FDA's Mammography Inspections: While Some Problems Need Attention,
Facility Compliance Is Growing (Letter Report, 01/27/97, GAO/HEHS-97-25).

Pursuant to a legislative requirement, GAO reviewed the Food and Drug
Administration's (FDA) program for implementing the requirements of the
Mammography Quality Standards Act of 1992, focusing on: (1) the extent
to which facilities are complying with the new mammography standards;
(2) whether FDA's procedures for evaluating image quality at mammography
facilities are adequate; and (3) whether FDA's monitoring and
enforcement process ensures timely correction of mammography
deficiencies.

GAO found that: (1) GAO's work points to growing compliance by
facilities with FDA's mammography standards; (2) FDA's first annual
inspection began in January 1995, and by mid-1996, over 9,000 facilities
had been inspected, and approximately 1,500 of these had undergone two
rounds of inspections; (3) the first time these 1,500 facilities were
evaluated, 26 percent had significant violations, but the second-year
inspection revealed that this figure had dropped to about 10 percent;
(4) the percentage of facilities with less significant deviations from
quality standards had decreased; (5) while these results are positive,
GAO did note some differences in how inspectors are conducting
inspections that, left unaddressed, could lead to inconsistent reporting
of violations, thereby limiting FDA's ability to determine the full
effect of the inspection process and to identify the extent of repeat
violations; (6) GAO's review of FDA's actions during the first 18 months
of its inspection program showed a need for management attention to two
additional aspects of the inspection program; (7) FDA's inspection
procedures for an important test of mammography equipment were
inadequate; (8) the way this test, called the phantom image test, was
conducted was open to variability, which could have resulted in
differing assessments of how well the equipment functioned; (9) in those
instances in which test results showed serious problems with the phantom
image quality, FDA's procedures allowed facilities to continue taking
mammograms without follow-up to evaluate whether their quality was
actually acceptable; (10) without such follow-up review, women are not
fully protected from getting poor mammograms from facilities with
potentially severe quality problems; (11) at the time of GAO's review,
FDA also lacked procedures to ensure that all violations of standards
were both corrected and corrected in a timely manner; (12) FDA's program
lacked criteria for defining conditions constituting a serious risk to
human health, which could delay enforcement of compliance and
notification to women who may have received substandard mammograms; (13)
for facilities with less severe but persistent violations, FDA's
follow-up efforts could not always ensure corrective action was taken;
and (14) delays in completing a management information system have kept
FDA's compliance staff from having complete, up-to-date information abo*

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

 REPORTNUM:  HEHS-97-25
     TITLE:  FDA's Mammography Inspections: While Some Problems Need 
             Attention, Facility Compliance Is Growing
      DATE:  01/27/97
   SUBJECT:  Breast cancer
             Disease detection or diagnosis
             Medical equipment
             Women
             Management information systems
             Quality control
             Inspection
             Noncompliance
             Sanctions
             Health care facilities
IDENTIFIER:  FDA Mammography Certification Program
             FDA Automated Mammography Facility Inspection Database
             FDA Inspector Audit Program
             California
             Illinois
             Michigan
             Arizona
             Georgia
             Louisiana
             North Carolina
             Washington
             
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Cover
================================================================ COVER


Report to Congressional Committees

January 1997

FDA'S MAMMOGRAPHY INSPECTIONS -
WHILE SOME PROBLEMS NEED
ATTENTION, FACILITY COMPLIANCE IS
GROWING

GAO/HEHS-97-25

FDA's Mammography Inspections

(108261)


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

  ACR - American College of Radiology
  FDA - Food and Drug Administration
  MQSA - Mammography Quality Standards Act of 1992

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


B-271339

January 27, 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 currently the second leading cause of cancer deaths
among American women.  One woman in eight will develop breast cancer
during her lifetime, and, in 1996 alone, an estimated 44,000 women
will have died from the disease.  If breast cancer is detected early,
however, the probability that a woman can survive is greater than 90
percent. 

Currently, the most effective technique for early detection of breast
cancer is mammography, an X-ray procedure that can often locate small
tumors and abnormalities up to 2 years before they can be detected by
touch.  However, mammography is one of the most technically
challenging X-ray procedures, and ensuring the quality of mammography
services is difficult.  To address concerns about variations in the
quality of mammography services provided by the more than 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
quality, including requiring accreditation and annual inspection of
mammography facilities. 

The act also requires us to report to the Congress on the Food and
Drug Administration's (FDA) program for implementing these
requirements.  Our first report, which focused on the accreditation
program, found that many facilities were upgrading their procedures
to meet accreditation requirements.\1 Since that report was issued,
FDA has fully implemented its annual inspection program for assessing
compliance with these requirements.  In our ongoing monitoring
efforts, we identified several inspection-related issues that we
thought important to call to your attention as you assess the act's
results.  This report focuses on the extent to which facilities are
complying with the new mammography standards, whether FDA's
procedures for evaluating image quality at mammography facilities are
adequate, and whether FDA's monitoring and enforcement process
ensures timely correction of mammography deficiencies. 

Our work is based on an analysis of results of inspections that took
place at more than 9,000 mammography facilities nationwide between
January 1995 and June 1996.  For a better understanding of how
inspections and follow-up efforts were being carried out, we also
visited eight state offices that contracted with FDA to conduct
inspections and three FDA field offices responsible for managing and
monitoring inspections.\2 We supplemented this information through
interviews with officials from FDA and other federal, state, and
private organizations involved with the program.  Our work was
conducted from November 1995 through September 1996 in accordance
with generally accepted government auditing standards. 


--------------------
\1 Mammography Services:  Initial Impact of New Federal Law Has Been
Positive (GAO/HEHS-96-17, Oct.  27, 1995). 

\2 The eight states were Arizona, California, Georgia, Illinois,
Louisiana, Michigan, North Carolina, and Washington.  The three FDA
field offices were located in the Atlanta, Baltimore, and Seattle
areas. 


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

Our work points to growing compliance by facilities with FDA's
mammography standards.  FDA's first annual inspection began in
January 1995.  By mid-1996, over 9,000 facilities had been inspected,
and approximately 1,500 of these had undergone two rounds of
inspections.  The first time these 1,500 facilities were evaluated,
26 percent had significant violations (violations requiring formal
responses to FDA as to the corrective actions taken); the second-year
inspection revealed that this figure had dropped to about 10 percent. 
Also, the percentage of facilities with less significant deviations
from quality standards had decreased.  While these results are
positive, we did note some differences in how inspectors are
conducting inspections that, left unaddressed, could lead to
inconsistent reporting of violations, thereby limiting FDA's ability
to determine the full effect of the inspection process and to
identify the extent of repeat violations. 

