Mammography
Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations
Gao ID: GAO-06-724 July 25, 2006
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 physicians 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.
GAO-06-724, Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
July 2006:
Mammography:
Current Nationwide Capacity Is Adequate, but Access Problems May Exist
in Certain Locations:
Mammography Services:
GAO-06-724:
GAO Highlights:
Highlights of GAO-06-724, a report to congressional requesters
Why GAO Did This Study:
Mammography, an X-ray procedure that can detect small breast tumors, is
an important tool for detecting breast cancer at an early stage and,
when coupled with appropriate treatment, can reduce breast cancer
deaths. In 2002, GAO reported in Mammography: Capacity Generally Exists
to Deliver Services (GAO-02-532) that the capacity to provide
mammography services was generally adequate, but that the number of
mammography facilities had decreased by 5 percent from 1998 to 2001 and
that about one-fourth of counties had no machines. GAO was asked to
update its information on facility closures and mammography service
capacity.
The Food and Drug Administration (FDA) regulates mammography quality
and maintains a database on mammography facilities and other capacity
elements. GAO reviewed FDA data on facility closures and examined
reasons for closures in recent years. GAO analyzed changes in the
nation‘s capacity for and use of mammography services using FDA
capacity data and National Center for Health Statistics data on service
use. GAO also interviewed state and local officials about the effects
of the loss or absence of mammography machines on access, including
access for medically underserved women, such as those who are poor or
uninsured.
What GAO Found:
Closures of certified mammography facilities outpaced openings during a
recent 3-year period, and financial considerations were most often
cited as the reason for facility closures. FDA data show that from
October 1, 2001, to October 1, 2004, the number of mammography
facilities nationwide decreased from 9,306 to 8,768. During this
period, 1,290 facilities closed and 752 began providing services,
resulting in a net loss of 538 facilities, or 6 percent. Mammography
facility officials most often cited financial considerations as the
reason their facility closed. Experts said that another factor that
could affect closures is difficulty recruiting and retaining radiologic
technologists who perform mammography and physicians who interpret
mammograms.
Although key elements that make up mammography capacity have decreased
and the use of screening mammography has grown, current nationwide
capacity is adequate. The numbers of mammography facilities, machines,
radiologic technologists, and interpreting physicans decreased from
2001 to 2004. From 2000 to 2003, the estimated number of women who
received a screening mammogram increased, mostly because of population
growth. Based on GAO‘s calculation that the estimated number of
mammograms performed in the United States in 2003 was substantially
lower than the number that could have been performed, GAO found that
current capacity is adequate. Most of the experts GAO interviewed
believe the nation‘s current overall capacity is likely adequate, but
all of the experts expressed concern that the flow of personnel into
the field may be insufficient to serve the growing number of women
needing screening. This potential development could result in access
problems in the future.
The loss or absence of machines in certain locations may have resulted
in access problems, including problems for women who are medically
underserved, such as those who have a low income or lack health
insurance. About one-fourth of counties had no mammography machines in
2004. The majority of officials GAO interviewed about access in their
states, including access in 18 of the 117 counties that had lost over
25 percent of their machines from 2001 to 2004, said that machine
losses had not resulted in access problems because women were able to
obtain services at other facilities. However, some officials told GAO
that the loss or absence of machines in certain counties resulted in
access problems consisting of lengthy wait times or travel distances to
obtain services. Lengthy travel distances may especially pose an access
barrier for medically underserved women. Access problems for these
women are of concern because uninsured and poor women have lower-than-
average screening mammography rates.
In commenting on a draft of this report, FDA provided additional
details and clarification regarding aspects of its regulation of
mammography, which GAO incorporated as appropriate.
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-06-724].
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Marcia Crosse at (202)
512-7119 or crossem@gao.gov.
[End of Section]
Contents:
Letter:
Results in Brief:
Background:
Facility Closures Outpaced Openings, with Financial Considerations Most
Often Cited as Reason for Closure:
Although Key Capacity Elements Have Decreased and Use of Mammography
Services Has Increased, Current Nationwide Capacity Is Adequate:
Loss or Absence of Mammography Machines May Have Resulted in Access
Problems in Certain Locations:
State Bodies Have Varying Measures to Avoid Conflicts of Interest, and
FDA's Evaluations Have Not Found Conflict-of-Interest Problems:
Concluding Observations:
Agency Comments:
Appendix I: The Food and Drug Administration's Mammography Facility
Inspection Demonstration Program:
Appendix II: Scope and Methodology:
Appendix III: Changes in the Number of Certified Mammography Facilities
by State, October 1, 2001, to October 1, 2004:
Appendix IV: Comments from the Food and Drug Administration:
Appendix V: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Reasons for Closures of ACR-Accredited Mammography Facilities
in the United States, October 1, 2001, to October 1, 2004:
Table 2: Changes in Numbers of Mammography Facilities, Machines,
Radiologic Technologists, and Interpreting Physicians from October 1,
2001, to October 1, 2004:
Table 3: State Accreditation and Certification Bodies' Measures to
Avoid Conflicts of Interest:
Table 4: Counties Randomly Selected for Review from Those That Lost
over 25 Percent of Their Mammography Machines from October 1, 2001, to
October 1, 2004:
Table 5: Selected Counties with Closures of Facilities That Had
Provided Mammography Services to Participants in CDC's National Breast
and Cervical Cancer Early Detection Program, 2001 through 2004:
Table 6: Selected Counties with Mammography Facility Closures and
Community Health Centers, October 2003 to October 2004:
Figures:
Figure 1: Overview of the Mammography Facility Accreditation and
Certification Processes:
Figure 2: Number of Mammography Machines by County, October 1, 2004:
Figure 3: Percentages of Mammography Facilities with MQSA Violations,
by Level of Violation, during FDA's IDP:
Abbreviations:
ACR: American College of Radiology:
CDC: Centers for Disease Control and Prevention:
CMS: Centers for Medicare & Medicaid Services:
FDA: Food and Drug Administration:
HHS: Department of Health and Human Services:
HRSA: Health Resources and Services Administration:
IDP: inspection demonstration program:
MQSA: Mammography Quality Standards Act of 1992:
MQSRA: Mammography Quality Standards Reauthorization Act:
NCI: National Cancer Institute:
NHIS: National Health Interview Survey:
QIO: quality improvement organization:
United States Government Accountability Office:
Washington, DC 20548:
July 25, 2006:
The Honorable Arlen Specter:
Chairman:
The Honorable Tom Harkin:
Ranking Minority Member:
Subcommittee on Labor, Health and Human Services, Education, and
Related Agencies:
Committee on Appropriations:
United States Senate:
The Honorable Barbara A. Mikulski:
Ranking Minority Member:
Subcommittee on Retirement Security and Aging Committee on Health,
Education, Labor, and Pensions:
United States Senate:
Breast cancer is the most common cancer among women in the United
States, excluding skin cancers, and is the second leading cause of
cancer deaths among U.S. women. The American Cancer Society has
estimated that in 2006, almost 213,000 new cases of breast cancer will
be diagnosed in women and over 40,900 women will die from the disease.
Early detection, however, when coupled with appropriate treatment, can
reduce breast cancer mortality. Mammography, an X-ray imaging procedure
that can detect small tumors and breast abnormalities, is an important
tool for detecting breast cancer at an early stage. Mammography is
performed for two different purposes: screening and diagnosis.
Screening mammography is an examination of a woman without breast
symptoms to detect a breast abnormality before it can be detected by
physical examination. Diagnostic mammography is an examination of a
woman who exhibits a symptom, such as a lump, that indicates the
possible presence of breast cancer or whose screening mammogram
indicated a possible cancer. The National Institutes of Health's
National Cancer Institute (NCI) and the U.S. Preventive Services Task
Force[Footnote 1] recommend screening mammography every 1 to 2 years
for women age 40 and over. Medically underserved women--such as those
who have low incomes, lack health insurance coverage, or are in certain
racial or ethnic minority groups--have been less likely to obtain
screening mammography than have other women. In addition, studies have
found that diagnoses of breast cancer for minority women have occurred
at a more advanced stage than for white women and that differences in
mammography use, such as a lower likelihood of obtaining regular
screening among minority women, may explain this disparity.[Footnote 2]
Although mammography is the most effective tool for detection of early-
stage breast cancer, it is not a perfect test. For example, mammograms
are among the most difficult radiographic images to interpret because
very early-stage breast cancer appears similar to noncancerous breast
tissue in the mammographic image. If a mammogram is interpreted as
normal when an abnormality is actually present, this could result in a
missed diagnosis and delayed treatment, which could cost a woman her
life. Conversely, if a mammogram is incorrectly interpreted as showing
an abnormality, this could cause a woman to undergo unnecessary and
costly follow-up procedures and experience unnecessary anxiety.
The Mammography Quality Standards Act of 1992 (MQSA) and the
Mammography Quality Standards Reauthorization Acts (MQSRA) of 1998 and
2004 established national quality standards for mammography to help
ensure the quality of the images and image interpretations that
mammography facilities produce.[Footnote 3] MQSA required the Secretary
of Health and Human Services to establish and enforce quality standards
for mammography equipment, personnel, and recordkeeping practices. The
Food and Drug Administration (FDA) administers the requirements of MQSA
on behalf of the Department of Health and Human Services (HHS).
Before a mammography facility can legally perform mammography services,
it must receive an MQSA certificate indicating that it meets FDA's
quality standards. To begin this process, the facility must be
accredited by an FDA-approved accreditation body, which assesses
whether the facility meets the quality standards. FDA has approved one
nonprofit organization--the American College of Radiology (ACR)--and
state agencies in three states--Arkansas, Iowa, and Texas--to serve as
accreditation bodies.[Footnote 4] ACR serves as the major accreditation
body and is responsible for over 90 percent of the accreditation
workload. State accreditation bodies may accredit facilities only
within their own state; facilities may apply for accreditation to
either their state body or ACR. Accreditation bodies must establish
measures that FDA approves to avoid conflicts of interest--such as an
accreditation body employee's financial interest in a facility being
reviewed--as the bodies carry out their work. Upon receiving
notification from an accreditation body that a facility meets the
quality standards and has therefore achieved accreditation, FDA or a
state certification body issues an MQSA certificate to the facility,
which allows it to legally operate for up to 3 years. To operate
subsequent to the 3-year period, the facility must apply for
reaccreditation prior to the expiration of its certificate. FDA has
approved state agencies in three states--Illinois, Iowa, and South
Carolina--as certification bodies.[Footnote 5] As with state
accreditation bodies, state certification bodies may certify facilities
only within their own state[Footnote 6] and are to establish FDA-
approved measures to avoid conflicts of interest. FDA and the state
certification bodies are also responsible for ensuring that all
facilities they certify receive an annual MQSA compliance
inspection.[Footnote 7] For most states where FDA certifies the
facilities, it contracts with the state to have state inspectors
perform MQSA compliance inspections.[Footnote 8] FDA is responsible for
overseeing accreditation and certification bodies' compliance with MQSA
and MQSA regulations.
To determine if the frequency of MQSA compliance inspections could be
reduced for facilities that had previously been found to be in
compliance with MQSA, FDA implemented an inspection demonstration
program (IDP) as authorized under MQSRA of 1998.[Footnote 9] The IDP
tested whether moving to a biennial inspection schedule would affect
the facilities' compliance levels. FDA implemented the IDP in November
2001 and ended it in August 2004.
We reported in 2002 that key elements that make up mammography
capacity--the numbers of mammography facilities, machines, and
radiologic technologists--were generally adequate to meet the demand
for services.[Footnote 10] We also reported that the number of
mammography facilities had decreased by 5 percent from 1998 to 2001 and
that over one-fourth of the nation's counties had no machines in 1998
and in 2001. You asked us to update this information and to provide
information on state accreditation and certification bodies. In this
report, we examine (1) mammography facility closures and factors that
have contributed to closures in recent years; (2) changes in the
nation's capacity for and use of mammography services in recent years
and whether current capacity is adequate; (3) the effects of the loss
or absence of mammography machines on access to services, including
access for medically underserved women; and (4) the measures state
accreditation and certification bodies have taken to avoid conflicts of
interest and FDA's oversight of state bodies' performance in this area.
You also asked us to provide information on the results of FDA's MQSA
compliance inspection IDP; this information is in appendix I.
To examine mammography facility closures, we analyzed data from FDA's
Mammography Program Reporting and Information System database on the
total numbers of certified facilities as of October 1, 2001, and
October 1, 2004. To examine the factors that have contributed to
mammography facility closures, we reviewed data from ACR and state
accreditation bodies in Arkansas, Iowa, and Texas on closures and
reasons for closure, and interviewed eight radiologists who are experts
in mammography about factors that contribute to facility closures.
To examine changes in the nation's capacity for and use of mammography
services in recent years and whether current capacity is adequate, we
first defined the key elements that make up mammography capacity as the
numbers of certified mammography facilities; machines; radiologic
technologists who perform mammography; and physicians who interpret
mammograms, who are usually radiologists.[Footnote 11] We then analyzed
data from FDA's mammography facility database on the total numbers of
these capacity elements as of October 1, 2001, and October 1, 2004. To
examine changes in the nationwide use of mammography services, we
analyzed data from the 2000 and 2003 National Health Interview Survey
(NHIS), administered by the Centers for Disease Control and
Prevention's (CDC) National Center for Health Statistics, to estimate
the number of women age 40 and older who received a screening or
diagnostic mammogram within the previous year.[Footnote 12] To examine
changes in the population of women age 40 and older, we used population
estimates from the Census Bureau. To determine the adequacy of current
capacity, we asked mammography experts for estimates of the amount of
time it takes to perform a screening mammogram and to perform a
diagnostic mammogram. We used those estimates and FDA data on the
number of machines available in 2003 to calculate the number of
screening mammograms that potentially could have been performed in
2003. We compared this estimate of capacity to the estimated number of
women age 40 and older who received a screening mammogram, based on the
2003 NHIS, and also took into account 2003 NHIS data on diagnostic
mammograms. In addition, we interviewed the following individuals about
issues related to mammography closures, mammography capacity, and
access to mammography services: officials from FDA, CDC, NCI, and the
Centers for Medicare & Medicaid Services (CMS); representatives from
several professional organizations, such as the American Board of
Radiology, American Cancer Society, ACR, and the American Society of
Radiologic Technologists; and mammography experts.
