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U.S. Department of Health and Human Services

Radiation-Emitting Products

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How long must we maintain the records of our medical outcomes audit?

Policy Guidance Help System logoFor MQSA purposes, the medical outcomes audit (including the associated surgical and/or pathology reports) is considered part of a facility's quality assurance program. Therefore, the data must be maintained according to the quality assurance requirements. The analysis must be kept until subsequent analyses have been performed two additional times at the required frequency or until the next annual inspection has been completed and FDA has determined that the facility is in compliance with QA requirements, whichever is longer (21 CFR 900.12(d)(2)). Because the audit analysis is required to be conducted at least once every 12 months, the audit analysis must be kept for 24 months following its completion. If the facility has obtained actual pathology reports, these 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 impose 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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