Section 235.110  Definitions

 

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.

 

(Source:  Amended at 40 Ill. Reg. 375, effective December 23, 2015)

 

Section 235.120  Referenced Materials

 

The following materials are referenced in this Part:

 

a)         State of Illinois statutes:

 

1)         Hospital Licensing Act [210 ILCS 85]

 

2)         Ambulatory Surgical Treatment Center Act [210 ILCS 5]

 

3)         University of Illinois Hospital Act [110 ILCS 330]

 

4)         Criminal Code of 2012 [720 ILCS 5]

 

5)         Code of Civil Procedure, Article VIII, Part 21 [735 ILCS 5/Art. VIII, Part 21]

 

6)         Health Care Surrogate Act [755 ILCS 40]

 

7)         Emancipation of Minors Act [750 ILCS 30]

 

b)                  State of Illinois Administrative Rules

Rules of Practice and Procedure in Administrative Hearings (Illinois Department of Public Health) (77 Ill. Adm. Code 100)

 

(Source:  Amended at 40 Ill. Reg. 375, effective December 23, 2015)

 

Section 235.130  Adverse Health Care Events

 

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

 

a)         Surgical or Invasive Procedure Events.  Events reportable under this subsection are:

 

1)         Any surgery or other invasive procedure performed on the wrong body part or site and that is not consistent with the correct documented informed consent for that patient, excluding emergent situations that occur in the course of surgery or other invasive procedure when exigency precludes obtaining informed consents.

 

2)         Surgery or other invasive procedure performed on the wrong patient.

 

3)         The wrong surgical or other invasive procedure performed on a patient that is not consistent with the correct documented informed consent for that patient.

 

4)         Unintended retention of a foreign object in a patient after surgery or other invasive procedure, including medical or surgical items intentionally placed by medical providers that are unintentionally left in place.  Unintended retention of a foreign object excludes:

 

A)        Objects present prior to surgery or other invasive procedure that are intentionally left in place;

 

B)        Objects intentionally implanted as part of a planned intervention; and

 

C)        Objects not present prior to surgery or other invasive procedure that are intentionally left in when the risk of removal exceeds the risk of retention (such as micro-needles, broken screws).

 

5)         Intraoperative or immediately postoperative or postprocedure death in an ASA Class I patient, including all ASA Class I patient deaths in situations in which anesthesia was administered, regardless of whether the planned surgical procedure was performed.

 

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

 

1)         Patient death or serious injury associated with the use of contaminated drugs, devices or biologics provided by the health care setting, including 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, including, but not limited to, catheters, drains and other specialized tubes, infusion pumps, ventilators and procedural and monitoring equipment.

 

3)         Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a health care setting, excluding deaths or serious injury associated with neurosurgical procedures known to present a high risk of intravascular air embolism.

 

c)         Patient Protection Events.  Events reportable under this subsection are:

 

1)         Discharge or release of a patient or resident of any age, who lacks decisional capacity, to anyone other than a guardian or other legally authorized person.

 

2)         Patient death or serious injury associated with patient elopement (disappearance), excluding events involving competent adults with decisionmaking capacity who leave against medical advice or voluntarily leave without being seen.

 

3)         Patient suicide, attempted suicide or self-harm that results in serious injury while being cared for in a health care setting.  Deaths resulting from self‑inflicted injuries that were the reason for admission or presentation to the health care facility are excluded from reporting requirements.

 

d)         Care Management Events.  Events reportable under this subsection are:

 

1)         Patient death or serious injury associated with a medication error (for example, errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration).

 

2)         Patient death or serious injury associated with unsafe administration of blood products.

 

3)         Maternal death or serious injury associated with labor or delivery in a low‑risk pregnancy while being cared for in a health care setting, including events that occur within 42 days post-delivery, but not deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy, or cardiomyopathy.

 

4)         Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy, including for the office-based surgery, birthing center or "home" setting, unplanned admission to an inpatient setting within 24 hours after delivery.

 

5)         Patient death or serious injury associated with a fall while being cared for in a health care setting, including, but not limited to, fractures, head injuries and intracranial hemorrhage.

 

6)         Any Stage 3, Stage 4 and unstageable pressure ulcers acquired after admission or presentation to a healthcare setting unless:

 

A)        Stage 2 pressure ulcer, which was recognized upon admission, progresses to a Stage 3; or

 

B)        A pressure ulcer develops in an area where deep tissue injury was documented as present upon admission or presentation.

