§ 175.60 Therapeutic Radiation Machines – General Requirements.
RCNY § 175.60
(a)Administrative controls. The registrant must ensure that the requirements of this Article are met in the operation of the therapeutic radiation machine that is registered with the Department pursuant to 24 RCNY Health Code § 175.41.
(b)A therapeutic radiation machine that does not meet the provisions of this Article shall not be used for irradiation of patients.
(c)Authorized users. The authorized user of any therapeutic radiation machine must be a physician who: (1) is certified in: (i) radiation oncology or therapeutic radiology by the American Board of Radiology or Radiology (combined diagnostic and therapeutic radiology program) by the American Board of Radiology prior to 1976; 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 (v) radiation oncology by the National Board 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 3 years of supervised clinical experience.
(i)To satisfy the requirement for instruction in this paragraph, 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.
(ii)To satisfy the requirement for supervised work experience in this paragraph, training must be under the supervision of an authorized user 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/patient treatment settings; (C) use of administrative controls to prevent medical events; (D) implementing emergency procedures to be followed in the event of the abnormal operation of an 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 in this paragraph, training must 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 must include: (A) examining individuals and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and any limitations/contraindications; (B) selecting proper dose and how it is to be administered; (C) calculating the therapeutic radiation machine doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses or treatment plans as warranted by patients' reaction to radiation; and (D) post-administration follow-up and review of case histories.
(3)For certain therapeutic modalities, such as proton, neutron, carbon, helium or any other heavy ion therapy, authorized users must document training and experience together with the specific modality. The training must include device operation, safety procedures and clinical use of the therapy unit. This training requirement may be satisfied by satisfactory completion of a training program provided by the particular therapy unit vendor or by receiving training supervised by another authorized user or QMP, who is authorized for the use of such therapy unit modality.
(4)Notwithstanding the other requirements of this section, the registrant for any therapeutic radiation machine may also submit the training of the prospective authorized user physician for Department review on a case-by-case basis.
(5)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)Qualifications of operators.
(1)Any person, other than a professional practitioner, who operates a therapeutic radiation machine for medical use shall be a licensed and registered radiation therapist, or a student currently enrolled in an approved program of study in radiation therapy technology and operating under the direct supervision of a professional practitioner or licensed radiation therapist.
(2)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 a period of at least 2 years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility.
(e)Written safety procedures and rules must be developed by a QMP and must be available in printed form in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine. The operator must be able to demonstrate familiarity with these rules.
(f)Individuals must not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing by a therapeutic radiation machine authorized user. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing-arts purposes.
(g)Visiting authorized user. Notwithstanding other provisions of this section, a registrant may permit any 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 if: (1) 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 (where applicable); and (2) the visiting authorized user meets the requirements established for authorized users in subdivision (c) of this section, and (3) the registrant maintains copies of the written permission required by paragraph (1) of this subdivision and documentation that the visiting authorized user met the requirements of paragraph (2) of this subdivision for 5 years from the date of the last visit.
(h)All individuals associated with the operation of a therapeutic radiation machine must be instructed in and must comply with the provisions of the registrant's quality assurance program. In addition to the requirements of this section, these individuals are also subject to the requirements of this Article.
(j)Records retention. All records required by this section must be retained until disposal is authorized by the Department, or unless another retention period is specifically authorized. All required records must be retained in an active file from at least the time of generation until 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 said record can be retrieved until such time as the Department authorizes final disposal. (Added City Record 4/24/2019, eff. 5/24/2019)
