Illinois Administrative Code
Title 32 - ENERGY
Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL
Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS
Section 335.1120 - Procedures for Administrations Requiring a Written Directive
Universal Citation: 32 IL Admin Code ยง 335.1120
Current through Register Vol. 48, No. 12, March 22, 2024
a) 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.
b) At a minimum, the procedures required by subsection (a) shall address the following items that are applicable to the licensee's use of radioactive 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 Section
335.2140
or
335.8010;
5) Determining if a medical event, as
described in Section
335.1080,
has occurred;
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; and
7) Determining, for administrations of I-131
in quantities greater than 1.11 MBq (30 µCi), the criteria to be used to
identify patients required to be tested for pregnancy in accordance with
subsection
335.5010(b),
including type of pregnancy testing permitted, time in advance of I-131
administration in which the tests shall be conducted, age range of patients to
be tested, and criteria a physician may use to determine that a patient is not
capable of childbirth.
c) A licensee shall retain a copy of the procedures required by subsection (a) for the duration of the license.
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