Effective Date: 01/08/97
Title: Section 16.123 - Specific licenses for certain medical uses of radioactive material

16.123 Specific licenses for certain medical uses of radioactive material.

(a) Subject to the provisions of subdivisions (c), (d), and (e) of this section, an application for a specific license pursuant to section 16.120 or 16.121 of this Part for any medical use or uses of radioactive material specified in paragraphs (1) through (5) of subdivision (b) of this section will be approved for all of the uses within the applicable paragraph which include the use or uses specified in the application if:

(1) the applicant satisfies the requirements of section 16.120 or 16.121 of this Part;

(2) the applicant, or physicians designated in the application as individual users, have training and experience in the types of uses included in the applicable paragraph of paragraphs (1) through (5) of subdivision (b) of this section, that includes as a minimum the requirements set forth in section 16.2(a)(134) 16.2 of this Part.

(3) the applicant or the physician and all other personnel who will be involved in the preparation and uses of the radioactive material have training and experience in the handling of radioactive material appropriate to their participation in the uses included in the applicable paragraph of paragraphs (1) through (5) of subdivision (b) of this section provided, however, that:

(i) personnel other than physicians or registered professional nurses involved in the performance of diagnostic procedures utilizing radioactive material, which includes performing parenteral administration of radioactive material by intravenous, intramuscular or subcutaneous methods:

(a) shall 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 administration; or

(b) shall possess certification as a nuclear medicine technologist by the American Registry of Radiologic Technologists or certification by the Nuclear Medicine Technology Board;

(ii) prior to permitting parenteral administration by a nuclear medicine technologist, the medical board of a hospital, or the radiation protection committee of an institution having no medical board, shall adopt with governing authority approval:

(a) procedures to assure that the nuclear medicine technologist possesses the education and training or certification set forth in paragraph (i) and is proficient in the competent performance of parenteral administration; and

(b) requirements for physician supervision which at a minimum shall require supervision by a physician on the premises when parenteral administration of radioactive material for diagnostic testing is performed by a qualified nuclear medicine technologist.

(4) the applicant's radiation detection and measuring instrumentation is designed for the conduct of procedures involved in the uses included in the applicable paragraph of paragraphs (1) through (5) of subdivision (b) of this section; and

(5) the applicant's radiation safety operating procedures for handling and disposal of the radioactive materials involved in the uses included in the applicable paragraph of paragraphs (1) through (5) of subdivision (b) of this section will protect public health and safety.

(b) Medical uses of radioactive material. A licensee may use radioactive materials described in the following, only if such use is authorized by the license:

(1) Use of radiopharmaceuticals for uptake, dilution and excretion studies:

(i) A licensee may use any radioactive material only if authorized by a license for such use, in any radiopharmaceutical for diagnostic uses involving measurements of uptake, dilution or excretion. The licensee shall use such radiopharmaceuticals in accordance with the manufacturer's instructions for radiation safety.

(ii) The licensee shall confine patients undergoing procedures authorized by subparagraph (i) of this paragraph until the total effective dose equivalent for the individual (other than the patient) likely to receive the greatest dose is 5 mSv (500 mrem) or less.

(iii) When the total effective dose equivalent to any individual that could result from the release of a patient is likely to exceed 1 mSv (100 mrem), the licensee shall provide the patient, or his/her competent representative, written information on risks of radiation and methods for reducing the exposure of individuals, and shall keep records of such patient release for a period of five years.

(2) Use of radiopharmaceuticals, generators and reagent kits for imaging and localization studies. (i) A licensee may use any radioactive material only if authorized by a license for such use, in any diagnostic radiopharmaceutical or reagent kit, except for aerosol and gaseous forms, for preparation and diagnostic use of a radiopharmaceutical for studies involving imaging and localization. The licensee shall prepare and use such radiopharmaceuticals in accordance with the manufacturer's instructions for radiation safety.

(ii) The licensee shall confine patients undergoing procedures authorized by subparagraph (i) of this paragraph until the total effective dose equivalent for the individuals (other than the patient) likely to receive the greatest dose is 5 mSv (500 mrem) or less.

