Can a medical physicist sign-off on mammography equipment evaluation done by a surrogate if the medical physicist was not present during the evaluation?
No. The qualified physicist would have to be present during the equipment evaluation and, at a minimum, provide direct supervision over his/her surrogate (supervisee). Direct supervision means that the supervisor (if the supervision is done after 4/28/99, the supervising medical physicist must have qualified under the Master’s or higher pathway) is present to observe and correct, as needed, the performance of the supervisee. 21 C.F.R. 900.2(o)(2). This requires that the supervisor be in the room during the performance of the individual equipment tests to assure that any mistakes made by the supervisee are corrected before the test is completed. The supervisor must review any calculations made from, and any conclusions drawn from the test results, before those results are provided to the facility.
The goal of direct supervision is to provide reasonable assurance that any mistakes made by the supervisee are corrected before the tests are completed.
The supervisor must be identified in the report. The qualifications of the supervising medical physicist will be checked during the inspection. The names of all those being supervised should also be identified in the report.