Radiation-Emitting Products

Facilities - Mammography Quality Standards Act Requirements

What are the Key Features of MQSA?

  • To operate lawfully, a mammography facility must be MQSA certified as providing quality mammography services.
  • For a facility to be certified, it must be accredited by a federally approved private nonprofit or state accreditation body. FDA has approved the American College of Radiology (ACR) and the States of Arkansas, Iowa, and Texas as accreditation bodies. If additional States become approved, FDA will make the appropriate announcement.
  • To be accredited, the facility must apply to an FDA-approved accreditation body; undergo periodic review of its clinical images; have an annual survey by a medical physicist; and meet federally developed quality standards for personnel qualifications, equipment, radiation dose, quality assurance programs, and recordkeeping and reporting.
  • The facility must also undergo an annual inspection conducted by federally trained and certified Federal or State personnel. Inspections began in January 1995. See MQSA Regulations and Guidance for more information.

Who Must Meet MQSA Requirements?

  • All mammography facilities that produce, process, or interpret mammograms.  (Exceptions are facilities that are under the Department of Veterans Affairs, which has developed its own mammography quality program similar to MQSA.) Requirements cover personnel, equipment, radiation dose, quality assurance programs, and recordkeeping and reporting.
  • Accreditation bodies (State or private nonprofit organizations).
  • The following personnel involved in the production, processing, or interpretation of mammograms:
    • Radiology technologists who perform mammographic procedures
    • Physicians who interpret mammographic images
    • Medical physicists who survey mammography equipment

Page Last Updated: 09/30/2014
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