Ohio Admin. Code 3701:1-58-16 - Procedures for administrations requiring a written directive
(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
paragraph (A) of this rule must 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; and
(4)
Verifying that any computer-generated dose calculations are correctly
transferred into the consoles of therapeutic medical units authorized by rule
3701:1-58-55
or
3701:1-58-72
of the Administrative Code.
;
(5)
Determining if a
medical event, as defined in rule
3701:1-58-101
of the Administrative Code, has occurred; and
(6)
Determining, for
permanent implant brachytherapy, within sixty 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.
(C) A licensee shall retain a copy
of the procedures required under paragraph (A) of this rule in accordance with
rule
3701:1-58-76
of the Administrative Code.
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005, 12/22/2008
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