| (4) The licensee shall notify the department by telephone
no later than the next calendar day after discovery of the medical
event.
(5) The licensee shall submit a written report to the
department within 15 calendar days after discovery of the medical
event. The written report shall include the following, excluding the
individual's name or any other information that could lead to identification
of the individual:
(A) the licensee's name and radioactive material license
number;
(B) a description of the licensed source of radiation
involved, including, for radioactive material, the kind, quantity,
chemical and physical form, source and device manufacturer, model
number, and serial number, if applicable;
(C) the name of the prescribing physician;
(D) a brief description of the medical event;
(E) why the event occurred;
(F) the effect, if any, on the individual(s) who received
the administration;
(G) actions, if any, that have been taken, or are planned,
to prevent recurrence; and
(H) certification that the licensee notified the individual
(or the individual's responsible relative or guardian), and if not,
why not.
(6) The licensee shall notify 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 within 24 hours,
the licensee shall notify the individual as soon as possible thereafter.
The licensee shall 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
the written description if requested.
(7) 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.
(8) The licensee shall annotate a copy of the report
provided to the department with the following information:
(A) the name of the individual who is the subject of
the event; and
(B) an identification number or if no other identification
number is available, the social security number of the individual
who is the subject of the event.
(9) The licensee shall provide a copy of the annotated
report to the referring physician, if other than the licensee, no
later than 15 calendar days after the discovery of the event.
(10) The licensee shall retain a copy of the annotated
report of the medical event in accordance with subsection (xxx) of
this section for inspection by the department.
(vvv) Report and notification of a dose to an embryo/fetus
or nursing child.
(1) The licensee shall report any dose to an embryo/fetus
that is greater than 5 rem (50 mSv) 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.
(2) The 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:
(A) is greater than 5 rem (50 mSv) TEDE; or
(B) has resulted in unintended permanent functional
damage to an organ or a physiological system, as determined by a physician.
(3) 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 accordance
with paragraphs (1) or (2) of this subsection.
(4) The licensee shall submit a written report to the
department no later than 15 calendar days after discovery of a dose
to the embryo/fetus or nursing child that requires a report in accordance
with paragraphs (1) or (2) of this subsection. The written report
shall include the following, excluding the individual's or child's
name or any other information that could lead to identification of
the individual or child:
(A) the licensee's name and radioactive material license
number;
(B) a description of the licensed source of radiation
involved, including, for radioactive material, the kind, quantity,
chemical and physical form, source and/or device manufacturer, model
number, and serial number, if applicable;
(C) the name of the prescribing physician;
(D) a brief description of the event;
(E) why the event occurred;
(F) the effect, if any, on the embryo/fetus or the
nursing child;
(G) actions, if any, that have been taken, or are planned,
to prevent recurrence; and
(H) 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.
(5) The licensee shall notify the referring physician
and also notify the pregnant individual or mother, both hereafter
referred to as the mother, no later than 24 hours after discovery
of an event that would require reporting in accordance with paragraphs
(1) or (2) of this subsection, 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 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 subsection, the notification may be made to the mother's or
child's responsible relative or guardian instead of the mother, when
appropriate. 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 such a
written description if requested.
(6) The licensee shall annotate a copy of the report
provided to the department with the following information:
(A) the name of the individual or the nursing child
who is the subject of the event; and
(B) an identification number or if no other identification
number is available, the social security number of the individual
who is the subject of the event.
(7) The licensee shall provide a copy of the annotated
report as described in paragraph (6) of this subsection to the referring
physician, if other than the licensee, no later than 15 days after
the discovery of the event.
(8) The licensee shall retain a copy of the annotated
report as described in paragraph (6) of this subsection of a dose
to an embryo/fetus or a nursing child in accordance with subsection
(xxx) of this section for inspection by the department.
(www) Report and notification for an eluate exceeding
permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
(1) The licensee shall notify by telephone the department
at (512) 458-7460 and the distributor of the generator within seven
calendar days after discovery that an eluate exceeded the permissible
concentration listed in subsection (ii) of this section at the time
of generator elution. The telephone report to the department must
include the manufacturer, model number, and serial number (or lot
number) of the generator; the results of the measurement; the date
of the measurement; whether dosages were administered to patients
or human research subjects, when the distributor was notified, and
the action taken.
Cont'd... |
