10A NCAC 15 .0203 APPLICATION FOR REGISTRATION PROCESS: GENERAL REQUIREMENTS FOR ALL FACILITIES, RADIATION MACHINES, AND SERVICES PROVIDED

(a) A person with an unregistered facility, X-ray machine, or radiation generating device, or an unregistered service provider shall apply for registration with the agency. After submitting the required application forms prescribed by the agency in this Rule, registration of the first X-ray machine, radiation generating device, or registration of services provided, constitutes registration of the facility or service provider.

(b) All application forms in this Rule shall be completed by meeting the following requirements:

(1) The owner or the individual responsible for the business operations of a facility with an X-ray machine, radiation generating device, or who provides radiological services, shall ensure that application forms, required by the agency in this Rule, meet the following requirements:

(A) are accurate, complete, and contain all the information required by the application forms and accompanying instructions; and

(B) are submitted to the agency at the e-mail address on the application for registration forms or mailed to the address in Rule .0111 of this Chapter.

(2) Incomplete application forms or application forms submitted without the requested documentation to provide radiological services will not be processed.

(3) The agency may require additional information at any time after submission of the application to determine if the notice of registration should be issued or denied.

(4) Application forms can be found at https://radiation.ncdhhs.gov/Xray/applic.htm and https://radiation.ncdhhs.gov/Xray/service.htm.

(5) The owner or individual responsible for business operations can designate a responsible person or persons within the organization to sign when amendments are made to forms by notifying the agency in writing.

(c) A Business Application form shall be submitted prior to the operation of a facility or providing services in this State, and the following additional requirements shall be met:

(1) The application shall be submitted by any person:

(A) with one or more X-ray machines or radiation generating devices at a facility; or

(B) that plans to engage in radiological services listed in Paragraphs (f) and (g) of this Rule.

(2) The application form requires the following:

(A) indication if the application is for a new facility, a change of ownership, relocation of a facility, or to update information by marking the corresponding checkbox;

(B) the legal business name, facility physical address, phone number, and type of business;

(D) the name of the individual on-site who is responsible for radiation protection. The training and experience qualifying him or her to perform the job duties and responsibilities in Rule .0211 of this Section, shall be made available during inspection or upon request by the agency;

(E) the name, title, mailing address, phone, and e-mail address for the invoice contact; and

(F) dated and signed by the owner or the individual responsible for business operations.

(d) An X-ray Machine Application or Radiation Generating Devices Application form shall be submitted in accordance with Rule .0204(c)(1) through (5) of this Section, for the type of X-ray machine or radiation generating device owned by the registrant or potential registrant or the service provided. The following additional requirements shall be met:

(1) The application shall be submitted by any person:

(A) with one or more unregistered X-Ray machines or radiation generating devices at a facility; or

(B) that is engaged in leasing or performing demonstrations using an unregistered X-Ray machine or radiation generating device.

(2) The application requires the following information:

(A) registration number;

(B) machine or device location;

(D) location of the machine or device when not in use;

(E) installer information; and

(F) dated and signed by the owner or individual responsible for business operations.

(e) A Disposal of an X-ray Machine or Radiation Generating Device Form shall be submitted when a facility disposes of an X-ray machine or radiation generating device. The agency form requires the following information:

(1) registration number, facility name, and physical address;

(2) identify if the application is for a new facility, for a change of ownership, a facility relocation, or to update information;

(3) X-ray machine or radiation generating device location, manufacturer, model and serial number;

(4) identify the method of disposal of the X-ray machine or radiation generating device;

(5) recipient of the X-ray machine or radiation generating device, physical and e-mail address, and phone number; and

(6) dated and signed by the owner or the individual responsible for business operations of the X-ray machine or radiation generating device.

