S.C. Code Regs. § § 61-64.II.RHB 2.8

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

Section 61-64.II.RHB 2.8 - Vendor Obligation

2.8.1 Any person who sells, leases, transfers, lends, moves, assembles, or installs x-ray machines in this state shall notify the Department within thirty (30) calendar days of:

2.8.1.1 The name and address of persons who have received these machines;

2.8.1.2 The manufacturer, the control and tube(s) model number, the control and tube(s) serial number of each radiation machine transferred; and

2.8.1.3 The date of transfer of each x-ray machine.

2.8.1.4 Notification to the Department shall be made on forms provided by the Department and shall be submitted to the Department each month by Class I and Class II-A vendors.

2.8.2 No person shall furnish any x-ray machine services or make, sell, lease, transfer, lend, maintain, calibrate, test, repair, assemble, reassemble, reinstall, or install radiation machines or the supplies used in connection with such machines unless such supplies and equipment when properly placed in operation and use, meet the requirements of this regulation. Each vendor shall ensure that the facility it is providing with services or supplies is registered with the Department prior to providing services or supplies.

2.8.2.1 Any vendor acting as a Radiation Safety Officer on behalf of a registered facility shall be registered as a Class VIII or IX vendor and shall meet all applicable Parts of this regulation.

2.8.3 Each vendor shall maintain records for review by the Department. These records shall include, at a minimum:

2.8.3.1 All information required by RHB 2.7 and 2.8;

2.8.3.2 A copy of any shielding plans and/or area surveys. Records of shielding plans and area surveys shall include the date that the service was performed and the legible signature of the person performing the service;

2.8.3.3 Tests performed at the time of installation to ensure that the equipment complies with this regulation. A copy of these results shall be provided to the registrant at the time of installation;

2.8.3.4 Records of any routine maintenance, repair, alterations, or reassembly of x-ray equipment. Records of maintenance, repair, alterations, or reassemblies shall include the date that the service was performed and the legible signature of the person performing the service. A copy of these records shall be provided to the registrant at the time the service is provided;

2.8.3.5 Names of all employees and their dates of employment with the vendor. Records shall also be maintained of training provided to the employees during their term of employment; and

2.8.3.6 A copy of equipment performance tests, including data collected during the testing.

2.8.3.6.1 A copy of the equipment performance test shall be provided to the facility either at the time of testing or within thirty (30) calendar days of the testing date.

2.8.3.6.2 The report of equipment performance testing shall include the testing of all items listed in Part IV, Appendix F, except as noted in the Appendix.

2.8.3.6.3 The equipment performance test record provided to the facility must clearly indicate all equipment parameters tested and each item must include a designation, such as "Pass/Fail" or "Compliant/Non-compliant," that is easily understandable by the facility. Use of any designation other than "Pass/Fail" or "Compliant/Non-compliant" shall be approved by the Department prior to use on equipment performance reports of testing.

2.8.3.6.4 The equipment performance test record shall include a summary of findings and recommendations for necessary improvements and/or corrective actions.

2.8.3.6.5 The record of equipment performance shall be legible and include the date that the testing was performed; the facility name, facility location address, and facility registration number issued by the Department; the legible signature of the person performing the service; manufacturer, model number, serial number, and the calibration date of the instrument used to perform the test; and the manufacturer, serial number, model number, and location of the equipment.

2.8.4 All records required by this Part shall be maintained by the vendor until their disposal is authorized by the Department. All records shall be legible, accurate, and factual.

2.8.5 Each vendor shall maintain sufficient calibrated and operable instruments to perform the testing appropriate to the class in which the vendor is registered. Instruments shall be calibrated with sources consistent with the conditions under which they are used. Legible records shall be maintained of the calibrations performed on instrumentation used for testing. All provisions of RHB 1.4.4 apply.

S.C. Code Regs. § 61-64.II.RHB 2.8

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.