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Report to Congressional Requesters: 

United States Government Accountability Office: 

GAO: 

July 2006: 

Mammography: 

Current Nationwide Capacity Is Adequate, but Access Problems May Exist 
in Certain Locations: 

Mammography Services: 

GAO-06-724: 

GAO Highlights: 

Highlights of GAO-06-724, a report to congressional requesters 

Why GAO Did This Study: 

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 one-fourth 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. 

What GAO Found: 

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. 

[Hyperlink, http://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. 

[End of Section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

Facility Closures Outpaced Openings, with Financial Considerations Most 
Often Cited as Reason for Closure: 

Although Key Capacity Elements Have Decreased and Use of Mammography 
Services Has Increased, Current Nationwide Capacity Is Adequate: 

Loss or Absence of Mammography Machines May Have Resulted in Access 
Problems in Certain Locations: 

State Bodies Have Varying Measures to Avoid Conflicts of Interest, and 
FDA's Evaluations Have Not Found Conflict-of-Interest Problems: 

Concluding Observations: 

Agency Comments: 

Appendix I: The Food and Drug Administration's Mammography Facility 
Inspection Demonstration Program: 

Appendix II: Scope and Methodology: 

Appendix III: Changes in the Number of Certified Mammography Facilities 
by State, October 1, 2001, to October 1, 2004: 

Appendix IV: Comments from the Food and Drug Administration: 

Appendix V: GAO Contact and Staff Acknowledgments: 

Tables: 

Table 1: Reasons for Closures of ACR-Accredited Mammography Facilities 
in the United States, October 1, 2001, to October 1, 2004: 

Table 2: Changes in Numbers of Mammography Facilities, Machines, 
Radiologic Technologists, and Interpreting Physicians from October 1, 
2001, to October 1, 2004: 

Table 3: State Accreditation and Certification Bodies' Measures to 
Avoid Conflicts of Interest: 

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: 

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: 

Table 6: Selected Counties with Mammography Facility Closures and 
Community Health Centers, October 2003 to October 2004: 

Figures: 

Figure 1: Overview of the Mammography Facility Accreditation and 
Certification Processes: 

Figure 2: Number of Mammography Machines by County, October 1, 2004: 

Figure 3: Percentages of Mammography Facilities with MQSA Violations, 
by Level of Violation, during FDA's IDP: 

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: 

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 
Force[Footnote 1] recommend screening mammography every 1 to 2 years 
for women age 40 and over. Medically underserved 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.[Footnote 2] 

Although mammography is the most effective tool for detection of early- 
stage 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.[Footnote 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 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.[Footnote 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.[Footnote 5] As with state 
accreditation bodies, state certification bodies may certify facilities 
only within their own state[Footnote 6] 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.[Footnote 7] For most states where FDA certifies the 
facilities, it contracts with the state to have state inspectors 
perform MQSA compliance inspections.[Footnote 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.[Footnote 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.[Footnote 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 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.[Footnote 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.[Footnote 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 
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.[Footnote 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.[Footnote 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. 

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. 

Results in Brief: 

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 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 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. 

Background: 

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 
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,[Footnote 15] and in 
1997, FDA issued final regulations establishing quality 
standards.[Footnote 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 FDA-approved 
accreditation body[Footnote 17] and have obtained a certificate 
permitting them to provide mammography services from FDA or an FDA- 
approved certification body.[Footnote 18] FDA is also responsible for 
ensuring that all 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. 

Quality Standards for Mammography Personnel: 

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 state[Footnote 
19] or certified by an appropriate board, such as the American Registry 
of Radiologic Technologists, in general radiography.[Footnote 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;[Footnote 21] and meet certain medical training, continuing 
education, and experience requirements related to mammography. 