(f) A Company Service Application form shall be submitted prior to furnishing or offering to furnish services in Parts (A) through (C) of Subparagraph (f)(1) of this Rule and the following additional requirements shall be met:

(1) The application shall be submitted by any person engaged in:

(A) direct sales, demonstration, leasing, or transfer of X-ray machines or radiation generating devices;

(B) providing individual monitoring devices; or

(C) radiation survey equipment calibrations, except when calibrations are performed by the manufacturer of the equipment.

(2) The application requires the following information:

(A) registration number;

(B) business name, facility physical address;

(C) identify if the application is for a new service provider, for a change of ownership, relocation of the facility, or to update information;

(D) identify each class and modality of services requested to be provided in the State;

(E) submit the requirements listed on the agency form for each class and modality requesting to provide services in the State;

(F) list any class or modality not listed on this form;

(G) description of service provider equipment used for output measurements and surveys; and

(H) dated and signed by the owner or the individual responsible for business operations.

(g) A Company Employee Services Application form shall be submitted prior to furnishing or offering to furnish services in Parts (A) through (G) of Subparagraph (g)(1) of this Rule and the following additional requirements shall be met:

(1) The application shall be submitted by any person engaged in providing the following services:

(A) area radiation surveys for X-ray machines;

(B) equipment surveys and shielding designs for radiation generating devices;

(C) general health physics consulting services to perform dose estimates, radiation output measurements, radiation safety program development, and radiation safety program training;

(D) installation or service repair of X-ray machines or radiation generating devices;

(E) qualified expert consulting services for CT and mammography X-ray machines;

(F) shielding designs for X-ray machines; and

(G) therapeutic shielding verification and area radiation surveys.

(2) The application requires the following information:

(A) name of the employee to be registered;

(B) start date if the employee is being added, and the stop date if the employee is being removed from the registration;

(D) class identification and modality of services to be provided;

(E) training and experience to submit for each class of services to be provided;

(F) date and signature of the employee applying for registration;

(G) date and signature of the owner or the individual responsible for business operations; and

(H) additional information the agency determines is necessary for evaluating the application for registration.

(h) Owners of radiation imaging systems and in-house personnel employed by a facility or corporation shall be exempt from the registration requirements in this Rule to provide services in this State, provided such personnel:

(1) meets the education requirements of the Class for the services provided, or is supervised by an individual who meets the training and experience requirements of the Class for the services provided;

(2) provides services at one facility or corporation; and

(3) provides documentation of the requirements in Subparagraph (h)(1) of this Rule for agency review during inspection.

(i) The following general requirements apply to all facilities and services provided in North Carolina.

(1) The registrant shall notify the agency when any change will render the information in an application for registration or notice of registration no longer accurate.

(2) A registrant that terminates all activities involving X-ray machines, radiation generating devices, or providing services shall meet the following requirements within 30 days:

(A) request termination of the notice of registration in writing by the owner or the individual responsible for business operations;

(B) submit to the agency, a Disposal of an X-ray Machine or Radiation Generating Device Form in accordance with Paragraph (e) of this Rule; and

(3) A registrant shall not transfer the registration as part of a change of ownership.

(4) A person who takes possession of an X-ray machine or radiation generating device because of bankruptcy, foreclosure, or state auction may possess the machine or device when the following additional requirements are met:

(A) The machine or device shall be posted with a visible sign stating that the new owner is responsible for registering with the agency if used in this State; and

(B) If the machine or device is energized, it shall only be energized by someone registered in accordance with this Section and only to demonstrate that it is operable for sale or transfer.

(5) No person shall in any advertisement refer to the fact that his or her facility is registered with the agency pursuant to the provisions of Rule .0204 or .0205 of this Section, and no person shall state or imply that under such registration any activities have been approved by the agency.

History Note: Authority G.S. 104E‑7; 104E‑12; 104E‑20;

Eff. February 1, 1980;

Amended Eff. May 1, 1992;

Transferred and Recodified from 15A NCAC 11 .0203 Eff. February 1, 2015;

Readopted Eff. October 1, 2025;

Amended Eff. October 1, 2026.