Moreover, our review of FDA's actions during the first 18 months of
its inspection program showed a need for management attention to two
additional aspects of the inspection program.  First, we noted that
FDA's inspection procedures for an important test of mammography
equipment were inadequate.  The way this test, called the phantom
image test, was conducted was open to variability, which could have
resulted in differing assessments of how well the equipment
functioned.  In addition, in those instances in which test results
showed serious problems with the phantom image quality, FDA's
procedures allowed facilities to continue taking mammograms without
follow-up to evaluate whether their quality was actually acceptable. 
Without such follow-up review, women are not fully protected from
getting poor mammograms from facilities with potentially severe
quality problems. 

Second, at the time of our review, FDA also lacked procedures to
ensure that all violations of standards were both corrected and
corrected in a timely manner.  FDA's program lacked criteria for
defining conditions constituting a serious risk to human health,
which could delay enforcement of compliance and notification to women
who may have received substandard mammograms.  For facilities with
less severe but persistent violations, FDA's follow-up efforts could
not always ensure corrective action was taken.  In addition, delays
in completing a management information system have kept FDA's
compliance staff from having complete, up-to-date information about
the compliance status of all mammography facilities. 

Our report contains several recommendations to the Commissioner of
FDA to establish procedures, guidance, and training to help ensure
timely compliance with MQSA standards by facilities.  In response to
our draft report, FDA informed us that they had recently taken
actions to address these matters. 


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

The best method known to reduce breast cancer mortality is early
detection.  Detection of breast cancer is accomplished through a
combination of self-examination, physical examination by a physician,
and mammography.  Of these methods, mammography is the single most
effective tool for detection of early-stage breast cancer.\3 The use
of mammography as a tool for detecting early or potential breast
cancer continues to increase.  The proportion of women aged 50 and
older who had received mammograms in the previous year increased from
26 percent in 1987 to 54 percent in 1993, according to the Centers
for Disease Control and Prevention.  Since 1992, at least 23 million
mammograms have been performed in the United States annually. 

The consequences of substandard mammograms can be very serious.  If
the image shows an abnormality when none exists, a woman may go
through unnecessary and costly follow-up procedures, such as
ultrasound or biopsies.  If the image is too poor to show an
abnormality that is actually present, a woman may lose the chance to
stop the cancer's spread. 

To help ensure the quality of images and their interpretation, MQSA
required FDA to implement both an accreditation and an inspection
process for mammography facilities.  For the accreditation process,
FDA established standards that included requirements for personnel
qualifications, equipment performance, and quality assurance
recordkeeping.  These standards were based on those used by the
American College of Radiology (ACR), a private, nonprofit
professional association of radiologists, and have been endorsed by
industry and government experts.  As of July 1996, almost 10,000
facilities had been accredited and had received an FDA certificate to
that effect.\4

MQSA inspection authority provides FDA with another means to ensure
that facilities comply with standards on a day-to-day operating
basis.  While for the vast majority of facilities accreditation
application and review are accomplished through the mail, all
inspections are conducted on site.  During an inspection, MQSA
inspectors conduct various equipment tests and review the facility's
records on personnel qualifications, quality controls, and quality
assurance as well as mammography reports. 

FDA, which has contracted with virtually all states and territories
to conduct inspections, began its first annual inspections of the
nation's mammography facilities in January 1995.\5 It established an
extensive program for training inspectors, and as of April 1996,
about 220 state and FDA personnel had become certified to perform
MQSA inspections.  The majority of the personnel chosen to become
MQSA inspectors had 5 or more years of prior experience in
radiological health.  FDA uses its own inspectors to conduct
follow-up inspections, monitor the performance of state inspectors,
and conduct inspections in states that either did not contract with
FDA or lacked enough FDA-certified inspectors to do all the
inspections.\6

FDA's field offices are responsible for following up on inspection
violations and enforcing facility compliance.  For the most serious
violations, FDA's field offices issue a warning letter informing the
facility of the seriousness of the violation.  The facility must
begin correcting its problem immediately and report the corrective
action taken in writing to FDA within 15 work days of receipt of the
letter.  In some cases, FDA conducts a follow-up inspection of the
facility to ensure that the problem is corrected.  If the facility
fails to correct a problem, FDA can take other enforcement actions,
such as imposing a Directed Plan of Correction; assessing a civil
penalty of up to $10,000 per day or per failure; or suspending or
revoking a facility's FDA certificate, which prevents a facility from
operating lawfully. 


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

\4 FDA approved ACR and the states of California, Arkansas, and Iowa
as official accrediting bodies.  ACR serves as the major
accreditation body, responsible for more than 95 percent of the
workload. 

\5 These contracts address such matters as the number and cost of
inspections to be conducted.  To cover these costs, FDA assesses an
inspection fee on each facility.  FDA has agreements with all states
except New Mexico. 

\6 FDA inspectors are also responsible for conducting inspections of
federal facilities. 


   COMPLIANCE WITH STANDARDS HAS
   IMPROVED BUT MORE CONSISTENT
   REPORTING IS NEEDED
------------------------------------------------------------ Letter :3

First-year inspections of mammography facilities showed that a
significant number of facilities were not in full compliance with
mammography standards.  So far, second-year inspections have shown a
considerable reduction in the proportion of facilities cited for
violations--an indication that the inspection process is having
positive results.  However, inspection results vary considerably from
state to state.  It is not clear how much these differences reflect
actual differences in the levels of quality in mammography facilities
and how much they reflect varying approaches to conducting
inspections and reporting the results.  To gain a true picture of the
full effect of the inspection process, more consistent reporting of
violations is needed. 


      SECOND-YEAR INSPECTIONS
      IDENTIFIED FEWER VIOLATIONS
      THAN FIRST-YEAR INSPECTIONS
---------------------------------------------------------- Letter :3.1

FDA's automated inspection database contained first-year inspection
results for 9,186 facilities as of June 20, 1996.\7 Of these, 6,177
showed one or more violations of the standards.  As table 1 shows,
1,849 facilities (or 20 percent) had violations that were serious
enough to require the facility to provide FDA with a formal response
as to the corrective actions taken.  Of these, 214 facilities had
violations that ranked in the most serious (or "level 1") category,
requiring FDA to send the facility a warning letter. 



