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(a) Types of license. The requirements specified in this section are in addition to, and not in substitution for, others in this Article. In particular, the incorporated provisions of 10 C.F.R. Part 30 apply to all license applications and all specific radioactive materials licenses. For the purposes of this Article, the following specific license types of radioactive materials apply:
(1) A specific license of limited scope for gamma stereotactic radiosurgery (GSR) or for teletherapy means a license that authorizes receipt, acquisition, ownership, possession, use and transfer of specified quantities and types of radioactive material for use in GSR or teletherapy programs.
(2) A specific license of limited scope for medical use means a license that authorizes receipt, acquisition, ownership, possession, use and transfer of specified quantities and types of radioactive material for use in or on humans in a medical program, but does not include GSR or teletherapy.
(3) A specific license of limited scope for other use means a license that authorizes receipt, production, acquisition, ownership, possession, use and transfer of specified quantities and types of radioactive material for uses other than in or on humans.
(4) A specific license of broad scope for medical use means a license that authorizes receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive materials specified in the license, for use in or on humans in a medical program, but does not include GSR or teletherapy.
(5) A specific license of broad scope for research and development means a license that authorizes receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive materials specified in the license, in quantities not exceeding those specified in the license, for uses other than in or on humans.
(b) Specific licenses for human use of radioactive materials in institutions. An application by a medical institution for a specific license for medical use of radioactive material may be approved if:
(2) the applicant possesses adequate facilities for the clinical care of patients; and
(3) the physician designated on the application as the individual authorized user has training and experience as specified in 10 C.F.R. Part 35, in the proposed use, handling and administration of radionuclides and the clinical management of radioactive patients. The physician must furnish evidence of such experience with the application. A statement from the physician's preceptor at the medical institution where the physician acquired such training and experience, indicating their amount and nature, may be submitted as evidence of such experience.
(4) The license application is signed by the chairman of the radiation safety committee and an authorized representative of the medical institution.
(c) Specific licenses to individual physicians for human use of radioactive materials. An application by an individual physician for a specific license for human use of radioactive material may be approved if:
(2) the applicant has training and experience as specified in 10 C.F.R. Part 35 in the proposed use, handling and administration of radionuclides, and the clinical management of radioactive patients. The physician must furnish evidence of such training and experience with the application. A statement from the physician's preceptor at the institution where the physician acquired such training and experience, indicating their amount and nature, may be submitted as evidence of such experience.
(d) Specific licenses of broad scope.
(1) A specific license of broad scope is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of the byproduct material specified in the license, but not exceeding quantities specified in the license. Approved authorized users do not need to be listed on the license. Specific licenses of broad scope for medical use are exempted from certain requirements as listed in 10 C.F.R. § 35.15.
(2) A specific license of broad scope shall be issued only to medical institutions, research laboratories, or institutions of higher education; such licenses shall not be issued to individuals.
(3) An application for a specific license of broad scope may be approved if:
(i) the applicant satisfies the general requirements specified in 10 C.F.R. § 30.33; and
(ii) the applicant has engaged in a reasonable number of activities involving the use of radioactive material as determined by the Department; and
(iii) the applicant has established administrative controls and provisions relating to organization and management, procedures, recordkeeping, material control, and accounting and management review that are necessary to assure safe operations, including:
(A) the establishment of a radiation safety committee pursuant to 24 RCNY Health Code § 175.102(c)(1)(i)(B); and
(B) the appointment of a full-time radiation safety officer pursuant to 10 C.F.R. Part 20; and
(C) the establishment of appropriate administrative procedures to assure:
a. control of procurement and use of radioactive material; and
b. completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and
c. review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with 24 RCNY Health Code § 175.104(d)(3)(iii)(C)(b) prior to the use of radioactive materials.
