpretation.  In addition,
as provided by MQSA, the National Cancer Institute (NCI) has
established a Breast Cancer Surveillance Consortium of nine research
projects.  These projects are making progress in both developing a
methodology and collecting clinical data for assessing trends in
mammography performance in detecting breast cancer and reducing
mortality. 

When MQSA was enacted, concern was expressed that some women might
have difficulty obtaining mammography services if facilities chose to
close down rather than to upgrade their operations to meet the new
quality standards.  We found no indication that access problems had
developed as a result of MQSA.  Nationwide, the number of facilities
that stopped offering mammograms was nearly offset by the number of
new entrants into the field.  Further, 92 percent of all facilities
that closed were within 5 miles of a facility that remained open, and
our discussions with officials in states with the highest closure
rates did not reveal any evidence that access problems had occurred. 

FDA has informed us that it has acted to implement our earlier
recommendations for strengthening the MQSA inspection program.  For
example, FDA has efforts under way to establish procedures, guidance,
and training to ensure timely compliance with MQSA standards.  Our
previous recommendations and the status of FDA actions taken on them
appear in appendix II. 


   BACKGROUND
------------------------------------------------------------ Letter :2

Research studies, including randomized clinical trials, indicate that
widespread use of mammography could reduce breast cancer mortality by
one-third, especially in older women.  The value of mammography in
reducing mortality is directly tied to its ability to detect cancer
at its earliest stages.  Mammography is capable of detecting tumors
much smaller than those detected by other means (see fig.  1).\3

   Figure 1:  Size of Breast
   Tumors Found by Mammography and
   Self-Examination

   (See figure in printed
   edition.)

Source:  Altered graphic from Choices, Marion Morra and Eve Potts
(New York City:  Avon Books, 1994), p.  303. 

Although mammography can be very useful in finding early-stage
cancer, it is one of the most technically challenging radiological
procedures, and ensuring the quality of the 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 2.  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 2:  Low- and
   High-Quality Mammography Images
   of the Same Patient

   (See figure in printed
   edition.)

Source:  FDA. 

Accurate interpretation of mammograms is equally as important as
image quality.  According to radiological experts, mammograms are the
most difficult radiographic images to read, and misreading mammograms
can have considerable consequences.  A mammogram that is incorrectly
interpreted 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 established minimum national quality standards for mammography
facilities and contained a number of provisions designed to ensure
the quality of the image and its interpretation.  Among other things,
MQSA required that

  -- FDA establish quality standards for mammography equipment,
     personnel, and practices;

  -- all mammography facilities be accredited by an FDA-approved
     accrediting body once every 3 years and obtain a certificate
     from FDA in order to legally provide mammography services after
     October 1, 1994; and

  -- all mammography facilities have an annual evaluation by a
     qualified medical physicist and an annual inspection by
     FDA-approved inspectors that includes a test of image quality. 

FDA implemented MQSA under interim regulations issued in December
1993.  The quality standards of FDA's interim regulations were
substantially based on standards and an accreditation program
developed in 1987 by the American College of Radiology (ACR), a
private, nonprofit professional association of radiologists.  Since
early 1994, FDA has been working with the National Mammography
Quality Assurance Advisory Committee to develop final regulations.\4
On April 3, 1996, FDA published the proposed final regulations for
public comment but as of September 1997 had not issued the final
regulations. 


--------------------
\3 Mammography, however, is not a perfect tool; even under ideal
conditions, 10 to 20 percent of breast cancers cannot be detected by
mammography. 

\4 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 sufficient
number of medical physicists after Oct.  1, 1999, to ensure
compliance with MQSA.  As of September 1997, the committee had not
submitted final reports to the Congress. 


   MQSA HAS HAD A POSITIVE EFFECT
   ON THE QUALITY OF MAMMOGRAPHY
   SERVICES
------------------------------------------------------------ Letter :3

To assess MQSA's effect on the quality of mammography services, we
analyzed the results of implementing three important quality
assurance requirements of the act:  accreditation review, annual
facility inspections, and testing the quality of X-ray images.  Both
accreditation and annual inspection processes required by MQSA show
that facilities are doing a better job of complying with quality
standards, and image tests show that the quality of images has
improved. 


      ACCREDITATION PROCESS HAS
      BROUGHT IMPROVEMENT IN
      COMPLIANCE WITH QUALITY
      STANDARDS
---------------------------------------------------------- Letter :3.1

MQSA required that all of the nation's approximately 10,000
mammography facilities, regardless of location or setting, pass an
accreditation review to ensure that they meet quality assurance
requirements for equipment performance, radiation safety, personnel
qualifications, and clinical image quality, among other things. 
Before MQSA, between 37 and 44 percent of mammography units in the
country met ACR's quality assurance requirements by participating in
ACR's voluntary accreditation program.  Since MQSA's implementation,
FDA has approved ACR and the states of Arkansas, California, and Iowa
as official accrediting bodies.  Because of ACR's pre-MQSA
involvement in establishing the voluntary accreditation program, it
serves as the major accreditation body, responsible for more than 95
percent of the workload. 

