S.C. Code Regs. § § 61-64.II.RHB 2.7

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

Section 61-64.II.RHB 2.7 - Registration Requirements-Servicing and Services (VENDOR)

2.7.1 Each person who is engaged in the business of selling, leasing, assembling, or installing or offering to sell, lease, assemble, or install x-ray machines or machine components or is engaged in the business of furnishing or offering to furnish x-ray equipment servicing or services in this state shall be registered as a vendor with the Department prior to furnishing or offering to furnish any such services.

2.7.1.1 The owner of an x-ray system and in-house personnel employed by a facility or corporation shall be exempt from the vendor registration requirement, provided such personnel:

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

2.7.1.1.2 Shall exclusively service one (1) facility or corporation.

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

2.7.2 Application for vendor registration shall be completed on the current version of the forms provided by the Department, be submitted with vendor application fees required by RHB 2.3, and contain all information required by the Department as indicated on the forms and accompanying instructions. This information shall include at a minimum:

2.7.2.1 The name, physical address, mailing address, email address, business website, and telephone number of the individual or company to be registered;

2.7.2.2 The full printed name of the owner and any partner, co-owner, or corporate owner, if applicable;

2.7.2.3 The printed name, title, mailing address, email address, and telephone number of the contact person for the company;

2.7.2.4 The description of the services and the x-ray machine types for which x-ray machine services are to be provided;

2.7.2.5 The printed name, title, signature, documented training, education, and experience of each person to provide x-ray machine servicing or services;

2.7.2.6 The date of the application;

2.7.2.7 A sample of equipment performance test procedures and forms, if registering as a Class II-C or Class IX vendor;

2.7.2.8 A sample of a shielding plan, if registering as a Class III, Class IV, Class VII, Class VIII, or Class IX vendor;

2.7.2.9 A sample area survey if registering as a Class III, Class IV, Class VII, Class VIII, or Class IX vendor;

2.7.2.10 The applicant's or registrant's printed name, title, and signature, assuring that the contents of the application are accurate and true, and that the applicant or registrant will comply with this regulation; and

2.7.2.11 Any additional information the Department determines to be necessary for evaluation of the application for registration.

2.7.3 Each person applying for registration under this Part shall specify that he or she has read and understands the applicable requirements of this regulation.

2.7.4 A vendor registration application will not be reviewed or otherwise processed until payment of the application fee.

2.7.5 Notice of Vendor Registration.

2.7.5.1 Upon a determination that an applicant meets the requirements of the regulation, the Department will issue a Notice of Vendor Registration.

2.7.5.2 No individual shall perform x-ray machine services except as specified on the Notice of Vendor Registration issued by the Department.

2.7.5.3 The Department may incorporate in the Notice of Vendor Registration at the time of issuance or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the registrant's receipt, possession, use, and transfer of x-ray machines as it deems appropriate or necessary.

2.7.5.4 A vendor shall not furnish or offer to furnish x-ray machine services until the Department has issued a Notice of Vendor Registration.

2.7.6 For the purpose of this section, x-ray machine services are:

2.7.6.1 Class I - Direct sale and transfer of radiation machines and machine components to end users;

2.7.6.2 Class II - Installation, assembly, servicing, or testing of radiation machines and associated radiation machine components including the making of machine diagnostic radiation output measurements to verify performance associated with the installation, assembly, or service;

2.7.6.2.1 Class II-A - Installation and assembly of radiation machines and associated radiation machine components;

2.7.6.2.2 Class II-B - Servicing of radiation machines and associated radiation machine components;

2.7.6.2.3 Class II-C - Perform "Equipment Performance Tests" as outlined in RHB 4.2.16. Refer to Appendix F;

2.7.6.3 Class III - Non-therapeutic healing arts facility shielding design and area radiation survey (e.g., shielding evaluation);

2.7.6.4 Class IV - Non-healing arts facility shielding design and area radiation survey (e.g., shielding evaluation);

2.7.6.5 Class VI - Radiation instrument calibration;

2.7.6.6 Class VII - Therapeutic facility and shielding design, area radiation surveys, and calibration;

2.7.6.7 Class VIII - General health physics consulting, non-healing arts (e.g., independent radiation output measurements, dose analysis, design of safety programs and radiation safety training programs, facility and shielding design, area radiation surveys, and acting as the Radiation Safety Officer);

2.7.6.8 Class IX - General health physics consulting, healing arts (e.g., independent diagnostic radiation output measurements, dose analysis, design of safety programs and radiation safety training programs, facility and shielding design, area radiation surveys, equipment performance tests, and acting as the Radiation Safety Officer); and

2.7.6.9 Such other x-ray machine services which can affect compliance with this regulation by a registrant, as determined by the Department.

2.7.7 Report of Change. The vendor shall notify the Department in writing, within thirty (30) calendar days, of any changes that would render the information contained on the vendor registration forms no longer accurate. Changes shall be made on forms provided by the Department and include, but not be limited to, changes in name, ownership, equipment type services, employee's status, physical address, mailing address, and contact person's name, address, email address, and telephone number.

2.7.8 Training and Educational Requirements for X-ray Machine Services. Each person providing x-ray machine services pursuant to RHB 2.7 shall be qualified by reason of education, training, and experience to provide the service for which registration is requested. The following are minimum qualifications for specific types of services:

2.7.8.1 Class I - Direct sale and transfer of radiation machines and machine components to end users: The applicant shall certify knowledge of familiarity with the rules and regulations which govern the possession, installation and use of radiation machines in South Carolina.