Accreditation and Certification of Facilities: 

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 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.[Footnote 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.[Footnote 23] FDA or the 
state certification body then issues a provisional certificate that 
allows the facility to operate legally for up to 6 months.[Footnote 24] 

Figure 1: Overview of the Mammography Facility Accreditation and 
Certification Processes: 

[See PDF for image] 

Source: GAO analysis of MQSA, MQSA regulations, and documents and 
information provided by FDA and the accreditation and certification 
bodies. 

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. 

[End of figure] 

Second, to achieve full accreditation, the facility must submit to the 
accreditation body phantom and clinical images,[Footnote 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.[Footnote 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.[Footnote 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.[Footnote 28] The on-site 
visits include reviewing samples of randomly selected clinical images 
to assess image quality,[Footnote 29] verifying the information that 
facilities provided in the accreditation application,[Footnote 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.[Footnote 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.[Footnote 32] For example, inspectors review quality 
control records for each film processor[Footnote 33] 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 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. 

National Database on Mammography Facilities: 

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. 

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.[Footnote 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.[Footnote 35] 

Initiatives to Help Improve Access to Mammography: 

The federal government supports two initiatives to help improve access 
to mammography services. The Breast and Cervical Cancer Mortality 
Prevention Act of 1990[Footnote 36] 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.[Footnote 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. 

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.[Footnote 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, 63 percent of patients were members of 
racial or ethnic minority populations, and 29 percent spoke a primary 
language other than English.[Footnote 39] 

Facility Closures Outpaced Openings, with Financial Considerations Most 
Often Cited as Reason for Closure: 

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.[Footnote 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.[Footnote 41] Forty 
states lost facilities during this period, including 10 states that 
each lost more than 20 facilities.[Footnote 42] These 10 states 
accounted for over half of the 538 net decrease. (See app. III for 
information by state.) 

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 closure[Footnote 
43] 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 considerations as the reason for closure.[Footnote 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. 

Table 1: Reasons for Closures of ACR-Accredited Mammography Facilities 
in the United States, October 1, 2001, to October 1, 2004: 

Reason for closure[A]: Financial decision; 
Number of closures[B]: 424; 
Percentage of total: 35. 

Reason for closure[A]: Relocation of facility to sister site; 
Number of closures[B]: 305; 
Percentage of total: 25. 

Reason for closure[A]: Other/equipment problems[C]; 
Number of closures[B]: 136; 
Percentage of total: 11. 

Reason for closure[A]: Staffing problems; 
Number of closures[B]: 124; 
Percentage of total: 10. 

Reason for closure[A]: Bankruptcy; 
Number of closures[B]: 25; 
Percentage of total: 2. 

Reason for closure[A]: Other/mobile facility merged with another site; 
Number of closures[B]: 28; 
Percentage of total: 2. 

Reason for closure[A]: Other/changes in ownership; 
Number of closures[B]: 23; 
Percentage of total: 2. 

Reason for closure[A]: Unknown; 
Number of closures[B]: 80; 
Percentage of total: 7. 

Reason for closure[A]: Other/miscellaneous; 
Number of closures[B]: 66; 
Percentage of total: 6. 

Reason for closure[A]: Total; 
Number of closures[B]: 1,211; 
Percentage of total: 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. 

[End of table] 

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 repetitious work because of the need to read large volumes of 
screening mammograms; and has a high rate of malpractice litigation. 

Although Key Capacity Elements Have Decreased and Use of Mammography 
Services Has Increased, Current Nationwide Capacity Is Adequate: 

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 Capacity to Provide Mammography Services Have 
Decreased: 

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.[Footnote 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. 

Table 2: Changes in Numbers of Mammography Facilities, Machines, 
Radiologic Technologists, and Interpreting Physicians from October 1, 
2001, to October 1, 2004: 

Facilities; 
2001: 9,306; 
2004: 8,768; 
Percentage change: -6. 

Machines; 
2001: 13,995; 
2004: 13,400; 
Percentage change: -4. 

Radiologic technologists who perform mammography; 
2001: 31,402; 
2004: 30,503; 
Percentage change: -3. 

