Compliance Deadline

The final rule takes effect on September 10, 2024. All mammography facilities subject to MQSA must comply with all applicable requirements, including the new breast density notification, by this date. To ensure your center stays compliant effortlessly, learn more about AbbaDox RIS Breast Health Workflow.

Breast Density Notification

Federal Requirements: All mammography facilities must comply with the FDA's breast density reporting requirements, even if their state has its own guidelines. The federal notification provides consistent information for all patients nationwide.

State and Federal Notifications: Facilities must provide both state and federal breast density notifications if required by the state. However, the state's notice must be separate from the federal statement.

No Combining Allowed: State and federal breast density statements cannot be combined into a single notice. They must remain separate and clearly distinct.

Consistent Format: Breast density statements, whether for dense or non-dense breast tissue, must be written exactly as outlined in the regulations without adding extra spaces or altering the formatting.

Required for All Patients: Breast density notifications are required for every patient, including male patients who undergo mammography.

Facility Information and Reporting

Facility-Specific Information: Mammography facilities must list their own accredited name and address on reports and lay summaries, not just the network name. If multiple locations are involved, clearly indicate where the mammogram was performed.

Electronic Delivery: Facilities may send reports and summaries electronically but are not required to verify whether patients read or viewed them. If a patient opts out of electronic communication, a paper copy must be provided.

Updated Assessment Categories: The new regulations require two separate statements for incomplete assessments:

  • One for needing additional imaging
  • One for needing prior mammograms

The previous combined statement will no longer be allowed. Additionally, a follow-up report to that exam must be issued within thirty calendar days of the initial report, whether or not comparison views can be obtained. It is up to the interpreting physician to determine, based on the images taken, which assessment category to assign.

Timeframe for Communicating Results: For exams with a final assessment of "Suspicious" or "Highly Suggestive of Malignancy," reports must be provided to healthcare providers and patients within 7 calendar days.

Special Circumstances

Lay Summaries for Known Biopsy-Proven Malignancies: A lay summary must be provided for every mammogram, even when a biopsy-proven malignancy is present. The summary should be specific to the findings but must also include the federal breast density notification.

Post-Procedure Mammograms for Marker Placement: If a post-procedure mammogram is logged as a separate exam, it must meet all MQSA standards, including the breast density notification.

The regulations exclude from MQSA radiography of the breast performed during invasive interventions for localization or biopsy procedures. So, such imaging is not subject to MQSA requirements.

Assessing Tissue Density in Limited Views: Interpreting physicians must assess breast density in every mammography report, regardless of the type of exam.

Administrative Requirements

Patient Record Release: Facilities must have a process to release patient records within 15 days but are not required to maintain a specific running list of releases. The process should be clear and demonstrable during inspections.

Medical Outcomes Audit: The annual medical outcomes audit must now include specific metrics such as:

  • Positive predictive value
  • Cancer detection rate
  • Recall rate for each interpreting physician and the facility as a whole

Equipment Requirements: All mammography devices must meet FDA premarket authorization requirements.

Personnel Records: Facilities must maintain personnel records for at least 24 months after an employee leaves and make these records available upon request.

Compliance Reminder: These updates are essential for ensuring compliance with the new MQSA regulations starting September 10th, 2024. Facilities should review and adjust their procedures accordingly to meet all new requirements.

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