MQSA Compliance
MammoTrac is purpose-built to help mammography facilities satisfy the Mammography Quality Standards Act (MQSA) requirements established by the FDA.
What is MQSA?
The Mammography Quality Standards Act (MQSA) is a federal law enacted in 1992 and enforced by the FDA. It requires all mammography facilities in the United States to meet uniform quality standards for equipment, personnel, and practices. MQSA mandates that facilities maintain systems for tracking patients, monitoring outcomes, and ensuring that all mammographic examinations meet established quality benchmarks.
Facilities are subject to annual MQSA inspections and must demonstrate compliance with tracking, reporting, and quality assurance requirements. Non-compliance can result in citations, required corrective actions, or loss of certification.
How MammoTrac Supports MQSA Compliance
MammoTrac addresses each of the following MQSA requirements through its integrated tracking and reporting capabilities:
Positive & Incomplete Exam Tracking
MQSA requires that all positive and incomplete mammography examinations be tracked to completion. MammoTrac maintains a running record of exam status and provides reporting to identify any examinations that have not reached final disposition.
Personnel Volume Monitoring
MQSA sets minimum interpretation and continuing-experience volumes for interpreting physicians, radiologic technologists, and medical physicists. MammoTrac tracks per-individual exam volumes against your facility's qualification windows and alerts you as personnel thresholds are approaching, so requalification or supervised-reading workflows can begin before a lapse occurs.
Outcome Data & Pathology Correlation
Facilities must collect and review outcome data for all mammograms performed, including follow-up on positive findings and correlation with pathology results. This analysis must be performed individually for each interpreting physician, collectively for all physicians, and for the facility as a whole on an annual basis. MammoTrac automates this data collection and generates the required statistical reports.
Annual Inspection Reporting
MQSA inspectors require documented proof of outcome analysis at each annual inspection. MammoTrac generates the statistical reports needed to demonstrate compliance, including outcomes by physician, BI-RADS distribution, and pathology correlation summaries.
Patient Tracking & Follow-Up
Effective follow-up tracking is central to MQSA compliance. MammoTrac provides the following patient tracking capabilities to ensure no patient falls through the cracks:
Generate a list of all patients seen for mammography within any date range at your facility.
Identify patients with BI-RADS 3 (probably benign) findings due for short-interval follow-up at six, twelve, and twenty-four months.
Identify patients who have not returned for recommended follow-up examinations so your facility can initiate outreach.
Track all patients who proceeded to breast biopsy and correlate pathology results with the original mammographic interpretation.
FDA Breast Density Notification
The FDA's final rule on breast density notification became effective on September 10, 2024. Every mammography report and patient lay summary must now include language that conveys the patient's breast-density category in plain, consistent terms.
MammoTrac records each exam's BI-RADS density category (A almost entirely fatty, B scattered fibroglandular, C heterogeneously dense, D extremely dense).
Lay-summary letters generated by MammoTrac include the FDA-prescribed density notification language so your facility's patient communications are compliant on every send.
EQUIP & Annual Inspections
Since 2017, the FDA has used the Enhancing Quality Using the Inspection Program (EQUIP) framework as the dominant focus of MQSA annual inspections. EQUIP shifts attention from documentation alone to demonstrated quality oversight.
MammoTrac surfaces the per-radiologist outcome metrics the lead interpreting physician needs for the EQUIP quality-oversight review.
Track image-quality review activity and corrective-action steps so your facility can demonstrate the ongoing review EQUIP expects.
Pull the documentation an MQSA inspector requests — medical outcomes audit, personnel volumes, callback queues — in minutes, not days of audit-prep panic.
ACR Accreditation Support
Most U.S. mammography facilities accredit through the American College of Radiology (ACR), which serves as an FDA-approved accreditation body for MQSA and adds its own clinical-image review and modality-specific requirements. MammoTrac supports both MQSA and ACR documentation needs from the same dataset.
- Per-modality accreditation tracking for mammography, breast ultrasound, and breast MRI
- Personnel credentials, continuing-experience volumes, and CME tracking aligned with ACR personnel standards
- Outcomes data formatted for ACR's reaccreditation cycles
Regulatory Reference
MQSA requirements are codified in 21 CFR Part 900 and enforced by the FDA through certified state and accreditation body inspectors. MammoTrac is designed to support compliance with these regulations but does not itself constitute regulatory certification. Each facility is responsible for ensuring its practices meet all applicable federal, state, and accreditation requirements.