Radiation-Emitting Products

Individuals providing physics services to mammography facilities must meet initial and continuing education requirements (900.12 (a)(3)). The training and experience needed to meet those qualifications must be acquired by providing physics services to facilities.

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To allow new people to acquire the necessary training, FDA has stated that they can carry out these actions under the direct supervision of qualified individuals. Also, medical physicists who have met the initial qualifications but fail to meet the continuing education requirement must requalify in order to practice independently. During their requalification period, the medical physicist must practice under direct supervision. This raises the question, "What constitutes direct supervision?"

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. 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, when conducting a physics survey, 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.

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Page Last Updated: 07/24/2014
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