HAR 11-45 — RADIATION CONTROL (Subchapter 1 to 14)

(a) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer or equivalent instructions approved by the department and shall maintain the instructions for the duration of source …

(a) A licensee shall keep syringes that contain radioactive material to be administered in a radiation shield. (b) A licensee shall require each individual who prepares or administers radiopharmaceuticals to use a syringe radiation shield unless the use of the shield is contraind…

Unless utilized immediately, a licensee shall conspicuously label each syringe, or syringe radiation shield as to contents or intended patient. Notes Haw. Code R. § 11-45-146 [Eff 11/12/99] (Auth: HRS §§ 321-10, 321-11, 321-71) (Imp: HRS §§ 321-1, 321-11(21), 321-71)

A licensee shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield. Notes Haw. Code R. § 11-45-147 [Eff 11/12/99] (Auth: HRS §§ 321-10, 321-11, 321-71) (Imp: HRS §§ 321-1, 321-11(21), 321-71)…

A licensee shall conspicuously label each vial radiation shield that contains a vial of a radiopharmaceutical with the radiopharmaceutical name or its abbreviation. Notes Haw. Code R. § 11-45-148 [Eff 11/12/99] (Auth: HRS §§ 321-10, 321-11, 321-71) (Imp: HRS §§ 321-1, 321-11(21),…

(a) A licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered. (b) A licensee shall survey with a radiation detection survey instrument at least once each …

Any person who violates any provisions of this chapter is subject to the penalties pursuant to § 321-18, HRS, the remedies pursuant to § 321-20, HRS, and injunctions pursuant to § 603-23, HRS. Notes Haw. Code R. § 11-45-15 [Eff 11/12/99] (Auth: HRS §§ 321-10, 321-11, 321-71) (Imp…

A licensee shall not authorize release from confinement for medical care any patient administered a radiopharmaceutical or administered a permanent implant until the dose rate from the patient at the time of release shall not result in a total effective dose equivalent exceeding …

A licensee providing mobile nuclear medicine service shall: (1) Transport to each address of use only syringes or vials containing prepared radiopharmaceuticals or radiopharmaceuticals that are intended for reconstitution of radiopharmaceutical kits; (2) Bring into each area of u…

(a) A licensee shall store volatile radiopharmaceuticals and radioactive gases in the shippers' radiation shield and container. (b) A licensee shall store and use a multidose container in a properly functioning fume hood. Notes Haw. Code R. § 11-45-152 [Eff 11/12/99] (Auth: HRS §…

(a) A licensee shall hold radioactive material for decay-in-storage before disposal in ordinary trash and is exempt from the waste disposal requirements of subchapter 4 if the licensee: (1) Holds radioactive material for decay a minimum of ten half-lives; (2) Monitors radioactive…

Notes Haw. Code R. § 11-45-154

(a) A licensee may use any radioactive material in a radiopharmaceutical for a diagnostic use involving measurements of uptake, dilution, or excretion; (1) Which has been granted acceptance or approval by the U.S. Department of Health and Human Services; or (2) Which is prepared …

(a) A licensee may use any radioactive material in a non-gaseous or non-aerosol diagnostic radiopharmaceutical or any generator or reagent kit for preparation and diagnostic use of a non-gaseous or non-aerosol radiopharmaceutical containing radioactive material: (1) Which has bee…

(a) A licensee may use any radioactive material in a radiopharmaceutical and for a therapeutic use: (1) Which has been granted acceptance or approval by the U.S. Department of Health and Human Services; or (2) Which has been prepared and compounded in accordance with chapter 16-9…

A licensee authorized to use radioactive material as a sealed source for diagnostic purposes shall have available for use a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem (one microsievert) per hour to fifty millirems (f…

(a) A licensee shall use radioactive sources in accordance with the manufacturer's radiation safety and handling instructions. (b) Safety instruction. (1) The licensee shall provide oral and written radiation safety instruction to all personnel caring for a patient receiving impl…

If any provisions of this chapter, or its application to any person or circumstances, is held invalid, the application of such provision to other persons or circumstances, and the remainder of this chapter, shall not be affected thereby. Notes Haw. Code R. § 11-45-16 [Eff 11/12/9…

Notes Haw. Code R. § 11-45-160

Notes Haw. Code R. § 11-45-161

Notes Haw. Code R. § 11-45-162

Notes Haw. Code R. § 11-45-163

Notes Haw. Code R. § 11-45-164

An individual fulfilling the responsibilities of the radiation safety officer shall: (1) Be certified by the: (A) American Board of Health Physics in Comprehensive Health Physics; or (B) American Board of Radiology in Radiological Physics, Therapeutic Radiological Physics, or Med…

An individual identified as a radiation safety officer on a license, or a U.S. Nuclear Regulatory Commission license on the effective date of this chapter who oversees only the use of radioactive material for which the licensee was authorized on that date need not comply with the…

Except as provided in sections 11-45-169 and 11-45-170, the licensee shall require the authorized user of a radiopharmaceutical listed in section 11-45-155 to be a physician who: (1) Is certified in: (A) Nuclear medicine by the American Board of Nuclear Medicine; or (B) Diagnosti…

