Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations
Published: 2006-07-25T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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 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.
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. 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. 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. As  with state accreditation bodies, state certification bodies may certify  facilities only within their own state 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. For most states where  FDA certifies the facilities, it contracts with the state to have state  inspectors perform MQSA compliance inspections. 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. 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. 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. 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. 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. 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. 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.
subsections: section_title: Background
paragraphs: 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.
subsections: section_title: FDA Oversight of Mammography
paragraphs: 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, and in 1997, FDA issued  final regulations establishing quality standards. 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 and have obtained a certificate permitting  them to provide mammography services from FDA or an FDA-approved  certification body. 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.
subsections: section_title: Quality Standards for Mammography Personnel
paragraphs: 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 or certified by an appropriate board, such as the  American Registry of Radiologic Technologists, in general radiography.  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; and meet certain medical training, continuing education, and  experience requirements related to mammography.
section_title: Accreditation and Certification of Facilities
paragraphs: 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. 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. FDA or the state certification body then  issues a provisional certificate that allows the facility to operate legally for  up to 6 months.
Second, to achieve full accreditation, the facility must submit to the  accreditation body phantom and clinical images, 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.  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. 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. The on-site visits include reviewing  samples of randomly selected clinical images to assess image quality,  verifying the information that facilities provided in the accreditation  application, 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. 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. For example, inspectors review quality control records for each  film processor 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.
section_title: National Database on Mammography Facilities
paragraphs: 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.
section_title: Oversight of Accreditation and Certification Bodies
paragraphs: 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. 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.
section_title: Initiatives to Help Improve Access to Mammography
paragraphs: The federal government supports two initiatives to help improve access to  mammography services. The Breast and Cervical Cancer Mortality  Prevention Act of 1990 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. 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. 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.
section_title: Facility Closures Outpaced Openings, with Financial Considerations Most Often Cited as Reason for Closure
paragraphs: 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.  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. Forty states lost facilities during this period, including 10 states  that each lost more than 20 facilities. 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 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. 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.
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.
section_title: Although Key Capacity Elements Have Decreased and Use of Mammography Services Has Increased, Current Nationwide Capacity Is Adequate
paragraphs: 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.
subsections: section_title: Key Elements That Make Up Capacity to Provide Mammography Services Have Decreased
paragraphs: 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. (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.
section_title: Number of Women Who Received Screening Mammograms Increased as Population of Women Age 40 and Older Grew
paragraphs: Reflecting the steady increase in the population of women age 40 and  older, 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. 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.  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.
section_title: Current Nationwide Mammography Capacity Is Adequate
paragraphs: 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. 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. 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. 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. 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.
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.
section_title: Loss or Absence of Mammography Machines May Have Resulted in Access Problems in Certain Locations
paragraphs: 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.
subsections: section_title: Number of Counties with Machines Remained Relatively Constant, but Number of Machines Decreased in Certain Counties
paragraphs: 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. 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. (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.
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. 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.
section_title: Loss or Absence of Mammography Machines in Certain Locations May Have Resulted in Considerable Travel Distances or Wait Times to Obtain Services
paragraphs: 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. 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, 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. 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, 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, 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. 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.
section_title: State Bodies Have Varying Measures to Avoid Conflicts of Interest, and FDA’s Evaluations Have Not Found Conflict-of- Interest Problems
paragraphs: 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.
subsections: section_title: State Accreditation and Certification Bodies Have Varying Measures to Avoid Conflicts of Interest
paragraphs: 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.)
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. These laws and policies vary in scope across the three states,  and each state has penalties associated with violating its laws. 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. In contrast, Iowa  requires only certain individuals, such as elected officials and higher level  agency officials, to file financial disclosure forms 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, 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. 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.
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. 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.
subsections: section_title: Certification Bodies
paragraphs: 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. 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. Illinois  ethics law also requires that all state employees annually complete ethics  training, which in the past has covered topics such as acceptance of gifts  and conflicts of interest.
section_title: FDA Approved State Bodies’ Measures to Avoid Conflicts of Interest, and Its Evaluations of State Bodies Have Not Found Problems
paragraphs: 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. 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. 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.
section_title: Concluding Observations
paragraphs: 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.
section_title: Agency Comments
paragraphs: 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.
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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.
section_title: Appendix I: The Food and Drug Administration’s Mammography Facility Inspection Demonstration Program
paragraphs: 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. 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. This appendix  summarizes the methodology and results of the IDP.
subsections: section_title: Methodology
paragraphs: 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. FDA  selected facilities for the IDP from states that indicated a willingness to  participate in the program and met certain criteria. 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. 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.
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.
section_title: Results
paragraphs: 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. (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. 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).
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.
section_title: Appendix II: Scope and Methodology
paragraphs: 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, 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), 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. 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.
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.
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) regarding the  effect of closures on their patients’ access to mammography services. (See  table 6.)
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. 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.
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.
section_title: Appendix III: Changes in the Number of Certified Mammography Facilities by State, October 1, 2001, to October 1, 2004
section_title: Appendix IV: Comments from the Food and Drug Administration
section_title: Appendix V: GAO Contact and Staff Acknowledgments
subsections: section_title: Acknowledgments
paragraphs: 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.