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

This chapter sets minimum standards for all persons and facilities who receive, possess, use, transfer, own, or acquire any source of radiation, all persons who install and service sources of radiation, and all persons who provide radiation services. Notes Haw. Code R. § 11-45-1 …

Notes Haw. Code R. § 11-45-10

X-ray systems shall be physically secured to prevent tampering or removal by unauthorized personnel. Notes Haw. Code R. § 11-45-100 [Eff 11/12/99] (Auth: HRS §§ 321-10, 321-11, 321-71) (Imp: HRS §§ 321-1, 321-11(21), 321-71)

(a) The licensee shall maintain sufficient calibrated and operable radiation survey instruments to make physical radiation surveys as required by this subchapter and subchapter 4. Instrumentation required by this section shall have a range such that two milliroentgens (5.16 x 10-…

Each licensee shall maintain current logs which shall be kept available for inspection by the department for three years, showing for each x-ray system the following information: (1) A unique identification, such as a serial number, of each x-ray system; (2) The identity of the r…

(a) Each licensee shall ensure that checks are made for obvious defects in x-ray systems before use each day. (b) Each licensee shall conduct a program of at least quarterly inspection and maintenance of x-ray systems to assure proper functioning of components important to safety…

Permanent radiographic installations having high radiation area entrance controls of the type described in subchapter 4 shall also meet the following requirements: (1) Each entrance that is used for personnel access to the high radiation area shall have both visible and audible w…

Notes Haw. Code R. § 11-45-105

(a) No licensee shall permit any individual to act as a radiographer trainee unless such individual has received copies of, instructions in, and has demonstrated an understanding of: (1) The subjects outlined in Appendix A of this subchapter; (2) This subchapter and subchapter 4;…

The licensee's operating and emergency procedures shall include instructions in at least the following: (1) Handling and use of sources of radiation to be employed such that no individual is likely to be exposed to radiation doses in excess of the limits established in subchapter…

(a) The licensee shall not permit any individual to act as a radiographer or as a radiographer trainee unless, at all times during radiographic operations, the individual wears a direct reading pocket dosimeter, an alarm ratemeter, and either a film badge or a thermoluminescent d…

During each radiographic operation, the radiographer, radiographer instructor or radiographer trainee shall maintain a direct surveillance of the operation to protect against unauthorized entry into a high radiation area, as defined in subchapter 1, except: (1) Where the high rad…

(a) The following sources of radiation shall not be used: (1) A hand-held fluoroscopic screen using x-ray equipment unless it has been listed in the Registry of Sealed Source and Devices or accepted for certification by the U.S. Department of Health and Human Services. (2) A dire…

Areas in which radiography is being performed shall be conspicuously posted as required by subchapter 4. Notes Haw. Code R. § 11-45-110 [Eff 11/12/99] (Auth: HRS §§ 321-10, 321-11, 321-71) (Imp: HRS §§ 321-1, 321-11(21), 321-71)

(a) No radiographic operation shall be conducted unless calibrated and operable radiation survey instrumentation is available and used at each site where radiographic exposures are made. (b) A physical radiation survey shall be made after each radiographic exposure to determine t…

Each licensee conducting industrial radiography at a temporary jobsite shall have the following records available at that site for inspection by the department for three years: (1) Copy of license; (2) Operating and emergency procedures; (3) Chapter 11-45; (4) Survey records purs…

(a) At a jobsite, the following shall be supplied by the licensee: (1) At least one operable, calibrated survey instrument; (2) A current whole body personnel monitor (TLD or film badge) for each individual; (3) An operable, calibrated pocket dosimeter with a range of zero to two…

(a) Systems for cabinet radiography designed to allow admittance of individuals shall: (1) Comply with all applicable requirements of this subchapter and subchapter 4. If such a system is a certified cabinet x-ray system, it shall comply with all applicable requirements of this s…

This subchapter establishes requirements for use of x-ray equipment in the healing arts. The requirements of this subchapter are in addition to, and not in substitution for, other applicable requirements of this chapter. Notes Haw. Code R. § 11-45-115 [Eff 11/12/99] (Auth: HRS §§…

(a) The licensee shall be responsible for directing the operation of the x-ray system(s) under the licensee's administrative control. The licensee or the licensee's agent shall assure that the requirements of this subchapter are met in the operation of the x-ray system(s). (1) An…

(a) The control panel containing the main power switch shall bear the warning statement, legible and accessible to view: "WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed." (b) On battery-powere…

(a) All fluoroscopic x-ray systems shall be image intensified or used in conjunction with a digital imaging system. (b) The useful beam shall be limited as follows: (1) Primary barrier: (A) The fluoroscopic imaging assembly shall be provided with a primary protective barrier whic…

(a) The useful beam shall be limited to the area of clinical interest. This shall be deemed to have been met if a positive beam limiting device has been properly used or if evidence of collimation is shown on at least three sides or three corners of the film, (e.g., projections f…

Notes Haw. Code R. § 11-45-12

(a) X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit source-to-skin distance to not less than eighteen centimeters. (b) Radiographic systems designed for use with an intraoral image receptor shall be provided with means to limi…

