Current through Register Vol. 48, No. 12, March 22, 2024
The following are "adverse health care events" for the purposes
of the Act and this Part:
a) Surgical
or Invasive Procedure Events. Events reportable under this subsection are:
1) Any surgery or other invasive procedure
performed on the wrong body part or site and that is not consistent with the
correct documented informed consent for that patient, excluding emergent
situations that occur in the course of surgery or other invasive procedure when
exigency precludes obtaining informed consents.
2) Surgery or other invasive procedure
performed on the wrong patient.
3)
The wrong surgical or other invasive procedure performed on a patient that is
not consistent with the correct documented informed consent for that
patient.
4) Unintended retention of
a foreign object in a patient after surgery or other invasive procedure,
including medical or surgical items intentionally placed by medical providers
that are unintentionally left in place. Unintended retention of a foreign
object excludes:
A) Objects present prior to
surgery or other invasive procedure that are intentionally left in
place;
B) Objects intentionally
implanted as part of a planned intervention; and
C) Objects not present prior to surgery or
other invasive procedure that are intentionally left in when the risk of
removal exceeds the risk of retention (such as micro-needles, broken
screws).
5)
Intraoperative or immediately postoperative or postprocedure death in an ASA
Class I patient, including all ASA Class I patient deaths in situations in
which anesthesia was administered, regardless of whether the planned surgical
procedure was performed.
b) Product or Device Events. Events
reportable under this subsection are:
1)
Patient death or serious injury associated with the use of contaminated drugs,
devices or biologics provided by the health care setting, including
contaminants in drugs, devices or biologics regardless of the source of the
contamination or the product.
2)
Patient death or serious disability associated with the use or function of a
device in patient care in which the device is used or functions other than as
intended, including, but not limited to, catheters, drains and other
specialized tubes, infusion pumps, ventilators and procedural and monitoring
equipment.
3) Patient death or
serious injury associated with intravascular air embolism that occurs while
being cared for in a health care setting, excluding deaths or serious injury
associated with neurosurgical procedures known to present a high risk of
intravascular air embolism.
c) Patient Protection Events. Events
reportable under this subsection are:
1)
Discharge or release of a patient or resident of any age, who lacks decisional
capacity, to anyone other than a guardian or other legally authorized
person.
2) Patient death or serious
injury associated with patient elopement (disappearance), excluding events
involving competent adults with decisionmaking capacity who leave against
medical advice or voluntarily leave without being seen.
3) Patient suicide, attempted suicide or
self-harm that results in serious injury while being cared for in a health care
setting. Deaths resulting from self-inflicted injuries that were the reason for
admission or presentation to the health care facility are excluded from
reporting requirements.
d) Care Management Events. Events reportable
under this subsection are:
1) Patient death
or serious injury associated with a medication error (for example, errors
involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate,
wrong preparation, or wrong route of administration).
2) Patient death or serious injury associated
with unsafe administration of blood products.
3) Maternal death or serious injury
associated with labor or delivery in a low-risk pregnancy while being cared for
in a health care setting, including events that occur within 42 days
post-delivery, but not deaths from pulmonary or amniotic fluid embolism, acute
fatty liver of pregnancy, or cardiomyopathy.
4) Death or serious injury of a neonate
associated with labor or delivery in a low-risk pregnancy, including for the
office-based surgery, birthing center or "home" setting, unplanned admission to
an inpatient setting within 24 hours after delivery.
5) Patient death or serious injury associated
with a fall while being cared for in a health care setting, including, but not
limited to, fractures, head injuries and intracranial hemorrhage.
6) Any Stage 3, Stage 4 and unstageable
pressure ulcers acquired after admission or presentation to a healthcare
setting unless:
A) Stage 2 pressure ulcer,
which was recognized upon admission, progresses to a Stage 3; or
B) A pressure ulcer develops in an area where
deep tissue injury was documented as present upon admission or
presentation.
7)
Artificial insemination with the wrong donor sperm or wrong egg.
8) Patient death or serious injury resulting
from the irretrievable loss of an irreplaceable biological specimen, including
events in which specimens are misidentified or when another procedure cannot be
done to produce a specimen.
9)
Patient death or serious injury resulting from failure to follow up or
communicate laboratory, pathology or radiology test results.
e) Environmental Events. Events
reportable under this subsection are:
1)
Patient or staff death or serious injury associated with an electric shock in
the course of a patient care process in a health care facility, excluding
events involving patients during planned treatments such as electric
countershock or elective cardioversion.
2) Any incident in which systems designated
for oxygen or other gas to be delivered to a patient contain no gas, or the
wrong gas, or is contaminated by toxic substances.
3) Patient or staff member death or serious
injury associated with a burn incurred from any source in the course of a
patient care process in a health care setting.
4) Patient death or serious injury associated
with the use of physical restraints or bedrails while being cared for in a
health care setting.
f)
Radiologic Events. Reportable under this subsection is death or serious injury
of a patient or staff member associated with the introduction of a metallic
object into the Magnetic Resonance Imaging area, including events related to
material inside the patient's body or projectiles outside the patient's
body.
g) Potential Criminal Events.
Events reportable under this subsection are:
1) Any instance of care ordered by or
provided by someone impersonating a physician, nurse, pharmacist or other
licensed health care provider.
2)
Abduction of a patient or resident of any age.
3) Sexual abuse or sexual assault on a
patient or staff member within or on the grounds of, a health care
setting.
4) Death or serious injury
of a patient or staff member resulting from a physical assault (for example,
battery) that occurs within or on the grounds of a health care
setting.