(4) The following are conditions of all specific licenses of broad scope. Unless specifically authorized pursuant to other provisions of this Article, broad scope licensees must not:
(i) conduct tracer studies in the environment involving direct release of radioactive material;
(ii) receive, acquire, own, possess, use, transfer, or import devices containing 3.7 E6 GBq (100,000 Ci) or more of radioactive material in sealed sources used for irradiation of materials;
(iii) add, or cause the addition of, radioactive material to any food, beverage, cosmetic, drug or other product designed for ingestion by, or application to, a human being except as authorized in the license.
(e) Specific licenses for non-human use. An application for a specific license authorizing non-human use of radioactive materials may be approved if:
(1) the applicant satisfies the general requirements specified in 10 C.F.R. § 30.33; and
(2) the applicant, or the applicant's personnel, has training and experience commensurate with the proposed amounts, types and uses of radioactive materials which must minimally include:
(i) a college degree at the bachelor level in a physical, biological, environmental or engineering science; and
(ii) at least 40 hours of training and experience in the safe handling of radioactive materials appropriate to the type and forms of such materials to be used, which must include:
(A) characteristics of ionizing radiation;
(B) units of radiation dose and quantities;
(C) radiation detection instrumentation; and
(D) biological hazards of exposure to radiation.
(f) General licenses.
(1) Except as set forth in paragraph (2) of this subdivision, 10 C.F.R. Part 31 is hereby incorporated by reference herein to this Article with the same force and effect as if fully set forth in its entirety.
(2) The following provisions from 10 C.F.R. Part 31 are not incorporated: § 31.1, § 31.2, § 31.4, § 31.22 and § 31.23.
(3) Any reference to "byproduct material" in the incorporated 10 C.F.R. § 31.9 means "radioactive material" as defined in this Article.
(4) Reference to "non-Agreement State" in the incorporated 10 C.F.R. § 31.6 means this Department. (5) Licensees exempt pursuant to incorporated 10 C.F.R. § 31.12(b) are similarly exempt from the analogous license requirements of this Article.
(Added City Record 4/24/2019, eff. 5/24/2019)
(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)
(a) Except as set forth in subdivision (b) of this section, 10 C.F.R. Part 71 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 71 are not so incorporated: § 71.2, § 71.6, § 71.11, § 71.14(b), § 71.19, §§ 71.31 through 71.45, §§ 71.51 through 71.77, § 71.85(a)- (c), § 71.91(b), § 71.99, § 71.100, § 71.101(c)(2), § 71.101(d)-(f), § 71.107 through § 71.125.
(c) Licensees must ascertain that the certificate holder determinations in subsections (a) through (c) of 10 C.F.R. § 71.85 have been made.
(d) The requirements of the incorporated 10 C.F.R. §§ 71.106 and 71.135 apply to general licensees and do not apply to certificate of compliance holders or applicants for certificates of compliance as those terms are defined in 10 C.F.R. § 71.4.
(e) A licensee's quality assurance program referenced in the incorporated 10 C.F.R. Part 71 Subpart H regulations as to packaging must be submitted to the Department at the address provided in 24 RCNY Health Code § 175.01(c).
(f) Transport authorized by the incorporated 10 C.F.R. § 71.13 must not be by public modes of transportation including, but not limited to, buses, subways, trams, taxicabs, car services, trains, ferries, or other public conveyance, which would be returned immediately to public use after transporting licensed material.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Except as set forth in subdivision (b) of this section, 10 C.F.R. Part 37 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 37 are not so incorporated: § 37.1, § 37.3, § 37.7, § 37.9, § 37.11(a-b), § 37.13, § 37.105, § 37.107 and § 37.109.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Purpose and scope. This section establishes requirements for the use of radioactive materials or the radiation therefrom for diagnostic and therapeutic uses in the healing arts. These requirements provide for the protection of the public health and safety and are in addition to, and not in substitution for, other requirements in this Article. The requirements of this section apply to all licensees subject to this Article.