To examine the effects of the loss or absence of mammography machines
on access to services, including access for medically underserved
women, we used FDA data to select a stratified random sample of 9 urban
counties and 9 rural counties, within 16 states, that lost more than 25
percent of their mammography machines from October 1, 2001, to October
1, 2004; we randomly selected the counties to avoid bias in their
selection.[Footnote 13] We interviewed officials familiar with these
counties to obtain their views on the effect of machine losses and
facility closures. These officials generally included county health
department personnel in the affected counties, state radiation control
personnel under contract to FDA to conduct annual on-site MQSA
compliance inspections of mammography facilities, and quality
improvement organization (QIO) officials under contract to CMS to
monitor and improve screening rates for Medicare
beneficiaries.[Footnote 14] To assess the effects of the absence of
machines on access to services, we used FDA data on the number and
locations of machines nationwide as of October 1, 2004, and identified
counties that had no machines. In our interviews with state radiation
control program personnel and QIO officials from the 16 states
containing the 18 counties in our random sample, we also asked about
access in their states beyond the sampled counties, including access
for medically underserved women. To obtain additional information on
the effects of facility closures on access for medically underserved
women, we interviewed state officials who direct CDC's National Breast
and Cervical Cancer Early Detection Program in selected states and
officials of several community health centers that receive funding
through the federal Consolidated Health Centers program.
To examine the measures state bodies have taken to avoid conflicts of
interest and FDA's oversight of state bodies' performance in this area,
we reviewed MQSA and MQSA regulations issued by FDA, FDA and state
documents, state ethics laws, state agency personnel policies, state
bodies' procedures, FDA evaluation protocols, and FDA reports on the
performance of state bodies. In addition, we interviewed officials from
FDA; ACR; accreditation bodies in Arkansas, Iowa, and Texas; and
certification bodies in Illinois and Iowa. We also interviewed FDA
officials about their oversight role and approach. California and South
Carolina are not included in our review because the California
accreditation body withdrew its participation in the MQSA program
before our review began and South Carolina's certification program
began operating after our review began.
To assess the reliability of the FDA, ACR, and state body data on
mammography facility closures and mammography capacity, we talked with
knowledgeable officials of these organizations about data quality
control procedures and reviewed relevant documentation. We also
electronically tested the FDA data to identify problems with accuracy
and completeness. To assess the reliability of the NHIS data on the
numbers of women age 40 and older who received a screening or
diagnostic mammogram in 2000 and 2003 and the population estimate data
from the Census Bureau, we reviewed the existing documentation on
methodology and data collection procedures. We determined that the data
were sufficiently reliable for the purposes of this report.
Appendix II provides additional information on our scope and
methodology. We conducted our work from November 2004 through July 2006
in accordance with generally accepted government auditing standards.
Results in Brief:
Closures of certified mammography facilities outpaced openings during a
recent 3-year period, and financial considerations were most often
cited as the reason for facility closures. FDA data show that from
October 1, 2001, to October 1, 2004, the number of certified
mammography facilities nationwide decreased from 9,306 to 8,768. During
this period, 1,290 certified mammography facilities closed, while 752
facilities began providing services, resulting in a net decrease of 538
facilities, or 6 percent. Mammography facility officials most often
reported to ACR that they closed for financial reasons, and officials
of state accreditation bodies in Arkansas, Iowa, and Texas told us that
closures in their states were generally due to financial concerns.
Experts we interviewed said that financial considerations and
difficulties recruiting and retaining staff have contributed to
closures.
Although key elements that make up mammography capacity have decreased
and use of mammography services has increased, we found that current
nationwide capacity is adequate. From October 1, 2001, to October 1,
2004, in addition to the 6 percent decrease in mammography facilities,
the number of machines decreased by 4 percent; the number of radiologic
technologists who perform mammography decreased by 3 percent; and the
number of physicians who interpret mammograms, who are usually
radiologists, decreased by 5 percent. While the nation lost capacity,
the estimated number of women age 40 and older who received a screening
mammogram within the previous year increased, largely because of the
increase in the number of women eligible for screening. From 2000 to
2003, the estimated number of women age 40 and older who received a
screening mammogram increased nationwide by 14 percent, from about 29
million to about 33 million. Over the same period, the estimated number
of women age 40 and older who received a diagnostic mammogram decreased
from about 3 million to about 2 million. Based on our calculation that
the estimated number of mammograms performed by U.S. machines in 2003
was substantially lower than the number that could have been performed,
we found that current capacity is adequate. Most experts we interviewed
told us that current overall capacity is likely adequate, but all of
the experts expressed concern that the numbers of radiologic
technologists and radiologists entering the mammography field might not
be sufficient to serve the increasing population of women age 40 and
over. This potential development could result in access problems in the
future.
The loss or absence of mammography machines in certain locations may
have resulted in access problems for women, including problems for
those who are medically underserved. FDA data show that from October 1,
2001, to October 1, 2004, the number of counties having mammography
machines remained relatively constant at about 72 percent, but the
number of machines decreased in certain counties. Of 413 U.S. counties
that had a net loss of at least one mammography machine during that
period, 117 counties lost more than 25 percent of their machines. As of
October 2004, 865 counties--containing 3.4 percent of the U.S.
population--had no machines. The majority of officials we interviewed
about access in their states, including access in 18 counties that had
lost over 25 percent of their mammography machines, told us that
machine losses had not resulted in access problems because women were
able to obtain services at other facilities. However, some officials
told us that the loss or absence of machines in certain counties has
resulted in access problems consisting of considerable wait times or
lengthy travel distances to obtain services. For example, a West
Virginia official working with CDC's early detection program for low-
income women estimated that after the closure of a facility in one
county, program participants' wait time for diagnostic mammography
averaged 8 weeks and was as long as 3 months. A Virginia official
estimated that after one county lost its only mammography facility, the
absence of a facility resulted in some women needing to travel 60 miles
to obtain services, in comparison with 20 to 25 miles before the
facility closed. Lengthy travel distances may especially pose a barrier
to access for underserved women who face transportation difficulties or
who would bear a significant burden if they had to take extra time away
from work or family responsibilities. Access problems for these women
are of particular concern because women who lack health insurance or
have low incomes have lower-than-average screening mammography rates.
State bodies that accredit or certify mammography facilities have
varying measures to help ensure that individuals conducting work for
these bodies--including state employees and contractual and volunteer
image reviewers--avoid conflicts of interest. These measures include
state ethics laws, state agency personnel policies, and procedures
state bodies use to carry out their duties. As required by regulation,
FDA has reviewed and approved the measures used by the state
accreditation and certification bodies to avoid conflicts of interest
and has conducted annual performance evaluations of state bodies to
assess whether they are complying with MQSA regulations. An FDA
official told us that agency officials have asked questions about
conflicts of interest during their evaluations and that they have not
found any conflicts. FDA's written protocols for performance
evaluations have not always included specific questions on the subject
of conflicts of interest, but FDA recently revised its written protocol
for evaluating certification bodies to increase attention to this
subject.
In commenting on a draft of this report, FDA provided additional
details and clarification regarding its activities for certifying
mammography facilities and overseeing state accreditation and
certification bodies. We incorporated FDA's comments as appropriate.
Background:
The purpose of screening mammography is to detect breast cancer before
there are apparent symptoms. Screening mammography usually consists of
two X-ray views of each breast. A physician need not be on site to
interpret a screening mammogram immediately, but may read a group of
mammograms at a later time. Diagnostic mammograms are used to evaluate
patients with abnormalities detected on a screening mammogram or during
a physical examination. Diagnostic mammography takes longer than
screening mammography, because an interpreting physician generally
examines the mammograms while the patient is waiting and the procedure
may require additional breast views, such as magnification views of
suspicious breast tissue, to provide more information about a lesion.
Because detecting breast cancer as early as possible improves the
likelihood that treatment will be successful, access to high-quality
mammography services is essential for improving a woman's chance of
survival. The federal government plays a role in both ensuring quality
and promoting access. FDA has responsibility for ensuring the quality
of mammography services. Other federal agencies have initiatives
intended to help improve access to mammography services.
FDA Oversight of Mammography:
Under MQSA, FDA has several responsibilities to ensure the quality of
mammography. FDA is responsible for establishing quality standards for
mammography equipment, personnel, and practices. In 1993, FDA issued
interim regulations establishing such standards,[Footnote 15] and in
1997, FDA issued final regulations establishing quality
standards.[Footnote 16] Most of these quality standards went into
effect in 1999. However, certain quality standards for mammography
equipment, which were more stringent than the previous standards, went
into effect in 2002. The agency is also responsible for ensuring that
all mammography facilities are accredited by an FDA-approved
accreditation body[Footnote 17] and have obtained a certificate
permitting them to provide mammography services from FDA or an FDA-
approved certification body.[Footnote 18] FDA is also responsible for
ensuring that all mammography equipment is evaluated at least annually
by a qualified medical physicist and that all mammography facilities
receive an annual MQSA compliance inspection from an FDA-approved
inspector. In addition to carrying out these activities, FDA maintains
the Mammography Program Reporting and Information System database, a
nationwide database on mammography facilities that incorporates data
from the accreditation and certification processes and inspections of
facilities. Finally, FDA is responsible for performing annual
evaluations of the accreditation and certification bodies.
Quality Standards for Mammography Personnel:
In addition to setting comprehensive quality standards for the
operation of mammography equipment, FDA regulations specify detailed
qualifications and continuing training requirements for mammography
personnel, such as radiologic technologists who perform the
examinations and physicians who interpret the images. Radiologic
technologists are required to be either licensed by a state[Footnote
19] or certified by an appropriate board, such as the American Registry
of Radiologic Technologists, in general radiography.[Footnote 20] They
must also meet additional training, continuing education, and
experience requirements related to mammography. FDA also specifies that
all interpreting physicians be licensed in a state; be certified in the
specialty by an appropriate board, such as the American Board of
Radiology;[Footnote 21] and meet certain medical training, continuing
education, and experience requirements related to mammography.
Accreditation and Certification of Facilities:
To legally perform mammography, a facility must be accredited by an FDA-
approved body and certified by FDA or an FDA-approved body. FDA
categorizes facilities applying for accreditation into three groups:
new applicants; reinstating applicants, such as a previously certified
facility whose certificate was suspended or revoked; and reaccrediting
applicants that have been accredited and certified for 3 years and are
seeking to renew their accreditation. To become accredited, a new
mammography facility must undergo a two-phase application review
process conducted by an FDA-approved accreditation body. (See fig. 1.)
First, the facility must pay an application fee and submit to the
accreditation body an entry application that provides such information
as equipment performance specifications, the qualifications of its
personnel, and the results of the facility medical physicist's
equipment tests.[Footnote 22] A facility seeking accreditation
reinstatement follows the same process as the new applicant, but must
also submit to the accreditation body a corrective action plan that
describes the action the facility has taken to correct problems that
prevented it from achieving or maintaining certification. If the
accreditation body determines that a new or reinstating facility meets
the MQSA standards for the initial accreditation phase, it notifies
FDA; for states with an FDA-approved state certification body, FDA in
turn notifies the state certification body.[Footnote 23] FDA or the
state certification body then issues a provisional certificate that
allows the facility to operate legally for up to 6 months.[Footnote 24]
Figure 1: Overview of the Mammography Facility Accreditation and
Certification Processes:
[See PDF for image]
Source: GAO analysis of MQSA, MQSA regulations, and documents and
information provided by FDA and the accreditation and certification
bodies.
Notes: As of June 2006, the states with accreditation bodies were
Arkansas, Iowa, and Texas. The states with certification bodies were
Illinois, Iowa, and South Carolina. (Because South Carolina's
certification program began operating after our review began, it was
not included in our review.) State accreditation and certification
bodies may review only facilities within their own state. Facilities in
a state with an accreditation body have the option of seeking
accreditation from either that body or ACR. However, facilities in a
state with a certification body may receive certification only from
their state body, not from FDA. The accreditation processes established
by ACR and the states differ slightly, such as on the points at which
facilities must submit certain information to accreditation bodies for
review.
[A] A reinstating facility must also submit to the accreditation body a
corrective action plan that describes the action the facility has taken
to correct problems that prevented it from achieving or maintaining
certification.
[B] ACR notifies both FDA and, when applicable, the state certification
body.
[C] A mammography facility seeking to renew its 3-year accreditation
and certification is not required to obtain a provisional certificate
if it completes the reaccreditation process prior to the expiration of
the existing MQSA certificate.
[End of figure]
Second, to achieve full accreditation, the facility must submit to the
accreditation body phantom and clinical images,[Footnote 25] quality
control tests, and other information required by MQSA. If the
accreditation body determines that the facility meets MQSA standards
applicable to the images and all other submitted information, it
accredits the facility and each of the facility's approved mammography
machines for 3 years. The accreditation body notifies FDA of each
mammography machine's approval; for states with certification bodies,
FDA in turn notifies the state certification body.[Footnote 26] On the
basis of the accreditation body's notification, FDA or the state
certification body issues a 3-year MQSA certificate to the facility,
which allows it to legally perform mammography up to the certificate
expiration date.[Footnote 27] Accreditation bodies notify facilities
they have accredited about 6 to 8 months prior to expiration of their 3-
year certification period that they must apply for reaccreditation.
Facilities applying for reaccreditation are not required to obtain a
provisional certificate if they submit all the information required for
full accreditation before their certificate expires and if the facility
meets FDA standards. After approval by its accreditation body, a
facility receives a new 3-year MQSA certificate from FDA or the state
certification body.
Each accreditation body is required to make annual on-site visits to a
sample of facilities that it accredited.[Footnote 28] The on-site
visits include reviewing samples of randomly selected clinical images
to assess image quality,[Footnote 29] verifying the information that
facilities provided in the accreditation application,[Footnote 30] and
reviewing documentation showing that facilities sent reports on
mammography results to patients and physicians. In addition, on-site
visits have an educational element; for example, members of the
accreditation body team may suggest ways to improve clinical image
quality.
The annual MQSA compliance inspections conducted by FDA and the state
certification bodies differ in focus and scope from the on-site
accreditation visits, although both the inspections and the on-site
accreditation visits are intended to monitor and assess facility
compliance with MQSA standards.[Footnote 31] In addition to verifying
information submitted during the accreditation process, FDA and the
state compliance inspectors--including those under contract to FDA and
those working for the state certification bodies--conduct several other
reviews. These include performing equipment tests and in-depth reviews
of personnel qualifications and reviewing quality control and quality
assurance records.[Footnote 32] For example, inspectors review quality
control records for each film processor[Footnote 33] and X-ray machine
used for mammography. FDA and state certification bodies are
responsible for monitoring and enforcing the correction of facility
problems discovered during MQSA compliance inspections. If a facility
fails to correct a problem, FDA and state certification bodies may take
enforcement actions, including suspending or revoking a facility's
certification.
