§ 175.105 Medical Use of Radioactive Materials.
(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.
(iv) The requirements of this paragraph concerning qualified personnel are in addition to, and not in place of, any other requirements in this Article or in the incorporated 10 C.F.R. sections relating to supervision or the presence of an authorized user.
(3) Possession, use, calibration and check of dose calibrators.
(i) A medical use licensee authorized to administer radioactive materials must possess a dose calibrator and use it to measure the amount of activity administered to each patient.
(ii) A licensee must:
(A) check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use. To satisfy this requirement, the check must be done on a frequently used setting with a sealed source of any photon-emitting radionuclide with a half-life greater than 90 days;
(B) test each dose calibrator for accuracy upon installation and at intervals not to exceed 12 months thereafter by assaying at least 2 sealed sources of appropriate source activity, containing different radionuclides, the activity of which the manufacturer has determined by traceability to a national standard to be within 5 percent of the stated activity;
(C) test each dose calibrator for linearity upon installation and at intervals not to exceed 3 months thereafter over the range of use between 1 MBq (27 µCi) and the highest dosage that will be administered; and
(D) test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used. The licensee must keep a record of this test for the duration of the use of the dose calibrator.
(iii) Notwithstanding the provisions of subparagraph (ii) of paragraph (3) of this subdivision, a licensee that uses a dose calibrator to measure the activity of beta- emitting radioactive materials to be administered to a patient must perform additional checks specified in clauses (A) and (B) of subparagraph (ii) of paragraph (3) of this subdivision using the same radionuclide to be administered and having an activity of at least 50 percent, but not more than 200 percent, of the prescribed activity or by equivalent procedures approved by the Department. Records must be kept pursuant to 24 RCNY Health Code § 175.105(c)(3)(vi).
(iv) A licensee must mathematically correct dosage readings for any geometry or linearity error that exceeds ±10 percent if the dosage is greater than 370 kBq (10µCi) and must repair or replace the dose calibrator if the accuracy or constancy error exceeds ±10 percent.
(v) A licensee must also perform checks and tests required by 24 RCNY Health Code § 175.103(c)(3)(ii) following adjustment or repair of the dose calibrator.
(vi) A licensee must retain a record of each check and test required by subparagraphs (ii), (iii) and (v) of 24 RCNY Health Code § 175.105(c)(3) for 3 years. Such records must include:
(A) for clause (A) of 24 RCNY Health Code § 175.105(c)(3)(ii), the models and serial numbers of the dose calibrator and check source, the identity and calibrated activity of the radionuclide contained in the check source, the date of the check, the activity measured, the instrument settings, and the name of the individual who performed the check;
(B) for clause (B) of 24 RCNY Health Code § 175.105(c)(3)(ii), the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radionuclide contained in the source and its activity, proof of traceability to a national standard, the date of the test, the results of the test, the instrument settings, and the signature of the radiation safety officer; (C) for clause (C) of 24 RCNY Health Code § 175.105(c)(3)(ii), the model and serial number of the dose calibrator, the calculated activities, the measured activities, the date of the test, and the signature of the radiation safety officer; and
(D) for clause (D) of 24 RCNY Health Code § 175.105(c)(3)(ii), the model and serial number of the dose calibrator, the configuration and calibrated activity of the source measured, the activity of the source, the activity measured and the instrument setting for each volume measured, the date of the test, and the signature of the radiation safety officer.
(4) Possession and calibration of portable survey instruments.
(i) A licensee authorized to use radioactive material for any medical use permitted in 10 C.F.R. §§ 35.100, 35.200, 35.300, 35.400, 35.500, or 35.600 must have in its possession a portable, radiation detection survey instrument capable of detecting dose rates over the range of 1.0 µSv (0.1 mrem) per hour to 1,000 µSv (100 mrem) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1,000 mrem) per hour. This requirement may be met by possession of two survey instruments or by possession of one survey instrument that meets both criteria. The instruments must be operable and calibrated in accordance with 10 C.F.R. § 35.61.
(ii) To meet the requirements of 24 RCNY Health Code § 175.105(c)(4)(i), the licensee must perform such calibrations as authorized by specific license condition, or must obtain the services of persons licensed by the U.S. Nuclear Regulatory Commission or an agreement state to perform calibrations of survey instruments.
(iii) A licensee must check each survey instrument for proper operation with the dedicated check source before each use. The licensee is not required to keep records of these checks.
(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.
(iii) establish dose rate action levels for the surveys required by 10 C.F.R. § 35.70 and 24 RCNY Health Code § 175.103(c)(5)(i) and must require that the individual performing the survey immediately notify the radiation safety officer if a dose rate exceeds an action level.
(iv) perform wipe tests for removable contamination once each week on all areas where radioactive materials are routinely prepared for use or administered and where unsealed sources of radioactive materials are stored, so as to be able to detect contamination on each wipe sample of 35 Bq (2100 disintegrations or transformations per minute).
(v) establish removable contamination action levels for the surveys required by 24 RCNY Health Code § 175.105(c)(5)(iv) and must require that the individual performing the survey immediately notify the radiation safety officer if contamination exceeds action levels.
(vi) retain a record of each survey or wipe test required by 10 C.F.R. § 35.70 and 24 RCNY Health Code § 175.105(c)(5) for 3 years. The record must include the date of the survey, a sketch of each area surveyed, action levels established for each area, the measured dose rate at several points in each area expressed in Sv (mrem) per hour or the removable contamination in each area expressed in becquerels (disintegrations or transformations per minute) per 100 square centimeters, the serial number and the model number of the instrument used to make the survey or analyze the samples, and the initials of the individual who performed the survey.
(6) Additional requirements for use of generators aerosols, gases, and volatile materials.