(b) Diagnostic facilities. A quality assurance program is a system of plans, actions, reviews, reports and records, the purpose of which is to ensure that diagnostic facilities achieve consistent high quality imaging and other diagnostic results, while maintaining personnel doses within limits prescribed by the Department.
(1) Each licensee performing diagnostic procedures must implement a quality assurance program, which includes at a minimum:
(i) the adoption of a manual containing written policies and procedures for radiation protection and describing the licensee's quality assurance program that is facility- and equipment-specific. Policies and processes must be consistent with the types of procedures provided including, but not limited to, identification of patients, personnel monitoring, and protection of pregnant workers and patients. The quality assurance manual must describe the various processing, generator and systems quality control tests appropriate for the types of procedures provided in sufficient detail to ensure that they will be performed properly;
(ii) the performance of quality control tests and the correction of deficiencies as specified in the quality assurance manual;
(iii) the provisions of a formalized in-service training program for employees including, but not limited to, quality assurance and radiation safety procedures;
(iv) the measurement of the amount of activity of each dose of a radiopharmaceutical/ radiobiologic administered to each patient;
(v) the provision of the information described in 24 RCNY Health Code § 175.108(b)(1)(iv) to any patient upon request; and
(vi) the performance of an ongoing program of analysis of repeated, rejected or wrongly administered diagnostic studies which are designed to identify and correct problems and to optimize quality.
(2) Each licensee must maintain written records documenting quality assurance and audit activities for review by the Department. Unless otherwise required, such records must be maintained by the licensee until after the next scheduled inspection is completed by the Department.
(c) External beam and brachytherapy. A quality assurance program for external beam therapy or brachytherapy is a system of plans, actions, reviews, reports and records, the purpose of which is to ensure a consistent and safe fulfillment of the dose prescription to the target volume with minimal dose to normal tissue.
(1) Each licensee authorized to administer external beam therapy or brachytherapy to humans must implement a quality assurance program to systematically monitor, evaluate and document radiation therapy services to ensure consistent and safe fulfillment of the dose prescription to the target volume, with minimal dose to normal tissue, minimal exposure to personnel and adequate patient monitoring aimed at determining the end result of the treatment. Each licensee must meet or exceed all quality assurance criteria described in this subdivision.
(2) Each licensee must adopt and maintain a quality assurance program that includes policies and procedures that require the following:
(i) Each patient's medical record must be complete, accurate, legible and must include the patient's initial clinical evaluation, treatment planning data, treatment execution data, clinical assessments during treatment, a treatment summary and plan for subsequent care. Treatment related data must be recorded in the patient's medical record at the time of each treatment.
(ii) A written directive or dated order or prescription for the medical use of radiation or radioactive material must be made for each patient in accordance with 10 C.F.R. § 35.40. The directive, order or prescription must be signed or approved electronically by a board certified radiation oncologist or qualified physician who restricts their practice to radiation oncology.
(iii) The accuracy of treatment plan data and any modifications to treatment plan data transferred to a radiation treatment delivery system must be verified by qualified clinical staff prior to patient treatment.
(iv) A radiation therapy technologist, physician or other qualified health practitioner must verify that the patient set up on the treatment machine is in accordance with the treatment plan prior to the first fraction of a course of treatment and prior to treatment for any changes to the initial treatment plan.
(v) Clinical staff must obtain clarification before beginning a patient's treatment if any element of the order or other record is confusing, ambiguous, erroneous or suspected of being erroneous.
(vi) Each patient's identification must be verified by at least two different means by qualified clinical staff prior to each treatment.
(vii) Each patient's response to treatment must be assessed by a board certified radiation oncologist or other qualified physician in the active practice of external beam therapy or brachytherapy. Unusual responses must be evaluated as possible indications of treatment errors and recorded in the patient's medical record.
(viii) The medical records of patients undergoing fractionated treatment must be checked for completeness and accuracy by qualified clinical staff at intervals not to exceed six fractions.
