Mammography: Current Nationwide Capacity Is Adequate, but Access 
Problems May Exist in Certain Locations (25-JUL-06, GAO-06-724). 
                                                                 
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.						 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-06-724 					        
    ACCNO:   A57442						        
  TITLE:     Mammography: Current Nationwide Capacity Is Adequate, but
Access Problems May Exist in Certain Locations			 
     DATE:   07/25/2006 
  SUBJECT:   Breast cancer					 
	     Disease detection or diagnosis			 
	     Health care services				 
	     Health statistics					 
	     Mammography					 
	     Medical equipment					 
	     Medical examinations				 
	     Women						 
	     Health care facilities				 

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GAO-06-724

     

     * Results in Brief
     * Background
          * FDA Oversight of Mammography
               * Quality Standards for Mammography Personnel
               * Accreditation and Certification of Facilities
               * National Database on Mammography Facilities
          * Oversight of Accreditation and Certification Bodies
          * Initiatives to Help Improve Access to Mammography
     * Facility Closures Outpaced Openings, with Financial Consider
     * Although Key Capacity Elements Have Decreased and Use of Mam
          * Key Elements That Make Up Capacity to Provide Mammography Se
          * Number of Women Who Received Screening Mammograms Increased
          * Current Nationwide Mammography Capacity Is Adequate
     * Loss or Absence of Mammography Machines May Have Resulted in
          * Number of Counties with Machines Remained Relatively Constan
          * Loss or Absence of Mammography Machines in Certain Locations
     * State Bodies Have Varying Measures to Avoid Conflicts of Int
          * State Accreditation and Certification Bodies Have Varying Me
               * Accreditation Bodies
               * Certification Bodies
          * FDA Approved State Bodies' Measures to Avoid Conflicts of In
     * Concluding Observations
     * Agency Comments
          * Methodology
          * Results
     * GAO Contact
     * Acknowledgments
     * GAO's Mission
     * Obtaining Copies of GAO Reports and Testimony
          * Order by Mail or Phone
     * To Report Fraud, Waste, and Abuse in Federal Programs
     * Congressional Relations
     * Public Affairs

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

GAO-06-724

Contents

Letter 1

Results in Brief 7
Background 9
Facility Closures Outpaced Openings, with Financial Considerations Most
Often Cited as Reason for Closure 18
Although Key Capacity Elements Have Decreased and Use of Mammography
Services Has Increased, Current Nationwide Capacity Is Adequate 21
Loss or Absence of Mammography Machines May Have Resulted in Access
Problems in Certain Locations 25
State Bodies Have Varying Measures to Avoid Conflicts of Interest, and
FDA's Evaluations Have Not Found Conflict-of-Interest Problems 31
Concluding Observations 37
Agency Comments 38
Appendix I The Food and Drug Administration's Mammography Facility
Inspection Demonstration Program 39
Appendix II Scope and Methodology 43
Appendix III Changes in the Number of Certified Mammography Facilities by
State, October 1, 2001, to October 1, 2004 52
Appendix IV Comments from the Food and Drug Administration 54
Appendix V GAO Contact and Staff Acknowledgments 56

Tables

Table 1: Reasons for Closures of ACR-Accredited Mammography Facilities in
the United States, October 1, 2001, to October 1, 2004 20
Table 2: Changes in Numbers of Mammography Facilities, Machines,
Radiologic Technologists, and Interpreting Physicians from October 1,
2001, to October 1, 2004 22
Table 3: State Accreditation and Certification Bodies' Measures to Avoid
Conflicts of Interest 32
Table 4: Counties Randomly Selected for Review from Those That Lost over
25 Percent of Their Mammography Machines from October 1, 2001, to October
1, 2004 46
Table 5: Selected Counties with Closures of Facilities That Had Provided
Mammography Services to Participants in CDC's National Breast and Cervical
Cancer Early Detection Program, 2001 through 2004 48
Table 6: Selected Counties with Mammography Facility Closures and
Community Health Centers, October 2003 to October 2004 49

Figures

Figure 1: Overview of the Mammography Facility Accreditation and
Certification Processes 13
Figure 2: Number of Mammography Machines by County, October 1, 2004 27
Figure 3: Percentages of Mammography Facilities with MQSA Violations, by
Level of Violation, during FDA's IDP 42

Abbreviations

ACR American College of Radiology CDC Centers for Disease Control and
Prevention CMS Centers for Medicare & Medicaid Services FDA Food and Drug
Administration HHS Department of Health and Human Services HRSA Health
Resources and Services Administration IDP inspection demonstration program
MQSA Mammography Quality Standards Act of 1992 MQSRA Mammography Quality
Standards Reauthorization Act NCI National Cancer Institute NHIS National
Health Interview Survey QIO quality improvement organization

This is a work of the U.S. government and is not subject to copyright
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United States Government Accountability Office

Washington, DC 20548

July 25, 2006

The Honorable Arlen Specter Chairman The Honorable Tom Harkin Ranking
Minority Member Subcommittee on Labor, Health and Human Services,
Education, and Related Agencies Committee on Appropriations United States
Senate

The Honorable Barbara A. Mikulski Ranking Minority Member Subcommittee on
Retirement Security and Aging Committee on Health, Education, Labor, and
Pensions United States Senate

Breast cancer is the most common cancer among women in the United States,
excluding skin cancers, and is the second leading cause of cancer deaths
among U.S. women. The American Cancer Society has estimated that in 2006,
almost 213,000 new cases of breast cancer will be diagnosed in women and
over 40,900 women will die from the disease. Early detection, however,
when coupled with appropriate treatment, can reduce breast cancer
mortality. Mammography, an X-ray imaging procedure that can detect small
tumors and breast abnormalities, is an important tool for detecting breast
cancer at an early stage. Mammography is performed for two different
purposes: screening and diagnosis. Screening mammography is an examination
of a woman without breast symptoms to detect a breast abnormality before
it can be detected by physical examination. Diagnostic mammography is an
examination of a woman who exhibits a symptom, such as a lump, that
indicates the possible presence of breast cancer or whose screening
mammogram indicated a possible cancer. The National Institutes of Health's
National Cancer Institute (NCI) and the U.S. Preventive Services Task
Force1 recommend screening mammography every 1 to 2 years for women age 40
and over. Medically underserved women-such as those who have low incomes,
lack health insurance coverage, or are in certain racial or ethnic
minority groups-have been less likely to obtain screening mammography than
have other women. In addition, studies have found that diagnoses of breast
cancer for minority women have occurred at a more advanced stage than for
white women and that differences in mammography use, such as a lower
likelihood of obtaining regular screening among minority women, may
explain this disparity.2

1The 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.

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.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.4 ACR
serves as the major accreditation body and is responsible for over 90
percent of the accreditation workload. State accreditation bodies may
accredit facilities only within their own state; facilities may apply for
accreditation to either their state body or ACR. Accreditation bodies must
establish measures that FDA approves to avoid conflicts of interest-such
as an accreditation body employee's financial interest in a facility being
reviewed-as the bodies carry out their work. Upon receiving notification
from an accreditation body that a facility meets the quality standards and
has therefore achieved accreditation, FDA or a state certification body
issues an MQSA certificate to the facility, which allows it to legally
operate for up to 3 years. To operate subsequent to the 3-year period, the
facility must apply for reaccreditation prior to the expiration of its
certificate. FDA has approved state agencies in three states-Illinois,
Iowa, and South Carolina-as certification bodies.5 As with state
accreditation bodies, state certification bodies may certify facilities
only within their own state6 and are to establish FDA-approved measures to
avoid conflicts of interest. FDA and the state certification bodies are
also responsible for ensuring that all facilities they certify receive an
annual MQSA compliance inspection.7 For most states where FDA certifies
the facilities, it contracts with the state to have state inspectors
perform MQSA compliance inspections.8 FDA is responsible for overseeing
accreditation and certification bodies' compliance with MQSA and MQSA
regulations.