Physicians who interpret mammograms; 
2001: 19,675; 
2004: 18,690; 
Percentage change: -5. 

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

[End of table] 

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,[Footnote 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.[Footnote 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.[Footnote 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 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.[Footnote 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.[Footnote 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.[Footnote 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 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.[Footnote 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.[Footnote 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 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.[Footnote 54] 

Loss or Absence of Mammography Machines May Have Resulted in Access 
Problems in Certain Locations: 

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. 

Number of Counties with Machines Remained Relatively Constant, but 
Number of Machines Decreased in Certain Counties: 

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.[Footnote 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.[Footnote 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. 

Figure 2: Number of Mammography Machines by County, October 1, 2004: 

[See PDF for image] 

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. 

[End of figure] 

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.[Footnote 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.[Footnote 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.[Footnote 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 25 
percent of their machines,[Footnote 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.[Footnote 
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,[Footnote 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 30 
to 60 miles to obtain mammography services. In Missouri,[Footnote 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.[Footnote 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 quarter of the state and was available to some communities 
once every 4 months and to others only once a year. 

State Bodies Have Varying Measures to Avoid Conflicts of Interest, and 
FDA's Evaluations Have Not Found Conflict-of-Interest Problems: 

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 Accreditation and Certification Bodies Have Varying Measures to 
Avoid Conflicts of Interest: 

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.) 

Table 3: State Accreditation and Certification Bodies' Measures to 
Avoid Conflicts of Interest: 

Measures: State laws or personnel policies: Code of ethics; 
State accreditation bodies: Arkansas: check; 
State accreditation bodies: Iowa[A]: check; 
State accreditation bodies: Texas[B]: check[C]; 
State certification bodies: Illinois: check; 
State certification bodies: Iowa[A]: check. 

Measures: State laws or personnel policies: Financial disclosure 
statement required of state body employees; 
State accreditation bodies: Arkansas: check[D]; 
State accreditation bodies: Iowa[A]: [Empty]; 
State accreditation bodies: Texas[B]: [Empty]; 
State certification bodies: Illinois: check[E]; 
State certification bodies: Iowa[A]: [Empty]. 

Measures: State laws or personnel policies: Required ethics training; 
State accreditation bodies: Arkansas: [Empty]; 
State accreditation bodies: Iowa[A]: [Empty]; 
State accreditation bodies: Texas[B]: check; 
State certification bodies: Illinois: check; 
State certification bodies: Iowa[A]: [Empty]. 

Measures: Procedures: Use a list of facilities where reviewers have a 
financial or other relationship in determining assignment of clinical 
images to reviewers; 
State accreditation bodies: Arkansas: check; 
State accreditation bodies: Iowa[A]: check; 
State accreditation bodies: Texas[B]: check[B]; 
State certification bodies: Illinois: N/A; 
State certification bodies: Iowa[A]: N/A. 

Measures: Procedures: Conduct "blind reviews" of mammography images by 
concealing facility identity[F]; 
State accreditation bodies: Arkansas: check; 
State accreditation bodies: Iowa[A]: check; 
State accreditation bodies: Texas[B]: [Empty]; 
State certification bodies: Illinois: N/A; 
State certification bodies: Iowa[A]: N/A. 

Measures: Procedures: For each clinical image and phantom image review, 
use two or more individuals working independently[G]; 
State accreditation bodies: Arkansas: check; 
State accreditation bodies: Iowa[A]: check; 
State accreditation bodies: Texas[B]: check[B]; 
State certification bodies: Illinois: N/A; 
State certification bodies: Iowa[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: check = 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. 

[End of table] 

Accreditation Bodies: 

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.[Footnote 65] These laws and policies vary in 
scope across the three states, and each state has penalties associated 
with violating its laws.[Footnote 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.[Footnote 67] In contrast, Iowa 
requires only certain individuals, such as elected officials and higher 
level agency officials, to file financial disclosure forms[Footnote 68] 
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,[Footnote 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.[Footnote 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.[Footnote 71] 

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 
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.[Footnote 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. 

