902 KAR 100:110. Registration of x-ray.

 

      RELATES TO: KRS 211.842-211.852, 211.990(4)

      STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844

      NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to regulate the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. The purpose of this administrative regulation is to provide for the registration of radiation producing machines and vendors in Kentucky.

 

      Section 1. Applicability. This administrative regulation shall apply to radiation producing machines received, possessed, used, or transferred in the Commonwealth of Kentucky. The provisions of this administrative regulation are in addition to other applicable radiation administrative regulations.

 

      Section 2. Preregistration. The person proposing to operate a radiation producing machine or accelerator except those specifically exempted in Section 5 of this administrative regulation shall preregister with the cabinet prior to acquisition of the machine. Preregistration under this section shall contain the following information and other information as may be required:

      (1) Name and address of the person having administrative control and responsibility for the proposed facility.

      (2) Address where the machine is to be located and used except that a central headquarters address may be given for a mobile x-ray to be used at various temporary field locations.

      (3) A designation of the general category of proposed use (dental, medical, industrial, veterinary, or other.)

      (4) Plans and specifications for the proposed facility and an evaluation by a qualified expert as required by 902 KAR 100:160.

 

      Section 3. Registration. (1) The preregistrant shall notify the cabinet within ten (10) days of the acquisition of a radiation producing machine or accelerator. Registration under this section requires the following information and other information as may be required:

      (a) A change which renders the information required in Section 2 of this administrative regulation no longer accurate.

      (b) A description of the type, model, serial number of the radiation machine and its rated capacity in peak kilovolts and milliamperes.

      (c) Date of initial operation of the radiation producing machine or accelerator.

      (d) Vendor registration number, name, address and telephone number.

      (2) The registrant shall notify the cabinet within ten (10) days of a change which increases the rating of the machine or of a change which renders the information required in subsection (1) of this section no longer accurate. A change of ownership or possession of the machine shall terminate the registration.

      (3) Each registrant, or his estate, if deceased, who permanently discontinues the use of or transfers radiation machines at an installation shall notify the cabinet in writing within thirty (30) days of this action. If a transfer occurs, the notification shall include the name and address of the transferee.

      (4) No person in an advertisement shall refer to the fact that a radiation machine is registered with the cabinet, and no person shall state or imply that an activity under the registration has been approved by the cabinet.

      (5) The registrant shall be subject to applicable requirements of these administrative regulations.

      (6) If a radiation machine is to be brought into this state, the person proposing to bring the machine into the state shall give written notice to the cabinet at least two (2) days before the machine enters the state. The notice shall include the type of radiation machine; the name of the individual in charge; the nature, duration, and scope of use; and the exact location where the radiation machine is to be used. If for a specific case the two (2) day period imposes an undue hardship on the person, he may, upon application to the cabinet, obtain permission to proceed sooner. In addition, the out-of-state person shall:

      (a) Comply with applicable administrative regulations of the cabinet; and

      (b) Supply the cabinet with other information as the cabinet may reasonably request.

      (7) No radiation producing machines shall be operated without a valid registration as stipulated in these administrative regulations.

 

      Section 4. Vendor Obligation. (1) The distributor, retailer or other agent who sells, leases, transfers, lends, or installs radiation producing machines shall apply for registration of these services with the cabinet within thirty (30) days following the effective date of these administrative regulations or, thereafter, prior to furnishing or offering to furnish these services. Registration under this section shall contain the following information and other information as may be required:

      (a) Name and address of the person having responsibility for the business' operations.

      (b) Name and address of the business' operation if different from paragraph (a) of this subsection.

      (c) Designation of the categories of equipment in which the business deals (dental, medical, industrial or other).

      (d) Date of application and signature.

      (2) Vendor registration certificates shall expire on the last day of the month, one (1) year after the date of issuance.

      (3) Vendor registration renewals shall be submitted to the cabinet within forty-five (45) days of the renewal notification date.

      (4) The vendor shall notify the cabinet within thirty (30) days of a change which would render the information contained in the application for registration no longer accurate. A change of ownership of the business shall terminate the registration.

      (5) Vendor services shall not be rendered without a valid registration as stipulated in these administrative regulations.

      (6) Vendor services shall only be rendered at a preregistered or registered facility.

      (7) No vendor in an advertisement shall refer to the fact that his business is registered with the cabinet and no vendor shall state or imply that an activity under his registration has been approved by the cabinet.

      (8) The vendor shall be subject to applicable requirements of these administrative regulations.

      (9) The vendor shall notify the cabinet within fifteen (15) days after the end of each month of:

      (a) The names and addresses of persons who have received these machines;

      (b) The manufacturer, model, and serial number of each machine transferred;

      (c) The date which the machine(s) were sold, leased, transferred, or loaned; and

      (d) The preregistration or registration number of persons who have received these machines.

      (10) No vendor or person shall make, sell, lease, transfer, lend or install x-ray equipment or the supplies used in connection with the equipment unless the supplies and equipment, if placed in operation and used, shall meet the requirements of these administrative regulations.

 

      Section 5. Exemptions. (1) No person shall be required to register due to the ownership or possession of the following:

      (a) Electronic equipment that produces radiation incidental to its operation for other purposes provided the dose equivalent rate averaged over an area of ten (10) square centimeters does not exceed five-tenths (0.5) mrem per hour at five (5) cm from an accessible surface of the equipment. The production, testing, or factory servicing of such equipment shall not be exempt.

      (b) Radiation producing machines while in transit or storage incident thereto.

      (2) Domestic television receivers are exempt from the requirements of this administrative regulation.

      (3) No registrant, or his estate, shall be required to comply with the provisions of Section 4 of this administrative regulation except Section 4(10) of this administrative regulation if the radiation producing machines had been previously obtained for his sole use.

 

      Section 6. Radiation Safety Officer. (1) The registrant or his duly authorized representative shall designate a radiation safety officer or may personally assume the radiation safety responsibility.

      (2) The person responsible for radiation safety shall:

      (a) Be qualified by training and experience to assume the responsibilities of appraising himself of all hazards and precautions involved in handling the radiation machine(s) for which he is responsible.

      (b) Give instructions concerning hazards and safety practices to persons who may be occupationally exposed to radiation.

      (c) Provide reasonable assurance that other provisions as required by these administrative regulations are carried out. (1 Ky.R. 411; eff. 2-5-75; Am. 12 Ky.R. 1391; eff. 3-4-86; Am. 18 Ky.R. 1544; eff. 1-10-92.)