La. Admin. Code tit. 33 § XV-719

Current through Register Vol. 50, No. 9, September 20, 2024

Section XV-719 - Requirements for Possession of Sealed Sources and Brachytherapy Sources

A. Each licensee shall do the following.

1. Follow radiation safety and handling instructions approved by the department, the U.S. Nuclear Regulatory Commission, an agreement state, or a licensing state, and furnished by the manufacturer on the label attached to the source, device, or permanent container thereof, or in the leaflet or brochure that accompanies the source or device, and maintain such instruction in a legible and conveniently available form.

2. Assure that needles or standard medical applicator cells containing cobalt-60 as wire, radium-226, or cesium-137 are not opened while in the licensee's possession unless specifically authorized by the department.

B. A licensee in possession of a sealed source shall assure that:

1. the source is tested for leakage 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 of this Section, the licensee shall assure that:

1. leak tests are capable of detecting the presence of 0.005 microcurie (185 Bq) of radioactive material on the test sample or, in the case of radium, the escape of radon at the rate of 0.001 microcurie (37 Bq) per 24 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 for two years. 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 radiation safety officer.

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

1. immediately withdraw the sealed source from use and store it in accordance with the requirements of these regulations; and

2. file a written report with the Office of Environmental Compliance 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 30 days;

2. sources containing only radioactive material as a gas;

3. sources containing 100 microcuries (3.7 MBq) or less of beta- or photon-emitting material or 10 microcuries (370 kBq) or less of alpha-emitting material;

4. seeds of iridium-192 encased in nylon ribbon; and

5. 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 for five years. 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 radiation safety officer.

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 sources in teletherapy units or sealed sources in diagnostic devices.

I. A licensee shall retain a record of each survey required in Subsection H of this Section for two years. 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 milliroentgens per hour, the model number and serial number of the survey instrument used to make the survey, and the signature of the radiation safety officer.

J. Before the first medical use of a brachytherapy source on or after October 24, 2002, a licensee shall have:

1. determined the source output or activity using a dosimetry system that meets the requirements of LAC 33:XV.755.A;

2. determined source positioning accuracy within applicators; and

3. used published protocols currently accepted by nationally-recognized bodies to meet the requirements of Paragraphs J.1 and J.2 of this Section.

K. A licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with Subsection J of this Section.

L. A licensee shall mathematically correct the outputs or activities determined in Subsection J of this Section for physical decay at intervals consistent with 1 percent physical decay.

M. ...

N. Strontium-90 Sources for Ophthalmic Treatments.

1. Licensees who use strontium-90 for ophthalmic treatments shall ensure that certain activities as specified in Paragraph N.2 of this Section are performed by either:

a. an authorized medical physicist; or

b. an individual who:

i. is identified as an ophthalmic physicist on a specific medical use license issued by the NRC or an agreement state; permit issued by an NRC or agreement state broad scope medical use licensee; medical use permit issued by an NRC master material licensee; or permit issued by an NRC master material licensee broad scope medical use permittee;

ii. holds a master's or doctor's degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university;

iii. has successfully completed one year of fulltime training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and

iv. has documented training in:

(a). the creation, modification, and completion of written directives;

(b). procedures for administrations requiring a written directive; and

(c). performing the calibration measurements of brachytherapy sources as detailed in LAC 33:XV.719.J.

2. The individuals who are identified in Paragraph N.1 of this Section shall:

a. calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay shall be based on the activity determined under LAC 33:XV.719.J; and

b. assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directive. These procedures shall:

i. include the frequencies that the individual meeting the requirements in Paragraph N.1 of this Section will observe treatments;

ii. review the treatment methodology;

iii. calculate treatment time for the prescribed dose; and

iv. review records to verify that the administrations were in accordance with the written directives.

3. Licensees shall retain a record of the activity of each strontium-90 source for the life of the source in accordance with LAC 33:XV.744.C.

La. Admin. Code tit. 33, § XV-719

Promulgated by the Department of Environmental Quality, Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 18:34 (January 1992), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 26:2589 (November 2000), LR 30:1176 (June 2004), amended by the Office of the Secretary, Legal Affairs Division, LR 31:2533 (October 2005), LR 33:2185 (October 2007), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 471856 (12/1/2021).

AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq. and 2104.B.