(i) At least once a year, each facility shall undergo a survey by a medical physicist or by an individual under the direct supervision of a medical physicist. At a minimum, this survey shall include the performance of tests to ensure that the facility meets the quality assurance requirements of the annual tests described in paragraphs (e)(5) and (e)(6) of this section and the weekly phantom image quality test described in paragraph (e)(2) of this section.
(ii) The results of all rests conducted by the facility in accordance with paragraphs (e)(1) through (e)(7) of this section, as well as written documentation of any corrective actions taken and their results, shall be evaluated for adequacy by the medical physicist performing the survey.
(iii) The medical physicist shall prepare a survey report that includes a summary of this review and recommendations for necessary improvements.
(iv) The survey report shall be sent to the facility within 30 days of the date of the survey.
(v) The survey report shall be dated and signed by the medical physicist performing or supervising the survey. If the survey was performed entirely or in part by another individual under the direct supervision of the medical physicist, that individual and the part of the survey that individual performed shall also be identified in the survey report.
- System Artifact Testing at Remote Mobile Mammography Sites Where Film Processing Takes Place Using Processors Permanently Located at the Site
- System Artifact Testing of Target Filter Combinations
- Must the medical physicist's name appear on the annual medical physicist survey report?
- How will the inspector respond if the only physicist's survey report performed within the last 14 months is the one already reviewed during the previous annual inspection?
- 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. 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?"
- What are the requirements of the annual survey?
- When performing a physics survey or mammography equipment evaluation on a unit with multiple target/filter combinations, what tests or measurements must be performed for each combination?
- A facility is using more than one type of screen-film combination. Must it perform the QC tests separately for each combination used?
- Does FDA allow some flexibility with respect to scheduling physics surveys?
- My medical physicist recommended several corrective actions in our physics survey. Will our facility be cited if we do not implement all the recommendations?
- When conducted for the annual survey, must all the tests be performed by, or under the direct supervision of, a medical physicist?
- What are the minimum tests and/or reviews that the medical physicist must perform for a facility survey, survey of a mammography unit, equipment evaluation of a unit or processor that has been installed or disassembled and reassembled, and an equipment evaluation of a unit or processor that has undergone a major repair?
- While performing a facility survey, unit survey, or equipment evaluation, the medical physicist determines that the unit fails a required test(s) and needs to be adjusted, changed, or repaired. After the adjustment, change, or repair has been completed, does the test(s) have to be repeated and must the medical physicist perform the test(s)?
- Under what circumstances must our medical physicist actually visit our facility in order to successfully carry out his/her responsibility to oversee our equipment-related quality assurance practices?
- For test failures, equipment evaluations and other adjustments, changes, or repairs, are there specific timeframes defining when the verification test(s) must be performed?