I attended the CRCPD Mammography Conference in Houston last week, and one of the sessions was the FDA Update: Amendments to MQSA Regulations. It was presented by Dr. David Lerner who is the Medical Officer, FDA Division of Mammography of Quality Standards of FDA. He expounded on the three broad categories in which the amendments are categorized: improvements that addresses changes in mammography technology; improvements that enhance enforcement of quality standards; and improvements in the way mammography results are categorized, reported, retained, and transferred to patients. The presentation and discussions highlighted the areas of policy and practice in mammography settings that will need review and outlined the strengthening of some areas of enforcement.
Improvements addressing mammography technology
The intent is to modernize the regulations by incorporating current science and mammography best practices. The MQSA regulations we have been operating under were written when film screen mammography was the only imaging modality. The new and amended language will make current clinical performance of digital mammography and quality control consistent with the language in the law and include changes in terminology and clarifications on equipment. The amendments also added or substituted “provider” or “healthcare provider” in lieu of references to the referring physician. This is reflective of the variety of health
Improvements that enhance enforcement of quality standards
This category does have several areas that will require facilities to evaluate their current policies and procedures to make sure that they comply and, in some instances, may raise questions about how to comply with the changes. The new amendment requires that all mammograms submitted for interpretation be presented in the mammographic modality in which they were originally produced. Images for interpretation cannot be copied or digitized from hardcopy original images that could adversely affect the accuracy of the interpretation. We have all seen or received “poor quality copies” submitted for comparisons.
Accreditation bodies will also be prohibited from accepting an application from a facility that has failed to become accredited after three consecutive attempts until 1 year after the most recent accreditation failure. This one year “time out” is for the facility to completely re-evaluate their mammogram program and proactively address all their deficiencies prior to reapplication.
Additionally, in the new amendments, FDA expressly states that a facility’s certificate may be suspended or revoked due to failure to comply with requests by the FDA, the State certification agency, or the AB (Accreditation Body) for records including clinical images for an additional mammography review (AMR), or with requests by current or former facility personnel for records documenting their qualifications. A request for images for an AMR cannot be ignored or a facility could risk a suspension or revocation of their accreditation.
A new amendment in this category will permit a state certification agency as an entity that may initiate an AMR to help detect quality issues without delays. Another significant change is the addition of the language that states that the FDA or State certification agency can notify patients and their providers either individually or through mass media when a facility is “unable or unwilling” to perform a required patient and referring physician notification (PPN). The intent is to ensure patients and providers are informed of serious risk to human health in a timely manner for a mammogram procedure they received that failed to meet quality standards.
Mammography facilities that close or no longer offer mammography services will be required by law to make prior arrangements for access by patients and healthcare providers to mammography images and reports. Also, facilities will be required to provide personnel with copies of their MQSA qualifications records. It will be left up to the facility to come up with a process to make this happen.
Improvements to Mammography Results Organization
The final category addresses improvements in the way mammography results are categorized, reported, retained, and transferred to patients. I am still reviewing these and will address in my next “what you need to know” blog. This will definitely be an area that will require facilities to review their policies, procedures, and processes to make you comply by September 10, 2024.