R313-30-3. 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 Director. The registrant or the registrant's agent shall ensure that the requirements of R313-30 are met in the operation of the therapeutic radiation machines.

  (2) A therapeutic radiation machine which does not meet the provisions of these rules shall not be used for irradiation of patients.

  (3) Training for External Beam Radiation Therapy Authorized Users. The registrant for a therapeutic radiation machine subject to R313-30-6 or R313-30-7 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; or

  (ii) Radiation oncology by the American Osteopathic Board of Radiology; or

  (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 three years of supervised clinical experience.

  (i) To satisfy the requirement for instruction, the classroom and laboratory training shall include:

  (A) Radiation physics and instrumentation;

  (B) Radiation protection;

  (C) Mathematics pertaining to the use and measurement of radioactivity; and

  (D) Radiation biology.

  (ii) To satisfy the requirement for supervised work experience, training shall be under the supervision of an authorized user and shall include:

  (A) Review of the full calibration measurements and periodic quality assurance checks;

  (B) Preparing treatment plans and calculating treatment times;

  (C) Using administrative controls to prevent misadministrations;

  (D) Implementing emergency procedures to be followed in the event of the abnormal operation of a external beam radiation therapy unit or console; and

  (E) Checking and using radiation survey meters.

  (iii) 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:

  (A) Examining individuals and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and limitations and contraindications;

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

  (C) 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

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

  (iv) An individual who satisfies the requirements in R313-30-3(b), but not R313-30-3(a), must submit an application to the Director and must satisfy the requirements in R313-30-3(a) within one year of initial application to the Director.

  (c) After December 31, 1994, a physician shall not act as an authorized user for a therapeutic radiation machine until the physician's training has been reviewed and approved by the Director.

  (4) Training for Radiation Therapy Physicist. The registrant for a therapeutic radiation machine subject to R313-30-6 or R313-30-7 shall require the Radiation Therapy Physicist to:

  (a) Satisfy the provisions of R313-16, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units; and

  (b) Be certified by the American Board of Radiology in:

  (i) Therapeutic radiological physics; or

  (ii) Roentgen-ray and gamma-ray physics; or

  (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 one year of full time training in therapeutic radiological physics and also one 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 R313-30-4(1), R313-30-6(16), R313-30-7(19), R313-30-6(17), and R313-30-7(20) under the supervision of a Radiation Therapy Physicist during the year of work experience.

  (f) Notwithstanding the provisions of R313-30-3(4)(e), certification pursuant to R313-30-3(4)(b), (c) or (d) shall be required on or before December 31, 1999 for all persons currently qualifying as a Radiation Therapy Physicist pursuant to R313-30-3(4)(e).

  (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.

  (b) The names and training of 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 at least two 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 available in the control area of a therapeutic radiation machine, including restrictions required for the safe operation of the particular therapeutic radiation machine. The operator shall be familiar with these rules as required in R313-18-12(1)(c).

  (7) Individuals shall not be exposed to the useful beam except for medical therapy purposes. Exposure for medical therapy purposes shall be ordered in writing by an authorized user 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) Visiting Authorized User. Notwithstanding the provisions of R313-30-3(7), a registrant may permit a physician to act as a visiting authorized user under the term of the registrant's Certificate of Registration for up to 60 days per calendar year under the following conditions:

  (a) The visiting authorized user has the prior written permission of the registrant's management and, if the use occurs on behalf of an institution, the institution's Radiation Safety Committee; and

  (b) The visiting authorized user meets the requirements established for authorized users in R313-30-3(3)(a) and R313-30-3(3)(b); and

  (c) The registrant maintains copies of records specified by R313-30-3(8) for five years from the date of the last visit.

  (9) 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 R313-30, these individuals are also subject to the requirements of R313-15-201, R313-15-202, R313-15-205 and R313-15-502.

  (10) Information and Maintenance Record and Associated Information. The registrant shall maintain the following information in a separate file or package for therapeutic radiation machines, for inspection by the representatives of the Director:

  (a) Report of acceptance testing;

  (b) Records of surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by R313-30, as well as the names of persons who performed the activities;

  (c) Records of major maintenance and modifications performed on the therapeutic radiation machine after the effective date of these rules, as well as the names of persons who performed the services; and

  (d) Signature of person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.

  (11) Records Retention. Records required by R313-30 shall be retained until disposal is authorized by the Director unless another retention period is specifically authorized in R313-30. Required records shall be retained in an active file from at least the time of generation until the next inspection by a representative of the Director. A required record generated prior to the last inspection may be microfilmed or otherwise archived as long as a complete copy of said record can be retrieved until the Director authorizes final disposal.