Ohio Admin. Code 3701:1-67-02

Current through all regulations passed and filed through October 28, 2024

Section 3701:1-67-02 - General administrative requirements

(A) The handler shall be responsible for directing the operation of the therapy equipmentto ensure that the requirements of Chapter 3701:1-67 of the Administrative Code are met .

(B) The handler shall not use therapy equipment that does not meet the provisions of Chapter 3701:1-67 of the Administrative Code to irradiate patients.

(C) For any therapy equipment subject to Chapter 3701:1-67 of the Administrative Code, the handler shall require the physician or veterinarian who authorizes use of the therapy equipment to be:

(1) Certified in one of the following:

(a) Radiation oncology or therapeutic radiology by the "American Board of Radiology" or combined diagnostic and therapeutic radiology program by the "American Board of Radiology" prior to 1976; 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

(e) Radiation oncology by the "American College of Veterinary Radiology"; or

(2) In 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 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 ionization radiation; and

(iv) Radiation biology.

(b) To satisfy the requirement for supervised work experience, training shall be under the supervision of a board certified authorized user who meets the qualifications of paragraph (C)(1) of this rule, and shall include:

(i) Review of the calibration measurements and quality assurance performance testing;

(ii) Evaluation of prepared treatment plans and calculation of treatment times/patient treatment settings;

(iii) Using administrative controls to prevent medical events;

(iv) Implementing emergency procedures to be followed in the event of the abnormal operation of an 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 and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user.

(i) The one year in a formal training program must be approved by either:

(a) The "Residency Review Committee" for "Radiology of the Accreditation Council for Graduate Medical Education"; or

(b) The "Committee on Postdoctoral Training" of the "American Osteopathic Association."

(ii) The additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user shall include:

(a) Examining patients and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and any limitations or contraindications;

(b) Selecting proper dose and how it is to be administered;

(c) Calculating the therapy equipment doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses and treatment plans as warranted by patients' reaction to radiation; and

(d) Post-administration follow-up and review of case histories.

(d) For veterinary radiation oncology, completion of a formal training program approved by the "Executive Council" of the "American College of Veterinary Radiology" shall satisfy the requirement for supervised clinical experience.

(D) For any therapy equipment subject to Chapter 3701:1-67 of the Administrative Code, the handler shall require the qualified medical physicist to:

(1) Be certified by the "American Board of Radiology" in one of the following:

(a) Therapeutic radiological physics;

(b) Roentgen-ray and gamma-ray physics;

(c) X-ray and radium physics;

(d) Radiological physics; or

(2) Be certified by the "American Board of Medical Physics in Radiation Oncology Physics"; or

(3) Be certified by the "Canadian College of Medical Physics"; or

(4) Meet all of the following:

(a) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;

(b) Have completed one year of full time training in medical physics and an additional year of full time work experience under the supervision of a board certified medical physicist who meets the qualifications of paragraph (D)(1), (D)(2) or (D)(3) of this rule at a medical institution;

(i) This training and work experience shall be conducted in clinical radiation facilities that provide high-energy external beam radiation therapy with photons and electrons with energies greater than or equal to one MV or one MeV; and

(ii) The individual shall have performed the tasks listed in rules 3701:1-67-08 and 3701:1-67-09 of the Administrative Code under the supervision of a qualified medical physicist during the year of work experience; and

(c) Obtain certification pursuant to paragraph (D)(1), (D)(2), or (D)(3) of this rule within five years of qualifying under paragraph (D)(4) of this rule.

(E) For any therapy equipment subject to Chapter 3701:1-67 of the Administrative Code, the handler shall require:

(1) Every individual who performs radiation therapy procedures on human beings holds a valid radiation therapist license as required by Chapter 3701-72 of the Administrative Code;

(2) Every individual who performs radiation therapy procedures is adequately instructed in the handler's safe operating procedures and can demonstrate competency in the safe use of the equipment; and

(3) The names and training of all personnel currently operating the therapy equipment shall be kept on file at the facility. The names and training of former operators shall be retained for a period of at least three years beyond the last date they were authorized to operate the therapy equipment at that facility.

