Mammography Symposium 2025

The Mammography Quality Standards Act (MQSA) has seen significant updates and clarifications from the FDA, particularly with the **2023 MQSA Final Rule** which became largely effective on **September 10, 2024**. This rule modernized the regulations initially established in 1992 and addresses changes in technology and best practices.

Here's what we've learned from the FDA clarifications and the 2023 MQSA Final Rule:

I. Enhanced Reporting and Patient Communication:

Mandatory Breast Density Notification:

• Facilities must now include an **overall assessment of breast density** in both the mammography report to the healthcare provider and the patient lay summary.
• Specific, **standardized language** is required for patient lay summaries, explaining the implications of breast density for cancer detection and risk. This often includes phrases like: "Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation."
• The four BI-RADS density categories (Almost entirely fatty, Scattered areas of fibroglandular density, Heterogeneously dense, Extremely dense) must be used.

Timeliness of Results Communication:

• For mammograms with a final assessment of **"Suspicious" or "Highly Suggestive of Malignancy"**, the mammography report must be provided to the healthcare provider and the patient lay summary to the patient within **7 calendar days** of the interpretation date.
• For exams with an assessment of **"Incomplete: Need prior mammograms for comparison"**, the facility must issue a follow-up report with a final overall assessment within **30 calendar days** of the initial report, regardless of whether comparison views are obtained.
• General patient lay summaries must be provided within 30 days of the examination date.

Mammography Report Content:

• Reports must include the **facility name and location** (at a minimum, city, state, ZIP code, and telephone number).
• Revised explanatory language for the "benign" final assessment category and clarification of other assessment categories.

II. Improved Facility Oversight and Quality Assurance:

Medical Outcomes Audit:

• The annual medical outcomes audit must include specific metrics: **positive predictive value (PPV), cancer detection rate (CDR), and recall rate (RR)** for each interpreting physician and for the facility as a whole. This aims to provide a more robust evaluation of diagnostic accuracy.

Personnel Records:

• Facilities must maintain records of training and experience for interpreting physicians, radiologic technologists, and medical physicists.
• Records for personnel no longer employed must be maintained for **at least 24 months** from their departure date and must be available for review during inspections.
• Facilities must provide copies of these records to current and former employees upon request within the 24-month period.

Equipment Standards:

• All devices used in mammography must have met the applicable FDA premarket authorization requirements for medical devices of that type with that intended use.
• The rule removes references to obsolete technology (e.g., xeromammography) and acknowledges modern digital modalities like digital breast tomosynthesis (DBT).

Recordkeeping and Transfer of Records:

• Facilities must maintain original mammograms and reports for the longest of: not less than **5 years**, not less than 10 years if no additional mammograms** are performed at the facility, or a longer period mandated by state/local law.
• Original mammograms must be retained in retrievable form in the modality they were produced (e.g., digital mammograms cannot be "produced" by copying hardcopy originals).
• Facilities must implement policies and procedures to minimize loss of records.
• Transfers of mammogram images and reports must occur within **15 calendar days** of receiving a request. For digital images, facilities must be able to provide original digital images electronically if transferred for final interpretation.

Accreditation Failures:

• If a facility fails to become accredited after **three consecutive attempts**, no accreditation body can accept an application from that facility for a period of **1 year** from the date of the most recent failure.

Enforcement Powers:

• The FDA and state certification agencies can now directly notify patients and their healthcare providers (individually or through mass media) if a facility is unable or unwilling to perform a required Patient and Referring Physician Notification (PPN).

III. Emphasis on Patient Empowerment and Informed Decision-Making:

The overarching goal of these amendments is to empower patients with more comprehensive and understandable information about their breast health, particularly regarding breast density. This enables more informed discussions with their healthcare providers about personalized screening strategies.

These clarifications and amendments demonstrate the FDA's commitment to continually updating MQSA to reflect advancements in medical science and technology, aiming to improve the quality, accuracy, and communication standards in mammography services nationwide.
 

Here's a summary of what we've learned from the MQSA Amendments, with links to relevant URLs:

• Mandatory Breast Density Notification:

  • What we learned: All mammography facilities are now required to inform patients directly about their breast density, its implications for cancer risk, and the challenges it poses for mammographic detection. This empowers patients to discuss supplemental screening options with their healthcare providers.

  • URL: MQSA Amendments to Final Rule - American College of Radiology

• Updated Reporting Requirements and Communication:

  • What we learned: There are new, stricter requirements for the content and timeliness of mammography reports and patient lay summaries. For suspicious findings, results must be communicated more quickly.

  • URL: MQSA Amendments to Final Rule - American College of Radiology

• Modernized Technology and Equipment Standards:

  • What we learned: The amendments update provisions to align with current digital imaging technologies and ensure that all equipment used in mammography meets applicable FDA premarket authorization requirements. Outdated references have been removed.

  • URL: Mammography Quality Standards Act final rule amendments - FDA

• Enhanced Enforcement and Accreditation Oversight:

  • What we learned: The FDA has strengthened enforcement provisions, including stricter rules for facilities that repeatedly fail accreditation and the ability for the FDA to directly notify patients and providers of quality concerns.

  • URL: MQSA Amendments to Final Rule - American College of Radiology

• Personnel and Recordkeeping Updates:

  • What we learned: Facilities must maintain more comprehensive and accessible records of personnel qualifications (interpreting physicians, technologists, medical physicists) and adhere to policies minimizing record loss.

  • URL: Mammography Quality Standards Act final rule amendments - FDA

• Updated Medical Outcomes Audit Requirements:

  • What we learned: Annual medical outcomes audits must now specifically include key metrics such as positive predictive value (PPV), cancer detection rate (CDR), and recall rate (RR) for both individual interpreting physicians and the facility as a whole.

  • URL: Mammography Quality Standards Act final rule amendments - FDA

For further details and official information, you can refer to the FDA's main page on the MQSA:

• Mammography Quality Standards Act (MQSA) - FDA

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