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 subsection (A) 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 Exhibit A Group 600 or 1000 of this Article;
- 5. Determining if a medical event, as defined in R9-7-745, has occurred; and
- 6. Determining, for permanent implant brachytherapy, within 60 calendar days after 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.
Historical Note
New Section R9-7-708 recodified from R12-1-708 at 24 A.A.R. 813, effective March 22, 2018 (Supp. 18-1).
Section amended by final expedited rulemaking at 31 A.A.R. 4744 (December 26, 2025), with an immediate effective date of December 3, 2025 (Supp. 25-4).