HAR §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 §11-45-137 45-121 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) §11-45-137 Records, notifications, and reports of misadministrations. (a) The following actions shall be taken for a misadministration by the licensee: (1) The licensee shall notify the department by telephone no later than twenty-four hours after discovery of the misadministration. (2) The licensee shall submit a written report to the department within fifteen days after discovery of the misadministration. The written report shall include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the patient; what improvements are needed to prevent recurrence; actions taken to §11-45-137 45-122 prevent recurrence; whether the licensee notified the patient; or the patient's responsible relative or guardian, and if not, why not, and if the patient was notified, what information was provided to the patient. The report shall not include the patient's name or other information that could lead to identification of the patient. (3) The licensee shall notify the referring physician and also notify the patient of the misadministration not later than twenty-four hours after its discovery, unless the referring physician personally informs the licensee either that he or she shall inform the patient or that, based on medical judgment, telling the patient would be harmful. The licensee is not required to notify the patient without first consulting the referring physician. If the referring physician or patient cannot be reached within twenty- four hours, the licensee shall notify the patient as soon as possible thereafter. The licensee may not delay any appropriate medical care for the patient, including any necessary remedial care as a result of the misadministration, because of any delay in notification. (4) If the patient was notified, the licensee shall also furnish, within fifteen days after discovery of the misadministration, a written report to the patient by sending either: (A) A copy of the report that was submitted to the department, or (B) A brief description of both the event and the consequences, as they may affect the patient, provided a statement is included that the report submitted to the department can be obtained from the licensee. (b) Each licensee shall retain a record of each misadministration. The record shall contain the names of all individuals involved including the prescribing physician, allied health personnel, the patient, and the patient's referring physician, the patient's social security number or identification number if one has been assigned, a brief description of the misadministration, why it occurred, the effect on the patient, what improvements are needed to prevent recurrence, and the action taken to prevent recurrence. (c) Aside from the notification requirement, nothing in subsections (a) and (b) shall affect any rights or duties of licensees, and physicians in relation to each other, patients, or patient's responsible relatives or guardians. [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71)