 

7)         Artificial insemination with the wrong donor sperm or wrong egg.

 

8)         Patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen, including events in which specimens are misidentified or when another procedure cannot be done to produce a specimen.

 

9)         Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology or radiology test results.

 

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

 

1)         Patient or staff death or serious injury associated with an electric shock in the course of a patient care process in a health care facility, excluding events involving patients during planned treatments such as electric countershock or elective cardioversion.

 

2)         Any incident in which systems designated for oxygen or other gas to be delivered to a patient contain no gas, or the wrong gas, or is contaminated by toxic substances.

 

3)         Patient or staff member death or serious injury associated with a burn incurred from any source in the course of a patient care process in a health care setting.

 

4)         Patient death or serious injury associated with the use of physical restraints or bedrails while being cared for in a health care setting.

 

f)         Radiologic Events.  Reportable under this subsection is death or serious injury of a patient or staff member associated with the introduction of a metallic object into the Magnetic Resonance Imaging area, including events related to material inside the patient's body or projectiles outside the patient's body.

 

g)         Potential Criminal 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 or resident of any age.

 

3)         Sexual abuse or sexual assault on a patient or staff member within or on the grounds of, a health care setting.

 

4)         Death or serious injury of a patient or staff member resulting from a physical assault (for example, battery) that occurs within or on the grounds of a health care setting.

 

(Source:  Amended at 40 Ill. Reg. 375, effective December 23, 2015)

 

Section 235.140  Adverse Health Care Event Reporting System

 

Reports of adverse health care events required.  Each health care facility shall report to the Department the occurrence of any of the adverse health care events described in Section 235.130 of this Part no later than 30 days after discovery of the event. (Section 10-15(a) of the Act) The reports required by the Act and this Part may be filed by electronic means.  The electronic system shall have uniform reporting templates, automated report receipts, a user "save" feature and automatic reminders to report the 90-day Root Cause Analysis and Corrective Action Plan.  Reports of adverse health care events shall include:

 

a)         The name, address and Department-assigned unique identifier of the health care facility making the report;

 

b)         The name, title and contact information of the person making the report;

 

c)         The exact location within the health care facility where the adverse health care event occurred;

 

d)         The date and time that the adverse health care event occurred;

 

e)         The date and time that any employee, contractor or representative of the health care facility was notified of the occurrence of the adverse health care event;

 

f)         Gender and age (range) of the patient;

 

g)         Race or ethnicity of the patient;

 

h)         Language spoken by patient; if the language was not English, was a translator present;

 

i)          Date on which the patient was admitted;

 

j)           Admitting diagnosis code of the patient;

 

k)          Principal procedure code of the patient if the event involved surgery;

 

l)          Description of the adverse health care event, including number and type of staff present at time of the event;

 

m)         Any immediate or emergency remedial actions taken prior to filing the adverse health care event report, including if the patient and/or the patient's family was informed of the event; and

 

n)          The outcome for the patient from the adverse event.

 

Section 235.150  Root Cause Analysis Findings and Corrective Action Plan

 

a)         Following the occurrence of an adverse health care event, the health care facility must conduct a root cause analysis of the event.  Following the analysis, the health care facility must:

 

1)         Implement a corrective action plan to address the findings of the analysis; or

 

2)         Report to the Department any reasons for not taking corrective action. 

 

b)         A copy of the findings of the root cause analysis and a copy of the corrective action plan must be filed with the Department within 90 days after the submission of the report to the Department. (Section 10-20 of the Act)

 

c)         The root cause analysis findings shall:

 

1)         Focus primarily on systems and processes;

 

2)         Progress from specific direct causes in clinical processes to contributing causes in organizational processes;

 

3)         Contain the following key elements:

 

A)        Details of the adverse health care event;

 

B)        Identification of any human factors related to the adverse health care event;

 

C)        Examination of any related processes and systems in place during the adverse health care event;

 

D)        Analysis of staffing levels at the times before, during and after the adverse health care event;

 

E)        Analysis of staff communication before, during and after the adverse health care event;

 

F)         Analysis of the training and education of staff in connection with the systems and processes associated with the root cause analysis of the adverse health care event;

 

G)        Analysis of any actions, inactions, literacy or knowledge gaps of the patient that may have contributed to the adverse health care event;

 

H)        Assessment of the equipment involved in the adverse health care event, if any;

 

I)         Analysis of the physical environment before, during and after the adverse health care event;

 

J)         Identification of any external factors beyond the control of the health care facility; and

 

K)        Identification of any other factors related to the adverse health care event;

 

4)         Describe contributing and underlying factors to the root cause; and

 

5)         Identify changes that could be made in systems and processes, either through redesign of existing systems or processes or development of new systems or processes, that would reduce the risk of such events occurring in the future.

