Current through Register Vol. 48, No. 9, September 27, 2024
A. The Facility
shall document every incident, and include an incident review, investigation,
and evaluation as well as corrective action taken, if any. The Facility shall
retain all documented incidents reported pursuant to this section for three (3)
years following the incident. For the first year following the incident, these
records shall be kept on site and readily available at that Facility.
B. The Facility shall report the following
types of incidents to the Department and the patient, patient's responsible
party, sponsor, or emergency contact within twenty-four (24) hours or by the
next regular business day from when the facility had reasonable cause to
believe an incident occurred. The Facility shall notify the Department via the
Department's electronic reporting system or as otherwise determined by the
Department. Initial reports to the Department are intended to collect basic
information as may be known at the time about the incident to include, at a
minimum, the location of the incident, the type of incident, the date the
incident is believed to have occurred or the date the report was filed, the
number of residents, clients or patients injured by the incident, as well as
contact information for the individual making the report. If the Facility does
not have all the information requested, it shall provide a partial report with
the information available to the Facility. The following types of incidents
require an initial report to the Department as specified in this section:
1. Surgery or other invasive procedure
performed on the wrong patient.
2.
Surgery or other invasive procedure performed on the wrong site.
3. Wrong surgical or other invasive procedure
performed on a patient.
4. Patient
death or serious injury associated with patient elopement
(disappearance).
5. Patient
suicide, attempted suicide, or self-harm that results in serious injury, while
being cared for in a healthcare setting.
6. Any incident in which systems designated
for oxygen or other gas to be delivered to a patient contain no gas, the wrong
gas, or are contaminated by toxic substances.
7. Patient death or serious injury associated
with the use of restraints or bedrails while being cared for in a healthcare
setting.
8. Any instance of care
ordered by or provided by someone impersonating a physician, nurse, pharmacist,
or other licensed healthcare provider.
9. Abduction of any patient of any
age.
C. In addition to
the initial report as may be required by Subsection (B), Facilities shall
submit a separate written investigation report for the following types of
incidents within seven (7) business days from when the facility had reasonable
cause to believe an incident occurred via the Department's electronic reporting
system or as otherwise determined by the Department. Investigation reports
submitted to the Department shall contain at a minimum: facility name, patient
age and sex, date of incident, location, witness names, extent and type of
injury and how treated, e.g., hospitalization, identified
cause of incident, internal investigation results if cause unknown, identity of
other agencies notified of incident and the date of the report. The following
types of incidents require a written investigation report to the Department as
specified in this section:
1. Surgical or
Invasive Procedure Events.
a. Surgery or
other invasive procedure performed on the wrong site;
b. Surgery or other invasive procedure
performed on the wrong patient;
c.
Wrong surgical or other invasive procedure performed on a patient;
d. Unintended retention of a foreign object
in a patient after surgery or other invasive procedure; and
e. Intraoperative or immediately
postoperative/post procedure death in an American Society of Anesthesiologists
(ASA) Class 1 patient.
2.
Product or Device Events.
a. Patient death or
serious injury associated with the use of contaminated drugs, devices, or
biologics provided by the healthcare setting.
b. Patient death or serious injury associated
with the use or function of a device in patient care, in which the device is
used or functions other than as intended; and
c. Patient death or serious injury associated
with intravascular air embolism that occurs while being cared for in a
healthcare setting.
3.
Patient Protection Events.
a. Discharge or
release of a patient of any age, who is unable to make decisions, to other than
an authorized person;
b. Patient
death or serious injury associated with patient elopement (disappearance);
and
c. Patient suicide, attempted
suicide, or self-harm that results in serious injury, while being cared for in
a healthcare setting.
4.
Care Management Events.
a. Patient death or
serious injury associated with a medication error (e.g., errors involving the
wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong
preparation, or wrong route of administration);
b. Patient death or serious injury associated
with unsafe administration of blood products;
c. Maternal death or serious injury
associated with labor or delivery in a low-risk pregnancy while being cared for
in a healthcare setting;
d. Death
or serious injury of a neonate associated with labor or delivery in a low-risk
pregnancy;
e. Patient death or
serious injury associated with a fall while being cared for in a healthcare
setting;
f. Any Stage 3, Stage 4,
and unstageable pressure ulcers acquired after admission/presentation to a
healthcare setting;
g. Artificial
insemination with the wrong donor sperm or wrong egg;
h. Patient death or serious injury resulting
from the irretrievable loss of an irreplaceable biological specimen;
and
i. Patient death or serious
injury resulting from failure to follow up or communicate laboratory,
pathology, or radiology test results.
5. Environmental Events.
a. Patient or staff death or serious injury
associated with an electric shock in the course of a patient care process in a
healthcare setting;
b. Any incident
in which systems designated for oxygen or other gas to be delivered to a
patient contains no gas, the wrong gas, or are contaminated by toxic
substances;
c. Patient or staff
death or serious injury associated with a burn incurred from any source in the
course of a patient care process in a healthcare setting; and
d. Patient death or serious injury associated
with the use of physical restraints or bedrails while being cared for in a
healthcare setting.
6.
Radiologic Events.
a. Death or serious injury
of a patient or staff associated with the introduction of a metallic object
into the MRI area.
7.
Potential Criminal Events.
a. Any instance of
care ordered by or provided by someone impersonating a physician, nurse,
pharmacist, or other licensed healthcare provider;
b. Abduction of a patient of any
age;
c. Sexual abuse/assault on a
patient or staff member within or on the grounds of a healthcare setting;
and
d. Death or serious injury of a
patient or staff member resulting from a physical assault (i.e., battery) that
occurs within or on the grounds of a healthcare setting.