MQSA's quality standards and the related accreditation process have
had a substantial effect on improving quality assurance activities. 
In an earlier report,\5 we noted that when MQSA initially took
effect, many mammography units did not meet the standards.  For
example, between October 1, 1994, and August 1, 1995, about 2,600 (35
percent) of the mammography units that sought ACR accreditation
initially failed to meet accreditation requirements.  While almost
all of these units were eventually granted full accreditation, they
first had to demonstrate that they had improved their quality
assurance activities. 

ACR data suggest that the accreditation process continues to result
in more facilities' meeting quality assurance standards.  For
example, the percentage of facilities that passed ACR's accreditation
on the first attempt increased from 66 percent in 1995 to 82 percent
in 1997.\6


--------------------
\5 GAO/HEHS-96-17, Oct.  27, 1995. 

\6 The accreditation process under ACR allows facilities to go
through two reviews.  Facilities that fail the first accreditation
review can correct deficiencies and resubmit their application
materials for a second review.  If a facility fails the second
review, accreditation is denied.  The Arkansas and Iowa accreditation
bodies allow facilities to have more than two reviews before denying
accreditation.  While the state of California has been approved as an
accreditation body, it contracts with ACR for a portion of
accreditation review. 


      ON-SITE INSPECTIONS SHOW
      CONTINUED IMPROVEMENT IN
      COMPLIANCE
---------------------------------------------------------- Letter :3.2

MQSA's inspection requirement gives FDA another means to ensure that
facilities comply with standards on a day-to-day operating level. 
While accreditation is generally a mail-in-process that involves the
submission and review of application materials, annual inspections
are conducted on site, which allows inspectors to verify information
provided during the accreditation process.\7

As FDA entered its third year of annual inspections, inspection
results continued to show improvement in facility compliance with
MQSA quality standards.  Both level 1 and level 2 violations, which
FDA considers to be significant and for which it requires the
facility to submit written plans for corrective actions, have
dropped.\8 As shown in figure 3, from fiscal year 1995 to fiscal year
1997, the proportion of inspected facilities whose highest-level
violation was level 1 dropped from 3 percent to 1 percent, and the
proportion whose highest-level violation was level 2 dropped from 20
percent to 12 percent.\9 Most facilities with violations had only
level 3 violations (considered by FDA to be minor deviations); these
numbers also dropped during the 3-year period.  The portion of
facilities with no violations at all nearly doubled, from about 30
percent in 1995 to about 55 percent in 1997. 

   Figure 3:  Comparison of
   Mammography Facilities'
   Inspection Results, Fiscal
   Years 1995-97

   (See figure in printed
   edition.)

Another way to assess whether facilities are improving their
compliance is to consider the extent of repeat violations--violations
found in one inspection and recurring in the next inspection.  As of
June 30, 1997, 8,619 facilities had been inspected at least twice. 
Facilities had a better record for not repeating the more severe
violations than they did for the minor deviations.  Less than 1
percent of facilities that had level 1 violations in the first year
repeated one or more of the same violations in the second year, while
about 17 percent of those with level 3 violations in the first year
repeated one or more of the same violations in the second year.  FDA
considers level 3 violations to be minor findings.  However, to
reduce the incidence of repeat violations, and in response to a
recommendation in our second report, FDA has revised its policy
guidance to include procedures for addressing repeat level 3
violations. 


--------------------
\7 Annual inspections are generally performed by FDA-approved state
inspectors.  FDA has contracted with virtually all states and
territories to conduct inspections. 

\8 Level 1 violations are those that can have the most detrimental
effect on the quality of mammography services--for example, a
facility's having personnel who do not meet FDA's minimum
qualification standards.  For level 1 violations, FDA issues a
warning letter; the facility must respond in writing to FDA within 15
working days of receiving the warning letter.  Level 2 violations are
considered less significant--for example, a facility's not having an
evaluation of equipment by a medical physicist during the past 14
months--and do not generate a warning letter.  However, the facility
must respond in writing to FDA within 30 working days of receiving
its inspection report.  Level 3 violations--for example, a facility's
not having the required documentation of a quality control test--do
not require a written response. 

