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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Audit Interpreting Physician

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Citation:

900.12(f)(3): Audit interpreting physician. Each facility shall designate at least one interpreting physician to review the medical outcomes audit data at least once every 12 months. This individual shall record the dates of the audit period(s) and shall be responsible for analyzing results based on this audit. This individual shall also be responsible for documenting the results and for notifying other interpreting physicians of their results and the facility aggregate results. If followup actions are taken, the audit interpreting physician shall also be responsible for documenting the nature of the followup.

Questions:
  1. Does the FDA require that the interpreting physician who reviews the medical outcomes audit data also be responsible for overall facility quality assurance?
  2. Why is the data analyzed for the aggregate and then for each interpreting physician?
  3. How long must a facility maintain the medical outcomes audit data on positive mammograms, including the associated surgical and/or pathology reports?
  4. Must the lead and audit physician(s) be listed as interpreting physician(s) at the facility?
  5. Can a facility designate more than one audit interpreting physician at a time?