Except as provided in sections 11-45-169 and 11-45-170, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit specified in section 11-45-156 to be a physician who: (1) Is certified in: (A) Nuclear medicine by the American Board of Nucl…

Practitioners of the healing arts identified as authorized users for the human use of radioactive material on an agreement state license, or U.S. Nuclear Regulatory Commission license on the effective date of this chapter who perform only those methods of use for which they were …

(a) This subchapter establishes requirements for the licensing of sources of radiation, the licensing of persons providing radiation services, and the licensing of persons transporting or delivering radioactive material to a carrier for transport. (b) In addition to the requireme…

A physician who, before July 1, 1984, began a three-month nuclear medicine training program approved by the Accreditation Council for Graduate Medical Education and has successfully completed the program, is exempted from the requirements of sections 11-45-167 or 11-45-168. Notes…

The training and experience specified in sections 11-45-165 through 11-45-168 shall have been obtained within the five years preceding the date of application or the individual shall have had continuing applicable experience since the required training and experience was complete…

This subchapter provides requirements for analytical x-ray equipment (x-ray diffraction and fluorescence analysis). The requirements of this subchapter are in addition to, and not in substitution for, other applicable requirements in this chapter. Notes Haw. Code R. § 11-45-172 […

Equipment utilizing sources of radiation licensed by the U.S. Nuclear Regulatory Commission are exempt from the requirements of this subchapter to the extent they are regulated by the U.S. Nuclear Regulatory Commission. Notes Haw. Code R. § 11-45-173 [Eff 11/12/99] (Auth: HRS §§ …

(a) A safety device which prevents the entry of any portion of an individual's body into the primary x-ray beam path or which causes the beam to be shut off upon entry into its path shall be provided on all open-beam configurations. A licensee may apply to the department for an e…

(a) The local components of an analytical x-ray system shall be located and arranged and shall include sufficient shielding or access control such that no radiation levels exist in any area surrounding the local component group which could result in a dose to an individual presen…

(a) Normal operating procedures shall be written and available to all analytical x-ray equipment workers. No individual shall be permitted to operate analytical x-ray equipment in any manner other than that specified in the procedures unless such individual has obtained written a…

(a) No individual shall be permitted to operate or maintain analytical x-ray equipment unless such individual has received instruction in and demonstrated competence as to: (1) Identification of radiation hazards associated with the use of the equipment; (2) Significance of the v…

(a) This subchapter establishes requirements for the non-healing arts use of particle accelerators. The requirements of this subchapter are in addition to, and not in substitution for, other applicable requirements in this chapter. Notes Haw. Code R. § 11-45-178 [Eff 11/12/99] (A…

(a) The licensee shall be qualified by reason of training and experience to use the accelerator in such a manner as to minimize danger to public health and safety or property. (b) The licensee's equipment, facilities, and operating and emergency procedures shall be adequate to pr…

(a) The following radiation machines are exempt from the requirements of this subchapter: (1) Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the license and notification requirements of this subchapter, provided that the…

Notes Haw. Code R. § 11-45-180

(a) No licensee shall permit an individual to act as an operator of a particle accelerator until such individual: (1) Has been instructed in radiation safety and has demonstrated an understanding thereof; (2) Has received copies of and instruction in this subchapter and the appli…

(a) A qualified health or medical physicist shall be consulted in the design of a particle accelerator installation and called upon to perform a radiation survey when the accelerator is first capable of producing radiation. (b) Each particle accelerator installation shall be prov…

(a) Instrumentation, readouts, and controls on the particle accelerator control console shall be clearly identified and easily discernible. (b) Each entrance into a target room or other high radiation area shall be provided with a safety interlock that shuts down the accelerator …

(a) Each location designated as high radiation area, and each entrance to such location, shall be equipped with easily observable warning lights that operate when, and only when, radiation is being produced. (b) Except in facilities designed for human exposure, each high radiatio…

(a) Particle accelerators, when not in operation, shall be secured to prevent unauthorized use. (b) The safety interlock system shall not be used to turn off the accelerator beam except in an emergency. (c) All safety and warning devices, including interlocks, shall be checked fo…

(a) There shall be available at each particle accelerator facility appropriate portable monitoring equipment which is operable and has been appropriately calibrated for the radiation being produced at the facility. Such equipment shall be tested for proper operation daily and cal…

(a) Ventilation systems shall be provided to ensure that personnel entering any area where airborne radioactivity may be produced shall not be exposed to airborne radioactive material in excess of those limits specified in subchapter 4. (b) A licensee shall not vent, release, or …

This subchapter establishes requirements for notices, instructions, and reports by licensees to individuals engaged in activities under a license and options available to such individuals in connection with department inspections of licensees to ascertain compliance with this cha…

(a) Each licensee shall post current copies of the following documents: (1) This subchapter and subchapter 4; (2) License and documents incorporated into the license by reference and amendments thereto; (3) The operating procedures applicable to activities under the license; and …