National Database on Mammography Facilities:
FDA maintains a national database--the Mammography Program Reporting
and Information System database--that incorporates data from the
accreditation and certification processes and from annual compliance
inspections of facilities. The database contains facility
identification information, as well as information on the number of
machines and personnel at a facility, the medical physicist who
evaluated equipment at the facility, the estimated number of mammograms
performed, and whether the facility is active or no longer certified.
Oversight of Accreditation and Certification Bodies:
Under MQSA, FDA can approve a state agency or a private nonprofit
organization to accredit facilities and a state agency to certify
facilities if the agency or organization meets MQSA standards. MQSA
regulations require that each accreditation body adopt standards for
mammography facilities that are substantially the same as the quality
standards established by FDA to ensure the safety and accuracy of
mammography; each certification body must establish standards that are
at least as stringent as FDA's standards. MQSA regulations do not allow
individuals who review facilities' phantom or clinical images for the
accreditation body or perform accreditation site visits to maintain a
financial relationship with or have any other conflict of interest or
bias in favor of or against the facility.[Footnote 34] This requirement
applies not only to individuals who review phantom or clinical images,
but also to state agency managers, consultants, administrative
personnel, and any other individuals working for the accreditation
body. MQSA regulations also require that FDA conduct annual performance
evaluations of accreditation bodies' and certification bodies'
compliance with MQSA standards. MQSA requires that FDA annually submit
to congressional oversight committees a written report on the
performance of the accreditation bodies.[Footnote 35]
Initiatives to Help Improve Access to Mammography:
The federal government supports two initiatives to help improve access
to mammography services. The Breast and Cervical Cancer Mortality
Prevention Act of 1990[Footnote 36] established CDC's National Breast
and Cervical Cancer Early Detection Program. Under this program, CDC
makes grants to states to provide mammography services to medically
underserved women, especially those with low incomes and without health
insurance coverage.[Footnote 37] From 2001 through 2003, over 50
percent of the women served by the program were from minority groups.
The second initiative relates to coverage for screening mammography
under Medicare, the federal government's health insurance program for
people age 65 and older and certain disabled people. CMS, which
administers Medicare, has contracted with QIOs in each state to assist
it in monitoring and improving the quality of health care, including
improving mammography screening rates among Medicare beneficiaries.
QIOs seek to improve mammography screening rates by working with
physician offices and other health care providers to establish improved
systems for referring patients for mammography and collaborating with
state and local coalitions and other organizations on promotion
efforts, such as the distribution of educational materials on
mammography and outreach to encourage Medicare beneficiaries to obtain
screening.
In addition to these initiatives, the federal Consolidated Health
Centers program, administered by HHS's Health Resources and Services
Administration (HRSA), increases access to health care services,
including screening mammography, for women in medically underserved
areas.[Footnote 38] In 2004, 71 percent of health center patients had a
family income at or below the federal poverty level, and 40 percent
were uninsured. In addition, 63 percent of patients were members of
racial or ethnic minority populations, and 29 percent spoke a primary
language other than English.[Footnote 39]
Facility Closures Outpaced Openings, with Financial Considerations Most
Often Cited as Reason for Closure:
From October 2001 to October 2004, certified mammography facility
closures outpaced openings, and financial considerations were most
often cited as the reason for facility closures. According to FDA data,
the number of certified mammography facilities nationwide decreased by
6 percent, from 9,306 to 8,768, from October 1, 2001, to October 1,
2004.[Footnote 40] During this period, 1,290 certified mammography
facilities closed, while 752 facilities received 6-month provisional
certificates to begin providing services, resulting in a net decrease
of 538 facilities, including a net decrease of 87 mobile mammography
facilities, which may serve multiple locations.[Footnote 41] Forty
states lost facilities during this period, including 10 states that
each lost more than 20 facilities.[Footnote 42] These 10 states
accounted for over half of the 538 net decrease. (See app. III for
information by state.)
The most commonly cited reasons for facility closures were related to
financial considerations. We relied on data from ACR for information on
what facility officials reported as the reasons for closure[Footnote
43] because FDA's Mammography Program Reporting and Information System
database does not include such data. For certified mammography
facilities that had been accredited by ACR and that closed from October
1, 2001, to October 1, 2004, facility officials most often reported
financial considerations as the reason for closure.[Footnote 44]
Specifically, for 35 percent of the closures, facility officials told
ACR that the primary reason was financial. (See table 1.) In addition,
even when they did not cite financial considerations specifically,
their reasons were often related to finances. For 25 percent of the
closures, facility officials reported that they moved their facility to
a sister site, and an ACR official said that many of the facilities
consolidated their mammography activities in an effort to conserve
financial resources. Facility officials also frequently reported
equipment and staffing problems as reasons for closure, and an ACR
official told us that these problems were sometimes financial in
nature. In addition, officials of state accreditation bodies told us
that closures in their states from 2001 to 2004 were generally related
to financial concerns. For example, a Texas accreditation body official
said she believed that the majority of closures accredited by the state
body were due to bankruptcy, low business volume, or low reimbursement
rates for services. FDA and mammography experts also identified
financial considerations as having contributed to facility closures.
Table 1: Reasons for Closures of ACR-Accredited Mammography Facilities
in the United States, October 1, 2001, to October 1, 2004:
Reason for closure[A]: Financial decision;
Number of closures[B]: 424;
Percentage of total: 35.
Reason for closure[A]: Relocation of facility to sister site;
Number of closures[B]: 305;
Percentage of total: 25.
Reason for closure[A]: Other/equipment problems[C];
Number of closures[B]: 136;
Percentage of total: 11.
Reason for closure[A]: Staffing problems;
Number of closures[B]: 124;
Percentage of total: 10.
Reason for closure[A]: Bankruptcy;
Number of closures[B]: 25;
Percentage of total: 2.
Reason for closure[A]: Other/mobile facility merged with another site;
Number of closures[B]: 28;
Percentage of total: 2.
Reason for closure[A]: Other/changes in ownership;
Number of closures[B]: 23;
Percentage of total: 2.
Reason for closure[A]: Unknown;
Number of closures[B]: 80;
Percentage of total: 7.
Reason for closure[A]: Other/miscellaneous;
Number of closures[B]: 66;
Percentage of total: 6.
Reason for closure[A]: Total;
Number of closures[B]: 1,211;
Percentage of total: 100.
Source: GAO analysis of ACR data on the number of ACR-accredited
mammography facilities that closed and reasons for closure.
[A] ACR asks facility officials to provide a closure memorandum in
which they are asked to check a reason for closure from among five
categories: unit moved to a sister site, bankruptcy, financial,
staffing problems, and other. Facility officials who checked other were
asked to specify the reason, and these reasons included equipment
problems, mobile facility merged with another site, and changes in
ownership. According to ACR, officials from 34 facilities reported two
reasons for closure. In these instances, ACR recorded the predominant
response provided during conversations with facility personnel prior to
closure.
[B] According to ACR, 1,211 ACR-accredited facilities closed during
this period. This number differs from the number of closures reported
by FDA during this period because although most closed facilities in
the two databases are the same, there are differences between the
databases. For example, FDA's data include facility closures reported
by state accreditation bodies, while ACR's do not. We relied on ACR
data for reported reasons for facility closures because FDA's database
does not include such information.
[C] An ACR official told us that equipment problems were most likely
either a facility's inability to meet the more stringent FDA quality
assurance regulations for equipment that went into effect in 2002 or
equipment failures that facilities decided were too costly to repair.
[End of table]
Experts also told us that difficulties in recruiting and retaining
staff have contributed to closures. Officials of the American Society
of Radiologic Technologists said that some radiologic technologists
think the repetitive nature of mammography procedures--especially
screening mammography--makes mammography seem like an unattractive,
assembly-line operation and that radiologic technologists who perform
mammography are paid less, in general, than those in other imaging
specialties. Experts also reported that some radiologists consider the
mammography field unappealing because it is stressful, "low tech," and
lower paying and less respected than other imaging specialties;
involves repetitious work because of the need to read large volumes of
screening mammograms; and has a high rate of malpractice litigation.
Although Key Capacity Elements Have Decreased and Use of Mammography
Services Has Increased, Current Nationwide Capacity Is Adequate:
Although key elements that make up mammography capacity have decreased
and the use of mammography services has increased--largely because of
the increase in the population of women age 40 and older--we found that
current nationwide capacity is adequate. Key capacity elements--the
numbers of facilities, machines, radiologic technologists, and
interpreting physicians--declined from 2001 to 2004. In contrast, from
2000 to 2003, the estimated number of women age 40 and older who
received a screening mammogram within the previous year increased.
Nevertheless, we determined that the estimated number of screening
mammograms that women age 40 and older received was substantially lower
than the number that could have been performed in 2003, and there was
also sufficient capacity for the number of diagnostic mammograms women
in that age group received. Although experts believe the nation's
current overall capacity to provide mammography services is adequate,
they are concerned that the numbers of radiologic technologists and
radiologists entering the mammography field might not be sufficient to
serve the increasing population that will need mammography services.
Key Elements That Make Up Capacity to Provide Mammography Services Have
Decreased:
Key elements that make up mammography capacity decreased from October
1, 2001, to October 1, 2004. In addition to the number of facilities
decreasing by 6 percent, the number of mammography machines decreased
by 4 percent, the number of radiologic technologists decreased by 3
percent, and the number of physicians who interpret mammograms
decreased by 5 percent.[Footnote 45] (See table 2.) During the period,
the average number of machines per facility remained about the same--
1.50 in 2001 and 1.53 in 2004--and the average number of radiologic
technologists per machine remained about the same--2.24 and 2.28,
respectively.
Table 2: Changes in Numbers of Mammography Facilities, Machines,
Radiologic Technologists, and Interpreting Physicians from October 1,
2001, to October 1, 2004:
Facilities;
2001: 9,306;
2004: 8,768;
Percentage change: -6.
Machines;
2001: 13,995;
2004: 13,400;
Percentage change: -4.
Radiologic technologists who perform mammography;
2001: 31,402;
2004: 30,503;
Percentage change: -3.
Physicians who interpret mammograms;
2001: 19,675;
2004: 18,690;
Percentage change: -5.
Source: GAO analysis of FDA's Mammography Program Reporting and
Information System database on mammography capacity elements.
[End of table]
Number of Women Who Received Screening Mammograms Increased as
Population of Women Age 40 and Older Grew:
Reflecting the steady increase in the population of women age 40 and
older,[Footnote 46] the estimated number of women in this age group who
received a screening mammogram within the previous year has increased
and is likely to continue to grow over the next several years. Based on
NHIS survey data, the estimated number of women age 40 and older who
received a screening mammogram within the previous year increased
nationwide by 14 percent from 2000 to 2003, from about 29 million to
about 33 million.[Footnote 47] This increase resulted from the
population growth in this age group coupled with a slight increase--
from 50 percent in 2000 to 51 percent in 2003--in the estimated
proportion of women in this age group who received a screening
mammogram within the previous year.[Footnote 48] The number of women
age 40 and older who receive a screening mammogram is likely to
continue to grow over the next several years because the number of
women age 40 and older is projected to increase from about 68 million
in 2003 to about 74 million in 2010 and about 78 million in 2015,
according to the Census Bureau.
Data from NHIS indicate that the proportion of women age 40 and older
who received a diagnostic mammogram within the previous year decreased
from 5 percent in 2000 to 3 percent in 2003. The estimated number of
women age 40 and older who received a diagnostic mammogram within the
previous year declined from about 3 million women in 2000 to about 2
million in 2003.
Current Nationwide Mammography Capacity Is Adequate:
National mammography capacity data we reviewed indicate that the
nation's current capacity to provide mammography services is adequate.
Our estimates of current capacity found that the number of mammograms
performed by U.S. machines was substantially lower than the number that
could be performed. Since screening mammograms accounted for 94 percent
of the mammograms provided in 2003, we began our capacity calculations
by focusing on screening mammograms. The majority of experts we
interviewed estimated that it normally takes 15 to 20 minutes of
machine and radiologic technologist time to perform a screening
mammogram.[Footnote 49] Using the upper range of this estimate, we
estimated that a machine and one radiologic technologist could perform
3 mammograms per hour, or 24 mammograms in an 8-hour day. This rate
would yield a potential capacity of 6,000 mammograms per machine per
year.[Footnote 50] Using FDA data on the number of machines in 2003
(13,510), we calculated that in 2003 about 81 million screening
mammograms could have been performed by U.S. machines.[Footnote 51]
Data from the 2003 NHIS indicate that nationwide an estimated 33
million women age 40 and older received a screening mammogram and that
an estimated 2 million women in that age group received a diagnostic
mammogram. Most experts we interviewed estimated that it takes 30 to 60
minutes of machine and radiologic technologist time to perform a
diagnostic mammogram. The excess capacity that we found for performing
screening mammograms in 2003 would have been more than adequate for
performing the estimated 2 million diagnostic mammograms that were
performed that year.[Footnote 52] These capacity estimates are rough
estimates, but the difference between estimated machine capacity and
estimated use is sufficiently large to indicate that there is unused
capacity nationwide. It is difficult to measure capacity precisely
because several variables can affect capacity at the individual
facility level, such as the efficiency of facilities'
operations.[Footnote 53]
Most of the experts we interviewed told us that current overall
capacity is likely adequate, but all of the experts expressed concern
that the numbers of radiologic technologists and radiologists entering
the mammography field might not be adequate to serve the increasing
population of women age 40 and older. For example, one expert
questioned whether the mammography workforce would be sufficient to
meet the demand for services in 10 years, in light of the increasing
number of women in this age group. Another expert commented that for
the past few years, facilities have been experiencing problems
recruiting mammography personnel. Data from the American Registry of
Radiologic Technologists show that the number of individuals who took
the mammography technologist examination to become certified for the
first time declined slightly from 1,214 in 2000 to 1,112 in 2005.
The number of available radiologists might also lead to future access
problems, according to an official of the American Board of Radiology.
