Current through Register Vol. 50, No. 3, March 20, 2024
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.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
30:2001 et seq., and
2104.B.