(iii) When the total effective dose equivalent to any individual that could result from the release of a patient is likely to exceed 1 mSv (100 mrem), the licensee shall provide the patient, or his/her competent representative, written information on risks of radiation and methods for reducing the exposure of individuals, and shall keep records of such patients release for a period of five years.

(3) Use of radiopharmaceuticals for therapy.

(i) A licensee may use any radioactive material only if authorized by a license for such use, in any radiopharmaceutical for a therapeutic use. The licensee shall prepare and use such radiopharmaceuticals in accordance with the manufacturer's instructions for radiation safety.

(ii) A licensee shall confine a patient for medical care after the administration of a radiopharmaceutical for therapeutic purposes until the total effective dose equivalent for the individual (other than the patient) likely to receive the greatest dose is 5 mSv (500 mrem) or less.

(iii) Whent the total effective dose equivalent to any individual that could result from the release of a patient is likely to exceed 1 mSv (100 mrem), the licensee shall provide the patient, or his/her competent representative, written information on risks of radiation and methods for reducing the exposure of individuals, and shall keep records of such patient release for a period of five years.

(4) Use of sources for radiation therapy by surface, intracavitary or interstitial application (brachytherapy).

(i) A licensee shall use the following sources in accordance with the manufacturer's radiation safety, handling and maintenance instructions:

(a) Cesium-137 as a sealed source in needles and applicator cells for topical, interstitial and intracavitary treatment of cancer;

(b) Cobalt-60 as a sealed source in needles and applicator cells for topical, interstitial and intracavitary treatment of cancer;

(c) Gold-198 as a sealed source in seeds for interstitial treatment of cancer;

(d) Iodine-125 as a sealed source in seeds for interstitial treatment of cancer;

(e) Iridium-192 as seeds encased in nylon ribbon for interstitial treatment of cancer;

(f) Strontium-90 as a sealed source in an applicator for treatment of superficial eye conditions; and

(g) Palladium-103 as a sealed source in seeds for interstitial treatment of cancer.

(ii) A licensee shall confine a patient for medical care after the administration of a permanent implant of a radioactive source or sources until the activity in the patient is such that the total effective dose equivalent for the individual (other than the patient) likely to receive the greatest dose is 5 mSv (500 mrem) or less.
(iii) When the total effective dose equivalent to any individual that could result from the release of a patient is likely to exceed 1 mSv (100 mrem), the licensee shall provide the patient, or his/her competent representative, written information on risks of radiation and methods for reducing the exposure of individuals, and shall keep records of such patient release for a period of five years.

(5) Use of sealed sources for diagnosis.

(i) A licensee shall use the following sealed sources in accordance with the manufacturer's radiation safety, handling and maintenance instructions:

(a) Iodine-125, americium-241 or gadolinium-153 as a sealed source in a device for bone mineral analysis; and

(b) Iodine-125 as a sealed source in a portable imaging device.

(c) Any licensee who is licensed to use radioactive material pursuant to subdivision (a) of this section is subject to the following conditions:

(1) A licensee that uses molybdenum-99/technetium-99m generators for preparing technetium-99m shall:

(i) not administer to humans a radiopharmaceutical containing more than 0.15 microcurie of molybdenum-99 per millicurie of technetium 99m;

(ii) measure the molybdenum-99 concentration in each eluate or extract; and (iii) retain a record of each measurement for 3 years. The record must contain for each eluate or extract, the measured activity of the technetium-99m expressed in millicuries, the measured activity of the molybdenum expressed in microcuries, the ratio of the measures expressed as microcuries of molybdenum per millicurie of technetium, the time and date of the measurement, and the initials of the person making the measurement.

(2) No licensee shall receive, possess, or use radioactive material specified in paragraph (4) of subdivision (b) of this section except as contained in a source or device that has been manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the United States Nuclear Regulatory Commission, the State Department of Health, the State Department of Labor, the New York City Department of Health or any agreement state to the manufacturer of such source or device pursuant to licensing requirements equivalent to those contained in 10 CFR 32.74 (see section 16.200 of this Part).