Certification Bodies: 

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 statement 
annually.[Footnote 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.[Footnote 74] Illinois ethics law also requires that all 
state employees annually complete ethics training,[Footnote 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.[Footnote 76] FDA officials told us that their staff have 
also reviewed several randomly 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.[Footnote 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. 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-of-interest 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 conflict-of-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. 

Concluding Observations: 

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 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. 

Agency Comments: 

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 [Hyperlink, 
http://www.gao.gov]. 

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. 

Signed by: 

Marcia Crosse: 
Director, Health Care: 

[End of section] 

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.[Footnote 78] 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.[Footnote 79] 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.[Footnote 80] FDA selected facilities for the IDP from 
states that indicated a willingness to participate in the program and 
met certain criteria.[Footnote 81] 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.[Footnote 82] To 
minimize the financial impact that a reduced inspection schedule would 
have on 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.[Footnote 83] 

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 were cited for violations.[Footnote 84] (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.[Footnote 85] 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). 

Figure 3: Percentages of Mammography Facilities with MQSA Violations, 
by Level of Violation, during FDA's IDP: 

[See PDF for image] 

Source: FDA. 

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. 

[End of figure] 

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. 

[End of section] 

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,[Footnote 86] and used an iterative process to edit 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),[Footnote 87] 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.[Footnote 88] To examine changes in the population of women 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. 

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: County: Navajo; 
Rural counties: State: Arizona; 
Urban counties: County: Houston; 
Urban counties: State: Alabama. 

Rural counties: County: Drew; 
Rural counties: State: Arkansas; 
Urban counties: County: Saint Johns; 
Urban counties: State: Florida. 

Rural counties: County: Putnam; 
Rural counties: State: Florida; 
Urban counties: County: Coweta; 
Urban counties: State: Georgia. 

Rural counties: County: Shiawassee; 
Rural counties: State: Michigan; 
Urban counties: County: Warren; 
Urban counties: State: Iowa. 

Rural counties: County: Newton; 
Rural counties: State: Mississippi; 
Urban counties: County: Butler; 
Urban counties: State: Kansas. 

Rural counties: County: Lewis and Clarke; 
Rural counties: State: Montana; 
Urban counties: County: Wayne; 
Urban counties: State: New York. 

Rural counties: County: Fulton; 
Rural counties: State: New York; 
Urban counties: County: Morton; 
Urban counties: State: North Dakota. 

Rural counties: County: Duplin; 
Rural counties: State: North Carolina; 
Urban counties: County: Pottawatomie; 
Urban counties: State: Oklahoma. 

Rural counties: County: Dickenson; 
Rural counties: State: Virginia; 
Urban counties: County: Lubbock; 
Urban counties: State: Texas. 

Source: GAO analysis, based on FDA's Mammography Program Reporting and 
Information System database. 

[End of table] 

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. 

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. 

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: Logan Sharp; 
State: Arkansas; 
Rural/urban county designation: Rural Rural. 

County: Fulton Wilkes; 
State: Georgia; 
Rural/urban county designation: Urban Rural. 

County: Gem Shoshone; 
State: Idaho; 
Rural/urban county designation: Rural Rural. 

County: Cook Peoria; 
State: Illinois; 
Rural/urban county designation: Urban Urban. 

County: Berrien Wayne; 
State: Michigan; 
Rural/urban county designation: Urban Urban. 

County: Kings Oneida Saint Lawrence Tioga; 
State: New York; 
Rural/urban county designation: Urban Urban Rural Urban. 

County: Dickenson Washington; 
State: Virginia; 
Rural/urban county designation: Rural Urban. 

County: Hardy Jackson; 
State: West Virginia; 
Rural/urban county designation: 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. 

[End of table] 

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)[Footnote 89] 
regarding the 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: Anchorage; 
State: Alaska; 
Community health center rural/urban designation: Rural. 