                                     Table 1
                     
                      Distribution of Facilities' First-Year
                     Inspection Results, by Highest Level of
                                    Violation

                                                           Facilities\a
                                                  ------------------------------
Violation level     Explanation                      Number          Percent
------------------  ----------------------------  -------------  ---------------
Level 1             Level 1 violations are             214              2
                     considered the most
                     serious--those that may
                     have a detrimental effect
                     on the quality of
                     mammography services. An
                     example is a facility's
                     having mammography
                     personnel who do not meet
                     FDA's minimum qualification
                     standards. Level 1
                     violations require FDA to
                     issue a warning letter; the
                     facility must begin
                     correcting problems
                     immediately and respond in
                     writing to FDA within 15
                     work days of receiving the
                     warning letter about the
                     corrective actions taken.
Level 2             Level 2 violations are            1,635            18
                     considered less significant
                     than level 1 violations but
                     may compromise the quality
                     of mammography services. An
                     example is a facility's not
                     having an evaluation of
                     equipment by a medical
                     physicist within the last
                     14 months. The facility
                     must begin correcting
                     problems immediately and
                     respond in writing to FDA
                     within 30 work days of
                     receiving an inspection
                     report about the corrective
                     actions taken.
Level 3             Level 3 violations are            4,328            47
                     generally considered minor
                     deviations from MQSA
                     standards. An example is a
                     facility's not having
                     records for one or more of
                     the quality control tests.
                     No written response is
                     required.
No findings of      The facility meets all            3,009            33
 violations          standards.
================================================================================
Total                                                 9,186            100
--------------------------------------------------------------------------------
\a Facilities could have had more than one level of violation and
more than one violation at each level.  In this table, facilities
that had multiple violations at more than one level were counted only
once, based on their highest level of violation. 

The most serious violations found in these inspections were mainly
personnel related:  88 percent of the level 1 violations were for
personnel who did not fully meet FDA's qualification standards (see
app.  I for a further breakdown of the types of level 1
violations).\8 Level 2 violations involved a greater mix of
personnel-related and equipment-related problems, and the majority of
level 3 violations involved missing or incomplete quality assurance
records and test results as well as medical physicist survey
problems. 

By June 20, 1996, FDA's database contained the results of 1,503
second-year inspections.  We compared the results of first-year and
second-year inspections for these 1,503 facilities and found a
substantial decrease in all three categories in the proportion of
facilities cited for violations (see fig.  1). 

   Figure 1:  Comparison of
   First-Year and Second-Year
   Inspection Results

   (See figure in printed
   edition.)

Another measure of facilities' improvement in compliance is the
extent of repeat violations, that is, violations identified in the
first year's inspection that are identified again when the facility
is reinspected the following year.  Facilities had a better record in
not repeating the more severe violations than they did with minor
findings.  More specifically, our analysis of the 1,503 facilities
showed the following: 

  -- None of the 50 facilities whose highest level of violation was
     at the level 1 category during the first-year inspection
     repeated one or more of the same violations in the second
     inspection. 

  -- Six percent of the 345 facilities whose highest level of
     violation was at the level 2 category during the first-year
     inspection repeated one or more of the same violations in the
     second inspection. 

  -- Twelve percent of the 669 facilities whose highest level of
     violation was at the level 3 category during the first-year
     inspection repeated one or more of the same violations in the
     second inspection. 


--------------------
\7 Under their contracts with FDA, many states began inspecting
facilities in January 1995, but some did not begin until later.  By
June 1996, the database did not contain first-year inspections for
all of the estimated 10,000 mammography facilities nationwide. 

\8 These personnel include interpreting physicians, medical
physicists, and radiologic technologists. 


      INCONSISTENT INSPECTION
      PRACTICES COULD LEAD TO
      UNDERREPORTING OF VIOLATIONS
---------------------------------------------------------- Letter :3.2

Our analysis of inspection results showed considerable state-by-state
variation in the degree to which facilities were cited for violations
of MQSA standards.\9 For example,14 states cited no facilities for
level 1 violations, while 6 states cited 5 to 12 percent of the
facilities inspected for level 1 violations (see app.  II for
state-by-state results).  We were unable to determine the reason for
these differences.  It may be, for example, that facilities in
low-violation states really were much better at complying with
standards than facilities in high-violation states.  Alternatively,
the differences may have been related to variations in the way
inspectors conducted their inspections.  In the eight states in which
we observed inspections, we saw several differences in inspection
practices that affected the number of violations reported.  The two
main differences follow. 

First, inspectors' adherence to time limits for resolving problems of
missing documents was inconsistent.  FDA's current procedures allow
inspectors to delay submitting their inspection reports for 5 to 30
days in order to resolve problems of missing documents.  This delay
is intended to avoid citing facilities for not having certain records
available on site.  For example, when a facility claims that its
personnel meet MQSA qualification requirements but does not have the
required documentation at hand, FDA guidelines instruct inspectors to
either delay the transmission of the inspection report or note the
"claimed items" in the inspection record.  These open items are to be
resolved within 30 days, at which time the inspection report is to be
finalized.  However, we found hundreds of cases in the inspection
report database that contained open items longer than 30 days--many
for over 6 months.\10 Several inspectors we interviewed said they
were not aware of the 30-day limit for resolving pending items.  On
the other hand, inspectors in two states we visited said they would
not wait more than 5 days under any circumstances before submitting a
report that a facility was in violation.  Thus, a facility in one
state might be reported as being in violation, while a facility with
the same problem in another state would not.  These differences may
have resulted in inconsistent reporting of violations; moreover,
these inconsistencies make it difficult to determine the full effect
of the inspection process. 

Second, while FDA's policy is to cite facilities for all violations
even if problems are corrected on the spot, we found that inspectors
do not always adhere to this policy.  For example, we observed that
an inspector did not cite a facility that failed its darkroom fog
test\11 --normally a level 2 violation--because the facility
immediately corrected the problem.  Further, FDA's procedures
instruct inspectors to note on-the-spot corrections in the "remarks"
section of the inspection software.  We observed two inspections on
site that involved on-the-spot corrections, but we did not see these
inspectors documenting them in the remarks section. 

We do not question the merit of giving inspectors time to resolve
such problems as missing documents or giving facilities opportunities
to correct their problems immediately.  However, not documenting
violations consistently creates problems in forming an accurate
picture of what the inspection process is accomplishing.  FDA
officials told us that they had begun a program in February 1996 to
review inspector performance and that, as of October 31, 1996, 65
percent of all inspectors had been audited.  FDA officials expect
that, when fully implemented, the audit program will help ensure that
policies are consistently applied.  We agree that the audit program
will help identify some inconsistent inspection practices; however,
we believe the inspection results should also be monitored to ensure
that open items are resolved in a timely manner and that on-the-spot
corrections are identified. 


--------------------
\9 We based this analysis on the 9,186 first-year inspections because
there were more first-year than second-year inspections conducted at
the time we performed our analysis and also because the first-year
inspections represented a broader distribution among all 50 states. 

\10 In November 1996, FDA told us it was in the process of
investigating and resolving these open items. 

\11 The darkroom fog test is conducted to determine if excessive
light exists, inside or leaking in from outside the darkroom, that
could fog mammographic images, thus reducing their quality. 