\9 Under their contracts with FDA, many states began inspecting
facilities in January 1995, but some did not begin until later.  In
fiscal year 1997, FDA began to manage its inspection workload and
compare its inspection results by fiscal years.  Results for 1997 are
for facilities inspected during the first 9 months of the fiscal
year.  We have no reason to assume that the percentages will change
greatly for facilities that will be inspected during the remainder of
the year. 


      MORE FACILITIES ARE PASSING
      TESTS OF IMAGE QUALITY
---------------------------------------------------------- Letter :3.3

One of the most important aspects of FDA's annual inspection process
is testing the performance of a facility's mammography system through
what is called a "phantom image test." This test involves taking an
X-ray image of a plastic block containing 16 test objects to
determine how many of the test objects can be seen on the image
generated by the facility's mammography equipment.\10 To pass the
evaluation, the phantom image must show at least the minimum number
of test objects required by FDA.\11

Because FDA was already conducting some phantom image testing before
MQSA, it is possible to make general comparisons about image quality
before and after the law took effect.  Before MQSA, FDA, in a
cooperative agreement with the Conference of Radiation Control
Program Directors (a professional association of state and local
radiation control program officials), conducted several Nationwide
Evaluation of X-ray Trends (NEXT) surveys to evaluate the technical
performance of mammography facilities.  The phantom image scores from
these pre-MQSA NEXT surveys are considered the baseline for
comparison with the phantom image scores from post-MQSA annual
inspections, because the standards for evaluating phantom images are
essentially identical. 

NEXT survey data before MQSA implementation showed that phantom image
scores were improving under ACR's voluntary accreditation program. 
Data from the post-MQSA inspections show continued improvement in
image quality, as indicated by the acceptable rates of phantom image
scores.  For example, the proportion of facilities with acceptable
phantom image scores has remained at 98 percent since 1995, as
compared with 89 percent in 1992. 


--------------------
\10 The plastic block, which represents an average-sized compressed
breast, contains a wax insert that holds 16 test objects--6 fibrous
structures (fibers), 5 embedded microcalcifications (speck groups),
and 5 different-sized tumor-like masses that simulate growths that
could be cancerous. 

\11 To pass the phantom image test, at least 4 fibers, 3 speck
groups, and 3 masses need to be visible in the phantom image. 


   DATA AND METHODOLOGY PROBLEMS
   PREVENT MEASURING MQSA'S IMPACT
   ON SAVING LIVES
------------------------------------------------------------ Letter :4

Because MQSA can be linked to improved quality of mammography images,
a logical case can be made that MQSA has also helped improve
mammography interpretation, thereby improving early breast cancer
detection and, ultimately, saving lives.  However, neither data nor
research methodologies are now in place to clearly demonstrate these
links.  One problem is that criteria have not been established to
assess how reliably images are being interpreted.  Another is the
lack of comparable clinical data\12 for measuring any outcome changes
that have occurred as a result of the act.  In addition, researchers
still disagree on how to compute mammography performance and cancer
outcome measures.  In response to MQSA requirements, NCI has funded
research and established a consortium that is making progress in
collecting clinical data and resolving disagreements over how to
measure mammography performance and cancer outcomes. 


--------------------
\12 Clinical data include patient information such as demographics,
risk factors, mammography results, and pathology results. 


      MQSA'S IMPACT ON THE QUALITY
      OF IMAGE INTERPRETATION IS
      UNKNOWN
---------------------------------------------------------- Letter :4.1

We were unable to determine if MQSA has had an effect on improving
the accuracy and reliability with which mammograms are interpreted,
because criteria are not available to determine an appropriate
measure.  How to develop a quality assurance system for monitoring
the accuracy with which mammograms are interpreted is a controversial
issue in the medical community.  Several academic studies have shown
wide variation in the interpretation of the same mammogram by
different radiologists.  On one hand, some experts suggest that some
type of peer review or proficiency test is needed to improve
accuracy.  On the other hand, FDA and others take the position that
such measures are too difficult and costly to implement and that a
self-monitoring, facility-based system of physician performance
assessment is a better approach to achieve the goal of quality
interpretation. 

FDA's current approach reflects its preference for a facility-based
monitoring system that tracks and reviews mammography and pathology
results.  Current MQSA regulations include a general requirement that
each facility have a medical audit system in place to collect and
review clinical data, which includes follow-up on positive mammograms
(those identified as suspicious or highly suggestive of cancer) and
their correlation to biopsy results.  In proposed final regulations
published in April 1996, FDA requires that at least one interpreting
physician review this information annually and that data be analyzed
both collectively for the facility and individually for each
interpreting physician.  The results are then to be used to provide
feedback to the interpreting physician as part of the facility's
quality assurance system.  However, these regulations do not include
standards for measuring physician performance.  FDA officials stated
that one of the main reasons for the general nature of FDA's
requirements is that there is no consensus in the medical and
scientific community on the most desirable methodologies for arriving
at such standards. 


