The Mammography Quality Standards Act. An overview of the regulations and guidance.

The US Congress passed the Mammography Quality Standards Act (MQSA) on October 23, 1992, in response to public and professional concerns that mammography facility quality varied throughout the United States and that some facilities did not meet even minimal standards. 14 The Act stipulated that after October 1, 1994, all facilities, except facilities of the Department of Veterans Affairs, were to be accredited by an approved accreditation body and certified by the Secretary of Health and Human Services. The authority to approve the accreditation body and to certify facilities was delegated by the Secretary of Health and Human Services to the Food and Drug Administration (FDA). Interim regulations were developed, largely based on the American College of Radiology (ACR) Mammography Voluntary Accreditation Program. 7 Published on October 28, 1997 in the Federal Register, the final regulations of the MQSA were effective April 28, 1999. 5 , 10 , 11 When MQSA was reauthorized by Congress (MQSRA) on October 9, 1998, changes to the final rule were made; specifically, this pertained to direct reporting of results to patients by a lay summary. 8 As this article is written, the first yearly round of FDA facility inspections under the final regulations is now under way. To operate lawfully, a mammography facility must be certified by the FDA. To obtain the certificate, facilities are required to meet the quality standards described in Section 900.12 of the final rule, and they are required to be accredited by an approved accreditation body or other entity designated by the FDA. 10 The currently approved accreditation bodies are the ACR, and the states of Iowa, Arkansas, Texas, and California. These state accreditation bodies may accredit only facilities that are located in their respective states. The accreditation body is responsible for reviewing a mammography facility's equipment, practices, and personnel including interpreting physicians, radiologic technologists, and medical physicist. The review of the facility includes details of personnel qualifications, a physicist's survey for each mammography unit, dosimetry evaluations, phantom images, results of various quality control tests on the equipment and processor, and clinical images from patients. If the accreditation body judges that the mammography facility personnel, equipment, and practices meet the quality standards established under MQSA, then the facility can be accredited. Certification is a process administered by the FDA and an MQSA certificate is issued to the facility when the accreditation body notifies the FDA that the facility has been accredited. Certification is valid for 3 years and can be renewed. To determine if the facility continues to meet MQSA quality standards, the accreditation body requires yearly updates and the FDA performs annual inspections. Penalties for performing mammography without FDA certification are severe and can be up to $10,000 for each examination performed without certification. The Health Care Financing Administration does not reimburse facilities for Medicare screening and diagnostic mammography if they do not have an MQSA certificate. The Health Care Financing Administration shares this information with insurance carriers, who reimburse only for lawfully performed mammography procedures. FDA certificates must be prominently displayed in facilities where patients can easily see them.