Ariz. Admin. Code § 9-7-913

Current through Register Vol. 30, No. 50, December 13, 2024

Section R9-7-913 - Misadministration

A. For purposes of this rule "misadministration" means:

1. A therapeutic radiation dose from a machine:

a. Delivered to the wrong patient;

b. Delivered using the wrong mode of treatment;

c. Delivered to the wrong treatment site; or

d. Delivered in one week to the correct patient, using the correct mode, to the correct therapy site, but greater than 130 percent of the prescribed weekly dose; or

2. A therapeutic radiation dose from a machine with errors in the calibration, time of exposure, or treatment geometry that result in a calculated total treatment dose differing from the final, prescribed total treatment dose by more than 20 percent, except for treatments given in 1 to 3 fractions, in which case a difference of more than 10 percent constitutes a misadministration.

B. Reports of therapy misadministration

1. Within 24 hours after discovery of a misadministration, a registrant shall notify the Department by telephone. The registrant shall also notify the referring physician of the affected patient and the patient or a responsible relative or guardian, unless the referring physician personally informs the registrant either that he or she will inform the patient, or that in his or her medical judgment, telling the patient or the patient's responsible relative or guardian would be harmful to one or the other, respectively. If the referring physician or the patient's responsible relative or guardian cannot be reached within 24 hours, the registrant shall notify them as soon as practicable. The registrant shall not delay medical care for the patient because of notification problems.

2. Within 15 days following the verbal notification to the Department, the registrant shall report, in writing, to the Department and individuals notified under subsection (B)(1). The written report shall include the registrant's name, the referring physician's name, a brief description of the event, the effect on the patient, the action taken to prevent recurrence, whether the registrant informed the patient or the patient's responsible relative or guardian, and if not, why not. The report shall not include the patient's name or other information that could lead to identification of the patient.

3. Each registrant shall maintain records of all misadministrations for Department inspection. The records shall:

a. Contain the names of all individuals involved in the event, including:

i. The physician,

ii. The allied health personnel,

iii. The patient,

iv. The patient's referring physician,

v. The patient's identification number if one has been assigned,

vi. A brief description of the event,

vii. The effect on the patient, and

viii. The action taken to prevent recurrence.

b. Be maintained for three years beyond the termination date of the affected registration.

Ariz. Admin. Code § R9-7-913

New Section R9-7-913 recodified from R12-1-913 at 24 A.A.R. 813, effective March 22, 2018 (Supp. 18-1).