Current through Register Vol. 24-18, September 15, 2024
(1)
A licensee shall report any event as a medical event, except for an event that
results from patient intervention, in which:
(a) The administration of radioactive
material or radiation from radioactive material, except permanent implant
brachytherapy, results in:
(i) A dose that
differs from the prescribed dose or dose that would have resulted from the
prescribed dosage by more than 0.05 Sv (five 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.
(ii) A dose that exceeds 0.05 Sv (five 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 radioactive
drug containing radioactive material or the wrong radionuclide for a
brachytherapy procedure;
(B) An
administration of a radioactive drug 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.
(iii) A dose to the skin or an
organ or tissue other than the treatment site that exceeds by:
(A) 0.5 Sv (50 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
(B) Fifty
percent 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.
(b) 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:
(i) The
total source strength administered differing by 20 percent or more from the
total source strength documented in the post-implantation portion of the
written directive;
(ii) The total
source strength administered outside of the treatment site exceeding 20 percent
of the total source strength documented in the post-implantation portion of the
written directive; or
(iii) An
administration that includes any of the following:
(A) The wrong radionuclide;
(B) The wrong individual or human research
subject;
(C) Sealed sources
implanted directly into a location discontiguous from the treatment site, as
documented in the post-implantation portion of the written directive;
or
(D) A leaking sealed source
resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or
tissue.
(2) 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.
(3) The licensee shall notify by telephone
(360-236-3300) the department no later than the next calendar day after
discovery of the medical event.
(4)
By an appropriate method listed in WAC 246-221-250, the licensee shall submit a
written report to the department at P.O. Box 47827, Olympia WA 98504-7827
within 15 days after discovery of the medical event.
(a) The written report must include:
(i) The licensee's name;
(ii) The name of the prescribing
physician;
(iii) A brief
description of the event;
(iv) Why
the event occurred;
(v) The effect,
if any, on the individuals who received the administration;
(vi) What actions, if any, have been taken or
are planned to prevent recurrence; and
(vii) Certification that the licensee
notified the individual (or the individual's responsible relative or guardian),
and if not, why not.
(b)
The report may not contain the individual's name or any other information that
could lead to identification of the individual.
(5) 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 they
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 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 a
written description if requested.
(6) 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.
(7) A licensee shall:
(a) Annotate a copy of the report provided to
the department with the:
(i) Name of the
individual who is the subject of the event; and
(ii) 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
(b) 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.
Statutory Authority:
RCW
70.98.050. 06-05-019, § 246-240-651,
filed 2/6/06, effective 3/9/06.
