United States Government Accountability Office

GAO Report to Congressional Requesters

MAMMOGRAPHY

Current Nationwide 

Capacity Is Adequate, 

but Access Problems 

May Exist in Certain 

Locations 

July 2006 

 

GAO-06-724 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

July 2006

MAMMOGRAPHY

Current Nationwide Capacity Is Adequate, 

but Access Problems May Exist in Certain 

Locations 

Highlights of GAO-06-724, a report to 

congressional requesters 

Mammography, an X-ray procedure 

that can detect small breast

tumors, is an important tool for 

detecting breast cancer at an early 

stage and, when coupled with 

appropriate treatment, can reduce

breast cancer deaths. In 2002, GAO 

reported in Mammography: 

Capacity Generally Exists to 

Deliver Services (GAO-02-532) that 

the capacity to provide 

mammography services was 

generally adequate, but that the 

number of mammography facilities 

had decreased by 5 percent from

1998 to 2001 and that about onefourth of counties had no 

machines. GAO was asked to

update its information on facility

closures and mammography

service capacity.

The Food and Drug Administration 

(FDA) regulates mammography 

quality and maintains a database on 

mammography facilities and other 

capacity elements. GAO reviewed

FDA data on facility closures and 

examined reasons for closures in

recent years. GAO analyzed 

changes in the nation’s capacity for 

and use of mammography services

using FDA capacity data and 

National Center for Health 

Statistics data on service use. GAO 

also interviewed state and local

officials about the effects of the

loss or absence of mammography

machines on access, including

access for medically underserved 

women, such as those who are 

poor or uninsured. 

Closures of certified mammography facilities outpaced openings during a 

recent 3-year period, and financial considerations were most often cited as 

the reason for facility closures. FDA data show that from October 1, 2001, to 

October 1, 2004, the number of mammography facilities nationwide 

decreased from 9,306 to 8,768. During this period, 1,290 facilities closed and 

752 began providing services, resulting in a net loss of 538 facilities, or 6 

percent. Mammography facility officials most often cited financial 

considerations as the reason their facility closed. Experts said that another 

factor that could affect closures is difficulty recruiting and retaining 

radiologic technologists who perform mammography and physicians who 

interpret mammograms. 

Although key elements that make up mammography capacity have 

decreased and the use of screening mammography has grown, current 

nationwide capacity is adequate. The numbers of mammography facilities,

machines, radiologic technologists, and interpreting physicans decreased 

from 2001 to 2004. From 2000 to 2003, the estimated number of women who 

received a screening mammogram increased, mostly because of population 

growth. Based on GAO’s calculation that the estimated number of 

mammograms performed in the United States in 2003 was substantially 

lower than the number that could have been performed, GAO found that 

current capacity is adequate. Most of the experts GAO interviewed believe 

the nation’s current overall capacity is likely adequate, but all of the experts 

expressed concern that the flow of personnel into the field may be 

insufficient to serve the growing number of women needing screening. This

potential development could result in access problems in the future. 

The loss or absence of machines in certain locations may have resulted in 

access problems, including problems for women who are medically 

underserved, such as those who have a low income or lack health insurance. 

About one-fourth of counties had no mammography machines in 2004. The 

majority of officials GAO interviewed about access in their states, including 

access in 18 of the 117 counties that had lost over 25 percent of their 

machines from 2001 to 2004, said that machine losses had not resulted in 

access problems because women were able to obtain services at other 

facilities. However, some officials told GAO that the loss or absence of 

machines in certain counties resulted in access problems consisting of 

lengthy wait times or travel distances to obtain services. Lengthy travel 

distances may especially pose an access barrier for medically underserved 

women. Access problems for these women are of concern because 

uninsured and poor women have lower-than-average screening 

mammography rates.

In commenting on a draft of this report, FDA provided additional details and 

clarification regarding aspects of its regulation of mammography, which 

GAO incorporated as appropriate. 

www.gao.gov/cgi-bin/getrpt?GAO-06-724.

To view the full product, including the scope 

and methodology, click on the link above. 

For more information, contact Marcia Crosse 

at (202) 512-7119 or crossem@gao.gov. 
Contents 

Letter 1

Results in Brief 7

Background 9

Facility Closures Outpaced Openings, with Financial 

Considerations Most Often Cited as Reason for Closure 18 

Although Key Capacity Elements Have Decreased and Use of 

Mammography Services Has Increased, Current Nationwide 

Capacity Is Adequate 21 

Loss or Absence of Mammography Machines May Have Resulted in 

Access Problems in Certain Locations 25 

State Bodies Have Varying Measures to Avoid Conflicts of Interest, 

and FDA’s Evaluations Have Not Found Conflict-of-Interest 

Problems 31

Concluding Observations 37 

Agency Comments 38 

Appendix I The Food and Drug Administration’s Mammography

Facility Inspection Demonstration Program 39 

Appendix II Scope and Methodology 43 

Appendix III Changes in the Number of Certified 

Mammography Facilities by State, October 1, 2001, 

to October 1, 2004 52 

Appendix IV Comments from the Food and Drug Administration 54 

Appendix V GAO Contact and Staff Acknowledgments 56 

Page i GAO-06-724 Mammography Services
Tables 

Table 1: Reasons for Closures of ACR-Accredited Mammography 

Facilities in the United States, October 1, 2001, to 

October 1, 2004 20 

Table 2: Changes in Numbers of Mammography Facilities, 

Machines, Radiologic Technologists, and Interpreting 

Physicians from October 1, 2001, to October 1, 2004 22 

Table 3: State Accreditation and Certification Bodies’ Measures to 

Avoid Conflicts of Interest 32 

Table 4: Counties Randomly Selected for Review from Those That 

Lost over 25 Percent of Their Mammography Machines 

from October 1, 2001, to October 1, 2004 46 

Table 5: Selected Counties with Closures of Facilities That Had 

Provided Mammography Services to Participants in CDC’s 

National Breast and Cervical Cancer Early Detection 

Program, 2001 through 2004 48 

Table 6: Selected Counties with Mammography Facility Closures 

and Community Health Centers, October 2003 to 

October 2004 49 

Figures 

Figure 1: Overview of the Mammography Facility Accreditation and 

Certification Processes 13 

Figure 2: Number of Mammography Machines by County, 

October 1, 2004 27 

Figure 3: Percentages of Mammography Facilities with MQSA

Violations, by Level of Violation, during FDA’s IDP 42 

Page ii GAO-06-724 Mammography Services
Abbreviations 

ACR American College of Radiology 

CDC Centers for Disease Control and Prevention 

CMS Centers for Medicare & Medicaid Services 

FDA Food and Drug Administration 

HHS Department of Health and Human Services 

HRSA Health Resources and Services Administration 

IDP inspection demonstration program 

MQSA Mammography Quality Standards Act of 1992 

MQSRA Mammography Quality Standards Reauthorization Act 

NCI National Cancer Institute 

NHIS National Health Interview Survey 

QIO quality improvement organization 

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. It may be reproduced and distributed in its entirety without further 

permission from GAO. However, because this work may contain copyrighted images or 

other material, permission from the copyright holder may be necessary if you wish to 

reproduce this material separately. 

Page iii GAO-06-724 Mammography Services
United States Government Accountability Office

Washington, DC 20548 

July 25, 2006

The Honorable Arlen Specter 

Chairman 

The Honorable Tom Harkin 

Ranking Minority Member 

Subcommittee on Labor, Health and Human 

 Services, Education, and Related Agencies 

Committee on Appropriations 

United States Senate 

The Honorable Barbara A. Mikulski 

Ranking Minority Member 

Subcommittee on Retirement Security and Aging 

Committee on Health, Education, Labor, and Pensions 

United States Senate 

Breast cancer is the most common cancer among women in the United 

States, excluding skin cancers, and is the second leading cause of cancer 

deaths among U.S. women. The American Cancer Society has estimated 

that in 2006, almost 213,000 new cases of breast cancer will be diagnosed

in women and over 40,900 women will die from the disease. Early 

detection, however, when coupled with appropriate treatment, can reduce 

breast cancer mortality. Mammography, an X-ray imaging procedure that 

can detect small tumors and breast abnormalities, is an important tool for 

detecting breast cancer at an early stage. Mammography is performed for 

two different purposes: screening and diagnosis. Screening mammography 

is an examination of a woman without breast symptoms to detect a breast 

abnormality before it can be detected by physical examination. Diagnostic 

mammography is an examination of a woman who exhibits a symptom, 

such as a lump, that indicates the possible presence of breast cancer or 

whose screening mammogram indicated a possible cancer. The National 

Institutes of Health’s National Cancer Institute (NCI) and the U.S. 

Preventive Services Task Force1

 recommend screening mammography 

every 1 to 2 years for women age 40 and over. Medically underserved 

 1

The U.S. Preventive Services Task Force is a committee of medical experts convened by 

the Department of Health and Human Services to evaluate evidence and make 

recommendations for screening services, such as mammography. 

Page 1 GAO-06-724 Mammography Services
women—such as those who have low incomes, lack health insurance 

coverage, or are in certain racial or ethnic minority groups—have been 

less likely to obtain screening mammography than have other women. In 

addition, studies have found that diagnoses of breast cancer for minority 

women have occurred at a more advanced stage than for white women 

and that differences in mammography use, such as a lower likelihood of 

obtaining regular screening among minority women, may explain this 

disparity.2

Although mammography is the most effective tool for detection of earlystage breast cancer, it is not a perfect test. For example, mammograms are 

among the most difficult radiographic images to interpret because very 

early-stage breast cancer appears similar to noncancerous breast tissue in 

the mammographic image. If a mammogram is interpreted as normal when 

an abnormality is actually present, this could result in a missed diagnosis 

and delayed treatment, which could cost a woman her life. Conversely, if a

mammogram is incorrectly interpreted as showing an abnormality, this 

could cause a woman to undergo unnecessary and costly follow-up 

procedures and experience unnecessary anxiety.

The Mammography Quality Standards Act of 1992 (MQSA) and the 

Mammography Quality Standards Reauthorization Acts (MQSRA) of 1998 

and 2004 established national quality standards for mammography to help

ensure the quality of the images and image interpretations that

mammography facilities produce.3

 MQSA required the Secretary of Health

and Human Services to establish and enforce quality standards for 

mammography equipment, personnel, and recordkeeping practices. The 

Food and Drug Administration (FDA) administers the requirements of 

MQSA on behalf of the Department of Health and Human Services (HHS). 

Before a mammography facility can legally perform mammography 

services, it must receive an MQSA certificate indicating that it meets FDA’s 

quality standards. To begin this process, the facility must be accredited by

an FDA-approved accreditation body, which assesses whether the facility 

 2

See, for example, Rebecca Smith-Bindman et al., “Does Utilization of Screening 

Mammography Explain Racial and Ethnic Differences in Breast Cancer?” Annals of 

Internal Medicine, vol. 144, no. 8 (2006), and Asma Ghafoor et al., “Trends in Breast 

Cancer by Race and Ethnicity,” CA: A Cancer Journal for Clinicians, vol. 53, no. 6 (2003). 

3

Pub. L. No. 102-539, 106 Stat. 3547; Pub. L. No. 105-248, 112 Stat. 1864; Pub. L. No. 108-365, 

118 Stat. 1738 (codified at 42 U.S.C. § 263b). 

Page 2 GAO-06-724 Mammography Services
meets the quality standards. FDA has approved one nonprofit 

organization—the American College of Radiology (ACR)—and state 

agencies in three states—Arkansas, Iowa, and Texas—to serve as 

accreditation bodies.4

 ACR serves as the major accreditation body and is 

responsible for over 90 percent of the accreditation workload. State 

accreditation bodies may accredit facilities only within their own state; 

facilities may apply for accreditation to either their state body or ACR. 

Accreditation bodies must establish measures that FDA approves to avoid

conflicts of interest—such as an accreditation body employee’s financial 

interest in a facility being reviewed—as the bodies carry out their work. 

Upon receiving notification from an accreditation body that a facility 

meets the quality standards and has therefore achieved accreditation, FDA 

or a state certification body issues an MQSA certificate to the facility, 

which allows it to legally operate for up to 3 years. To operate subsequent 

to the 3-year period, the facility must apply for reaccreditation prior to the 

expiration of its certificate. FDA has approved state agencies in three 

states—Illinois, Iowa, and South Carolina—as certification bodies.5

 As 

with state accreditation bodies, state certification bodies may certify 

facilities only within their own state6

 and are to establish FDA-approved 

measures to avoid conflicts of interest. FDA and the state certification 

bodies are also responsible for ensuring that all facilities they certify 

receive an annual MQSA compliance inspection.7

 For most states where 

FDA certifies the facilities, it contracts with the state to have state 

 4

FDA approved ACR and state agencies in Arkansas and Iowa to serve as accreditation 

bodies in 1994. FDA approved a state agency in Texas to serve as an accreditation body in 

1999. These bodies are currently approved to serve as accreditation bodies through 

April 28, 2013. FDA approved a state agency in California to operate as an accreditation 

body in 1994, but California withdrew its application to continue operating as an 

accreditation body on May 5, 2004. FDA required that facilities previously accredited by 

California obtain accreditation from ACR within 1 year of California’s withdrawal as an 

accreditation body. 

5

FDA approved state agencies in Illinois and Iowa to serve as certification bodies in 1998. 

In April 2005, FDA approved a state agency in South Carolina to serve as a state 

certification body. These state certification bodies are currently approved to serve in that 

capacity for an indefinite period. 

6

Facilities in states with certifying bodies may receive certification only from their state 

body, not from FDA. 

7

MQSA requires the annual inspection of mammography facilities to ensure compliance

with the act’s requirements. 42 U.S.C. § 263b(g). 

Page 3 GAO-06-724 Mammography Services
inspectors perform MQSA compliance inspections.

8

 FDA is responsible for 

overseeing accreditation and certification bodies’ compliance with MQSA

and MQSA regulations. 

To determine if the frequency of MQSA compliance inspections could be 

reduced for facilities that had previously been found to be in compliance 

with MQSA, FDA implemented an inspection demonstration program 

(IDP) as authorized under MQSRA of 1998.9

 The IDP tested whether 

moving to a biennial inspection schedule would affect the facilities’ 

compliance levels. FDA implemented the IDP in November 2001 and 

ended it in August 2004. 