Although the number of first-time candidates who sat for diagnostic
radiology examinations increased from 816 in 2001 to 1,057 in 2005, the
official expressed concern about whether the current flow of candidates
would be sufficient to meet the expected growth in the population who
will need imaging procedures. In addition, experts told us that there
were many unfilled job openings for radiologic technologists who
perform mammography services and for radiologists who interpret
mammograms. In a 2004 survey of community-based mammography facilities
in three states, 44 percent reported experiencing a shortage of
radiologists and 46 percent reported having some level of difficulty in
maintaining adequate numbers of qualified technologists.[Footnote 54]
Loss or Absence of Mammography Machines May Have Resulted in Access
Problems in Certain Locations:
The loss or absence of mammography machines in certain locations may
have resulted in access problems consisting of lengthy travel distances
or considerable wait times to obtain mammography services, including
problems for women who are medically underserved. FDA data show that
from October 1, 2001, to October 1, 2004, the number of counties with
machines remained relatively constant, but the number of machines
decreased in certain counties. During the 3-year period, 117 counties
lost more than 25 percent of their machines. As of October 1, 2004,
there were 865 counties that had no machines. While the majority of
officials we interviewed told us that the loss of machines in counties
in their states had not resulted in access problems, some officials
told us that the loss or absence of machines in certain counties had
resulted in lengthy travel distances to obtain services or had resulted
in significant wait times for services.
Number of Counties with Machines Remained Relatively Constant, but
Number of Machines Decreased in Certain Counties:
While nationwide the proportion of counties that had at least one
mammography machine remained relatively constant from 2001 to 2004 at
about 72 percent, in some counties the number of machines decreased
during that period. FDA data show that the number of counties that had
at least one machine rose slightly from October 1, 2001, to October 1,
2004--from 2,259 to 2,276.[Footnote 55] As of October 1, 2004, 865
counties had no mammography machines; these counties tended to be
concentrated in certain midwestern, southern, and western states and
contained 3.4 percent of the U.S. population.[Footnote 56] (See fig.
2.) Some of these counties, however, may have been served by mobile
mammography machines; as of October 1, 2004, there were 266 mammography
machines in 222 mobile facilities nationwide.
Figure 2: Number of Mammography Machines by County, October 1, 2004:
[See PDF for image]
Source: Gao analysis of FDA's Mammography Program Reporting and
Information System database on the number and locations of mammography
machines.
Notes: Federal facilities operated by the Department of Defense,
facilities at prisons and correctional institutions, and facilities
that had not achieved provisional or accreditation status were excluded
from our analysis of FDA's Mammography Program Reporting and
Information System database. The numbers of mammography machines shown
include mobile mammography facilities that were located in one county
but may also have provided services to other counties, including
counties that had no machines.
[End of figure]
Nationwide, 413 counties that had at least one machine at some point
during the 3-year period had experienced a net loss of mammography
machines as of October 1, 2004. Of these counties, 117--containing 2.6
percent of the total 2004 U.S. population--lost more than 25 percent of
their machines.[Footnote 57] Our analysis of the available supply of
mammography machines in counties that are adjacent to these 117
counties found that 75 are not adjacent to any county that gained
machines during this period, and 47 of these 75 counties are adjacent
to at least one other county that lost machines.[Footnote 58]
Loss or Absence of Mammography Machines in Certain Locations May Have
Resulted in Considerable Travel Distances or Wait Times to Obtain
Services:
Although national mammography capacity appears to be adequate in
general, in certain locations the loss or absence of machines may have
resulted in access problems consisting of lengthy travel distances or
significant wait times. The majority of officials we interviewed about
the effects of the loss or absence of machines told us that machine
losses had not resulted in access problems because women were able to
obtain mammography services at other facilities.[Footnote 59] However,
several of the officials told us that the loss or absence of machines
had affected access for some women.
In certain locations, the loss or absence of mammography machines
resulted in women--including women who are medically underserved--
needing to travel lengthy distances for mammography services. For 6 of
the 18 counties we randomly selected for review that lost more than 25
percent of their machines,[Footnote 60] one local or QIO official told
us that facility closures and machine losses in those counties had
resulted in women traveling longer distances than previously.[Footnote
61] For example, a Mississippi QIO official estimated that after one
facility closure left Newton County with one facility that provided
only screening mammography, some women had to travel about 30 miles for
screening and about 50 miles for diagnostic mammography. He said that
women depended on working family members for transportation, and that
according to mammography facility staff, fewer women were obtaining
mammograms. Similarly, in four states,[Footnote 62] officials working
with CDC's early detection program for medically underserved women told
us that seven facility closures, involving the loss of seven machines,
had affected program participants' travel distances. For example, a
Virginia official estimated that after Dickenson County lost its
mammography facility and associated machine, program participants who
previously traveled from 20 to 25 miles for services had to travel
about 60 miles to obtain services. A West Virginia official working
with the CDC program noted that program participants in Jackson County
had to travel a longer distance to obtain mammography services because
of a facility closure and faced problems of increased travel cost and
time away from families and jobs.
State and QIO officials also told us about certain locations in their
states other than the 18 counties we randomly sampled where the absence
of machines resulted in lengthy travel to obtain mammography services.
For example, as of October 1, 2004, 12 of Alabama's 67 counties had no
mammography machines. An Alabama QIO official identified 10 counties
that to her knowledge had never had a mammography facility and were not
being served by mobile mammography facilities; each of the counties was
designated by HRSA as a medically underserved area. She estimated that
women living in the 10 counties had to travel distances ranging from 30
to 60 miles to obtain mammography services. In Missouri,[Footnote 63]
50 of the state's 115 counties had no machines as of October 1, 2004. A
Missouri QIO official told us that two mobile mammography facilities
provided services once or twice a year to the northeast and southeast
corners of the state, which have neighboring counties without
mammography facilities. However, if a mobile facility could not provide
for films to be read on site, she estimated that women requiring repeat
films and additional studies because their mammograms indicated a
possible breast problem would have to travel about 250 miles to the
provider's central location--about a 5-hour trip in each direction.
The loss or absence of machines in certain counties may also have
caused women--including those who are medically underserved--to
experience significant wait times for mammography services. Although
there is no specific medical standard for the maximum amount of time a
woman should have to wait for mammography services, most experts we
interviewed said that it was best if the wait time for screening
mammography did not exceed 30 days and if the wait time for diagnostic
mammography did not exceed 2 days. State officials working with CDC's
early detection program and a QIO official told us of situations where
the loss or absence of machines in certain locations might have
resulted in wait times that exceeded wait times the experts said were
appropriate. For example, New York officials working with CDC's early
detection program estimated that after the closure of two facilities
involving the loss of two machines in Brooklyn, the screening wait time
for participants who had used those facilities was about 2 months; at
the busiest time of the year, the wait time was 3 to 4 months. The West
Virginia program official estimated that after the facility closure in
Jackson County, participants' wait time for diagnostic mammography
averaged 8 weeks, and could be as much as 3 months.[Footnote 64] A
North Dakota QIO official told us that women in parts of the state face
significant wait times for mammography services. Sixty percent of North
Dakota's counties had no machines as of October 1, 2004, and the
official said that a limited number of providers served large
geographic locations in the largely rural state. For example, she told
us that one provider's mobile facility served almost the entire
northwest quarter of the state and was available to some communities
once every 4 months and to others only once a year.
State Bodies Have Varying Measures to Avoid Conflicts of Interest, and
FDA's Evaluations Have Not Found Conflict-of-Interest Problems:
State accreditation and certification bodies have varying measures to
help ensure that individuals conducting work for these bodies,
including state employees and contractual and volunteer image
reviewers, avoid conflicts of interest. FDA has approved the measures
used by the state bodies to avoid conflicts of interest and has
conducted annual performance evaluations of state bodies to assess
whether they are complying with MQSA regulations. An FDA official told
us that agency officials have asked questions about conflicts of
interest during their evaluations and that they have not found any
conflicts. FDA's written protocols for performance evaluations have not
always included specific questions on the subject of conflicts of
interest, but FDA recently revised its written protocol for evaluating
certification bodies to increase attention to this subject.
State Accreditation and Certification Bodies Have Varying Measures to
Avoid Conflicts of Interest:
State mammography accreditation and certification bodies have varying
measures to help ensure that state employees avoid conflicts of
interest, such as those caused by a financial interest, outside
employment, or a family tie. These measures also apply to physicians
who work for accreditation bodies on a contract or volunteer basis as
clinical image reviewers and who also conduct image reviews for their
main business practice. The measures are a combination of state ethics
laws, state agency personnel policies, and procedures state bodies use
to carry out their duties. FDA has approved each state's combination of
measures. (See table 3.)
Table 3: State Accreditation and Certification Bodies' Measures to
Avoid Conflicts of Interest:
Measures: State laws or personnel policies: Code of ethics;
State accreditation bodies: Arkansas: check;
State accreditation bodies: Iowa[A]: check;
State accreditation bodies: Texas[B]: check[C];
State certification bodies: Illinois: check;
State certification bodies: Iowa[A]: check.
Measures: State laws or personnel policies: Financial disclosure
statement required of state body employees;
State accreditation bodies: Arkansas: check[D];
State accreditation bodies: Iowa[A]: [Empty];
State accreditation bodies: Texas[B]: [Empty];
State certification bodies: Illinois: check[E];
State certification bodies: Iowa[A]: [Empty].
Measures: State laws or personnel policies: Required ethics training;
State accreditation bodies: Arkansas: [Empty];
State accreditation bodies: Iowa[A]: [Empty];
State accreditation bodies: Texas[B]: check;
State certification bodies: Illinois: check;
State certification bodies: Iowa[A]: [Empty].
Measures: Procedures: Use a list of facilities where reviewers have a
financial or other relationship in determining assignment of clinical
images to reviewers;
State accreditation bodies: Arkansas: check;
State accreditation bodies: Iowa[A]: check;
State accreditation bodies: Texas[B]: check[B];
State certification bodies: Illinois: N/A;
State certification bodies: Iowa[A]: N/A.
Measures: Procedures: Conduct "blind reviews" of mammography images by
concealing facility identity[F];
State accreditation bodies: Arkansas: check;
State accreditation bodies: Iowa[A]: check;
State accreditation bodies: Texas[B]: [Empty];
State certification bodies: Illinois: N/A;
State certification bodies: Iowa[A]: N/A.
Measures: Procedures: For each clinical image and phantom image review,
use two or more individuals working independently[G];
State accreditation bodies: Arkansas: check;
State accreditation bodies: Iowa[A]: check;
State accreditation bodies: Texas[B]: check[B];
State certification bodies: Illinois: N/A;
State certification bodies: Iowa[A]: N/A.
Source: GAO analysis of state laws and policies and of documents and
information provided by FDA, Arkansas, Illinois, Iowa, and Texas
officials.
Legend: check = a measure is in place;
N/A = not applicable.
Note: South Carolina's certification body is not included in our review
because its certification program began operating after our review
began.
[A] Iowa is the only state that has authority to accredit and certify
mammography facilities.
[B] Texas contracts with ACR to review phantom and clinical mammography
images. ACR has policies to avoid conflicts of interest, including a
requirement that its reviewers sign a statement that provides
information about financial or other relationships that may constitute
a conflict of interest.
[C] Texas law requires that all state employees file a written
statement acknowledging receipt of the state's standard of conduct
laws.
[D] Arkansas ethics laws require that state agency heads, department
directors, and division directors file a financial disclosure
statement. In addition, all Arkansas state employees are required to
file a statement disclosing any income source other than their regular
salary from which they received over $500.
[E] Illinois ethics laws require a statement of economic interest from
state employees who function as the head of a department, supervise 20
or more employees, or have authority to approve certifications or
licenses.
[F] Personnel from the accreditation body cover the name of the
facility that appears in the mammography film to conceal the facility's
identity prior to submitting the image for clinical review.
[G] State accreditation bodies use private-sector physicians working
under contract or as volunteers to review clinical images. State
accreditation bodies use their own qualified staff to review phantom
images, except the accreditation body in Texas, which uses ACR's
reviewers.
[End of table]
Accreditation Bodies:
Employees and others, such as contractual reviewers, who provide
services for the three state accreditation bodies are subject to state
ethics laws and policies that generally prohibit them from having a
conflict of interest.[Footnote 65] These laws and policies vary in
scope across the three states, and each state has penalties associated
with violating its laws.[Footnote 66] For example, with regard to
financial disclosure, Arkansas requires all state employees to file a
statement disclosing any income source other than their regular salary
from which they received over $500.[Footnote 67] In contrast, Iowa
requires only certain individuals, such as elected officials and higher
level agency officials, to file financial disclosure forms[Footnote 68]
and in general does not require this of employees carrying out
accreditation responsibilities. While Texas also requires only certain
individuals, such as elected officials and higher level agency
officials, to file financial disclosure forms,[Footnote 69] the Texas
accreditation body contracts with ACR for its phantom and clinical
image reviews, and ACR's reviewers are subject to ACR's requirement to
disclose financial and other relationships with businesses or clients
involving mammography and to report related compensation over
$200.[Footnote 70] The Texas accreditation body is the only one that
requires its employees to attend ethics training when they are hired.
In addition, Texas law requires its employees to acknowledge that they
have received copies of the state employee standards of
conduct.[Footnote 71]
In addition to state laws and policies, the state accreditation bodies
have various procedures to help ensure that phantom and clinical image
reviewers avoid conflicts of interest. For example, all three state
accreditation bodies assign at least two individuals to independently
review clinical and phantom images. (See table 3.) In addition, in all
three states, reviewers are required to submit a list of facilities
where they have a financial interest, perform services, or have other
associations, and accreditation officials refer to these lists when
assigning clinical images to reviewers. Arkansas's clinical image
reviewers are not permitted to review images from facilities located
within 50 miles of their primary practice locations. Moreover, because
clinical image reviewers in Arkansas and Iowa may be familiar with
mammography facilities in their states, accreditation bodies in these
states use blind reviews of clinical images. That is, state employees
mask the names of facilities before presenting images to reviewers. In
Iowa, furthermore, state employees proctor the clinical image reviews
to ensure that the facility's identity is not revealed during the
process. In ACR's review of Texas facilities' phantom and clinical
images, reviewers from Texas or the surrounding states cannot conduct
the reviews. ACR procedures do not include blind reviews; instead, ACR
requires that reviewers sign a form disclosing any financial or other
relationship that could constitute a conflict of interest.[Footnote 72]
ACR legal staff review all potential conflicts of interest annually,
according to an ACR official, and if an actual conflict of interest
exists, the reviewer may be removed or allowed to perform only limited
types of reviews. In addition, reviewers who are familiar with a
facility must immediately report any conflict of interest to the
appropriate ACR official and recuse themselves. In assigning images to
reviewers, ACR uses computer software that automatically blocks
reviewers from reviewing images from facilities in states where they
live or practice or in other states they have identified where they may
have a conflict of interest.
