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.
What You Need to Know? 👇
What are the key changes in the 2023 MQSA Rule effective September 10, 2024?
The 2023 MQSA Rule introduces federal breast density reporting requirements, updates assessment categories, and enhances patient notification timelines. Facilities must now include specific breast density assessments in mammography reports and provide standardized density notification statements to patients.
How must facilities report breast density to patients under the new regulations?
Facilities must include one of four specific breast density categories in mammography reports and provide prescribed notification statements in patient lay summaries. Dense tissue notifications must inform patients that dense tissue makes cancer detection harder and increases cancer risk.
What are the new timeframes for reporting suspicious or highly suggestive mammography results?
When assessments are “Suspicious” or “Highly Suggestive of Malignancy,” facilities must provide written lay summaries to patients within 7 calendar days of final interpretation, compared to the standard 30-day requirement for other assessments.
What medical outcomes audit metrics are now required for mammography facilities?
Facilities must calculate three minimum metrics: positive predictive value (PPV), cancer detection rate (CDR), and recall rate. These calculations must be performed for each interpreting physician individually and collectively for all facility interpreting physicians.
How long must facilities retain mammographic images and reports under the updated regulations?
Facilities must maintain original mammograms and reports for the longest of: 5 years minimum, 10 years if no additional mammograms are performed at the facility, or any period mandated by state/local law. Digital images must be retained in their original mammographic modality.
What are the consequences if mammography personnel fail to meet continuing experience requirements?
Personnel who fail to meet continuing experience requirements cannot perform mammography independently until re-qualified. Interpreting physicians must complete supervised interpretations, while radiologic technologists must perform supervised examinations. Facilities may face enforcement actions including certificate suspension or revocation.
What You Need to Do 👇
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 đź”—
Related references and norms đź“‚
- 21 CFR Part 900: Mammography Quality Standards
- 42 U.S.C. 263b: Mammography Facilities