2See, 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).

3Pub. 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. S: 263b).

4FDA 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.

5FDA 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.

6Facilities in states with certifying bodies may receive certification
only from their state body, not from FDA.

7MQSA requires the annual inspection of mammography facilities to ensure
compliance with the act's requirements. 42 U.S.C. S: 263b(g).

To determine if the frequency of MQSA compliance inspections could be
reduced for facilities that had previously been found to be in compliance
with MQSA, FDA implemented an inspection demonstration program (IDP) as
authorized under MQSRA of 1998.9 The IDP tested whether moving to a
biennial inspection schedule would affect the facilities' compliance
levels. FDA implemented the IDP in November 2001 and ended it in August
2004.

We reported in 2002 that key elements that make up mammography
capacity-the numbers of mammography facilities, machines, and radiologic
technologists-were generally adequate to meet the demand for services.10
We also reported that the number of mammography facilities had decreased
by 5 percent from 1998 to 2001 and that over one-fourth of the nation's
counties had no machines in 1998 and in 2001. You asked us to update this
information and to provide information on state accreditation and
certification bodies. In this report, we examine (1) mammography facility
closures and factors that have contributed to closures in recent years;
(2) changes in the nation's capacity for and use of mammography services
in recent years and whether current capacity is adequate; (3) the effects
of the loss or absence of mammography machines on access to services,
including access for medically underserved women; and (4) the measures
state accreditation and certification bodies have taken to avoid conflicts
of interest and FDA's oversight of state bodies' performance in this area.
You also asked us to provide information on the results of FDA's MQSA
compliance inspection IDP; this information is in appendix I.

To examine mammography facility closures, we analyzed data from FDA's
Mammography Program Reporting and Information System database on 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.

8In 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.

9Pub. L. No. 105-248, S: 8, 112 Stat. 1864, 1865-66.

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

To examine changes in the nation's capacity for and use of mammography
services in recent years and whether current capacity is adequate, we
first defined the key elements that make up mammography capacity as the
numbers of certified mammography facilities; machines; radiologic
technologists who perform mammography; and physicians who interpret
mammograms, who are usually radiologists.11 We then analyzed data from
FDA's mammography facility database on the total numbers of these capacity
elements as of October 1, 2001, and October 1, 2004. To examine changes in
the nationwide use of mammography services, we analyzed data from the 2000
and 2003 National Health Interview Survey (NHIS), administered by the
Centers for Disease Control and Prevention's (CDC) National Center for
Health Statistics, to estimate the number of women age 40 and older who
received a screening or diagnostic mammogram within the previous year.12
To examine changes in the population of women age 40 and older, we used
population estimates from the Census Bureau. To determine the adequacy of
current capacity, we asked mammography experts for estimates of the amount
of time it takes to perform a screening mammogram and to perform a
diagnostic mammogram. We used those estimates and FDA data on the number
of machines available in 2003 to calculate the number of screening
mammograms that potentially could have been performed in 2003. We compared
this estimate of capacity to the estimated number of women age 40 and
older who received a screening mammogram, based on the 2003 NHIS, and also
took into account 2003 NHIS data on diagnostic mammograms. In addition, we
interviewed the following individuals about issues related to mammography
closures, mammography capacity, and 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.

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

12NHIS is the principal source of information on the health of the
civilian noninstitutionalized population of the United States and is one
of the major data collection programs for the National Center for Health
Statistics. In 2000 and 2003, NHIS asked women age 30 and older about the
length of time since their last mammogram and about the reason for the
mammogram. NHIS data on the use of mammography services are based on data
that are self-reported by respondents. The 2003 data were the most recent
data available on the use of mammography services at the time we conducted
our analysis.

To examine the effects of the loss or absence of mammography machines on
access to services, including access for medically underserved women, we
used FDA data to select a stratified random sample of 9 urban counties and
9 rural counties, within 16 states, that lost more than 25 percent of
their mammography machines from October 1, 2001, to October 1, 2004; we
randomly selected the counties to avoid bias in their selection.13 We
interviewed officials familiar with these counties to obtain their views
on the effect of machine losses and facility closures. These officials
generally included county health department personnel in the affected
counties, state radiation control personnel under contract to FDA to
conduct annual on-site MQSA compliance inspections of mammography
facilities, and quality improvement organization (QIO) officials under
contract to CMS to monitor and improve screening rates for Medicare
beneficiaries.14 To assess the effects of the absence of machines on
access to services, we used FDA data on the number and locations of
machines nationwide as of October 1, 2004, and identified counties that
had no machines. In our interviews with state radiation control program
personnel and QIO officials from the 16 states containing the 18 counties
in our random sample, we also asked about access in their states beyond
the sampled counties, including access for medically underserved women. To
obtain additional information on the effects of facility closures on
access for medically underserved women, we interviewed state officials who
direct CDC's National Breast and Cervical Cancer Early Detection Program
in selected states and officials of several community health centers that
receive funding through the federal Consolidated Health Centers program.

13The sample of 18 counties is too small to project the results of our
work to the entire group of counties that lost more than 25 percent of
their mammography machines during this period.

14In addition to monitoring and trying to improve mammography screening
rates for Medicare beneficiaries, QIO officials responsible for each U.S.
state and territory and the District of Columbia work, under CMS's
direction, with consumers, physicians, hospitals, and other health care
providers to improve service delivery and help ensure that patients
receive quality care, with particular attention to underserved
populations.

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,15 and in 1997, FDA issued
final regulations establishing quality standards.16 Most of these quality
standards went into effect in 1999. However, certain quality standards for
mammography equipment, which were more stringent than the previous
standards, went into effect in 2002. The agency is also responsible for
ensuring that all mammography facilities are accredited by an FDA-approved
accreditation body17 and have obtained a certificate permitting them to
provide mammography services from FDA or an FDA-approved certification
body.18 FDA is also responsible for ensuring that all 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.

1558 Fed. Reg. 67565-72 (Dec. 21, 1993). Interim regulations issued on the
same day included standards for accreditation bodies. See 58 Fed. Reg.
67558-65.

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

17Under MQSA, mammography facilities operated by the Department of
Veterans Affairs are excluded from FDA's review, but they are accredited
by ACR and are required by the Veterans' Health Care Eligibility Reform
Act to meet standards equivalent to those in MQSA. Pub. L. No. 104-262, S:
321(a)(1), 110 Stat. 3177, 3195 (codified at 38 U.S.C. S: 7319).

18FDA's final MQSA regulations also included standards for accreditation
bodies that took effect in 1999. In 2002, FDA issued regulations
containing standards for certification bodies. See 67 Fed. Reg. 5446-69
(Feb. 6, 2002).

  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 state19 or certified by an appropriate board, such as the
American Registry of Radiologic Technologists, in general radiography.20
They must also meet additional training, continuing education, and
experience requirements related to mammography. FDA also specifies that
all interpreting physicians be licensed in a state; be certified in the
specialty by an appropriate board, such as the American Board of
Radiology;21 and meet certain medical training, continuing education, and
experience requirements related to mammography.

