S.C. Code Regs. § § 61-64.V.RHB 5.1

Current through Register Vol. 48, No. 10, October 25, 2024

Section 61-64.V.RHB 5.1 - Scope

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.

S.C. Code Regs. § 61-64.V.RHB 5.1

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.