Procedures for Administrations Requiring a Written Directive

Section 335.1120  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 subsection (a) shall 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 Section 335.2140 or 335.8010; 5)         Determining if a medical event, as described in Section 335.1080, has occurred; 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; and 7)         Determining, for administrations of I-131 in quantities greater than 1.11 MBq (30 μCi), the criteria to be used to identify patients required to be tested for pregnancy in accordance with subsection 335.5010(b), including type of pregnancy testing permitted, time in advance of I-131 administration in which the tests shall be conducted, age range of patients to be tested, and criteria a physician may use to determine that a patient is not capable of childbirth. c)         A licensee shall retain a copy of the procedures required by subsection (a) for the duration of the license.