  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.22 A facility
seeking accreditation reinstatement follows the same process as the new
applicant, but must also submit to the accreditation body a corrective
action plan that describes the action the facility has taken to correct
problems that prevented it from achieving or maintaining certification. If
the accreditation body determines that a new or reinstating facility meets
the MQSA standards for the initial accreditation phase, it notifies FDA;
for states with an FDA-approved state certification body, FDA in turn
notifies the state certification body.23 FDA or the state certification
body then issues a provisional certificate that allows the facility to
operate legally for up to 6 months.24

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

20The American Registry of Radiologic Technologists is the nation's
credentialing organization for radiologic technologists. It administers an
examination for certification, maintains a registry of currently certified
general radiologic technologists, and administers a subspecialty
examination and certification program for mammography technologists.
Although technologists who perform mammography do not have to be certified
in the mammography subspecialty, the majority of the technologists who
perform mammography, including those who are licensed by states, have such
certification.

21Physicians who interpret mammograms can also meet FDA's requirements if
they have had a minimum of 3 months of documented specialized training in
the interpretation of mammograms.

22Although all accreditation bodies follow MQSA standards for accrediting
mammography facilities, the accreditation processes established by each
accreditation body vary slightly, such as with respect to when facilities
must submit certain information for review and when to submit the
accreditation application fee. For example, Iowa's application fee is
required as part of the second phase of the accreditation process.

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

24A facility that does not complete the accreditation process within the
6-month provisional period must either cease performing mammography or
apply for a onetime 90-day extension of the provisional certificate. MQSA
requires that to receive the extension, the facility must show that access
to mammography in the geographic area served by the facility would be
significantly reduced if the facility did not receive the extension. 42
U.S.C. S: 263b(c)(2).

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

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.

aA 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.

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

cA 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.

Second, to achieve full accreditation, the facility must submit to the
accreditation body phantom and clinical images,25 quality control tests,
and other information required by MQSA. If the accreditation body
determines that the facility meets MQSA standards applicable to the images
and all other submitted information, it accredits the facility and each of
the facility's approved mammography machines for 3 years. The
accreditation body notifies FDA of each mammography machine's approval;
for states with certification bodies, FDA in turn notifies the state
certification body.26 On the basis of the accreditation body's
notification, FDA or the state certification body issues a 3-year MQSA
certificate to the facility, which allows it to legally perform
mammography up to the certificate expiration date.27 Accreditation bodies
notify facilities they have accredited about 6 to 8 months prior to
expiration of their 3-year certification period that they must apply for
reaccreditation. Facilities applying for reaccreditation are not required
to obtain a provisional certificate if they submit all the information
required for full accreditation before their certificate expires and if
the facility meets FDA standards. After approval by its accreditation
body, a facility receives a new 3-year MQSA certificate from FDA or the
state certification body.

Each accreditation body is required to make annual on-site visits to a
sample of facilities that it accredited.28 The on-site visits include
reviewing samples of randomly selected clinical images to assess image
quality,29 verifying the information that facilities provided in the
accreditation application,30 and reviewing documentation showing that
facilities sent reports on mammography results to patients and physicians.
In addition, on-site visits have an educational element; for example,
members of the accreditation body team may suggest ways to improve
clinical image quality.

25A phantom image is a radiographic (X-ray) image of a phantom, which is a
plastic block used to simulate radiographic characteristics of breast
tissue. FDA-approved phantoms simulate a 4.2-centimeter-thick compressed
breast consisting of 50 percent glandular and 50 percent fatty tissue, and
contain16 test objects that simulate aspects of breast disease and cancer.
The phantom is used to assess the ability of the facility's imaging
equipment to detect breast disease and cancer. Under Arkansas's and Iowa's
procedures, facilities must submit the phantom images as part of the
initial application package.

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

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

28MQSA regulations require that each accreditation body annually visit at
least 5 percent of the facilities it accredits and that at least half of
the facilities be selected randomly. The other facilities are selected
based on problems identified in various ways, such as through state or FDA
compliance inspections, previous history of noncompliance, and serious
consumer complaints. The accreditation body must visit at least 5
facilities each year, but is not required to visit more than 50 unless
problems that had been identified indicate a need to visit more than 50
facilities. See 21 C.F.R. S: 900.4(f)(1).

The annual MQSA compliance inspections conducted by FDA and the state
certification bodies differ in focus and scope from the on-site
accreditation visits, although both the inspections and the on-site
accreditation visits are intended to monitor and assess facility
compliance with MQSA standards.31 In addition to verifying information
submitted during the accreditation process, FDA and the state compliance
inspectors-including those under contract to FDA and those working for the
state certification bodies-conduct several other reviews. These include
performing equipment tests and in-depth reviews of personnel
qualifications and reviewing quality control and quality assurance
records.32 For example, inspectors review quality control records for each
film processor33 and X-ray machine used for mammography. FDA and state
certification bodies are responsible for monitoring and enforcing the
correction of facility problems discovered during MQSA compliance
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.

29The random sample of clinical images that each accreditation body
reviews annually must include images from at least 3 percent of the
facilities the body accredited. See 21 C.F.R. S: 900.4(f) (2).

30Accreditation body staff verify, among other things, that the facility
personnel and equipment identified in the application are the ones used to
perform mammography services and that the facility has in place a consumer
complaint system and a medical audit system, which is a system for
reviewing and tracking outcomes of positive mammograms-those identified as
having abnormalities-and correlating them with biopsy results. See 21
C.F.R. S: 900.4(f)(1)(ii) for a description of the minimum review
requirements accreditation body site visits must meet.

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

32The purpose of reviewing quality control records is to ensure that the
equipment quality control tests performed by radiologic technologists are
routinely done at the required frequencies, that test records are in
order, and that corrective actions are taken when warranted. The purpose
of reviewing quality assurance records is to ensure that the facility
develops and maintains policies and procedures to monitor the performance
of facility personnel and equipment.

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

  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.34 This requirement applies not only
to individuals who review phantom or clinical images, but also to state
agency managers, consultants, administrative personnel, and any other
individuals working for the accreditation body. MQSA regulations also
require that FDA conduct annual performance evaluations of accreditation
bodies' and certification bodies' compliance with MQSA standards. MQSA
requires that FDA annually submit to congressional oversight committees a
written report on the performance of the accreditation bodies.35

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

3542 U.S.C. S: 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.

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 199036 established CDC's National Breast and Cervical Cancer Early
Detection Program. Under this program, CDC makes grants to states to
provide mammography services to medically underserved women, especially
those with low incomes and without health insurance coverage.37 From 2001
through 2003, over 50 percent of the women served by the program were from
minority groups. The second initiative relates to coverage for screening
mammography under Medicare, the federal government's health insurance
program for people age 65 and older and certain disabled people. CMS,
which administers Medicare, has contracted with QIOs in each state to
assist it in monitoring and improving the quality of health care,
including improving mammography screening rates among Medicare
beneficiaries. QIOs seek to improve mammography screening rates by working
with physician offices and other health care providers to establish
improved systems for referring patients for mammography and collaborating
with state and local coalitions and other organizations on promotion
efforts, such as the distribution of educational materials on mammography
and outreach to encourage Medicare beneficiaries to obtain screening.

In addition to these initiatives, the federal Consolidated Health Centers
program, administered by HHS's Health Resources and Services
Administration (HRSA), increases access to health care services, including
screening mammography, for women in medically underserved areas.38 In
2004, 71 percent of health center patients had a family income at or below
the federal poverty level, and 40 percent were uninsured. In addition, 63
percent of patients were members of racial or ethnic minority populations,
and 29 percent spoke a primary language other than English.39

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

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

38Criteria for designating a medically underserved area or population
include the ratio of primary medical care physicians per 1,000 population,
infant mortality rate, percentage of the population with incomes below the
federal poverty level, and percentage of the population age 65 or older.
In 2005, the federal poverty level for a family of four was an annual
income of $19,350 in the 48 contiguous states and the District of
Columbia.

