019.01
DATE AND SIGNATURE. A written directive must be dated
and signed by an authorized user prior to administration of I-131 sodium iodide
greater than 1.11 megabecquerels (MBq) (30 microcuries (µCi)), any
therapeutic dosage of unsealed radioactive material or any therapeutic dose of
radiation from radioactive material.
(A) 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, provided that the information contained in the oral
directive is documented as soon as possible in writing in the patient's record
and a written directive is prepared within 48 hours of the oral
directive.
019.02
REQUIRED INFORMATION. The written directive must
contain the patient or human research subject's name and the following
information:
(A) For any administration of
dosage of radioactive drug containing radioactive material: the radioactive
drug containing radioactive material, dosage, and the route of
administration;
(B) For gamma
stereotactic radiosurgery: the total dose, treatment site, and number of target
coordinate settings per treatment for each anatomically distinct treatment
site;
(C) For teletherapy: the
total dose, dose per fraction, number of fractions, and treatment
site;
(D) For HDR remote
afterloading brachytherapy: the radionuclide, treatment site, dose per
fraction, number of fractions, and total dose;
(E) For permanent implant brachytherapy:
(i) Before implantation: The treatment site,
the radionuclide, and the total source strength; and
(ii) After implantation but before the
patient leaves the post-treatment recovery area:
The treatment site, the number of sources implanted, the
total source strength implanted, and date; or
(F) For all other brachytherapy, including
low, medium, and pulsed dose rate remote afterloaders:
(i) Before implantation: treatment site, the
radionuclide, and dose; and
(ii)
After implantation but prior to completion of the procedure: the radioisotope,
treatment site, number of sources, and total source strength and exposure time,
or the total dose; and the date.
019.03
WRITTEN
REVISIONS. A written revision to an existing written directive may
be made provided that the revision is dated and signed by an authorized user
prior to the administration of the dosage of radioactive drug containing
unsealed radioactive material, the brachytherapy dose, the gamma stereotactic
radiosurgery dose, the teletherapy dose, or the next fractional dose.
(A) 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 must be documented as soon as
possible in the patient's record and a revised written directive is signed by
the authorized user within 48 hours of the oral revision.
019.04
RETENTION.
The licensee must retain a copy of the written directive according to 180 NAC
7-088.
