Final Rule to Amend the Mammography Quality Standards Act (MQSA)

On March 10, 2023, the FDA issued the final rule to amend the MQSA regulations. Facilities subject to the MQSA must comply with all applicable requirements, including the breast density notification, no later than September 10, 2024.

The final rule in its entirety may be accessed online at Federal Register: Mammography Quality Standards Act.

MQSA Inspections

Beginning on September 10, 2024, the MQSA regulations will have certain additional requirements.

In addition to certain requirements currently reviewed, MQSA inspectors will also look for new items, including:

Mammography Reports

• Name and location of the facility performing the exam (at a minimum, the city, State, ZIP code, and telephone number).
• An overall final assessment of findings, classified in one of the following categories: "Negative," "Benign," "Probably Benign," "Suspicious," "Highly Suggestive of Malignancy," "Known-Biopsy-Proven Malignancy," or "Post-Procedure Mammogram for Marker Placement"; in cases where no final assessment category can be assigned due to incomplete work-up, one of the following: "Incomplete: Need additional imaging evaluation," or "Incomplete: Need prior mammograms for comparison."
• An overall assessment of breast density, classified in one of the categories from the list to the right.

Patient Lay Summaries

• The patient's name, and name, address, and telephone number of the facility performing the exam.
• A breast density notification statement from the list to the right.

Communication of Results

• When the exam has a final assessment category of "Suspicious" or "Highly Suggestive of Malignancy," the mammography report is provided to the healthcare provider and the patient lay summary is provided to the patient within 7 calendar days of the date the mammogram was interpreted.
• When the exam has an assessment of "Incomplete: Need prior mammograms for comparison," the facility issued a follow-up report with a final overall assessment within 30 calendar days of the initial report, regardless of whether comparison views are obtained.

Medical Outcomes Audit

• The annual medical outcomes audit includes positive predictive value, cancer detection rate, and recall rate for each interpreting physician and for the facility as a whole.