We reported in 2002 that key elements that make up mammography 

capacity—the numbers of mammography facilities, machines, and 

radiologic technologists—were generally adequate to meet the demand for 

services.10 We also reported that the number of mammography facilities 

had decreased by 5 percent from 1998 to 2001 and that over one-fourth of 

the nation’s counties had no machines in 1998 and in 2001. You asked us to 

update this information and to provide information on state accreditation 

and certification bodies. In this report, we examine (1) mammography 

facility closures and factors that have contributed to closures in recent 

years; (2) changes in the nation’s capacity for and use of mammography 

services in recent years and whether current capacity is adequate; (3) the 

effects of the loss or absence of mammography machines on access to 

services, including access for medically underserved women; and (4) the 

measures state accreditation and certification bodies have taken to avoid

conflicts of interest and FDA’s oversight of state bodies’ performance in 

this area. You also asked us to provide information on the results of FDA’s 

MQSA compliance inspection IDP; this information is in appendix I. 

To examine mammography facility closures, we analyzed data from FDA’s 

Mammography Program Reporting and Information System database on 

 8

In addition to contracting with states, FDA also contracts with New York City and Puerto

Rico to have their inspectors perform MQSA compliance inspections. As of June 2006, FDA

did not have contracts with Nebraska, New Hampshire, and the District of Columbia, 

according to FDA officials. FDA inspectors are responsible for conducting inspections in

these jurisdictions and in federal facilities. 

9

Pub. L. No. 105-248, § 8, 112 Stat. 1864, 1865-66. 

10GAO, Mammography: Capacity Generally Exists to Deliver Services, GAO-02-532 

(Washington, D.C.: Apr. 19, 2002). 

Page 4 GAO-06-724 Mammography Services
the total numbers of certified facilities as of October 1, 2001, and 

October 1, 2004. To examine the factors that have contributed to 

mammography facility closures, we reviewed data from ACR and state 

accreditation bodies in Arkansas, Iowa, and Texas on closures and 

reasons for closure, and interviewed eight radiologists who are experts in

mammography about factors that contribute to facility closures. 

To examine changes in the nation’s capacity for and use of mammography 

services in recent years and whether current capacity is adequate, we first 

defined the key elements that make up mammography capacity as the 

numbers of certified mammography facilities; machines; radiologic 

technologists who perform mammography; and physicians who interpret 

mammograms, who are usually radiologists.11 We then analyzed data from 

FDA’s mammography facility database on the total numbers of these 

capacity elements as of October 1, 2001, and October 1, 2004. To examine

changes in the nationwide use of mammography services, we analyzed 

data from the 2000 and 2003 National Health Interview Survey (NHIS), 

administered by the Centers for Disease Control and Prevention’s (CDC) 

National Center for Health Statistics, to estimate the number of women 

age 40 and older who received a screening or diagnostic mammogram 

within the previous year.

12 To examine changes in the population of 

women age 40 and older, we used population estimates from the Census 

Bureau. To determine the adequacy of current capacity, we asked 

mammography experts for estimates of the amount of time it takes to 

perform a screening mammogram and to perform a diagnostic 

mammogram. We used those estimates and FDA data on the number of 

machines available in 2003 to calculate the number of screening 

mammograms that potentially could have been performed in 2003. We 

compared this estimate of capacity to the estimated number of women age 

40 and older who received a screening mammogram, based on the 2003 

NHIS, and also took into account 2003 NHIS data on diagnostic 

mammograms. In addition, we interviewed the following individuals about 

issues related to mammography closures, mammography capacity, and 

 11In our last report, we examined three of these elements. In this report we added 

physicians who interpret mammograms as a fourth element of capacity. 

12NHIS is the principal source of information on the health of the civilian 

noninstitutionalized population of the United States and is one of the major data collection

programs for the National Center for Health Statistics. In 2000 and 2003, NHIS asked 

women age 30 and older about the length of time since their last mammogram and about 

the reason for the mammogram. NHIS data on the use of mammography services are based

on data that are self-reported by respondents. The 2003 data were the most recent data 

available on the use of mammography services at the time we conducted our analysis. 

Page 5 GAO-06-724 Mammography Services
access to mammography services: officials from FDA, CDC, NCI, and the

Centers for Medicare & Medicaid Services (CMS); representatives from 

several professional organizations, such as the American Board of 

Radiology, American Cancer Society, ACR, and the American Society of

Radiologic Technologists; and mammography experts. 

To examine the effects of the loss or absence of mammography machines

on access to services, including access for medically underserved women, 

we used FDA data to select a stratified random sample of 9 urban counties 

and 9 rural counties, within 16 states, that lost more than 25 percent of 

their mammography machines from October 1, 2001, to October 1, 2004;

we randomly selected the counties to avoid bias in their selection.13 We 

interviewed officials familiar with these counties to obtain their views on 

the effect of machine losses and facility closures. These officials generally

included county health department personnel in the affected counties, 

state radiation control personnel under contract to FDA to conduct annual 

on-site MQSA compliance inspections of mammography facilities, and 

quality improvement organization (QIO) officials under contract to CMS to 

monitor and improve screening rates for Medicare beneficiaries.14 To 

assess the effects of the absence of machines on access to services, we 

used FDA data on the number and locations of machines nationwide as of 

October 1, 2004, and identified counties that had no machines. In our 

interviews with state radiation control program personnel and QIO 

officials from the 16 states containing the 18 counties in our random 

sample, we also asked about access in their states beyond the sampled 

counties, including access for medically underserved women. To obtain 

additional information on the effects of facility closures on access for 

medically underserved women, we interviewed state officials who direct 

CDC’s National Breast and Cervical Cancer Early Detection Program in 

selected states and officials of several community health centers that 

receive funding through the federal Consolidated Health Centers program. 

 13The sample of 18 counties is too small to project the results of our work to the entire

group of counties that lost more than 25 percent of their mammography machines during 

this period. 

14In addition to monitoring and trying to improve mammography screening rates for 

Medicare beneficiaries, QIO officials responsible for each U.S. state and territory and the 

District of Columbia work, under CMS’s direction, with consumers, physicians, hospitals,

and other health care providers to improve service delivery and help ensure that patients

receive quality care, with particular attention to underserved populations. 

Page 6 GAO-06-724 Mammography Services
To examine the measures state bodies have taken to avoid conflicts of 

interest and FDA’s oversight of state bodies’ performance in this area, we 

reviewed MQSA and MQSA regulations issued by FDA, FDA and state 

documents, state ethics laws, state agency personnel policies, state bodies’

procedures, FDA evaluation protocols, and FDA reports on the 

performance of state bodies. In addition, we interviewed officials from 

FDA; ACR; accreditation bodies in Arkansas, Iowa, and Texas; and 

certification bodies in Illinois and Iowa. We also interviewed FDA officials 

about their oversight role and approach. California and South Carolina are 

not included in our review because the California accreditation body 

withdrew its participation in the MQSA program before our review began

and South Carolina’s certification program began operating after our 

review began. 

To assess the reliability of the FDA, ACR, and state body data on 

mammography facility closures and mammography capacity, we talked 

with knowledgeable officials of these organizations about data quality 

control procedures and reviewed relevant documentation. We also 

electronically tested the FDA data to identify problems with accuracy and 

completeness. To assess the reliability of the NHIS data on the numbers of 

women age 40 and older who received a screening or diagnostic 

mammogram in 2000 and 2003 and the population estimate data from the 

Census Bureau, we reviewed the existing documentation on methodology 

and data collection procedures. We determined that the data were 

sufficiently reliable for the purposes of this report. 

Appendix II provides additional information on our scope and 

methodology. We conducted our work from November 2004 through July 

2006 in accordance with generally accepted government auditing 

standards. 

Closures of certified mammography facilities outpaced openings during a 

recent 3-year period, and financial considerations were most often cited as

the reason for facility closures. FDA data show that from October 1, 2001, 

to October 1, 2004, the number of certified mammography facilities 

nationwide decreased from 9,306 to 8,768. During this period, 1,290 

certified mammography facilities closed, while 752 facilities began 

providing services, resulting in a net decrease of 538 facilities, or 

6 percent. Mammography facility officials most often reported to ACR that 

they closed for financial reasons, and officials of state accreditation bodies

in Arkansas, Iowa, and Texas told us that closures in their states were 

generally due to financial concerns. Experts we interviewed said that 

Results in Brief 

Page 7 GAO-06-724 Mammography Services
financial considerations and difficulties recruiting and retaining staff have 

contributed to closures. 

Although key elements that make up mammography capacity have 

decreased and use of mammography services has increased, we found that 

current nationwide capacity is adequate. From October 1, 2001, to 

October 1, 2004, in addition to the 6 percent decrease in mammography 

facilities, the number of machines decreased by 4 percent; the number of 

radiologic technologists who perform mammography decreased by 

3 percent; and the number of physicians who interpret mammograms, who 

are usually radiologists, decreased by 5 percent. While the nation lost 

capacity, the estimated number of women age 40 and older who received a 

screening mammogram within the previous year increased, largely 

because of the increase in the number of women eligible for screening.

From 2000 to 2003, the estimated number of women age 40 and older who 

received a screening mammogram increased nationwide by 14 percent,

from about 29 million to about 33 million. Over the same period, the 

estimated number of women age 40 and older who received a diagnostic

mammogram decreased from about 3 million to about 2 million. Based on 

our calculation that the estimated number of mammograms performed by 

U.S. machines in 2003 was substantially lower than the number that could

have been performed, we found that current capacity is adequate. Most 

experts we interviewed told us that current overall capacity is likely 

adequate, but all of the experts expressed concern that the numbers of 

radiologic technologists and radiologists entering the mammography field

might not be sufficient to serve the increasing population of women age 40 

and over. This potential development could result in access problems in 

the future. 

The loss or absence of mammography machines in certain locations may 

have resulted in access problems for women, including problems for those 

who are medically underserved. FDA data show that from October 1, 2001, 

to October 1, 2004, the number of counties having mammography 

machines remained relatively constant at about 72 percent, but the 

number of machines decreased in certain counties. Of 413 U.S. counties 

that had a net loss of at least one mammography machine during that 

period, 117 counties lost more than 25 percent of their machines. As of 

October 2004, 865 counties—containing 3.4 percent of the U.S.

population—had no machines. The majority of officials we interviewed 

about access in their states, including access in 18 counties that had lost 

over 25 percent of their mammography machines, told us that machine 

losses had not resulted in access problems because women were able to

obtain services at other facilities. However, some officials told us that the 

Page 8 GAO-06-724 Mammography Services
loss or absence of machines in certain counties has resulted in access 

problems consisting of considerable wait times or lengthy travel distances

to obtain services. For example, a West Virginia official working with 

CDC’s early detection program for low-income women estimated that after 

the closure of a facility in one county, program participants’ wait time for 

diagnostic mammography averaged 8 weeks and was as long as 3 months. 

A Virginia official estimated that after one county lost its only 

mammography facility, the absence of a facility resulted in some women 

needing to travel 60 miles to obtain services, in comparison with 20 to 

25 miles before the facility closed. Lengthy travel distances may especially

pose a barrier to access for underserved women who face transportation 

difficulties or who would bear a significant burden if they had to take 

extra time away from work or family responsibilities. Access problems for 

these women are of particular concern because women who lack health 

insurance or have low incomes have lower-than-average screening 

mammography rates. 

State bodies that accredit or certify mammography facilities have varying 

measures to help ensure that individuals conducting work for these 

bodies—including state employees and contractual and volunteer image 

reviewers—avoid conflicts of interest. These measures include state ethics 

laws, state agency personnel policies, and procedures state bodies use to 

carry out their duties. As required by regulation, FDA has reviewed and 

approved the measures used by the state accreditation and certification 

bodies to avoid conflicts of interest and has conducted annual 

performance evaluations of state bodies to assess whether they are 

complying with MQSA regulations. An FDA official told us that agency 

officials have asked questions about conflicts of interest during their 

evaluations and that they have not found any conflicts. FDA’s written 

protocols for performance evaluations have not always included specific

questions on the subject of conflicts of interest, but FDA recently revised 

its written protocol for evaluating certification bodies to increase attention 

to this subject. 

In commenting on a draft of this report, FDA provided additional details 

and clarification regarding its activities for certifying mammography 

facilities and overseeing state accreditation and certification bodies. We 

incorporated FDA’s comments as appropriate. 

The purpose of screening mammography is to detect breast cancer before

there are apparent symptoms. Screening mammography usually consists 

of two X-ray views of each breast. A physician need not be on site to 

Background 

Page 9 GAO-06-724 Mammography Services
interpret a screening mammogram immediately, but may read a group of 

mammograms at a later time. Diagnostic mammograms are used to 

evaluate patients with abnormalities detected on a screening mammogram 

or during a physical examination. Diagnostic mammography takes longer

than screening mammography, because an interpreting physician generally 

examines the mammograms while the patient is waiting and the procedure 

may require additional breast views, such as magnification views of 

suspicious breast tissue, to provide more information about a lesion. 

Because detecting breast cancer as early as possible improves the 

likelihood that treatment will be successful, access to high-quality 

mammography services is essential for improving a woman’s chance of 

survival. The federal government plays a role in both ensuring quality and

promoting access. FDA has responsibility for ensuring the quality of 

mammography services. Other federal agencies have initiatives intended 

to help improve access to mammography services. 

FDA Oversight of 

Mammography 

Under MQSA, FDA has several responsibilities to ensure the quality of 

mammography. FDA is responsible for establishing quality standards for 

mammography equipment, personnel, and practices. In 1993, FDA issued 

interim regulations establishing such standards,15 and in 1997, FDA issued 

final regulations establishing quality standards.16 Most of these quality 

standards went into effect in 1999. However, certain quality standards for 

mammography equipment, which were more stringent than the previous 

standards, went into effect in 2002. The agency is also responsible for 

ensuring that all mammography facilities are accredited by an FDAapproved accreditation body17 and have obtained a certificate permitting 

them to provide mammography services from FDA or an FDA-approved 

certification body.18 FDA is also responsible for ensuring that all 

 1558 Fed. Reg. 67565-72 (Dec. 21, 1993). Interim regulations issued on the same day included 

standards for accreditation bodies. See 58 Fed. Reg. 67558-65. 

1662 Fed. Reg. 55852-994 (Oct. 28, 1997) (codified at 21 C.F.R. Part 900). 

17Under MQSA, mammography facilities operated by the Department of Veterans Affairs 

are excluded from FDA’s review, but they are accredited by ACR and are required by the 

Veterans’ Health Care Eligibility Reform Act to meet standards equivalent to those in 

MQSA. Pub. L. No. 104-262, § 321(a)(1), 110 Stat. 3177, 3195 (codified at 38 U.S.C. § 7319). 

