Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations
Released: 2006-08-16T00:00:00

Letter

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, 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.

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 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.

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. 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.

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. 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.

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 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.

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. 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.

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. (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.

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, 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.

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. 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.

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. 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.

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. 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.

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.)

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.

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. 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.

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. 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.

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.

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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. 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.

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. 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.

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. (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.

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, 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.

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

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.