S.C. Code Regs. § § 61-64.V.RHB 5.25

Current through Register Vol. 48, 12, December 27, 2024

Section 61-64.V.RHB 5.25 - Mammography Units Used for Localization or Stereotactic Breast Biopsy Procedures

5.25.1 Personnel. The following requirements apply to all personnel involved in localization or biopsy procedures performed with mammography units:

5.25.1.1 Interpreting Physicians. The interpreting physician shall:

5.25.1.1.1 Be responsible for quality assurance activities including medical audit (tracking of number of biopsies done, cancers found, benign lesions, biopsies needing repeat, and complications);

5.25.1.1.2 Be responsible for oversight of all quality control;

5.25.1.1.3 Be responsible for the supervision of the radiologic technologist and the medical physicist;

5.25.1.1.4 Be responsible for post-biopsy management of the patient; and

5.25.1.1.5 Provide documentation of compliance with this Part to the Department upon request.

5.25.1.2 Radiologic Technologists.

5.25.1.2.1 The radiologic technologist shall be currently registered in good standing with the American Registry of Radiologic Technologists.

5.25.1.2.2 The technologist shall have previously received documented training specifically in stereotactic breast biopsy procedures and techniques along with positioning for stereotactic units. This training shall consist of fifteen (15) hours of continuing education in mammography every three (3) years and three (3) hours of Category A continuing education in stereotactic breast biopsy every three (3) years.

5.25.1.2.3 Documentation of registration and training shall be provided to the Department upon request.

5.25.1.3 Medical Physicists. The medical physicist shall:

5.25.1.3.1 Be approved by the Department as a Class IX vendor as required in RHB 2.7.8.8 and be certified in diagnostic radiological physics or radiological physics by either the American Board of Radiology (ABR) or The American Board of Medical Physics (ABMP);

5.25.1.3.2 Meet the requirements of RHB 5.9.3.1.1, 5.9.3.1.2, and 5.9.3.1.3;

5.25.1.3.3 Have fifteen (15) hours of continuing education in mammography physics every three (3) years;

5.25.1.3.4 Have performed at least two (2) stereotactic breast biopsy surveys per year; and

5.25.1.3.5 Have three (3) hours of continuing education in stereotactic breast biopsy physics every three (3) years.

5.25.2 Equipment. Mammography units used for stereotactic breast biopsy or localization procedures shall meet the requirements of RHB 5.10, 5.13.5.2, 5.13.5.3, and 5.13.5.8 with the exception of RHB 5.13.5.10. Digital output mammography systems that do not use screen-film image receptors are exempt from the requirements of RHB 5.10 of this regulation as they relate to screen-film image receptors.

5.25.3 Quality Assurance.

5.25.3.1 Each facility shall establish and maintain a quality assurance program to ensure the safety, reliability, clarity, and accuracy of mammography localization or biopsy procedures performed at the facility.

5.25.3.2 Each facility shall have the services of a medical physicist available to survey mammography equipment and to oversee the equipment-related quality assurance practices of the facility.

5.25.3.3 The quality assurance program shall be in writing and shall have been developed by a medical physicist. The program shall include, but need not be limited to, the following:

5.25.3.3.1 Specifications of the tests that are to be performed, including instructions to be employed in the performance of those tests; and

5.25.3.3.2 Specifications of the frequency at which tests are to be performed, the acceptable tolerance for each parameter measured, and actions to be taken if tolerances are exceeded.

5.25.3.4 The medical physicist shall conduct a review of the quality assurance program each year. Such review shall include evaluation of the results of quality assurance testing and quality control tests as specified in the American College of Radiology's Stereotactic Breast Biopsy QC Manual.

5.25.3.5 Each facility shall maintain written records of the radiation dose measurements and quality assurance testing performed, as required in this Part, for inspection by the Department for a period of at least one (1) year, or until the next Department inspection, whichever is later. Such records shall include, but not be limited to, the following:

5.25.3.5.1 The date of the test and identification of the person performing the test;

5.25.3.5.2 Identification of the type of testing that was performed; and

5.25.3.5.3 Notification of whether the results of the testing were within the parameters established by the medical physicist.

5.25.3.6 The facility shall maintain a copy of the medical physicist's survey report, including documentation of any required corrective action, for Department review.

5.25.3.7 The survey report shall be dated and signed by the medical physicist performing and/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.

S.C. Code Regs. § 61-64.V.RHB 5.25

Replaced and amended by State Register Volume 40, Issue No. 06, eff. 6/24/2016; State Register Volume 47, Issue No. 05, eff. 5/26/2023.