Hawaii Administrative Rules
Title 11 - DEPARTMENT OF HEALTH
Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS
Chapter 45 - RADIATION CONTROL
Subchapter 7 - USE OF RADIONUCLIDES IN THE HEALING ARTS
Section 11-45-137 - Records, notifications, and reports of misadministrations

Universal Citation: HI Admin Rules 11-45-137

Current through February, 2024

(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 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.

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