Full Text of HB5093 093rd General Assembly
HB5093 93RD GENERAL ASSEMBLY
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93RD GENERAL ASSEMBLY
State of Illinois
2003 and 2004 HB5093
Introduced 02/05/04, by Mary E. Flowers SYNOPSIS AS INTRODUCED: |
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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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A BILL FOR
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HB5093 |
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LRB093 15482 AMC 41085 b |
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| AN ACT concerning health care.
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| Be it enacted by the People of the State of Illinois, | 3 |
| represented in the General Assembly:
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| 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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| (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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| (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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| 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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| Section 10. Definitions. As used in this Law:
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| "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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| 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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| "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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| Section 15. Patient safety plan. |
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| (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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| (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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| (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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| 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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| 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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| (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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| 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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| 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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| 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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| 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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LRB093 15482 AMC 41085 b |
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| adverse incidents that occur in health care facilities subject | 2 |
| to this Law. |
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