Ohio Admin. Code 3701:1-58-102 - Report and notification of a dose to an embryo/fetus or a nursing child
(A) A licensee shall report any dose to an
embryo/fetus that is greater than fifty millisievert (five 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 fifty millisievert (five
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 by telephone
the Ohio department of health, bureau of radiation protection no later than the
next calendar day after discovery of a dose to the embryo/fetus or nursing
child that requires a report in paragraph (A) or (B) in this rule.
(D) The licensee shall submit a written
report to the appropriate address listed in rule
3701:1-40-04 of the
Administrative Code within fifteen days after discovery of a dose to the
embryo/fetus or nursing child that requires a report in paragraph (A) or (B) in
this rule.
(1) The written report must
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 the embryo/fetus or the nursing child;
(f) What actions, if any, have been taken or
are planned to prevent recurrence; and
(g) Certification that the licensee notified
the pregnant individual or mother (or the mother's or child's personal
representative), and if not, why not.
(2) The report must not contain the
individual's or child's name or any other information that could lead to
identification of the individual or child.
(E) The licensee shall provide notification
of the event to the referring physician and also notify the pregnant individual
or mother, both hereafter referred to as the mother, no later than twenty-four
hours after discovery of an event that would require reporting under paragraph
(A) or (B) of this rule, 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 to the mother. 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
twenty-four hours, the licensee shall make the appropriate notifications as
soon as possible thereafter. The licensee may 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 paragraph, the notification may be made to the
mother's or child's personal representative instead of the mother. If a verbal
notification is made, the licensee shall inform the mother, or the mother's or
child's personal representative, 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) A licensee shall:
(1) Annotate a copy of the report provided to
the director with the:
(a) Name of the
pregnant individual or the nursing child who is the subject of the event;
and
(b)
Social security number or other identification number, if
one has been assigned, of the pregnant individual or the nursing child
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 fifteen days
after the discovery of the event.
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005, 10/04/2010
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