HAR §11-45-142. Assay of radiopharmaceutical dosages

(a) An assay shall be conducted, before medical use, of the activity of each radiopharmaceutical dosage that contains more than ten microcuries (three hundred seventy kilobecquerels) of a photon- emitting radionuclide; §11-45-142 45-126 (b) Radiopharmaceuticals emitting alpha and/or beta radiations as the radiation of principal interest shall be obtained: (1) In unit dose form, calibrated by the supplier for individual patients; and (2) From a supplier which participates in a measurement quality assurance program with the National Institute of Standards and Technology, and which is designed to ensure that unit doses have a calibration traceable to a national standard. (c) The licensee shall retain a record of the assays or calibrations required by subsections (a) and (b). To satisfy this requirement, the record shall contain the: (1) Radiopharmaceutical, or the radionuclide administered; (2) Patient's name, and identification number if one has been assigned; (3) Prescribed dosage and measured activity of the dosage at the time of assay, or a notation that the total activity was determined by a calibration traceable to a national standard; (4) Date and time of the assay or calibration and the date and time of the administration; and (5) Initials of the individual who performed the assay or documentation of the supplier's participation in the measurement quality assurance program. [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71) §11-45-143 Authorization for calibration and reference sources. A licensee for medical use of radioactive material may receive, possess, and use the following radioactive material for check, calibration and reference use: (1) Sealed sources manufactured and distributed by persons specifically licensed pursuant to these rules or provisions of the U.S. Nuclear Regulatory Commission, and that do not exceed fifteen millicuries (five hundred fifty-five megabecquerels) each; (2) Any radioactive material with a half-life of one hundred days or less in individual amounts not to exceed fifteen millicuries (five hundred fifty- five megabecquerels); and (3) Any radioactive material with a half-life greater than one hundred days in individual amounts not to exceed two hundred microcuries (7.4 megabecquerels) each. [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71) §11-45-144 Possession of sealed sources and brachytherapy sources. (a) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer or equivalent instructions approved by the department and shall maintain the §11-45-144 45-127 instructions for the duration of source use in a legible form convenient to users. (b) A licensee in possession of a sealed source shall assure that: (1) The source is tested before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within six months before transfer to the licensee; and (2) The source is tested for leakage at intervals not to exceed six months or at intervals approved by the department, another agreement state, a licensing state, or the U.S. Nuclear Regulatory Commission. (c) To satisfy the leak test requirements of subsection (b), the licensee shall assure that: (1) Leak tests are capable of detecting the presence of 0.005 microcuries (one hundred eighty-five becquerels) of radioactive material on the test sample, or in the case of radium, the escape of radon at the rate of 0.001 microcuries (thirty-seven becquerels) per twenty-four hours; (2) Test samples are taken from the source or from the surfaces of the device in which the source is mounted or stored on which radioactive contamination might be expected to accumulate; and (3) Test samples are taken when the source is in the "off" position. (d) A licensee shall retain leak test records. The records shall contain the model number and serial number, if assigned, of each source tested, the identity of each source radionuclide and its estimated activity, the measured activity of each test sample expressed in microcuries (becquerels), a description of the method used to measure each test sample, the date of the test, and the signature of the individual who performed the test. (e) If the leak test reveals the presence of 0.005 microcuries (one hundred eighty-five becquerels) or more of removable contamination, the licensee shall: (1) Immediately withdraw the sealed source from use and store, repair, or dispose of it in accordance with the requirements of subchapter 4; and (2) File a report with the department within five days of receiving the leak test results describing the equipment involved, the test results, and the action taken. (f) A licensee need not perform a leak test on the following sources: (1) Sources containing only radioactive material with a half-life of less than thirty days; (2) Sources containing only radioactive material as a gas; (3) Sources containing one hundred microcuries (3.7 megabecquerels) or less of beta- or photon-emitting material or ten microcuries (three hundred seventy kilobecquerels) or less of alpha-emitting material; and §11-45-144 45-128 (4) Sources stored and not being used. The licensee shall, however, test each such source for leakage before any use or transfer unless it has been tested for leakage within six months before the date of use or transfer. (g) A licensee in possession of a sealed source or brachytherapy source shall conduct a physical inventory of all such sources at intervals not to exceed three months. The licensee shall retain each inventory record. The inventory records shall contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its estimated activity, the location of each source, date of the inventory, and the signature of the individual who performed the inventory. (h) A licensee in possession of a sealed source or brachytherapy source shall survey with a radiation survey instrument at intervals not to exceed three months all areas where such sources are stored. This does not apply to teletherapy units or sealed sources in diagnostic devices. (i) A licensee shall retain a record of each survey required in subsection (h). The record shall include the date of the survey, a sketch of each area that was surveyed, the measured dose rate at several points in each area expressed in millirem (millisieverts) per hour, the model number and serial number of the survey intrument used to make the survey, and the signature of the individual who performed the survey. [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71)