HAR §11-45-232. Purpose and scope

This subchapter establishes requirements for the use of therapeutic radiation machines. The requirements of this subchapter are in addition to, and not in substitution for, other applicable requirements of this chapter. [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71) §11-45-233 General administrative requirements for facilities using therapeutic radiation machines. (a) The licensee shall be responsible for directing the operation of the therapeutic radiation machine. The licensee or the licensee's agent shall ensure that the requirements of this subchapter are met in the operation of the therapeutic radiation machine(s). (b) A therapeutic radiation machine which does not meet the provisions of this subchapter shall not be used for irradiation of patients. (c) The licensee for any therapeutic radiation machine subject to section 11-45-236 or section 11-45-238 shall require the authorized user to be a physician who: (1) Is certified in: (A) Radiology or therapeutic radiology by the American Board of Radiology; or (B) Radiation oncology by the American Osteopathic Board of Radiology; or (C) Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or (D) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or (2) Is in the active practice of therapeutic radiology, and has completed two hundred hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit, five hundred hours of supervised work experience, and a minimum of three years of supervised clinical experience. (A) To satisfy the requirement for instruction, the classroom and laboratory training shall include: (i) Radiation physics and instrumentation; (ii) Radiation protection; §11-45-233 45-166 (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology. (B) To satisfy the requirement for supervised work experience, training shall be under the supervision of an authorized user and shall include: (i) Review of the full calibration measurements and periodic quality assurance checks; (ii) Preparing treatment plans and calculating treatment times; (iii) Using administrative controls to prevent misadministrations; (iv) Implementing emergency procedures to be followed in the event of the abnormal operation of a external beam radiation therapy unit or console; and (v) Checking and using radiation survey meters. (C) To satisfy the requirement for a period of supervised clinical experience, training shall include one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user. The supervised clinical experience shall include: (i) Examining individuals and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and any limitations/contraindications; (ii) Selecting proper dose and how it is to be administered; (iii) Calculating the external beam radiation therapy doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses as warranted by patients' reaction to radiation; and (iv) Post-administration follow-up and review of case histories. (3) Notwithstanding the requirements of subparagraphs (A) and (B), the licensee for any therapeutic radiation machine less than five hundred kilovolts may also submit the training of the prospective authorized user physician for department review on a case-by-case basis. §11-45-233 45-167 (4) A physician shall not act as an authorized user for any therapeutic radiation machine until such time as said physician's training has been reviewed and approved by the department. (d) The licensee for any photon therapy systems (five hundred kilovolts and above) and electron therapy systems (five hundred kilo electron volts and above) shall utilize the services of a qualified medical physicist in radiation therapy. (e) Individuals operating a therapeutic radiation machine and practicing radiation therapy technology shall be licensed under chapter 11-44. (f) Written safety procedures shall be developed by a qualified medical physicist and shall be available at the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine. The operator shall be able to demonstrate familiarity with these rules. (g) Individuals shall not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing by a licensed practitioner of the healing arts facility. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing arts purposes. (h) Notwithstanding the provisions of subsection (c), a licensee may permit any physician to act as a visiting authorized user for up to sixty days per calendar year under the following conditions: (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 institution's radiation safety committee; and (2) The visiting authorized user meets the requirements established for authorized user(s) in subsection (c). (i) All individuals associated with the operation of a therapeutic radiation machine shall be instructed in and shall comply with the provisions of the licensee's quality management program. (j) The licensee shall maintain the following information in a separate file or package for each therapeutic radiation machine: (1) Report of acceptance testing; (2) Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by this subchapter, as well as the name(s) of person(s) who performed such activities; (3) Records of major maintenance and/or modifications performed on the therapeutic radiation machine after the effective date of this chapter, as well as the name(s) of person(s) who performed such services; (4) Signature of person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade. [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71) §11-45-234 45-168 §11-45-234 General technical requirements for facilities using therapeutic radiation machines. (a) Protection surveys. (1) The licensee shall ensure that radiation protection surveys of all new facilities, and existing facilities not previously surveyed are performed with an operable radiation measurement survey instrument calibrated in accordance with this subchapter. The radiation protection survey shall be performed by, or under the direction of, a qualified medical physicist and shall verify that, with the therapeutic radiation machine in a "BEAM-ON" condition, with the largest clinically available treatment field and with a scattering phantom in the useful beam of radiation: (A) Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in subchapter 4; and (B) Radiation levels in unrestricted areas do not exceed the limits specified in subchapter 4. (2) In addition to the requirements of paragraph (1), a radiation protection survey shall also be performed before any subsequent medical use and: (A) After making any change in the treatment room shielding; (B) After making any change in the location of the therapeutic radiation machine within the treatment room; (C) After relocating the therapeutic radiation machine; or (D) Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room. (3) The survey record shall indicate all instances where the facility, in the opinion of the qualified medical physicist, is in violation of applicable chapters. The survey record shall also include the date of the measurements, the reason the survey is required, the manufacturer's name, model number and serial number of the therapeutic radiation machine, the instrument(s) used to measure radiation levels, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in millirems (microsieverts) per hour, the calculated maximum level of radiation over a period of one week for each restricted and unrestricted area, and the signature of the individual responsible for conducting the survey; (4) If the results of the surveys required by subsection (a) indicate any radiation levels in excess of the respective limit specified in paragraph (1), the licensee shall lock the control in the "OFF" position and not use the unit; (A) Except as may be necessary to repair, replace, or test the therapeutic radiation machine, the §11-45-234 45-169 therapeutic radiation machine shielding, or the treatment room shielding; or (B) Until the licensee has received a specific exemption from the department. (b) If the survey required by subsection (a) indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by subchapter 4, before beginning the treatment program the licensee shall: (1) Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with subchapter 4; (2) Perform the survey required by subsection (a); and (3) Include in the report required by subsection (d), the results of the initial survey, a description of the modification made to comply with paragraph (1), and the results of the second survey. (c) Dosimetry equipment. (1) The licensee shall have a calibrated dosimetry system available for use. The system shall have been calibrated for Cobalt-60 by the National Institute of Standards and Technology or by an American Association of Physicists in Medicine Accredited Dosimetry Calibration Laboratory. The calibration shall have been performed within the previous twenty-four months and after any servicing that may have affected system calibration; (2) The licensee shall have available for use a dosimetry system for quality assurance check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with paragraph (1). This comparison shall have been performed within the previous twelve months (six months if the dosimetry system is an ionization chamber) and after each servicing that may have affected system calibration. The quality assurance check system may be the same system used to meet the requirement in paragraph (1); (3) The licensee shall maintain a record of each dosimetry system calibration, intercomparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record shall include the date, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by paragraphs (1) and (2), the correction factors that were determined, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison was performed by, or under the direct supervision of, a qualified medical physicist. (d) The licensee for any therapeutic radiation machine subject to section 11-45-236 or section 11-45-238 shall furnish a copy of the records required in subsections (a) and (b) to the department within thirty days following completion of the action §11-45-234 45-170 that initiated the record requirement. [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71)