Radiation-Emitting Products

How long must a facility maintain the medical outcomes audit data on positive mammograms, including the associated surgical and/or pathology reports?

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For the purpose of MQSA, the medical outcomes audit (including the associated surgical and/or pathology reports) is considered part of a facility's internal quality assurance program. Therefore, the data should be maintained according to the quality assurance requirements. The applicable section of the regulations state that the analyses must be kept until the test has been performed two additional times at the required frequency. 21 C.F.R. 900.12(d)(2). Since the audit analyses are required to be conducted at least once every 12 months, the audit analyses should be kept for an additional 24 consecutive months following the analysis.If the facility has obtained actual pathology reports, those should be maintained until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the quality assurance requirements. However, State laws may define the data as part of a patient’s or facility’s medical records, and may have more stringent requirements for the retention of this data. A facility may want to check with the State regarding its requirements.

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Page Last Updated: 07/18/2014
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