(3) Any licensee who possesses and uses sources or devices containing radioactive material specified in paragraph (4) of subdivision (b) of this section shall:

(i) designate a source custodian who shall provide accountability checks of sealed sources and shall keep a record of the issue and return of all sealed sources. The source custodian shall conduct a quarterly physical inventory to account for all sources and devices received and possessed. Records of the inventories shall be maintained for inspection by the department for 3 years and shall include the quantities and kinds of radioactive material, location of sources and devices, and the date of the inventory;

(ii) cause each source or device, except Iridium 192 seeds encased in nylon ribbon, to be tested for contamination or leakage pursuant to the requirements of paragraph (4), subdivision (a), of section 16.10 of this Part;

(iii) follow the radiation safety and handling instructions approved by the United States Nuclear Regulatory Commission, the State Department of Health, the State Department of Labor, the New York City Department of Health or an agreement State and furnished by the manufacturer on the label attached to the source, device or permanent container thereof, or in the leaflet or brochure that accompanies the source or device, and maintain such instruction in a legible and conveniently available form;

(iv) assure that patients with temporary implants of radioactive sources who are hospitalized for reasons of radiation protection shall remain hospitalized until the implants are removed and that each such patient is surveyed with a radiation detection instrument to confirm that all sources have been removed before the patient is released;

(v) survey all areas where sources are stored at intervals not to exceed 3 months. Records of the surveys shall be maintained for inspection by the department for 3 years.

(d) Any licensee who is licensed pursuant to subdivision (a) of this section for one or more of the types of medical uses specified in paragraphs (1) through (5) of subdivision (b) of this section also is authorized to use radioactive material under the general license in Appendix 16-A, Table 6, Item (i) infra, for the specified "in vitro" uses without filing Form GEN 373 as required by Appendix 16-A, Table 6, Item (i), subdivision (2), infra, provided, however, that the licensee is subject to the other provisions of Appendix 16-A, Table 6, Item (i), infra.

(e) Any licensee who is licensed pursuant to subdivision (a) of this section for one or more of the types of medical uses specified in paragraphs (1) through (5) of subdivision (b) of this section also is authorized, subject to the provisions of subdivisions (f) and (g) of this section, to receive, possess, and use for calibration and reference standards:

(1) any radioactive material specified in paragraphs (1) and (2) of subdivision (b) of this section with a half-life not longer than 100 days, in amounts not to exceed a total of 15 millicuries except for technetium 99m;

(2) any radioactive material specified in paragraphs (1) and (2) of subdivision (b) of this section with a half-life greater than 100 days in amounts not to exceed 200 microcuries each;

(3) no more than 30 millicuries of technetium 99m;

(4) any radioactive material, in amounts not to exceed 15 millicuries per source, contained in calibration or reference sources that have been manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the United States Nuclear Regulatory Commission or which have been manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the State Department of Health, the State Department of Labor, the New York City Department of Health or any agreement state to the manufacturer of such radioactive material pursuant to licensing requirements equivalent to those of 10 CFR 32.74. (See section 16.200 of this Part.) (f) Any licensee who possesses sealed sources as calibration or reference sources pursuant to subdivision (e) of this section shall cause each sealed source containing radioactive material to be tested for leakage and/or contamination pursuant to the requirements of subdivision (a) of section 16.10 of this Part.

(g) Any licensee who possesses and uses calibration and reference sources pursuant to paragraph (4) of subdivision (e) of this section shall:

(1) follow the radiation safety and handling instructions approved by the United States Nuclear Regulatory Commission, the State Department of Health, the State Department of Labor, the New York City Department of Health or any agreement state and furnished by the manufacturer on the label attached to the source, or permanent container thereof, or in the leaflet or brochure that accompanies the source, and maintains such instruction in a legible and conveniently available form;

(2) designate a source custodian who shall conduct a quarterly physical inventory to account for all sources received and possessed. Records of the inventories shall be maintained for inspection by the department for 3 years and shall include the quantities and kinds of radioactive material, location of sources, and the date of the inventory.




Volume: A