      CLINICAL DATA ARE
      INSUFFICIENT TO ASSESS
      MQSA'S CONTRIBUTION TO
      MAMMOGRAPHY PERFORMANCE AND
      CANCER OUTCOMES
---------------------------------------------------------- Letter :4.2

Comparable clinical data for measuring outcome changes are not
available for a number of reasons.  Some data are available from
clinical trials, CDC's National Breast and Cervical Cancer Early
Detection Program, a facility-based medical audit system, and cancer
registries.  However, none of these is an appropriate source to use
in assessing MQSA's effect on mammography performance and cancer
outcomes. 

Randomized clinical trials and other less comprehensive studies have
demonstrated that regular screening mammography can significantly
reduce breast cancer mortality.  Such studies, while lending support
to using mammography as a cancer detection technique, have not
reported data that allow MQSA's specific contribution to be assessed. 
For example, the only clinical trial in the United States--New York's
Health Insurance Plan Study--was conducted from 1963 to 1986 and was
based on equipment, imaging, and interpreting techniques that are no
longer applicable today.\13 Also, although several community studies
have shown the effectiveness of mammography screening in early
detection, the results of each study were applicable to only one
geographic area, and none of the studies was current enough for a
pre- and post-MQSA comparison.\14

CDC's National Breast and Cervical Cancer Early Detection Program,
established in 1991 to provide screening services to medically
underserved women, has collected a fairly large volume of mammography
and cancer outcome data.  However, the data focus on only a subset of
the population and are too incomplete to yield a meaningful analysis
of the effect of MQSA on cancer outcomes.\15

The current MQSA requirement for a facility-based medical audit
system also has numerous limitations that prevent its consideration
in developing national measures of MQSA's effectiveness.  The
fundamental limitation is that because the data collected in this
process were not intended to serve as a mechanism for comparable
reporting, little attention has been given to ensuring data and
system consistency across facilities.  Each facility decides how to
collect and use the results as a quality control feedback tool, and
FDA acknowledges that, as expected, there is wide variability in the
data facilities include in their medical audits and in how they track
results. 

Problems also exist with trying to use various regional, state, and
local cancer registries to evaluate MQSA's effects.  These registries
collect clinical data on breast cancer cases, including stage and
tumor size of cancer detected.  For example, the National Cancer
Institute's Surveillance, Epidemiology, and End Results Program
(SEER) has nine cancer registries that have been in existence since
1973.\16 Since 1992, CDC has also funded a national program that
establishes or improves cancer registries in states that do not have
registries such as those of the SEER program.  While these registries
contain clinical data that track the status of cancer cases, they do
not collect data showing whether the cancer was detected by
mammography.  Thus, they cannot be used to measure mammography
performance over time.  Furthermore, while SEER cancer registry data
(which contain substantial historical data) can be used to evaluate
the trends of cancer incidence, cancer detection, and mortality, they
are not current enough to enable a pre- and post-MQSA implementation
comparison.  For example, MQSA inspection of facilities began in 1995
and, at the time of our review, the SEER registry data were only
current through 1994. 


--------------------
\13 Four other major clinical trials have been undertaken in Sweden,
two in the United Kingdom, and two in Canada. 

\14 For example, one of the largest community studies was conducted
in Albuquerque, New Mexico.  The study tracked mammography and
pathology results of 87,433 patients from 1991 to 1993 to assess the
performance of community mammography screening.  The study showed
that community mammography screening could detect breast cancer at
early, treatable stages and that the distribution of cancer stages
was similar to that seen in successful clinical trials. 

\15 CDC's program works with state public health agencies to provide
screening, referral, and follow-up services for underserved women. 
The program began with 6 states in 1991 and is currently operating in
35 states.  We attempted to use CDC data to compare the cancer
detection rates of the program before and after MQSA, but several key
data elements, such as history of prior mammograms and stage of
cancers, were too incomplete to be useful for our analysis. 

\16 The program consists of nine regional population-based cancer
registries covering about 14 percent of the U.S.  population. 


      NO CLEAR CONSENSUS EXISTS ON
      APPROPRIATE MEASURES FOR
      MAMMOGRAPHY PERFORMANCE AND
      CANCER OUTCOMES

---------------------------------------------------------- Letter :4.3

In addition to the problems involved with the lack of data,
controversy exists over how to measure mammography performance and
related cancer outcomes. 


