Mammography Quality Standards Act

The Mammography Quality Standards Act (MQSA) was enacted by the United States Congress to regulate the quality of care in mammography. The act was officially effective in 1994, and was extended in 2004 to continue through 2007. The U.S. Food and Drug Administration (FDA) began inspections of mammography facilities to ensure compliance in 1995. In 1997, more comprehensive regulation was added to become effective in 1999.The Mammography Quality Standards Act requires mammography facilities across the nation to meet uniform quality standards. Congress passed this law in 1992 to assure high-quality mammography for early breast cancer detection, which can lead to early treatment, a range of treatment options leading to an increased chance of survival. Under the law, all mammography facilities must: 1) be accredited by an FDA-approved accreditation body, 2) be certified by FDA, or its State, as meeting the standards, 3) undergo an annual MQSA inspection, and 4) prominently display the certificate issued by the agency.In a nationwide survey of mammography facilities conducted in 1985, called Nationwide Evaluation of X-ray Trends (NEXT), the U.S. Food and Drug Administration found 36 percent to be producing mammographic images of unacceptable quality. The FDA also found that 15 percent of facilities were using general purpose X-ray equipment for mammography. The American College of Radiology responded by initiating a voluntary accreditation program for these facilities in August 1987 and found that 30 percent of facilities failed on their first application for accreditation.MQSA requires facilities to 'be accredited by an FDA-approved accreditation body.' Currently the only nationally-approved body is the American College of Radiology (ACR).MQSA is intended to maintain high quality mammography in the United States and its territories. Changes in the final regulations directly affecting regular patients include: