93RD GENERAL ASSEMBLY
State of Illinois
2003 and 2004
HB5093

 

Introduced 02/05/04, by Mary E. Flowers

 

SYNOPSIS AS INTRODUCED:
 
New Act

    Creates the Medical Error Reporting Law. Requires a health care facility to develop and implement a patient safety plan for the purpose of improving the health and safety of patients at the facility. Requires a health care facility to report to the Department of Public Health every serious preventable adverse incident that occurs in that facility. Provides that a health care facility shall ensure that the patient affected by a serious preventable adverse incident is informed of the serious preventable adverse incident.


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FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

HB5093 LRB093 15482 AMC 41085 b

1     AN ACT concerning health care.
 
2     Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
 
4     Section 1. Short title. This Act may be cited as the
5 Medical Error Reporting Law.
 
6     Section 5. Findings. The General Assembly finds and
7 declares that:
8         (1) adverse incidents, some of which are the result of
9     preventable errors, are inherent in all systems;
10         (2) well-designed systems have processes built in to
11     minimize the occurrence of errors, as well as to detect
12     those that do occur; they incorporate mechanisms to
13     continually improve their performance;
14         (3) to enhance patient safety, the goal is to craft a
15     health care delivery system that minimizes, to the greatest
16     extent feasible, the harm to patients that results from the
17     delivery system itself;
18         (4) an important component of a successful patient
19     safety strategy is a feedback mechanism that allows
20     detection and analysis not only of adverse incidents, but
21     also of "near-misses";
22         (5) to encourage disclosure of these incidents so that
23     they can be analyzed and used for improvement, it is
24     critical to create a non-punitive culture that focuses on
25     improving processes rather than assigning blame;
26         (6) under current Illinois law, hospitals are required
27     to investigate any unusual incidents that occur at any time
28     on a patient care unit and summarized reports of these
29     unusual incidents are to be made available to the
30     Department of Public Health;
31         (7) governing boards of hospitals are responsible for
32     the establishment of policy for the investigation of

 

 

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1     unusual incidents that may occur;
2         (8) hospitals are required to maintain accurate,
3     current, and complete personnel records for each employee,
4     including current and background information sufficient to
5     justify the initial and continuing employment of the
6     individual;
7         (9) hospitals are routinely denied information about
8     prospective employees from their former employers with
9     regard to patient error or unusual incidents because these
10     former employers fear that their former employees may file
11     defamation or other civil lawsuits; and
12         (10) by establishing an environment that both mandates
13     the confidential disclosure of the most serious
14     preventable adverse incidents and encourages the
15     voluntary, anonymous and confidential disclosure of less
16     serious adverse incidents, as well as preventable
17     incidents and near-misses, the State seeks to increase the
18     amount of information on systems failures, analyze the
19     sources of these failures, and disseminate information on
20     effective practices for reducing systems failures and
21     improving the safety of patients.
 
22     Section 10. Definitions. As used in this Law:
23     "Adverse incident" means an unusual incident that is a
24 negative consequence of care that results in unintended injury
25 or illness, which may or may not have been preventable.
26     "Anonymous" means that information is presented in a form
27 and manner that prevents the identification of the person
28 filing the report.
29     "Department" means the Department of Public Health.
30     "Director" means the Director of Public Health.
31     "Incident" means a discrete, auditable, and clearly
32 defined occurrence.
33     "Health care facility" means a facility or institution,
34 whether public or private, engaged principally in providing
35 services for health maintenance organizations or in diagnosis

 

 

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1 of treatment of human disease, pain, injury, deformity, or
2 physical condition, including, but not limited to, a general
3 hospital, special hospital, mental hospital, public health
4 center, diagnostic center, treatment center, rehabilitation
5 center, extended care facility, skilled nursing home, nursing
6 home, intermediate care facility, tuberculosis hospital,
7 chronic disease hospital, maternity hospital, outpatient
8 clinic, dispensary, home health care agency, residential
9 health care facility, and bioanalytical laboratory (except as
10 specifically excluded hereunder) or central services facility
11 serving one or more such institutions but excluding
12 institutions that provide healing solely by prayer and
13 excluding such bioanalytical laboratories as are independently
14 owned and operated, and are not owned, operated, managed or
15 controlled, in whole or in part, directly or indirectly by any
16 one or more health care facilities, and the predominant source
17 of business of which is not by contract with health care
18 facilities within the State.
19     "Health care professional" means an individual who, acting
20 within the scope of his or her licensure or certification,
21 provides health care services and includes, but is not limited
22 to, a physician, dentist, nurse, pharmacist, or other health
23 care professional whose professional practice is regulated
24 pursuant to Chapter 225 of the Illinois Compiled Statutes.
25     "Near-miss" means an occurrence that could have resulted in
26 an adverse incident but the adverse incident was prevented.
27     "Preventable incident" means an incident that could have
28 been anticipated and prepared against, but occurs because of an
29 error or other system failure.
30     "Serious preventable adverse incident" means an adverse
31 incident that is a preventable incident and results in death or
32 loss of a body part, or disability or loss of bodily function
33 lasting more than 7 days or still present at the time of
34 discharge from a health care facility.
 
35     Section 15. Patient safety plan.

 

 

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1     (a) In accordance with the requirements established by the
2 Director by rule, a health care facility shall develop and
3 implement a patient safety plan for the purpose of improving
4 the health and safety of patients at the facility.
5     (b) The patient safety plan shall, at a minimum, include
6 all of the following:
7         (1) A patient safety committee, as prescribed by rule.
8         (2) A process for teams of facility staff, which teams
9     are comprised of personnel who are representative of the
10     facility's various disciplines and have appropriate
11     competencies, to conduct ongoing analysis and application
12     of evidence-based patient safety practices in order to
13     reduce the probability of adverse incidents resulting from
14     exposure to the health care system across a range of
15     diseases and procedures.
16         (3) A process for teams of facility staff, which teams
17     are comprised of personnel who are representative of the
18     facility's various disciplines and have appropriate
19     competencies, to conduct analyses of near-misses, with
20     particular attention to serious preventable adverse
21     incidents and adverse incidents.
22         (4) A process for the provision of ongoing patient
23     safety training for facility personnel.
24     (c) Any documents, materials, or information developed by a
25 health care facility as part of a process of self-critical
26 analysis conducted pursuant to this Section concerning
27 preventable incidents, near-misses, and adverse incidents,
28 including serious preventable adverse incidents, and any
29 document or oral statement that constitutes the disclosure
30 provided to a patient or the patient's family member or
31 guardian pursuant to subsection (b) of Section 20, shall not be
32 (i) subject to discovery or admissible as evidence or otherwise
33 disclosed in any civil, criminal, or administrative action or
34 proceeding or (ii) used in an adverse employment action or in
35 the evaluation of decisions made in relation to accreditation,
36 certification, credentialing, or licensing of an individual,

 

 

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1 which is based on the individual's participation in the
2 development, collection, reporting, or storage of information
3 in accordance with this Section. The provisions of this
4 subsection shall not be construed to limit a health care
5 facility from taking disciplinary action against a health care
6 professional in a case in which the professional has displayed
7 recklessness, gross negligence, or willful misconduct or in
8 which there is evidence, based on other similar cases known to
9 the facility, of a pattern of significant substandard
10 performance that resulted in serious preventable adverse
11 incidents.
 
