N.M. Admin. Code § 20.3.7.703

Current through Register Vol. 36, No. 1, January 14, 2025

Section 20.3.7.703 - GENERAL TECHNICAL REQUIREMENTS

A.Possession, use and calibration of instruments used to measure the activity of unsealed radioactive material. Other than unit dosages of beta-emittingunsealed radioactive material obtained from the manufacturer or preparer, licensed pursuant to Subsection J of 20.3.3.315 NMAC, a medical use licensee authorized to administer radiopharmaceuticals shall possess a dose calibrator, and use it to measure the activity of unsealed radioactive material prior to the administration to each patient or human research subject for diagnostic applications. For therapeutic applications, a medical use licensee authorized to administer radiopharmaceuticals shall possess a dose calibrator, and use it to measure the activity of unsealed radioactive material prior to and after the administration to each patient or human research subject.

(1) A licensee shall:

(a) check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use; to satisfy the requirements of this section, the check shall be done on a frequently used setting with a sealed source of not less than 10 microcuries (370 kilobecquerels) of radium-226 or 50 microcuries (1.85 megabecquerels) of any other photon-emitting radionuclide;

(b) test each dose calibrator for accuracy upon installation and at intervals not to exceed 12 months thereafter by assaying at least two sealed sources containing different radionuclides, the activity of which the manufacturer has determined within five percent of the stated activity, with minimum activity of 10 microcuries (370 kilobecquerels) for radium-226 and 50 microcuries (1.85 megabecquerels) for any other photon-emitting radionuclide, and at least one of which has a principal photon energy between 100 kiloelectron volts and 500 kiloelectron volts;

(c) test each dose calibrator for linearity upon installation and at intervals not to exceed three months thereafter over the range of use between 30 microcuries (1.11 megabecquerels), and the highest dosage that will be administered to a patient or human research subject; 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 shall keep a record of this test for the duration of the use of the dose calibrator.

(2) A licensee shall mathematically correct dosage readings for any geometry or linearity error that exceeds ten percent if the dosage is greater than 10 microcuries (370 kilobecquerels), and shall repair or replace the dose calibrator if the accuracy or constancy error exceeds ten percent.

(3) A licensee shall also perform checks and tests required under this subsection, following adjustment or repair of the dose calibrator.

(4)Beta-emitting radionuclides. A licensee shall develop quality control procedures and use appropriate instrumentation to measure the radioactivity for beta-emitting radiopharmaceuticals. A licensee may use checks, tests or calibration techniques other than those described in this section for instruments measuring the dosages of beta-emitting unsealed radioactive material if checks, tests or calibration techniques are in accordance with nationally recognized standards or the equipment manufacturer's instructions and have been approved by the department.

(5) A licensee shall retain a record of each instrument check, test and calibration required by this subsection in accordance with Subsection E of 20.3.7.715 NMAC.

B.Determination of dosages of unsealed radioactive material for medical use.

(1) A licensee shall determine and record the activity of each dosage before medical use for diagnostic applications and before and after medical use for therapeutic applications.

(2) This determination must be made by:

(a) direct measurement of radioactivity pursuant to Subsection A of this section;

(b) combination of direct measurement of radioactivity pursuant to Subsection A of this section and mathematical calculations;

(c) combination of volumetric measurements and mathematical calculations, based on the measurement made by:

(i) a manufacturer or preparer licensed under Subsection J of 20.3.3.315 NMAC or equivalent requirement of NRC or agreement state; or

(ii) a PET radioactive drug producer licensed under Subsection J of 20.3.3.307 NMAC or equivalent NRC or agreement state requirements; or

(d) decay correction, for unit dosages of beta-emitting unsealed radioactive material, based on the activity or activity concentration determined by:

(i) a manufacturer or preparer licensed under Subsection J of 20.3.3.315 NMAC or equivalent NRC or agreement state requirement;

(ii) a department, NRC or agreement state licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug (IND) protocol accepted by FDA; or

(iii) a PET radioactive drug producer licensed under Subsection J of 20.3.3.307 NMAC or equivalent NRC or agreement state requirements.

(3) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than twenty percent.

