Current through Register Vol. 48, No. 9, September 27, 2024
4.17.1 A written
directive must be dated and signed by an authorized user before the administration
of I-131 sodium iodide greater than 1.11 Megabequerels (MBq) (30 microcuries (uCi)),
any therapeutic dosage of unsealed radioactive material or any therapeutic dose of
radiation from radioactive material.
4.17.1.1 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 must be documented as
soon as possible in writing in the patient's record. A written directive must be
prepared within 48 hours of the oral directive.
4.17.2 The written directive must contain the
patient or human research subject's name and the following information--
4.17.2.1 For any administration of quantities
greater than 1.11 MBq (30 uCi) of sodium iodide I-131: the dosage;
4.17.2.2 For an administration of a therapeutic
dosage of unsealed radioactive material other than sodium iodide I-131: the
radioactive drug, dosage, and route of administration;
4.17.2.3 For gamma stereotactic radiosurgery: the
total dose, treatment site, and values for the target coordinate settings per
treatment for each anatomically distinct treatment site;
4.17.2.4 For teletherapy: the total dose, dose per
fraction, number of fractions, and treatment site;
4.17.2.5 For high dose-rate remote afterloading
brachytherapy: the radionuclide, treatment site, dose per fraction, number of
fractions, and total dose;
4.17.2.6 For
permanent implant brachytherapy:
4.17.2.6.1 Before
implantation: The treatment site, the radionuclide, and the total source strength;
and
4.17.2.6.2 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 the date;
or
4.17.2.7 For all other
brachytherapy, including low, medium, and pulsed dose rate remote afterloaders:
4.17.2.7.1 Before implantation: The treatment
site, radionuclide, and dose; and
4.17.2.7.2 After implantation but before
completion of the procedure: the radionuclide, treatment site, number of sources,
and total source strength and exposure time (or the total dose), and
date.
4.17.3 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 the dosage of
unsealed radioactive material, the brachytherapy dose, the gamma stereotactic
radiosurgery dose, the teletherapy dose, or the next fractional dose.
4.17.3.1 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. A revised written directive must be signed by the authorized user
within 48 hours of the oral revision.
4.17.4 The licensee shall retain a copy of the
written directive in accordance with RHA 4.91.
