To qualify INITIALLY as an MQSA interpreting physician, the required reading experience is:
960 mammograms in the prior 24 months; 240 mammograms in the prior 6 months; 480 mammograms in the prior 12 months; No volume requirement if board certified
Answer: 240 mammograms in the prior 6 months. Initial qualification requires 240 mammographic examinations interpreted (or multi-read) in the 6 months immediately before qualifying, under supervision. The 960/24-month figure is the CONTINUING experience requirement — a different clock answering a different question. Board certification does not waive the volume.
The CONTINUING experience requirement for an interpreting physician is:
240 mammograms every 6 months; 960 mammograms in the prior 24 months; 1,200 mammograms per year; 15 mammograms per week averaged annually
Answer: 960 mammograms in the prior 24 months. Once qualified, you must have interpreted or multi-read at least 960 examinations in the 24 months preceding each facility's annual assessment date. Falling short means requalification steps, not just a warning.
Continuing education under MQSA requires:
15 category 1 CME in mammography every 36 months; 40 hours of CME annually; 60 hours of CME every 36 months; No CME once board certified
Answer: 15 category 1 CME in mammography every 36 months. 15 category 1 CME credits in mammography every 36 months. The 60-hour figure is the INITIAL education requirement (documented medical education in mammography before qualifying) — another initial-versus-continuing pairing the exam loves.
The written lay summary of a mammography result must reach the patient:
Only if she requests it; Only when results are abnormal; Within 30 days, every exam; Within 60 days
Answer: Within 30 days, every exam. Every patient gets a written summary in lay language within 30 days of the examination — normal or not. For assessments suggestive of malignancy, the facility must make reasonable attempts to communicate results as soon as possible.
Since the FDA's 2023 amendment (effective September 2024), the lay summary must also include:
The raw BI-RADS category number only; An estimate of cancer risk percentage; The radiologist's audit statistics; A national standardized breast density notification
Answer: A national standardized breast density notification. The 2023 MQSA amendments made breast density notification federal: every lay summary states whether the breasts are dense or not dense, in standardized national language — superseding the state-by-state patchwork.
Original mammograms must be retained by the facility for:
Exactly 7 years in all cases; Until the patient requests them; 1 year; At least 5 years — 10 if no subsequent mammogram at that facility
Answer: At least 5 years — 10 if no subsequent mammogram at that facility. Retention is not less than 5 years, extended to not less than 10 when no additional mammograms were performed there (longer where state law says so). Originals must also be transferred on request — permanently or temporarily — to the patient or her providers.
The MQSA medical outcomes audit must, at minimum:
Follow positive mammograms (BI-RADS 0, 4, 5 on screening) and correlate with biopsy pathology; Compare radiologist salaries to volume; Re-read 10% of all examinations; Track every BI-RADS 1 and 2 for stability
Answer: Follow positive mammograms (BI-RADS 0, 4, 5 on screening) and correlate with biopsy pathology. The required audit follows positives to outcome: screening assessments of incomplete (0), suspicious (4) and highly suggestive (5), with attempts to obtain pathology results and correlation for each interpreting physician and the facility aggregate, reviewed at least annually.
Facility equipment quality under MQSA requires:
A medical physicist survey every 3 years; An annual medical physicist survey; Physicist surveys only after equipment repair; Technologist-performed surveys quarterly
Answer: An annual medical physicist survey. The medical physicist surveys each mammography unit annually (plus after major repairs via mammography equipment evaluation). Facilities are also inspected annually by FDA or state inspectors, and accreditation renews on a 3-year cycle.
EQUIP, added to MQSA inspections in 2017, is:
A PACS integrity check; A new dose limit for digital units; An ongoing facility program of image-quality review by the lead interpreting physician; A patient satisfaction survey
Answer: An ongoing facility program of image-quality review by the lead interpreting physician. EQUIP (Enhancing Quality Using the Inspection Program) requires the facility to show an ongoing process — owned by the lead interpreting physician — for reviewing clinical image quality and corrective actions, checked at every annual inspection.
A facility's MQSA certificate:
Must be prominently displayed where patients can see it; Exists only electronically; Is optional for mobile units; May be kept in a drawer for inspection
Answer: Must be prominently displayed where patients can see it. The certificate must be displayed prominently — patients are entitled to see that the facility is certified. Mobile units are certified too, and each must meet the same standards wherever it parks.