Section 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; (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.Ohio Admin. Code 3701:1-58-16
Effective: 8/15/2021
Five Year Review (FYR) Dates: 11/13/2020 and 08/15/2026
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005, 12/22/2008