§ 175.105 Medical Use of Radioactive Materials.
RCNY § 175.105
(a)Except as set forth in subdivision (b) of this section, 10 C.F.R. Part 35 is hereby incorporated by reference herein to this Article with the same force and effect as if fully set forth in its entirety.
(b)The following provisions from 10 C.F.R. Part 35 are not so incorporated: § 35.1, § 35.8, § 35.11(c)(1), § 35.13(a)(1), § 35.4001 and § 35.4002.
(c)Additional requirements.
(1)ALARA program.
(i)Each licensee must develop and implement a written program to maintain radiation doses and releases of radioactive material in effluents to unrestricted areas to be As Low As Reasonably Achievable (ALARA) in accordance with this subdivision.
(ii)To satisfy the requirement of subparagraph (i) of this paragraph (1): (A) for licensees that are medical institutions, the management, radiation safety officer and all authorized users must participate in the establishment, implementation, and operation of the program as required by this Article or required by the radiation safety committee; or (B) for licensees that are not medical institutions, management and all authorized users must participate in the program as requested by the radiation safety officer.
(iii)The ALARA program must include notice to workers of the program's existence and workers' responsibility to help keep dose equivalents ALARA.
(iv)For licensees that are medical institutions, the ALARA program must include an annual review by the radiation safety committee as indicated in paragraph (1) of subdivision (c) of 24 RCNY Health Code § 175.102.
(v)For licensees that are not medical institutions, the ALARA program must include an annual management review of summaries of the types and amounts of radioactive material used, occupational dose reports, and continuing education and training for all personnel who work with or in the vicinity of radioactive material, prepared by all authorized users or the radiation safety officer.
(vi)The purpose of the review required by subparagraphs (iv) and (v) of this paragraph (1) is to ensure that every reasonable effort to maintain occupational doses, doses to the general public, and releases of radioactive material to unrestricted areas, are ALARA, taking into account the state of technology and the cost of improvements in relation to benefits.
(vii)The licensee must retain a current written description of their ALARA program for the duration of the license. The written description must include: (A) a commitment by management to keep occupational doses as low as reasonably achievable; (B) a requirement that the radiation safety officer brief management at least once each year on the radiation safety program; personnel exposure investigational levels that, when exceeded, will initiate an investigation by the radiation safety officer of the cause of the exposure (ALARA I); and personnel exposure investigational levels that, when exceeded, will initiate a prompt investigation by the radiation safety officer of the cause of the exposure and a consideration of actions that might to be taken to reduce the probability of recurrence (ALARA II).
(2)Qualified personnel. Personnel, duly licensed by the New York State Department of Health to practice nuclear medicine technology (other than physicians or registered professional nurses), at licensee locations involved in the performance of diagnostic procedures utilizing radioactive material, which includes parenteral administration of radioactive material by intravenous, intramuscular or subcutaneous methods, must: (i) have satisfactorily completed an educational program in nuclear medicine technology accredited by the Committee on Allied Health Education and Accreditation, or the accrediting agency of the state in which the program was completed, provided such state accreditation requires education and training in the above methods of parenteral administration; or (ii) possess certification as a nuclear medicine technologist by the American Registry of Radiologic Technologists or certification by the Nuclear Medicine Technology Board; and (iii) prior to permitting parenteral administration by a nuclear medicine technologist, the medical board of a hospital, a physician, or the radiation safety committee of an institution who have no medical board, must adopt with governing authority approval: (A) procedures to assure that the nuclear medicine technologist possesses the education and training or certification set forth in this subdivision and is proficient in the competent performance of parenteral administration; and (B) requirements for authorized user physician, which at a minimum must require supervision by such physician when parenteral administration of radioactive material for diagnostic testing is performed by a qualified nuclear medicine technologist.
(3)Possession, use, calibration and check of dose calibrators.
(4)Possession and calibration of portable survey instruments.
(5)Surveys of exposure rate and contamination. In addition to the requirements of 10 C.F.R. § 35.70, a licensee must: (i) survey with a radiation detection survey instrument at least once each week all areas where unsealed byproduct materials or radioactive wastes are stored; (ii) conduct the surveys required by 10 C.F.R. § 35.70 and 24 RCNY Health Code § 175.105(c)(5)(i) so as to be able to detect and measure dose rates as low as 1 µSv (0.1 mrem) per hour.
(6)Additional requirements for use of generators aerosols, gases, and volatile materials.
(7)Radioactive cadavers.
(8)Safety requirements for uses authorized in 10 C.F.R. § 35 Subparts E and F. For each patient or research subject who cannot be released pursuant to 10 C.F.R. § 35.75, a licensee must: (i) authorize visits by individuals under age 18 only on a patient-by- patient basis with the approval of the authorized user after consultation with the radiation safety officer.
(9)Additional requirements for uses authorized in 10 C.F.R. § 35 Subpart H.
(10)Records.
(11)Visiting authorized user. Notwithstanding other provisions of this Article, a licensee may permit any physician to act as a visiting authorized user under the term of the license for up to 60 days per calendar year if: (i) the visiting authorized user has the prior written permission of the licensee's management and, if the use occurs on behalf of an institution, the institution's Radiation Safety Committee (where applicable); and (ii) the visiting authorized is specifically named as a user on a license issued by the Department, Nuclear Regulatory Commission, or an Agreement State, and only performs procedures for which they are specifically authorized on that license, and (iii) the licensee maintains copies of the written permission required by subparagraph (i) of this paragraph and documentation that the visiting authorized user met the requirements of subparagraph (ii) of this paragraph for 5 years from the date of the last visit. (Added City Record 4/24/2019, eff. 5/24/2019)
