Section 235.130  Adverse Health Care Events

The following are "adverse health care events" for the purposes of the requirements of the Act and this Part:

a)         Surgical events.  Events reportable under this subsection are:

1)         Surgery performed on a wrong body part that is not consistent with the documented informed consent for that patient.  Reportable events under this subsection do not include situations requiring prompt action that occur in the course of surgery or situations whose urgency precludes obtaining informed consent.

2)         Surgery performed on the wrong patient.

3)         The wrong surgical procedure performed on a patient that is not consistent with the documented informed consent for that patient. Reportable events under this subsection do not include situations requiring prompt action that occur in the course of surgery or situations whose urgency precludes obtaining informed consent.

4)         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.

5)         Death during or immediately 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. (Section 10-15(b) of the Act)

b)         Product or device events.  Events reportable under this subsection are:

1)         Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the health care facility when the contamination is the result of generally detectable contaminants in drugs, devices, or biologics regardless of the source of the contamination or the product.  For example, devices and drugs that are intended to be sterile and are not, rather than devices that may be contaminated after use begins.

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.  "Device" includes, but is not limited to, catheters, drains, and other specialized tubes, infusion pumps, and ventilators.  For example, use of a Foley catheter (for urinary drainage) to insert a central venous line, thus using the wrong equipment.  Not, for example, using the correct device incorrectly, such as inserting a naso-gastric tube in the larynx instead of the esophagus.

3)         Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a health care facility, excluding deaths associated with neurosurgical procedures known to present a high risk of intravascular air embolism. (Section 10-15(c) of the Act)

c)         Patient protection events.  Events reportable under this subsection are:

1)         An infant discharged to the wrong person.

2)         Patient death or serious disability associated with patient disappearance for more than 4 hours, excluding events involving adults who have decision-making capacity.

3)         Patient suicide or attempted suicide resulting in serious disability while being cared for in a health care facility due to patient actions after admission to the health care facility, excluding deaths resulting from self-inflicted injuries that were the reason for admission to the health care facility.  (Section 10-15(d) of the Act)

d)         Care management events.  Events reportable under this subsection are:

1)         Patient death or serious disability associated with a medication error, including, but not limited to, errors 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.

2)         Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products.

3)         Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a health care facility, excluding deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy, or cardiomyopathy.

4)         Patient death or serious disability directly related to hypoglycemia, the onset of which occurs while the patient is being cared for in a health care facility for a condition unrelated to hypoglycemia. (Section 10-15(e) of the Act)

e)         Environmental events.  Events reportable under this subsection are:

1)         Patient death or serious disability associated with an electric shock while being cared for in a health care facility, excluding events involving planned treatments such as electric countershock.

2)         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 toxic substances.

3)         Patient death or serious disability associated with a burn incurred from any source while being cared for in a health care facility that is not consistent with the documented informed consent for that patient.  Reportable events under this subsection do not include situations requiring prompt action that occur in the course of surgery or situations whose urgency precludes obtaining informed consent.

4)         Patient death or serious disability associated with a fall while being cared for in a health care facility.

5)         Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health care facility.  (Section 10-15(f) of the Act)

f)          Physical security 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 of any age.

3)         Sexual assault on a patient within or on the grounds of a health care facility.

4)         Death or significant injury of a patient or staff member resulting from a physical assault that occurs within or on the grounds of a health care facility.  (Section 10-15(g) of the Act)

5)         In case of an event listed in subsection (f)(4) in which a staff member is harmed, the health care facility shall generate a report to the Department, substituting staff information for patient information.