HAR §11-45-27. Assembly and transfer

(a) No radiation machines shall be assembled or installed in a facility which does not have a current license. (b) No source of radiation shall be transferred to a facility which does not have a current license. (c) No person shall manufacture, sell, lease, transfer, lend, assemble, or install one or more components of radiation machines or the supplies used in connection with such machines without having a current license. Radiation machines and supplies when properly placed in operation and used shall meet the requirements of this chapter. (d) Any person who sells, leases, transfers, lends, disposes, assembles, or installs one or more components of radiation machines in this State shall notify the department within fifteen days of: (1) The name and address of persons who have received these machines; (2) The manufacturer, model, and serial number of the control assembly of each radiation machine transferred; and (3) The date of transfer of one or more radiation machine components. (e) The following items are exempt from the requirements specified in subsection (d): (1) Reloaded or replacement tube housing assemblies that are reinstalled in or newly assembled into an existing x-ray system; (2) Certified accessory components that have been identified as such to the U.S. Department of Health and Human Services; (3) Repaired components, whether or not removed from the system and reinstalled during the course of repair, provided the original installation into the x-ray system was reported; or (4) Components installed temporarily in an x-ray system in place of components removed temporarily for repair, provided the temporarily installed component is identified by a tag or label bearing the following information: "Temporarily Installed Component This certified component has been assembled, installed, adjusted, and tested by me according to the instructions provided by the manufacturer. §11-45-27 45-46 Signature Company Name Street Address, P.O. Box City, State, Zip Code Date of Installation" The replacement of the temporarily installed component by a component other than the component originally removed for repair shall be reported as specified by subsection (d). (f) In the case of diagnostic x-ray systems which contain one or more certified components, a copy of the assembler's report prepared in compliance with requirements of the federal diagnostic x-ray standard, 21 C.F.R. §1020.30(d), shall be submitted to the department within fifteen days following completion of the assembly. Such report shall suffice in lieu of any other report by the assembler. [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71)