Mammography Quality Standards: Requirements for Facilities, Personnel, Equipment, and Reporting
This guidance provides detailed information for mammography facilities to comply with the Mammography Quality Standards Act (MQSA) and its implementing regulations, with a focus on the amendments that become effective September 10, 2024. It covers requirements for certification, accreditation, inspections, personnel qualifications, equipment standards, quality control, medical outcomes audit, recordkeeping, and reporting of results to patients and healthcare providers.
Recommended Actions
- Review and update facility policies and procedures to comply with new requirements effective September 10, 2024
- Implement required breast density reporting language in mammography reports and lay summaries
- Establish medical outcomes audit procedures including the three required metrics
- Update recordkeeping systems to maintain required documentation
- Ensure personnel meet qualification and continuing education requirements
- Implement quality control program according to manufacturer specifications or approved alternative standards
- Establish procedures for patient notification and records access
- Prepare for annual MQSA inspections by organizing required documentation
- Subscribe to FDA MQSA updates to stay informed of requirements
- Contact MQSA Hotline for clarification of requirements as needed
Key Considerations
Clinical testing
- Medical outcomes audit must include positive predictive value, cancer detection rate, and recall rate calculations
- Follow-up required on all positive mammograms and known breast cancer cases
- Correlation of pathology results with mammography reports required
Non-clinical testing
- Equipment performance testing through annual surveys and mammography equipment evaluations required
- Quality control testing according to manufacturer specifications or approved alternative standards
- Phantom image testing during inspections
Human Factors
- Personnel qualifications and continuing education requirements for interpreting physicians, radiologic technologists, and medical physicists
- Direct supervision requirements for training
- Documentation of training and experience records
Software
- Software must meet FDA premarket authorization requirements
- Quality control requirements apply to remote review workstations
- Lossy compression not allowed for image storage
Labelling
- Specific breast density notification language required in reports and lay summaries
- Required elements for mammography reports and lay summaries
- Timeframes for communicating results to patients and providers
Safety
- Maximum dose limits for mammography exposures
- Equipment performance standards
- Quality control program requirements
Other considerations
- Record retention requirements
- Patient complaint system
- Facility closure procedures
- Inspection requirements and processes
Relevant Guidances
- Appeals Process for Mammography Facilities under MQSA: Adverse Accreditation Decisions, Certificate Actions, and Patient Notifications
Related references and norms
- 21 CFR Part 900: Mammography Quality Standards
- 42 U.S.C. 263b: Mammography Facilities
Original guidance
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