Ariz. Admin. Code § R9-7-745 - Report and Notification of a Medical Event
A. A licensee shall report any "medical"
event, except for an event that results from patient intervention, in which the
administration of radioactive material or radiation from radioactive material
results in:
1. A dose that differs from the
prescribed dose or dose that would have resulted from the prescribed dosage by
more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an
organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and
a. The total dose delivered differs from the
prescribed dose by 20 percent or more;
b. The total dosage delivered differs from
the prescribed dosage by 20 percent or more or falls outside the prescribed
dosage range; or
c. The
fractionated dose delivered differs from the prescribed dose, for a single
fraction, by 50 percent or more.
2. A dose that exceeds 0.05 Sv (5 rem)
effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50
rem) shallow dose equivalent to the skin from any of the following:
a. An administration of a wrong
radiopharmaceutical containing radioactive material;
b. An administration of a radiopharmaceutical
containing radioactive material by the wrong route of administration;
c. An administration of a dose or dosage to
the wrong individual or human research subject;
d. An administration of a dose or dosage
delivered by the wrong mode of treatment; or
e. A leaking sealed source.
3. A dose to the skin or an organ
or tissue other than the treatment site that exceeds by 0.5 Sv (50 rem) to an
organ or tissue and 50 percent or more of the dose expected from the
administration defined in the written directive (excluding, for permanent
implants, seeds that were implanted in the correct site but migrated outside
the treatment site).
B. A
licensee shall report any event resulting from intervention of a patient or
human research subject in which the administration of radio-active material or
radiation from radioactive material results or will result in unintended
permanent functional damage to an organ or a physiological system, as
determined by a physician.
C. The
licensee shall notify by telephone the Department no later than the next
calendar day after discovery of the medical event.
D. The licensee shall submit a written report
to the Department within 15 days after discovery of the medical event.
1. The written report shall include:
a. The licensee's name;
b. The name of the prescribing
physician;
c. A brief description
of the event;
d. Why the event
occurred;
e. The effect, if any, on
each individual who received the administration;
f. What actions, if any, have been taken or
are planned to prevent recurrence; and
g. Certification that the licensee notified
each individual (or the individual's responsible relative or guardian), and if
not, why not.
2. The
report may not contain an individual's name or any other information that could
lead to identification of the individual.
E. The licensee shall provide notification of
the event to the referring physician and also notify the individual who is the
subject of the medical event no later than 24 hours after its discovery, unless
the referring physician personally informs the licensee either that he or she
will inform the individual or that, based on medical judgment, telling the
individual would be harmful. The licensee is not required to notify the
individual without first consulting the referring physician. If the referring
physician or the affected individual cannot be reached with-in 24 hours, the
licensee shall notify the individual as soon as possible thereafter. The
licensee may not delay any appropriate medical care for the individual,
including any necessary remedial care as a result of the medical event, because
of any delay in notification. To meet the requirements of this subsection, the
notification of the individual who is the subject of the medical event may be
made instead to that individual's responsible relative or guardian. If a verbal
notification is made, the licensee shall inform the individual, or appropriate
responsible relative or guardian, that a written description of the event can
be obtained from the licensee upon request. The licensee shall provide such a
written description if requested.
F. Aside from the notification requirement,
nothing in this Section affects any rights or duties of licensees and
physicians in relation to each other, to individuals affected by the medical
event, or to that individual's responsible relatives or guardians.
G. A licensee shall:
1. Annotate a copy of the report provided to
the Department with the:
a. Name of the
individual who is the subject of the event; and
b. Identification number or, if no other
identification number is available, the Social Security number of the
individual who is the subject of the event; and
2. Provide a copy of the annotated report to
the referring physician, if other than the licensee, no later than 15 days
after the discovery of the event.
Notes
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