FDA Proposes Updates to the Mammography Quality Standards Act

• Require mammograms to be presented in the mammographic modality they are produced in, prohibiting facilities from submitting copied or digitized clinical images to referring physicians;
• Prohibit an accreditation body from accepting applications from facilities that have failed to become accredited after 3 consecutive attempts, until 1 year after most recent failure;
• Expressly state a facility’s certificate may be suspended/revoked due to a failure to comply with reasonable requests from the FDA, State certification agency, or accreditation body for records;
• Permit the State certification agency to initiate an additional mammography review (AMR), and expressly permit the FDA and State certification agency to notify patients and providers when a facility is unable/unwilling to perform required patient and referring physician notification;
• Require a closing facility, or a facility that will no longer provide mammography services, to make arrangements for patient and provider access to mammography reports/images;
• Require facilities to provide personnel with copies of their MQSA qualification records;
• Require mammographic exam reports to include facility name and location;
• Change language in the “benign” final assessment category and add 3 new categories of assessment for: a known malignancy, post-procedure mammogram for marker placement, and an incomplete assessment requiring review of previous screenings;
• Require facilities to provide mammography results to patients and providers within 7 days after a final interpretation, if the report is “suspicious” or “highly suggestive of malignancy”, but no later than 14 calendar days from the examination date in any case;
• Require a summary, written in lay language, to be sent to patients specifying whether the mammograms are “suspicious” or “highly suggestive of malignancy”;
• Require reports to patients and providers to include an assessment of breast density;
• Require each facility to implement policies and procedures to minimize the loss of mammography images/reports; and
• Clarify the minimum information a facility must collect during the mammography medical outcomes audit.

“If your mammogram demonstrates that you have dense breast tissue, which could hide small abnormalities, you might benefit from supplementary screening tests . . . A report of your mammography results, which contains information about your breast density, has been sent to your physician’s office and you should contact your physician if you have any questions or concerns about this report.”