United States General Accounting Office

GAO Report to Congressional Committees

January 1997 FDA’s MAMMOGRAPHY

INSPECTIONS

While Some Problems

Need Attention, Facility

Compliance Is Growing

GAO/HEHS-97-25

GAO United States

General Accounting Office

Washington, D.C. 20548

Health, Education, and

Human Services Division

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

1

Mammography Services: Initial Impact of New Federal Law Has Been Positive (GAO/HEHS-96-17,

Oct. 27, 1995).

Page 1 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

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.

Results in Brief 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

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.

Page 2 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

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 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.

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.

Page 3 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

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

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.

Page 4 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

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.

Compliance With

Standards Has

Improved but More

Consistent Reporting

Is Needed

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

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.

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.

Page 5 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

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

Facilitiesa

Violation level Explanation Number Percent

Level 1 Level 1 violations are 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.

214 2

Level 2 Level 2 violations are 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.

1,635 18

Level 3 Level 3 violations are 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.

4,328 47

No findings of violations The facility meets all standards. 3,009 33

Total 9,186 100

aFacilities 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).

8

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

Page 6 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

Figure 1: Comparison of First-Year and

Second-Year Inspection Results Percent of Facilities in Each Category

0

10

20

30

40

50

60

70

80

Level 1 Violation Level 2 Violation Level 3 Violation

First-year Inspection

Second-year Inspection

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.

Page 7 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

Inconsistent Inspection

Practices Could Lead to

Underreporting of

Violations

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

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.

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

Page 8 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

always adhere to this policy. For example, we observed that an inspector

did not cite a facility that failed its darkroom fog test11—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.

Procedures for

Assessing Image

Quality Need

Strengthening

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.

Issues in Evaluating

Phantom Image Test

Results

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

11The 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.

12Mammography equipment generally includes the mammography unit (machine) used to produce

X-ray images, the processor, and other equipment used in developing images.

13The 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.

Page 9 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

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

14One 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.

15An 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.

Page 10 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

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.

Taking Additional Steps to

Better Ascertain the

Seriousness of

Deficiencies

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

Page 11 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

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

16In 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.

17The 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.

18FDA 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.

Page 12 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

FDA’s Monitoring and

Enforcement Process

Does Not Ensure

Timely Correction of

Deficiencies

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

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

1942 U.S.C. 263b(i)(2) (1994).

20After 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.

21FDA 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.

Page 13 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

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.

Determining Whether a

Stronger Approach Is

Needed to Resolve Level 3

Violations

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.

Page 14 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

FDA Field Offices Need a

Better Information System

to Manage Inspections

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

Page 15 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

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.

Conclusions 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

22In 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.

Page 16 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

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

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

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.

Page 17 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

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

Page 18 GAO/HEHS-97-25 FDA’s Mammography Inspections
B-271339 

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).

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

Page 19 GAO/HEHS-97-25 FDA’s Mammography Inspections
Contents

Letter 1

Appendix I 

Distribution of Level 1

Violations by Type,

First-Year Inspections

22

Appendix II 

Results of States’

First-Year Inspections

23

Appendix III 

Chronology of FDA’s

Enforcement Actions

for the North Carolina

Mobile Facility

25

Appendix IV 

Comments From the

Food and Drug

Administration and

Our Evaluation

26

GAO Comments 37

Appendix V 

GAO Contacts and

Staff

Acknowledgments

39

Table Table 1: Distribution of Facilities’ First-Year Inspection Results,

by Highest Level of Violation

6

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

Results

7

Page 20 GAO/HEHS-97-25 FDA’s Mammography Inspections
Contents

Abbreviations

ACR American College of Radiology

FDA Food and Drug Administration

MQSA Mammography Quality Standards Act of 1992

Page 21 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix I 

Distribution of Level 1 Violations by Type,

First-Year Inspections

Violations

Type of noncompliance Number Percent

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

aLess than one-half of 1 percent.

