Mammography Quality Standards Act (MQSA)

Mammography Quality Standards Act (MQSA)

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.

MQSA Personnel Requirements
Interpreting Physician initial requirements are:
  1. Must be State licensed to practice medicine; and
  2. Must be certified by the the American Board of Radiology (ABR), the American Osteopathic Board of Radiology (AOBR), or the Royal College of Physicians and Surgeons of Canada  (RCPSC) in diagnostic radiology; or have 3 months of documented formal training in interpreting mammograms; and
  3. Must have 60 hours of documented medical education in mammography.
Radiologic Technologist initial requirements are:
  1. Must be State licensed (please visit the Technologist Education and Licensing Section for information on becoming licensed); and
  2. Must have completed at least 40 contact hours of documented training specific to mammography under the direct supervision of a qualified instructor.
Medical Physicist initial requirements are:
  1. Must be certified by the state; and
  2. Must have a master’s degree or higher in a physical science from an accredited institution, including at least 20 semester hours or equivalent of college undergraduate or graduate-level physics; and
  3. Must have 20 hours of documented specialized training in conducting surveys of mammography facilities; and
  4. Must have the experience of conducting surveys of at least one mammography facility and a total of at least 10 mammography units.

NOTE:Medical physicists must meet the qualifications for a qualified medical physicist for the supervision of quality assurance programs for diagnostic x-ray equipment (N.J.A.C. 15.2). List of qualified medical physicists who meet New Jersey requirements.

NOTE:The personnel requirements listed above are initial requirements ONLY. All qualified mammography personnel must comply with continuing education and experience requirements. All mammography personnel qualifications are evaluated during the facility’s annual inspection. If you have questions concerning personnel qualifications, please call our office.

Certified MQSA Facilities

To find a certified MQSA facility you can visit the U.S. Food & Drug Administration (FDA). You can run the report based off of zip code or the State in which you want to have the study done at.

Additional Information

The American Cancer Society (ACS) recommends the following guidelines for women:

  1. If you are age 40 or older, mammograms should be done every year.
  2. Get yearly breast exams by your Health Care Provider.
  3. Perform monthly breast self-examinations.

If you do not have insurance and cannot afford a mammogram, the New Jersey Cancer Education and Early Detection (NJCEED) may be able to help. Please visit their site for further information.

More information on Breast Cancer can be found on the National Institutes of Health Breast Cancer Homepage.