County: Tulare; 
State: California; 
Community health center rural/urban designation: Rural. 

County: Leon; 
State: Florida; 
Community health center rural/urban designation: Rural. 

County: Delaware; 
State: Indiana; 
Community health center rural/urban designation: Urban. 

County: Orleans; 
State: Louisiana; 
Community health center rural/urban designation: Urban. 

County: Baltimore; 
State: Maryland; 
Community health center rural/urban designation: Urban. 

County: Onondaga; 
State: New York; 
Community health center rural/urban designation: Urban. 

County: Harris; 
State: Texas; 
Community health center rural/urban designation: Urban. 

County: King; 
State: Washington; 
Community health center rural/urban designation: Urban. 

County: Washburn; 
State: Wisconsin; 
Community health center rural/urban designation: 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. 

[End of table] 

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, and Texas; certification bodies in Illinois and Iowa; and 
ACR.[Footnote 90] 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 FDA-approved 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 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.[Footnote 
91] 

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. 

[End of section] 

Appendix III: Changes in the Number of Certified Mammography Facilities 
by State, October 1, 2001, to October 1, 2004: 

Table 7: 

State: Alabama; 
Number of facilities in 2001: 157; 
Number of facilities in 2004: 140; 
Net change in number of facilities: -17. 

State: Alaska; 
Number of facilities in 2001: 32; 
Number of facilities in 2004: 30; 
Net change in number of facilities: -2. 

State: Arizona; 
Number of facilities in 2001: 148; 
Number of facilities in 2004: 151; 
Net change in number of facilities: +3. 

State: Arkansas; 
Number of facilities in 2001: 111; 
Number of facilities in 2004: 102; 
Net change in number of facilities: -9. 

State: California; 
Number of facilities in 2001: 768; 
Number of facilities in 2004: 736; 
Net change in number of facilities: -32. 

State: Colorado; 
Number of facilities in 2001: 111; 
Number of facilities in 2004: 106; 
Net change in number of facilities: -5. 

State: Connecticut; 
Number of facilities in 2001: 154; 
Number of facilities in 2004: 143; 
Net change in number of facilities: -11. 

State: Delaware; 
Number of facilities in 2001: 24; 
Number of facilities in 2004: 30; 
Net change in number of facilities: +6. 

State: District of Columbia; 
Number of facilities in 2001: 21; 
Number of facilities in 2004: 19; 
Net change in number of facilities: -2. 

State: Florida; 
Number of facilities in 2001: 487; 
Number of facilities in 2004: 460; 
Net change in number of facilities: -27. 

State: Georgia; 
Number of facilities in 2001: 261; 
Number of facilities in 2004: 240; 
Net change in number of facilities: -21. 

State: Hawaii; 
Number of facilities in 2001: 41; 
Number of facilities in 2004: 40; 
Net change in number of facilities: -1. 

State: Idaho; 
Number of facilities in 2001: 47; 
Number of facilities in 2004: 44; 
Net change in number of facilities: -3. 

State: Illinois; 
Number of facilities in 2001: 418; 
Number of facilities in 2004: 384; 
Net change in number of facilities: -34. 

State: Indiana; 
Number of facilities in 2001: 229; 
Number of facilities in 2004: 219; 
Net change in number of facilities: -10. 

State: Iowa; 
Number of facilities in 2001: 151; 
Number of facilities in 2004: 147; 
Net change in number of facilities: -4. 

State: Kansas; 
Number of facilities in 2001: 134; 
Number of facilities in 2004: 122; 
Net change in number of facilities: -12. 

State: Kentucky; 
Number of facilities in 2001: 172; 
Number of facilities in 2004: 164; 
Net change in number of facilities: -8. 

State: Louisiana; 
Number of facilities in 2001: 166; 
Number of facilities in 2004: 160; 
Net change in number of facilities: -6. 

State: Maine; 
Number of facilities in 2001: 62; 
Number of facilities in 2004: 61; 
Net change in number of facilities: -1. 

