Mammography Accreditation History
The Mammography Quality Standards Act (MQSA) of 1992 requires that all mammography facilities in the United States be (1) accredited by an approved body, (2) certified by the U.S. Department of Health and Human Services (HHS), and (3) receive an on-site inspection by a state agency acting on behalf of the HHS (or by HHS inspectors). This law covers all mammography facilities, including those that examine Medicare or private pay patients and those that are only screening or diagnostic facilities. A mammography facility is defined by the Food and Drug Administration (FDA) as “a hospital, outpatient department, clinic, radiology practice, mobile unit, office of a physician, or other facility that conducts mammography activities.” Effective Oct. 1, 1994, all mammography facilities in the United States were required to be certified by the FDA; facilities not certified after that date were practicing unlawfully. On Oct. 28, 1997, FDA published the Quality Mammography Standards; Final Rule. All mammography facilities must have met these regulations by April 28, 1999, and the tighter equipment regulations by Oct. 28, 2002.
The FDA has designated the American College of Radiology (ACR) as an accrediting body for both screen-film and full-field digital mammography units. This is the country’s oldest and largest accrediting body for mammography. Initially developed in 1987 by the ACR Task Force on Breast Cancer, the ACR program is currently directed by the Committee on Mammography Accreditation of the Commission on Quality and Safety. The ACR Mammography Accreditation Program offers radiologists the opportunity for peer review and evaluation of their facility’s staff qualifications, equipment, quality control and quality assurance programs, image quality, breast dose, and processor quality control.