General Administrative Requirements for Facilities Using Therapeutic

General Administrative Requirements for Facilities Using Therapeutic Radiation Machines. 1. Administrative Controls. The registrant shall be responsible for directing the operation of the therapeutic radiation machines which have been registered with the Agency. The registrant or the registrant's agent shall ensure that the requirements of Subchapter 15 are met in the operation of the therapeutic radiation machine(s). 2. A therapeutic radiation machine which does not meet the provisions of these regulations shall not be used for irradiation of patients. 3. Training for External Beam Radiation Therapy Authorized User. The registrant for any therapeutic radiation machine subject to 1.15.6 or 1.15.7 shall require the authorized user to be a physician who: a. Is certified in: i. Radiology or therapeutic radiology by the American Board of Radiology; ii. Radiation oncology by the American Osteopathic Board of Radiology; iii. Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or iv. Therapeutic Radiology by the Canadian Royal College of Physicians and Surgeons; or b. Is in the active practice of therapeutic radiology, and has completed 200 hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit, 500 hours of supervised work experience, and a minimum of 3 years of supervised clinical experience.To satisfy the requirement for instruction, the classroom and laboratory training shall include: i. Radiation physics and instrumentation; i Radiation protection; ii Mathematics pertaining to the use and measurement of radioactivity; and iii Radiation biology. ii. 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 an external beam radiation therapy unit or console; and v. Checking and using survey meters. iii. To satisfy the requirement for a period of supervised clinical experience, training shall include 1 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 2 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. c. Notwithstanding the requirements of 1.15.3(3)(a) and 1.15.3(3)(b), the registrant for any therapeutic radiation machine subject to 1.15.6 may also submit the training of the prospective authorized user physician for Agency review on a case-by-case basis. d. 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 Agency. 4. Training for Radiation Therapy Physicist. The registrant for any therapeutic radiation machine subject to 1.15.6 or 1.15.7 shall require the Radiation Therapy Physicist to: a. Be registered with the Agency, under the provisions of Subchapter 2 of these regulations, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units. b. Be certified by the American Board of Radiology in: i. Therapeutic radiological physics; ii. Roentgen-ray and gamma-ray physics; iii. X-ray and radium physics; or iv. Radiological physics; or c. Be certified by the American Board of Medical Physics in Radiation Oncology Physics; or d. Be certified by the Canadian College of Medical Physics; or e. Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed 1 year of full-time training in therapeutic radiological physics and also 1 year of full-time work experience under the supervision of a Radiation Therapy Physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in 1.15.4(1), 1.15.6(16), 1.15.6(17), 1.15.7(20), and 1.15.7(21) under the supervision of a Radiation Therapy Physicist during the year of work experience; or f. Hold a bachelor's degree in a physical science and have completed 1 additional year of full-time training in therapeutic radiological physics and also 2 years of full-time work experience under the supervision of a Radiation Therapy Physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in 1.15.4(1), 1.15.6(16), 1.15.6(17), 1.15.7(20), and 1.15.7(21) under the supervision of a Radiation Therapy Physicist during the 2 years of work experience. Agency review of applicants in this category will only be on a case-by-case basis and additional information may be required for the Agency to determine if the applicant is qualified to function as a Radiation Therapy Physicist. 5. Qualifications of Operators a. Individuals who will be operating a therapeutic radiation machine for medical use shall be American Registry of Radiologic Technologists (ARRT) Registered Radiation Therapy Technologists. Individuals who are not ARRT Registered Radiation Therapy Technologists shall submit evidence that they have satisfactorily completed a radiation therapy technologist training program that complies with the requirements of the Joint Review Committee on Education in Radiologic Technology. ARRT Registered Radiologic Technologists, who have been working for two years or more in radiation therapy, will be allowed three years from the effective date of these regulations to fulfill the above listed requirements.7 b. The names and training of all personnel currently operating a therapeutic radiation machine shall be kept on file at the facility. Information on former operators shall be retained for a period of 2 years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility. 6. Written safety procedures and rules shall be developed by a Radiation Therapy Physicist and shall be provided to each individual operating a therapeutic radiation machine, including any restrictions of the operating technique required for the safe 7 “Essentials and Guidelines of an Accredited Educational Program for the Radiation Therapy Technologist", Joint Review Committee on Education in Radiologic Technology, 1988. operation of the particular therapeutic radiation machine. The operator shall be able to demonstrate familiarity with these rules. 7. 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 who is specifically identified on the Certificate of Registration. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing-arts purposes. 8. All individuals associated with the operation of a therapeutic radiation machine shall be instructed in and shall comply with the provisions of the registrant's quality management program. In addition to the requirements of Subchapter 15, these individuals are also subject to the requirements of 1.4.5, 1.4.10, and 1.4.18. 9. Information and Maintenance Record and Associated Information. The registrant shall maintain the following information in a separate file or package for each therapeutic radiation machine, for inspection by the Agency: a. Report of acceptance testing; b. Records of surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by Subchapter 15, as well as the name(s) of person(s) who performed such activities; c. Records of major maintenance and modifications performed on the therapeutic radiation machine after the effective date of these regulations, as well as the name(s) of person(s) who performed such services; and d. Signature of person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade. 10. Records Retention. All records required by Subchapter 15 shall be retained until disposal is authorized by the Agency unless another retention period is specifically authorized in Subchapter 15. All required records shall be retained in an active file from at least the time of generation until the next Agency inspection. Any required record generated prior to the last Agency inspection may be microfilmed or otherwise archived as long as a complete copy of said record can be retrieved until such time as the Agency authorizes final disposal.