S.C. Code Regs. § § 61-64.V.RHB 5.28

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

Section 61-64.V.RHB 5.28 - Notification Requirements for Mobile Mammography Facilities Certified by Another Certifying Agency

Mobile mammography facilities that operate in South Carolina and are certified under MQSA by the FDA, or another state authorized by FDA to certify mammography facilities under MQSA, shall:

5.28.1 Notify the Department by telephone, facsimile, or letter of each date and location of operation of the mobile mammography facility in South Carolina prior to conducting such operation as required by RHB 2.4.2.1.4.

5.28.2 At all times while operating in South Carolina, have the following documentation available for review and inspection by the Department:

5.28.2.1 A copy of the mammography facility certificate issued by the FDA or another state, showing that the facility is currently certified;

5.28.2.2 A summary of the most recent physics survey of the mammography machine(s) and documentation of any corrective actions recommended by the medical physicist who performed the physics survey; and

5.28.2.3 Documentation that personnel meet the qualifications of RHB 5.9.

5.28.3 All provisions of RHB 2.3.4 and 2.4.2 apply.

S.C. Code Regs. § 61-64.V.RHB 5.28

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.