         MAMMOGRAPHY PERFORMANCE
         MEASURES
-------------------------------------------------------- Letter :4.3.1

Several performance measures are based on assessments of the extent
to which mammography results are accurate.  The two most common
measures involve sensitivity and specificity.\17 Sensitivity is
defined as the probability of detecting cancer when a cancer really
exists, and specificity is defined as the probability of obtaining a
negative mammogram when no cancer exists.  The computation of these
measures is shown in the following formulas: 

Sensitivity = True Positive/(True Positive + False Negative)

Specificity = True Negative/(True Negative + False Positive)

Although the definitions of sensitivity and specificity are widely
accepted, calculating sensitivity and specificity is complicated by
the need to know the number of true and false positives, as well as
the number of true and false negatives (see table 1 for definitions). 



                                Table 1
                
                 Definitions of True and False Positive
                              and Negative

Classification of
mammogram result        Definition
----------------------  ----------------------------------------------
True positive           Cancer diagnosed\a during the specified
                        follow-up period after a mammogram was
                        interpreted as positive

False positive          No cancer diagnosed during the specified
                        follow-up period after a mammogram was
                        interpreted as positive

True negative           No cancer diagnosed during the specified
                        follow-up period after a mammogram was
                        interpreted as negative

False negative          Cancer diagnosed during the specified follow-
                        up period after a mammogram was interpreted as
                        negative
----------------------------------------------------------------------
\a Cancer is generally considered present only after being confirmed
by a pathological diagnosis. 

Moreover, while researchers generally accept the above definitions,
they have not agreed on the proper length of time for the follow-up
period.  For example, researchers have used various follow-up time
periods, ranging from 7 months to over a year.  Using different time
periods can result in different determinations of true or false
positives and true or false negatives.  For example, if a mammogram
is interpreted as negative and the follow-up period is 12 months,
then the negative mammogram is considered a false negative if a
cancer is detected during the next 12 months.  However, if the
specified follow-up period is 7 months, then the negative mammogram
is considered a false negative only if a cancer is detected within 7
months. 

In addition, researchers disagree on how certain mammography results
should be classified.  In 1992, the ACR developed the Breast Imaging
Reporting and Data System, which established six discrete categories
for interpreting physicians to use in recording the results of
mammograms:  "needs additional evaluation," "negative," "benign
finding," "probably benign finding," "suspicious finding," and
"highly suggestive of malignancy."\18 Although researchers generally
agree that two categories ("negative" and "benign finding") should be
considered to be negative mammograms and that two other categories
("suspicious finding" and "highly suggestive of malignancy") should
be considered positive mammograms, they disagree on how the remaining
categories ("needs additional evaluation" and "probably benign
finding") should be classified.\19

Standards for the follow-up time period and mammography result
categories are essential for consistent application of such
performance measures. 


--------------------
\17 Another type of performance measure uses the positive predictive
values of mammograms (the proportion of women with a positive
mammogram who are found to actually have breast cancer).  This
measure can be used with three separate definitions:  it can be based
on the number of cancers detected from positive mammograms, the
number of biopsies recommended, and the number of biopsies performed. 
Using the second and third definitions would require information to
be readily available about the number of positive mammograms that
resulted in biopsy recommendations and the number of recommendations
that actually resulted in biopsies' being performed. 

\18 Although many interpreting physicians are using these categories,
they are not required to do so under MQSA.  However, in FDA's
proposed final regulations, recording mammography results using these
categories will be required for standardization purposes. 

\19 The "probably benign" category is often associated with a
recommendation for another mammogram within 6 months. 


         CANCER OUTCOME MEASURES
-------------------------------------------------------- Letter :4.3.2

Because the ultimate goal of mammography is to reduce breast cancer
mortality, some studies have used mortality reduction as a measure of
mammography effectiveness in cancer outcomes.  However, because women
with breast cancer generally survive longer than 5 years, measuring
the change in mortality reduction requires a long follow-up time. 
This need for a long follow-up period makes it difficult to use
mortality reduction as a measure for assessing MQSA's effect on
cancer outcomes, since not enough time has elapsed since MQSA's
implementation. 

As an alternative to mortality reduction rates, some researchers have
used the early-stage disease rate as an intermediate measure of the
effectiveness of mammography.\20 This intermediate measure is thought
to be appropriate because early detection of breast cancer has been
shown to improve survival rates.  However, considerable disagreement
exists about how to define early-stage cancer for measurement
purposes.  Perhaps the most controversial problem relates to whether
or not cases of carcinoma in situ (CIS) should be included when
measuring mammography effectiveness.  CIS is considered the earliest
stage of breast cancer and is confined to the place or site where it
started.  In recent years, as the number of CIS cases detected by
mammography has continued to increase, researchers have questioned
how to classify them.  Some experts view CIS as a very slow-growing,
noninvasive tumor and contend that including CIS cases as early
stages of cancer will overstate the benefit of mammography in
reducing mortality, since a large proportion of CIS tumors never
spread.  Others argue that some CIS tumors can grow quickly and
develop into serious, even fatal, disease and, therefore, CIS cases
should be considered early-stage cancer.  Because of the above
controversies, some researchers now believe that the late-stage
disease rate is a more appropriate intermediate measure than the
early-stage disease rate.  However, there is no clear consensus on
the use of this measure either. 


