Fla. Admin. Code Ann. R. 64E-5.614 - Possession, Use, Calibration, and Check of Dose Calibrators in the Use of Unsealed Radiopharmaceuticals
(1) A
medical use licensee authorized to administer radiopharmaceuticals shall
possess a dose calibrator and use it to measure the amount of activity
administered to each patient or human research subject.
(2) A licensee shall check each dose
calibrator before use each day of use, or during an assigned shift for
facilities operating continuously, for constancy with a dedicated check source.
The check shall be performed 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. A record shall be made of each check, which shall include:
(a) The model and serial number of the dose
calibrator;
(b) The identity and
decay corrected activity of the radionuclide contained in the check
source;
(c) The date of the
check;
(d) The activity
measured;
(e) The percent
error;
(f) The instrument settings;
and,
(g) The name or initials of
the individual performing the check.
(3) The licensee shall test each dose
calibrator for accuracy at the time of installation and at least every 12
months. The test shall be completed by assaying at least two sealed sources
containing different radionuclides, the activity of which has been determined
by the National Institute of Standards and Technology (NIST) or by the
manufacturer who has compared their source to a source calibrated by the NIST.
The sources shall have a minimum activity of 10 microcuries (370 kBq) for
radium 226 and 50 microcuries (1.85 MBq) for any other photon-emitting
radionuclide. At least one of the sources shall have a principal photon energy
between 100 kiloelectron volts and 500 kiloelectron volts. A record shall be
made of each test, which shall include:
(a)
The model and serial number of the dose calibrator;
(b) The model and serial number of each
source used and the identity of the radionuclide contained in the source and
its activity;
(c) The date of the
test;
(d) The results of the
test;
(e) The instrument settings;
and,
(f) The name of the individual
performing this test.
(4)
The licensee shall test each dose calibrator for linearity at the time of
installation and at least every 3 months over the range of use between 10
microcuries (370 kBq) and the highest dosage that will be administered. A
record shall be made of each test, which shall include:
(a) The model and serial number of the dose
calibrator;
(b) The calculated
activities;
(c) The measured
activities;
(d) The date of the
test; and,
(e) The name of the
individual performing this test.
(5) The licensee shall test each dose
calibrator for geometry dependence at the time of 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. A record shall be made of each test, which shall include:
(a) The model and serial number of the dose
calibrator;
(b) The configuration
of the source measured;
(c) The
activity measured and the instrument setting for each volume
measured;
(d) The date of the test;
and,
(e) The name of the individual
performing this test.
(6)
A licensee shall correct mathematically 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.
(7) A licensee shall also perform checks and
tests required by Rule
64E-5.614, F.A.C., following
adjustment or repair of the dose calibrator.
(8) A licensee shall retain a record of each
check and test required by Rule
64E-5.614, F.A.C., for 3
years.
(9) A licensee may calibrate
instrumentation used in Rule
64E-5.614, F.A.C., using
nationally recognized standards or the manufacturer's instructions. The
standards or instructions used by the licensee must be available for inspection
by the department.
Notes
Rulemaking Authority 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS.
New 8-25-91, Formerly 10D-91.720, Amended 2-11-10, 12-26-13.
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
(1) A medical use licensee authorized to administer radiopharmaceuticals shall possess a dose calibrator and use it to measure the amount of activity administered to each patient or human research subject.
(2) A licensee shall check each dose calibrator before use each day of use, or during an assigned shift for facilities operating continuously, for constancy with a dedicated check source. The check shall be performed 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. A record shall be made of each check, which shall include:
(a) The model and serial number of the dose calibrator;
(b) The identity and decay corrected activity of the radionuclide contained in the check source;
(c) The date of the check;
(d) The activity measured;
(e) The percent error;
(f) The instrument settings; and,
(g) The name or initials of the individual performing the check.
(3) The licensee shall test each dose calibrator for accuracy at the time of installation and at least every 12 months. The test shall be completed by assaying at least two sealed sources containing different radionuclides, the activity of which has been determined by the National Institute of Standards and Technology (NIST) or by the manufacturer who has compared their source to a source calibrated by the NIST. The sources shall have a minimum activity of 10 microcuries (370 kBq) for radium 226 and 50 microcuries (1.85 MBq) for any other photon-emitting radionuclide. At least one of the sources shall have a principal photon energy between 100 kiloelectron volts and 500 kiloelectron volts. A record shall be made of each test, which shall include:
(a) The model and serial number of the dose calibrator;
(b) The model and serial number of each source used and the identity of the radionuclide contained in the source and its activity;
(c) The date of the test;
(d) The results of the test;
(e) The instrument settings; and,
(f) The name of the individual performing this test.
(4) The licensee shall test each dose calibrator for linearity at the time of installation and at least every 3 months over the range of use between 10 microcuries (370 kBq) and the highest dosage that will be administered. A record shall be made of each test, which shall include:
(a) The model and serial number of the dose calibrator;
(b) The calculated activities;
(c) The measured activities;
(d) The date of the test; and,
(e) The name of the individual performing this test.
(5) The licensee shall test each dose calibrator for geometry dependence at the time of 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. A record shall be made of each test, which shall include:
(a) The model and serial number of the dose calibrator;
(b) The configuration of the source measured;
(c) The activity measured and the instrument setting for each volume measured;
(d) The date of the test; and,
(e) The name of the individual performing this test.
(6) A licensee shall correct mathematically 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.
(7) A licensee shall also perform checks and tests required by Rule 64E-5.614, F.A.C., following adjustment or repair of the dose calibrator.
(8) A licensee shall retain a record of each check and test required by Rule 64E-5.614, F.A.C., for 3 years.
(9) A licensee may calibrate instrumentation used in Rule 64E-5.614, F.A.C., using nationally recognized standards or the manufacturer's instructions. The standards or instructions used by the licensee must be available for inspection by the department.
Notes
Rulemaking Authority 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS.
New 8-25-91, Formerly 10D-91.720, Amended 2-11-10, 12-26-13.