Ohio Admin. Code 3701:1-58-101 - Report and notification of a medical event
(A) A licensee shall report any event as a
medical event, except for an event that results from patient intervention, in
which:
(1) The administration of radioactive
material or radiation from radioactive material, except permanent implant
brachytherapy, results in:
(a) A dose that
differs from the prescribed dose or dose that would have resulted from the
prescribed dosage by more than
0.05 sievert (five rem)
effective dose equivalent,
0.5 sievert (fifty rem) to an
organ or tissue, or 0.5 sievert (fifty rem) shallow
dose equivalent to the skin; and
(i) The
total dose delivered differs from the prescribed dose by twenty per cent or
more;
(ii) The total dosage
delivered differs from the prescribed dosage by twenty per cent or more or
falls outside the prescribed dosage range; or
(iii) The fractionated dose delivered differs
from the prescribed dose for a single fraction, by fifty per cent or
more.
(b) A dose that
exceeds 0.05 sievert (five rem)
effective dose equivalent,
0.5 sievert (fifty rem) to an
organ or tissue, or 0.5 sievert (fifty rem) shallow
dose equivalent to the skin from any of the following:
(i) An administration of a wrong radioactive
drug containing radioactive material or the wrong radionuclide for a
brachytherapy procedure;
(ii) An
administration of a radioactive drug containing radioactive material by the
wrong route of administration;
(iii) An administration of a dose or dosage
to the wrong individual or human research subject;
(iv) An administration of a dose or dosage
delivered by the wrong mode of treatment; or
(v) A leaking sealed source.
(c) A dose to the skin or an organ
or tissue other than the treatment site that exceeds by:
(i)
0.5 sievert (fifty rem) or more
the expected dose to that site from the procedure if the administration had
been given in accordance with the written directive prepared or revised before
administration; and
(ii) Fifty per
cent or more the expected dose to that site from the procedure if the
administration had been given in accordance with the written directive prepared
or revised before administration.
(2) For permanent implant brachytherapy, the
administration of radioactive material or radiation from radioactive material
(excluding sources that were implanted in the correct site but migrated outside
the treatment site) that results in:
(a) The
total source strength administered differing by twenty per cent or more from
the total source strength documented in the post-implantation portion of the
written directive;
(b) The total
source strength administered outside of the treatment site exceeding twenty per
cent of the total source strength documented in the post-implantation portion
of the written directive; or
(c) An
administration that includes any of the following:
(i) The wrong radionuclide;
(ii) The wrong individual or human research
subject;
(iii) Sealed source(s)
implanted directly into a location discontiguous from the treatment site, as
documented in the post-implantation portion of the written directive;
or
(iv) A leaking sealed source
resulting in a dose that exceeds
0.5 sievert (fifty rem) to an
organ or tissue.
(B) A licensee shall report any event
resulting from intervention of a patient or human research subject in which the
administration of radioactive 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 Ohio department of health, bureau of environmental health and radiation
protection no later than the next calendar day after discovery of the medical
event.
(D) The licensee shall
submit a written report to the Ohio department of health, bureau of
environmental health and radiation protection to the address listed in listed
in rule
3701:1-40-04 of the
Administrative Code within fifteen days after discovery of the medical event.
(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 individual(s) 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
the individual (or the individual's personal representative), and if not, why
not.
(2) The report may
not contain the 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 twenty-four 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 to the individual. 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 twenty-four 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 paragraph, the notification of the individual who
is the subject of the medical event may be made instead to that individual's
personal representative. If a verbal notification is made, the licensee shall
inform the individual, or appropriate 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) 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 personal representative.
(G) A licensee shall:
(1) Annotate a copy of the report provided to
the Ohio department of health, bureau of environmental health and radiation
protection with the:
(a) Name of the
individual who is the subject of the event; and
(b)
Social
security number or other identification number, if one has been
assigned,
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, 08/15/2021
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