   PROCEDURES FOR ASSESSING IMAGE
   QUALITY NEED STRENGTHENING
------------------------------------------------------------ Letter :4

Although many factors can affect the quality of mammography images,
one key factor is the condition of mammography equipment.\12 We
identified a need for FDA to clarify the procedures it requires for a
major equipment test that evaluates image quality and to follow up
when test results suggest problems with the quality of the images
being produced. 


--------------------
\12 Mammography equipment generally includes the mammography unit
(machine) used to produce X-ray images, the processor, and other
equipment used in developing images. 


      ISSUES IN EVALUATING PHANTOM
      IMAGE TEST RESULTS
---------------------------------------------------------- Letter :4.1

One of the most important aspects of the inspection process is
testing mammography equipment by evaluating what is called a "phantom
image." In this procedure, the inspector uses the facility's
mammography equipment to take an X-ray image of a plastic block
containing 16 test objects.  This block is X-rayed as though it were
a breast to determine how many of the test objects can be seen on the
image.\13 The inspector evaluates aspects of the performance of the
facility's imaging system by scoring the number of objects that can
be seen.  We found two questions that need to be answered with regard
to evaluating phantom images. 

  -- What is the impact of inconsistent phantom image scoring?  FDA's
     current inspection procedures instruct inspectors to score the
     phantom images under viewing conditions at the facilities. 
     However, differences in inspectors' experience and in
     facilities' viewing conditions may influence the phantom image
     scores.  For greater uniformity in scoring the images, two
     states we visited go beyond FDA's standards by having their
     inspectors score phantom images using standardized viewing
     conditions (that is, away from the facility), having two or more
     persons read the images to ensure more consistent scoring, or
     both.\14 FDA officials told us that the impact of these
     variations in procedure on the accuracy of image evaluation is
     unknown and that they are studying the problem. 

  -- How should large image receptors be evaluated?\15 FDA procedures
     currently require that phantom images be checked using the
     receptor that is more commonly used by the facility.  Since
     facilities use small image receptors for most mammograms, these
     receptors are typically tested during an inspection.  Although
     facilities may use large image receptors for some women, FDA
     does not require that the large image receptor be tested and
     does not have specific criteria for evaluating the phantom
     images of the large receptor. 

Inconsistent phantom image scoring and lack of standards for
evaluating large image receptors can affect inspection results, as
can be seen in the example of a 1995 inspection of a large mobile
mammography facility headquartered in North Carolina and operating in
five states.  The facility is reported to perform over 20,000
mammograms a year.  A state inspector cited the facility for multiple
problems based on the viewing conditions at the facility and images
from the small receptor.  Although it was not required by FDA, the
inspector also evaluated the phantom images from the large image
receptor and noted in the remarks section of the inspection report
that, for three of four mammography units, these images did not pass
the review.  An FDA inspector conducted a follow-up inspection, also
using the viewing conditions at the facility and images from both the
small and large image receptors.  This inspector cited the facility
for many violations related to both the small and large image
receptors.  Finally, four reviewers at FDA headquarters examined
these same images away from the facility and together found fewer
violations related to both the small and large image receptors than
the state inspector and the FDA inspector had found.  The reviewers,
however, did confirm the serious violations related to the large
image receptor that were found by the state inspector and the FDA
inspector. 

Although this facility was cited for serious violations related to
the large image receptor as a result of the follow-up inspection, FDA
officials told us that, because of the lack of inspection criteria,
imposing strong sanctions on the basis of phantom image failures from
the large receptor could prove problematic.  According to FDA,
standards for testing the large receptor have not yet been developed
because the technical issues relating to the receptor have not yet
been resolved by the scientific and medical community.  We discussed
this case with senior FDA officials, who said that they plan to both
provide additional training and guidance to minimize the variability
in phantom image scoring and study the development of standards for
evaluating images from the large image receptor. 


--------------------
\13 The plastic block with a wax insert, which is the average size of
a compressed breast, contains 16 test objects--5 embedded
micro-calcifications, 6 fibrous structures, and 5 different-sized
tumor-like masses that simulate growths that could be cancerous. 

\14 One state requires all phantom images to be scored by a group of
four reviewers using the standardized view boxes in their offices. 
In the other state, the inspector scores the phantom images twice,
once using the facility's view boxes and once using the standardized
view box in the office.  In addition, the inspector also asks the
facility's technologist to score the images to see if the scores are
the same.  If there are discrepancies, the inspector asks another
inspector to score the images. 

\15 An image receptor is a medium (screen-film or xerox) that is used
by mammography facilities to record breast images.  The receptor
comes in two sizes:  small (18 by 24 centimeters) and large (24 by 30
centimeters).  The large image receptor is generally used in imaging
large-breasted women. 


      TAKING ADDITIONAL STEPS TO
      BETTER ASCERTAIN THE
      SERIOUSNESS OF DEFICIENCIES
---------------------------------------------------------- Letter :4.2

Another issue raised by the inspections of the facility discussed
above is how to proceed if the phantom image test suggests serious
problems with image quality.  FDA views phantom image failures as
early indications of potential problems deserving further
investigation.  FDA's procedures allow facilities with serious
phantom image failures to continue performing mammograms while FDA
investigates and the facility corrects problems.  During the course
of our work, we heard varying opinions on the risk of allowing
facilities with serious phantom image failures to continue doing
mammograms.  Some people we spoke with believe the risk of patients'
getting poor mammograms from facilities with serious phantom image
failures is high enough that the facilities should not be allowed to
do any mammograms until their problems are corrected and those
corrections are verified by a reinspection.  Several states,
including California, Illinois, and Michigan, have rules empowering
inspectors to immediately stop facilities with level 1 phantom image
failures from doing additional mammograms.  However, others
(including FDA officials in charge of the MQSA program) do not
believe that such drastic action should be taken on the basis of
phantom image test results alone.  They assert that phantom image
failures are an indicator of possible image system problems but are
not conclusive evidence that actual mammograms are faulty.\16

At the time of our review, FDA did not have a follow-up system in
place for reviewing the actual mammograms (called "clinical images")
of facilities with serious phantom image violations to ensure that
they were not producing poor mammograms.  However, in the case of the
mobile facility discussed earlier, FDA did ask ACR to conduct two
reviews of the clinical images produced by the facility because of
image quality concerns.  The more comprehensive review was conducted
in July 1996, subsequent to our inquiry about FDA's handling of the
case.\17 This review selected a total of 28 sets of images from five
units operated by the facility for three different time frames over a
1-year period.  In early September 1996, ACR completed the review and
found most of these clinical images of unacceptable quality.  On the
basis of these results, FDA obtained the facility's agreement to
discontinue performing mammography until its radiologic technologists
and its radiologist obtained additional training approved by FDA and
ACR, which they did the following week.  In addition, at FDA's
request, ACR is planning to review another sample of clinical images
produced by the facility to determine to what extent patients should
be notified of past quality problems at the facility. 