(ix) Radiation treatment plans and related calculations must be checked by qualified clinical staff for accuracy before 25 percent of the prescribed dose for external beam therapy or 50 percent of the prescribed dose for brachytherapy is administered, except the check must be performed prior to treatment for: any single fraction treatment; any fractional dose that exceeds 300cGy or 700 monitor units; or when the output of a medical therapy accelerator exceeds 600 monitor units per minute during treatment. If a treatment plan and related calculations were originally prepared by a board certified radiation oncologist or an authorized medical physicist possessing the qualifications specified in 10 C.F.R. § 35.51, it may be rechecked by the same individual using a different calculation method. Treatment plans and related calculations prepared by other qualified clinical personnel must be checked by a second qualified person using procedures specified in the treatment planning procedures manual required pursuant to paragraph (3) of this subdivision and who has received training in use of this manual.
(x) All equipment and other technology used in planning and administering radiation therapy must function properly and safely, and must be calibrated properly and repaired and maintained in accordance with the manufacturer's instructions. The equipment and technology that is subject to such quality control, includes but is not limited to: computer software and hardware including upgrades and new releases; equipment used to perform simulation; dosimetry equipment; equipment used to guide treatment delivery, including but not limited to ultrasound units, kV and mV imaging equipment and monitors that are used to view patient imaging studies and personnel radiation safety equipment. Data communication between various systems, including but not limited to treatment planning systems, treatment delivery systems and data networks/storage media must be evaluated and tested to ensure accurate and complete data transfer.
(xi) Quality control tests performed on equipment and technology used in planning and implementing radiation treatment must be documented, including:
(A) Detailed procedures for performing each test;
(B) The frequency of each test;
(C) Acceptable results for each test;
(D) Corrective actions taken;
(E) Record keeping and reporting procedures for test results including the tester's name, signature and date of the test; and
(F) The qualifications are specified for the individual conducting the test and for the person who reviews test data.
(xii) Test results that exceed tolerances/limits must be immediately reported to the authorized medical physicist or QMP.
(xiii) Records for all maintenance, repairs and upgrades of equipment and technology must be maintained for at least 5 years.
(xiv) Errors or defects in technology or equipment, including computer hardware and software, must be reported to the technology or equipment manufacturer and to the United States Food and Drug Administration (MedWatch) as soon as possible and in no event more than 30 days of discovery, and records of equipment errors and reports required by this subparagraph must be maintained for review by the Department for at least 3 years.
(xv) Patients with permanent brachytherapy implants must be provided with instructions to take radiation safety precautions, as required by 10 C.F.R. § 35.75 and the licensee's radioactive materials license, after being released from the licensee's facility.
(xvi) All personnel involved in planning or implementing radiation therapy must be credentialed and acting within their scope of practice as provided in New York State law. Credentialing must include verifying that all professional staff are appropriately licensed, including medical physicists and radiation therapy technologists. Records of credentialing must be maintained during the period in which the credentialed person provides services to the licensee or registrant, and for 3 years thereafter.
(xvii) Any unintended deviation from the treatment plan that is identified must be evaluated and corrective action to prevent recurrence must be implemented. Records of unintended deviations and corrective action must be maintained for audits required by paragraph (5) of this subdivision and for review by the Department. (xviii) There must be a process to ensure quick and effective response to any radiation therapy related recalls, notices, safety alerts and hazards.
(3) Each licensee must adopt and maintain a radiation treatment manual prepared by an authorized medical physicist possessing the qualifications specified in 10 C.F.R. § 35.51. The manual must include the calculation methods and formulas to be used at the facility (including the methods for performing the checks of treatment plans and related calculations as required by clause (I) of subparagraph (i) of paragraph (3) of this subdivision). The treatment planning manual may be part of the quality assurance manual. The radiation treatment manual must be included in training given pursuant to 10 C.F.R. § 19.12 to facility staff who will participate in treatment planning. Each licensee must ensure that an authorized medical physicist possessing the qualifications specified in 10 C.F.R. § 35.51 prepares or reviews and approves a procedures manual describing how radiation therapy treatment planning is to be performed at the licensee's facility and reviews the treatment planning manual at least annually.
