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 5.12 - Quality Assurance Requirements
Universal Citation: SC Code Regs 61-64.V.RHB 5.12
Current through Register Vol. 48, No. 9, September 27, 2024
Each facility shall establish and maintain a quality assurance program to ensure the safety, reliability, clarity, and accuracy of mammography services performed at the facility.
5.12.1 Responsible individuals. Responsibility for the quality assurance program and for each of its elements shall be assigned to individuals who are qualified for their assignments and who shall be allowed adequate time to perform these duties.
5.12.1.1 Lead interpreting physician. The
facility shall identify a lead interpreting physician who shall have the
general responsibility of ensuring that the quality assurance program meets all
requirements of this Part. No other individual shall be assigned or shall
retain responsibility for quality assurance tasks unless the lead interpreting
physician has determined that the individual's qualifications for, and
performance of, the assignment are adequate.
5.12.1.2 Interpreting physicians. All
physicians interpreting mammograms for the facility shall:
5.12.1.2.1 Follow the facility procedures for
corrective action when the images that they are asked to interpret are of poor
quality; and
5.12.1.2.2 Participate
in the facility's medical outcomes audit program.
5.12.1.3 Medical physicist. Each facility
shall have the services of a medical physicist available to survey mammography
equipment and oversee the equipment-related quality assurance practices of the
facility. At a minimum, the medical physicist(s) shall be responsible for
performing the surveys and mammography equipment evaluations and providing the
facility with the reports described in
RHB 5.14 and 5.15.
5.12.1.4 Quality control technologist.
Responsibility for all individual tasks within the quality assurance program
not assigned to the lead interpreting physician or the medical physicist shall
be assigned to a quality control technologist(s). The tasks are to be performed
by the quality control technologist or by other personnel qualified to perform
the tasks. When other personnel are utilized for these tasks, the quality
control technologist shall ensure that the tasks are completed in such a way as
to meet the requirements of
RHB 5.13.
5.12.2 Quality assurance records.
5.12.2.1 The lead interpreting physician
shall ensure that the following records are properly maintained and updated:
5.12.2.1.1 Employee qualifications;
5.12.2.1.2 Mammography technique and
procedures;
5.12.2.1.3 Quality
control (including monitoring data, problems detected by analysis of that data,
corrective actions and the effectiveness of the corrective actions);
and
5.12.2.1.4 Report of the
medical physicist's test results with numerical values as well as written
documentation of any corrective actions taken.
5.12.2.2 These quality control records shall
be kept for each test specified in
RHB 5.13 until the next annual
inspection has been completed and the Department has determined that the
facility is in compliance with the quality assurance requirements or until the
test has been performed two (2) additional times at the required frequency,
whichever is longer.
Disclaimer: These regulations may not be the most recent version. South Carolina may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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