State: Maryland; 
Number of facilities in 2001: 148; 
Number of facilities in 2004: 135; 
Net change in number of facilities: -13. 

State: Massachusetts; 
Number of facilities in 2001: 194; 
Number of facilities in 2004: 177; 
Net change in number of facilities: -17. 

State: Michigan; 
Number of facilities in 2001: 334; 
Number of facilities in 2004: 316; 
Net change in number of facilities: -18. 

State: Minnesota; 
Number of facilities in 2001: 212; 
Number of facilities in 2004: 202; 
Net change in number of facilities: -10. 

State: Mississippi; 
Number of facilities in 2001: 104; 
Number of facilities in 2004: 104; 
Net change in number of facilities: 0. 

State: Missouri; 
Number of facilities in 2001: 182; 
Number of facilities in 2004: 172; 
Net change in number of facilities: -10. 

State: Montana; 
Number of facilities in 2001: 48; 
Number of facilities in 2004: 48; 
Net change in number of facilities: 0. 

State: Nebraska; 
Number of facilities in 2001: 92; 
Number of facilities in 2004: 92; 
Net change in number of facilities: 0. 

State: Nevada; 
Number of facilities in 2001: 61; 
Number of facilities in 2004: 70; 
Net change in number of facilities: +9. 

State: New Hampshire; 
Number of facilities in 2001: 49; 
Number of facilities in 2004: 46; 
Net change in number of facilities: -3. 

State: New Jersey; 
Number of facilities in 2001: 278; 
Number of facilities in 2004: 250; 
Net change in number of facilities: -28. 

State: New Mexico; 
Number of facilities in 2001: 48; 
Number of facilities in 2004: 49; 
Net change in number of facilities: +1. 

State: New York; 
Number of facilities in 2001: 701; 
Number of facilities in 2004: 631; 
Net change in number of facilities: -70. 

State: North Carolina; 
Number of facilities in 2001: 249; 
Number of facilities in 2004: 234; 
Net change in number of facilities: -15. 

State: North Dakota; 
Number of facilities in 2001: 42; 
Number of facilities in 2004: 43; 
Net change in number of facilities: +1. 

State: Ohio; 
Number of facilities in 2001: 440; 
Number of facilities in 2004: 417; 
Net change in number of facilities: -23. 

State: Oklahoma; 
Number of facilities in 2001: 102; 
Number of facilities in 2004: 100; 
Net change in number of facilities: -2. 

State: Oregon; 
Number of facilities in 2001: 99; 
Number of facilities in 2004: 99; 
Net change in number of facilities: 0. 

State: Pennsylvania; 
Number of facilities in 2001: 440; 
Number of facilities in 2004: 402; 
Net change in number of facilities: -38. 

State: Rhode Island; 
Number of facilities in 2001: 43; 
Number of facilities in 2004: 38; 
Net change in number of facilities: -5. 

State: South Carolina; 
Number of facilities in 2001: 123; 
Number of facilities in 2004: 116; 
Net change in number of facilities: -7. 

State: South Dakota; 
Number of facilities in 2001: 48; 
Number of facilities in 2004: 46; 
Net change in number of facilities: -2. 

State: Tennessee; 
Number of facilities in 2001: 207; 
Number of facilities in 2004: 199; 
Net change in number of facilities: -8. 

State: Texas; 
Number of facilities in 2001: 563; 
Number of facilities in 2004: 529; 
Net change in number of facilities: -34. 

State: Utah; 
Number of facilities in 2001: 46; 
Number of facilities in 2004: 47; 
Net change in number of facilities: +1. 

State: Vermont; 
Number of facilities in 2001: 19; 
Number of facilities in 2004: 17; 
Net change in number of facilities: -2. 

State: Virginia; 
Number of facilities in 2001: 204; 
Number of facilities in 2004: 183; 
Net change in number of facilities: -21. 

