Radiation-Emitting Products

Can a medical physicist sign-off on a physics survey or mammography equipment evaluation (MEE) done by a surrogate if the medical physicist was not present during the survey or (MEE)?

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No. The qualified physicist (the supervising medical physicist must have qualified under the Master’s or higher pathway, 21 C.F.R. 900.12(a)(3)(i)(B)(3)) would have to be present during the survey or MEE and, at a minimum, provide direct supervision over his/her surrogate (supervisee). 21 C.F.R. 900.12(o)(2). Direct supervision means that the qualified medical physicist (supervisor) is present to observe and correct, as needed, the performance of the supervisee. 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. Furthermore, the supervisor and supervisee must jointly review the QC program records. The supervisor does not have to be present when the supervisee initially reviews the QC program records. However, the supervisor must review, discuss, confirm, and if necessary, correct the findings made by the supervisee prior to either the initial or final survey report being issued. The goal of direct supervision is to provide reasonable assurance that any mistakes made by the supervisee are corrected before the QC program review or tests are completed. The supervisor must sign the survey report. 21 C.F.R. 900.12(e)(9)(v). The qualifications of the supervising medical physicist will be checked during the inspection. The names of all those being supervised must also be identified in the report. 21 C.F.R. 900.12(e)(9)(v).

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Page Last Updated: 06/26/2014
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