--------------------
\20 The most widely used approach to categorizing cancers involves
the use of staging classifications, with the size of the tumor being
one of the most important factors in determining the stage of the
cancer. 


      CONSORTIUM IS MAKING
      PROGRESS IN RESOLVING DATA
      AND MEASUREMENT PROBLEMS
---------------------------------------------------------- Letter :4.4

To help evaluate mammography's overall impact, MQSA called for a
system that would collect a large volume of data on mammography
results and cancer detection from select geographical areas.  In
response, NCI established the Breast Cancer Surveillance Consortium
in 1994, which consists of nine federally funded research projects at
sites in most of the major geographical regions of the United
States.\21 These projects collect data from affiliated area
mammography practices and link mammography data to cancer registry
data.  The Consortium's goal is to ensure that the data collected can
be analyzed to address issues relating to mammography performance and
cancer outcomes.  By the year 2000, the Consortium expects to have
data on more than 3.2 million mammography examinations and more than
24,000 breast cancer cases.\22

According to Consortium members, the large sample is necessary to
examine mammography performance and cancer outcomes in different
health care delivery systems and regions of the country and in
populations of diverse race and socioeconomic status. 

To create an effective database, the Consortium is taking the
following steps to overcome the kinds of data and measurement
problems discussed above. 

  -- With regard to collecting clinical data, the Consortium has
     spent considerable time developing a consensus on which data
     elements to collect in order to obtain consistent and reliable
     data.  The Consortium has been using standardized data
     collection procedures and linkage mechanisms to pool data from
     individual projects, but 1996 was the first year common data
     elements were collected at all projects.  The Consortium has
     just begun some descriptive analysis using pooled data from all
     projects; however, analysis of cancer outcomes will not begin
     until the winter of 1998, because valid data on cases of breast
     cancer will not be available until then. 

  -- The Consortium is also working to obtain a consensus on
     performance measures such as sensitivity and specificity. 
     Officials of the Consortium informed us that they had just begun
     to test aspects of these performance measures and could not tell
     us when they will be able to reach a consensus. 

These efforts can help strengthen the quality of information about
the general efficacy of mammography in improving cancer outcomes, but
they are unlikely to provide substantial information about MQSA's
specific effect because data are not available for a pre- and
post-MQSA comparison.  However, the Consortium efforts may have other
positive MQSA-related benefits in that researchers involved with
several of the nine research projects are currently helping
mammography facilities collect data for cancer outcomes audits to
meet MQSA requirements. 


--------------------
\21 These projects are being administered by the University of
California at San Francisco, the Colorado Department of Public Health
and the Environment, the Norris Cancer Center, the Fred Hutchinson
Cancer Research Center, the Group Health Cooperative of Puget Sound,
the University of New Mexico, the University of North Carolina, the
University of Vermont, and the University of Iowa. 

\22 Studies show that the incidence of breast cancer ranges from 2 to
10 cancers per 1,000 mammography examinations. 


   MQSA DID NOT LIMIT ACCESS
------------------------------------------------------------ Letter :5

When MQSA 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.  This has not occurred.  Facility
closures, both in anticipation of MQSA and since MQSA took effect,
appear to have had no adverse effect on access to mammography
services. 

We addressed the question of the initial closures in our 1995 report. 
In all, 404 facilities, or about 4 percent of the approximately
10,000 facilities that were providing mammography services before
MQSA was implemented, had ceased providing mammography services
during the 12 months before MQSA became effective.  On the basis of
(1) a study conducted by a private research firm under contract with
FDA and (2) our interviews with state officials, we concluded that
these initial closures had no negative impact on access to services. 

To assess the impact of facility closures since MQSA implementation,
FDA asked the same contractor to do an updated study.  The study,
completed in May 1997, found that 1,085 facilities had stopped
offering mammography services either temporarily or permanently
between December 15, 1994, and March 19, 1997.  During the same
period, 922 facilities had opened or had resumed providing services. 
This net loss of 163 facilities since MQSA was implemented is a
relatively small number when compared with the approximately 10,000
facilities operating before MQSA.  Further, 99 percent of the closed
facilities were located within 25 miles of another certified
mammography facility, and 92 percent were within 5 miles. 