This case clearly demonstrates the need for a procedure to review
clinical images when there is sufficient evidence to suggest problems
with the quality of a facility's mammograms.  Without the criteria
and process in place for determining when and how follow-up review of
clinical images should be conducted and patient notification should
be carried out, there is no assurance that patients are protected
from the risk of receiving poor mammograms.  FDA officials agreed
that there is a need to incorporate a follow-up clinical image review
process.  In its proposed final regulation dated April 3, 1996, FDA
has included a provision that specifically provides FDA with
authority to require clinical image review and patient notification
if FDA finds that image quality at a facility has been severely
compromised.\18


--------------------
\16 In support of this position, FDA cited data from ACR's
accreditation program showing that failed phantom images (level 1 and
level 2 phantom image violations under the inspection program)
correlate with failed mammograms about 24 percent of the time. 

\17 The other review, conducted in November 1995, involved ACR's
check of one set of clinical images from each of two units operated
by the facility. 

\18 FDA implemented MQSA by issuing interim regulations in December
1993.  It published the proposed final regulations for public comment
on April 3, 1996, but does not expect to have the final regulations
issued until some time in 1998. 


   FDA'S MONITORING AND
   ENFORCEMENT PROCESS DOES NOT
   ENSURE TIMELY CORRECTION OF
   DEFICIENCIES
------------------------------------------------------------ Letter :5

Although FDA has made progress in bringing facilities into compliance
with mammography standards, it lacks procedures to enforce timely
correction of all deficiencies found during inspections.  One major
problem involves the need to develop criteria for defining conditions
constituting a serious risk to human health and determining when
severe sanctions are warranted.  Other problems that also merit
attention relate to determining whether a stronger approach is needed
to resolve repeated level 3 violations and establishing an effective
information system for follow-up on inspection results.  FDA is
developing such an information system. 


      DEVELOPING CRITERIA FOR
      DEFINING A SERIOUS RISK TO
      HUMAN HEALTH AND DETERMINING
      WHEN SEVERE SANCTIONS ARE
      JUSTIFIED
---------------------------------------------------------- Letter :5.1

MQSA provides FDA a broad range of sanctions to impose against
noncomplying facilities, but it emphasizes bringing facilities into
compliance through those sanctions that are less severe, such as
imposing a Directed Plan of Correction.  FDA has the authority to
impose stronger sanctions, such as an immediate suspension of a
facility's FDA certificate, if it determines that the facility's
operation presents a serious risk to human health.\19 Since the
implementation of MQSA, FDA has never done so.\20 We found evidence
that FDA needs to define those circumstances in which such actions
are warranted. 

In dealing with the continuing problems at the mobile facility
discussed earlier, there was considerable internal debate at FDA
about the level of action that should be taken.  Inspections of the
facility beginning in June 1995 had disclosed serious violations. 
(See app.  III for a chronology of key events surrounding the
resolution of quality assurance problems at the facility.) Several
state and FDA field personnel involved in the case told us they
thought the severity of violations warranted an immediate suspension
of the facility's certificate and had made such a recommendation. 
FDA officials decided against suspending the facility's certificate
because they thought the evidence of health risk was not clear and
compelling enough to do so.\21 In September 1996, when ACR's review
of clinical images eventually confirmed that the quality of the
mammograms was unacceptable, FDA obtained the facility's agreement to
discontinue performing mammography until facility personnel received
more training.  Because of the agreement, FDA did not have to go
through the process of imposing an immediate suspension of the
facility's certificate.  Nevertheless, this incident points to the
need for having criteria in place to impose such a sanction to
protect patients, if necessary, from continuing to receive poor
mammograms.  We believe--and FDA officials agreed--that timely
imposition of an appropriate sanction is in part dependent on (1)
criteria for when conditions constitute a serious risk to human
health, justifying immediate suspension of operations, and (2) a
process for discontinuing mammography services until the problems are
corrected. 


--------------------
\19 42 U.S.C.  263b(i)(2) (1994). 

\20 After reviewing a draft of this report, FDA informed us that it
had issued a suspension without a hearing to a facility for the first
time in September 1996. 

\21 FDA stated that there was countervailing evidence that the
facility was producing mammograms of acceptable quality. 
Specifically, in August 1995 and November 1995, two of the five units
operated by the facility had passed ACR's clinical image review as
part of the facility's accreditation process.  Further, in November
1995, ACR conducted a review of one set of clinical images from each
of two other accredited units.  In February 1996, ACR notified the
facility and FDA that it found them to be acceptable. 


      DETERMINING WHETHER A
      STRONGER APPROACH IS NEEDED
      TO RESOLVE LEVEL 3
      VIOLATIONS
---------------------------------------------------------- Letter :5.2

Another matter that also merits attention from FDA is whether more
serious follow-up is needed for facilities with multiple or repeated
level 3 violations.  Current policy for facilities whose most serious
violations are in the level 3 category requires no reporting on the
facility's part and no follow-up on the part of FDA until the next
year's inspection.  However, of the facilities that had gone through
two inspections, 18 percent of those whose most serious violation was
in the level 3 category during the first year had five or more such
violations, and 12 percent repeated one or more of the same
violations in the next year.  Several state inspectors we interviewed
expressed concern that current procedures do not call for stronger
action against such facilities.  Inspectors from one state told us
that their state regulations allow them to impose more serious
penalties for recurring level 3 violations.  Some inspectors also
told us that even though level 3 violations were generally considered
less serious, some level 3 violations--such as a facility's failure
to take corrective action when called for in the medical physicist's
survey report--are serious enough that they should be corrected as
soon as possible to maintain quality assurance. 

We did not evaluate the appropriateness of FDA's classification of
the various levels of violations.  Because of the concerns expressed
by the inspectors and the extent of multiple and repeat violations
noted above, however, we believe that FDA should evaluate its
classification of level 3 violations and the enforcement actions
taken on them.  If FDA believes these violations are important and
need to be corrected, it could raise the violation level for
facilities with multiple or repeated violations, which would ensure
formal follow-up.  However, if FDA views some of these violations as
insignificant or having little effect on mammography, it may choose
not to classify them as violations. 


