Section 235.110  Definitions

For the purpose of this Part:

"ABO-incompatible blood or blood products" means blood or blood products that are inconsistent with a given patient's blood type.

"Act" means the Illinois Adverse Health Care Events Reporting Law of 2005 [410 ILCS 522].

"Admitting diagnosis code" means a standard medical code associated with an injury or illness of a patient, which is assigned to the patient at the time of admission to the health care facility.

"Adverse health care event" means any event listed in Section 235.130 of this Part.

"Biologics" means products made from living organisms. Biologics are derived from living material (human, plant, animal or microorganism) and used for the treatment, prevention, or cure of disease in humans.

"Contamination" means the presence of a detectable foreign substance or material that renders a substance, preparation, device or equipment impure, unstable or unsuitable for use.

"Corrective action plan" means a document that describes the specific steps that the health care facility has taken or intends to take to resolve or reduce the risk of similar adverse health care events occurring in the facility.  This document will address responsibility for implementation, oversight, time lines and strategies for measuring the effectiveness of the actions. 

"Death" means patient death related to an adverse event and not related solely to the natural course of the patient's illness or underlying condition.  Events otherwise reportable under this Part shall be reported even if the death might have otherwise occurred as the natural course of the patient's illness or underlying condition. (Section 10-15(h) of the Act)

"Department" means the Illinois Department of Public Health.  (Section 10-10 of the Act)

"Device" includes, but is not limited to, catheters, drains and other specialized tubes, infusion pumps and ventilators.  (Section 10-15 of the Act)

"Findings of root cause analysis" means the conclusions of the organizational root cause analysis that summarize how the adverse event happened and reasons for the adverse event occurrence. Reportable findings do not include investigatory notes, data, staff interviews and other unrelated documentation that led to the conclusions of the root cause analysis.

"Health care facility" means a hospital maintained by the State or any department or agency of the State where such department or agency has authority under law to establish and enforce standards for the hospital under its management and control a hospital maintained by any university or college established under the laws of this State and supported principally by public funds raised by taxation, a hospital licensed under the Hospital Licensing Act [210 ILCS 85], a hospital organized under the University of Illinois Hospital Act [110 ILCS 330], and an ambulatory surgical treatment center licensed under the Ambulatory Surgical Treatment Center Act [210 ILCS 5]. (Section 10-10 of the Act)

"Health care facility environment" means the totality of the conditions of a health care facility, including infrastructure, services and physical plant. 

"Hypoglycemia" is defined as blood glucose levels <70 milligrams/deciliter, based on National Institute of Health (NIH) guidelines and American Diabetes Association Standards of Medical Care, although severe hypoglycemia usually occurs with blood glucose levels <60 mg/dl.  Hypoglycemia may occur with or without symptoms, as hypoglycemic unawareness can be present in some individuals.  Patient death or serious disability related to hypoglycemia that occurs while the patient is being cared for in a health care facility for a condition unrelated to hypoglycemia (such as congestive heart failure or foot amputation) would qualify as an adverse event.

"Low risk pregnancy" means a pregnancy that is anticipated to be free of problems based on a woman's past medical history, past gynecological and obstetric history and any other relevant issues as the pregnancy continues.

"Major life activity" means an activity of daily living that an individual can perform with little or no difficulty, such as walking, seeing, hearing, eating, speaking, breathing, learning, performing manual tasks or taking care of one's self.

"Principal procedure code" means a code that identifies the procedure performed for definitive treatment of a patient, rather than for diagnostic or exploratory purposes, or that is necessary to take care of a complication.

"Process" means a systematic sequence of actions used to produce something or achieve an end.

"Product" means something produced by human or mechanical effort or by a natural process.

"Restraint" means any method of restricting a patient's freedom of movement that:  is not a usual and customary part of a medical diagnostic or treatment procedure to which the patient or his or her legal representative has consented; is not indicated to treat the patient's medical condition or symptoms; or does not promote the patient's independent functioning.

"Root cause" means a fundamental reason or reasons for an adverse event, without which the adverse health care event would not have occurred.

"Root cause analysis" means the process for determining how an error occurred.

"Serious disability" means a physical or mental impairment, including loss of a body part, related to an adverse event and not related solely to the natural course of the patient's illness or underlying condition, that substantially limits one or more of the major life activities of an individual or results in a loss of bodily function, if the impairment or loss lasts more than 7 days prior to discharge or is still present at the time of discharge from an inpatient health care facility. (Section 10-15(h) of the Act)

"Sexual Assault" means an act of nonconsensual forced sexual penetration or sexual conduct as defined in Section 12-12 of the Criminal Code of 1961 [720 ILCS 5], including, without limitation, acts prohibited under Sections 12-13 through 12-16 of the Criminal Code of 1961.

"Significant injury" means harm or hurt through damage inflicted on the body by an external force.

"Surgery" means treatment of diseases or injuries by manual and/or instrumental methods.  Such methods may include invasive, minimally invasive or non-invasive procedures, depending on the conditions treated and the nature of the instruments and technology used.

"System" means a set of interdependent elements, both human and nonhuman, interacting to achieve a common goal.

"Systemic disturbance" means a human or nonhuman malfunction, intrusion or interruption that affects multiple organs, tissues or processes, or affects the health care organization as a whole.