(4) Each licensee must ensure that all equipment used in planning and administering radiation therapy is functioning properly, designed for the intended purpose, properly calibrated, and maintained in accordance with the manufacturer's instructions and the quality assurance program described in the licensee's quality assurance manual. Such equipment must be calibrated prior to use on patients, at least annually thereafter and following any change, repair or replacement of any component which may alter the radiation output.
(5) Each licensee must implement written procedures for auditing the effectiveness of the radiation therapy quality assurance program that includes the following:
(i) Audits must be conducted at intervals not to exceed 12 months by an authorized medical physicist possessing the qualifications specified in 10 C.F.R. § 35.51, and also by a physician, both of whom are in the active practice of the type of radiation therapy conducted by the licensee; and
(ii) The licensee must ensure that the individuals who conduct the audit prepare and deliver to the licensee a report which contains an assessment of the effectiveness of the quality assurance program and makes recommendations for any needed modifications or improvements; and
(iii) The licensee must promptly review the audit findings, address the need for modifications or improvements and document actions taken. If recommendations are not acted on, the licensee must document the reasons therefor and also any alternative actions taken to address the audit findings; and
(iv) Each licensee must maintain complete written records relating to quality assurance and audit activities for review and inspection by the Department. Audit records must be maintained for at least 6 years.
(6) Accreditation in Radiation Oncology.
(i) Each licensee must maintain accreditation in radiation oncology by the American College of Radiology, the American College of Radiation Oncology or other equivalent accrediting organization as determined by the Department.
(ii) The licensee must maintain a record of accreditation, including a copy of the application, all supplemental application information and all correspondence transmitted between the accrediting body and the licensee. Records must be maintained for at least 6 years.
(d) Unsealed byproduct material for which a written directive is required. A quality assurance program for unsealed byproduct material for which a written directive is required is a system of plans, actions, reviews, reports and records, the purpose of which is to ensure a consistent and safe fulfillment of the dose prescription.
(1) Each licensee who uses unsealed byproduct material for which a written directive is required in humans must implement a quality assurance program which includes at a minimum:
(i) The adoption of a manual containing written policies and procedures designed to assure effective supervision, safety, proper performance of equipment, effective communication and quality control. The manual must include procedures to assure that:
(A) each patient's evaluation and intended treatment is documented in the patient's record;
(B) a written, signed and dated order for medical use of radioactive material is made in accordance with 10 C.F.R. § 35.40;
(C) each patient is positively identified;
(D) all orders and other treatment records are clear and legible;
(E) staff must be instructed to obtain clarification before treating a patient if any element of the order or other record is confusing, ambiguous or suspected of being erroneous;
(F) each patient's response to treatment must be assessed by an authorized user physician, or a physician under the supervision of an authorized user physician, for unsealed byproduct material for which a written directive is required and that unusual responses are evaluated as possible indications of treatment errors; and
(G) complete treatment records containing data recorded at the time of each treatment are maintained.
(2) Each licensee must ensure that all equipment used in planning and administering unsealed byproduct material for which a written directive is required is designed and used for the intended purpose and is properly functioning, is properly calibrated and is maintained in accordance with the manufacturer's instructions and the QA program described in the licensee's QA manual.
(3) Each licensee must audit its activities related to the use of unsealed byproduct material for which a written directive is required as part of its quality assurance program at intervals not to exceed 12 months to assess the effectiveness of the program, document the audit findings and any modifications or improvements found to be needed and institute corrective actions and improvements as indicated by the audit findings.
(Added City Record 4/24/2019, eff. 5/24/2019)
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