18FDA’s final MQSA regulations also included standards for accreditation bodies that took 

effect in 1999. In 2002, FDA issued regulations containing standards for certification 

bodies. See 67 Fed. Reg. 5446-69 (Feb. 6, 2002). 

Page 10 GAO-06-724 Mammography Services
mammography equipment is evaluated at least annually by a qualified 

medical physicist and that all mammography facilities receive an annual 

MQSA compliance inspection from an FDA-approved inspector. In 

addition to carrying out these activities, FDA maintains the Mammography 

Program Reporting and Information System database, a nationwide 

database on mammography facilities that incorporates data from the 

accreditation and certification processes and inspections of facilities. 

Finally, FDA is responsible for performing annual evaluations of the 

accreditation and certification bodies. 

In addition to setting comprehensive quality standards for the operation of 

mammography equipment, FDA regulations specify detailed qualifications 

and continuing training requirements for mammography personnel, such 

as radiologic technologists who perform the examinations and physicians 

who interpret the images. Radiologic technologists are required to be 

either licensed by a state19 or certified by an appropriate board, such as the 

American Registry of Radiologic Technologists, in general radiography.20

They must also meet additional training, continuing education, and 

experience requirements related to mammography. FDA also specifies that

all interpreting physicians be licensed in a state; be certified in the 

specialty by an appropriate board, such as the American Board of 

Radiology;21 and meet certain medical training, continuing education, and 

experience requirements related to mammography. 

Quality Standards for 

Mammography Personnel 

To legally perform mammography, a facility must be accredited by an 

FDA-approved body and certified by FDA or an FDA-approved body. FDA 

categorizes facilities applying for accreditation into three groups: new 

applicants; reinstating applicants, such as a previously certified facility 

whose certificate was suspended or revoked; and reaccrediting applicants 

that have been accredited and certified for 3 years and are seeking to 

Accreditation and Certification 

of Facilities

 19As of January 2006, 41 states had licensing requirements for radiologic technologists. 

20The American Registry of Radiologic Technologists is the nation’s credentialing 

organization for radiologic technologists. It administers an examination for certification, 

maintains a registry of currently certified general radiologic technologists, and administers

a subspecialty examination and certification program for mammography technologists. 

Although technologists who perform mammography do not have to be certified in the

mammography subspecialty, the majority of the technologists who perform mammography, 

including those who are licensed by states, have such certification. 

21Physicians who interpret mammograms can also meet FDA’s requirements if they have 

had a minimum of 3 months of documented specialized training in the interpretation of 

mammograms. 

Page 11 GAO-06-724 Mammography Services
renew their accreditation. To become accredited, a new mammography 

facility must undergo a two-phase application review process conducted 

by an FDA-approved accreditation body. (See fig. 1.) First, the facility 

must pay an application fee and submit to the accreditation body an entry 

application that provides such information as equipment performance 

specifications, the qualifications of its personnel, and the results of the 

facility medical physicist’s equipment tests.22 A facility seeking

accreditation reinstatement follows the same process as the new 

applicant, but must also submit to the accreditation body a corrective 

action plan that describes the action the facility has taken to correct 

problems that prevented it from achieving or maintaining certification. If 

the accreditation body determines that a new or reinstating facility meets 

the MQSA standards for the initial accreditation phase, it notifies FDA; for 

states with an FDA-approved state certification body, FDA in turn notifies 

the state certification body.23 FDA or the state certification body then 

issues a provisional certificate that allows the facility to operate legally for

up to 6 months.24

 22Although all accreditation bodies follow MQSA standards for accrediting mammography

facilities, the accreditation processes established by each accreditation body vary slightly, 

such as with respect to when facilities must submit certain information for review and 

when to submit the accreditation application fee. For example, Iowa’s application fee is 

required as part of the second phase of the accreditation process.

23ACR notifies both FDA and, when applicable, the state certification body. 

24A facility that does not complete the accreditation process within the 6-month provisional 

period must either cease performing mammography or apply for a onetime 90-day 

extension of the provisional certificate. MQSA requires that to receive the extension, the

facility must show that access to mammography in the geographic area served by the

facility would be significantly reduced if the facility did not receive the extension. 42 U.S.C.

§ 263b(c)(2).

Page 12 GAO-06-724 Mammography Services
Figure 1: Overview of the Mammography Facility Accreditation and Certification Processes 

Source: GAO analysis of MQSA, MQSA regulations, and documents and information provided by FDA and the 

accreditation and certification bodies.

Certification:

By FDA or a state certification body

On the basis of the accreditation body’s 

notification, FDA or the state certification 

body issues a provisional certificate allowing 

the facility to legally operate for up to 

6 months while the facility prepares 

information for phase 2.

Accreditation:

By ACR or a state accreditation body

A new or reinstating mammography facility 

submits an entry application to the accreditation 

body that provides information on the facility and 

its equipment and personnel.a If the accreditation 

body determines that the facility meets MQSA 

standards for the initial accreditation phase, it 

notifies FDA that it has accepted the facility’s 

application. FDA notifies the state certification 

body in states that have such bodies.b

Phase 1: 

Entry application

6-month

provisional

certificate

Certification:

By FDA or a state certification body

On the basis of the accreditation body's 

notification, FDA or the state certification 

body issues a 3-year certificate to the 

facility allowing it to legally operate. Before 

the end of the 3-year period, the facility 

must apply for reaccreditation.c

Accreditation:

By ACR or a state accreditation body

A facility with provisional certification or a fully 

certified facility seeking reaccreditation submits 

clinical images and other required information. 

If the accreditation body determines that the facility 

meets MQSA quality standards, it accredits the 

facility for 3 years and notifies FDA that it has 

accredited the facility. FDA notifies the state 

certification body in states that have such bodies.b

3-year

MQSA

certificate

Phase 2: 

Full application

Notes: As of June 2006, the states with accreditation bodies were Arkansas, Iowa, and Texas. The 

states with certification bodies were Illinois, Iowa, and South Carolina. (Because South Carolina’s

certification program began operating after our review began, it was not included in our review.) State 

accreditation and certification bodies may review only facilities within their own state. Facilities in a 

state with an accreditation body have the option of seeking accreditation from either that body or 

ACR. However, facilities in a state with a certification body may receive certification only from their 

state body, not from FDA. The accreditation processes established by ACR and the states differ 

slightly, such as on the points at which facilities must submit certain information to accreditation 

bodies for review. 

a

A reinstating facility must also submit to the accreditation body a corrective action plan that describes 

the action the facility has taken to correct problems that prevented it from achieving or maintaining 

certification. 

b

ACR notifies both FDA and, when applicable, the state certification body. 

c

A mammography facility seeking to renew its 3-year accreditation and certification is not required to 

obtain a provisional certificate if it completes the reaccreditation process prior to the expiration of the 

existing MQSA certificate. 

Page 13 GAO-06-724 Mammography Services
Second, to achieve full accreditation, the facility must submit to the 

accreditation body phantom and clinical images,25 quality control tests, and 

other information required by MQSA. If the accreditation body determines 

that the facility meets MQSA standards applicable to the images and all 

other submitted information, it accredits the facility and each of the 

facility’s approved mammography machines for 3 years. The accreditation 

body notifies FDA of each mammography machine’s approval; for states 

with certification bodies, FDA in turn notifies the state certification body.26

On the basis of the accreditation body’s notification, FDA or the state 

certification body issues a 3-year MQSA certificate to the facility, which 

allows it to legally perform mammography up to the certificate expiration 

date.27 Accreditation bodies notify facilities they have accredited about 6 to

8 months prior to expiration of their 3-year certification period that they

must apply for reaccreditation. Facilities applying for reaccreditation are 

not required to obtain a provisional certificate if they submit all the 

information required for full accreditation before their certificate expires 

and if the facility meets FDA standards. After approval by its accreditation 

body, a facility receives a new 3-year MQSA certificate from FDA or the 

state certification body. 

Each accreditation body is required to make annual on-site visits to a 

sample of facilities that it accredited.28 The on-site visits include reviewing 

 25A phantom image is a radiographic (X-ray) image of a phantom, which is a plastic block 

used to simulate radiographic characteristics of breast tissue. FDA-approved phantoms 

simulate a 4.2-centimeter-thick compressed breast consisting of 50 percent glandular and 

50 percent fatty tissue, and contain16 test objects that simulate aspects of breast disease 

and cancer. The phantom is used to assess the ability of the facility’s imaging equipment to

detect breast disease and cancer. Under Arkansas’s and Iowa’s procedures, facilities must 

submit the phantom images as part of the initial application package. 

26ACR notifies both FDA and, when applicable, the state certification body. 

27The facility must display its MQSA certificate to operate legally. 42 U.S.C. § 

263b(b)(1)(A)(iii). 

28MQSA regulations require that each accreditation body annually visit at least 5 percent of 

the facilities it accredits and that at least half of the facilities be selected randomly. The 

other facilities are selected based on problems identified in various ways, such as through 

state or FDA compliance inspections, previous history of noncompliance, and serious 

consumer complaints. The accreditation body must visit at least 5 facilities each year, but 

is not required to visit more than 50 unless problems that had been identified indicate a 

need to visit more than 50 facilities. See 21 C.F.R. § 900.4(f)(1). 

Page 14 GAO-06-724 Mammography Services
samples of randomly selected clinical images to assess image quality,29

verifying the information that facilities provided in the accreditation 

application,

30 and reviewing documentation showing that facilities sent 

reports on mammography results to patients and physicians. In addition,

on-site visits have an educational element; for example, members of the 

accreditation body team may suggest ways to improve clinical image 

quality. 

The annual MQSA compliance inspections conducted by FDA and the 

state certification bodies differ in focus and scope from the on-site 

accreditation visits, although both the inspections and the on-site 

accreditation visits are intended to monitor and assess facility compliance 

with MQSA standards.31 In addition to verifying information submitted 

during the accreditation process, FDA and the state compliance 

inspectors—including those under contract to FDA and those working for 

the state certification bodies—conduct several other reviews. These 

include performing equipment tests and in-depth reviews of personnel 

qualifications and reviewing quality control and quality assurance 

records.32 For example, inspectors review quality control records for each 

film processor33 and X-ray machine used for mammography. FDA and state 

certification bodies are responsible for monitoring and enforcing the 

correction of facility problems discovered during MQSA compliance 

 29The random sample of clinical images that each accreditation body reviews annually must 

include images from at least 3 percent of the facilities the body accredited. See 21 C.F.R. §

900.4(f) (2). 

30Accreditation body staff verify, among other things, that the facility personnel and 

equipment identified in the application are the ones used to perform mammography 

services and that the facility has in place a consumer complaint system and a medical audit 

system, which is a system for reviewing and tracking outcomes of positive mammograms—

those identified as having abnormalities—and correlating them with biopsy results. See 21

C.F.R. § 900.4(f)(1)(ii) for a description of the minimum review requirements accreditation 

body site visits must meet. 

31FDA and certification bodies must perform annual inspections to ensure compliance with 

all the quality standards found in 21 C.F.R. § 900.12. 

32The purpose of reviewing quality control records is to ensure that the equipment quality 

control tests performed by radiologic technologists are routinely done at the required

frequencies, that test records are in order, and that corrective actions are taken when

warranted. The purpose of reviewing quality assurance records is to ensure that the facility 

develops and maintains policies and procedures to monitor the performance of facility 

personnel and equipment. 

33The film processor is the device that develops the film to produce a mammographic 

image. 

Page 15 GAO-06-724 Mammography Services
inspections. If a facility fails to correct a problem, FDA and state 

certification bodies may take enforcement actions, including suspending 

or revoking a facility’s certification. 

FDA maintains a national database—the Mammography Program 

Reporting and Information System database—that incorporates data from

the accreditation and certification processes and from annual compliance 

inspections of facilities. The database contains facility identification 

information, as well as information on the number of machines and 

personnel at a facility, the medical physicist who evaluated equipment at 

the facility, the estimated number of mammograms performed, and 

whether the facility is active or no longer certified. 

National Database on 

Mammography Facilities 

Oversight of Accreditation 

and Certification Bodies 

Under MQSA, FDA can approve a state agency or a private nonprofit 

organization to accredit facilities and a state agency to certify facilities if 

the agency or organization meets MQSA standards. MQSA regulations 

require that each accreditation body adopt standards for mammography 

facilities that are substantially the same as the quality standards 

established by FDA to ensure the safety and accuracy of mammography; 

each certification body must establish standards that are at least as 

stringent as FDA’s standards. MQSA regulations do not allow individuals 

who review facilities’ phantom or clinical images for the accreditation 

body or perform accreditation site visits to maintain a financial 

relationship with or have any other conflict of interest or bias in favor of 

or against the facility.34 This requirement applies not only to individuals 

who review phantom or clinical images, but also to state agency managers, 

consultants, administrative personnel, and any other individuals working 

for the accreditation body. MQSA regulations also require that FDA 

conduct annual performance evaluations of accreditation bodies’ and 

certification bodies’ compliance with MQSA standards. MQSA requires 

that FDA annually submit to congressional oversight committees a written 

report on the performance of the accreditation bodies.35

 3421 C.F.R. § 900.4(a)(4) and 21 C.F.R. § 900.22(a) (2005). 

3542 U.S.C. § 263b(e)(6) requires the annual report to the Senate Committee on Health, 

Education, Labor, and Pensions and the House Committee on Energy and Commerce. 

Page 16 GAO-06-724 Mammography Services
The federal government supports two initiatives to help improve access to

mammography services. The Breast and Cervical Cancer Mortality 

Prevention Act of 199036 established CDC’s National Breast and Cervical 

Cancer Early Detection Program. Under this program, CDC makes grants 

to states to provide mammography services to medically underserved 

women, especially those with low incomes and without health insurance 

coverage.37 From 2001 through 2003, over 50 percent of the women served 

by the program were from minority groups. The second initiative relates to 

coverage for screening mammography under Medicare, the federal 

government’s health insurance program for people age 65 and older and 

certain disabled people. CMS, which administers Medicare, has contracted

with QIOs in each state to assist it in monitoring and improving the quality 

of health care, including improving mammography screening rates among 

Medicare beneficiaries. QIOs seek to improve mammography screening 

rates by working with physician offices and other health care providers to 

establish improved systems for referring patients for mammography and 

collaborating with state and local coalitions and other organizations on 

promotion efforts, such as the distribution of educational materials on 

mammography and outreach to encourage Medicare beneficiaries to 

obtain screening. 