(F) The handler's written safe operating procedures shall be developed by a qualified medical physicist to include any operation restrictions for the therapy equipment. The written safe operating procedures shall be available in the control area of the therapy equipment, in hard copy or electronic format, and the operator shall be able to demonstrate familiarity with these procedures. The written safe operating procedures shall address at least the following :

(1) The therapy equipment shall not be used for irradiation of patients unless the applicable requirements of rule 3701:1-67-09 of the Administrative Code have been met;

(2) Therapy equipment shall not be left unattended unless secured to prevent unauthorized use;

(3) When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used;

(4) When only adjustable beam limiting devices are used for patient positioning purposes, the position and shape of the radiation field shall be indicated by a light field. The therapy equipment shall not be used for irradiation of patients unless the light field is operational;

(5) The therapy equipment shall not be used for patient irradiation unless at least one viewing system is operational;

(6) The therapy equipment shall not be used for irradiation of patients unless continuous two-way aural communication is possible;

(7) The equipment shall only be operated as designed by the manufacturer;

(8) No individual other than the patient shall be in the treatment room during treatment or during any irradiation for testing or calibration purposes from therapy equipment operating above one hundred fifty kV. At energies less than or equal to one hundred fifty kV, any individual, other than the patient, in the treatment room shall be protected by a barrier sufficient to meet the requirements of rule 3701:1-38-12 of the Administrative Code; and

(9) For equipment operating at less than one megavolt (MV), the tube housing assembly shall not be held by an individual during operation unless the assembly is designed to require such holding and the peak tube potential of the system does not exceed fifty kV. In such cases, the holder shall wear protective gloves and an apron of not less than 0.5 millimeters lead equivalency at one hundred kV.

(10) How to contact the qualified medical physicist for problems or emergencies, as well as the specific actions, if any, to be taken until the qualified medical physicist can be contacted.

(G) An individual shall not expose another individual to the useful beam unless ordered by a licensed practitioner acting within his or her scope-of-practice for dental, medical or radiation therapy purposes. Exposing an individual for training, demonstration or other purposes is prohibited unless otherwise specified in rules promulgated under Chapter 4773. or 3748. of the Revised Code.

(H) All individuals associated with the operation of therapy equipment shall be instructed in and shall comply with the provisions of the handler's quality management program. In addition to the requirements in Chapter 3701:1-67 of the Administrative Code, these individuals are also subject to the applicable requirements in Chapter 3701:1-38 and rule 3701:1-66-04 of the Administrative Code.

(I) The handler shall assure the individual responsible for radiation protection (IRRP) is qualified as one of the following:

(1) Ohio licensed to operate radiation-generating equipment excluding general x-ray machine operators;

(2) Registered veterinary technician and trained to operate veterinary radiationgenerating equipment;

(3) Certified by the American registry of radiologic technologists in a pathway involving ionizing radiation or certified by the nuclear medicine technologist certification board;

(4) A radiation expert as defined in rule 3701:1-66-01 of the Administrative Code;

(5) A health physicist certified by the American board of health physics; or

(6) An associate's degree or higher in health physics, radiologic science, nuclear medicine or nuclear engineering.

(J) The handler shall maintain the following information in a separate file or package for each piece of therapy equipment, for inspection by the department:

(1) Report of acceptance testing;

(2) Records of all surveys, calibrations, and quality assurance performance testing of the therapeutic radiation machine required by Chapter 3701:1-67 of the Administrative Code, as well as the names of people who performed such activities;

(3) Records of maintenance and/or modifications performed on each piece of therapy equipment, as well as the names of people who performed such services;

(4) Name and signature of the qualified medical physicist or authorized individual, as delineated in the quality assurance manual, authorizing the return of the therapy equipment to clinical use after any service or intervention that significantly affects patient treatment.

(K) The director may, upon application thereof or upon his or her own initiative, grant a variance to the requirements of this chapter as he or she determines is authorized by law, provided that the handler shows to the satisfaction of the director that there is good cause for the variance, and that the variance shall not result in any undue hazard or effect on the public health and safety. The terms, conditions, and expiration of the variance shall be set forth in writing by the director. Failure to comply with the terms of the variance may result in immediate revocation of the variance.

Ohio Admin. Code 3701:1-67-02

Effective: 9/1/2022
Five Year Review (FYR) Dates: 6/1/2022 and 08/15/2027
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.01, 3748.02, 3748.04, 3748.05, 3748.06, 3748.07, 3748.12, 3748.121, 3748.13, 3748.14, 3748.15, 3748.17, 3748.18, 3748.19, 3748.20, 3748.22, 3748.99
Prior Effective Dates: 02/15/2001, 09/01/2005, 01/14/2011, 06/01/2013, 03/01/2016