Or. Admin. Code § 333-116-0107

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-116-0107 - Procedures for Administrations Requiring a Written Directive

(1) For any administration requiring a written directive, the licensee must 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) The procedures required by section (1) of this rule must, at a minimum, address the following items applicable to the licensee's use of radioactive material:

(a) Verifying the identity of the patient or human research subject;

(b) Verifying that the specific details of the administration are in accordance with the written directive and, if applicable, the treatment plan;

(c) Checking both manual and computer-generated dose calculations;

(d) Verifying that any computer-generated dose calculations are correctly transferred into the console of therapeutic medical units authorized by OAR 333-116-0480 and 333-116-0485;

(e) Determining if a medical event, as defined in OAR 333-116-0020 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) The licensee must retain a copy of procedures in accordance with OAR 333-100-0057.

Or. Admin. Code § 333-116-0107

PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 81-2021, amend filed 11/19/2021, effective 11/23/2021

Statutory/Other Authority: ORS 453.635

Statutes/Other Implemented: ORS 453.605 - 453.807