State: Washington; 
Number of facilities in 2001: 175; 
Number of facilities in 2004: 158; 
Net change in number of facilities: -17. 

State: West Virginia; 
Number of facilities in 2001: 84; 
Number of facilities in 2004: 75; 
Net change in number of facilities: -9. 

State: Wisconsin; 
Number of facilities in 2001: 250; 
Number of facilities in 2004: 250; 
Net change in number of facilities: 0. 

State: Wyoming; 
Number of facilities in 2001: 27; 
Number of facilities in 2004: 25; 
Net change in number of facilities: -2. 

State: Total; 
Number of facilities in 2001: 9,306; 
Number of facilities in 2004: 8,768; 
Net change in number of facilities: -538. 

Source: GAO analysis of FDA's Mammography Program Reporting and 
Information System database on mammography facilities. 

[End of table] 

[End of section] 

Appendix IV: Comments from the Food and Drug Administration: 

Department Of Health & Human Services: 
Food and Drug Administration: 
Rockville MD 20857: 

June 30, 2006: 

Marcia Crosse: 
Director, Health Care: 
United States Government Accountability Office: 
441 G Street, NW: 
Washington, DC 20548: 

Dear Ms. Crosse: 

Please find enclosed the Food and Drug Administration's general 
comments in response to the General Accountability Office's 
correspondence entitled, "Mammography Current Nationwide Capacity is 
Adequate, but Access Problems May Exist in Certain Locations (GAO-06- 
724)." 

We appreciate the opportunity to review and comment on this draft 
correspondence before it is published, as well as the opportunity to 
work with your staff in its development. 

Sincerely, 

Signed by: 

Andrew C. von Eschenbach, M.D. 
Acting Commissioner of Food and Drugs: 

Enclosure: 

General Comments To The Draft Report Entitled, "Mammography: Current 
Nationwide Capacity Is Adequate, But Access Problems May Exist In 
Certain Locations, (GAO-06-724)" 

1. On page 3, 

* First paragraph, lines 16 and 17, which states, "For most states 
where FDA certifies the facilities, it contracts with state inspectors 
to perform MQSA compliance inspections." FDA suggests adding a 
reference 8a after the above-mentioned sentence and making the 
following sentence footnote 8a, "FDA also contracts with certain non-
state entities, i.e., the City of New York and the Commonwealth of 
Puerto Rico." 

* Change footnote 8 to footnote 8b and revise the footnote reading, "As 
of January 2006, FDA did not have contracts with Nebraska, New 
Hampshire and New Mexico, according to FDA officials. FDA inspectors 
are responsible for conducting inspections in these states and in 
federal facilities." to read, "As of June 2006, FDA did not have 
contracts with Nebraska, New Hampshire, and Washington, D.C. FDA 
inspectors are responsible for conducting inspections in Nebraska, New 
Hampshire, Washington, D.C., and in federal facilities." 

2. On page 9, first full paragraph, revise the sentence at lines 5-8 to 
read, "As required by regulation, the measures used by the state 
accreditation and certification bodies to avoid conflicts of interest 
must be submitted for FDA's review and approval. FDA has conducted 
annual performance evaluations of state bodies to assess whether they 
are complying with MQSA regulations." 

3. On page 14, footnote 26, after the phrase, ".facilities it 
accredits" add the words in parentheses, "(but no more than 50 
facilities must be visited)." 

[End of section] 

Appendix V: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Marcia Crosse, (202) 512-7119 or crossem@gao.gov: 

Acknowledgments: 

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. 

FOOTNOTES 

[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. 

[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). 

[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). 

[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. 

[10] GAO, Mammography: Capacity Generally Exists to Deliver Services, 
GAO-02-532 (Washington, D.C.: Apr. 19, 2002). 

[11] In our last report, we examined three of these elements. In this 
report we added physicians who interpret mammograms as a fourth element 
of capacity. 

[12] NHIS 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. 

[13] 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. 

[14] In 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. 

[15] 58 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. 

