Section 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;(iii) Mathematics pertaining to the use and measurement of radioactivity; and(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.(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)