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 5.1 - Scope
Universal Citation: SC Code Regs 61-64.V.RHB 5.1
Current through Register Vol. 48, No. 9, September 27, 2024
This Part establishes quality standards and certification requirements for facilities performing mammography to ensure that all mammography facilities are adequately and consistently evaluated for compliance with the standards provided.
5.1.1 Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the Department. When requesting such approval, that person shall submit the information outlined in Appendix A of Part IV. Approval to conduct a healing arts screening program shall be renewed on an annual basis if deemed necessary by the Department.
5.1.2 Exemptions.
5.1.2.1 Mammography units used only during
invasive interventions for localization or biopsy procedures are exempt from
the requirements of this Part, except that such systems shall satisfy the
criteria specified in
RHB 5.25, and all Parts to
which RHB 5.25
refers.
5.1.2.2 Each mobile
mammography facility based outside of South Carolina that operates in South
Carolina and which has not been certified by the Department is exempt from the
requirements of
RHB 5.4 and 5.8, provided that:
5.1.2.2.1 The mobile mammography facility is
certified to perform mammography by the U.S. Food and Drug Administration (FDA)
or other FDA-approved certifying agency at all times while conducting
operations in South Carolina;
5.1.2.2.2 The mobile mammography facility
meets the requirements of
RHB 5.28;
5.1.2.2.3 The mobile mammography facility
complies with all other requirements in Part V; and
5.1.2.2.4 The mobile mammography facility
meets the requirements of
RHB 2.3 and 2.4.
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