Certification Bodies:
The two state certification bodies apply state ethics laws and
personnel policies that prohibit state employees from having a
financial interest or other interest, including one based on family
ties or outside employment, that conflicts with their duties. The same
state ethics laws that govern Iowa's accreditation body activities
apply to its certification body activities. Illinois ethics law
requires that state employees who function as the head of a department,
supervise 20 or more employees, or have authority to approve
certifications or licenses file a financial disclosure statement
annually.[Footnote 73] Illinois officials told us that employees of the
Illinois certification body with decision-making responsibilities--
including the coordinator of MQSA certification functions--submit a
financial disclosure statement. However, in general, Illinois employees
who inspect mammography facilities are not required to file such
statements.[Footnote 74] Illinois ethics law also requires that all
state employees annually complete ethics training,[Footnote 75] which
in the past has covered topics such as acceptance of gifts and
conflicts of interest.
FDA Approved State Bodies' Measures to Avoid Conflicts of Interest, and
Its Evaluations of State Bodies Have Not Found Problems:
As part of the state accreditation and certification body application
processes, FDA approved the measures each state body submitted as its
approach for avoiding conflicts of interest. These measures consisted
of the state ethics laws, state agency personnel policies, and
procedures the state body would use to carry out its duties. (See table
3.) FDA officials told us that in determining whether these measures
were adequate to ensure independence, they based their decisions on the
conflict-of-interest standards in MQSA regulations. MQSA regulatory
standards on conflicts of interest are broadly written; they do not
provide specific guidance to states on what measures they should take
to avoid conflicts.
Using written protocols, FDA has conducted annual performance
evaluations of state accreditation and certification bodies to assess
whether these bodies are complying with MQSA regulations. Evaluations
of state accreditation bodies have covered, among other things, state
bodies' procedures for reviewing phantom and clinical images and for
resolving consumer complaints about mammography facilities. These
procedures are a part of the accreditation bodies' efforts to avoid
conflicts of interest. In addition, FDA staff have independently
reviewed samples of phantom and clinical images previously reviewed by
the accreditation body to monitor the quality of the accreditation
body's work.[Footnote 76] FDA officials told us that their staff have
also reviewed several randomly selected facility files, including files
on any complaints received by the accreditation bodies since the
previous FDA evaluation, and accreditation body staffing
qualifications. FDA has submitted to the Congress its required annual
written evaluation reports on the performance of accreditation bodies.
FDA's annual evaluations of state certification bodies have included
reviews of each body's policies and procedures for certification,
inspection, appeals, consumer complaints, and certification revocation
and suspension. In addition, FDA officials told us that FDA auditors
have annually evaluated the performance of FDA inspectors and state
inspectors by accompanying them on facility compliance inspections.
Prior to going on these inspections, the auditors review inspection
records completed by the inspectors they will be accompanying. FDA
prepares an annual written evaluation report on the performance of
state certification bodies; it is not required to submit these reports
to the Congress. An FDA official told us that these annual evaluations
allow FDA to oversee state accreditation and certification bodies'
performance regarding avoiding conflicts of interest.
An FDA official told us that during the on-site visits that have been
part of FDA annual evaluations and during FDA's quarterly meetings with
state body officials, FDA officials have asked whether any conflict-of-
interest problems have arisen.[Footnote 77] According to this official,
state body officials have never reported to FDA during a quarterly
meeting that they had experienced a conflict-of-interest problem.
During on-site visits, FDA officials have inquired about state bodies'
overall policies and procedures. State bodies' staff have generally
described their policies and procedures for avoiding conflicts of
interest and orally assured FDA that they are following these measures.
FDA relies on the states to oversee the implementation of state ethics
laws and policies. However, FDA requires state bodies to immediately
report any situation that might adversely affect the public's health,
including complaints about conflicts of interest involving state
bodies' personnel. The FDA official also said that no state body has
ever reported a problem or concern related to a conflict of interest
involving a reviewer or inspector and that FDA has never found a
conflict-of-interest problem in its evaluations of state bodies'
performance. Officials of HHS's Office of the Inspector General,
similar state agencies responsible for overseeing state bodies that we
reviewed, and the Department of Justice told us that they have not
undertaken any investigations related to conflicts of interest or
complaints of fraud or abuse involving state agencies that accredit or
certify mammography facilities.
While FDA officials told us that they have asked questions related to
conflicts of interest during on-site visits, until recently the
agency's written protocols for conducting annual evaluations of state
bodies' performance have not explicitly addressed state bodies'
implementation of conflict-of-interest policies and procedures or the
application of state ethics laws. In addition, FDA's annual reports to
the Congress on the performance of the accreditation bodies have not
discussed the subject of conflicts of interest, and its annual
evaluation reports on certification bodies have not consistently
included this topic.
In June 2005, FDA revised its written protocol for evaluating
certification bodies to include a review of certain aspects of state
bodies' performance related to conflicts of interest. The revised
protocol requires FDA to (1) review any changes that the certification
bodies made to their conflict-of-interest policies and procedures since
FDA's last annual evaluation, (2) review any complaints related to
conflicts of interest involving state personnel or MQSA inspectors and
the resolution of the complaints, and (3) cover the topic of conflict
of interest in the annual reports it prepares on the performance of
certification bodies. FDA has not revised its protocol for conducting
annual evaluations of accreditation bodies to include specific
questions about conflicts of interest, and FDA officials told us they
currently have no plans to revise it.
Concluding Observations:
Current nationwide capacity for mammography services is adequate,
despite recent decreases in the facility and human resources that
affect capacity and an increase in the number of women eligible for
screening mammography. However, women may have difficulty gaining
access to mammography services in certain locations, particularly where
the loss or absence of machines has resulted in lengthy travel
distances or significant wait times. Lengthy travel distances may
especially pose a barrier to access for underserved women who lack
means of transportation, must incur increased travel costs, or must
take extra time away from work or family responsibilities. Access
problems for these women are of particular concern because they have
lower-than-average mammography screening rates. Furthermore, while
current overall capacity is adequate, if the numbers of radiologic
technologists and radiologists entering the mammography field are
insufficient to serve the growing population of women eligible for
regular screening, access problems could occur in the future.
Agency Comments:
We provided a draft of this report to FDA for comment. FDA's comments
are reprinted in Appendix IV. In its comments, FDA provided additional
details and clarification regarding its activities in certifying
mammography facilities and overseeing state accreditation and
certification bodies; FDA also provided technical comments. We
incorporated FDA's comments as appropriate.
As arranged with your offices, unless you publicly announce the
contents of this report earlier, we plan no further distribution of it
until 30 days after its date. At that time, we will send copies of this
report to the Secretary of Health and Human Services, the Commissioner
of FDA, and other interested parties. We will also make copies
available to others upon request. In addition, the report will be
available at no charge on the GAO Web site at [Hyperlink,
http://www.gao.gov].
If you or your staff members have any questions, please contact me at
(202) 512-7119 or crossem@gao.gov. Contact points for our Offices of
Congressional Relations and Public Affairs may be found on the last
page of this report. GAO staff members who made contributions to this
report are listed in appendix V.
Signed by:
Marcia Crosse:
Director, Health Care:
[End of section]
Appendix I: The Food and Drug Administration's Mammography Facility
Inspection Demonstration Program:
As authorized under the Mammography Quality Standards Reauthorization
Act of 1998 (MQSRA), the Food and Drug Administration (FDA) conducted
an inspection demonstration program (IDP) to evaluate the feasibility
and impact of conducting mammography facility compliance inspections
less frequently than annually.[Footnote 78] FDA's goal for the IDP was
to determine whether the inspection frequency of mammography facilities
that had been found to be in compliance with the Mammography Quality
Standards Act of 1992 (MQSA) standards could be reduced from yearly to
once every 2 years without a decrease in compliance rates. FDA carried
out the IDP from November 2001 through August 2004.[Footnote 79] This
appendix summarizes the methodology and results of the IDP.
Methodology:
MQSRA required that facilities selected for the IDP be "substantially
free of incidents of noncompliance" and that the number of facilities
selected be sufficient to provide a statistically significant sample of
facilities.[Footnote 80] FDA selected facilities for the IDP from
states that indicated a willingness to participate in the program and
met certain criteria.[Footnote 81] For example, FDA excluded states
that had laws, regulations, or policies requiring annual inspections,
and considered states that could accept changes to their existing
inspection contract with FDA to reflect the reduction in the number of
facilities that they would inspect during the IDP.[Footnote 82] To
minimize the financial impact that a reduced inspection schedule would
have on states that depend on income from their FDA inspection
contracts to fund inspectors' salaries, FDA officials placed a 10
percent limit on the number of facilities from each state that could
participate in the IDP. On the basis of these criteria, FDA selected 11
states, the District of Columbia, Puerto Rico, and New York City to
participate in the IDP. The states were Arkansas, Florida, Mississippi,
New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Washington,
Wisconsin, and Wyoming.
FDA established that to be eligible to participate in the IDP, a
facility had to be free of MQSA violations during the two most recent
annual inspections and have undergone at least two annual inspections
under the final MQSA regulations that took effect in April 28, 1999.
Among other things, a facility also had to maintain full accreditation
and certification throughout the program and expect to provide services
through the duration of the IDP. Using random selection, FDA divided
the eligible facilities in the 14 jurisdictions into a study group and
a control group. The study group consisted of 146 facilities. The
control group had 132 facilities in the first year of the program and
126 of those facilities in the second year.[Footnote 83]
FDA officials told us that they were not able to achieve a
statistically valid sample that would allow the results to be projected
nationwide, primarily because a number of states were not willing to
participate in the demonstration program or had state laws that
required annual inspections. An FDA official said that FDA implemented
the demonstration program even though the results could not be
projected nationwide because agency officials believed that the results
of the program would be useful to the Congress.
Results:
Overall, the inspections of the study group facilities, which occurred
after a 2-year interval, found that facilities did not maintain the
violation-free compliance level that they had previously. Of the 146
study group facilities, 58 percent were in full compliance with MQSA,
while 42 percent were cited for violations.[Footnote 84] (See fig. 3.)
Moreover, the study group facilities had a lower compliance rate than
facilities inspected annually, either as part of the IDP's control
group or outside of the demonstration program. The facilities in the
study group had a higher percentage of violations across all three
violation levels than facilities that had annual inspections. Most of
the study group's level 1, or most serious, violations were related to
missing records of the quality control tests, such as those required
for the mammography film processor.[Footnote 85] Level 2 violations--
the most prevalent category of violation for all groups--were almost
twice as high in the study group (27 percent) as in the control group
(14 percent).
Figure 3: Percentages of Mammography Facilities with MQSA Violations,
by Level of Violation, during FDA's IDP:
[See PDF for image]
Source: FDA.
Notes: Level 1 violations are the most serious, and level 3 the least
serious. Some facilities had multiple violations within each level or
across two or more levels, but for this analysis FDA placed the
facility in the level representing its most serious violation.
Percentages for a given period may not sum to 100 because of rounding.
[A] Facilities in the study group did not receive inspections during
the period of May 1, 2002, through April 30, 2003.
[End of figure]
Because the study group had a decrease in compliance, FDA officials
decided not to expand the demonstration program and returned all
mammography facilities to the annual inspection schedule. In commenting
on the IDP results, an FDA official responsible for the program noted
that the IDP did not provide evidence that facilities could maintain
their violation-free status without annual compliance inspections.
[End of section]
Appendix II: Scope and Methodology:
To identify the number of certified mammography facilities that closed
nationwide in recent years, we obtained and analyzed data from FDA's
Center for Devices and Radiological Health Mammography Program
Reporting and Information System database on the number of certified
mammography facilities that closed and those that received 6-month
provisional certificates to begin providing services from October 1,
2001, to October 1, 2004. To examine information on the factors that
contributed to mammography facility closures in recent years, we used
three sources. We obtained data from the American College of Radiology
(ACR) on mammography facilities accredited by ACR that closed from
October 1, 2001, to October 1, 2004, and the reasons for closures
reported by officials of facilities accredited by ACR. We reviewed data
and interviewed officials of state accreditation bodies in Arkansas,
Iowa, and Texas about closures of facilities accredited by these states
from 2001 through 2004. We also interviewed eight radiologists who are
experts in mammography about factors that contribute to mammography
facility closures.
To examine changes in the nation's capacity for and use of mammography
services in recent years and the adequacy of current capacity, we
analyzed data from FDA's Mammography Program Reporting and Information
System database on the total numbers of certified facilities, machines,
radiologic technologists who perform mammography, and physicians who
interpret mammograms as of October 1, 2001, and October 1, 2004. We
excluded facilities in U.S. territories. We also excluded federal
facilities operated by the Department of Defense, and facilities at
prisons and correctional institutions because they are not generally
accessible to the public. We also excluded facilities that had not
achieved provisional or accreditation status that were in FDA's
Mammography Program Reporting and Information System database because
they had not been certified by FDA or a state certification body as of
October 1, 2001, and October 1, 2004. FDA's database contains many
duplicate names of radiologic technologists and interpreting physicians
because many of these individuals work at multiple facilities and their
names are counted at each facility they serve. To remove the
duplicates, we analyzed data files from FDA that contained the names
and addresses of radiologic technologists and interpreting physicians
who worked at mammography facilities as of October 1, 2001, and October
1, 2004,[Footnote 86] and used an iterative process to edit the data
fields containing the technologists' and physicians' first and last
names. The first step was to "clean" the fields of extraneous commas,
spaces, punctuation, and other values. The next step was to correct
obvious and common spelling errors, such as Michael spelled Micheal.