(i) A licensee approved to use unsealed byproduct material for medical use permitted in 10 C.F.R. § 35 Subpart D may use generators, radioactive aerosols, or radioactive gases only if specific application is made to and approved by the Department. (ii) Storage of volatiles and gases.
(A) A licensee must store volatile radiopharmaceuticals and radioactive gases in the shippers' radiation shield and container.
(B) After drawing the first dosage, a licensee must store and use a multidose container in a properly functioning fume hood.
(iii) Control of aerosols and gases.
(A) A licensee who administers radioactive aerosols or gases must do so with a system that will keep airborne concentrations within the limits prescribed by 10 C.F.R. Part 20.
(B) The system must provide for collection and decay or disposal of the unused aerosol or gas in a shielded container.
(C) Before receiving, producing, using, or storing a radioactive gas, the licensee must calculate the amount of time needed after a release to reduce the concentration in the area of use to the ALI listed in Table 1 of Appendix A of 10 C.F.R. Part 20. The calculation must be based on the highest activity of gas handled in a single container and the measured available air exhaust rate.
(D) A licensee must post the time calculated in 24 RCNY Health Code § 175.105(c)(6)(iii)(C) at the area of use, as well as safety measures to be instituted in case of a spill at the area of use.
(E) A licensee must check the operation of collection systems monthly and measure the ventilation rates in areas of use at intervals not to exceed 6 months. Records of these checks and measurements must be maintained for 3 years.
(F) A copy of the calculations, including assumptions, measurements and calculations made, required in 24 RCNY Health Code § 175.105(c)(6)(iii)(C) must be recorded and retained for the duration of the license.
(7) Radioactive cadavers.
(i) If any patient containing radioactive material administered/implanted for therapeutic purposes dies, the physician who pronounces such patient as dead must notify immediately the physician in charge of the case or such physician's designated representative.
(ii) No person shall commence any autopsy on any cadaver that contains more than 185 MBq (5 mCi) of radioactive material administered/implanted for therapeutic purposes without first having consulted with, and having been advised by, the radiation safety officer of the hospital or the physician responsible for the administration/implantation of the radioactive material. If neither is available, a designated representative may serve.
(iii) A radioactivity report on every cadaver containing more than 185 MBq (5 mCi) of radioactive material administered/implanted for therapeutic purposes must be completed by the radiation safety officer or the physician responsible for the administration of the radioactive material or their designated representative. The report must include the name, address and radioactive materials license number of the hospital; the name of the deceased; the name, address and telephone number of the next of kin; the name, address and telephone number of the funeral home to which the deceased will be sent; the radionuclide involved; the approximate activity on the date of the report and the physical form; the location of the radioactive materials within the body and the external dose rate at the body surface closest to the source; the precautions to be observed during autopsy or handling of the body by the funeral director; and the name of the person who prepared the form. This report must accompany the body, whether autopsied or not, when it is surrendered to the funeral director. The Department must be notified in person, by telephone, or by facsimile within 24 hours of the death and a copy of the radioactivity report must be sent to the Department within 15 days of the date of death.
(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.
(ii) promptly after implanting the dosage or sources, measure the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of 10 C.F.R. Part 20 and retain for 3 years a record of each survey that includes the time and date of the survey, a sketch of the area or list of points surveyed, the measured dose rate at several points expressed in mSv (mrem) per hour, the instrument used to make the survey, and the initials of the individual who made the survey.
(9) Additional requirements for uses authorized in 10 C.F.R. § 35 Subpart H.
(i) Amendment requests. In addition to the requirements specified in 10 C.F.R. § 35.13, a licensee must apply for and have received a license amendment prior to:
(A) making any change in the treatment room shielding;
(B) making any change in the location of a gamma stereotactic radiosurgery (GSR) unit or a teletherapy unit within the treatment room;
(C) using the GSR or teletherapy unit in a manner that could result in increased radiation levels in areas outside the treatment room;
(D) relocating the GSR or teletherapy unit; or
(E) allowing an individual not listed on the licensee's license to perform the duties of the authorized medical physicist.
(ii) A licensee must furnish a copy of the records required in 10 C.F.R. §§ 35.632 and 35.635 and the output from the teletherapy source expressed as Sv (rem) per hour at one meter from the source determined during the surveys required in 10 C.F.R. § 35.652 to the Department within 30 days following completion of the action that initiated the record requirement.
(iii) Modification of a GSR or teletherapy unit or room before beginning a treatment program. If the survey required by 10 C.F.R. § 35.652 or 24 RCNY Health Code § 175.105(c)(9)(iv) indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 10 C.F.R. Part 20, before beginning the treatment program, the licensee must:
(A) either equip the unit with stops or add additional radiation shielding to ensure compliance with 10 C.F.R. Part 20;
(B) perform the survey required by 10 C.F.R. § 35.652 again; and
(C) include in the report required by 24 RCNY Health Code § 175.105(c)(9)(ii), the results of the initial survey, a description of the modification made to comply with 10 C.F.R. § 35.652(a) and the results of the second survey; or
(D) request and receive a license amendment that authorizes radiation levels in unrestricted areas greater than those permitted by 10 C.F.R. Part 20.
(10) Records.
(i) In lieu of the retention requirements of 10 C.F.R. § 35.2067, records of leak tests required by 10 C.F.R. § 35.67(b) and the semi-annual physical inventory of sealed sources and brachytherapy sources required by 10 C.F.R. § 35.67(g) shall be retained for 5 years.
(ii) In addition to the requirements of 10 C.F.R. § 35.2630, for each intercomparison, the record must include evidence that the intercomparison reading was sanctioned by a calibration laboratory or radiologic physics center accredited by the American Association of Physicists in Medicine.
(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)