 

d)         The corrective action shall include:

 

1)         Specific actions to correct the identified causes of the event to prevent a similar event occurring in the future, including if an apology was given to the patient and/or the patient's family;

 

2)         Identified and measurable outcomes;

 

3)         A designated person responsible for implementation and evaluation; and

 

4)         A specific implementation plan with the following:

 

A)        Completion dates;

 

B)        Provisions for education of and communication with appropriate hospital staff; and

 

C)        A description of how the hospital's performance will be assessed and evaluated following full implementation.

 

e)         The Department will determine whether the root cause analysis and corrective action plan are acceptable, based on the requirements of this Section.  If the root cause analysis and corrective action plan are acceptable, the Department will instruct the facility to begin follow-up activity to measure the success of the corrective action plan. 

 

f)         If the Department determines that the root cause analysis and corrective action plan are unacceptable, based on the requirements of this Section, the Department will provide consultation on the criteria that have not been met and will allow an additional time period (up to 30 calendar days) for resubmission.

 

g)         A health care facility shall report to the Department regarding the outcome of the corrective action plans at eight and 18 months following the initiation of the plan.

 

Section 235.160  Communication and Annual Report

 

The Department will communicate with health care facilities to maximize the use of the adverse health care event reporting system to improve health care quality. (Section 10-30(b) of the Act)

 

a)         The Department will collect and analyze data from adverse health care event reports to determine patterns of system failure in the health care system and successful methods to correct these failures.  (Section 10-30(b) of the Act)

 

b)         The data collected will be used to provide adverse health care event prevention recommendations to Illinois health care facilities and to help to ensure a data base of adverse health care event reports that will provide greater understanding of adverse health care events and promote the reduction of risk for those events.

 

c)         The Department will publish an annual report to increase general knowledge about adverse health care events, their causes, and strategies for prevention.  This report will be made available to the public.

 

(Source:  Amended at 40 Ill. Reg. 375, effective December 23, 2015)

 

Section 235.170  Enforcement

 

a)         A health care facility that fails to comply with the requirements of the Act and this Part shall be subject to enforcement action by the Department.

 

b)         After notice and opportunity for a hearing, the Department may deny, suspend, or revoke a license to open, conduct, operate, and maintain a hospital in any case in which the Department finds that there has been a substantial failure to comply with the provisions of the Act or this Part. (Section 7(a) of the Hospital Licensing Act)

 

c)         When the Department determines that an ambulatory surgical treatment center has failed to comply with the Act or this Part, the Department may issue a notice of fine assessment which shall specify the violations for which the fine is assessed.  (Section 10(d) of the Ambulatory Surgical Treatment Center Act) Fines will be assessed in accordance with Section 10(d) of the Ambulatory Surgical Treatment Center Act. The Department will provide notice and opportunity for hearing to the ambulatory surgical treatment center.

 

d)         Hearings shall be conducted in accordance with the Department's Rules of Practice and Procedure in Administrative Hearings (77 Ill. Adm. Code 100).

 

(Source:  Amended at 40 Ill. Reg. 375, effective December 23, 2015)

 

Section 235.180  Confidentiality

 

Other than the annual report required under paragraph (4) of Section 10-35 of the Act, adverse health care event reports, findings of root cause analyses, and corrective action plans filed by a health care facility under the Act and records created or obtained by the Department in reviewing or investigating these 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 a health care facility or health care professional.  No report or Department disclosure under the Act or this Part may contain information identifying a patient, employee, or licensed professional.  Notwithstanding any other provision of law, under no circumstances shall the Department disclose information obtained from a health care facility that is confidential under Part 21 of Article VIII of the Code of Civil Procedure.  (Section 10-25 of the Act)