South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-64 - X-Rays (Title B)
Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY
Section 61-64.V.RHB 5.25 - Mammography Units Used for Localization or Stereotactic Breast Biopsy Procedures
Universal Citation: SC Code Regs 61-64.V.RHB 5.25
Current through Register Vol. 48, No. 9, September 27, 2024
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.
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