To determine if the states most affected by these closures had
experienced problems with access, we conducted additional follow-up
work on the contractor's study.  For the District of Columbia and the
seven states identified in the contractor's study as having closure
rates of at least 4 percent, we asked state health officials to
determine if the closure of any facility on the list had caused
access problems.  No problems were reported to us.  Officials said
many of the closed facilities were either low-volume providers that
did not generate enough revenue to cover the costs of meeting MQSA
requirements or poor-quality providers that could not pass
accreditation.  Furthermore, in five of the seven states, more than
40 percent of the facilities identified as closed have actually
continued to provide services in some form.  For example, some
facilities continued to provide services by merging with another
facility or consolidating their equipment from satellite clinics. 
Some other facilities contracted with mobile service providers to
continue serving their patients. 


   CONCLUSIONS
------------------------------------------------------------ Letter :6

As the Congress considers reauthorization of MQSA, two points are
clear with regard to assessing what the act has accomplished.  First,
overall, MQSA has had a positive impact on the quality of mammography
services and no effect on access to them.  In looking at the
currently measurable areas, such as the accreditation and inspection
results, the quality of X-ray images, and the extent of facility
closures, the evidence is strong that the quality of services has
improved and that access has not been adversely affected.  We believe
it is reasonable to attribute a large part of the quality improvement
to (1) MQSA processes that enforced accreditation standards that were
not previously followed by many facilities and (2) FDA's annual
inspection process, which provides a valuable, systematic means of
helping ensure that these higher standards are maintained. 

Second, quantifying MQSA's effect on the accuracy of mammogram
interpretation or on the improvement in cancer outcomes is much more
problematic.  Although data collection efforts now under way will
probably make it easier to monitor the quality of image
interpretation and the effects of mammography on cancer outcomes in
the future, the absence of pre-MQSA data means that analysts may not
be able to fully measure how the act itself has affected image
interpretation and cancer outcomes. 


   AGENCY COMMENTS
------------------------------------------------------------ Letter :7

In commenting on a draft of this report, Department of Health and
Human Services (HHS) officials agreed with our presentation of the
issues.  In addition, ACR officials provided some technical comments,
which we incorporated as appropriate.  Appendix III contains the full
text of HHS' comments. 

We are sending copies of this report to the Secretary of Health and
Human Services, the Commissioner of the Food and Drug Administration,
the Director of the National Cancer Institute, the Director of the
Centers for Disease Control and Prevention, 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) 512-7719 if you or your staff have any
questions.  Other GAO contacts and staff acknowledgments are listed
in appendix IV. 

Bernice Steinhardt
Director, Health Services, Quality
 and Public Health Issues


SCOPE AND METHODOLOGY
=========================================================== Appendix I

To assess whether the Food and Drug Administration's (FDA)
implementation of the Mammography Quality Standards Act of 1992
(MQSA) has resulted in improvement in the quality of mammography
services, we relied on three analyses:  the American College of
Radiology's (ACR) accreditation results, FDA's annual inspection
results, and FDA's pre-MQSA surveys of mammography equipment
performance.  Specifically, we obtained and reviewed data on ACR's
accreditation failure rates and reasons for failures for each fiscal
year from 1995 to 1997.  In addition, we analyzed the results of
FDA's annual inspections that took place between January 1995 and
June 1997 at about 10,000 mammography facilities nationwide.  To
assess improvement in the quality of X-ray images, we compared pre-
and post-MQSA phantom image scores using data from the Nationwide
Evaluation of X-ray Trends (NEXT) surveys and FDA's annual
inspections.  The NEXT surveys collected data on the technical
performance of mammography, including such things as phantom image
scores, radiation dose, and existence of darkroom fog (excessive
light that fogs the image).  We considered the phantom image scores
from pre-MQSA NEXT surveys to be the baseline for comparison with the
phantom image scores from post-MQSA annual inspections.  Although we
did not perform a reliability assessment of FDA's data systems, we
conducted several data tests and found FDA's data to be adequate to
meet our objectives. 

To assess whether MQSA has improved the early detection of breast
cancer, we reviewed numerous studies and analyses on the accuracy of
physician interpretation, breast cancer incidence and mortality, and
mammography's effectiveness in cancer detection.  We also interviewed
many mammography and cancer experts; researchers; and officials from
FDA, the National Cancer Institute (NCI), and the Centers for Disease
Control and Prevention (CDC) to discuss mammography performance and
cancer outcome measures, as well as the availability of current and
future data to assess performance and outcome improvement.  In
addition, we consulted with members of NCI's Breast Cancer
Surveillance Consortium who provided a written response to our
questions on the methodological and data problems in measuring
mammography performance and assessing MQSA's impact on cancer
outcomes. 