Page 22 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix II 

Results of States’ First-Year Inspections

Percentage of facilities with the

most serious violation at:

State

Total

number of

facilities

inspected Level 1 Level 2 Level 3

Percentage

of facilities

with no

violations

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

(continued)

Page 23 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix II 

Results of States’ First-Year Inspections

Percentage of facilities with the

most serious violation at:

State

Total

number of

facilities

inspected Level 1 Level 2 Level 3

Percentage

of facilities

with no

violations

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

Page 24 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix III 

Chronology of FDA’s Enforcement Actions

for the North Carolina Mobile Facility

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.

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

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

11/13/95 FDA notified the facility that its response was inadequate because it did not 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.

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

11/30/95 The facility responded to FDA’s 11/13/95 letter by sending new phantom images 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 FDAand 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.

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

11/12/96 FDA denied the facility’s appeal.

Page 25 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix IV 

Comments From the Food and Drug

Administration and Our Evaluation

Note: GAO comments

supplementing those in the

report text appear at the

end of this appendix.

Page 26 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix IV 

Comments From the Food and Drug

Administration and Our Evaluation

Page 27 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix IV 

Comments From the Food and Drug

Administration and Our Evaluation

Page 28 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix IV 

Comments From the Food and Drug

Administration and Our Evaluation

Page 29 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix IV 

Comments From the Food and Drug

Administration and Our Evaluation

See comment 1.

Page 30 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix IV 

Comments From the Food and Drug

Administration and Our Evaluation

See comment 2. Now on

pp. 2 and 8.

See comment 3.

Page 31 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix IV 

Comments From the Food and Drug

Administration and Our Evaluation

See comment 4.

See comment 5.

Page 32 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix IV 

Comments From the Food and Drug

Administration and Our Evaluation

Page 33 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix IV 

Comments From the Food and Drug

Administration and Our Evaluation

Page 34 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix IV 

Comments From the Food and Drug

Administration and Our Evaluation

Page 35 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix IV 

Comments From the Food and Drug

Administration and Our Evaluation

Page 36 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix IV 

Comments From the Food and Drug

Administration and Our Evaluation

The following are GAO’s additional comments on the letter received from

the Food and Drug Administration dated November 18, 1996.

GAO Comments

Comment 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 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 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.

Page 37 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix IV 

Comments From the Food and Drug

Administration and Our Evaluation

Comment 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 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.

Page 38 GAO/HEHS-97-25 FDA’s Mammography Inspections
Appendix V 

GAO Contacts and Staff Acknowledgments

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.

(108261) Page 39 GAO/HEHS-97-25 FDA’s Mammography Inspections
Ordering Information

The first copy of each GAO report and testimony is free.

Additional copies are $2 each. Orders should be sent to the

following address, accompanied by a check or money order

made out to the Superintendent of Documents, when

necessary. VISA and MasterCard credit cards are accepted, also.

Orders for 100 or more copies to be mailed to a single address

are discounted 25 percent.

Orders by mail:

U.S. General Accounting Office

P.O. Box 6015

Gaithersburg, MD 20884-6015

or visit:

Room 1100

700 4th St. NW (corner of 4th and G Sts. NW)

U.S. General Accounting Office

Washington, DC

Orders may also be placed by calling (202) 512-6000 

or by using fax number (301) 258-4066, or TDD (301) 413-0006.

Each day, GAO issues a list of newly available reports and

testimony. To receive facsimile copies of the daily list or any

list from the past 30 days, please call (202) 512-6000 using a

touchtone phone. A recorded menu will provide information on

how to obtain these lists.

For information on how to access GAO reports on the INTERNET,

send an e-mail message with "info" in the body to:

info@www.gao.gov

or visit GAO’s World Wide Web Home Page at:

http://www.gao.gov

PRINTED ON RECYCLED PAPER
United States

General Accounting Office

Washington, D.C. 20548-0001

Official Business

Penalty for Private Use $300

Address Correction Requested

Bulk Rate

Postage & Fees Paid

GAO

Permit No. G100