The Mammography Section within the Bureau of X-Ray Compliance (Bureau) is responsible for annually inspecting all U.S. Food and Drug Administration (FDA) certified Mammography Quality Standards Act (MQSA) facilities. The Bureau has a contract with the FDA for the inspection of all MQSA facilities in New Jersey. On October 27, 1992, the MQSA was enacted and set standards for mammography facilities which include requirements in the following areas:
- Equipment performance including image quality and dose
- Technologist and physicist quality control/quality assurance tests and tasks
- Medical audit and outcome analysis records
- Medical records (mammography reports and films)
- Personnel qualifications and records
FDA-MQSA regulations require mammography facilities to be accredited by an approved accreditation body. The American College of Radiology (ACR) is the accreditation body for all New Jersey facilities. All MQSA facilities must be certified by the FDA prior to performing mammography services. MQSA requires that mammography facilities have a quality assurance/quality control program, and that qualified personnel establish, monitor, and direct the program.
MQSA facilities must be inspected annually by FDA certified inspectors. Each inspector must complete six weeks of training and must pass written and practical examinations. Additionally, certified inspectors must document fifteen hours of continuing education every three years. New Jersey has four certified MQSA inspectors.
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