Initiatives to Help Improve 

Access to Mammography 

In addition to these initiatives, the federal Consolidated Health Centers 

program, administered by HHS’s Health Resources and Services 

Administration (HRSA), increases access to health care services, including 

screening mammography, for women in medically underserved areas.38 In 

2004, 71 percent of health center patients had a family income at or below 

the federal poverty level, and 40 percent were uninsured. In addition, 

 36Pub. L. No. 101-354, 104 Stat. 409 (codified at 42 U.S.C. §§ 300k through n). 

37The program operates in every state, the District of Columbia, 4 U.S. territories, and 13 

American Indian and Alaska Native organizations. 

38Criteria for designating a medically underserved area or population include the ratio of

primary medical care physicians per 1,000 population, infant mortality rate, percentage of 

the population with incomes below the federal poverty level, and percentage of the 

population age 65 or older. In 2005, the federal poverty level for a family of four was an 

annual income of $19,350 in the 48 contiguous states and the District of Columbia. 

Page 17 GAO-06-724 Mammography Services
63 percent of patients were members of racial or ethnic minority 

populations, and 29 percent spoke a primary language other than English.39

From October 2001 to October 2004, certified mammography facility 

closures outpaced openings, and financial considerations were most often 

cited as the reason for facility closures. According to FDA data, the 

number of certified mammography facilities nationwide decreased by 

6 percent, from 9,306 to 8,768, from October 1, 2001, to October 1, 2004.40

During this period, 1,290 certified mammography facilities closed, while 

752 facilities received 6-month provisional certificates to begin providing 

services, resulting in a net decrease of 538 facilities, including a net

decrease of 87 mobile mammography facilities, which may serve multiple 

locations.41 Forty states lost facilities during this period, including 10 states 

that each lost more than 20 facilities.42 These 10 states accounted for over 

half of the 538 net decrease. (See app. III for information by state.) 

Facility Closures 

Outpaced Openings, 

with Financial 

Considerations Most 

Often Cited as Reason 

for Closure 

The most commonly cited reasons for facility closures were related to 

financial considerations. We relied on data from ACR for information on 

what facility officials reported as the reasons for closure43 because FDA’s 

Mammography Program Reporting and Information System database does 

not include such data. For certified mammography facilities that had been 

accredited by ACR and that closed from October 1, 2001, to 

October 1, 2004, facility officials most often reported financial

 39Information on health center patients is based on data from HRSA’s Uniform Data 

System. The percentages related to income level and race/ethnicity exclude patients whose 

status HRSA reported as unknown. The income level of 19 percent of patients was reported 

as unknown, and the race/ethnicity of 6 percent was reported as unknown.

40Facilities in U.S. territories, federal facilities operated by the Department of Defense, 

facilities at prisons and correctional institutions, and facilities that had not achieved 

provisional or accreditation status were excluded from the analysis. 

41A mobile mammography facility performs mammography using a vehicle equipped with a

mammography X-ray machine and travels from one location to another. In some cases, one

or more of these mobile facilities are dedicated to a fixed facility, such as a hospital,

outpatient clinic, or radiology practice. 

42The 10 states that lost more than 20 facilities are California, Florida, Georgia, Illinois, New 

Jersey, New York, Ohio, Pennsylvania, Texas, and Virginia. 

43In April 2001, ACR began tracking the number of closures of facilities that it accredited 

and the reasons for closure that were reported by facility officials. 

Page 18 GAO-06-724 Mammography Services
considerations as the reason for closure.44 Specifically, for 35 percent of 

the closures, facility officials told ACR that the primary reason was 

financial. (See table 1.) In addition, even when they did not cite financial 

considerations specifically, their reasons were often related to finances. 

For 25 percent of the closures, facility officials reported that they moved 

their facility to a sister site, and an ACR official said that many of the 

facilities consolidated their mammography activities in an effort to 

conserve financial resources. Facility officials also frequently reported 

equipment and staffing problems as reasons for closure, and an ACR 

official told us that these problems were sometimes financial in nature. In 

addition, officials of state accreditation bodies told us that closures in 

their states from 2001 to 2004 were generally related to financial concerns. 

For example, a Texas accreditation body official said she believed that the 

majority of closures accredited by the state body were due to bankruptcy, 

low business volume, or low reimbursement rates for services. FDA and 

mammography experts also identified financial considerations as having 

contributed to facility closures. 

 44ACR learns of facility closures from a variety of sources, including facility personnel, 

FDA, state certifiers, state inspectors, local cancer societies, and patients. When ACR is 

notified that a facility has closed, ACR contacts the facility by telephone to confirm the 

closure and sends a facility closure memorandum. A facility closure memorandum asks for 

general information about the closure and the reason for closure. ACR officially lists the 

facility as closed in its records after the memorandum has been signed by the facility’s lead 

radiologist, chief executive officer, or president. If the memorandum is not returned to

ACR within 10 business days after it has been sent, ACR closes the facility in its database. 

Page 19 GAO-06-724 Mammography Services
Table 1: Reasons for Closures of ACR-Accredited Mammography Facilities in the 

United States, October 1, 2001, to October 1, 2004 

Reason for closurea

Number of 

closuresb 

Percentage

of total

Financial decision 424 35

Relocation of facility to sister site 305 25

Other/equipment problemsc136 11

Staffing problems 124 10

Bankruptcy 25 2

Other/mobile facility merged with another site 28 2

Other/changes in ownership 23 2

Unknown 80 7

Other/miscellaneous 66 6

Total 1,211 100

Source: GAO analysis of ACR data on the number of ACR-accredited mammography facilities that closed and reasons for closure.

a

ACR asks facility officials to provide a closure memorandum in which they are asked to check a 

reason for closure from among five categories: unit moved to a sister site, bankruptcy, financial, 

staffing problems, and other. Facility officials who checked other were asked to specify the reason, 

and these reasons included equipment problems, mobile facility merged with another site, and 

changes in ownership. According to ACR, officials from 34 facilities reported two reasons for closure. 

In these instances, ACR recorded the predominant response provided during conversations with 

facility personnel prior to closure.

b

According to ACR, 1,211 ACR-accredited facilities closed during this period. This number differs from

the number of closures reported by FDA during this period because although most closed facilities in 

the two databases are the same, there are differences between the databases. For example, FDA’s 

data include facility closures reported by state accreditation bodies, while ACR’s do not. We relied on 

ACR data for reported reasons for facility closures because FDA’s database does not include such

information. 

c

An ACR official told us that equipment problems were most likely either a facility’s inability to meet 

the more stringent FDA quality assurance regulations for equipment that went into effect in 2002 or

equipment failures that facilities decided were too costly to repair. 

Experts also told us that difficulties in recruiting and retaining staff have 

contributed to closures. Officials of the American Society of Radiologic 

Technologists said that some radiologic technologists think the repetitive 

nature of mammography procedures—especially screening 

mammography—makes mammography seem like an unattractive, 

assembly-line operation and that radiologic technologists who perform 

mammography are paid less, in general, than those in other imaging 

specialties. Experts also reported that some radiologists consider the 

mammography field unappealing because it is stressful, “low tech,” and 

lower paying and less respected than other imaging specialties; involves 

Page 20 GAO-06-724 Mammography Services
repetitious work because of the need to read large volumes of screening

mammograms; and has a high rate of malpractice litigation.

Although key elements that make up mammography capacity have 

decreased and the use of mammography services has increased—largely 

because of the increase in the population of women age 40 and older—we 

found that current nationwide capacity is adequate. Key capacity 

elements—the numbers of facilities, machines, radiologic technologists, 

and interpreting physicians—declined from 2001 to 2004. In contrast, from 

2000 to 2003, the estimated number of women age 40 and older who 

received a screening mammogram within the previous year increased. 

Nevertheless, we determined that the estimated number of screening 

mammograms that women age 40 and older received was substantially 

lower than the number that could have been performed in 2003, and there 

was also sufficient capacity for the number of diagnostic mammograms 

women in that age group received. Although experts believe the nation’s 

current overall capacity to provide mammography services is adequate, 

they are concerned that the numbers of radiologic technologists and 

radiologists entering the mammography field might not be sufficient to 

serve the increasing population that will need mammography services. 

Key elements that make up mammography capacity decreased from 

October 1, 2001, to October 1, 2004. In addition to the number of facilities 

decreasing by 6 percent, the number of mammography machines 

decreased by 4 percent, the number of radiologic technologists decreased

by 3 percent, and the number of physicians who interpret mammograms 

decreased by 5 percent.45 (See table 2.) During the period, the average

number of machines per facility remained about the same—1.50 in 2001 

and 1.53 in 2004—and the average number of radiologic technologists per 

machine remained about the same—2.24 and 2.28, respectively. 

Although Key 

Capacity Elements 

Have Decreased and 

Use of Mammography 

Services Has 

Increased, Current 

Nationwide Capacity 

Is Adequate 

Key Elements That Make 

Up Capacity to Provide 

Mammography Services 

Have Decreased 

 45Many of the names in FDA’s database within each year are duplicates because many of

these individuals work at multiple facilities and their names are counted at each facility 

they serve. After correcting errors in the spelling of names and other data entry mistakes,

we calculated the unduplicated numbers of radiologic technologists and interpreting

physicians. We determined that the unduplicated numbers of radiologic technologists in 

FDA’s Mammography Program Reporting and Information System database were 31,402 in

2001 and 30,503 in 2004. We determined that the unduplicated numbers of interpreting

physicians in the database were 19,675 in 2001 and 18,690 in 2004. (See app. II.) 

Page 21 GAO-06-724 Mammography Services
Table 2: Changes in Numbers of Mammography Facilities, Machines, Radiologic 

Technologists, and Interpreting Physicians from October 1, 2001, to October 1, 2004 

2001 2004

Percentage

change

Facilities 9,306 8,768 -6

Machines 13,995 13,400 -4

Radiologic technologists who perform 

mammography 31,402 30,503 -3

Physicians who interpret mammograms 19,675 18,690 -5

Source: GAO analysis of FDA’s Mammography Program Reporting and Information System database on mammography capacity 

elements.

Number of Women Who 

Received Screening 

Mammograms Increased 

as Population of Women 

Age 40 and Older Grew 

Reflecting the steady increase in the population of women age 40 and 

older,46 the estimated number of women in this age group who received a 

screening mammogram within the previous year has increased and is 

likely to continue to grow over the next several years. Based on NHIS 

survey data, the estimated number of women age 40 and older who 

received a screening mammogram within the previous year increased 

nationwide by 14 percent from 2000 to 2003, from about 29 million to 

about 33 million.47 This increase resulted from the population growth in 

this age group coupled with a slight increase—from 50 percent in 2000 to

51 percent in 2003—in the estimated proportion of women in this age 

group who received a screening mammogram within the previous year.48

The number of women age 40 and older who receive a screening 

mammogram is likely to continue to grow over the next several years 

 46The population of women age 40 and older increased by about 6 percent from 2000 to 

2003. 

47Based on NHIS survey data, screening mammograms accounted for 91 percent of the

number of women age 40 and older who received a mammogram in 2000 and 94 percent in

2003. 

48In the 2003 NHIS survey, uninsured women age 40 and older and poor women age 40 and 

older reported lower screening rates than other women in that age group. Twenty-six 

percent of uninsured women age 40 and older reported having a screening mammogram 

within the previous year, in comparison with 57 percent of women in the same age group 

who had private insurance or were enrolled in the U.S. military’s medical health benefits

program. Similarly, 36 percent of poor women age 40 and older reported having a screening 

mammogram within the previous year, in comparison with 52 percent of women with 

middle incomes and 60 percent of women with high incomes. The following are the 2003 

NHIS screening rates for this age group by ethnicity: White—52 percent; African 

American—51 percent; Hispanic—48 percent; Asian—44 percent; and Native American—

35 percent. 

Page 22 GAO-06-724 Mammography Services
because the number of women age 40 and older is projected to increase 

from about 68 million in 2003 to about 74 million in 2010 and about 

78 million in 2015, according to the Census Bureau. 

Data from NHIS indicate that the proportion of women age 40 and older 

who received a diagnostic mammogram within the previous year 

decreased from 5 percent in 2000 to 3 percent in 2003. The estimated 

number of women age 40 and older who received a diagnostic

mammogram within the previous year declined from about 3 million 

women in 2000 to about 2 million in 2003. 

Current Nationwide 

Mammography Capacity Is 

Adequate 

National mammography capacity data we reviewed indicate that the 

nation’s current capacity to provide mammography services is adequate. 

Our estimates of current capacity found that the number of mammograms 

performed by U.S. machines was substantially lower than the number that 

could be performed. Since screening mammograms accounted for 

94 percent of the mammograms provided in 2003, we began our capacity

calculations by focusing on screening mammograms. The majority of 

experts we interviewed estimated that it normally takes 15 to 20 minutes 

of machine and radiologic technologist time to perform a screening 

mammogram.49 Using the upper range of this estimate, we estimated that a 

machine and one radiologic technologist could perform 3 mammograms 

per hour, or 24 mammograms in an 8-hour day. This rate would yield a 

potential capacity of 6,000 mammograms per machine per year.50 Using 

FDA data on the number of machines in 2003 (13,510), we calculated that 

in 2003 about 81 million screening mammograms could have been 

performed by U.S. machines.51 Data from the 2003 NHIS indicate that 

nationwide an estimated 33 million women age 40 and older received a 

screening mammogram and that an estimated 2 million women in that age 

group received a diagnostic mammogram. Most experts we interviewed 

estimated that it takes 30 to 60 minutes of machine and radiologic 

technologist time to perform a diagnostic mammogram. The excess 

 49Of the eight experts we consulted, five experts estimated a time of 15 to 20 minutes. Two 

other experts and an FDA official estimated a time of 10 to 15 minutes. One expert did not

provide an estimate. 

50This yearly total is based on the assumption that a machine was in operation 5 days per 

week and 50 weeks per year. 

51We did not determine whether there were a sufficient number of radiologic technologists 

available to perform mammograms for the estimated level of machine capacity. 

Page 23 GAO-06-724 Mammography Services
capacity that we found for performing screening mammograms in 2003 

would have been more than adequate for performing the estimated 

2 million diagnostic mammograms that were performed that year.52 These 

capacity estimates are rough estimates, but the difference between 

estimated machine capacity and estimated use is sufficiently large to 

indicate that there is unused capacity nationwide. It is difficult to measure 

capacity precisely because several variables can affect capacity at the 

individual facility level, such as the efficiency of facilities’ operations.53

Most of the experts we interviewed told us that current overall capacity is

likely adequate, but all of the experts expressed concern that the numbers 

of radiologic technologists and radiologists entering the mammography 

field might not be adequate to serve the increasing population of women 

age 40 and older. For example, one expert questioned whether the 

mammography workforce would be sufficient to meet the demand for 

services in 10 years, in light of the increasing number of women in this age 

group. Another expert commented that for the past few years, facilities 

have been experiencing problems recruiting mammography personnel. 