      FDA FIELD OFFICES NEED A
      BETTER INFORMATION SYSTEM TO
      MANAGE INSPECTIONS
---------------------------------------------------------- Letter :5.3

FDA generally delegates inspection responsibility through contracts
with states but remains responsible for follow-up and enforcement
when violations are reported.  For level 1 violations, FDA's field
offices are responsible for validating inspection results and issuing
a warning letter that requires the facility to respond within 15 work
days.  For level 2 violations, no warning letters are sent, but
facilities are required to respond in writing within 30 work days of
the receipt of an inspection report.  Since June 1995, FDA has been
working with contractors to develop an automated compliance system
that would supply its field offices with computer-based information
to manage this compliance effort.  Development problems have delayed
the system, which is now projected to be operational early in 1997. 
In the meantime, FDA has been relying on field offices to maintain
their own tracking systems. 

Our reviews at three of FDA's field offices showed that these interim
systems were inadequate.  Staff responsible for compliance follow-up
had no direct access to inspection databases and were relying either
on the state inspectors or on FDA headquarters to send them copies of
inspection reports showing level 1 and level 2 violations that needed
to be tracked.  Staff said that sometimes they did not receive
reports from headquarters until 2 to 3 months after the inspections
and that state inspectors did not always send reports on level 2
cases.  As a result, field office staff often received facility
responses on corrective actions taken for level 2 violations before
they even knew that violations had been cited.  None of the three
offices maintained case logs or prepared any status reports on their
tracking efforts or the timeliness of facility responses. 

Problems in these makeshift systems have stymied our attempts to
determine how quickly and completely violations were being corrected. 
To determine whether field offices were sending out warning letters
in a timely manner and whether facilities were correcting their
deficiencies within required time frames, at our request, FDA
headquarters in April 1996 sent all of its field offices a list of
all level 1 and level 2 violations cited in their jurisdictions and
asked them to compile data on facility response times for corrective
actions.  Field offices had difficulty responding with complete
information.  FDA headquarters had initially told us that these data
would be available in early June, but at the time that we completed
our field work, discrepancies still remained unresolved.\22 We
conducted an on-site file review at one FDA field office in August
and September 1996 and found that the office had incomplete
documentation for 13 of the 40 cases with level 2 violations cited
between July 1, 1995, and June 20, 1996.  In one case, documentation
was absent altogether. 

We also found problems with the timeliness of follow-up on level 1
violations.  For example, while FDA guidelines require a field office
to issue a warning letter for a level 1 violation within 15 to 30
business days after the inspection, the office we reviewed took up to
132 business days.  Also, although FDA procedures require a facility
to respond within 15 business days of receiving the warning letter,
in two of the eight level 1 cases that we reviewed the facilities did
not respond within the required time frame, and one case file
contained no record of a facility response. 

These findings highlight the importance of completing and
implementing the automated compliance system as soon as possible. 
Until field offices have ready access to up-to-date information, it
will be difficult for them to conduct effective follow-up and
enforcement for facilities that violate the standards. 


--------------------
\22 In November 1996, in response to our draft report, FDA provided
us the spreadsheet data for the period ending March 1996 that we had
earlier requested.  While the data showed that all level 1 cases had
been resolved, we noticed that 46 percent of the warning letters had
not been issued within FDA's established time frame and, when warning
letters were sent, 20 percent of facilities did not respond on time. 
For level 2 cases, 6 percent of 1995 cases still had not been
resolved as of November 1996.  For those cases that had been
resolved, 20 percent of the facility responses were not received
within the required time frame. 


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

The results of the current inspection program of mammography
facilities appear to be generally positive.  Establishing this
comprehensive inspection program has been a substantial effort on
FDA's part and, as mammography facilities move into their second year
of inspections, violations of mammography standards are declining. 

Despite these encouraging results, at the time of our review, we
found indications that certain aspects of the inspection program
needed attention.  First, to ensure an accurate picture of how many
problems were found and how well the inspection program was working,
violations would need to be more consistently recorded.  In addition,
even though serious violations do not occur often, when they do, they
have the potential for posing a serious health risk to those women
affected.  To ensure high quality mammography, FDA must be vigilant
in its efforts to confirm that facilities promptly and adequately
correct violations.  As a result, FDA would need to provide an
expeditious means to follow up, including notifying patients, when
serious problems affecting image quality were indicated.  Finally,
improvements would be needed in systems and procedures for monitoring
facilities with violations and for ensuring that they corrected
deficiencies. 


   RECOMMENDATIONS TO THE
   COMMISSIONER OF THE FOOD AND
   DRUG ADMINISTRATION
------------------------------------------------------------ Letter :7

We recommend that FDA take action in the following areas: 

  -- Strengthening the inspection reporting process.  To better
     reflect the extent to which inspections detect compliance
     problems, FDA needs to monitor its inspection results more
     closely to ensure that its procedures for resolving open items
     and documenting on-the-spot corrections are consistently
     followed. 

  -- Strengthening procedures for assessing image quality and
     protecting patients.  To minimize the variability in how phantom
     images are scored, additional training and guidance should be
     provided, including guidance for evaluating phantom images using
     the large image receptor.  Also, to minimize patients' risk of
     poor quality mammograms, the final implementing regulations
     should include the criteria and process for requiring follow-up
     clinical image reviews and, when necessary, patient notification
     when inspections detect violations, such as serious phantom
     image failures, that could severely compromise image quality. 

  -- Ensuring that violations are corrected in a timely manner. 
     Several steps are needed here.  First, to help ensure that
     appropriate action is taken when serious problems are
     discovered, procedures need to be developed for (1) determining
     when the health risk is serious enough to justify immediate
     suspension of certification and (2) implementing the suspension. 
     Second, to help ensure better performance from facilities that
     exhibit lingering, though less serious, deficiencies, the
     classification and enforcement policy on level 3 violations
     needs reevaluation to determine if additional follow-up is
     needed on facilities with multiple and repeated level 3
     violations.  Third, so that compliance personnel can have access
     to complete, up-to-date information on violations reported, all
     necessary steps need to be taken to ensure that the compliance
     tracking system currently under development is completed as soon
     as possible. 


   AGENCY COMMENTS AND OUR
   EVALUATION
------------------------------------------------------------ Letter :8

In commenting on a draft of this report, FDA generally agreed with
our recommendations and cited specific program enhancements and
corrective actions it had recently undertaken.  FDA was, however,
critical of our draft on several accounts. 

FDA said that the scope of our work did not address some aspects of
MQSA requirements and that the draft did not adequately reflect many
of FDA's accomplishments in implementing MQSA.  Moreover, FDA
believed the report did not recognize changes FDA had made to improve
those aspects of the inspection program that we had found in need of
attention.  FDA cited recent actions it had taken, including (1)
establishing procedures and guidance for clinical image reviews,
sanctions for failure to comply with standards, and procedures for
follow-up on repeated level 3 violations; (2) implementing an
inspector audit program that had evaluated 65 percent of inspectors
as of October 31, 1996; and (3) making a commitment to fully
implement its automated compliance tracking system in January 1997. 
FDA expressed concern that not acknowledging these actions would
create an inaccurate impression that the program was fraught with
problems, which could undermine the public confidence in mammography. 

