Current through November, 2024
Section 11-45-136 - Procedures for human administrations(a) Each licensee shall establish and maintain a written program to provide assurance that radioactive material or radiation therefrom is administered to humans as directed by the authorized user. The program shall include procedures for: (1) Preparing written directives for the administration of radiation, however, a written directive is not required when an authorized user personally assays and administers a dosage provided the pertinent facts are documented as otherwise required;(2) Verifying by more than one method the identity of the individual to be administered radiation or radioactive material;(3) Updating the diagnostic clinical procedures manual;(4) Verifying that final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with respective written directives;(5) Assuring that administration of radiation is carried out as specified in the written directive or the diagnostic clinical procedures manual;(6) Identifying and evaluating unintended deviations from the written directive or diagnostic clinical procedures manual including taking appropriate action for recordable events and misadministrations;(b) Each licensee shall evaluate and respond to misadministrations in accordance with section 11-45-137.(c) Each licensee shall evaluate and respond to recordable events within thirty days after discovery by assembling the relevant facts, identifying the cause of the recordable event, and taking appropriate action to prevent recurrence.(d) Each licensee shall conduct an annual evaluation of the human administration program including any recommendations for changes to be made as well as any modifications made since the last evaluation and, if required, revise procedures to assure that radioactive material and the radiation therefrom is administered as directed by the authorized user. Modifications made to the program shall not decrease the effectiveness of the program.(e) Each licensee shall retain, in auditable form: (1) Each written directive;(2) A record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required;(3) A record of each annual review of the program including the evaluations and findings of the review;(4) A record of each recordable event, the relevant facts, and any corrective actions taken.(f) Individuals practicing nuclear medicine technology shall be licensed under chapter 11-44.[Eff 11/12/99] (Auth: HRS §§ 321-10, 321-11, 321-71) (Imp: HRS §§ 321-1, 321-11(21), 321-71)