1279.1
. (a) A health facility licensed pursuant to subdivision (a),
(b), or (f) of Section 1250 shall report an adverse event to the
department no later than five days after the adverse event has been
detected, or, if that event is an ongoing urgent or emergent threat
to the welfare, health, or safety of patients, personnel, or
visitors, not later than 24 hours after the adverse event has been
detected. Disclosure of individually identifiable patient information
shall be consistent with applicable law.
(b) For purposes of this section, "adverse event" includes any of
the following:
(1) Surgical events, including the following:
(A) Surgery performed on a wrong body part that is inconsistent
with the documented informed consent for that patient. A reportable
event under this subparagraph does not include a situation requiring
prompt action that occurs in the course of surgery or a situation
that is so urgent as to preclude obtaining informed consent.
(B) Surgery performed on the wrong patient.
(C) The wrong surgical procedure performed on a patient, which is
a surgical procedure performed on a patient that is inconsistent with
the documented informed consent for that patient. A reportable event
under this subparagraph does not include a situation requiring
prompt action that occurs in the course of surgery, or a situation
that is so urgent as to preclude the obtaining of informed consent.
(D) Retention of a foreign object in a patient after surgery or
other procedure, excluding objects intentionally implanted as part of
a planned intervention and objects present prior to surgery that are
intentionally retained.
(E) Death during or up to 24 hours after induction of anesthesia
after surgery of a normal, healthy patient who has no organic,
physiologic, biochemical, or psychiatric disturbance and for whom the
pathologic processes for which the operation is to be performed are
localized and do not entail a systemic disturbance.
(2) Product or device events, including the following:
(A) Patient death or serious disability associated with the use of
a contaminated drug, device, or biologic provided by the health
facility when the contamination is the result of generally detectable
contaminants in the drug, device, or biologic, regardless of the
source of the contamination or the product.
(B) 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. For purposes of this subparagraph,
"device" includes, but is not limited to, a catheter, drain, or other
specialized tube, infusion pump, or ventilator.
(C) Patient death or serious disability associated with
intravascular air embolism that occurs while being cared for in a
facility, excluding deaths associated with neurosurgical procedures
known to present a high risk of intravascular air embolism.
(3) Patient protection events, including the following:
(A) An infant discharged to the wrong person.
(B) Patient death or serious disability associated with patient
disappearance for more than four hours, excluding events involving
adults who have competency or decisionmaking capacity.
(C) A patient suicide or attempted suicide resulting in serious
disability while being cared for in a health facility due to patient
actions after admission to the health facility, excluding deaths
resulting from self-inflicted injuries that were the reason for
admission to the health facility.
(4) Care management events, including the following:
(A) A patient death or serious disability associated with a
medication error, including, but not limited to, an error involving
the wrong drug, the wrong dose, the wrong patient, the wrong time,
the wrong rate, the wrong preparation, or the wrong route of
administration, excluding reasonable differences in clinical judgment
on drug selection and dose.
(B) A patient death or serious disability associated with a
hemolytic reaction due to the administration of ABO-incompatible
blood or blood products.
(C) Maternal death or serious disability associated with labor or
delivery in a low-risk pregnancy while being cared for in a facility,
including events that occur within 42 days postdelivery and
excluding deaths from pulmonary or amniotic fluid embolism, acute
fatty liver of pregnancy, or cardiomyopathy.
(D) Patient death or serious disability directly related to
hypoglycemia, the onset of which occurs while the patient is being
cared for in a health facility.
(E) Death or serious disability, including kernicterus, associated
with failure to identify and treat hyperbilirubinemia in neonates
during the first 28 days of life. For purposes of this subparagraph,
"hyperbilirubinemia" means bilirubin levels greater than 30
milligrams per deciliter.
(F) A Stage 3 or 4 ulcer, acquired after admission to a health
facility, excluding progression from Stage 2 to Stage 3 if Stage 2
was recognized upon admission.
(G) A patient death or serious disability due to spinal
manipulative therapy performed at the health facility.
(5) Environmental events, including the following:
(A) A patient death or serious disability associated with an
electric shock while being cared for in a health facility, excluding
events involving planned treatments, such as electric countershock.
(B) Any incident in which a line designated for oxygen or other
gas to be delivered to a patient contains the wrong gas or is
contaminated by a toxic substance.
(C) A patient death or serious disability associated with a burn
incurred from any source while being cared for in a health facility.
(D) A patient death associated with a fall while being cared for
in a health facility.
(E) A patient death or serious disability associated with the use
of restraints or bedrails while being cared for in a health facility.
(6) Criminal events, including the following:
(A) Any instance of care ordered by or provided by someone
impersonating a physician, nurse, pharmacist, or other licensed
health care provider.
(B) The abduction of a patient of any age.
(C) The sexual assault on a patient within or on the grounds of a
health facility.
(D) The death or significant injury of a patient or staff member
resulting from a physical assault that occurs within or on the
grounds of a facility.
(7) An adverse event or series of adverse events that cause the
death or serious disability of a patient, personnel, or visitor.
(c) The facility shall inform the patient or the party responsible
for the patient of the adverse event by the time the report is made.
(d) "Serious disability" means a physical or mental impairment
that substantially limits one or more of the major life activities of
an individual, or the loss of bodily function, if the impairment or
loss lasts more than seven days or is still present at the time of
discharge from an inpatient health care facility, or the loss of a
body part.
(e) Nothing in this section shall be interpreted to change or
otherwise affect hospital reporting requirements regarding reportable
diseases or unusual occurrences, as provided in Section 70737 of
Title 22 of the California Code of Regulations. The department shall
review Section 70737 of Title 22 of the California Code of
Regulations requiring hospitals to report "unusual occurrences" and
consider amending the section to enhance the clarity and specificity
of this hospital reporting requirement.