Current through Register Vol. 50, No. 9, September 20, 2024
A. A licensee shall report any event as a
medical event, except for an event that results from patient intervention, in
which the administration of byproduct material or radiation from byproduct
material, except permanent implant brachytherapy, results in:
1. a dose that differs from the prescribed
dose, or the dose that would have resulted from the prescribed dosage, by more
than 0.05 Sv (5 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;
2. a dose that exceeds 0.05 Sv (5 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 byproduct material or the wrong radionuclide for a
brachytherapy procedure;
b. an
administration of a radioactive drug containing byproduct 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. 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. 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 byproduct material or radiation from byproduct 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 0.5 Sv (50 rem) to an organ or
tissue.
C. A
licensee shall report any event resulting from intervention of a patient or
human research subject in which the administration of byproduct material or
radiation from byproduct material results or will result in unintended
permanent functional damage to an organ or a physiological system, as
determined by a physician.
D. The
following notifications are required for a medical event.
1. The licensee shall notify the Office of
Environmental Compliance by telephone at (225) 765-0160 in the manner provided
in LAC 33:I.3923 no later than the next calendar day after discovery of the
medical event.
2. The licensee
shall submit a written report to the Office of Environmental Compliance using
the procedures provided in LAC 33:I.3925.B and C within 15 days after discovery
of the medical event.
a. The written report
shall 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 individual(s) 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.
3. 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 judgement, 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 Paragraph, the notification to 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 such a written description if
requested.
E. Each
licensee shall retain a record of each medical event for five years. The record
shall contain the names of all individuals involved (including the prescribing
physician, allied health personnel, the individual affected by the medical
event, and the individual's referring physician), the individual's driver's
license or state identification number and the issuing state, a brief
description of the medical event, why it occurred, the effect on the
individual, what improvements are needed to prevent recurrence, and the actions
taken to prevent recurrence.
F.
Aside from the notification requirement, nothing in this Section affects any
rights or duties of licensees and physicians in relation to each other, the
individual, or the individual's responsible relatives or guardians.
G. A licensee shall:
1. annotate a copy of the report provided to
the department with:
a. the name of the
individual who is the subject of the event; and
b. 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
2. 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.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
30:2001 et seq. and
2104.B.
