Section 180-20-003 - GENERAL ADMINISTRATIVE REQUIREMENTS FOR REGISTRANTS OF THERAPEUTIC RADIATION MACHINES The general administrative requirements for registrants using therapeutic radiation machines are as follows.
003.01ADMINISTRATIVE CONTROLS. The registrant must be responsible for directing the operation of the therapeutic radiation machines that have been registered with the Department. The registrant or the registrant's agent must ensure that the requirements of this chapter are met in the operation of the therapeutic radiation machine or machines.003.02PROHIBITION. A therapeutic radiation machine that does not meet the provisions of these regulations cannot be used for irradiation of patients.003.03TRAINING FOR EXTERNAL BEAM RADIATION THERAPY USERS. The registrant of any therapeutic radiation machine subject to 180 NAC 20-006 or 20-007 must require the user to be a physician who is licensed in the State of Nebraska and who: (1) Is certified in: (i) Radiology, combined diagnostic and therapeutic radiology program, therapeutic radiology or radiation oncology, 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(2) 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 must include: (a) Radiation physics and instrumentation;(b) Radiation protection;(c) Mathematics pertaining to the use and measurement of ionization radiation; and(d) Radiation biology; and(ii) To satisfy the requirement for supervised work experience, training must be under the supervision of an individual meeting the requirements of 180 NAC 20-003.03 and must include: (a) Review of the full calibration measurements and periodic quality assurance checks;(b) Evaluation of prepared treatment plans and calculation of treatment times and patient treatment settings;(c) Using administrative controls to prevent misadministrations; and(d) Implementing emergency procedures to be followed in the event of the abnormal operation of an external beam radiation therapy unit or console; and(iii) To satisfy the requirement for a period of supervised clinical experience, training must 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 individual meeting the requirements of 180 NAC 20-003.03. The supervised clinical experience must include: (a) Examining individuals 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 external beam radiation therapy doses and collaborating with the user in the review of patients' progress and consideration of the need to modify originally prescribed doses or treatment plans, or both as warranted by patients' reaction to radiation; and(d) Post administration follow up and review of case histories.003.03(A)TRAINING DOCUMENTATION. The names and training of all current users of therapeutic radiation machines must be kept on file at the facility. Information on former users of therapeutic radiation machines must be maintained for at least two years beyond the last date they were authorized as a user of the therapeutic radiation machine at that facility.003.04TRAINING FOR RADIOLOGICAL MEDICAL PHYSICIST. The registrant for any therapeutic radiation machine subject to 20 NAC 20-006 or 20-007 must require the individual to meet the training requirements of 180 NAC 15-004.01.003.05QUALIFICATIONS OF OPERATORS. Individuals who will be operating therapeutic radiation machines for medical use must meet the following requirements. (A) Individuals who will be operating a therapeutic radiation machine for medical use must be American Registry of Radiologic Technologists (ARRT) Registered Radiation Therapy Technologists. Individuals who are not American Registry of Radiologic Technologists (ARRT) Registered Radiation Therapy Technologists must 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, "Standards for Accredited Educational Program in Radiologic Sciences - Effective January 1, 2002", Joint Review Committee on Education in Radiologic Technology, January 1996; Revised 2001. This document is available for viewing at the Department of Health and Human Services, Division of Public Health, Office of Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509.(B) The names and training of all personnel currently operating a therapeutic radiation machine must be kept on file at the facility. Information on former operators must be retained for at least two (2) years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility.003.06WRITTEN SAFETY PROCEDURES. Written safety procedures and rules must be developed by a radiological medical physicist and must be available in the control area of a therapeutic radiation machine. The written safety procedures must include any restrictions required for the safe operation of the each therapeutic radiation machine. The operator must be able to demonstrate familiarity with these procedures.003.07LIMITATIONS. Individuals must not be exposed to the useful beam except for medical therapy purposes and unless the exposure has been ordered in writing by a licensed practitioner of the healing arts. This provision prohibits deliberate exposure of an individual for training, demonstration, or other non-healing arts purposes.003.08COMPLIANCE WITH QUALITY MANAGEMENT PROGRAM. All individuals associated with the operation of a therapeutic radiation machine must be instructed in and comply with the provisions of the registrant's quality management program. In addition to the requirements of this chapter, these individuals are also subject to the requirements of 180 NAC 4-005, 4-009 and 4-021.003.09INFORMATION AND MAINTENANCE RECORD AND ASSOCIATED INFORMATION. The registrant must maintain the following information in a separate file or package for each therapeutic radiation machine for inspection by the Department: (A) A report of acceptance testing;(B) The records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by this chapter, to include the name or names of the individual or individuals who performed the activities;(C) The records of maintenance or modifications, or both, performed on the therapeutic radiation machine, to include the name or names of the individual or individuals who performed the services; and(D) A signature of person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.003.10RECORDS RETENTION. All records required by this chapter must be retained until disposal is authorized by the Department, unless another retention period is authorized in this chapter. All required records must be retained in an active file from the time of generation, until at least the next Department inspection. Any required record generated prior to the last Department inspection may be microfilmed or otherwise archived as long as a complete copy of the record can be retrieved until the Department authorizes final disposal.180 Neb. Admin. Code, ch. 20, § 003
Amended effective 11/21/2020