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06/01/2007

ILLINOIS HEALTH-CARE FACILITIES WILL SOON BE REQUIRED BY STATUTE TO REPORT THE OCCURRENCE OF CERTAIN “NEVER EVENTS.”

By: Timothy G. Savage, J.D.

Beginning in January 2008, the Illinois Adverse Health Care Events Reporting Law of 2005, 410 ILCS 522, will require Illinois health-care facilities to report to the Illinois Department of Public Health (the “Department”) when they discover that a so-called “never event” has occurred within the facility. “Never events”—referred to as “adverse health care events” by the General Assembly—are events which many believe should never occur in a health-care facility.

The Act was established “to facilitate quality improvement in the health care system through communication and collaboration between the Department [of Public Health] and health care facilities.” The law was not designed to punish errors, or to investigate or take disciplinary action against health-care professionals, facilities, or employees. Indeed, reports made to the Department under the Act may not include any information “that tends to identify any of the health care professionals, employees, or patients involved.”

The Act requires health-care facilities to report the occurrence of twenty-four specific adverse events. The General Assembly divided the twenty-four adverse events into six categories:

Surgical events
  1. Surgery performed on a wrong body part that is not consistent with the documented informed consent for that patient. Reportable events under this clause 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 clause 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.

Product or device events
  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.
  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.
  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.

Patient-protection events
  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.

Care-management events
  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.

Environmental events
  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 clause 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 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 bed rails while being cared for in a health care facility

Physical-security events
  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.


Health-care facilities will be required to report to the Department within thirty days after discovering that one of the adverse events set out in the Act has occurred within the facility. The facility must then conduct a root-cause analysis and implement a corrective action plan to address the findings of the root-cause analysis, or report to the Department any reasons for not taking corrective action. Copies of the findings of the root-cause analysis and the corrective-action plan must be filed with the Department within ninety days after the adverse-event report is filed with the Department.

Importantly, the Act provides that other than the annual reports the Department is required to prepare, adverse health-care-event reports, findings of root-cause analyses, and corrective-action plans, as well as any records created or obtained by the Department in reviewing or investigating the reports, findings and plans, shall not be available to the public, and shall not be discoverable or admissible in any civil, criminal, or administrative proceeding against any health-care facility or health-care professional.

The annual report from the Department—which will be publicly available—will describe, by institution, adverse health-care events reported, and will summarize, in aggregate form, the corrective-action plans and findings of root-cause analyses submitted to the Department by health-care facilities.

The Act requires the reporting system to be fully operational by January 2008, and requires the Department to establish the format and reporting requirements by July 1, 2007. Nevertheless, as of June 5, 2007, the Department has not issued any proposed or emergency rules for the reporting of adverse health care events, and has not provided any information about the operation of the Division of Patient Safety, which Governor Blagojevich created by executive order on July 13, 2006, in part to implement the requirements of the Act.

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