 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, 2004.40 During this
period, 1,290 certified mammography facilities closed, while 752
facilities received 6-month provisional certificates to begin providing
services, resulting in a net decrease of 538 facilities, including a net
decrease of 87 mobile mammography facilities, which may serve multiple
locations.41 Forty states lost facilities during this period, including 10
states that each lost more than 20 facilities.42 These 10 states accounted
for over half of the 538 net decrease. (See app. III for information by
state.)

The most commonly cited reasons for facility closures were related to
financial considerations. We relied on data from ACR for information on
what facility officials reported as the reasons for closure43 because
FDA's Mammography Program Reporting and Information System database does
not include such data. For certified mammography facilities that had been
accredited by ACR and that closed from October 1, 2001, to October 1,
2004, facility officials most often reported financial considerations as
the reason for closure.44 Specifically, for 35 percent of the closures,
facility officials told ACR that the primary reason was financial. (See
table 1.) In addition, even when they did not cite financial
considerations specifically, their reasons were often related to finances.
For 25 percent of the closures, facility officials reported that they
moved their facility to a sister site, and an ACR official said that many
of the facilities consolidated their mammography activities in an effort
to conserve financial resources. Facility officials also frequently
reported equipment and staffing problems as reasons for closure, and an
ACR official told us that these problems were sometimes financial in
nature. In addition, officials of state accreditation bodies told us that
closures in their states from 2001 to 2004 were generally related to
financial concerns. For example, a Texas accreditation body official said
she believed that the majority of closures accredited by the state body
were due to bankruptcy, low business volume, or low reimbursement rates
for services. FDA and mammography experts also identified financial
considerations as having contributed to facility closures.

39Information on health center patients is based on data from HRSA's
Uniform Data System. The percentages related to income level and
race/ethnicity exclude patients whose status HRSA reported as unknown. The
income level of 19 percent of patients was reported as unknown, and the
race/ethnicity of 6 percent was reported as unknown.

40Facilities in U.S. territories, federal facilities operated by the
Department of Defense, facilities at prisons and correctional
institutions, and facilities that had not achieved provisional or
accreditation status were excluded from the analysis.

41A mobile mammography facility performs mammography using a vehicle
equipped with a mammography X-ray machine and travels from one location to
another. In some cases, one or more of these mobile facilities are
dedicated to a fixed facility, such as a hospital, outpatient clinic, or
radiology practice.

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

43In April 2001, ACR began tracking the number of closures of facilities
that it accredited and the reasons for closure that were reported by
facility officials.

44ACR learns of facility closures from a variety of sources, including
facility personnel, FDA, state certifiers, state inspectors, local cancer
societies, and patients. When ACR is notified that a facility has closed,
ACR contacts the facility by telephone to confirm the closure and sends a
facility closure memorandum. A facility closure memorandum asks for
general information about the closure and the reason for closure. ACR
officially lists the facility as closed in its records after the
memorandum has been signed by the facility's lead radiologist, chief
executive officer, or president. If the memorandum is not returned to ACR
within 10 business days after it has been sent, ACR closes the facility in
its database.

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

                                                Number of                     
Reason for closurea                          closuresb Percentage of total
Financial decision                                 424                  35 
Relocation of facility to sister site              305                  25 
Other/equipment problemsc                          136                  11 
Staffing problems                                  124                  10 
Bankruptcy                                          25                   2 
Other/mobile facility merged with another           28                   2 
site                                                   
Other/changes in ownership                          23                   2 
Unknown                                             80                   7 
Other/miscellaneous                                 66                   6 
Total                                            1,211                 100 

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

aACR 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.

bAccording 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.

cAn ACR official told us that equipment problems were most likely either a
facility's inability to meet the more stringent FDA quality assurance
regulations for equipment that went into effect in 2002 or equipment
failures that facilities decided were too costly to repair.

Experts also told us that difficulties in recruiting and retaining staff
have contributed to closures. Officials of the American Society of
Radiologic Technologists said that some radiologic technologists think the
repetitive nature of mammography procedures-especially screening
mammography-makes mammography seem like an unattractive, assembly-line
operation and that radiologic technologists who perform mammography are
paid less, in general, than those in other imaging specialties. Experts
also reported that some radiologists consider the mammography field
unappealing because it is stressful, "low tech," and lower paying and less
respected than other imaging specialties; involves 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.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.

45Many of the names in FDA's database within each year are duplicates
because many of these individuals work at multiple facilities and their
names are counted at each facility they serve. After correcting errors in
the spelling of names and other data entry mistakes, we calculated the
unduplicated numbers of radiologic technologists and interpreting
physicians. We determined that the unduplicated numbers of radiologic
technologists in FDA's Mammography Program Reporting and Information
System database were 31,402 in 2001 and 30,503 in 2004. We determined that
the unduplicated numbers of interpreting physicians in the database were
19,675 in 2001 and 18,690 in 2004. (See app. II.)

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

                                                2001   2004 Percentage change 
Facilities                                  9,306  8,768                -6 
Machines                                   13,995 13,400                -4 
Radiologic technologists who perform                                       
mammography                                31,402 30,503                -3
Physicians who interpret mammograms        19,675 18,690                -5 

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

Number of Women Who Received Screening Mammograms Increased as Population of
Women Age 40 and Older Grew

Reflecting the steady increase in the population of women age 40 and
older,46 the estimated number of women in this age group who received a
screening mammogram within the previous year has increased and is likely
to continue to grow over the next several years. Based on NHIS survey
data, the estimated number of women age 40 and older who received a
screening mammogram within the previous year increased nationwide by 14
percent from 2000 to 2003, from about 29 million to about 33 million.47
This increase resulted from the population growth in this age group
coupled with a slight increase-from 50 percent in 2000 to 51 percent in
2003-in the estimated proportion of women in this age group who received a
screening mammogram within the previous year.48 The number of women age 40
and older who receive a screening mammogram is likely to continue to grow
over the next several years 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.

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

47Based on NHIS survey data, screening mammograms accounted for 91 percent
of the number of women age 40 and older who received a mammogram in 2000
and 94 percent in 2003.

48In the 2003 NHIS survey, uninsured women age 40 and older and poor women
age 40 and older reported lower screening rates than other women in that
age group. Twenty-six percent of uninsured women age 40 and older reported
having a screening mammogram within the previous year, in comparison with
57 percent of women in the same age group who had private insurance or
were enrolled in the U.S. military's medical health benefits program.
Similarly, 36 percent of poor women age 40 and older reported having a
screening mammogram within the previous year, in comparison with 52
percent of women with middle incomes and 60 percent of women with high
incomes. The following are the 2003 NHIS screening rates for this age
group by ethnicity: White-52 percent; African American-51 percent;
Hispanic-48 percent; Asian-44 percent; and Native American- 35 percent.

Data from NHIS indicate that the proportion of women age 40 and older who
received a diagnostic mammogram within the previous year decreased from 5
percent in 2000 to 3 percent in 2003. The estimated number of women age 40
and older who received a diagnostic mammogram within the previous year
declined from about 3 million women in 2000 to about 2 million in 2003.