(4) A licensee shall retain a record of the dosage determination required by this subsection in accordance with Subsection G of 20.3.7.715 NMAC.

C.Calibration and check of radiation survey instruments.

(1) A licensee shall calibrate the radiation survey instruments used to show compliance with this part and 20.3.4 NMAC before first use, annually and following a repair that affects the calibration.

(2) A licensee shall:

(a) calibrate all scales with readings up to 1000 millirems (10 millisieverts) per hour with a radiation source;

(b) calibrate two separate readings on each scale or decade that will be used to show compliance; and

(c) conspicuously note on the instrument the date of calibration.

(3) A licensee shall consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by no more than twenty percent.

(4) A licensee shall check each radiation survey instrument for proper operation with a dedicated check source at the beginning of each day of use.

(5) A licensee shall retain a record of each radiation survey instrument calibration in accordance with Subsection F of 20.3.7.715 NMAC.

D.Quality control for other equipment. Each licensee shall establish written quality control procedures (checks, tests, calibrations, efficiency measurements, etc.) for equipment used to obtain quantitative radiation measurements for radionuclide studies, described in this part, or radiation safety surveys, necessary to demonstrate compliance with this part and 20.3.4 NMAC. At a minimum, quality control procedures and their frequencies shall be those recommended by the equipment manufacturer.

E.Authorization for calibration, transmission and reference sources. Any person authorized by Subsection D of 20.3.7.700 NMAC for medical use of radioactive material may receive, possess and use any of the following radioactive material for check, calibration, transmission and reference use:

(1) sealed sources, not exceeding 30 millicuries (1.11 gigabecquerels) each, manufactured and distributed by a person specifically licensed under Subsection K of 20.3.3.315 NMAC or equivalent NRC or an agreement state requirements;

(2) sealed sources, not exceeding 30 millicuries (1.11 gigabecquerels) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under Subsection K of 20.3.3.315 NMAC, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions;

(3) any radioactive material with a half-life no longer than 120 days in individual amounts not to exceed 15 millicuries (0.56 gigabecquerel);

(4) any radioactive material with a half-life longer than 120 days in individual amounts not to exceed 200 microcuries (7.4 megabecquerels) or 1000 times the quantities in 20.3.3.338 NMAC; and

(5) technetium-99m in amounts as needed but not to exceed 100 millicuries.

F.Requirements for possession of sealed sources and brachytherapy sources.

(1) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer and shall maintain the instructions for the duration of source use in a legible form convenient for users.

(2) A licensee in possession of a sealed source shall:

(a) test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months before transfer to the licensee; and

(b) test the source for leakage at intervals not to exceed six months or at other intervals approved by the department, NRC or an agreement state.

(3) To satisfy the leak test requirements of this subsection, the licensee shall measure the sample so that the leak test can detect the presence of 0.005 microcurie (185 becquerels) of radioactive material in the sample.

(4) A licensee shall retain leak test records in accordance with Paragraph (1) of Subsection H of 20.3.7.715 NMAC.

(5) If the leak test reveals the presence of 0.005 microcurie (185 becquerels) or more of removable contamination, the licensee shall:

(a) immediately withdraw the sealed source from use and store, cause it to be repaired or disposed of in accordance with the requirements in 20.3.3 NMAC and 20.3.4 NMAC; and

(b) file a report within five days of the leak test result in accordance with Subsection C of 20.3.7.716 NMAC.

(6) A licensee need not perform a leak test on the following sources:

(a) sources containing only radioactive material with a half-life of less than 30 days;

(b) sources containing only radioactive material as a gas;

(c) sources containing 100 microcuries (3.7 megabecquerels) or less of beta or gamma-emitting material or 10 microcuries (0.37 megabecquerel) or less of alpha-emitting material;

(d) seeds of iridium-192 encased in nylon ribbon; and

(e) sources stored and not being used; however, the licensee shall test each such source for leakage before any use or transfer unless it has been leak tested within six months, or other frequency approved by the department, NRC or an agreement state, before the date of use or transfer.

(7) A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession. The licensee shall retain each inventory record in accordance with Paragraph (2) of Subsection H of 20.3.7.715 NMAC.

