Subpart
1.
Report required.
A licensee must 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:
(1) a dose that differs from the
prescribed dose or dose that would have resulted from the prescribed dose by
more than five rems (0.05 Sv) effective dose equivalent, 50 rems (0.5 Sv) to an
organ or tissue, or 50 rems (0.5 Sv) 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;
(2) a
dose that exceeds five rems (0.05 Sv) effective dose equivalent, 50 rems (0.5
Sv) to an organ or tissue, or 50 rems (0.5 Sv) shallow dose equivalent to the
skin from:
(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; or
(3) a dose to the skin or an
organ or tissue other than the treatment site that exceeds by:
(a) 50 rems (0.5 Sv) 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) 50 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:
(1) 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;
(2) 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
(3) an
administration that includes any of the following:
(a) the wrong radionuclide;
(b) the wrong individual or human research
subject;
(c) 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
(d) a leaking sealed source
resulting in a dose that exceeds 50 rem (0.5 Sv) to an organ or tissue.
Subp.
2.
Events from patient intervention.
A licensee must 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.
Subp. 3.
24-hour notification
required.
A licensee must notify the commissioner within 24 hours after
discovery of a medical event.
Subp.
4.
Written report.
A licensee must submit a written report to the commissioner
within 15 days after discovery of a medical event. The report must not contain
an individual's name or any other information that could lead to identification
of an individual. The 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 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 responsible relative or guardian and, if
not, why.
Subp. 5.
Notification of individual.
A. A
licensee must provide notification of a medical 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 the physician will inform
the individual or that, based on medical judgment, telling the individual would
be harmful.
B. A 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 must notify the individual as soon as
possible thereafter.
C. A 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.
D. To meet the
notification requirements in this subpart, notification of the individual who
is the subject of the medical event may be made instead to that individual's
responsible relative or guardian.
E. If a verbal notification is made, the
licensee must 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 must provide a written description if
requested.
Subp. 6.
Construction.
Aside from the notification requirement, nothing in this part
affects any rights or duties of licensees and physicians in relation to each
other, to individuals affected by a medical event, or to that individual's
responsible relatives or guardians.
Subp. 7.
Individual identification.
A licensee must:
A.
annotate a copy of the report provided to the commissioner with:
(1) the name of the individual who is the
subject of the event; and
(2) the
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 medical event.