Current Nationwide Mammography Capacity Is Adequate

National mammography capacity data we reviewed indicate that the nation's
current capacity to provide mammography services is adequate. Our
estimates of current capacity found that the number of mammograms
performed by U.S. machines was substantially lower than the number that
could be performed. Since screening mammograms accounted for 94 percent of
the mammograms provided in 2003, we began our capacity calculations by
focusing on screening mammograms. The majority of experts we interviewed
estimated that it normally takes 15 to 20 minutes of machine and
radiologic technologist time to perform a screening mammogram.49 Using the
upper range of this estimate, we estimated that a machine and one
radiologic technologist could perform 3 mammograms per hour, or 24
mammograms in an 8-hour day. This rate would yield a potential capacity of
6,000 mammograms per machine per year.50 Using FDA data on the number of
machines in 2003 (13,510), we calculated that in 2003 about 81 million
screening mammograms could have been performed by U.S. machines.51 Data
from the 2003 NHIS indicate that nationwide an estimated 33 million women
age 40 and older received a screening mammogram and that an estimated 2
million women in that age group received a diagnostic mammogram. Most
experts we interviewed estimated that it takes 30 to 60 minutes of machine
and radiologic technologist time to perform a diagnostic mammogram. The
excess capacity that we found for performing screening mammograms in 2003
would have been more than adequate for performing the estimated 2 million
diagnostic mammograms that were performed that year.52 These capacity
estimates are rough estimates, but the difference between estimated
machine capacity and estimated use is sufficiently large to indicate that
there is unused capacity nationwide. It is difficult to measure capacity
precisely because several variables can affect capacity at the individual
facility level, such as the efficiency of facilities' operations.53

49Of the eight experts we consulted, five experts estimated a time of 15
to 20 minutes. Two other experts and an FDA official estimated a time of
10 to 15 minutes. One expert did not provide an estimate.

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

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

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.54

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

53Factors that can affect capacity include a facility's balance between
screening and diagnostic mammograms and its approach to scheduling those
services. For example, some facilities achieve greater efficiency by
scheduling screening and diagnostic mammograms at different times.
Facilities also differ in the way they manage their personnel and
schedules. At some facilities, radiologic technologists who perform
mammograms help patients complete forms and prepare for the examination,
reducing the number of mammograms they can perform, while at other
facilities assistants perform this work. Some facilities have evening and
weekend hours, increasing their capacity.

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.

54Carl D'Orsi, et al., "Current Realities of Delivering Mammography
Services in the Community: Do Challenges with Staffing and Scheduling
Exist?" Radiology, vol. 235, no. 2 (2005): 391-395.

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 2,276.55 As of October 1, 2004, 865 counties had no mammography
machines; these counties tended to be concentrated in certain midwestern,
southern, and western states and contained 3.4 percent of the U.S.
population.56 (See fig. 2.) Some of these counties, however, may have been
served by mobile mammography machines; as of October 1, 2004, there were
266 mammography machines in 222 mobile facilities nationwide.

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

56U.S. Census Bureau, Population Estimates Program, County Population
Estimates and Estimated Components of Change: April 1, 2000 to July 1,
2004 (Washington, D.C.: April 2005) http://www.census.gov/popest/counties 
(downloaded March 6, 2006).

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

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.

Nationwide, 413 counties that had at least one machine at some point
during the 3-year period had experienced a net loss of mammography
machines as of October 1, 2004. Of these counties, 117-containing 2.6
percent of the total 2004 U.S. population-lost more than 25 percent of
their machines.57 Our analysis of the available supply of mammography
machines in counties that are adjacent to these 117 counties found that 75
are not adjacent to any county that gained machines during this period,
and 47 of these 75 counties are adjacent to at least one other county that
lost machines.58

Loss or Absence of Mammography Machines in Certain Locations May Have Resulted
in Considerable Travel Distances or Wait Times to Obtain Services

Although national mammography capacity appears to be adequate in general,
in certain locations the loss or absence of machines may have resulted in
access problems consisting of lengthy travel distances or significant wait
times. The majority of officials we interviewed about the effects of the
loss or absence of machines told us that machine losses had not resulted
in access problems because women were able to obtain mammography services
at other facilities.59 However, several of the officials told us that the
loss or absence of machines had affected access for some women.

In certain locations, the loss or absence of mammography machines resulted
in women-including women who are medically underserved-needing to travel
lengthy distances for mammography services. For 6 of the 18 counties we
randomly selected for review that lost more than 25 percent of their
machines,60 one local or QIO official told us that facility closures and
machine losses in those counties had resulted in women traveling longer
distances than previously.61 For example, a Mississippi QIO official
estimated that after one facility closure left Newton County with one
facility that provided only screening mammography, some women had to
travel about 30 miles for screening and about 50 miles for diagnostic
mammography. He said that women depended on working family members for
transportation, and that according to mammography facility staff, fewer
women were obtaining mammograms. Similarly, in four states,62 officials
working with CDC's early detection program for medically underserved women
told us that seven facility closures, involving the loss of seven
machines, had affected program participants' travel distances. For
example, a Virginia official estimated that after Dickenson County lost
its mammography facility and associated machine, program participants who
previously traveled from 20 to 25 miles for services had to travel about
60 miles to obtain services. A West Virginia official working with the CDC
program noted that program participants in Jackson County had to travel a
longer distance to obtain mammography services because of a facility
closure and faced problems of increased travel cost and time away from
families and jobs.

57In 82 (70 percent) of the 117 counties that lost more than 25 percent of
their machines, the population increased from 2001 to 2004, with increases
ranging from less than 1 percent to 21 percent.

58In 51 (68 percent) of the 75 counties, the population increased from
2001 to 2004, with increases ranging from less than 1 percent to 17
percent.

59State, local, and QIO officials discussing 11 of the 18 counties in our
study that lost more than 25 percent of their machines told us that the
loss of machines had not affected access to mammography services. We do
not have information on 1 of the 18 counties because for that county only
one QIO official responded and she had no knowledge of machine losses in
the county. Officials who work with CDC's early detection program in four
of eight states we reviewed said that facility closures had no effect on
access to mammography services for underserved women in their program. In
addition, 9 of the 10 community health center officials we interviewed
reported that facility closures in their counties did not create access
problems for their patients.

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,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.

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

61For each of the six counties, one of the three officials we interviewed
reported that women had experienced longer travel distances. The other
officials who responded to our request for information stated either that
women's access to mammography services had not been adversely affected or
that they did not have knowledge of the effects of facility closures and
machine losses from 2001 to 2004.

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

The loss or absence of machines in certain counties may also have caused
women-including those who are medically underserved-to experience
significant wait times for mammography services. Although there is no
specific medical standard for the maximum amount of time a woman should
have to wait for mammography services, most experts we interviewed said
that it was best if the wait time for screening mammography did not exceed
30 days and if the wait time for diagnostic mammography did not exceed 2
days. State officials working with CDC's early detection program and a QIO
official told us of situations where the loss or absence of machines in
certain locations might have resulted in wait times that exceeded wait
times the experts said were appropriate. For example, New York officials
working with CDC's early detection program estimated that after the
closure of two facilities involving the loss of two machines in Brooklyn,
the screening wait time for participants who had used those facilities was
about 2 months; at the busiest time of the year, the wait time was 3 to 4
months. The West Virginia program official estimated that after the
facility closure in Jackson County, participants' wait time for diagnostic
mammography averaged 8 weeks, and could be as much as 3 months.64 A North
Dakota QIO official told us that women in parts of the state face
significant wait times for mammography services. Sixty percent of North
Dakota's counties had no machines as of October 1, 2004, and the official
said that a limited number of providers served large geographic locations
in the largely rural state. For example, she told us that one provider's
mobile facility served almost the entire northwest quarter of the state
and was available to some communities once every 4 months and to others
only once a year.