The last step was to visually check for additional misspellings, using
the address information on the FDA file to confirm that an entry was
indeed a duplicate with a misspelled first or last technologist or
physician name. The duplicates were removed from the edited file, and
the analysis continued using the edited file of unduplicated names of
radiologic technologists and interpreting physicians. To examine
changes in the nationwide use of mammography services, we analyzed data
from the 2000 and 2003 National Health Interview Survey
(NHIS),[Footnote 87] administered by the Centers for Disease Control
and Prevention's (CDC) National Center for Health Statistics, to
estimate the number of women age 40 and older who received a screening
or diagnostic mammogram within the previous year. NHIS data on the use
of mammography services are based on data that are self-reported by
respondents. NHIS asked women age 30 and older about the length of time
since their last mammogram and about the reason for the mammogram. NHIS
surveys conducted in 2000 and 2003 provided the most recent trend data
available at the time we conducted our analysis. Using the 2000 and
2003 NHIS data, we compared screening rates and diagnostic rates for
women age 40 and older and estimates of the number of women receiving
screening and diagnostic mammograms nationwide within the previous
year. To determine the adequacy of current capacity, we obtained
estimates from mammography experts of the amount of time it takes to
perform a screening mammogram, and we used those estimates and FDA data
on the number of machines available in 2003 to calculate the number of
screening mammograms that potentially could have been performed in
2003. We compared our estimate of 81 million screening mammograms that
could have been performed by U.S. machines to the estimated number of
women age 40 and older who received a screening mammogram within the
previous year, based on data from the 2003 NHIS. We also obtained
estimates from mammography experts of the amount of time it takes to
perform a diagnostic mammogram and data on the estimated number of
women age 40 and older who received a diagnostic mammogram in
2003.[Footnote 88] To examine changes in the population of women age 40
and over, we used Census Bureau population data for 2003 and
projections for 2010 and 2015. In addition, we interviewed a number of
individuals about issues related to mammography facility closures,
mammography capacity, and access to mammography services. These
individuals included officials from FDA, CDC, the National Cancer
Institute, and the Centers for Medicare & Medicaid Services;
representatives from several professional organizations, such as the
American Board of Radiology, the American Cancer Society" , ACR, and
the American Society of Radiologic Technologists; and eight
radiologists who are experts in mammography.
We took three steps to assess the effects of the loss or absence of
mammography machines on access to services, including access for
medically underserved women. First, we used data from FDA's Mammography
Program Reporting and Information System database to randomly select 18
counties in 16 states that lost more than 25 percent of their machines
and interviewed officials about the effects of the loss of machines in
these counties. Second, using data from FDA's database, we identified
counties with no machines and interviewed officials knowledgeable about
access, including access for medically underserved women, in locations
beyond the 18 counties we reviewed. Third, we interviewed officials
working with CDC's National Breast and Cervical Cancer Early Detection
Program and officials from community health centers that are funded
through the Health Resources and Services Administration's (HRSA)
Consolidated Health Centers program regarding the effect of facility
closures on access for medically underserved women.
Specifically, for our first step of assessing the effects of machine
loss on access to services, we used data from FDA's database to
identify counties that lost mammography machines and focused on those
that lost more than 25 percent of their machines from October 1, 2001,
to October 1, 2004. We selected for our review a stratified random
sample of 9 urban counties and 9 rural counties, within 16 states, of
the 117 counties nationwide that lost more than 25 percent of their
mammography machines. (See table 4.) We randomly selected the counties
to avoid bias in their selection. However, the sample of 18 counties is
too small to project the results of our work to the entire group of
counties that lost more than 25 percent of their mammography machines
during this period.
Table 4: Counties Randomly Selected for Review from Those That Lost
over 25 Percent of Their Mammography Machines from October 1, 2001, to
October 1, 2004:
Rural counties: County: Navajo;
Rural counties: State: Arizona;
Urban counties: County: Houston;
Urban counties: State: Alabama.
Rural counties: County: Drew;
Rural counties: State: Arkansas;
Urban counties: County: Saint Johns;
Urban counties: State: Florida.
Rural counties: County: Putnam;
Rural counties: State: Florida;
Urban counties: County: Coweta;
Urban counties: State: Georgia.
Rural counties: County: Shiawassee;
Rural counties: State: Michigan;
Urban counties: County: Warren;
Urban counties: State: Iowa.
Rural counties: County: Newton;
Rural counties: State: Mississippi;
Urban counties: County: Butler;
Urban counties: State: Kansas.
Rural counties: County: Lewis and Clarke;
Rural counties: State: Montana;
Urban counties: County: Wayne;
Urban counties: State: New York.
Rural counties: County: Fulton;
Rural counties: State: New York;
Urban counties: County: Morton;
Urban counties: State: North Dakota.
Rural counties: County: Duplin;
Rural counties: State: North Carolina;
Urban counties: County: Pottawatomie;
Urban counties: State: Oklahoma.
Rural counties: County: Dickenson;
Rural counties: State: Virginia;
Urban counties: County: Lubbock;
Urban counties: State: Texas.
Source: GAO analysis, based on FDA's Mammography Program Reporting and
Information System database.
[End of table]
The determination of the 18 counties as urban or rural is based on the
2003 Rural-Urban Continuum Codes published by the Department of
Agriculture, which classifies all U.S. counties into nine categories.
The Department of Agriculture groups nonmetropolitan counties into six
rural categories by size of the urban population and nearness to a
metropolitan area; it groups metropolitan counties into three urban
categories based on the size of the metropolitan area in which the
county is located.
For the 18 counties selected, we interviewed officials familiar with
access to mammography services in these counties and asked them about
their views on the effects of the loss of machines and facilities on
access in these counties. These officials generally included county
health department officials who coordinate health programs; state
radiation control personnel under contract to FDA to conduct annual on-
site inspections of mammography facilities; and quality improvement
organization (QIO) officials under contract to CMS to monitor and
improve the quality of care, including increasing statewide mammography
screening rates for Medicare beneficiaries. We also interviewed two QIO
officials--one from Missouri and one from Washington--about access in
areas of their states. The 18 counties we selected did not include any
in Missouri or Washington, but these two officials were among three QIO
officials we attempted to contact who were recommended by a CMS
official as being knowledgeable about mammography access issues in
their states.
For our second step of assessing the effects of the absence of machines
on access to services, we used FDA data on the number and locations of
mammography machines nationwide as of October 1, 2004, to identify
counties that had no machines. In interviews with state radiation
control program personnel and QIO officials in 11 states that had
counties with no machines, we obtained their views on the effects of
the absence of mammography machines on access in their state, including
access for medically underserved women. We also discussed Missouri
counties that had no mammography machines with the Missouri QIO
official.
For our third step, to provide additional information on the effects of
facility closures on access for medically underserved women, we
interviewed state officials who direct CDC's National Breast and
Cervical Cancer Early Detection Program and officials of community
health centers. To identify facilities that closed and where program
participants had been receiving services, we worked with CDC officials
to request from state directors of CDC's early detection program the
names and addresses of mammography facilities that provided mammography
services to program participants from 2001 through 2004. In all,
officials of 37 states and the District of Columbia provided complete
or partial lists of facilities. We matched the facility lists provided
by the state directors with facility closures from October 1, 2001, to
October 1, 2004, in FDA's database. This analysis resulted in a total
of 164 closed facilities. We identified the counties and states where
these facilities were located and selected for review 9 rural and 9
urban counties where a total of 24 closed facilities were located. (See
table 5.) We selected 4 of the 9 urban counties because they are
central counties of metropolitan areas with populations of 250,000 to 1
million or more--Fulton County, Georgia; Cook County, Illinois; Wayne
County, Michigan; and Kings County, New York--and we selected 3
counties because they were located in American Indian Health Service
areas. In total, we interviewed officials in 8 states that work with
CDC's early detection program about the effect of the facility closures
in the 18 counties.
Table 5: Selected Counties with Closures of Facilities That Had
Provided Mammography Services to Participants in CDC's National Breast
and Cervical Cancer Early Detection Program, 2001 through 2004:
County: Logan Sharp;
State: Arkansas;
Rural/urban county designation: Rural Rural.
County: Fulton Wilkes;
State: Georgia;
Rural/urban county designation: Urban Rural.
County: Gem Shoshone;
State: Idaho;
Rural/urban county designation: Rural Rural.
County: Cook Peoria;
State: Illinois;
Rural/urban county designation: Urban Urban.
County: Berrien Wayne;
State: Michigan;
Rural/urban county designation: Urban Urban.
County: Kings Oneida Saint Lawrence Tioga;
State: New York;
Rural/urban county designation: Urban Urban Rural Urban.
County: Dickenson Washington;
State: Virginia;
Rural/urban county designation: Rural Urban.
County: Hardy Jackson;
State: West Virginia;
Rural/urban county designation: Rural Rural.
Source: GAO analysis, based on state National Breast and Cervical
Cancer Early Detection Program lists of facilities that provided
mammography services to National Breast and Cervical Cancer Early
Detection Program clients and information on facility closures from
FDA's Mammography Program Reporting and Information System database.
[End of table]
With the assistance of HRSA, we obtained a list of facility closures
that were located in the same counties as community health centers.
HRSA identified the closures from data it requested from FDA on our
behalf on mammography facilities that were certified as of October 2003
but were closed as of October 2004. HRSA then matched the addresses of
the closures with its list of community health centers funded in 2004.
This yielded a list of 34 closed mammography facilities that were in
the same counties as community health centers. We selected 10 counties
and interviewed a community health center official in each county (six
officials from urban centers and four from rural centers)[Footnote 89]
regarding the effect of closures on their patients' access to
mammography services. (See table 6.)
Table 6: Selected Counties with Mammography Facility Closures and
Community Health Centers, October 2003 to October 2004:
County: Anchorage;
State: Alaska;
Community health center rural/urban designation: Rural.
County: Tulare;
State: California;
Community health center rural/urban designation: Rural.
County: Leon;
State: Florida;
Community health center rural/urban designation: Rural.
County: Delaware;
State: Indiana;
Community health center rural/urban designation: Urban.
County: Orleans;
State: Louisiana;
Community health center rural/urban designation: Urban.
County: Baltimore;
State: Maryland;
Community health center rural/urban designation: Urban.
County: Onondaga;
State: New York;
Community health center rural/urban designation: Urban.
County: Harris;
State: Texas;
Community health center rural/urban designation: Urban.
County: King;
State: Washington;
Community health center rural/urban designation: Urban.
County: Washburn;
State: Wisconsin;
Community health center rural/urban designation: Rural.
Source: GAO analysis of FDA data on mammography facilities that closed
from October 2003 to October 2004 and HRSA data on community health
centers that were funded during fiscal year 2004.
[End of table]
In each of our interviews with officials on access to mammography
services, we asked the official to provide estimates of the numbers of
days women had to wait to obtain screening mammography and diagnostic
mammography in counties that had a loss or absence of machines. In
counties where officials reported access problems, we asked them to
provide estimates of the distances women had to travel to mammography
facilities both before and after the loss of machines, and when state
and QIO officials identified counties with an absence of machines, we
asked them to provide estimates of the travel distance to mammography
services. While most officials had not conducted formal studies to
gather information on wait times and travel distances, they generally
provided information based on informal surveys they had conducted of
facilities in their counties or nearby counties or on their involvement
and frequent contacts with mammography facilities.
To examine the measures state bodies have taken to avoid conflicts of
interest and FDA's oversight of state bodies' performance in this area,
we reviewed MQSA and MQSA regulations that govern state bodies'
functions, FDA documents, state ethics laws, and state bodies' policies
and procedures. In addition, we interviewed officials from FDA's Center
for Devices and Radiological Health; accreditation bodies in Arkansas,
Iowa, and Texas; certification bodies in Illinois and Iowa; and
ACR.[Footnote 90] We reviewed state and FDA documents containing ethics
laws and policies and procedures, including information on conflict-of-
interest policies that state bodies are required to submit to FDA as
part of the initial application process. We also reviewed FDA's
inspection procedures, which states are required to use to conduct
inspections. The California and South Carolina state agencies are not
included in our review because the California state agency withdrew its
application to continue to operate as an FDA-approved accreditation
body before our review began, and South Carolina's certification
program began operating after our review began.
In examining FDA's oversight of state bodies, we reviewed FDA's annual
evaluation reports on the performance of each state accreditation and
certification body for calendar years 2003 and 2004 and FDA's annual
reports to the Congress covering the performance of all accreditation
bodies for calendar years 2000 through 2004--the most recent available
at the time of our review. In addition, we reviewed the protocols that
FDA officials use to conduct their evaluations of state bodies'
performance and the timetables for FDA evaluations.
During our interviews with FDA officials, we discussed the criteria
they use to determine whether states have any conflict-of-interest
problems that could affect their impartiality in carrying out
accreditation, certification, and inspection functions and actions FDA
takes to oversee state bodies. We did not review state and federal
documents, such as financial disclosure statements, employment records,
or any other documents typically used in making assessments about
potential or actual conflicts of interest. In addition, we did not make
on-site visits to state accreditation and certification bodies or
observe MQSA inspections.
To describe the methodology and results of FDA's IDP, we reviewed FDA
documents and interviewed officials from FDA's Center for Devices and
Radiological Health. We also examined whether the sample of facilities
that FDA included in the IDP met the criterion of being free of
violations for 2 consecutive years prior to IDP implementation by
reviewing reports of MQSA inspections conducted during 2000, 2001, and
January through April 2002. We reviewed reports on a sample of 49
mammography facilities, with 25 randomly selected from the universe of
study control group facilities and 24 from the control group.[Footnote
91]
To assess the reliability of the FDA, ACR, and state body data on
mammography facility closures and mammography capacity, we talked with
knowledgeable officials of these organizations about data quality
control procedures and reviewed relevant documentation. We also
electronically tested the FDA data to identify problems with accuracy
and completeness. To assess the reliability of the NHIS data on the
numbers of women age 40 and older who received a screening or
diagnostic mammogram in 2000 and 2003 and the population estimate data
from the Census Bureau, we reviewed the existing documentation on
methodology and data collection procedures. We determined that the data
were sufficiently reliable for the purposes of this report.
We conducted our work from November 2004 through July 2006 in
accordance with generally accepted government auditing standards.
[End of section]
Appendix III: Changes in the Number of Certified Mammography Facilities
by State, October 1, 2001, to October 1, 2004:
Table 7:
State: Alabama;
Number of facilities in 2001: 157;
Number of facilities in 2004: 140;
Net change in number of facilities: -17.
State: Alaska;
Number of facilities in 2001: 32;
Number of facilities in 2004: 30;
Net change in number of facilities: -2.
State: Arizona;
Number of facilities in 2001: 148;
Number of facilities in 2004: 151;
Net change in number of facilities: +3.
State: Arkansas;
Number of facilities in 2001: 111;
Number of facilities in 2004: 102;
Net change in number of facilities: -9.
State: California;
Number of facilities in 2001: 768;
Number of facilities in 2004: 736;
Net change in number of facilities: -32.
State: Colorado;
Number of facilities in 2001: 111;
Number of facilities in 2004: 106;
Net change in number of facilities: -5.
State: Connecticut;
Number of facilities in 2001: 154;
Number of facilities in 2004: 143;
Net change in number of facilities: -11.
State: Delaware;
Number of facilities in 2001: 24;
Number of facilities in 2004: 30;
Net change in number of facilities: +6.
State: District of Columbia;
Number of facilities in 2001: 21;
Number of facilities in 2004: 19;
Net change in number of facilities: -2.