Data from the American Registry of Radiologic Technologists show that 

the number of individuals who took the mammography technologist 

examination to become certified for the first time declined slightly from 

1,214 in 2000 to 1,112 in 2005. 

The number of available radiologists might also lead to future access 

problems, according to an official of the American Board of Radiology.

Although the number of first-time candidates who sat for diagnostic 

radiology examinations increased from 816 in 2001 to 1,057 in 2005, the 

official expressed concern about whether the current flow of candidates 

would be sufficient to meet the expected growth in the population who 

will need imaging procedures. In addition, experts told us that there were 

many unfilled job openings for radiologic technologists who perform 

 52The excess capacity also would have been adequate to provide the estimated 3 million 

mammograms received that year by women age 30 to 39. 

53Factors that can affect capacity include a facility’s balance between screening and 

diagnostic mammograms and its approach to scheduling those services. For example, some

facilities achieve greater efficiency by scheduling screening and diagnostic mammograms 

at different times. Facilities also differ in the way they manage their personnel and 

schedules. At some facilities, radiologic technologists who perform mammograms help 

patients complete forms and prepare for the examination, reducing the number of 

mammograms they can perform, while at other facilities assistants perform this work. 

Some facilities have evening and weekend hours, increasing their capacity. 

Page 24 GAO-06-724 Mammography Services
mammography services and for radiologists who interpret mammograms. 

In a 2004 survey of community-based mammography facilities in three 

states, 44 percent reported experiencing a shortage of radiologists and 

46 percent reported having some level of difficulty in maintaining adequate 

numbers of qualified technologists.54

The loss or absence of mammography machines in certain locations may 

have resulted in access problems consisting of lengthy travel distances or 

considerable wait times to obtain mammography services, including 

problems for women who are medically underserved. FDA data show that 

from October 1, 2001, to October 1, 2004, the number of counties with 

machines remained relatively constant, but the number of machines 

decreased in certain counties. During the 3-year period, 117 counties lost 

more than 25 percent of their machines. As of October 1, 2004, there were 

865 counties that had no machines. While the majority of officials we 

interviewed told us that the loss of machines in counties in their states had 

not resulted in access problems, some officials told us that the loss or 

absence of machines in certain counties had resulted in lengthy travel 

distances to obtain services or had resulted in significant wait times for 

services. 

Loss or Absence of 

Mammography 

Machines May Have 

Resulted in Access 

Problems in Certain 

Locations 

 54Carl D’Orsi, et al., “Current Realities of Delivering Mammography Services in the

Community: Do Challenges with Staffing and Scheduling Exist?” Radiology, vol. 235, no. 2 

(2005): 391-395. 

Page 25 GAO-06-724 Mammography Services
While nationwide the proportion of counties that had at least one 

mammography machine remained relatively constant from 2001 to 2004 at 

about 72 percent, in some counties the number of machines decreased 

during that period. FDA data show that the number of counties that had at 

least one machine rose slightly from October 1, 2001, to October 1, 2004—

from 2,259 to 2,276.55 As of October 1, 2004, 865 counties had no

mammography machines; these counties tended to be concentrated in 

certain midwestern, southern, and western states and contained 

3.4 percent of the U.S. population.56 (See fig. 2.) Some of these counties, 

however, may have been served by mobile mammography machines; as of 

October 1, 2004, there were 266 mammography machines in 222 mobile 

facilities nationwide. 

Number of Counties with 

Machines Remained 

Relatively Constant, but 

Number of Machines 

Decreased in Certain 

Counties 

 55There are 3,141 counties, including the District of Columbia. 

56U.S. Census Bureau, Population Estimates Program, County Population Estimates and

Estimated Components of Change: April 1, 2000 to July 1, 2004 (Washington, D.C.: April 

2005) http://www.census.gov/popest/counties (downloaded March 6, 2006). 

Page 26 GAO-06-724 Mammography Services
Figure 2: Number of Mammography Machines by County, October 1, 2004

Number of mammography

machines by county, 2004

 0

 1

 2 or more

Source: GAO analysis of FDA’s Mammography Program Reporting and Information System database on the number and locations of

mammography machines.

Notes: Federal facilities operated by the Department of Defense, facilities at prisons and correctional 

institutions, and facilities that had not achieved provisional or accreditation status were excluded from

our analysis of FDA’s Mammography Program Reporting and Information System database. The 

numbers of mammography machines shown include mobile mammography facilities that were

located in one county but may also have provided services to other counties, including counties that 

had no machines. 

Page 27 GAO-06-724 Mammography Services
Nationwide, 413 counties that had at least one machine at some point 

during the 3-year period had experienced a net loss of mammography 

machines as of October 1, 2004. Of these counties, 117—containing 

2.6 percent of the total 2004 U.S. population—lost more than 25 percent of

their machines.57 Our analysis of the available supply of mammography 

machines in counties that are adjacent to these 117 counties found that 75 

are not adjacent to any county that gained machines during this period, 

and 47 of these 75 counties are adjacent to at least one other county that 

lost machines.58

Loss or Absence of 

Mammography Machines 

in Certain Locations May 

Have Resulted in 

Considerable Travel 

Distances or Wait Times to 

Obtain Services 

Although national mammography capacity appears to be adequate in 

general, in certain locations the loss or absence of machines may have 

resulted in access problems consisting of lengthy travel distances or 

significant wait times. The majority of officials we interviewed about the 

effects of the loss or absence of machines told us that machine losses had 

not resulted in access problems because women were able to obtain 

mammography services at other facilities.59 However, several of the 

officials told us that the loss or absence of machines had affected access 

for some women. 

In certain locations, the loss or absence of mammography machines 

resulted in women—including women who are medically underserved—

needing to travel lengthy distances for mammography services. For 6 of 

the 18 counties we randomly selected for review that lost more than 

 57In 82 (70 percent) of the 117 counties that lost more than 25 percent of their machines,

the population increased from 2001 to 2004, with increases ranging from less than 1 percent 

to 21 percent. 

58In 51 (68 percent) of the 75 counties, the population increased from 2001 to 2004, with 

increases ranging from less than 1 percent to 17 percent. 

59State, local, and QIO officials discussing 11 of the 18 counties in our study that lost more 

than 25 percent of their machines told us that the loss of machines had not affected access 

to mammography services. We do not have information on 1 of the 18 counties because for 

that county only one QIO official responded and she had no knowledge of machine losses

in the county. Officials who work with CDC’s early detection program in four of eight 

states we reviewed said that facility closures had no effect on access to mammography

services for underserved women in their program. In addition, 9 of the 10 community 

health center officials we interviewed reported that facility closures in their counties did 

not create access problems for their patients. 

Page 28 GAO-06-724 Mammography Services
25 percent of their machines,60 one local or QIO official told us that facility 

closures and machine losses in those counties had resulted in women 

traveling longer distances than previously.61 For example, a Mississippi 

QIO official estimated that after one facility closure left Newton County 

with one facility that provided only screening mammography, some 

women had to travel about 30 miles for screening and about 50 miles for 

diagnostic mammography. He said that women depended on working 

family members for transportation, and that according to mammography 

facility staff, fewer women were obtaining mammograms. Similarly, in four 

states,62 officials working with CDC’s early detection program for 

medically underserved women told us that seven facility closures, 

involving the loss of seven machines, had affected program participants’ 

travel distances. For example, a Virginia official estimated that after 

Dickenson County lost its mammography facility and associated machine, 

program participants who previously traveled from 20 to 25 miles for 

services had to travel about 60 miles to obtain services. A West Virginia 

official working with the CDC program noted that program participants in 

Jackson County had to travel a longer distance to obtain mammography 

services because of a facility closure and faced problems of increased 

travel cost and time away from families and jobs.

State and QIO officials also told us about certain locations in their states 

other than the 18 counties we randomly sampled where the absence of 

machines resulted in lengthy travel to obtain mammography services. For 

example, as of October 1, 2004, 12 of Alabama’s 67 counties had no 

mammography machines. An Alabama QIO official identified 10 counties 

that to her knowledge had never had a mammography facility and were 

not being served by mobile mammography facilities; each of the counties 

was designated by HRSA as a medically underserved area. She estimated 

that women living in the 10 counties had to travel distances ranging from 

 60The six counties are Navajo County, Arizona; Warren County, Iowa; Butler County,

Kansas; Newton County, Mississippi; Wayne County, New York; and Dickenson County, 

Virginia. 

61For each of the six counties, one of the three officials we interviewed reported that

women had experienced longer travel distances. The other officials who responded to our

request for information stated either that women’s access to mammography services had 

not been adversely affected or that they did not have knowledge of the effects of facility 

closures and machine losses from 2001 to 2004. 

62The states are Idaho, New York, Virginia, and West Virginia. 

Page 29 GAO-06-724 Mammography Services
30 to 60 miles to obtain mammography services. In Missouri,63 50 of the

state’s 115 counties had no machines as of October 1, 2004. A Missouri 

QIO official told us that two mobile mammography facilities provided 

services once or twice a year to the northeast and southeast corners of the 

state, which have neighboring counties without mammography facilities. 

However, if a mobile facility could not provide for films to be read on site, 

she estimated that women requiring repeat films and additional studies 

because their mammograms indicated a possible breast problem would 

have to travel about 250 miles to the provider’s central location—about a 

5-hour trip in each direction. 

The loss or absence of machines in certain counties may also have caused 

women—including those who are medically underserved—to experience 

significant wait times for mammography services. Although there is no 

specific medical standard for the maximum amount of time a woman 

should have to wait for mammography services, most experts we 

interviewed said that it was best if the wait time for screening 

mammography did not exceed 30 days and if the wait time for diagnostic 

mammography did not exceed 2 days. State officials working with CDC’s 

early detection program and a QIO official told us of situations where the 

loss or absence of machines in certain locations might have resulted in 

wait times that exceeded wait times the experts said were appropriate. For 

example, New York officials working with CDC’s early detection program 

estimated that after the closure of two facilities involving the loss of two 

machines in Brooklyn, the screening wait time for participants who had 

used those facilities was about 2 months; at the busiest time of the year, 

the wait time was 3 to 4 months. The West Virginia program official 

estimated that after the facility closure in Jackson County, participants’ 

wait time for diagnostic mammography averaged 8 weeks, and could be as

much as 3 months.64 A North Dakota QIO official told us that women in 

parts of the state face significant wait times for mammography services. 

Sixty percent of North Dakota’s counties had no machines as of October 1, 

2004, and the official said that a limited number of providers served large 

geographic locations in the largely rural state. For example, she told us 

that one provider’s mobile facility served almost the entire northwest 

 63Missouri counties were not part of our random sample of counties. We spoke with a

Missouri QIO official because of her expertise in access to mammography. 

64The New York and West Virginia officials did not provide estimates of the number of days

women had to wait for mammography services prior to the facility closures. 

Page 30 GAO-06-724 Mammography Services
quarter of the state and was available to some communities once every 

4 months and to others only once a year. 

State accreditation and certification bodies have varying measures to help 

ensure that individuals conducting work for these bodies, including state 

employees and contractual and volunteer image reviewers, avoid conflicts 

of interest. FDA has approved the measures used by the state bodies to 

avoid conflicts of interest and has conducted annual performance 

evaluations of state bodies to assess whether they are complying with 

MQSA regulations. An FDA official told us that agency officials have asked 

questions about conflicts of interest during their evaluations and that they 

have not found any conflicts. FDA’s written protocols for performance 

evaluations have not always included specific questions on the subject of 

conflicts of interest, but FDA recently revised its written protocol for 

evaluating certification bodies to increase attention to this subject. 

State mammography accreditation and certification bodies have varying 

measures to help ensure that state employees avoid conflicts of interest, 

such as those caused by a financial interest, outside employment, or a 

family tie. These measures also apply to physicians who work for 

accreditation bodies on a contract or volunteer basis as clinical image 

reviewers and who also conduct image reviews for their main business 

practice. The measures are a combination of state ethics laws, state 

agency personnel policies, and procedures state bodies use to carry out 

their duties. FDA has approved each state’s combination of measures. (See 

table 3.) 

State Bodies Have 

Varying Measures to 

Avoid Conflicts of 

Interest, and FDA’s 

Evaluations Have Not 

Found Conflict-ofInterest Problems 

State Accreditation and 

Certification Bodies Have 

Varying Measures to Avoid 

Conflicts of Interest 

Page 31 GAO-06-724 Mammography Services
Table 3: State Accreditation and Certification Bodies’ Measures to Avoid Conflicts of Interest 

State accreditation bodies State certification bodies 

Measures Arkansas Iowaa

TexasbIllinois Iowaa

State laws or personnel policies

Code of ethics • • •

c

• •

Financial disclosure statement required of state body employees •

d

•

e

Required ethics training • • 

Procedures 

Use a list of facilities where reviewers have a financial or other 

relationship in determining assignment of clinical images to

reviewers 

• • •

b

N/A N/A

Conduct “blind reviews” of mammography images by concealing 

facility identityf

• • N/A N/A

For each clinical image and phantom image review, use two or 

more individuals working independentlyg

• • •

b

N/A N/A

Source: GAO analysis of state laws and policies and of documents and information provided by FDA, Arkansas, Illinois, Iowa, and

Texas officials. 

Legend: • = a measure is in place; N/A = not applicable. 

Note: South Carolina’s certification body is not included in our review because its certification 

program began operating after our review began. 

a

Iowa is the only state that has authority to accredit and certify mammography facilities.

b

Texas contracts with ACR to review phantom and clinical mammography images. ACR has policies 

to avoid conflicts of interest, including a requirement that its reviewers sign a statement that provides

information about financial or other relationships that may constitute a conflict of interest. 

c

Texas law requires that all state employees file a written statement acknowledging receipt of the 

state’s standard of conduct laws.

d

Arkansas ethics laws require that state agency heads, department directors, and division directors 

file a financial disclosure statement. In addition, all Arkansas state employees are required to file a 

statement disclosing any income source other than their regular salary from which they received over

$500. 

e

Illinois ethics laws require a statement of economic interest from state employees who function as 

the head of a department, supervise 20 or more employees, or have authority to approve

certifications or licenses.

f

Personnel from the accreditation body cover the name of the facility that appears in the 

mammography film to conceal the facility’s identity prior to submitting the image for clinical review. 

g

State accreditation bodies use private-sector physicians working under contract or as volunteers to 

review clinical images. State accreditation bodies use their own qualified staff to review phantom 

images, except the accreditation body in Texas, which uses ACR’s reviewers. 

