La. Admin. Code tit. 33 § XV-777

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

Section XV-777 - Written Directives

A. A written directive shall be dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 1.11 megabecquerels (MBq) (30 microcuries (µCi)), any therapeutic dosage of unsealed byproduct material, or any therapeutic dose of radiation from byproduct material. If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive shall be documented as soon as possible in writing in the patient's record. A written directive shall be prepared within 48 hours of the oral directive.

B. The written directive shall contain the patient's or human research subject's name and the following information:

1. for any administration of quantities greater than 1.11 MBq (30 m Ci) of sodium iodide I-131, the dosage;

2. for an administration of a therapeutic dosage of unsealed byproduct material other than sodium iodide I-131:

a. the radioactive drug;

b. the dosage; and

c. the route of administration;

3. for gamma stereotactic radiosurgery:

a. the total dose;

b. the treatment site; and

c. the values for the target coordinate settings per treatment for each anatomically distinct treatment site;

4. for teletherapy:

a. the total dose;

b. the dose per fraction;

c. the number of fractions; and

d. the treatment site;

5. for high dose-rate remote afterloading brachytherapy:

a. the radionuclide;

b. the treatment site;

c. the dose per fraction;

d. the number of fractions; and

e. the total dose;

6. for permanent implant brachytherapy:

a. before implantation:

i. the treatment site;

ii. the radionuclide; and

iii. the total source strength; and

b. after implantation but before the patient leaves the post-treatment recovery area:

i. the treatment site;

ii. the number of sources implanted;

iii. the total source strength implanted; and

iv. the date; or

7. for all other brachytherapy, including low, medium, and pulsed dose-rate remote afterloaders:

a. before implantation:

i. the treatment site;

ii. the radionuclide; and

iii. the dose; and

b. after implantation but before completion of the procedure:

i. the radionuclide;

ii. the treatment site;

iii. the number of sources;

iv. the total source strength and exposure time (or the total dose); and

v. the date.

C. A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of:

1. the dosage of unsealed byproduct material;

2. the brachytherapy dose;

3. the gamma stereotactic radiosurgery dose;

4. the teletherapy dose; or

5. the next fractional dose.

D. If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision shall be documented as soon as possible in the patient's record. A revised written directive shall be signed by the authorized user within 48 hours of the oral revision.

E. The licensee shall retain a copy of each written directive as required by this Section for three years.

F. For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that:

1. the patient's or human research subject's identity is verified before each administration; and

2. each administration is in accordance with the written directive.

G. At a minimum, the procedures required by Subsection F of this Section shall address the following items that are applicable to the licensee's use of byproduct material:

1. verifying the identity of the patient or human research subject;

2. verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive;

3. checking both manual and computer-generated dose calculations;

4. verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by LAC 33:XV.747;

5. determining if a medical event, as described in LAC 33:XV.712, has occurred; and

6. determining, for permanent implant brachytherapy, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented.

H. The licensee shall retain a copy of the procedures required under Subsection F of this Section for the duration of the license.

La. Admin. Code tit. 33, § XV-777

Promulgated by the Department of Environmental Quality, Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 18:34 (January 1992), amended LR 21:554 (June 1995), LR 24:2110 (November 1998), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 26:2591 (November 2000), LR 30:1187 (June 2004), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 471867 (12/1/2021).

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