Effective October 1, 1994, all mammography facilities must be certified by the Food and Drug Administration (FDA) as meeting quality standards to continue lawful operation. The FDA issued comprehensive regulations which became effective on April 28, 1999.
Why MQSA? The first and most important reason is breast cancer. In the late 1980’s, the incidence of breast cancer (numbers of new cases per year) rose dramatically. This resulted, in part, from the increased use of screening mammography. This meant more otherwise undetectable breast cancer cases were caught early and women were afforded better survival odds. Increased screening only partially explains the rise in numbers of new breast cancer rates. There is still an underlying trend of increasing breast cancer incidence that began in the early 1980’s and is still not understood.
Breast cancer is second only to lung cancer in taking women’s lives (lung cancer recently surpassed breast cancer as the number one cancer killer). As a result, women who survived breast cancer (and some who eventually did not), along with professional organizations and concerned legislators, all lobbied for MQSA. Women must be assured that their mammograms are produced and interpreted accurately.
Roughly 25 million mammograms were taken in 1992. Most of these were for healthy women undergoing screening. They need protection from risks such as excess radiation or needless biopsy for false positive interpretations. In addition, women with symptoms or otherwise undetectable cancers need to be diagnosed and quickly referred into treatment protocols. These women need the benefits of high quality mammography to diagnose their disease.
For more information on the MQSA check with the FDA Center for Radiological Health MQSA Program.
In Virginia there are approximately 194 facilities that provide mammography services. Virginia has imposed additional requirements on mammography facilities. The federal regulations require federal/state inspectors performing federal inspections to provide advanced notification to the facility prior to the federal survey. Inspections on each mammography facility is conducted annually. State statutes provide the X-ray program the ability to conduct unannounced inspections if conditions warrant.
May 25, 2016 Update: Recently the FDA decided that printers will no longer be regulated under MQSA. With technology constantly evolving many facilities wish to completely eliminate the printer and go completely digital. While this option is permitted we urge all facilities to discuss this issue with their medical physicist and/or MQSA inspector before moving forward. Please see the link below from the FDA for more information.
May 2, 2013 Update: The 2013 Virginia General Assembly passed HB1778 to amend Section 32.1-229 of the Code of Virginia by clarifying what must be contained in letters that must be sent to patients who are identified as having dense breast tissue. Letters have been sent to all Mammography facilities in the Commonwealth of Virginia. The letter dated May 1, 2013 can be viewed by clicking: 5-1-13 Mammography Letter. The appropriate wording in the lay letters will be reviewed during the annual MQSA Inspection.
Office of Radiological Health | 109 Governor Street, 7th Floor | Richmond, VA 23219
Telephone (804) 864-8150 | X-ray Fax: (804) 864-8175