Page 32 GAO-06-724 Mammography Services
Employees and others, such as contractual reviewers, who provide 

services for the three state accreditation bodies are subject to state ethics 

laws and policies that generally prohibit them from having a conflict of 

interest.65 These laws and policies vary in scope across the three states, 

and each state has penalties associated with violating its laws.66 For 

example, with regard to financial disclosure, Arkansas requires all state 

employees to file a statement disclosing any income source other than 

their regular salary from which they received over $500.67 In contrast, Iowa 

requires only certain individuals, such as elected officials and higher level

agency officials, to file financial disclosure forms68 and in general does not 

require this of employees carrying out accreditation responsibilities. While 

Texas also requires only certain individuals, such as elected officials and 

higher level agency officials, to file financial disclosure forms,69 the Texas 

accreditation body contracts with ACR for its phantom and clinical image 

reviews, and ACR’s reviewers are subject to ACR’s requirement to disclose 

financial and other relationships with businesses or clients involving 

mammography and to report related compensation over $200.70 The Texas 

accreditation body is the only one that requires its employees to attend 

ethics training when they are hired. In addition, Texas law requires its 

employees to acknowledge that they have received copies of the state 

employee standards of conduct.71

Accreditation Bodies 

In addition to state laws and policies, the state accreditation bodies have 

various procedures to help ensure that phantom and clinical image 

reviewers avoid conflicts of interest. For example, all three state 

 65Ark. Code Ann. § 21-8-304 (2005); Iowa Code Ann. § 68B2.A (2005); Tex. Gov’t Code Ann.

§§ 572.001 and 572.051 (2005). 

66Ark. Code Ann. § 21-8-302 (2005); Iowa Code Ann. § 68B.25 (2005); Tex. Gov’t Code Ann. 

§§ 572.007, 572.033, and 572.0034 (2005). 

67Ark. Code Ann. § 21-8-203 (2005). 

68Iowa Code Ann. § 68B.35 (2005). 

69Tex. Gov’t Code Ann. § 572.021 (2005). 

70ACR’s image reviewers are not ACR employees but experts in their fields who volunteer 

their services to ACR and receive modest reimbursement. Texas’s contract includes

reviews associated with new mammography facilities or equipment, accreditation renewal, 

random on-site reviews, and additional mammography reviews. Additional mammography

reviews are performed outside the normal accreditation or reaccreditation process when 

there are concerns about mammography quality at a facility. 

71Tex. Gov’t Code Ann. § 2113.014 (2005). 

Page 33 GAO-06-724 Mammography Services
accreditation bodies assign at least two individuals to independently 

review clinical and phantom images. (See table 3.) In addition, in all three 

states, reviewers are required to submit a list of facilities where they have 

a financial interest, perform services, or have other associations, and 

accreditation officials refer to these lists when assigning clinical images to

reviewers. Arkansas’s clinical image reviewers are not permitted to review

images from facilities located within 50 miles of their primary practice 

locations. Moreover, because clinical image reviewers in Arkansas and 

Iowa may be familiar with mammography facilities in their states, 

accreditation bodies in these states use blind reviews of clinical images. 

That is, state employees mask the names of facilities before presenting 

images to reviewers. In Iowa, furthermore, state employees proctor the 

clinical image reviews to ensure that the facility’s identity is not revealed 

during the process. In ACR’s review of Texas facilities’ phantom and 

clinical images, reviewers from Texas or the surrounding states cannot 

conduct the reviews. ACR procedures do not include blind reviews; 

instead, ACR requires that reviewers sign a form disclosing any financial 

or other relationship that could constitute a conflict of interest.

72 ACR legal 

staff review all potential conflicts of interest annually, according to an 

ACR official, and if an actual conflict of interest exists, the reviewer may 

be removed or allowed to perform only limited types of reviews. In 

addition, reviewers who are familiar with a facility must immediately 

report any conflict of interest to the appropriate ACR official and recuse 

themselves. In assigning images to reviewers, ACR uses computer 

software that automatically blocks reviewers from reviewing images from 

facilities in states where they live or practice or in other states they have 

identified where they may have a conflict of interest. 

The two state certification bodies apply state ethics laws and personnel 

policies that prohibit state employees from having a financial interest or 

other interest, including one based on family ties or outside employment, 

that conflicts with their duties. The same state ethics laws that govern 

Iowa’s accreditation body activities apply to its certification body 

activities. Illinois ethics law requires that state employees who function as 

the head of a department, supervise 20 or more employees, or have 

authority to approve certifications or licenses file a financial disclosure 

Certification Bodies 

 72An ACR official told us that ACR does not use blind reviews because of the regulatory 

requirement to verify that each clinical image contains the name and location of the facility 

that produced it. In Arkansas and Iowa, accreditation body employees first verify that an

image contains the appropriate identifying information and then conceal this information 

before giving the image to the reviewer. 

Page 34 GAO-06-724 Mammography Services
statement annually.73 Illinois officials told us that employees of the Illinois 

certification body with decision-making responsibilities—including the 

coordinator of MQSA certification functions—submit a financial 

disclosure statement. However, in general, Illinois employees who inspect 

mammography facilities are not required to file such statements.74 Illinois 

ethics law also requires that all state employees annually complete ethics 

training,75 which in the past has covered topics such as acceptance of gifts 

and conflicts of interest. 

FDA Approved State 

Bodies’ Measures to Avoid 

Conflicts of Interest, and 

Its Evaluations of State 

Bodies Have Not Found 

Problems 

As part of the state accreditation and certification body application 

processes, FDA approved the measures each state body submitted as its 

approach for avoiding conflicts of interest. These measures consisted of 

the state ethics laws, state agency personnel policies, and procedures the 

state body would use to carry out its duties. (See table 3.) FDA officials 

told us that in determining whether these measures were adequate to 

ensure independence, they based their decisions on the conflict-of-interest 

standards in MQSA regulations. MQSA regulatory standards on conflicts of

interest are broadly written; they do not provide specific guidance to 

states on what measures they should take to avoid conflicts. 

Using written protocols, FDA has conducted annual performance 

evaluations of state accreditation and certification bodies to assess 

whether these bodies are complying with MQSA regulations. Evaluations 

of state accreditation bodies have covered, among other things, state 

bodies’ procedures for reviewing phantom and clinical images and for 

resolving consumer complaints about mammography facilities. These 

procedures are a part of the accreditation bodies’ efforts to avoid conflicts 

of interest. In addition, FDA staff have independently reviewed samples of 

phantom and clinical images previously reviewed by the accreditation 

body to monitor the quality of the accreditation body’s work.76 FDA 

officials told us that their staff have also reviewed several randomly 

 735 Ill. Comp. Stat. Ann. § 420/4A-101(f)(1-8) (2005). 

74FDA officials told us that MQSA compliance inspectors employed by FDA are required to 

file financial disclosure statements, but state inspectors working under contract with FDA 

are not required to do so. 

755 Ill. Comp. Stat. Ann. § 430/5-10 (2005). 

76Two FDA interpreting physicians independently review samples of clinical images, and 

two FDA expert staff independently review samples of phantom images. 

Page 35 GAO-06-724 Mammography Services
selected facility files, including files on any complaints received by the 

accreditation bodies since the previous FDA evaluation, and accreditation 

body staffing qualifications. FDA has submitted to the Congress its 

required annual written evaluation reports on the performance of 

accreditation bodies. FDA’s annual evaluations of state certification 

bodies have included reviews of each body’s policies and procedures for 

certification, inspection, appeals, consumer complaints, and certification 

revocation and suspension. In addition, FDA officials told us that FDA 

auditors have annually evaluated the performance of FDA inspectors and 

state inspectors by accompanying them on facility compliance inspections. 

Prior to going on these inspections, the auditors review inspection records 

completed by the inspectors they will be accompanying. FDA prepares an 

annual written evaluation report on the performance of state certification

bodies; it is not required to submit these reports to the Congress. An FDA 

official told us that these annual evaluations allow FDA to oversee state 

accreditation and certification bodies’ performance regarding avoiding 

conflicts of interest. 

An FDA official told us that during the on-site visits that have been part of 

FDA annual evaluations and during FDA’s quarterly meetings with state 

body officials, FDA officials have asked whether any conflict-of-interest 

problems have arisen.77 According to this official, state body officials have 

never reported to FDA during a quarterly meeting that they had 

experienced a conflict-of-interest problem. During on-site visits, FDA 

officials have inquired about state bodies’ overall policies and procedures. 

State bodies’ staff have generally described their policies and procedures 

for avoiding conflicts of interest and orally assured FDA that they are 

following these measures. FDA relies on the states to oversee the 

implementation of state ethics laws and policies. However, FDA requires 

state bodies to immediately report any situation that might adversely 

affect the public’s health, including complaints about conflicts of interest 

involving state bodies’ personnel. The FDA official also said that no state 

body has ever reported a problem or concern related to a conflict of 

interest involving a reviewer or inspector and that FDA has never found a 

conflict-of-interest problem in its evaluations of state bodies’ performance. 

 77Until recently, the annual evaluations included on-site visits to state bodies, but in 2005

FDA decided to visit state bodies every other year, alternating visits to accreditation and 

certification bodies. For example, FDA planned to visit accreditation bodies in 2005 and 

certification bodies in 2006. The biennial schedule is due to budget constraints and state 

bodies’ consistent performance in implementing policies and procedures, according to FDA

officials. 

Page 36 GAO-06-724 Mammography Services
Officials of HHS’s Office of the Inspector General, similar state agencies 

responsible for overseeing state bodies that we reviewed, and the 

Department of Justice told us that they have not undertaken any 

investigations related to conflicts of interest or complaints of fraud or 

abuse involving state agencies that accredit or certify mammography 

facilities. 

While FDA officials told us that they have asked questions related to 

conflicts of interest during on-site visits, until recently the agency’s written 

protocols for conducting annual evaluations of state bodies’ performance 

have not explicitly addressed state bodies’ implementation of conflict-ofinterest policies and procedures or the application of state ethics laws. In 

addition, FDA’s annual reports to the Congress on the performance of the 

accreditation bodies have not discussed the subject of conflicts of interest, 

and its annual evaluation reports on certification bodies have not 

consistently included this topic. 

In June 2005, FDA revised its written protocol for evaluating certification 

bodies to include a review of certain aspects of state bodies’ performance 

related to conflicts of interest. The revised protocol requires FDA to 

(1) review any changes that the certification bodies made to their conflictof-interest policies and procedures since FDA’s last annual evaluation, 

(2) review any complaints related to conflicts of interest involving state 

personnel or MQSA inspectors and the resolution of the complaints, and 

(3) cover the topic of conflict of interest in the annual reports it prepares 

on the performance of certification bodies. FDA has not revised its 

protocol for conducting annual evaluations of accreditation bodies to 

include specific questions about conflicts of interest, and FDA officials 

told us they currently have no plans to revise it. 

Current nationwide capacity for mammography services is adequate,

despite recent decreases in the facility and human resources that affect

capacity and an increase in the number of women eligible for screening 

mammography. However, women may have difficulty gaining access to 

mammography services in certain locations, particularly where the loss or 

absence of machines has resulted in lengthy travel distances or significant 

wait times. Lengthy travel distances may especially pose a barrier to 

access for underserved women who lack means of transportation, must 

incur increased travel costs, or must take extra time away from work or 

family responsibilities. Access problems for these women are of particular

concern because they have lower-than-average mammography screening 

rates. Furthermore, while current overall capacity is adequate, if the 

Concluding 

Observations 

Page 37 GAO-06-724 Mammography Services
numbers of radiologic technologists and radiologists entering the 

mammography field are insufficient to serve the growing population of 

women eligible for regular screening, access problems could occur in the 

future. 

We provided a draft of this report to FDA for comment. FDA’s comments 

are reprinted in Appendix IV. In its comments, FDA provided additional 

details and clarification regarding its activities in certifying mammography 

facilities and overseeing state accreditation and certification bodies; FDA 

also provided technical comments. We incorporated FDA’s comments as 

appropriate.

As arranged with your offices, unless you publicly announce the contents 

of this report earlier, we plan no further distribution of it until 30 days 

after its date. At that time, we will send copies of this report to the 

Secretary of Health and Human Services, the Commissioner of FDA, and 

other interested parties. We will also make copies available to others upon 

request. In addition, the report will be available at no charge on the GAO 

Web site at http://www.gao.gov. 

Agency Comments 

If you or your staff members have any questions, please contact me at 

(202) 512-7119 or crossem@gao.gov. Contact points for our Offices of 

Congressional Relations and Public Affairs may be found on the last page 

of this report. GAO staff members who made contributions to this report 

are listed in appendix V.

Marcia Crosse 

Director, Health Care 

Page 38 GAO-06-724 Mammography Services
Appendix I: Th

Adm

Inspec

e Food and Drug 

inistration’s Mammography Facility 

tion Demonstration Program 

Page 39 GAO-06-724

Appendix I: The Food and Drug 

Administration’s Mammography Facility 

Inspection Demonstration Program 

As authorized under the Mammography Quality Standards Reauthorization 

Act of 1998 (MQSRA), the Food and Drug Administration (FDA) 

conducted an inspection demonstration program (IDP) to evaluate the 

feasibility and impact of conducting mammography facility compliance 

inspections less frequently than annually.1

 FDA’s goal for the IDP was to 

determine whether the inspection frequency of mammography facilities 

that had been found to be in compliance with the Mammography Quality 

Standards Act of 1992 (MQSA) standards could be reduced from yearly to 

once every 2 years without a decrease in compliance rates. FDA carried 

out the IDP from November 2001 through August 2004.2

 This appendix 

summarizes the methodology and results of the IDP. 

Methodology MQSRA required that facilities selected for the IDP be “substantially free 

of incidents of noncompliance” and that the number of facilities selected 

be sufficient to provide a statistically significant sample of facilities.3

 FDA 

selected facilities for the IDP from states that indicated a willingness to 

participate in the program and met certain criteria.

