MQSA (Mammography Quality Standards Act)
Mammography Quality Standards Act — 1992 federal law (with subsequent amendments) requiring every U.S. clinical mammography facility to be FDA-certified and ACR-accredited (or accredited by an FDA-approved state body — Arkansas, Iowa, Texas). Administered by the FDA's Division of Mammography Quality Standards. The single most prescriptive QA framework in U.S. medical imaging — every clinical mammography unit operates under it from install to decommissioning.
Requirements
- FDA certification — facility-level certificate, displayed publicly.
- Accreditation — by ACR or an FDA-approved state body; per-unit, with three-year renewal.
- Annual medical physicist survey — measures dose, image quality, mechanical / collimation accuracy, automatic exposure control performance, paddle integrity, monitor calibration, and more.
- Ongoing QC per the MQSA Quality Control Manual — daily phantom imaging, weekly checks, monthly checks. The QC binder is the inspection-ready documentation.
- Personnel credentialing — interpreting physicians (initial qualifications, continuing education, continuing experience), radiologic technologists (state licensure, mammography-specific training and continuing education), and medical physicists (specific qualifications and continuing experience in mammography physics).
- Patient lay summaries — every patient receives a results-summary letter written in lay language.
- EQUIP (Enhancing Quality Using the Inspection Program) — 2017 enhancement adding clinical-image-quality oversight to MQSA inspections.
Inspection cycle
- Annual MQSA inspection by FDA-trained state inspectors. Pass / pre-revoke / serious-deficiency outcomes.
- Equipment failures during the annual physicist survey take the unit out of clinical service until corrective action and re-test pass.
- Failure to maintain compliance can result in certificate suspension, revocation, or facility closure. Patients are notified by FDA in revocation cases.
What MQSA covers and what it doesn't
- Covered: 2D FFDM (full-field digital), digital breast tomosynthesis (DBT), C-View / synthesized 2D, contrast-enhanced mammography (CEM), stereotactic biopsy, breast specimen radiography.
- Not covered: breast ultrasound, breast MRI — those operate under ACR accreditation frameworks but not under MQSA itself.
Why it matters to buyers
- Non-MQSA mammography units cannot legally scan U.S. patients. A refurb purchase that doesn't transfer or re-establish MQSA certification is a paperweight in the U.S. market.
- Equipment-evaluation ("equipment evaluation" by physicist) is required before clinical use of a newly installed or relocated mammography unit. Plan physicist time and cost into install schedule.
- Detector age + condition is the single biggest factor in passing physicist survey. A used Selenia Dimensions with a 2020 detector replacement is a different proposition than one on the original 2014 panel.
- Paddle inventory — cracked or missing paddles fail MQSA. Spare paddles are operational essentials, not nice-to-haves.
- Monitor calibration — acquisition and review monitors are surveyed; replacement monitors must be diagnostic-grade.
- Software-license tier — 3D, C-View, biopsy package, CEM are separately licensed; non-licensed units have a narrower clinical envelope.
Decommissioning
MQSA facility deregistration at unit retirement is the central regulatory closeout for mammography. The MQSA accreditation file (annual physicist surveys, daily / weekly QC binder, lead-apron survey, paddle inspection records, image-quality phantom records) is retained per FDA requirements after closure. See Mammography decommissioning.