Questions Key Words/Related Topics
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.
Discussion:
No. The regulations do not require that the audit and lead interpreting physicians be the same person.
Aggregate medical outcomes audit data provide a picture of how the facility is detecting breast cancer among its patients. Individual analyses are important to identify interpreting physicians who have results that are very different from the aggregate.
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.
Yes. The lead and audit physician(s) must be qualified interpreting physicians and must also be listed as interpreting physician(s) at the facility so that their qualifications can be evaluated at the time of the inspection. 21 C.F.R. 900.12(f)(3), 900.2(u). This does not require that the physician(s) actually interpret mammographic examinations at that specific facility.
While the regulations allow a facility to designate more than one audit interpreting physician at a time, FDA recommends that this option be used sparingly. Having a single audit interpreting physician who has overall responsibility for the medical audit generally allows for better management of the system.
Related Topics:
Medical Outcomes Audit Program
Medical Outcomes Audit General Requirements
Frequency of Medical Outcomes Audit Analysis