La. Admin. Code tit. 33, § XV-715 - Possession, Use, Calibration, and Checking of Dose Calibrators and of Instruments to Measure Dosages of Alpha-Emitting or Beta-Emitting Radionuclides

Current through Register Vol. 48, No. 3, March 20, 2022

A. For direct measurements performed in accordance with LAC 33:XV.717, a licensee shall possess and use instrumentation to measure the activity of unsealed radioactive material before it is administered to each patient or human research subject.
B. A licensee shall do the following.
1. 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 kBq) of radium-226 or 50 microcuries (1.85 MBq) of any other photon-emitting radionuclide with a half-life greater than 90 days.
2. 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 5 percent of the stated activity, with minimum activity of 10 microcuries (370 kBq) for radium-226 and 50 microcuries (1.85 MBq) for any other photon-emitting radionuclide, and at least one of which has a principal photon energy between 100 keV and 500 keV.
3. Test each dose calibrator for linearity upon installation and at intervals not to exceed three months thereafter over the range of use between 10 microcuries (370 kBq) and the highest dosage that will be administered.
4. 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.
C. A licensee shall mathematically correct dosage readings for any geometry or linearity error that exceeds 10 percent if the dosage is greater than 10 microcuries (370 kBq) and shall repair or replace the dose calibrator if the accuracy or constancy error exceeds 10 percent.
D. A licensee shall also perform checks and tests required by Subsection B of this Section following adjustment or repair of the dose calibrator.
E. A licensee shall retain a record of each check and test required by this Section for two years. The records for the checks and tests required by Subsection B of this Section shall include:
1. for Paragraph B.1 of this Section, the model and serial number of the dose calibrator, 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 initials of the individual who performed the check;
2. for Paragraph B.2 of this Section, 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, the date of the test, the results of the test, the instrument settings, and the signature of the radiation safety officer;
3. for Paragraph B.3 of this Section, 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
4. for Paragraph B.4 of this Section, 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.
F. Possession, Use, Calibration, and Check of Instruments to Measure Dosages of Alpha-Emitting or Beta-Emitting Radionuclides
1. This Subsection does not apply to unit dosages of alpha-emitting or beta-emitting radionuclides that are obtained from a manufacturer or preparer licensed in accordance with LAC 33:XV.Chapter 3, equivalent agreement state, or Nuclear Regulatory Commission requirements.
2. For other than unit dosages obtained in accordance with Paragraph F.1 of this Section, a licensee shall possess and use instrumentation to measure the radioactivity of alpha-emitting or beta-emitting radionuclides. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-emitting or beta-emitting radionuclides prior to administration to each patient or human research subject. In addition, the licensee shall:
a. perform tests before initial use, periodically, and following repair on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument and make adjustments when necessary; and
b. check each instrument for constancy and proper operation at the beginning of each day of use.
G. A licensee shall calibrate the instrumentation required in Subsection A of this Section in accordance with nationally-recognized standards or the manufacturer's instructions.

Notes

La. Admin. Code tit. 33, § XV-715
Promulgated by the Department of Environmental Quality, Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 18:34 (January 1992), amended LR 24:2103 (November 1998), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 30:1175 (June 2004).
AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq.

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