(a) General requirements: (1) Means shall be provided to terminate the x-ray exposure automatically by either de-energizing the x-ray source or shuttering the x-ray beam in the event of equipment failure affecting data collection. Such termination shall occur within an interval t…

(a) Only systems certified by the U.S. Department of Health and Human Services shall be utilized for healing arts purposes. (b) System performance shall be maintained in accordance with all performance standards specified by the U.S. Department of Health and Human Services. (c) O…

Notes Haw. Code R. § 11-45-123

Notes Haw. Code R. § 11-45-124

(a) Only x-ray systems, pursuant to the Mammography Quality Standards Act of 1992, Public Law 102-539, 42 U.S.C. 263 b, and 21 C.F.R. Part 900, shall be used for screening and diagnostic mammography. (b) A facility performing mammography shall have a valid certificate issued by t…

This subchapter establishes requirements for the receipt, possession, production, preparation, compounding, use, and transfer of radionuclides in the healing arts. The requirements of this subchapter are in addition to, and not in substitution for, other requirements in this chap…

Radionuclides 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. § 11-45-127 [Eff 11/12/99] (Auth: HRS ??321-10, 321-11, 321-71) (Imp…

A licensee shall notify the department in writing within thirty days when an authorized user, radiation safety officer, or qualified medical physicist, permanently discontinues performance of duties. Notes Haw. Code R. § 11-45-128 [Eff 11/12/99] (Auth: HRS §§ 321-10, 321-11, 321-…

(a) Each licensee shall develop and implement a written program to maintain radiation doses and releases of radioactive material in effluents to unrestricted areas as low as reasonably achievable. (b) To satisfy the requirement of subsection (a): (1) The management, radiation saf…

(a) As used in these rules, the unit of exposure is the coulomb per kilogram (C/kg). One roentgen is equal to 2.58 x 10-4 coulomb per kilogram of air. (b) As used in these rules, the units of dose are: (1) Gray (Gy) is the SI unit of absorbed dose. One gray is equal to an absorbe…

(a) A licensee shall appoint a radiation safety officer responsible for implementing the radiation safety program. The licensee, through the radiation safety officer, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regu…

(a) Each medical institution licensee shall establish a radiation safety committee to oversee the use of radioactive material. (b) The committee shall meet the following administrative requirements: (1) Membership shall consist of at least three individuals and shall include an a…

(a) A licensee shall provide sufficient authority and organizational freedom to the radiation safety officer and the radiation safety committee to: (1) Identify radiation safety problems; (2) Initiate, recommend, or provide solutions; and (3) Verify implementation of corrective a…

(a) A licensee who allows the receipt, possession, production, preparation, compounding, use, or transfer of radioactive material by an individual under the supervision of an authorized user shall: (1) Instruct the supervised individual in the principles of radiation safety appro…

(a) A licensee may permit any visiting authorized user to use radioactive materials for medical use for sixty days each year if: (1) The visiting authorized user has the prior written permission of the licensee's management and, if the use occurs on behalf of an institution, the …

(a) The mobile nuclear medicine service shall be licensed if the service receives, uses, or possesses radioactive material. The client of the mobile nuclear medicine service shall be licensed if the client receives or possesses radioactive material to be used by a mobile nuclear …

(a) Each licensee shall establish and maintain a written program to provide assurance that radioactive material or radiation therefrom is administered to humans as directed by the authorized user. The program shall include procedures for: (1) Preparing written directives for the …

(a) The following actions shall be taken for a misadministration by the licensee: (1) The licensee shall notify the department by telephone no later than twenty-four hours after discovery of the misadministration. (2) The licensee shall submit a written report to the department w…

A licensee shall use for medical use only: (1) Radioactive material manufactured, produced, labeled, prepared, compounded, packaged, and distributed pursuant to these rules or the equivalent regulations of an agreement state or the U.S. Nuclear Regulatory Commission; and (2) Reag…

Each licensee shall establish written quality control procedures for all diagnostic equipment used for radionuclide studies. As a minimum, quality control procedures and frequencies shall be those recommended by equipment manufacturers and procedures which have been approved by t…

For purposes of these rules, activity is expressed in the SI unit of becquerel (Bq) or in the special unit of curie (Ci), or their multiples, or disintegrations or transformations per unit of time: (1) One becquerel (Bq) = one disintegration or transformation per second (s-1). (2…

(a) A medical use licensee authorized to administer radiopharmaceuticals shall possess a dose calibrator and use it to measure the amount of activity administered to each patient. In the case where the ionization type dose calibrator cannot be used effectively to verify administe…

(a) A licensee shall ensure that the survey instruments used to show compliance with this part have been calibrated before first use, annually, and following repair. (b) To satisfy the requirements of subsection (a), the licensee shall: (1) Calibrate all required scale readings u…

(a) An assay shall be conducted, before medical use, of the activity of each radiopharmaceutical dosage that contains more than ten microcuries (three hundred seventy kilobecquerels) of a photon-emitting radionuclide; (b) Radiopharmaceuticals emitting alpha and/or beta radiations…

A licensee for medical use of radioactive material may receive, possess, and use the following radioactive material for check, calibration and reference use: (1) Sealed sources manufactured and distributed by persons specifically licensed pursuant to these rules or provisions of …