4

 For example, FDA 

excluded states that had laws, regulations, or policies requiring annual

inspections, and considered states that could accept changes to their 

existing inspection contract with FDA to reflect the reduction in the 

number of facilities that they would inspect during the IDP.5

 To minimize

the financial impact that a reduced inspection schedule would have on

 1

The Mammography Quality Standards Act of 1992 (MQSA) requires the annual inspection 

of mammography facilities to ensure compliance with the act’s requirements. See 42 U.S.C. 

§ 263b(g). Members of the mammography industry had questioned the need to annually 

inspect facilities that had been found to be in compliance with the FDA MQSA regulations. 

MQSRA retained the annual inspection requirement, but included a provision that allowed 

FDA to carry out the inspection demonstration program. See Pub. L. No. 105-248, § 8, 112

Stat. 1864, 1865-66 (codified at 42 U.S.C. § 263b(g)(6)). 

2

FDA issued a report describing the results of the IDP in January 2005. 

3

MQSRA did not stipulate an implementation deadline, program duration, or inspection 

interval, but stated that the program could not be implemented before April 1, 2001. 

4

To develop criteria for selecting states and facilities to participate in the program, FDA 

officials from the Division of Mammography Quality and Radiation Programs worked with 

various groups, including the Conference of Radiation Control Program Directors, a 

professional organization whose members include directors of state radiation control 

programs; the National Mammography Quality Assurance Advisory Committee; and

officials from other FDA units. 

5

FDA contracts with most states to conduct the annual compliance inspections for which 

FDA is responsible in its role as a certifying body. Its contracts specify, among other things,

the number and cost of inspections to be conducted. 

Mammography Services
Appendix I: The Food and Drug 

Administration’s Mammography Facility 

Inspection Demonstration Program 

states that depend on income from their FDA inspection contracts to fund 

inspectors’ salaries, FDA officials placed a 10 percent limit on the number 

of facilities from each state that could participate in the IDP. On the basis 

of these criteria, FDA selected 11 states, the District of Columbia, Puerto 

Rico, and New York City to participate in the IDP. The states were 

Arkansas, Florida, Mississippi, New York, Ohio, Oklahoma, Pennsylvania,

South Dakota, Washington, Wisconsin, and Wyoming. 

FDA established that to be eligible to participate in the IDP, a facility had 

to be free of MQSA violations during the two most recent annual 

inspections and have undergone at least two annual inspections under the 

final MQSA regulations that took effect in April 28, 1999. Among other 

things, a facility also had to maintain full accreditation and certification 

throughout the program and expect to provide services through the 

duration of the IDP. Using random selection, FDA divided the eligible 

facilities in the 14 jurisdictions into a study group and a control group. The 

study group consisted of 146 facilities. The control group had 132 facilities

in the first year of the program and 126 of those facilities in the second 

year.6

FDA officials told us that they were not able to achieve a statistically valid 

sample that would allow the results to be projected nationwide, primarily 

because a number of states were not willing to participate in the 

demonstration program or had state laws that required annual inspections. 

An FDA official said that FDA implemented the demonstration program 

even though the results could not be projected nationwide because agency

officials believed that the results of the program would be useful to the 

Congress. 

Results Overall, the inspections of the study group facilities, which occurred after 

a 2-year interval, found that facilities did not maintain the violation-free 

compliance level that they had previously. Of the 146 study group 

facilities, 58 percent were in full compliance with MQSA, while 42 percent

 6

The lower number of control group facilities available for inspection in the second year of 

the IDP was due primarily to facility closures. 

Page 40 GAO-06-724 Mammography Services
Appendix I: The Food and Drug 

Administration’s Mammography Facility 

Inspection Demonstration Program 

were cited for violations.7 (See fig. 3.) Moreover, the study group facilities 

had a lower compliance rate than facilities inspected annually, either as 

part of the IDP’s control group or outside of the demonstration program. 

The facilities in the study group had a higher percentage of violations 

across all three violation levels than facilities that had annual inspections. 

Most of the study group’s level 1, or most serious, violations were related

to missing records of the quality control tests, such as those required for 

the mammography film processor.8

 Level 2 violations—the most prevalent 

category of violation for all groups—were almost twice as high in the 

study group (27 percent) as in the control group (14 percent). 

 7

FDA classifies facility noncompliance with MQSA standards into three violation levels, 

ranging from level 1, the most severe with the most detrimental effect on quality, to level 3,

the least severe, where the violations are generally minor deviations from standards. Some 

facilities had multiple violations within each level or across two or more levels. In 

determining the percentage of facilities cited at each violation level, FDA placed each 

facility in the violation level representing its most serious violation. 

8

The processor is the device that develops the film to produce a mammographic image. 

MQSA regulations require that film processors used to develop mammograms be adjusted

and maintained to meet certain technical development specifications. A processor 

performance test must be performed each day before any clinical films are processed. See

21 C.F.R. § 900.12(e). 

Page 41 GAO-06-724 Mammography Services
Appendix I: The Food and Drug 

Administration’s Mammography Facility 

Inspection Demonstration Program 

Figure 3: Percentages of Mammography Facilities with MQSA Violations, by Level 

of Violation, during FDA’s IDP 

Percentage

 Study group Control group All other facilities

Level 1 violations 3% 1% 1% 2% 2%

Level 2 violations 27% 17% 14% 25% 21%

Level 3 violations 12% 6% 10% 9% 9%

Compliance/no violations 58% 76% 75% 63% 68%

Source: FDA. 

 5/1/03- 5/1/02- 5/1/03- 5/1/02- 5/1/03- 

 4/30/04a 4/30/03 4/30/04 4/30/03 4/30/04 

Dates are the periods during which inspections occurred. 

0

20

40

60

80

100

Notes: Level 1 violations are the most serious, and level 3 the least serious. Some facilities had 

multiple violations within each level or across two or more levels, but for this analysis FDA placed the

facility in the level representing its most serious violation. Percentages for a given period may not 

sum to 100 because of rounding.

a

Facilities in the study group did not receive inspections during the period of May 1, 2002, through 

April 30, 2003. 

Because the study group had a decrease in compliance, FDA officials 

decided not to expand the demonstration program and returned all 

mammography facilities to the annual inspection schedule. In commenting 

on the IDP results, an FDA official responsible for the program noted that 

the IDP did not provide evidence that facilities could maintain their 

violation-free status without annual compliance inspections. 

Page 42 GAO-06-724 Mammography Services
Appendix II: Scope and Methodology Appendix II: Scope and Methodology 

To identify the number of certified mammography facilities that closed 

nationwide in recent years, we obtained and analyzed data from FDA’s 

Center for Devices and Radiological Health Mammography Program 

Reporting and Information System database on the number of certified 

mammography facilities that closed and those that received 6-month 

provisional certificates to begin providing services from October 1, 2001,

to October 1, 2004. To examine information on the factors that contributed

to mammography facility closures in recent years, we used three sources. 

We obtained data from the American College of Radiology (ACR) on 

mammography facilities accredited by ACR that closed from October 1, 

2001, to October 1, 2004, and the reasons for closures reported by officials 

of facilities accredited by ACR. We reviewed data and interviewed officials 

of state accreditation bodies in Arkansas, Iowa, and Texas about closures 

of facilities accredited by these states from 2001 through 2004. We also 

interviewed eight radiologists who are experts in mammography about 

factors that contribute to mammography facility closures. 

To examine changes in the nation’s capacity for and use of mammography 

services in recent years and the adequacy of current capacity, we analyzed

data from FDA’s Mammography Program Reporting and Information 

System database on the total numbers of certified facilities, machines, 

radiologic technologists who perform mammography, and physicians who 

interpret mammograms as of October 1, 2001, and October 1, 2004. We 

excluded facilities in U.S. territories. We also excluded federal facilities 

operated by the Department of Defense, and facilities at prisons and 

correctional institutions because they are not generally accessible to the 

public. We also excluded facilities that had not achieved provisional or 

accreditation status that were in FDA’s Mammography Program Reporting 

and Information System database because they had not been certified by 

FDA or a state certification body as of October 1, 2001, and October 1, 

2004. FDA’s database contains many duplicate names of radiologic 

technologists and interpreting physicians because many of these 

individuals work at multiple facilities and their names are counted at each 

facility they serve. To remove the duplicates, we analyzed data files from 

FDA that contained the names and addresses of radiologic technologists 

and interpreting physicians who worked at mammography facilities as of 

October 1, 2001, and October 1, 2004,

1

 and used an iterative process to edit

 1

FDA’s Mammography Program Reporting and Information database reported for 

October 1, 2001, and October 1, 2004, respectively, 43,596 and 42,602 radiologic 

technologists and 62,559 and 59,718 interpreting physicians. 

Page 43 GAO-06-724 Mammography Services
Appendix II: Scope and Methodology 

the data fields containing the technologists’ and physicians’ first and last 

names. The first step was to “clean” the fields of extraneous commas, 

spaces, punctuation, and other values. The next step was to correct 

obvious and common spelling errors, such as Michael spelled Micheal. The 

last step was to visually check for additional misspellings, using the 

address information on the FDA file to confirm that an entry was indeed a 

duplicate with a misspelled first or last technologist or physician name. 

The duplicates were removed from the edited file, and the analysis 

continued using the edited file of unduplicated names of radiologic 

technologists and interpreting physicians. To examine changes in the 

nationwide use of mammography services, we analyzed data from the 2000 

and 2003 National Health Interview Survey (NHIS),2

 administered by the 

Centers for Disease Control and Prevention’s (CDC) National Center for 

Health Statistics, to estimate the number of women age 40 and older who 

received a screening or diagnostic mammogram within the previous year. 

NHIS data on the use of mammography services are based on data that are 

self-reported by respondents. NHIS asked women age 30 and older about 

the length of time since their last mammogram and about the reason for 

the mammogram. NHIS surveys conducted in 2000 and 2003 provided the

most recent trend data available at the time we conducted our analysis. 

Using the 2000 and 2003 NHIS data, we compared screening rates and 

diagnostic rates for women age 40 and older and estimates of the number 

of women receiving screening and diagnostic mammograms nationwide 

within the previous year. To determine the adequacy of current capacity, 

we obtained estimates from mammography experts of the amount of time 

it takes to perform a screening mammogram, and we used those estimates 

and FDA data on the number of machines available in 2003 to calculate the 

number of screening mammograms that potentially could have been 

performed in 2003. We compared our estimate of 81 million screening 

mammograms that could have been performed by U.S. machines to the 

estimated number of women age 40 and older who received a screening 

mammogram within the previous year, based on data from the 2003 NHIS. 

We also obtained estimates from mammography experts of the amount of 

time it takes to perform a diagnostic mammogram and data on the 

estimated number of women age 40 and older who received a diagnostic

mammogram in 2003.3

 To examine changes in the population of women 

 2

In 2000 and 2003, NHIS asked women age 30 and older about the length of time since their 

last mammogram and the reason for the last mammogram. 

3

According to NHIS data, about 92 percent of the women who received a mammogram in

2003 were 40 and older. 

Page 44 GAO-06-724 Mammography Services
Appendix II: Scope and Methodology 

age 40 and over, we used Census Bureau population data for 2003 and 

projections for 2010 and 2015. In addition, we interviewed a number of 

individuals about issues related to mammography facility closures, 

mammography capacity, and access to mammography services. These 

individuals included officials from FDA, CDC, the National Cancer 

Institute, and the Centers for Medicare & Medicaid Services; 

representatives from several professional organizations, such as the 

American Board of Radiology, the American Cancer Society, ACR, and the 

American Society of Radiologic Technologists; and eight radiologists who

are experts in mammography. 

We took three steps to assess the effects of the loss or absence of 

mammography machines on access to services, including access for 

medically underserved women. First, we used data from FDA’s 

Mammography Program Reporting and Information System database to 

randomly select 18 counties in 16 states that lost more than 25 percent of 

their machines and interviewed officials about the effects of the loss of 

machines in these counties. Second, using data from FDA’s database, we 

identified counties with no machines and interviewed officials 

knowledgeable about access, including access for medically underserved

women, in locations beyond the 18 counties we reviewed. Third, we 

interviewed officials working with CDC’s National Breast and Cervical 

Cancer Early Detection Program and officials from community health 

centers that are funded through the Health Resources and Services 

Administration’s (HRSA) Consolidated Health Centers program regarding 

the effect of facility closures on access for medically underserved women. 

Specifically, for our first step of assessing the effects of machine loss on 

access to services, we used data from FDA’s database to identify counties 

that lost mammography machines and focused on those that lost more 

than 25 percent of their machines from October 1, 2001, to October 1, 

2004. We selected for our review a stratified random sample of 9 urban 

counties and 9 rural counties, within 16 states, of the 117 counties 

nationwide that lost more than 25 percent of their mammography 

machines. (See table 4.) We randomly selected the counties to avoid bias 

in their selection. However, the sample of 18 counties is too small to 

project the results of our work to the entire group of counties that lost 

more than 25 percent of their mammography machines during this period. 

Page 45 GAO-06-724 Mammography Services
Appendix II: Scope and Methodology 

Table 4: Counties Randomly Selected for Review from Those That Lost over 

25 Percent of Their Mammography Machines from October 1, 2001, to 

October 1, 2004 

Rural counties Urban counties

County State County State

Navajo Arizona Houston Alabama 

Drew Arkansas Saint Johns Florida

Putnam Florida Coweta Georgia 

Shiawassee Michigan Warren Iowa

Newton Mississippi Butler Kansas 

Lewis and Clarke Montana Wayne New York 

Fulton New York Morton North Dakota 

Duplin North Carolina Pottawatomie Oklahoma 

Dickenson Virginia Lubbock Texas 

Source: GAO analysis, based on FDA’s Mammography Program Reporting and Information System database. 

The determination of the 18 counties as urban or rural is based on the 2003 

Rural-Urban Continuum Codes published by the Department of 

Agriculture, which classifies all U.S. counties into nine categories. The 

Department of Agriculture groups nonmetropolitan counties into six rural 

categories by size of the urban population and nearness to a metropolitan 

area; it groups metropolitan counties into three urban categories based on

the size of the metropolitan area in which the county is located. 

For the 18 counties selected, we interviewed officials familiar with access 

to mammography services in these counties and asked them about their 

views on the effects of the loss of machines and facilities on access in 

these counties. These officials generally included county health

department officials who coordinate health programs; state radiation 

control personnel under contract to FDA to conduct annual on-site 

inspections of mammography facilities; and quality improvement 

organization (QIO) officials under contract to CMS to monitor and 

improve the quality of care, including increasing statewide mammography 

screening rates for Medicare beneficiaries. We also interviewed two QIO 

officials—one from Missouri and one from Washington—about access in 

areas of their states. The 18 counties we selected did not include any in 

Missouri or Washington, but these two officials were among three QIO 

officials we attempted to contact who were recommended by a CMS 

official as being knowledgeable about mammography access issues in 

their states. 

