S.C. Code Regs. § 61-65.II.RHC 2.5 - Vendor Registration and Obligation

2.5.1 Each person who is a) engaged in the business of selling, leasing, or installing particle accelerators or machine components; or b) offering to sell, lease, or install particle accelerators or machine components; or c) engaged in the business of furnishing or offering to furnish any equipment services in South Carolina shall apply for registration as a vendor with the Department within 30 days following the effective dates of these regulations or thereafter prior to furnishing or offering to furnish any such services.

2.5.1.1 In-house personnel employed by a registered facility or corporation shall be exempt from the registration requirement, provided such personnel:

2.5.1.1.1 Shall meet the education, training, and experience requirements for the appropriate vendor Class and;

2.5.1.1.2 Shall exclusively service one facility or corporation.

2.5.1.2 Documentation of education, training, and experience for in-house service personnel shall be maintained by the facility or corporation and available for Department review.

2.5.2 Any person who sells, leases, transfers, lends, moves, assembles or installs particle accelerators in South Carolina shall notify the Department of the following within 30 days of the transaction:

2.5.2.1 The name and address of persons who have received the machine;

2.5.2.2 The manufacturer, control model and serial number, and tube(s) model and serial number of each particle accelerator transferred; and

2.5.2.3 The date of transfer of each particle accelerator.

2.5.2.4 Notification to the Department shall be made on DHEC Form 823. A DHEC 823 form shall be submitted to the Department each month by Class I and Class II vendors, as outlined in Part II "Registration of X-Ray Machines and Services" of R.61-64, X-Rays (Title B), regardless of whether a particle accelerator was sold that month.

2.5.3 No person shall make, sell, lease, transfer, lend, maintain, repair, assemble, reassemble, reinstall or install particle accelerators or the supplies used in connection with such machines unless such supplies and equipment, when properly placed in operation and used, meet the requirements of these regulations. 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.

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

2.5.4.1 All information required by RHC 2.5;

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

2.5.4.3 Records of any routine maintenance, repair, alterations, or reassembly of particle accelerators. 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;

2.5.4.4 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.

2.5.5 All records required by this Part shall be maintained by the vendor for review by the Department. Training records shall be retained for personnel currently acting in any role as described in this Part. All other records shall be retained for five years. All records shall be accurate and factual.

2.5.6 Each vendor shall maintain sufficient calibrated and operable instruments to perform the testing appropriate to the class in which the vendor is registered. Instruments must be calibrated with sources consistent with the conditions under which they are used. Records shall be maintained of the calibrations performed on instrumentation used for testing.

2.5.6.1 Survey meters used for radiation area surveys shall be calibrated at intervals not to exceed 12 months and after each instrument servicing.

Notes

S.C. Code Regs. § 61-65.II.RHC 2.5

Replaced and amended by State Register Volume 39, Issue No. 06, eff. 6/26/2015.