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1 | AN ACT concerning health care.
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2 | Be it enacted by the People of the State of Illinois, | ||||||||||||||||||||||||
3 | represented in the General Assembly:
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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;
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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";
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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.
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22 | Section 10. Definitions. As used in this Law:
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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.
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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.
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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.
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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
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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.
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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.
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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.
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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.
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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. |