63Missouri counties were not part of our random sample of counties. We
spoke with a Missouri QIO official because of her expertise in access to
mammography.

64The New York and West Virginia officials did not provide estimates of
the number of days women had to wait for mammography services prior to the
facility closures.

  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

                                                                    State
                                State accreditation             certification
                                       bodies                      bodies
Measures                   Arkansas Iowaa Texasb    Illinois     Iowaa
State laws or personnel                                             
policies                                                            
Code of ethics                   o          o    o             o      o    
                                                    c                  
Financial disclosure            o d                           o e   
statement required of                                               
state body employees                                                
Required ethics training                         o             o    
Procedures                                                          
Use a list of facilities         o          o    o            N/A    N/A   
where reviewers have a                           b                  
financial or other                                                  
relationship in                                                     
determining assignment of                                           
clinical images to                                                  
reviewers                                                           
Conduct "blind reviews" of       o          o                 N/A    N/A   
mammography images by                                               
concealing facility                                                 
identityf                                                           
For each clinical image          o          o    o            N/A    N/A   
and phantom image review,                        b                  
use two or more                                                     
individuals working                                                 
independentlyg                                                      

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

Legend:  o  = 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.

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

bTexas 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.

cTexas law requires that all state employees file a written statement
acknowledging receipt of the state's standard of conduct laws.

dArkansas 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.

eIllinois 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.

fPersonnel 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.

gState 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.

  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.65 These laws and policies vary in scope across the three states,
and each state has penalties associated with violating its laws.66 For
example, with regard to financial disclosure, Arkansas requires all state
employees to file a statement disclosing any income source other than
their regular salary from which they received over $500.67 In contrast,
Iowa requires only certain individuals, such as elected officials and
higher level agency officials, to file financial disclosure forms68 and in
general does not require this of employees carrying out accreditation
responsibilities. While Texas also requires only certain individuals, such
as elected officials and higher level agency officials, to file financial
disclosure forms,69 the Texas accreditation body contracts with ACR for
its phantom and clinical image reviews, and ACR's reviewers are subject to
ACR's requirement to disclose financial and other relationships with
businesses or clients involving mammography and to report related
compensation over $200.70 The Texas accreditation body is the only one
that requires its employees to attend ethics training when they are hired.
In addition, Texas law requires its employees to acknowledge that they
have received copies of the state employee standards of conduct.71

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.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.

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

66Ark. Code Ann. S: 21-8-302 (2005); Iowa Code Ann. S: 68B.25 (2005); Tex.
Gov't Code Ann. S:S: 572.007, 572.033, and 572.0034 (2005).

67Ark. Code Ann. S: 21-8-203 (2005).

68Iowa Code Ann. S: 68B.35 (2005).

69Tex. Gov't Code Ann. S: 572.021 (2005).

70ACR's image reviewers are not ACR employees but experts in their fields
who volunteer their services to ACR and receive modest reimbursement.
Texas's contract includes reviews associated with new mammography
facilities or equipment, accreditation renewal, random on-site reviews,
and additional mammography reviews. Additional mammography reviews are
performed outside the normal accreditation or reaccreditation process when
there are concerns about mammography quality at a facility.

71Tex. Gov't Code Ann. S: 2113.014 (2005).

  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.73 Illinois officials told us that employees
of the Illinois certification body with decision-making
responsibilities-including the coordinator of MQSA certification
functions-submit a financial disclosure statement. However, in general,
Illinois employees who inspect mammography facilities are not required to
file such statements.74 Illinois ethics law also requires that all state
employees annually complete ethics training,75 which in the past has
covered topics such as acceptance of gifts and conflicts of interest.

72An ACR official told us that ACR does not use blind reviews because of
the regulatory requirement to verify that each clinical image contains the
name and location of the facility that produced it. In Arkansas and Iowa,
accreditation body employees first verify that an image contains the
appropriate identifying information and then conceal this information
before giving the image to the reviewer.

FDA Approved State Bodies' Measures to Avoid Conflicts of Interest, and Its
Evaluations of State Bodies Have Not Found Problems

As part of the state accreditation and certification body application
processes, FDA approved the measures each state body submitted as its
approach for avoiding conflicts of interest. These measures consisted of
the state ethics laws, state agency personnel policies, and procedures the
state body would use to carry out its duties. (See table 3.) FDA officials
told us that in determining whether these measures were adequate to ensure
independence, they based their decisions on the conflict-of-interest
standards in MQSA regulations. MQSA regulatory standards on conflicts of
interest are broadly written; they do not provide specific guidance to
states on what measures they should take to avoid conflicts.

Using written protocols, FDA has conducted annual performance evaluations
of state accreditation and certification bodies to assess whether these
bodies are complying with MQSA regulations. Evaluations of state
accreditation bodies have covered, among other things, state bodies'
procedures for reviewing phantom and clinical images and for resolving
consumer complaints about mammography facilities. These procedures are a
part of the accreditation bodies' efforts to avoid conflicts of interest.
In addition, FDA staff have independently reviewed samples of phantom and
clinical images previously reviewed by the accreditation body to monitor
the quality of the accreditation body's work.76 FDA officials told us that
their staff have also reviewed several randomly 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.

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

74FDA officials told us that MQSA compliance inspectors employed by FDA
are required to file financial disclosure statements, but state inspectors
working under contract with FDA are not required to do so.

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

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

An FDA official told us that during the on-site visits that have been part
of FDA annual evaluations and during FDA's quarterly meetings with state
body officials, FDA officials have asked whether any conflict-of-interest
problems have arisen.77 According to this official, state body officials
have never reported to FDA during a quarterly meeting that they had
experienced a conflict-of-interest problem. During on-site visits, FDA
officials have inquired about state bodies' overall policies and
procedures. State bodies' staff have generally described their policies
and procedures for avoiding conflicts of interest and orally assured FDA
that they are following these measures. FDA relies on the states to
oversee the implementation of state ethics laws and policies. However, FDA
requires state bodies to immediately report any situation that might
adversely affect the public's health, including complaints about conflicts
of interest involving state bodies' personnel. The FDA official also said
that no state body has ever reported a problem or concern related to a
conflict of interest involving a reviewer or inspector and that FDA has
never found a conflict-of-interest problem in its evaluations of state
bodies' performance. 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.

77Until recently, the annual evaluations included on-site visits to state
bodies, but in 2005 FDA decided to visit state bodies every other year,
alternating visits to accreditation and certification bodies. For example,
FDA planned to visit accreditation bodies in 2005 and certification bodies
in 2006. The biennial schedule is due to budget constraints and state
bodies' consistent performance in implementing policies and procedures,
according to FDA officials.

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 http://www.gao.gov .

If you or your staff members have any questions, please contact me at
(202) 512-7119 or [email protected] . Contact points for our Offices of
Congressional Relations and Public Affairs may be found on the last page
of this report. GAO staff members who made contributions to this report
are listed in appendix V.

Marcia Crosse Director, Health Care

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

As authorized under the Mammography Quality Standards Reauthorization Act
of 1998 (MQSRA), the Food and Drug Administration (FDA) conducted an
inspection demonstration program (IDP) to evaluate the feasibility and
impact of conducting mammography facility compliance inspections less
frequently than annually.1 FDA's goal for the IDP was to determine whether
the inspection frequency of mammography facilities that had been found to
be in compliance with the Mammography Quality Standards Act of 1992 (MQSA)
standards could be reduced from yearly to once every 2 years without a
decrease in compliance rates. FDA carried out the IDP from November 2001
through August 2004.2 This appendix summarizes the methodology and results
of the IDP.

