Ariz. Admin. Code § 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.
Notes
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