Ill. Admin. Code tit. 32, § 335.1110 - 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 MBq (30 µCi), any
therapeutic dosage of unsealed radioactive material or any therapeutic dose of
radiation from radioactive 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 after 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 µCi) of sodium iodide I-131, the
dosage.
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.
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) For teletherapy, the total dose, dose per
fraction, number of fractions and treatment site.
5) For high dose-rate remote afterloading
brachytherapy, the radionuclide, treatment site, dose per fraction, number of
fractions and total dose.
6) For
permanent implant brachytherapy:
A) Before
implantation: the treatment site, the radionuclide, and the total source
strength; and
B) 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
7) For all
other brachytherapy, including low, medium and pulsed dose rate remote
afterloaders:
A) Before implantation:
treatment site, the radionuclide and dose; and
B) After implantation but before completion
of the procedure: the radionuclide, treatment site, number of sources, total
source strength, and exposure time (or the total dose) and 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 the dosage of
unsealed radioactive material, the brachytherapy dose, the gamma stereotactic
radiosurgery dose, the teletherapy dose or the next fractional dose. 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 after the oral revision.
d) A
licensee shall retain a copy of each written directive as required by
subsections (a) and (c) for 5 years.
Notes
Added at 30 Ill. Reg. 9029, effective April 28, 2006
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