Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 235 - ADVERSE HEALTH CARE EVENTS REPORTING CODE › Section 235.110 - Definitions

Current through Register Vol. 48, No. 28, July 12, 2024
For the purpose of this Part:
"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 identified
				as a serious reportable event
as listed in Section
				235.130.
"ASA Class I patient", as designated by the American Society of
				Anesthesiologists (ASA) Physical Status Classification System, means a normal,
				healthy patient prior to surgery.
"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)
"Decisional capacity" means the ability to understand
				and appreciate the nature and consequences of a decision regarding medical
				treatment or forgoing life-sustaining treatment and the ability to reach and
				communicate an informed decision in the matter as determined by the attending
				physician
as defined by Section 10 of the Health Care Surrogate Act.
				[755 ILCS 40/10
				]
"
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, ventilators, and procedural and
				monitoring equipment.
"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.
"Guardian" means a court appointed guardian of the
				person who serves as a representative of a minor or as a representative of a
				person under legal disability
as defined by Section 10 of the Health
				Care Surrogate Act. [755 ILCS 40/10]
"Health care facility"
or "health care
				setting"
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.
"Immediately post-operative" means within 24 hours after
				surgery or other invasive procedure was completed or after administration of
				anesthesia (if surgery/procedure not completed).
"Licensed health care provider" means any person licensed by
				the State to provide medical, nursing or other health care services.
"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)
"Serious injury" means an injury that can result in death, loss
				of a body part, disability, loss of bodily function, or require major
				intervention for correction (for example, higher level of care,
				surgery).
"Sexual abuse" includes criminal sexual abuse or criminal
				sexual assault as defined in Sections 11-1.20 through 11-1.60 of the Criminal
				Code of 2012.
"Sexual Assault" includes, without limitation, acts prohibited
				under Sections 11-1.20 through 11-1.60 of the Criminal Code of 2012.
"Staff member" means any full-time or part-time employee,
				contractor or volunteer who is authorized to work at the reporting facility and
				who is responsible for carrying out the work of the reporting facility whether
				in a paid or unpaid capacity.
"Surgery" means an invasive operative procedure in which skin
				or mucous membranes and connective tissue is incised or the procedure is
				carried out using an instrument that is introduced through a natural body
				orifice. Surgery includes minimally invasive procedures involving biopsies or
				placement of probes or catheters requiring the entry into a body cavity through
				a needle or trocar. Surgeries include a range of procedures from minimally
				invasive dermatological procedures (biopsy, excision and deep cryotherapy for
				malignant lesions) to Caesarian delivery to extensive multiorgan
				transplantation. Surgery does not include such things as otoscopes and drawing
				blood.
"System" means a set of interdependent elements, both human and
				nonhuman, interacting to achieve a common goal.
"Unemancipated minor" means a minor who has not been granted
				the legal status of emancipated, pursuant to the Emancipation of Minors
				Act.