Concerning the scope of our work, this report is not intended as a
vehicle for commenting on implementation of MQSA as a whole; it deals
only with FDA's inspection program.  However, we think that the
report speaks both to FDA's accomplishments related to the inspection
program and to those problems that we found--and that FDA has now
moved to correct.  The main reason that FDA's recent actions were not
reflected in the original draft was that they occurred about the same
time or, in most cases, after we had provided FDA the draft for
comment.  We generally consider FDA's subsequent actions and
approaches to our recommendations to be responsive and believe that,
if properly implemented, they should strengthen the inspection
program.  We recognize FDA's concern about the importance of
promoting public confidence in mammography, and, in fact, our
recommendations to promote timely compliance with MQSA were made with
that objective in mind. 

While we generally concur with FDA's approaches for addressing our
recommendations, we continue to believe that opportunity exists for
FDA to improve its reporting process.  We recognize that FDA has
acted to implement the inspector audit program, but we believe that
FDA still needs to monitor its inspection results to ensure timely
follow-up on "open items" and accurate reporting of on-the-spot
corrections.  As a result, we have clarified our recommendation on
strengthening the inspection reporting process accordingly. 

FDA also provided technical comments, which we considered and
incorporated where appropriate, and cited several other areas of the
report that it thought needed clarification.  The full text of FDA's
comments, accompanied by our response, is contained in appendix IV. 

We also received comments from the North Carolina facility that we
cited in the report.  The facility stated that our report addressed
many of its concerns with the MQSA program.  It also commented that
its case demonstrates the need for an organized approach to
evaluation and for all involved agencies to agree upon an appropriate
standard for clinical image evaluation.  The facility asserted that
FDA's process lacks these critical elements and that the facility was
being held to unreasonable standards.  As a result, in October 1996,
the facility appealed its Directed Plan of Correction to FDA.  We
have updated the chronology of FDA's enforcement actions regarding
the facility to reflect the facility's appeal and the subsequent
denial of the appeal by FDA (see app.  III). 


---------------------------------------------------------- Letter :8.1

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 Office of Management and Budget, and other
interested parties.  We will also make copies available to others
upon 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
V. 

Bernice Steinhardt
Director, Health Services Quality
 and Public Health Issues


DISTRIBUTION OF LEVEL 1 VIOLATIONS
BY TYPE, FIRST-YEAR INSPECTIONS
=========================================================== Appendix I

                                                          Violations
                                                        --------------
                                                                Percen
Type of noncompliance                                   Number       t
------------------------------------------------------  ------  ------
Personnel do not meet FDA's qualification standards        261      88
Failing phantom image score                                 16       5
Processor quality control charts not available              11       4
No survey conducted by medical physicist                     4       1
Mammography records improperly maintained or recorded        3       1
Self-referred system inadequate or not in place              2       1
Radiation dose exceeds limits                                1      \a
======================================================================
Total                                                      298     100
----------------------------------------------------------------------
\a Less than one-half of 1 percent. 


RESULTS OF STATES' FIRST-YEAR
INSPECTIONS
========================================================== Appendix II

                                            Percentage of
                                         facilities with the
                                        most serious violation
                                                 at:
                                        ----------------------
                                                                Percen
                                                                  tage
                                 Total                              of
                                number                          facili
                                    of                            ties
                                facili                            with
                                  ties                              no
                                inspec   Level   Level   Level  violat
State                              ted       1       2       3    ions
------------------------------  ------  ------  ------  ------  ------
Alabama                            156       2      15      51      32
Alaska                              28       0      18      68      14
Arizona                            155       1      15      27      57
Arkansas                            84       1      10      40      49
California                         940       3      22      48      27
Colorado                           114       3      12      54      31
Connecticut                        167       2      13      44      42
Delaware                            25       4      48      24      24
District of Columbia                24       4      38      29      29
Florida                            470       2       9      39      51
Georgia                            270       1      10      35      54
Hawaii                              43       0      33      30      37
Idaho                               39       3      15      41      41
Illinois                           398       1      16      51      32
Indiana                            223       0      17      56      27
Iowa                               139       0      23      49      28
Kansas                              95       1      17      55      27
Kentucky                           163      12      29      41      18
Louisiana                          155       0      11      34      55
Maine                               55       0       7      22      71
Maryland                           169       1      14      35      50
Massachusetts                      222       0       7      31      62
Michigan                           337       1      14      56      29
Minnesota                          188       5      32      55       7
Mississippi                         96       0      15      46      40
Missouri                           174       3      18      52      26
Montana                             47       0      21      51      28
Nebraska                            85       1       6      62      31
Nevada                              61       0       2      46      52
New Hampshire                       42       0       5      24      71
New Jersey                         263       4      18      52      27
New Mexico                          49       0      20      59      20
New York                           700       3      32      49      16
North Carolina                     216       8      29      47      16
North Dakota                        36       3      19      47      31
Ohio                               314       5      18      48      29
Oklahoma                           102       0       9      58      33
Oregon                              98       5      41      41      13
Pennsylvania                       474       2      14      51      33
Rhode Island                        48       2       4      48      46
South Carolina                     114       0      16      48      36
South Dakota                        43       2      12      49      37
Tennessee                          177       8      22      55      15
Texas                              495       1       9      50      40
Utah                                48       4       8      46      42
Vermont                             19       0      10      53      37
Virginia                           228       1       9      47      42
Washington                         175       3      27      44      25
West Virginia                       83       1      16      47      36
Wisconsin                          229       2      19      52      28
Wyoming                             24       0      33      42      25
----------------------------------------------------------------------

CHRONOLOGY OF FDA'S ENFORCEMENT
ACTIONS FOR THE NORTH CAROLINA
MOBILE FACILITY
========================================================= Appendix III

Date      Summary of event
--------  -------------------------------------------------------------------------------
6/28/95   Initial inspection revealed 1 level 1 violation for phantom image failure, 2
          level 2 violations for phantom image failure, 1 level 2 violation for processor
          quality control problems, and 31 level 3 violations for various other problems.

8/29/95   ACR's clinical image review for one unit found mammograms acceptable and
          resulted in ACR accreditation for that unit.

10/10/    FDA issued its warning letter to the facility for the violations found in June
95        1995.

10/18/    The facility responded by submitting new phantom images and a processor quality
95        control chart for review.

11/13/    FDA notified the facility that its response was inadequate because it did not
95        identify the machine on which the phantom images were taken and it did not
          include proper paperwork for the processor.

          ACR clinical image review for another unit found mammograms acceptable, and ACR
          accreditation was granted for that unit.

