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 5.28 - Notification Requirements for Mobile Mammography Facilities Certified by Another Certifying Agency
Universal Citation: SC Code Regs 61-64.V.RHB 5.28
Current through Register Vol. 48, No. 9, September 27, 2024
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.
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