G.Labeling of vials and syringes. Each syringe and vial that contains unsealed radioactive material must be labeled to identify the radioactive drug. Each syringe shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded.

H.Surveys for contamination and ambient radiation exposure rate.

(1) In addition to the surveys required by 20.3.4 NMAC:

(a) a licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared or administered; and

(b) a licensee shall survey for removable contamination at the end of each day of use all areas where radiopharmaceuticals requiring written directive are routinely prepared for use or administered.

(2) A licensee does not need to perform the surveys required by Paragraph (1) of this subsection in areas where patients or human research subjects are confined when they cannot be released under Subsection I of 20.3.7.703 NMAC.

(3) A licensee shall retain a record of each survey in accordance with Subsection I of 20.3.7.715 NMAC.

I.Release of individuals containing radiopharmaceuticals or permanent implants.

(1) A licensee may authorize the release from its control of any individual who has been administered unsealed radioactive material or implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 0.5 rem ( five millisieverts) (the current revision of the NRC guidance NUREG-1556, volume 9, "consolidated guidance about materials licenses: program-specific guidance about medical licenses", describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 0.5 rem ( five millisieverts)).

(2) A licensee shall provide the released individual or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 0.1 rem (one millisievert). If the total effective dose equivalent to a nursing infant or child could exceed 0.1 rem (one millisievert), assuming there was no interruption of breast-feeding, the instructions must also include:

(a) guidance on the interruption or discontinuation of breast-feeding; and

(b) information on the potential consequences, if any, of failure to follow the guidance.

(3) A licensee shall maintain a record of the basis for authorizing the release of an individual, in accordance with Paragraph (1) of Subsection J of 20.3.7.715 NMAC.

(4) The licensee shall maintain a record of instructions provided to a breast-feeding female in accordance with Paragraph (2) of Subsection J of 20.3.7.715 NMAC.

J.Provision of mobile medical service.

(1) A licensee providing mobile medical service shall:

(a) obtain a letter signed by the management of each client for which services are rendered that permits the use of radioactive material at the client's address and clearly delineates the authority and responsibility of the licensee and the client;

(b) check instruments used to measure the activity of unsealed radioactive material for proper function before medical use at each client's address or on each day of use, whichever is more frequent; at a minimum, the check for proper function required by this paragraph must include a constancy check;

(c) check radiation survey instruments for proper operation with a dedicated check source before use at each client's address or on each day of use, whichever is more frequent; and

(d) before leaving a client's address, survey all areas of use to ensure compliance with the requirements in 20.3.4 NMAC and 20.3.7 NMAC.

(2) A mobile medical service may not have radioactive material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client must be received and handled in conformance with the client's license.

(3) A licensee providing mobile medical services shall retain the letter required in Subparagraph (a) of Paragraph (1) of this subsection and the record of each survey required in Subparagraph (d) of Paragraph (1) of this subsection in accordance with Paragraphs (1) and (2) of Subsection K of 20.3.7.715 NMAC, respectively.

K.Storage of volatiles and gases.

(1) A license shall store volatile radiopharmaceuticals and radioactive gases in the shipper's radiation shield and container.

(2) A license shall store and use a multi-dosage container in a properly functioning fume hood.

L.Decay-in-storage.

(1) A licensee may hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard of its radioactivity if the licensee:

(a) holds radioactive material for decay a minimum of 10 half-lives;

(b) monitors radioactive material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey instrument set on its most sensitive scale and with no interposed shielding;

(c) removes or obliterates all radiation labels, except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee; and

(d) separates and monitors each generator column individually with all radiation shielding removed to ensure that its content have decayed to background radiation level before disposal.

(2) A licensee shall retain a record of each disposal permitted under Paragraph (1) of this subsection in accordance with Subsection L of 20.3.7.715 NMAC.

N.M. Admin. Code § 20.3.7.703

20.3.7.703 NMAC - Rp, 20 NMAC 3.1.7.703, 4/30/2009, Amended by New Mexico Register, Volume XXVIII, Issue 11, June 13, 2017, eff. 6/13/2017