Mammography Inspection FAQs
What is a mammogram?
A mammogram is an X-ray that provides an image of the breast tissue which allows a physician to determine the presence, size, location and extent of cancerous or potentially cancerous tissue in the breast. This imaging technique know as mammography allows a physician to identify tumors or other changes in the breast tissue at very early stages of the disease process.
Are mammography facilities licensed?
Yes, mammography facilities are licensed by the Massachusetts Department of Public Health's Radiation Control Program (RCP).
Are mammography facilities inspected?
Yes, mammography facilities are inspected annually. RCP also responds to complaints regarding mammography facilities and may conduct additional inspections based upon such complaints.
What is the Mammography Quality Standards Act (MQSA) and Program?
The Mammography Quality Standards Act requires mammography facilities across the nation to meet uniform quality standards. This law was passed by Congress in 1992 to assure high-quality mammography for early breast cancer detection. Under this law, all mammography facilities must be accredited by an FDA-approved accreditation body or be certified by FDA or its State, as meeting the standards. The MQSA also requires that all facilities undergo an annual inspection and that the certificate issued by the agency be prominently displayed.
MQSA inspections results are maintained by the U.S. FDA . The Massachusetts Radiation Control Program maintains records related to annual inspections based on State regulations.
What are the requirements for mammography facilities?
Mammography facilities must meet many requirements related to staff qualifications and training; quality assurance programs; equipment standards; image quality assurance; recordkeeping, radiation safety and other factors. Following each inspection where a deficiency or violation is identified, mammography facilities must develop and implement a plan of correction for each violation/deficiency.
What does the mammography database show?
The RCP's database shows the name of the facility, its license number, address, contact information. In addition, the database will show whether the facility was "compliant", that is, it met all regulatory requirements at the time of the inspection, or if it was "in violation". Facilities that are in violation did not meet one or more of the regulatory standards. Such violations range from record keeping lapses to problems with image development, professional training, or issues with the mammography unit itself.
Who should I contact if I have information related to an unlicensed mammography facility, or if I have a complaint?
For more information on a particular facility or to file a complaint, contact the Massachusetts Radiation Control Program at (617) 242-3035.