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Electronic Code of Federal Regulations

e-CFR data is current as of June 3, 2020

Title 10Chapter IPart 35Subpart B → §35.41


Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
Subpart B—General Administrative Requirements


§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.

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 45151, Aug. 13, 2007; 83 FR 33104, July 16, 2018]

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