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Due to a lapse in appropriations, the NRC has ceased normal operations. However, excepted and exempted activities necessary to maintain critical health and safety functions—as well as essential progress on designated critical activities, including those specified in Executive Order 14300—will continue, consistent with the OMB-Approved NRC Lapse Plan.

§ 35.41 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 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;

(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;

(5) Determining if a medical event, as defined in § 35.3045, has occurred; and

(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.

(c) A licensee shall retain a copy of the procedures required under paragraph (a) in accordance with § 35.2041.

[72 FR 45151, Aug. 13, 2007; 83 FR 33104, Jul. 16, 2018]

Page Last Reviewed/Updated Wednesday, January 16, 2019

Page Last Reviewed/Updated Wednesday, January 16, 2019