January 2020

The FDA has proposed changes to the Mammography Quality Standards Act (MQSA) regulations which will have dire consequences for mammography facilities which fail inspections or image submissions for accreditation. One proposed change * Failure to pass accreditation due to submitted image quality after three attempts may close a facility. The closure may be required for as much as an entire year prior to permission to apply for accreditation again. Another proposed change * The FDA may have the ability to notify referring healthcare providers and patients when a facility is closed for substandard work.

Because of these likely changes, it is critical for every facility to ensure that daily images meet MQSA standard quality as well as having all of the other MQSA requirements in place. When random inspections of accredited facilities occur, images from daily work are selected for review. If the images are below MQSA standards a review of the facility may be initiated. In some cases this has resulted in retraction of the accreditation and closure or suspension of mammography services.

The FDA is currently reviewing public comments and will make its final determination in the near future.

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