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What criteria will FDA use to determine that facilities meet the MQSA requirements for the medical outcomes audit program?

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For facilities that have had positive examinations, the medical outcomes audit program requirements can be met by demonstrating to the MQSA inspector that the facility has obtained, or attempted to obtain, pathology results for its positive cases (and cases of breast cancer among patients imaged at the facility that subsequently became known to the facility) and has performed appropriate analyses annually. The audit interpreting physician(s) needs to be identified. For facilities that have not had positive examinations, the medical outcomes audit program requirements can be met by providing written documentation describing how the facility's medical audit system would follow-up on positive cases (and any cases of breast cancer among patients imaged at the facility that subsequently became known to the facility), would correlate pathology results with the interpreting physician's findings and would perform appropriate analyses annually. The audit interpreting physician(s) needs to be identified. An example of such a facility is a screening facility that classifies all problematic mammograms as “Incomplete, Need additional imaging evaluation” and sends those patients to a diagnostic center for further evaluation. Because the screening facility never classifies a patient as positive, the facility does not have any patients that require tracking and has no patients to include in its audit.

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Page Last Updated: 08/12/2014
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