Methodology

MQSRA required that facilities selected for the IDP be "substantially free
of incidents of noncompliance" and that the number of facilities selected
be sufficient to provide a statistically significant sample of
facilities.3 FDA selected facilities for the IDP from states that
indicated a willingness to participate in the program and met certain
criteria.4 For example, FDA excluded states that had laws, regulations, or
policies requiring annual inspections, and considered states that could
accept changes to their existing inspection contract with FDA to reflect
the reduction in the number of facilities that they would inspect during
the IDP.5 To minimize the financial impact that a reduced inspection
schedule would have on 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.

1The 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. S: 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, S: 8, 112 Stat. 1864, 1865-66 (codified at 42 U.S.C. S:
263b(g)(6)).

2FDA issued a report describing the results of the IDP in January 2005.

3MQSRA did not stipulate an implementation deadline, program duration, or
inspection interval, but stated that the program could not be implemented
before April 1, 2001.

4To 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.

5FDA 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.

FDA established that to be eligible to participate in the IDP, a facility
had to be free of MQSA violations during the two most recent annual
inspections and have undergone at least two annual inspections under the
final MQSA regulations that took effect in April 28, 1999. Among other
things, a facility also had to maintain full accreditation and
certification throughout the program and expect to provide services
through the duration of the IDP. Using random selection, FDA divided the
eligible facilities in the 14 jurisdictions into a study group and a
control group. The study group consisted of 146 facilities. The control
group had 132 facilities in the first year of the program and 126 of those
facilities in the second year.6

FDA officials told us that they were not able to achieve a statistically
valid sample that would allow the results to be projected nationwide,
primarily because a number of states were not willing to participate in
the demonstration program or had state laws that required annual
inspections. An FDA official said that FDA implemented the demonstration
program even though the results could not be projected nationwide because
agency officials believed that the results of the program would be useful
to the Congress.

Results

Overall, the inspections of the study group facilities, which occurred
after a 2-year interval, found that facilities did not maintain the
violation-free compliance level that they had previously. Of the 146 study
group facilities, 58 percent were in full compliance with MQSA, while 42
percent were cited for violations.7 (See fig. 3.) Moreover, the study
group facilities had a lower compliance rate than facilities inspected
annually, either as part of the IDP's control group or outside of the
demonstration program. The facilities in the study group had a higher
percentage of violations across all three violation levels than facilities
that had annual inspections. Most of the study group's level 1, or most
serious, violations were related to missing records of the quality control
tests, such as those required for the mammography film processor.8 Level 2
violations-the most prevalent category of violation for all groups-were
almost twice as high in the study group (27 percent) as in the control
group (14 percent).

6The lower number of control group facilities available for inspection in
the second year of the IDP was due primarily to facility closures.

7FDA 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.

8The 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. S:
900.12(e).

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

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.

aFacilities in the study group did not receive inspections during the
period of May 1, 2002, through April 30, 2003.

Because the study group had a decrease in compliance, FDA officials
decided not to expand the demonstration program and returned all
mammography facilities to the annual inspection schedule. In commenting on
the IDP results, an FDA official responsible for the program noted that
the IDP did not provide evidence that facilities could maintain their
violation-free status without annual compliance inspections.

Appendix II: Scope and Methodology

To identify the number of certified mammography facilities that closed
nationwide in recent years, we obtained and analyzed data from FDA's
Center for Devices and Radiological Health Mammography Program Reporting
and Information System database on the number of certified mammography
facilities that closed and those that received 6-month provisional
certificates to begin providing services from October 1, 2001, to October
1, 2004. To examine information on the factors that contributed to
mammography facility closures in recent years, we used three sources. We
obtained data from the American College of Radiology (ACR) on mammography
facilities accredited by ACR that closed from October 1, 2001, to October
1, 2004, and the reasons for closures reported by officials of facilities
accredited by ACR. We reviewed data and interviewed officials of state
accreditation bodies in Arkansas, Iowa, and Texas about closures of
facilities accredited by these states from 2001 through 2004. We also
interviewed eight radiologists who are experts in mammography about
factors that contribute to mammography facility closures.

To examine changes in the nation's capacity for and use of mammography
services in recent years and the adequacy of current capacity, we analyzed
data from FDA's Mammography Program Reporting and Information System
database on the total numbers of certified facilities, machines,
radiologic technologists who perform mammography, and physicians who
interpret mammograms as of October 1, 2001, and October 1, 2004. We
excluded facilities in U.S. territories. We also excluded federal
facilities operated by the Department of Defense, and facilities at
prisons and correctional institutions because they are not generally
accessible to the public. We also excluded facilities that had not
achieved provisional or accreditation status that were in FDA's
Mammography Program Reporting and Information System database because they
had not been certified by FDA or a state certification body as of October
1, 2001, and October 1, 2004. FDA's database contains many duplicate names
of radiologic technologists and interpreting physicians because many of
these individuals work at multiple facilities and their names are counted
at each facility they serve. To remove the duplicates, we analyzed data
files from FDA that contained the names and addresses of radiologic
technologists and interpreting physicians who worked at mammography
facilities as of October 1, 2001, and October 1, 2004,1 and used an
iterative process to edit the data fields containing the technologists'
and physicians' first and last names. The first step was to "clean" the
fields of extraneous commas, spaces, punctuation, and other values. The
next step was to correct obvious and common spelling errors, such as
Michael spelled Micheal. The last step was to visually check for
additional misspellings, using the address information on the FDA file to
confirm that an entry was indeed a duplicate with a misspelled first or
last technologist or physician name. The duplicates were removed from the
edited file, and the analysis continued using the edited file of
unduplicated names of radiologic technologists and interpreting
physicians. To examine changes in the nationwide use of mammography
services, we analyzed data from the 2000 and 2003 National Health
Interview Survey (NHIS),2 administered by the Centers for Disease Control
and Prevention's (CDC) National Center for Health Statistics, to estimate
the number of women age 40 and older who received a screening or
diagnostic mammogram within the previous year. NHIS data on the use of
mammography services are based on data that are self-reported by
respondents. NHIS asked women age 30 and older about the length of time
since their last mammogram and about the reason for the mammogram. NHIS
surveys conducted in 2000 and 2003 provided the most recent trend data
available at the time we conducted our analysis. Using the 2000 and 2003
NHIS data, we compared screening rates and diagnostic rates for women age
40 and older and estimates of the number of women receiving screening and
diagnostic mammograms nationwide within the previous year. To determine
the adequacy of current capacity, we obtained estimates from mammography
experts of the amount of time it takes to perform a screening mammogram,
and we used those estimates and FDA data on the number of machines
available in 2003 to calculate the number of screening mammograms that
potentially could have been performed in 2003. We compared our estimate of
81 million screening mammograms that could have been performed by U.S.
machines to the estimated number of women age 40 and older who received a
screening mammogram within the previous year, based on data from the 2003
NHIS. We also obtained estimates from mammography experts of the amount of
time it takes to perform a diagnostic mammogram and data on the estimated
number of women age 40 and older who received a diagnostic mammogram in
2003.3 To examine changes in the population of women 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.

1FDA'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.

2In 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.

3According to NHIS data, about 92 percent of the women who received a
mammogram in 2003 were 40 and older.