11/20/    ACR, at FDA's request, performed a clinical image review of one set of
95        mammograms for each of two units.

11/30/    The facility responded to FDA's 11/13/95 letter by sending new phantom images
95        and processor quality control charts.

12/8/95   FDA notified the facility that the 11/30/95 response was adequate.

1/16/96   FDA did a follow-up reinspection and found 5 level 1 and 7 level 2 phantom
          image failures using the large image receptor, 11 level 2 phantom image
          failures using the small image receptor, and numerous other level 2 and level 3
          violations.

2/19/96   ACR notified the facility and FDA that the clinical images reviewed on 11/20/
          95 were acceptable.

3/19/96   FDA imposed a Directed Plan of Correction requiring the facility to (1) have a
          medical physicist complete a survey of all units within 30 days, (2) correct
          problems identified in the survey within 15 business days, (3) perform phantom
          image evaluation weekly and submit results to FDA monthly, and (4) perform
          other quality control tests.

4/17/96   FDA and state officials met with the facility's management to discuss the
          Directed Plan of Correction and to review progress.

7/1/96    FDA reinspected the facility and found one level 2 violation involving dark
          room fog and two level 3 violations in other areas, but no phantom image
          failures for either large or small image receptors. FDA directed the facility
          to select a total of 28 sets of clinical images from three time periods between
          July 1995 and June 1996 for ACR review.

9/3/96    ACR review found most of the clinical images were unacceptable.

9/10/96   FDA imposed an amended Directed Plan of Correction and obtained agreement from
          the facility to discontinue performing mammography with the resident radiologic
          technologists and interpreting physician until they were retrained.

9/17/96   All but one of the facility's radiologic technologists and the interpreting
          physician completed training, and a new FDA-and ACR-approved technologist was
          added to the facility's staff. The facility reopened and reestablished
          mammography services.

9/18/96   FDA notified the facility that ACR would conduct additional clinical image
          reviews of (1) a sample of clinical images after the personnel had resumed
          performing mammography for about 1 month and (2) all mammograms taken between
          June 6, 1996, and September 9, 1996.

10/11/    The facility appealed FDA's amended Directed Plan of Correction.
96

11/12/    FDA denied the facility's appeal.
96
-----------------------------------------------------------------------------------------



(See figure in printed edition.)Appendix IV
COMMENTS FROM THE FOOD AND DRUG
ADMINISTRATION AND OUR EVALUATION
========================================================= Appendix III



(See figure in printed edition.)



(See figure in printed edition.)



(See figure in printed edition.)



(See figure in printed edition.)



(See figure in printed edition.)

Now on pp.  2 and 8. 



(See figure in printed edition.)



(See figure in printed edition.)



(See figure in printed edition.)



(See figure in printed edition.)



(See figure in printed edition.)


The following are GAO's additional comments on the letter received
from the Food and Drug Administration dated November 18, 1996. 


   GAO COMMENTS
------------------------------------------------------- Appendix III:1


      COMMENT 1
----------------------------------------------------- Appendix III:1.1

FDA commented that the draft report did not discuss the inherent
limitations of the phantom image test or the lack of scientific
consensus on a test for the large image receptor.  While our draft
report correctly reflected FDA's view that the phantom image test is
only an indicator of image problems, we agreed to add clarifying
information to recognize limitations suggested by FDA.  Similarly, we
have added clarification to recognize that, according to FDA,
developing a standard for the large image receptor would require
additional scientific testing.  While we recognize that developing
guidance for the large image receptor will take time, FDA is in a
position to continue to provide leadership in conducting experiments
and in building a scientific consensus on a particular test method. 


      COMMENT 2
----------------------------------------------------- Appendix III:1.2

FDA commented that our method of presenting aggregate data on the
extent of all violations detected during the first and second years
of inspections tended to give too much weight to level 3 violations,
which FDA characterized as minor.  While our report points out that
all level 3 violations are not universally regarded as minor, we
agree with FDA that aggregating all levels of violations could
potentially be misleading.  As a result, we have eliminated the
aggregate totals from our final report. 


      COMMENT 3
----------------------------------------------------- Appendix III:1.3

While FDA acknowledged that there have been some start-up problems
with the timely follow-up of violations, it asserted that it now has
all necessary procedures in place to follow up on violations.  We
believe that the lack of an adequate compliance follow-up system has
been an ongoing problem.  Our contacts with FDA field offices, one as
recent as late September 1996, showed the lack of a systematic
approach to follow up on previous inspection violations.  We agree
with FDA, however, that the establishment of its automated Compliance
Tracking System has significant potential to alleviate the problems
with follow-up. 


      COMMENT 4
----------------------------------------------------- Appendix III:1.4

FDA commented that variation among the states in the number of
violations reported would be expected because some states had
well-developed mammography programs before MQSA and, as a result,
presumably would have had fewer violations than other states.  In
addition, FDA stated that some states may have imposed stricter
standards than those provided by MQSA.  We agree that there could be
variation in frequency of violations among the states attributable to
the states' pre-MQSA experiences with mammography standards. 
However, the violation data, in our view, are not reported in a
consistent enough fashion to sustain such analysis of variation. 
Moreover, whether states have higher standards than MQSA should not
affect violation data if they are correctly reported by the states. 
States that establish and enforce higher standards than MQSA should,
according to FDA's own guidance, enforce these standards outside of
the MQSA process. 


      COMMENT 5
----------------------------------------------------- Appendix III:1.5

FDA also commented that our draft report did not accurately reflect
the circumstances surrounding FDA's enforcement in the case of the
North Carolina facility.  We believe our draft report provided an
adequate summary of the key facts in the North Carolina case
sufficient to justify our recommendations for additional enforcement
procedures, guidance, and training.  We note that, after reviewing
our draft report, FDA took action to implement our recommendations. 
However, since FDA believes that additional facts are relevant to the
discussion, we have added them to our final report.  Specifically, we
have (1) added a footnote to the body of the report to explain more
fully how FDA reached its conclusion that it would not suspend the
facility operation; (2) amended the appendix that contains the
chronology of events related to the facility; and (3) as explained
above, added information recognizing the limitations of phantom
images and clarifying the lack of consensus on available tests for
the large image receptor. 


GAO CONTACTS AND STAFF
ACKNOWLEDGMENTS
=========================================================== Appendix V

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:  Sarah F.  Jaggar, Special
Advisor for Health Issues; Susan Lawes, Senior Social Science
Analyst; Donna Bulvin, Evaluator; Stan Stenersen, Senior Evaluator;
Evan Stoll, Computer Specialist; Craig Winslow and Stefanie Weldon,
Senior Attorneys; and Clair Hur, Intern. 


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