2.7.8.2 Class II - A, B, or C - Installation, assembly, service, and testing of radiation machines and machine components:

2.7.8.2.1 Experience or education providing familiarity with the type of equipment to be serviced;

2.7.8.2.2 Knowledge of radiation safety to include principles of radiation protection;

2.7.8.2.3 Six (6) months of supervised installation, assembly, service, and/or testing of the type of equipment to be serviced;

2.7.8.2.4 And one (1) of the following:

2.7.8.2.4.1 One (1) year of documented formal training from the manufacturer's school, military technical training school, or other courses in radiation machine installation, assembly or repair, or an equivalent combination of training and experience;

2.7.8.2.4.2 An associate's degree in biomedical equipment technology; or

2.7.8.2.4.3 A bachelor's degree in electrical engineering with specialized training in radiation producing devices.

2.7.8.3 Class III - Non-therapeutic healing arts facility shielding design and area radiation survey (e.g., shielding evaluation):

2.7.8.3.1 Documented training in principles of radiation protection;

2.7.8.3.2 Documented training in shielding design and shielding evaluation;

2.7.8.3.3 One (1) year of experience in healing arts facility and shielding design for the specific type of machine application; and

2.7.8.3.4 One (1) year of experience performing area radiation surveys.

2.7.8.4 Class IV - Non-healing arts facility and shielding design and area radiation survey (e.g., shielding evaluation):

2.7.8.4.1 Documented training in principles of radiation protection;

2.7.8.4.2 Documented training in shielding design and shielding evaluation; and

2.7.8.4.3 One year of experience in non-healing arts facility and shielding design for the specific type of machine application; and

2.7.8.4.4 One (1) year of experience performing area radiation surveys.

2.7.8.5 Class VI - Radiation instrument calibration:

2.7.8.5.1 Possess a current radioactive materials license if instrument calibration is done utilizing radioactive materials or registration authorizing radiation instrument calibration;

2.7.8.5.2 Training in principles of radiation protection;

2.7.8.5.3 Training in operation and calibration of radiation detection and measurement instrumentation;

2.7.8.5.4 One (1) year experience in an instrument calibration laboratory; and

2.7.8.5.5 Shall submit a description of the procedures that will be utilized in performing instrument calibrations.

2.7.8.6 Class VII - Therapeutic facility and shielding design, area radiation survey, and calibration:

2.7.8.6.1 Certification by the American Board of Radiology in therapeutic radiological physics, radiological physics, or x-ray and gamma ray physics, or certification by the American Board of Medical Physics in therapeutic radiological physics; or

2.7.8.6.2 Having the following minimum training and experience:

2.7.8.6.2.1 A Master's or a Doctoral degree in Physics, Biophysics, Radiological Physics, or Health Physics or Medical Physics; one (1) year full-time training in therapeutic radiological physics; and

2.7.8.6.2.2 One (1) year full-time experience in a therapeutic facility where the individual's duties involve calibration and spot checks of a medical accelerator, and includes personal calibration and spot check of at least one (1) machine.

2.7.8.6.3 Shall submit a description of the procedures that will be utilized in performing therapeutic calibrations including a list of all guides and references to be employed.

2.7.8.6.4 Shall submit a copy of all forms, reports, and documents that will be supplied to registrants; and shall submit one (1) sample of each specific type (e.g., therapy, accelerator).

2.7.8.7 Class VIII - General health physics consulting, non-healing arts (e.g., independent radiation output measurements, dose analysis, design of safety programs and radiation safety training programs, facility and shielding design, area radiation surveys, and acting as the Radiation Safety Officer):

2.7.8.7.1 Master's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university and have forty (40) hours practical training and/or supervised experience in x-ray physics; or

2.7.8.7.2 Certification by the American Board of Health Physics, American Board of Radiology, or American Board of Medical Physics in the appropriate fields or specialties in which services are provided.

2.7.8.7.3 All training and experience requirements of RHB 2.7.8.4, as applicable.

2.7.8.7.4 Any person registered as a vendor of this Class prior to the effective date of this regulation and holding a baccalaureate degree in a physical science (e.g., physics, chemistry, or radiologic science), engineering or related field, and having two (2) years of progressive experience in medical or health physics or two (2) years of graduate training in medical or health physics is exempt from the requirements in RHB 2.7.8.7.1 and 2.7.8.7.2, provided he/she is in good standing with the Department.

2.7.8.8 Class IX - General health physics consulting, healing arts (e.g., independent diagnostic radiation output measurements, dose analysis, design of safety programs and radiation safety training programs, facility and shielding design, area radiation surveys, equipment performance tests, and acting as the Radiation Safety Officer):

2.7.8.8.1 Master's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university and have forty (40) hours practical training and/or supervised experience in x-ray physics; or

2.7.8.8.2 Certification by the American Board of Health Physics, American Board of Radiology, or American Board of Medical Physics in the appropriate fields or specialties in which services are provided.

2.7.8.8.3 Medical physicists for mammography shall meet the requirements specified by RHB 5.9.3.

2.7.8.8.4 All training and experience requirements of RHB 2.7.8.3, as applicable.

2.7.8.8.5 Any person registered as a vendor of this Class prior to the effective date of this regulation and holding a baccalaureate degree in a physical science (e.g., physics, chemistry, or radiologic science), engineering or related field, and having two (2) years of progressive experience in medical or health physics or two (2) years of graduate training in medical or health physics is exempt from the requirements in RHB 2.7.8.8.1 and 2.7.8.8.2, provided he/she is in good standing with the Department.

2.7.8.9 For the purpose of RHB 2.7, the required work experience may be gained while working for a manufacturer or while working under the direct supervision of a vendor registered in the particular class.

2.7.9 Any branch office of a vendor shall be considered a separate entity and shall be registered separately pursuant to RHB 2.7.

S.C. Code Regs. § 61-64.II.RHB 2.7

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.