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. 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. 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. 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. 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. 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. 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.