Page 46 GAO-06-724 Mammography Services
Appendix II: Scope and Methodology 

For our second step of assessing the effects of the absence of machines on 

access to services, we used FDA data on the number and locations of 

mammography machines nationwide as of October 1, 2004, to identify 

counties that had no machines. In interviews with state radiation control 

program personnel and QIO officials in 11 states that had counties with no 

machines, we obtained their views on the effects of the absence of 

mammography machines on access in their state, including access for 

medically underserved women. We also discussed Missouri counties that 

had no mammography machines with the Missouri QIO official. 

For our third step, to provide additional information on the effects of 

facility closures on access for medically underserved women, we 

interviewed state officials who direct CDC’s National Breast and Cervical

Cancer Early Detection Program and officials of community health 

centers. To identify facilities that closed and where program participants 

had been receiving services, we worked with CDC officials to request from 

state directors of CDC’s early detection program the names and addresses 

of mammography facilities that provided mammography services to 

program participants from 2001 through 2004. In all, officials of 37 states 

and the District of Columbia provided complete or partial lists of facilities. 

We matched the facility lists provided by the state directors with facility 

closures from October 1, 2001, to October 1, 2004, in FDA’s database. This

analysis resulted in a total of 164 closed facilities. We identified the 

counties and states where these facilities were located and selected for 

review 9 rural and 9 urban counties where a total of 24 closed facilities 

were located. (See table 5.) We selected 4 of the 9 urban counties because

they are central counties of metropolitan areas with populations of 250,000 

to 1 million or more—Fulton County, Georgia; Cook County, Illinois; 

Wayne County, Michigan; and Kings County, New York—and we selected 

3 counties because they were located in American Indian Health Service 

areas. In total, we interviewed officials in 8 states that work with CDC’s 

early detection program about the effect of the facility closures in the 

18 counties. 

Page 47 GAO-06-724 Mammography Services
Appendix II: Scope and Methodology 

Table 5: Selected Counties with Closures of Facilities That Had Provided 

Mammography Services to Participants in CDC’s National Breast and Cervical 

Cancer Early Detection Program, 2001 through 2004 

County State

Rural/urban county

designation 

Logan 

Sharp 

Arkansas Rural

Rural 

Fulton 

Wilkes 

Georgia Urban

Rural 

Gem 

Shoshone 

Idaho Rural

Rural 

Cook 

Peoria 

Illinois Urban

Urban 

Berrien 

Wayne 

Michigan Urban

Urban 

Kings 

Oneida 

Saint Lawrence 

Tioga 

New York Urban 

Urban 

Rural 

Urban 

Dickenson 

Washington 

Virginia Rural

Urban 

Hardy 

Jackson 

West Virginia Rural 

Rural 

Source: GAO analysis, based on state National Breast and Cervical Cancer Early Detection Program lists of facilities that provided 

mammography services to National Breast and Cervical Cancer Early Detection Program clients and information on facility closures 

from FDA’s Mammography Program Reporting and Information System database. 

With the assistance of HRSA, we obtained a list of facility closures that 

were located in the same counties as community health centers. HRSA 

identified the closures from data it requested from FDA on our behalf on 

mammography facilities that were certified as of October 2003 but were 

closed as of October 2004. HRSA then matched the addresses of the 

closures with its list of community health centers funded in 2004. This 

yielded a list of 34 closed mammography facilities that were in the same 

counties as community health centers. We selected 10 counties and 

interviewed a community health center official in each county (six 

officials from urban centers and four from rural centers)4

 regarding the 

 4

The urban/rural designation is self-reported by health centers in their grant application to

HRSA. HRSA instructs health centers to classify themselves as urban or rural based on

where the majority of their patients reside. For example, if a health center is located in an 

urban area, but more than 50 percent of its patients reside in rural areas, the center should 

classify itself as rural. 

Page 48 GAO-06-724 Mammography Services
Appendix II: Scope and Methodology 

effect of closures on their patients’ access to mammography services. (See

table 6.) 

Table 6: Selected Counties with Mammography Facility Closures and Community 

Health Centers, October 2003 to October 2004 

County State

Community health center 

rural/urban designation

Anchorage Alaska Rural

Tulare California Rural 

Leon Florida Rural 

Delaware Indiana Urban

Orleans Louisiana Urban 

Baltimore Maryland Urban 

Onondaga New York Urban 

Harris Texas Urban 

King Washington Urban 

Washburn Wisconsin Rural 

Source: GAO analysis of FDA data on mammography facilities that closed from October 2003 to October 2004 and HRSA data on

community health centers that were funded during fiscal year 2004.

In each of our interviews with officials on access to mammography 

services, we asked the official to provide estimates of the numbers of days 

women had to wait to obtain screening mammography and diagnostic 

mammography in counties that had a loss or absence of machines. In 

counties where officials reported access problems, we asked them to 

provide estimates of the distances women had to travel to mammography 

facilities both before and after the loss of machines, and when state and 

QIO officials identified counties with an absence of machines, we asked 

them to provide estimates of the travel distance to mammography 

services. While most officials had not conducted formal studies to gather 

information on wait times and travel distances, they generally provided 

information based on informal surveys they had conducted of facilities in

their counties or nearby counties or on their involvement and frequent 

contacts with mammography facilities. 

To examine the measures state bodies have taken to avoid conflicts of 

interest and FDA’s oversight of state bodies’ performance in this area, we 

reviewed MQSA and MQSA regulations that govern state bodies’ functions, 

FDA documents, state ethics laws, and state bodies’ policies and 

procedures. In addition, we interviewed officials from FDA’s Center for 

Devices and Radiological Health; accreditation bodies in Arkansas, Iowa, 

Page 49 GAO-06-724 Mammography Services
Appendix II: Scope and Methodology 

and Texas; certification bodies in Illinois and Iowa; and ACR.5 We 

reviewed state and FDA documents containing ethics laws and policies 

and procedures, including information on conflict-of-interest policies that

state bodies are required to submit to FDA as part of the initial application

process. We also reviewed FDA’s inspection procedures, which states are 

required to use to conduct inspections. The California and South Carolina 

state agencies are not included in our review because the California state 

agency withdrew its application to continue to operate as an FDAapproved accreditation body before our review began, and South 

Carolina’s certification program began operating after our review began.

In examining FDA’s oversight of state bodies, we reviewed FDA’s annual 

evaluation reports on the performance of each state accreditation and 

certification body for calendar years 2003 and 2004 and FDA’s annual 

reports to the Congress covering the performance of all accreditation 

bodies for calendar years 2000 through 2004—the most recent available at 

the time of our review. In addition, we reviewed the protocols that FDA 

officials use to conduct their evaluations of state bodies’ performance and 

the timetables for FDA evaluations. 

During our interviews with FDA officials, we discussed the criteria they 

use to determine whether states have any conflict-of-interest problems 

that could affect their impartiality in carrying out accreditation, 

certification, and inspection functions and actions FDA takes to oversee 

state bodies. We did not review state and federal documents, such as 

financial disclosure statements, employment records, or any other 

documents typically used in making assessments about potential or actual

conflicts of interest. In addition, we did not make on-site visits to state 

accreditation and certification bodies or observe MQSA inspections. 

To describe the methodology and results of FDA’s IDP, we reviewed FDA 

documents and interviewed officials from FDA’s Center for Devices and 

Radiological Health. We also examined whether the sample of facilities 

that FDA included in the IDP met the criterion of being free of violations 

for 2 consecutive years prior to IDP implementation by reviewing reports 

 5

The state accreditation bodies are the Arkansas Department of Health and Human 

Services’s Division of Health Radiation Section; Iowa Department of Public Health’s

Bureau of Radiological Health; and Texas Department of State Health Services’ Radiation 

Control Program. The state certification bodies are the Illinois Emergency Management 

Agency’s Bureau of Radiation Safety and Iowa Department of Public Health’s Bureau of

Radiological Health. 

Page 50 GAO-06-724 Mammography Services
Appendix II: Scope and Methodology 

of MQSA inspections conducted during 2000, 2001, and January through 

April 2002. We reviewed reports on a sample of 49 mammography 

facilities, with 25 randomly selected from the universe of study control 

group facilities and 24 from the control group.6

To assess the reliability of the FDA, ACR, and state body data on 

mammography facility closures and mammography capacity, we talked 

with knowledgeable officials of these organizations about data quality 

control procedures and reviewed relevant documentation. We also 

electronically tested the FDA data to identify problems with accuracy and 

completeness. To assess the reliability of the NHIS data on the numbers of 

women age 40 and older who received a screening or diagnostic 

mammogram in 2000 and 2003 and the population estimate data from the 

Census Bureau, we reviewed the existing documentation on methodology 

and data collection procedures. We determined that the data were 

sufficiently reliable for the purposes of this report. 

We conducted our work from November 2004 through July 2006 in 

accordance with generally accepted government auditing standards. 

 6

Our sample included 25 facilities randomly selected from the study group total of 146 

facilities and 24 facilities randomly selected from the control group total of 258 facilities. 

FDA selected facilities for the IDP in November 2001 and May 2002. 

Page 51 GAO-06-724 Mammography Services
Appendix III: Changes in the Number of 

Certified Mammography Facilities by State, 

October 1, 2001, to October 1, 2004 

State 

Number of 

facilities in 2001

Number of 

facilities in 2004 

Net change in 

number of facilities

Alabama 157 140 -17

Alaska 32 30 -2

Arizona 148 151 +3

Arkansas 111 102 -9

California 768 736 -32

Colorado 111 106 -5

Connecticut 154 143 -11

Delaware 24 30 +6

District of Columbia 21 19 -2

Florida 487 460 -27

Georgia 261 240 -21

Hawaii 41 40 -1

Idaho 47 44 -3

Illinois 418 384 -34

Indiana 229 219 -10

Iowa 151 147 -4

Kansas 134 122 -12

Kentucky 172 164 -8

Louisiana 166 160 -6

Maine 62 61 -1

Maryland 148 135 -13

Massachusetts 194 177 -17

Michigan 334 316 -18

Minnesota 212 202 -10

Mississippi 104 104 0

Missouri 182 172 -10

Montana 48 48 0

Nebraska 92 92 0

Nevada 61 70 +9

New Hampshire 49 46 -3

New Jersey 278 250 -28

New Mexico 48 49 +1

New York 701 631 -70

North Carolina 249 234 -15

Appendix III: Changes in the Number of 

Certified Mammography Facilities by State, 

October 1, 2001, to October 1, 2004 

Page 52 GAO-06-724 Mammography Services
Appendix III: Changes in the Number of 

Certified Mammography Facilities by State, 

October 1, 2001, to October 1, 2004 

State 

Number of 

facilities in 2001

Number of 

facilities in 2004 

Net change in 

number of facilities

North Dakota 42 43 +1

Ohio 440 417 -23

Oklahoma 102 100 -2

Oregon 99 99 0

Pennsylvania 440 402 -38

Rhode Island 43 38 -5

South Carolina 123 116 -7

South Dakota 48 46 -2

Tennessee 207 199 -8

Texas 563 529 -34

Utah 46 47 +1

Vermont 19 17 -2

Virginia 204 183 -21

Washington 175 158 -17

West Virginia 84 75 -9 

Wisconsin 250 250 0

Wyoming 27 25 -2

Total 9,306 8,768 -538

Source: GAO analysis of FDA’s Mammography Program Reporting and Information System database on mammography facilities. 

Page 53 GAO-06-724 Mammography Services
Appendix IV: Comments from the Food and Appendix IV Drug Administration : Comments from the Food and 

Drug Administration 

Page 54 GAO-06-724 Mammography Services
Appendix IV: Comments from the Food and

Drug Administration 

Page 55 GAO-06-724 Mammography Services
Appendix V: 

St

GAO Contact and 

aff Acknowledgments

Page 56 GAO-06-724

Appendix V: GAO Contact and Staff 

Acknowledgments 

GAO Contact Marcia Crosse, (202) 512-7119 or crossem@gao.gov

In addition to the contact named above, Helene Toiv, Assistant Director; 

Darryl Joyce; Roseanne Price; Mary Reich; Carmen Rivera-Lowitt; and 

Suzanne Worth made key contributions to this report. 

Mammography Services

Acknowledgments 

(290418) 
GAO’s Mission The Government Accountability Office, the audit, evaluation and 

investigative arm of Congress, exists to support Congress in meeting its 

constitutional responsibilities and to help improve the performance and 

accountability of the federal government for the American people. GAO 

examines the use of public funds; evaluates federal programs and policies; 

and provides analyses, recommendations, and other assistance to help

Congress make informed oversight, policy, and funding decisions. GAO’s 

commitment to good government is reflected in its core values of 

accountability, integrity, and reliability. 

The fastest and easiest way to obtain copies of GAO documents at no cost

is through GAO’s Web site (www.gao.gov). Each weekday, GAO posts 

newly released reports, testimony, and correspondence on its Web site. To

have GAO e-mail you a list of newly posted products every afternoon, go 

to www.gao.gov and select “Subscribe to Updates.” 

The first copy of each printed report is free. Additional copies are $2 each. 

A check or money order should be made out to the Superintendent of 

Documents. GAO also accepts VISA and Mastercard. Orders for 100 or 

more copies mailed to a single address are discounted 25 percent. Orders 

should be sent to: 

U.S. Government Accountability Office 

441 G Street NW, Room LM 

Washington, D.C. 20548 

To order by Phone: Voice: (202) 512-6000 

TDD: (202) 512-2537 

Fax: (202) 512-6061 

Contact: 

Web site: www.gao.gov/fraudnet/fraudnet.htm

E-mail: fraudnet@gao.gov

Automated answering system: (800) 424-5454 or (202) 512-7470 

Gloria Jarmon, Managing Director, JarmonG@gao.gov (202) 512-4400 

U.S. Government Accountability Office, 441 G Street NW, Room 7125 

Washington, D.C. 20548 

Paul Anderson, Managing Director, AndersonP1@gao.gov (202) 512-4800

U.S. Government Accountability Office, 441 G Street NW, Room 7149 

Washington, D.C. 20548 

Obtaining Copies of 

GAO Reports and 

Testimony

Order by Mail or Phone 

To Report Fraud,

Waste, and Abuse in 

Federal Programs 

Congressional 

Relations 

Public Affairs 

PRINTED ON RECYCLED PAPER