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                Urban counties
County           State           County       State        
Navajo           Arizona         Houston      Alabama      
Drew             Arkansas        Saint Johns  Florida      
Putnam           Florida         Coweta       Georgia      
Shiawassee       Michigan        Warren       Iowa         
Newton           Mississippi     Butler       Kansas       
Lewis and Clarke Montana         Wayne        New York     
Fulton           New York        Morton       North Dakota 
Duplin           North Carolina  Pottawatomie Oklahoma     
Dickenson        Virginia        Lubbock      Texas        

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

The determination of the 18 counties as urban or rural is based on the
2003 Rural-Urban Continuum Codes published by the Department of
Agriculture, which classifies all U.S. counties into nine categories. The
Department of Agriculture groups nonmetropolitan counties into six rural
categories by size of the urban population and nearness to a metropolitan
area; it groups metropolitan counties into three urban categories based on
the size of the metropolitan area in which the county is located.

For the 18 counties selected, we interviewed officials familiar with
access to mammography services in these counties and asked them about
their views on the effects of the loss of machines and facilities on
access in these counties. These officials generally included county health
department officials who coordinate health programs; state radiation
control personnel under contract to FDA to conduct annual on-site
inspections of mammography facilities; and quality improvement
organization (QIO) officials under contract to CMS to monitor and improve
the quality of care, including increasing statewide mammography screening
rates for Medicare beneficiaries. We also interviewed two QIO
officials-one from Missouri and one from Washington-about access in areas
of their states. The 18 counties we selected did not include any in
Missouri or Washington, but these two officials were among three QIO
officials we attempted to contact who were recommended by a CMS official
as being knowledgeable about mammography access issues in their states.

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

                                                Rural/urban county            
County                         State         designation                   
Logan Sharp                    Arkansas      Rural Rural                   
Fulton Wilkes                  Georgia       Urban Rural                   
Gem Shoshone                   Idaho         Rural Rural                   
Cook Peoria                    Illinois      Urban Urban                   
Berrien Wayne                  Michigan      Urban Urban                   
Kings Oneida Saint Lawrence    New York      Urban Urban Rural Urban       
Tioga                                        
Dickenson Washington           Virginia      Rural Urban                   
Hardy Jackson                  West Virginia Rural Rural                   

Source: GAO analysis, based on state National Breast and Cervical Cancer
Early Detection Program lists of facilities that provided mammography
services to National Breast and Cervical Cancer Early Detection Program
clients and information on facility closures from FDA's Mammography
Program Reporting and Information System database.

With the assistance of HRSA, we obtained a list of facility closures that
were located in the same counties as community health centers. HRSA
identified the closures from data it requested from FDA on our behalf on
mammography facilities that were certified as of October 2003 but were
closed as of October 2004. HRSA then matched the addresses of the closures
with its list of community health centers funded in 2004. This yielded a
list of 34 closed mammography facilities that were in the same counties as
community health centers. We selected 10 counties and interviewed a
community health center official in each county (six officials from urban
centers and four from rural centers)4 regarding the effect of closures on
their patients' access to mammography services. (See table 6.)

4The 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.

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

County    State      Community health center rural/urban designation 
Anchorage Alaska     Rural                                           
Tulare    California Rural                                           
Leon      Florida    Rural                                           
Delaware  Indiana    Urban                                           
Orleans   Louisiana  Urban                                           
Baltimore Maryland   Urban                                           
Onondaga  New York   Urban                                           
Harris    Texas      Urban                                           
King      Washington Urban                                           
Washburn  Wisconsin  Rural                                           

Source: GAO analysis of FDA data on mammography facilities that closed
from October 2003 to October 2004 and HRSA data on community health
centers that were funded during fiscal year 2004.

In each of our interviews with officials on access to mammography
services, we asked the official to provide estimates of the numbers of
days women had to wait to obtain screening mammography and diagnostic
mammography in counties that had a loss or absence of machines. In
counties where officials reported access problems, we asked them to
provide estimates of the distances women had to travel to mammography
facilities both before and after the loss of machines, and when state and
QIO officials identified counties with an absence of machines, we asked
them to provide estimates of the travel distance to mammography services.
While most officials had not conducted formal studies to gather
information on wait times and travel distances, they generally provided
information based on informal surveys they had conducted of facilities in
their counties or nearby counties or on their involvement and frequent
contacts with mammography facilities.

To examine the measures state bodies have taken to avoid conflicts of
interest and FDA's oversight of state bodies' performance in this area, we
reviewed MQSA and MQSA regulations that govern state bodies' functions,
FDA documents, state ethics laws, and state bodies' policies and
procedures. In addition, we interviewed officials from FDA's Center for
Devices and Radiological Health; accreditation bodies in Arkansas, Iowa,
and Texas; certification bodies in Illinois and Iowa; and ACR.5 We
reviewed state and FDA documents containing ethics laws and policies and
procedures, including information on conflict-of-interest policies that
state bodies are required to submit to FDA as part of the initial
application process. We also reviewed FDA's inspection procedures, which
states are required to use to conduct inspections. The California and
South Carolina state agencies are not included in our review because the
California state agency withdrew its application to continue to operate as
an 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.6

5The 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.

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.

6Our 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.

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

                      Number of     Number of                                 
                  facilities in facilities in         Net change in number of 
State                   2001          2004                      facilities
Alabama                  157           140                             -17 
Alaska                    32            30                              -2 
Arizona                  148           151                              +3 
Arkansas                 111           102                              -9 
California               768           736                             -32 
Colorado                 111           106                              -5 
Connecticut              154           143                             -11 
Delaware                  24            30                              +6 
District of               21            19                              -2 
Columbia                                   
Florida                  487           460                             -27 
Georgia                  261           240                             -21 
Hawaii                    41            40                              -1 
Idaho                     47            44                              -3 
Illinois                 418           384                             -34 
Indiana                  229           219                             -10 
Iowa                     151           147                              -4 
Kansas                   134           122                             -12 
Kentucky                 172           164                              -8 
Louisiana                166           160                              -6 
Maine                     62            61                              -1 
Maryland                 148           135                             -13 
Massachusetts            194           177                             -17 
Michigan                 334           316                             -18 
Minnesota                212           202                             -10 
Mississippi              104           104                               0 
Missouri                 182           172                             -10 
Montana                   48            48                               0 
Nebraska                  92            92                               0 
Nevada                    61            70                              +9 
New Hampshire             49            46                              -3 
New Jersey               278           250                             -28 
New Mexico                48            49                              +1 
New York                 701           631                             -70 
North Carolina           249           234                             -15 
North Dakota              42            43                              +1 
Ohio                     440           417                             -23 
Oklahoma                 102           100                              -2 
Oregon                    99            99                               0 
Pennsylvania             440           402                             -38 
Rhode Island              43            38                              -5 
South Carolina           123           116                              -7 
South Dakota              48            46                              -2 
Tennessee                207           199                              -8 
Texas                    563           529                             -34 
Utah                      46            47                              +1 
Vermont                   19            17                              -2 
Virginia                 204           183                             -21 
Washington               175           158                             -17 
West Virginia             84            75                              -9 
Wisconsin                250           250                               0 
Wyoming                   27            25                              -2 
Total                  9,306         8,768                            -538 

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

Appendix IV: Comments from the Food and Drug Administration

Appendix V: GAO Contact and Staff Acknowledgments

                                  GAO Contact

Marcia Crosse, (202) 512-7119 or [email protected]

                                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.

(290418)

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

July 2006

MAMMOGRAPHY

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

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.

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.
*** End of document. ***