Section 0400-20-07-.21 - PROCEDURES FOR ADMINISTRATIONS REQUIRING A WRITTEN DIRECTIVE(1) For any administration requiring a written directive, a licensee shall develop, implement, and maintain written procedures to provide high confidence that: (a) The patient's or human research subject's identity is verified before each administration; and(b) Each administration is in accordance with the written directive.(2) At a minimum, the procedures required by paragraph (1) of this rule must address the following activities that are applicable to the licensee's use of radioactive material: (a) Verifying the identity of the patient or human research subject;(b) Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive;(c) Checking both manual and computer-generated dose calculations;(d) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by Rule 0400-20-07-.63 or 0400-20-07-.81;(e) Determining if a patient or medical event, as defined in Rule 0400-20-07-.114, has occurred; and(f) 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.(3) A licensee shall retain a copy of the procedures required under paragraph (1) of this rule in accordance with Rule 0400-20-07-.112.Tenn. Comp. R. & Regs. 0400-20-07-.21
Original rule filed February 22, 2012; effective May 22, 2012. Amendments filed December 4, 2023; effective 3/3/2024.Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.