Ariz. Admin. Code § R9-7-746 - Report and Notification of a Dose to an Embryo, Fetus, or Nursing Child
A. A licensee shall
report any dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose
equivalent that is a result of an administration of radioactive material or
radiation from radioactive material to a pregnant individual unless the dose to
the embryo/fetus was specifically approved, in advance, by the authorized
user.
B. A licensee shall report
any dose to a nursing child that is a result of an administration of
radioactive material to a breast-feeding individual that:
1. Is greater than 50 mSv (5 rem) total
effective dose equivalent; or
2.
Has resulted in unintended permanent functional damage to an organ or a
physiological system of the child, as determined by a physician.
C. The licensee shall notify the
Department by telephone no later than the next calendar day after discovery of
a dose to the embryo, fetus, or nursing child that requires a report in
subsections (A) or (B).
D. The
licensee shall submit a written report to the Department within 15 days after
discovery of a dose to the embryo, fetus, or nursing child that requires a
report in subsections (A) or (B). The written report shall include:
1. The licensee's name;
2. The name of the prescribing
physician;
3. A brief description
of the event;
4. Why the event
occurred;
5. The effect, if any, on
the embryo/fetus or the nursing child;
6. What actions, if any, have been taken or
are planned to prevent recurrence; and
7. Certification that the licensee notified
the pregnant individual or mother (or the mother's or child's responsible
relative or guardian), and if not, why not.
E. The report, required in subsection (D),
shall not contain the individual's or child's name or any other information
that could lead to identification of the individual or child.
F. The licensee shall provide notification of
the event to the referring physician and also notify the pregnant individual or
mother, both here-after referred to as the mother, no later than 24 hours after
discovery of an event that would require reporting under subsections (A) or
(B), unless the referring physician personally informs the licensee either that
he or she will inform the mother or that, based on medical judgment, telling
the mother would be harmful. The licensee is not required to notify the mother
without first consulting with the referring physician. If the referring
physician or mother cannot be reached within 24 hours, the licensee shall make
the appropriate notifications as soon as possible thereafter. The licensee
shall not delay any appropriate medical care for the embryo, fetus, or for the
nursing child, including any necessary remedial care as a result of the event,
because of any delay in notification. To meet the requirements of this
subsection, the notification may be made to the mother's or child's responsible
relative or guardian instead of the mother. If a verbal notification is made,
the licensee shall inform the mother, or the mother's or child's responsible
relative or guardian, that a written description of the event can be obtained
from the licensee upon request. The licensee shall provide the written
description upon request.
G. A
licensee shall:
1. Make a copy of the report
provided to the Department and include with it the:
a. Name of the pregnant individual or the
nursing child 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 pregnant
individual or the nursing child who is the subject of the event; and
2. Provide the copy of the
information required in subsection (G)(1) 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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