10 CFR 35.41, Procedures for Administrations Requiring a Written Directive
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Procedures for administrations requiring a written directive
a
(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
(b) At a minimum, the procedures required by paragraph (a) of this section must address the following items that are applicable to the licensee's use of byproduct 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 §§ 35.600 or 35.1000.
c
(c) A licensee shall retain a copy of the procedures required under paragraph (a) in accordance with § 35.2041.
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