To assess MQSA's effect on accessibility, we examined an FDA
contractor's study on newly opened and newly closed mammography
facilities, by state, between December 1994 and March 1997.  We
supplemented this work by interviewing state radiation control
program officials in seven states--California, Colorado, Florida,
Kansas, New Hampshire, North Dakota, and Virginia--and the District
of Columbia to discuss why facilities in their localities closed and
the impact that these closures had on access to mammography services. 


FOLLOW-UP ON OUR JANUARY 1997
REPORT
========================================================== Appendix II

In our January 1997 report reviewing FDA's mammography inspection
program,\23 we identified several issues that needed management
attention with regard to conducting inspections and following up on
deficiencies.  FDA generally agreed with our recommendations and has
taken action on all of them.  The following table summarizes the
problems, our recommendations, and the actions that FDA has taken in
response. 



                         Table II.1
          
             Summary of Recommendations and FDA
                          Actions

                    Our
Problems we found   recommendations     FDA's actions
------------------  ------------------  ------------------
Inspection results  Monitor the         FDA distributed
varied              inspection results  new inspection
considerably from   more closely to     software to
state to state. It  ensure consistent   monitor inspection
was not clear       reporting of        results more
whether the         violations and      closely. FDA also
differences were    corrections.        conducted
due to variations                       additional
in the quality of                       training of staff
mammography at                          who audit the
different                               performance of
facilities or the                       MQSA inspectors to
inspectors'                             ensure consistent
approaches in                           application of
conducting                              inspection
inspections and                         procedures.
reporting results.

We found            Strengthen          FDA implemented an
variability in how  procedures for      annual program to
inspectors scored   assessing image     test MQSA
phantom images.     quality by          inspectors on
                    providing           phantom image
                    additional          scoring.
                    inspector training
                    and guidance.

FDA had no          Protect patients    FDA established a
procedure in place  from risk of poor   policy that allows
for clinical image  mammograms by       it to initiate a
review or patient   requiring follow-   clinical image
notification when   up clinical image   review and patient
evidence suggested  reviews and         notification when
problems with the   patient             serious violations
quality of a        notification when   are found.
facility's          inspections detect
mammograms.         serious
                    violations.

When violations     Develop procedures  FDA issued
posed a serious     for (1)             guidance to
health risk, FDA    determining when    compliance
did not have        the health risk is  officers to
criteria to help    serious enough to   establish the
determine when to   justify the         criteria and
require the         immediate           procedures
immediate           suspension of a     necessary to
suspension of a     facility's          determine the
facility's          certificate and     degree of health
certificate.        (2) implementing    risks and when to
                    the suspension.     seek suspension of
                                        a facility's
                                        certificate.

FDA's follow-up     Reevaluate the      FDA revised its
efforts did not     classification and  policy guidance to
always ensure that  enforcement policy  strengthen its
corrective actions  for level 3         procedures for
were taken on less  violations.         addressing less
serious                                 serious violations
violations.                             that recur from
                                        one inspection to
                                        another.

FDA's compliance    Make complete, up-  FDA distributed an
system was          to-date             automated
inadequate in       information on      compliance
three field         violations          information system
offices included    accessible to       that provides
in our review       compliance          current
because staff did   personnel.          information on
not have direct                         inspection
access to                               violations.
inspection
databases.
----------------------------------------------------------


(See figure in printed edition.)Appendix III

--------------------
\23 GAO/HEHS-97-25, Jan.  27, 1997. 


COMMENTS FROM THE DEPARTMENT OF
HEALTH AND HUMAN SERVICES
========================================================== Appendix II


GAO CONTACTS AND STAFF
ACKNOWLEDGMENTS
========================================================== Appendix IV

GAO CONTACTS

Frank Pasquier, Assistant Director, (206) 287-4861
Sophia Ku, Evaluator-in-Charge, (206) 287-4888

STAFF ACKNOWLEDGMENTS

In addition to those named above, the following individuals made
important contributions to this report:  Donna Bulvin, Senior
Evaluator; Susan Lawes, Senior Social Science Analyst; Stan
Stenersen, Senior Evaluator; Evan Stoll, Computer Specialist; and
Craig Winslow, Senior Attorney. 


ACKNOWLEDGMENTS
=========================================================== Appendix V

We would like to acknowledge the members of the NCI's Breast Cancer
Surveillance Consortium and officials from CDC's Division of Cancer
Prevention and Control for their advice and technical assistance on
the methodological and data problems of measuring mammography
performance and cancer outcomes. 


*** End of document. ***