12     Section 20. Reports; use of information.
13     (a) A health care facility must report to the Department in
14     a form and manner established by the Director every serious
15     preventable adverse incident that occurs in that facility.
16     (b) A health care facility shall ensure that the patient
17 affected by a serious preventable adverse incident, or, in the
18 case of a minor or a patient who is incapacitated, the
19 patient's parent or guardian or other family member, as
20 appropriate, is informed of the serious preventable adverse
21 incident, no later than the end of the episode of care, or, if
22 discovery occurs after the end of the episode of care, in a
23 timely fashion as established by the Director by rule. If the
24 patient's physician determines, in accordance with criteria
25 established by the Director by rule, that the disclosure would
26 seriously and adversely affect the patient's health, then the
27 facility shall notify the family member, if available. In the
28 event that an adult patient is not informed of the serious
29 preventable adverse incident, the facility shall ensure that
30 the physician includes a statement in the patient's medical
31 record that provides the reason for not informing the patient
32 pursuant to this Section.
33     (c) A health care professional or other employee of a
34 health care facility is encouraged to make anonymous reports to
35 the Department in a form and manner established by the Director

 

 

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1 regarding near-misses, preventable incidents, and adverse
2 incidents that are otherwise not subject to mandatory reporting
3 pursuant to subsection (a) of this Section. The Director shall
4 establish procedures for and a system to collect, store, and
5 analyze information voluntarily reported pursuant to this
6 subsection. The repository shall function as a clearinghouse
7 for trend analysis of the information collected pursuant to
8 this subsection.
9     (d) Any documents, materials, or information received by
10 the Department pursuant to the provisions of subsections (a)
11 and (c) of this Section concerning serious preventable adverse
12 incidents, near-misses, preventable incidents, and adverse
13 incidents that are otherwise not subject to mandatory reporting
14 pursuant to subsection (a) of this Section shall not be (i)
15 subject to discovery or admissible as evidence or otherwise
16 disclosed in any civil, criminal, or administrative action or
17 proceeding, (ii) considered a public record under the Freedom
18 of Information Act, or (iii) used in an adverse employment
19 action or in the evaluation of decisions made in relation to
20 accreditation, certification, credentialing, or licensing of
21 an individual, which is based on the individual's participation
22 in the development, collection, reporting, or storage of
23 information in accordance with this Section. The provisions of
24 this subsection shall not be construed to limit a health care
25 facility from taking disciplinary action against a health care
26 professional in a case in which the professional has displayed
27 recklessness, gross negligence, or willful misconduct or in
28 which there is evidence, based on other similar cases known to
29 the facility, of a pattern of significant substandard
30 performance that resulted in serious preventable adverse
31 incidents.
32     The information received by the Department may be used by
33 the Department and the Attorney General for the purposes of
34 this Law and for oversight of facilities and health care
35 professionals. The Department and the Attorney General shall
36 not use the information for any other purpose. In using the

 

 

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1 information to exercise oversight, the Department and the
2 Attorney General shall place primary emphasis on ensuring
3 effective corrective action by the facility or health care
4 professional, reserving punitive enforcement or disciplinary
5 action for those cases in which the facility or the
6 professional has displayed recklessness, gross negligence, or
7 willful misconduct or in which there is evidence, based on
8 other similar cases known to the Department or the Attorney
9 General, of a pattern of significant substandard performance
10 that has the potential for or actually results in harm to
11 patients.
 
12     Section 25. Rules. The Director shall adopt any rules
13 necessary to carry out the provisions of this Law. The
14 regulations shall establish: criteria for a health care
15 facility's patient safety plan and patient safety committee;
16 the time frame and format for mandatory reporting of serious
17 preventable adverse incidents at a health care facility; the
18 types of incidents that qualify as serious preventable adverse
19 incidents; and the circumstances under which a health care
20 facility is not required to inform a patient or the patient's
21 family about a serious preventable adverse incident. In
22 establishing the criteria for reporting serious preventable
23 adverse incidents, the Director shall, to the extent feasible,
24 use criteria for these incidents that have been or are
25 developed by organizations engaged in the development of
26 nationally recognized standards.
 
27     Section 30. Report to General Assembly. The Director of
28 Public Health shall issue an annual report to the General
29 Assembly, which is also available to the general public, no
30 later than 18 months after the effective date of this Law on
31 the status of patient safety plans established by health care
32 facilities subject to this Law and information reported to the
33 Department as required by this Law or which is voluntarily
34 reported as permitted by this Law regarding serious preventable

 

 

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1 adverse incidents that occur in health care facilities subject
2 to this Law.