Current through Register Vol. 50, No. 3, March 20, 2024
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.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
30:2001 et
seq.