State: Florida;
Number of facilities in 2001: 487;
Number of facilities in 2004: 460;
Net change in number of facilities: -27.
State: Georgia;
Number of facilities in 2001: 261;
Number of facilities in 2004: 240;
Net change in number of facilities: -21.
State: Hawaii;
Number of facilities in 2001: 41;
Number of facilities in 2004: 40;
Net change in number of facilities: -1.
State: Idaho;
Number of facilities in 2001: 47;
Number of facilities in 2004: 44;
Net change in number of facilities: -3.
State: Illinois;
Number of facilities in 2001: 418;
Number of facilities in 2004: 384;
Net change in number of facilities: -34.
State: Indiana;
Number of facilities in 2001: 229;
Number of facilities in 2004: 219;
Net change in number of facilities: -10.
State: Iowa;
Number of facilities in 2001: 151;
Number of facilities in 2004: 147;
Net change in number of facilities: -4.
State: Kansas;
Number of facilities in 2001: 134;
Number of facilities in 2004: 122;
Net change in number of facilities: -12.
State: Kentucky;
Number of facilities in 2001: 172;
Number of facilities in 2004: 164;
Net change in number of facilities: -8.
State: Louisiana;
Number of facilities in 2001: 166;
Number of facilities in 2004: 160;
Net change in number of facilities: -6.
State: Maine;
Number of facilities in 2001: 62;
Number of facilities in 2004: 61;
Net change in number of facilities: -1.
State: Maryland;
Number of facilities in 2001: 148;
Number of facilities in 2004: 135;
Net change in number of facilities: -13.
State: Massachusetts;
Number of facilities in 2001: 194;
Number of facilities in 2004: 177;
Net change in number of facilities: -17.
State: Michigan;
Number of facilities in 2001: 334;
Number of facilities in 2004: 316;
Net change in number of facilities: -18.
State: Minnesota;
Number of facilities in 2001: 212;
Number of facilities in 2004: 202;
Net change in number of facilities: -10.
State: Mississippi;
Number of facilities in 2001: 104;
Number of facilities in 2004: 104;
Net change in number of facilities: 0.
State: Missouri;
Number of facilities in 2001: 182;
Number of facilities in 2004: 172;
Net change in number of facilities: -10.
State: Montana;
Number of facilities in 2001: 48;
Number of facilities in 2004: 48;
Net change in number of facilities: 0.
State: Nebraska;
Number of facilities in 2001: 92;
Number of facilities in 2004: 92;
Net change in number of facilities: 0.
State: Nevada;
Number of facilities in 2001: 61;
Number of facilities in 2004: 70;
Net change in number of facilities: +9.
State: New Hampshire;
Number of facilities in 2001: 49;
Number of facilities in 2004: 46;
Net change in number of facilities: -3.
State: New Jersey;
Number of facilities in 2001: 278;
Number of facilities in 2004: 250;
Net change in number of facilities: -28.
State: New Mexico;
Number of facilities in 2001: 48;
Number of facilities in 2004: 49;
Net change in number of facilities: +1.
State: New York;
Number of facilities in 2001: 701;
Number of facilities in 2004: 631;
Net change in number of facilities: -70.
State: North Carolina;
Number of facilities in 2001: 249;
Number of facilities in 2004: 234;
Net change in number of facilities: -15.
State: North Dakota;
Number of facilities in 2001: 42;
Number of facilities in 2004: 43;
Net change in number of facilities: +1.
State: Ohio;
Number of facilities in 2001: 440;
Number of facilities in 2004: 417;
Net change in number of facilities: -23.
State: Oklahoma;
Number of facilities in 2001: 102;
Number of facilities in 2004: 100;
Net change in number of facilities: -2.
State: Oregon;
Number of facilities in 2001: 99;
Number of facilities in 2004: 99;
Net change in number of facilities: 0.
State: Pennsylvania;
Number of facilities in 2001: 440;
Number of facilities in 2004: 402;
Net change in number of facilities: -38.
State: Rhode Island;
Number of facilities in 2001: 43;
Number of facilities in 2004: 38;
Net change in number of facilities: -5.
State: South Carolina;
Number of facilities in 2001: 123;
Number of facilities in 2004: 116;
Net change in number of facilities: -7.
State: South Dakota;
Number of facilities in 2001: 48;
Number of facilities in 2004: 46;
Net change in number of facilities: -2.
State: Tennessee;
Number of facilities in 2001: 207;
Number of facilities in 2004: 199;
Net change in number of facilities: -8.
State: Texas;
Number of facilities in 2001: 563;
Number of facilities in 2004: 529;
Net change in number of facilities: -34.
State: Utah;
Number of facilities in 2001: 46;
Number of facilities in 2004: 47;
Net change in number of facilities: +1.
State: Vermont;
Number of facilities in 2001: 19;
Number of facilities in 2004: 17;
Net change in number of facilities: -2.
State: Virginia;
Number of facilities in 2001: 204;
Number of facilities in 2004: 183;
Net change in number of facilities: -21.
State: Washington;
Number of facilities in 2001: 175;
Number of facilities in 2004: 158;
Net change in number of facilities: -17.
State: West Virginia;
Number of facilities in 2001: 84;
Number of facilities in 2004: 75;
Net change in number of facilities: -9.
State: Wisconsin;
Number of facilities in 2001: 250;
Number of facilities in 2004: 250;
Net change in number of facilities: 0.
State: Wyoming;
Number of facilities in 2001: 27;
Number of facilities in 2004: 25;
Net change in number of facilities: -2.
State: Total;
Number of facilities in 2001: 9,306;
Number of facilities in 2004: 8,768;
Net change in number of facilities: -538.
Source: GAO analysis of FDA's Mammography Program Reporting and
Information System database on mammography facilities.
[End of table]
[End of section]
Appendix IV: Comments from the Food and Drug Administration:
Department Of Health & Human Services:
Food and Drug Administration:
Rockville MD 20857:
June 30, 2006:
Marcia Crosse:
Director, Health Care:
United States Government Accountability Office:
441 G Street, NW:
Washington, DC 20548:
Dear Ms. Crosse:
Please find enclosed the Food and Drug Administration's general
comments in response to the General Accountability Office's
correspondence entitled, "Mammography Current Nationwide Capacity is
Adequate, but Access Problems May Exist in Certain Locations (GAO-06-
724)."
We appreciate the opportunity to review and comment on this draft
correspondence before it is published, as well as the opportunity to
work with your staff in its development.
Sincerely,
Signed by:
Andrew C. von Eschenbach, M.D.
Acting Commissioner of Food and Drugs:
Enclosure:
General Comments To The Draft Report Entitled, "Mammography: Current
Nationwide Capacity Is Adequate, But Access Problems May Exist In
Certain Locations, (GAO-06-724)"
1. On page 3,
* First paragraph, lines 16 and 17, which states, "For most states
where FDA certifies the facilities, it contracts with state inspectors
to perform MQSA compliance inspections." FDA suggests adding a
reference 8a after the above-mentioned sentence and making the
following sentence footnote 8a, "FDA also contracts with certain non-
state entities, i.e., the City of New York and the Commonwealth of
Puerto Rico."
* Change footnote 8 to footnote 8b and revise the footnote reading, "As
of January 2006, FDA did not have contracts with Nebraska, New
Hampshire and New Mexico, according to FDA officials. FDA inspectors
are responsible for conducting inspections in these states and in
federal facilities." to read, "As of June 2006, FDA did not have
contracts with Nebraska, New Hampshire, and Washington, D.C. FDA
inspectors are responsible for conducting inspections in Nebraska, New
Hampshire, Washington, D.C., and in federal facilities."
2. On page 9, first full paragraph, revise the sentence at lines 5-8 to
read, "As required by regulation, the measures used by the state
accreditation and certification bodies to avoid conflicts of interest
must be submitted for FDA's review and approval. FDA has conducted
annual performance evaluations of state bodies to assess whether they
are complying with MQSA regulations."
3. On page 14, footnote 26, after the phrase, ".facilities it
accredits" add the words in parentheses, "(but no more than 50
facilities must be visited)."
[End of section]
Appendix V: GAO Contact and Staff Acknowledgments:
GAO Contact:
Marcia Crosse, (202) 512-7119 or crossem@gao.gov:
Acknowledgments:
In addition to the contact named above, Helene Toiv, Assistant
Director; Darryl Joyce; Roseanne Price; Mary Reich; Carmen Rivera-
Lowitt; and Suzanne Worth made key contributions to this report.
FOOTNOTES
[1] The U.S. Preventive Services Task Force is a committee of medical
experts convened by the Department of Health and Human Services to
evaluate evidence and make recommendations for screening services, such
as mammography.
[2] See, for example, Rebecca Smith-Bindman et al., "Does Utilization
of Screening Mammography Explain Racial and Ethnic Differences in
Breast Cancer?" Annals of Internal Medicine, vol. 144, no. 8 (2006),
and Asma Ghafoor et al., "Trends in Breast Cancer by Race and
Ethnicity," CA: A Cancer Journal for Clinicians, vol. 53, no. 6 (2003).
[3] Pub. L. No. 102-539, 106 Stat. 3547; Pub. L. No. 105-248, 112 Stat.
1864; Pub. L. No. 108-365, 118 Stat. 1738 (codified at 42 U.S.C. §
263b).
[4] FDA approved ACR and state agencies in Arkansas and Iowa to serve
as accreditation bodies in 1994. FDA approved a state agency in Texas
to serve as an accreditation body in 1999. These bodies are currently
approved to serve as accreditation bodies through April 28, 2013. FDA
approved a state agency in California to operate as an accreditation
body in 1994, but California withdrew its application to continue
operating as an accreditation body on May 5, 2004. FDA required that
facilities previously accredited by California obtain accreditation
from ACR within 1 year of California's withdrawal as an accreditation
body.
[5] FDA approved state agencies in Illinois and Iowa to serve as
certification bodies in 1998. In April 2005, FDA approved a state
agency in South Carolina to serve as a state certification body. These
state certification bodies are currently approved to serve in that
capacity for an indefinite period.
[6] Facilities in states with certifying bodies may receive
certification only from their state body, not from FDA.
[7] MQSA requires the annual inspection of mammography facilities to
ensure compliance with the act's requirements. 42 U.S.C. § 263b(g).
[8] In addition to contracting with states, FDA also contracts with New
York City and Puerto Rico to have their inspectors perform MQSA
compliance inspections. As of June 2006, FDA did not have contracts
with Nebraska, New Hampshire, and the District of Columbia, according
to FDA officials. FDA inspectors are responsible for conducting
inspections in these jurisdictions and in federal facilities.
[9] Pub. L. No. 105-248, § 8, 112 Stat. 1864, 1865-66.
[10] GAO, Mammography: Capacity Generally Exists to Deliver Services,
GAO-02-532 (Washington, D.C.: Apr. 19, 2002).
[11] In our last report, we examined three of these elements. In this
report we added physicians who interpret mammograms as a fourth element
of capacity.
[12] NHIS is the principal source of information on the health of the
civilian noninstitutionalized population of the United States and is
one of the major data collection programs for the National Center for
Health Statistics. In 2000 and 2003, NHIS asked women age 30 and older
about the length of time since their last mammogram and about the
reason for the mammogram. NHIS data on the use of mammography services
are based on data that are self-reported by respondents. The 2003 data
were the most recent data available on the use of mammography services
at the time we conducted our analysis.
[13] The sample of 18 counties is too small to project the results of
our work to the entire group of counties that lost more than 25 percent
of their mammography machines during this period.
[14] In addition to monitoring and trying to improve mammography
screening rates for Medicare beneficiaries, QIO officials responsible
for each U.S. state and territory and the District of Columbia work,
under CMS's direction, with consumers, physicians, hospitals, and other
health care providers to improve service delivery and help ensure that
patients receive quality care, with particular attention to underserved
populations.
[15] 58 Fed. Reg. 67565-72 (Dec. 21, 1993). Interim regulations issued
on the same day included standards for accreditation bodies. See 58
Fed. Reg. 67558-65.
[16] 62 Fed. Reg. 55852-994 (Oct. 28, 1997) (codified at 21 C.F.R. Part
900).
[17] Under MQSA, mammography facilities operated by the Department of
Veterans Affairs are excluded from FDA's review, but they are
accredited by ACR and are required by the Veterans' Health Care
Eligibility Reform Act to meet standards equivalent to those in MQSA.
Pub. L. No. 104-262, § 321(a)(1), 110 Stat. 3177, 3195 (codified at 38
U.S.C. § 7319).
[18] FDA's final MQSA regulations also included standards for
accreditation bodies that took effect in 1999. In 2002, FDA issued
regulations containing standards for certification bodies. See 67 Fed.
Reg. 5446-69 (Feb. 6, 2002).
[19] As of January 2006, 41 states had licensing requirements for
radiologic technologists.
[20] The American Registry of Radiologic Technologists is the nation's
credentialing organization for radiologic technologists. It administers
an examination for certification, maintains a registry of currently
certified general radiologic technologists, and administers a
subspecialty examination and certification program for mammography
technologists. Although technologists who perform mammography do not
have to be certified in the mammography subspecialty, the majority of
the technologists who perform mammography, including those who are
licensed by states, have such certification.
[21] Physicians who interpret mammograms can also meet FDA's
requirements if they have had a minimum of 3 months of documented
specialized training in the interpretation of mammograms.
[22] Although all accreditation bodies follow MQSA standards for
accrediting mammography facilities, the accreditation processes
established by each accreditation body vary slightly, such as with
respect to when facilities must submit certain information for review
and when to submit the accreditation application fee. For example,
Iowa's application fee is required as part of the second phase of the
accreditation process.
[23] ACR notifies both FDA and, when applicable, the state
certification body.
[24] A facility that does not complete the accreditation process within
the 6-month provisional period must either cease performing mammography
or apply for a onetime 90-day extension of the provisional certificate.
MQSA requires that to receive the extension, the facility must show
that access to mammography in the geographic area served by the
facility would be significantly reduced if the facility did not receive
the extension. 42 U.S.C. § 263b(c)(2).
[25] A phantom image is a radiographic (X-ray) image of a phantom,
which is a plastic block used to simulate radiographic characteristics
of breast tissue. FDA-approved phantoms simulate a 4.2-centimeter-thick
compressed breast consisting of 50 percent glandular and 50 percent
fatty tissue, and contain16 test objects that simulate aspects of
breast disease and cancer. The phantom is used to assess the ability of
the facility's imaging equipment to detect breast disease and cancer.
