MQSA Compliance Requirements: What Mammography Providers Need to Know (2025 Update)

The Mammography Quality Standards Act (MQSA) remains a cornerstone for quality and safety in breast imaging. While the last official update to the MQSA guidelines was in mid-2024, this post provides a 2025 update to ensure mammography providers have a clear understanding of the latest MQSA compliance requirements and their implications. Staying informed is essential for maintaining compliance and delivering exceptional patient care.

Latest Updates to MQSA Compliance Requirements

The 2024 updates to the MQSA introduced measures to improve patient communication, ensure imaging quality, and enhance compliance monitoring. Here’s what providers need to know:

1. Breast Density Notification Requirements

• For Patients: Mammography reports now include breast density information in patient-friendly lay summaries. This ensures patients understand how their breast density affects screening results and potential breast cancer risk.

• For Providers: Detailed breast density information is also included in reports sent to healthcare providers to support further diagnostic decisions.

  
  

2. Improved Communication of Mammography Results

• Suspicious Findings: Results categorized as “Suspicious” or “Highly Suggestive of Malignancy” must be communicated to patients and healthcare providers within 7 days of interpretation.

• Comparison Delays: If prior mammograms are needed, facilities must issue a follow-up report within 30 daysof the initial incomplete assessment.

3. Standardized Reporting Requirements

• Mammography Reports: Reports must include:

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  • The facility’s name and contact information.

  • Final assessment categories.

  • Breast density categorization.

    
    

• Patient Lay Summaries: These must present findings in clear, non-technical language and provide the facility’s contact details for further questions.

4. Enhanced Medical Outcomes Audits

Facilities are required to conduct annual audits that assess:

• Diagnostic accuracy metrics such as cancer detection rates and recall rates.

• Performance at both individual physician and facility levels to identify trends and ensure consistent quality.

Preventative Maintenance: A Key Aspect of Compliance

While the MQSA does not specify exact preventative maintenance (PM) schedules, facilities are required to follow the maintenance recommendations of the equipment manufacturer. For most mammography modalities:

• Bi-annual PMs are recommended to ensure consistent imaging quality and functionality.

• Exception: ATEC biopsy systems typically require PM only once annually.

Annual MQSA inspections verify that these maintenance schedules are followed, with inspectors reviewing service records and equipment performance. Facilities must maintain thorough documentation of PM activities to demonstrate compliance.

By adhering to these schedules, facilities not only ensure regulatory compliance but also enhance patient safety and imaging reliability.

AI in Mammography: Governed by Broader FDA Regulations

While the MQSA does not directly regulate artificial intelligence (AI) tools in mammography, the FDA oversees their use to ensure diagnostic accuracy and patient safety. Facilities integrating AI into their workflows should:

• Validate AI Software: Ensure it meets FDA standards for accuracy and effectiveness.

• Document Workflow Integration: Maintain records detailing how AI tools are used alongside human interpretation to ensure quality control and compliance.

AI holds immense potential to enhance breast cancer detection and streamline workflows, but it should complement—not replace—the expertise of radiologists.

How Precision MammoCare Can Help

Precision MammoCare supports mammography providers in maintaining compliance and optimizing equipment performance. Our specialized services include:

• Comprehensive Maintenance and Repairs: Ensuring your Hologic equipment operates reliably and meets the highest imaging quality standards.

• Regulatory Compliance Support: Assisting with documentation and evaluations for audits and inspections.

By partnering with us, you can stay ahead of regulatory requirements and technological advancements, ensuring your facility delivers exceptional care.

Conclusion

The MQSA guidelines remain a cornerstone for quality and compliance in mammography. By staying informed and proactively maintaining your systems, your facility can continue to deliver exceptional patient outcomes while meeting regulatory expectations.

For more information or to schedule a consultation, contact Precision MammoCare today.

Stay ahead of compliance and innovation with Precision MammoCare—your trusted partner in mammography excellence.