Current through Register 1537, December 20, 2024
Section 120.522 - 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) The procedures required by 105 CMR 120.522(A) must, at a minimum, address the following items that are applicable for the licensee's use of radioactive material: (1) Verifying the identity of the patient or human research subject;(2) Verifying that the specific details of the administration are 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 105 CMR 120.570 or 120.589;(5) Determining if a medical event, as defined in 105 CMR 120.594(A), has occurred; and(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.Amended by Mass Register Issue 1480, eff. 10/14/2022.