[16] 62 Fed. Reg. 55852-994 (Oct. 28, 1997) (codified at 21 C.F.R. Part 
900). 

[17] Under 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). 

[18] FDA'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). 

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

[20] The 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. 

[21] Physicians 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. 

[22] Although 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. 

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

[24] A 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). 

[25] A 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. 

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

[27] The facility must display its MQSA certificate to operate legally. 
42 U.S.C. § 263b(b)(1)(A)(iii). 

[28] MQSA 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). 

[29] The 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). 

[30] Accreditation 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. 

[31] FDA and certification bodies must perform annual inspections to 
ensure compliance with all the quality standards found in 21 C.F.R. § 
900.12. 

[32] The 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. 

[33] The film processor is the device that develops the film to produce 
a mammographic image. 

[34] 21 C.F.R. § 900.4(a)(4) and 21 C.F.R. § 900.22(a) (2005). 

[35] 42 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. 

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

[37] The program operates in every state, the District of Columbia, 4 
U.S. territories, and 13 American Indian and Alaska Native 
organizations. 

[38] Criteria 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. 

[39] Information 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. 

[40] Facilities 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. 

[41] A 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. 

[42] The 10 states that lost more than 20 facilities are California, 
Florida, Georgia, Illinois, New Jersey, New York, Ohio, Pennsylvania, 
Texas, and Virginia. 

[43] In 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. 

[44] ACR 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. 

[45] Many 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.) 

[46] The population of women age 40 and older increased by about 6 
percent from 2000 to 2003. 

[47] Based 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. 

[48] In 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. 

[49] Of 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. 

[50] This yearly total is based on the assumption that a machine was in 
operation 5 days per week and 50 weeks per year. 

[51] We did not determine whether there were a sufficient number of 
radiologic technologists available to perform mammograms for the 
estimated level of machine capacity. 

[52] The excess capacity also would have been adequate to provide the 
estimated 3 million mammograms received that year by women age 30 to 
39. 

[53] Factors 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. 

[54] Carl 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. 

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

[56] U.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) [Hyperlink, 
http://www.census.gov/popest/counties] (downloaded March 6, 2006). 

[57] In 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. 

[58] In 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. 

[59] State, 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. 

[60] The six counties are Navajo County, Arizona; Warren County, Iowa; 
Butler County, Kansas; Newton County, Mississippi; Wayne County, New 
York; and Dickenson County, Virginia. 

[61] For 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. 

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

[63] Missouri 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. 

[64] The 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. 

[65] Ark. Code Ann. § 21-8-304 (2005); Iowa Code Ann. § 68B2.A (2005); 
Tex. Gov't Code Ann. §§ 572.001 and 572.051 (2005). 

[66] Ark. 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). 

[67] Ark. Code Ann. § 21-8-203 (2005). 

[68] Iowa Code Ann. § 68B.35 (2005). 

[69] Tex. Gov't Code Ann. § 572.021 (2005). 

[70] ACR'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. 

[71] Tex. Gov't Code Ann. § 2113.014 (2005). 

[72] An 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. 

[73] 5 Ill. Comp. Stat. Ann. § 420/4A-101(f)(1-8) (2005). 

[74] FDA 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. 

[75] 5 Ill. Comp. Stat. Ann. § 430/5-10 (2005). 

[76] Two FDA interpreting physicians independently review samples of 
clinical images, and two FDA expert staff independently review samples 
of phantom images. 

[77] Until 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. 

[78] 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)). 

[79] FDA issued a report describing the results of the IDP in January 
2005. 

[80] 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. 

[81] 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. 

[82] 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. 

[83] The lower number of control group facilities available for 
inspection in the second year of the IDP was due primarily to facility 
closures. 

[84] 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. 

[85] 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). 

[86] 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. 

[87] 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. 

[88] According to NHIS data, about 92 percent of the women who received 
a mammogram in 2003 were 40 and older. 

[89] 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. 

[90] 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. 

[91] 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. 

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