Under Arkansas's and Iowa's procedures, facilities must submit the
phantom images as part of the initial application package.
[26] ACR notifies both FDA and, when applicable, the state
certification body.
[27] The facility must display its MQSA certificate to operate legally.
42 U.S.C. § 263b(b)(1)(A)(iii).
[28] MQSA regulations require that each accreditation body annually
visit at least 5 percent of the facilities it accredits and that at
least half of the facilities be selected randomly. The other facilities
are selected based on problems identified in various ways, such as
through state or FDA compliance inspections, previous history of
noncompliance, and serious consumer complaints. The accreditation body
must visit at least 5 facilities each year, but is not required to
visit more than 50 unless problems that had been identified indicate a
need to visit more than 50 facilities. See 21 C.F.R. § 900.4(f)(1).
[29] The random sample of clinical images that each accreditation body
reviews annually must include images from at least 3 percent of the
facilities the body accredited. See 21 C.F.R. § 900.4(f) (2).
[30] Accreditation body staff verify, among other things, that the
facility personnel and equipment identified in the application are the
ones used to perform mammography services and that the facility has in
place a consumer complaint system and a medical audit system, which is
a system for reviewing and tracking outcomes of positive mammograms--
those identified as having abnormalities--and correlating them with
biopsy results. See 21 C.F.R. § 900.4(f)(1)(ii) for a description of
the minimum review requirements accreditation body site visits must
meet.
[31] FDA and certification bodies must perform annual inspections to
ensure compliance with all the quality standards found in 21 C.F.R. §
900.12.
[32] The purpose of reviewing quality control records is to ensure that
the equipment quality control tests performed by radiologic
technologists are routinely done at the required frequencies, that test
records are in order, and that corrective actions are taken when
warranted. The purpose of reviewing quality assurance records is to
ensure that the facility develops and maintains policies and procedures
to monitor the performance of facility personnel and equipment.
[33] The film processor is the device that develops the film to produce
a mammographic image.
[34] 21 C.F.R. § 900.4(a)(4) and 21 C.F.R. § 900.22(a) (2005).
[35] 42 U.S.C. § 263b(e)(6) requires the annual report to the Senate
Committee on Health, Education, Labor, and Pensions and the House
Committee on Energy and Commerce.
[36] Pub. L. No. 101-354, 104 Stat. 409 (codified at 42 U.S.C. §§ 300k
through n).
[37] The program operates in every state, the District of Columbia, 4
U.S. territories, and 13 American Indian and Alaska Native
organizations.
[38] Criteria for designating a medically underserved area or
population include the ratio of primary medical care physicians per
1,000 population, infant mortality rate, percentage of the population
with incomes below the federal poverty level, and percentage of the
population age 65 or older. In 2005, the federal poverty level for a
family of four was an annual income of $19,350 in the 48 contiguous
states and the District of Columbia.
[39] Information on health center patients is based on data from HRSA's
Uniform Data System. The percentages related to income level and race/
ethnicity exclude patients whose status HRSA reported as unknown. The
income level of 19 percent of patients was reported as unknown, and the
race/ethnicity of 6 percent was reported as unknown.
[40] Facilities in U.S. territories, federal facilities operated by the
Department of Defense, facilities at prisons and correctional
institutions, and facilities that had not achieved provisional or
accreditation status were excluded from the analysis.
[41] A mobile mammography facility performs mammography using a vehicle
equipped with a mammography X-ray machine and travels from one location
to another. In some cases, one or more of these mobile facilities are
dedicated to a fixed facility, such as a hospital, outpatient clinic,
or radiology practice.
[42] The 10 states that lost more than 20 facilities are California,
Florida, Georgia, Illinois, New Jersey, New York, Ohio, Pennsylvania,
Texas, and Virginia.
[43] In April 2001, ACR began tracking the number of closures of
facilities that it accredited and the reasons for closure that were
reported by facility officials.
[44] ACR learns of facility closures from a variety of sources,
including facility personnel, FDA, state certifiers, state inspectors,
local cancer societies, and patients. When ACR is notified that a
facility has closed, ACR contacts the facility by telephone to confirm
the closure and sends a facility closure memorandum. A facility closure
memorandum asks for general information about the closure and the
reason for closure. ACR officially lists the facility as closed in its
records after the memorandum has been signed by the facility's lead
radiologist, chief executive officer, or president. If the memorandum
is not returned to ACR within 10 business days after it has been sent,
ACR closes the facility in its database.
[45] Many of the names in FDA's database within each year are
duplicates because many of these individuals work at multiple
facilities and their names are counted at each facility they serve.
After correcting errors in the spelling of names and other data entry
mistakes, we calculated the unduplicated numbers of radiologic
technologists and interpreting physicians. We determined that the
unduplicated numbers of radiologic technologists in FDA's Mammography
Program Reporting and Information System database were 31,402 in 2001
and 30,503 in 2004. We determined that the unduplicated numbers of
interpreting physicians in the database were 19,675 in 2001 and 18,690
in 2004. (See app. II.)
[46] The population of women age 40 and older increased by about 6
percent from 2000 to 2003.
[47] Based on NHIS survey data, screening mammograms accounted for 91
percent of the number of women age 40 and older who received a
mammogram in 2000 and 94 percent in 2003.
[48] In the 2003 NHIS survey, uninsured women age 40 and older and poor
women age 40 and older reported lower screening rates than other women
in that age group. Twenty-six percent of uninsured women age 40 and
older reported having a screening mammogram within the previous year,
in comparison with 57 percent of women in the same age group who had
private insurance or were enrolled in the U.S. military's medical
health benefits program. Similarly, 36 percent of poor women age 40 and
older reported having a screening mammogram within the previous year,
in comparison with 52 percent of women with middle incomes and 60
percent of women with high incomes. The following are the 2003 NHIS
screening rates for this age group by ethnicity: White--52 percent;
African American--51 percent; Hispanic--48 percent; Asian--44 percent;
and Native American--35 percent.
[49] Of the eight experts we consulted, five experts estimated a time
of 15 to 20 minutes. Two other experts and an FDA official estimated a
time of 10 to 15 minutes. One expert did not provide an estimate.
[50] This yearly total is based on the assumption that a machine was in
operation 5 days per week and 50 weeks per year.
[51] We did not determine whether there were a sufficient number of
radiologic technologists available to perform mammograms for the
estimated level of machine capacity.
[52] The excess capacity also would have been adequate to provide the
estimated 3 million mammograms received that year by women age 30 to
39.
[53] Factors that can affect capacity include a facility's balance
between screening and diagnostic mammograms and its approach to
scheduling those services. For example, some facilities achieve greater
efficiency by scheduling screening and diagnostic mammograms at
different times. Facilities also differ in the way they manage their
personnel and schedules. At some facilities, radiologic technologists
who perform mammograms help patients complete forms and prepare for the
examination, reducing the number of mammograms they can perform, while
at other facilities assistants perform this work. Some facilities have
evening and weekend hours, increasing their capacity.
[54] Carl D'Orsi, et al., "Current Realities of Delivering Mammography
Services in the Community: Do Challenges with Staffing and Scheduling
Exist?" Radiology, vol. 235, no. 2 (2005): 391-395.
[55] There are 3,141 counties, including the District of Columbia.
[56] U.S. Census Bureau, Population Estimates Program, County
Population Estimates and Estimated Components of Change: April 1, 2000
to July 1, 2004 (Washington, D.C.: April 2005) [Hyperlink,
http://www.census.gov/popest/counties] (downloaded March 6, 2006).
[57] In 82 (70 percent) of the 117 counties that lost more than 25
percent of their machines, the population increased from 2001 to 2004,
with increases ranging from less than 1 percent to 21 percent.
[58] In 51 (68 percent) of the 75 counties, the population increased
from 2001 to 2004, with increases ranging from less than 1 percent to
17 percent.
[59] State, local, and QIO officials discussing 11 of the 18 counties
in our study that lost more than 25 percent of their machines told us
that the loss of machines had not affected access to mammography
services. We do not have information on 1 of the 18 counties because
for that county only one QIO official responded and she had no
knowledge of machine losses in the county. Officials who work with
CDC's early detection program in four of eight states we reviewed said
that facility closures had no effect on access to mammography services
for underserved women in their program. In addition, 9 of the 10
community health center officials we interviewed reported that facility
closures in their counties did not create access problems for their
patients.
[60] The six counties are Navajo County, Arizona; Warren County, Iowa;
Butler County, Kansas; Newton County, Mississippi; Wayne County, New
York; and Dickenson County, Virginia.
[61] For each of the six counties, one of the three officials we
interviewed reported that women had experienced longer travel
distances. The other officials who responded to our request for
information stated either that women's access to mammography services
had not been adversely affected or that they did not have knowledge of
the effects of facility closures and machine losses from 2001 to 2004.
[62] The states are Idaho, New York, Virginia, and West Virginia.
[63] Missouri counties were not part of our random sample of counties.
We spoke with a Missouri QIO official because of her expertise in
access to mammography.
[64] The New York and West Virginia officials did not provide estimates
of the number of days women had to wait for mammography services prior
to the facility closures.
[65] Ark. Code Ann. § 21-8-304 (2005); Iowa Code Ann. § 68B2.A (2005);
Tex. Gov't Code Ann. §§ 572.001 and 572.051 (2005).
[66] Ark. Code Ann. § 21-8-302 (2005); Iowa Code Ann. § 68B.25 (2005);
Tex. Gov't Code Ann. §§ 572.007, 572.033, and 572.0034 (2005).
[67] Ark. Code Ann. § 21-8-203 (2005).
[68] Iowa Code Ann. § 68B.35 (2005).
[69] Tex. Gov't Code Ann. § 572.021 (2005).
[70] ACR's image reviewers are not ACR employees but experts in their
fields who volunteer their services to ACR and receive modest
reimbursement. Texas's contract includes reviews associated with new
mammography facilities or equipment, accreditation renewal, random on-
site reviews, and additional mammography reviews. Additional
mammography reviews are performed outside the normal accreditation or
reaccreditation process when there are concerns about mammography
quality at a facility.
[71] Tex. Gov't Code Ann. § 2113.014 (2005).
[72] An ACR official told us that ACR does not use blind reviews
because of the regulatory requirement to verify that each clinical
image contains the name and location of the facility that produced it.
In Arkansas and Iowa, accreditation body employees first verify that an
image contains the appropriate identifying information and then conceal
this information before giving the image to the reviewer.
[73] 5 Ill. Comp. Stat. Ann. § 420/4A-101(f)(1-8) (2005).
[74] FDA officials told us that MQSA compliance inspectors employed by
FDA are required to file financial disclosure statements, but state
inspectors working under contract with FDA are not required to do so.
[75] 5 Ill. Comp. Stat. Ann. § 430/5-10 (2005).
[76] Two FDA interpreting physicians independently review samples of
clinical images, and two FDA expert staff independently review samples
of phantom images.
[77] Until recently, the annual evaluations included on-site visits to
state bodies, but in 2005 FDA decided to visit state bodies every other
year, alternating visits to accreditation and certification bodies. For
example, FDA planned to visit accreditation bodies in 2005 and
certification bodies in 2006. The biennial schedule is due to budget
constraints and state bodies' consistent performance in implementing
policies and procedures, according to FDA officials.
[78] The Mammography Quality Standards Act of 1992 (MQSA) requires the
annual inspection of mammography facilities to ensure compliance with
the act's requirements. See 42 U.S.C. § 263b(g). Members of the
mammography industry had questioned the need to annually inspect
facilities that had been found to be in compliance with the FDA MQSA
regulations. MQSRA retained the annual inspection requirement, but
included a provision that allowed FDA to carry out the inspection
demonstration program. See Pub. L. No. 105-248, § 8, 112 Stat. 1864,
1865-66 (codified at 42 U.S.C. § 263b(g)(6)).
[79] FDA issued a report describing the results of the IDP in January
2005.
[80] MQSRA did not stipulate an implementation deadline, program
duration, or inspection interval, but stated that the program could not
be implemented before April 1, 2001.
[81] To develop criteria for selecting states and facilities to
participate in the program, FDA officials from the Division of
Mammography Quality and Radiation Programs worked with various groups,
including the Conference of Radiation Control Program Directors, a
professional organization whose members include directors of state
radiation control programs; the National Mammography Quality Assurance
Advisory Committee; and officials from other FDA units.
[82] FDA contracts with most states to conduct the annual compliance
inspections for which FDA is responsible in its role as a certifying
body. Its contracts specify, among other things, the number and cost of
inspections to be conducted.
[83] The lower number of control group facilities available for
inspection in the second year of the IDP was due primarily to facility
closures.
[84] FDA classifies facility noncompliance with MQSA standards into
three violation levels, ranging from level 1, the most severe with the
most detrimental effect on quality, to level 3, the least severe, where
the violations are generally minor deviations from standards. Some
facilities had multiple violations within each level or across two or
more levels. In determining the percentage of facilities cited at each
violation level, FDA placed each facility in the violation level
representing its most serious violation.
[85] The processor is the device that develops the film to produce a
mammographic image. MQSA regulations require that film processors used
to develop mammograms be adjusted and maintained to meet certain
technical development specifications. A processor performance test must
be performed each day before any clinical films are processed. See 21
C.F.R. § 900.12(e).
[86] FDA's Mammography Program Reporting and Information database
reported for October 1, 2001, and October 1, 2004, respectively, 43,596
and 42,602 radiologic technologists and 62,559 and 59,718 interpreting
physicians.
[87] In 2000 and 2003, NHIS asked women age 30 and older about the
length of time since their last mammogram and the reason for the last
mammogram.
[88] According to NHIS data, about 92 percent of the women who received
a mammogram in 2003 were 40 and older.
[89] The urban/rural designation is self-reported by health centers in
their grant application to HRSA. HRSA instructs health centers to
classify themselves as urban or rural based on where the majority of
their patients reside. For example, if a health center is located in an
urban area, but more than 50 percent of its patients reside in rural
areas, the center should classify itself as rural.
[90] The state accreditation bodies are the Arkansas Department of
Health and Human Services's Division of Health Radiation Section; Iowa
Department of Public Health's Bureau of Radiological Health; and Texas
Department of State Health Services' Radiation Control Program. The
state certification bodies are the Illinois Emergency Management
Agency's Bureau of Radiation Safety and Iowa Department of Public
Health's Bureau of Radiological Health.
[91] Our sample included 25 facilities randomly selected from the study
group total of 146 facilities and 24 facilities randomly selected from
the control group total of 258 facilities. FDA selected facilities for
the IDP in November 2001 and May 2002.
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