Report Title:

Patient Safety; Medical Errors; Incident Reporting

Description:

Establishes a patient safety and medical errors reduction program for all health care facilities in the State, including a risk management and risk prevention education and training component for nonphysician personnel and the development and implementation of an incident reporting system.

 

THE SENATE

S.B. NO.

1571

TWENTY-SECOND LEGISLATURE, 2003

 

STATE OF HAWAII

 


 

A BILL FOR AN ACT

 

relating to patient safety.

 

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

SECTION 1. The legislature finds that in November 1999, the Institute of Medicine released a report estimating that as many as ninety-eight thousand Americans die as the result of preventable medical errors in hospitals each year. Moreover, the cost in lost income, disability, and health care costs is as much as $29,000,000,000 annually.

Accordingly, the purpose of this Act is to address these issues by establishing a patient safety and medical errors reduction program for all hospitals and other health care facilities in the State, including a risk management and risk prevention education and training component for nonphysician personnel. This program shall also include the development and implementation of an incident reporting system based upon the affirmative duty of all health care providers and all agents and employees of the health care facility to report "adverse incidents" to the facility's risk manager or a designee within three business days after their occurrence.

SECTION 2. The Hawaii Revised Statutes is amended by adding a new chapter to be appropriately designated and to read as follows:

"Chapter

PATIENT SAFETY AND MEDICAL ERRORS REDUCTION

§   -1 Definitions. As used in this chapter, unless the context clearly requires otherwise:

"Adverse incident" means an event over which health care personnel could exercise control and that is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred, and that:

(1) Results in one of the following injuries:

(A) Death;

(B) Brain or spinal damage;

(C) Permanent disfigurement;

(D) Fracture or dislocation of bones or joints;

(E) A resulting limitation of neurological, physical, or sensory function that continues after discharge from the facility;

(F) Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given informed consent; or

(G) Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient's condition prior to the adverse incident;

(2) Was the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient's diagnosis or medical condition;

(3) Required the surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage was not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process; or

(4) Was a procedure to remove unplanned foreign objects remaining from a surgical procedure.

"Department" means the department of health.

"Emergency medical condition" means:

(1) A medical condition manifesting itself by acute symptoms of sufficient severity, which may include severe pain, such that the absence of immediate medical attention could reasonably be expected to result in any of the following:

(A) Serious jeopardy to patient health, including a pregnant woman or fetus;

(B) Serious impairment to bodily functions; or

(C) Serious dysfunction of any bodily organ or part; or

(2) With respect to a pregnant woman:

(A) That there is inadequate time to effect safe transfer to another hospital prior to delivery;

(B) That a transfer may pose a threat to the health and safety of the patient or fetus; or

(C) That there is evidence of the onset and persistence of uterine contractions or rupture of the membranes.

"Health care facility" has the same meaning as defined in section 323D-2.

"Program" means the patient safety and medical errors reduction program established pursuant to section    -2.

"Wrong surgical procedure" includes a procedure other than the procedure intended for a particular patient or a procedure that has been inappropriately or incorrectly prescribed.

§   -2 Patient safety and medical errors reduction program. (a) Every health care facility, as a part of its administrative functions, shall establish a program that includes all of the following components:

(1) The investigation and analysis of the frequency and causes of general categories and specific types of adverse incidents to patients;

(2) The development of appropriate measures to minimize the risk of adverse incidents to patients, including:

(A) Risk management and risk prevention education and training of all nonphysician personnel as follows:

(i) Risk management and risk prevention education and training of all nonphysician personnel as part of their initial orientation; and

(ii) At least one hour of risk management and risk prevention education and training annually for all nonphysician personnel of the health care facility working in clinical areas and providing patient care; and

(B) A prohibition, except when emergency circumstances require otherwise, against a staff member of the health care facility attending a patient in the recovery room, unless the staff member is authorized to attend the patient in the recovery room and is in the company of at least one other person. However, a health care facility is exempt from the two-person requirement if it has:

(i) Live visual observation;

(ii) Electronic observation; or

(iii) Any other reasonable measure taken to ensure patient protection and privacy;

(3) The analysis of patient grievances that relate to patient care and the quality of medical services; and

(4) The development and implementation of an incident reporting system based upon the affirmative duty of all health care providers and all agents and employees of the health care facility to report adverse incidents to the risk manager, or to the risk manager's designee, within three business days after their occurrence.

(b) The program is the responsibility of the governing board of the health care facility. Each health care facility shall hire a risk manager who is responsible for implementation and oversight of the facility's program as required by this section. A risk manager shall not be made responsible for more than four programs in separate health care facilities, unless the facilities are under one corporate ownership or the programs are in rural health care facilities.

(c) In addition to the programs mandated by this section, other innovative approaches intended to reduce the frequency and severity of medical malpractice and patient injury claims shall be encouraged and their implementation and operation facilitated. Additional approaches may include extending programs to health care providers' offices and the assuming of provider liability by a health care facility for acts or omissions occurring within that facility.

(d) The department shall adopt rules pursuant to chapter 91 governing the establishment of programs to meet the needs of individual health care facilities. Each program shall include the use of incident reports to be filed with an individual of responsibility who is competent in risk management techniques in the employ of each health care facility, such as an insurance coordinator, or who is retained by the facility as a consultant. The individual responsible for the program shall have free access to all medical records of the health care facility. The incident reports are part of the work papers of the attorney defending the health care facility in litigation relating to the facility and are subject to discovery, but are not admissible as evidence in court. A person filing an incident report is not subject to civil suit by virtue of the incident report. As a part of each program, the incident reports shall be used to develop categories of incidents which identify problem areas. Once identified, procedures shall be adjusted to correct the problem areas.

(e) There shall be no monetary liability on the part of, and no cause of action for damages shall arise against, any risk manager for the implementation and oversight of the program in a health care facility under this chapter for any act or proceeding undertaken or performed within the scope of the functions of that program, if the risk manager acts without intentional fraud.

§   -3 Annual report. (a) Each health care facility subject to this chapter shall submit an annual report to the department summarizing the incident reports that have been filed in the facility for that year. The report shall include:

(1) The total number of adverse incidents;

(2) A listing, by category, of the types of operations, diagnostic or treatment procedures, or other actions causing the injuries and the number of incidents occurring within each category;

(3) A listing, by category, of the types of injuries caused and the number of incidents occurring within each category;

(4) A code number using the health care professional's licensure number and a separate code number identifying all other individuals directly involved in adverse incidents to patients, the relationship of the individual to the health care facility, and the number of incidents in which each individual has been directly involved. Each health care facility shall maintain names of the health care professionals and individuals identified by code numbers for purposes of this section; and

(5) A description of all malpractice claims filed against the health care facility, including the total number of pending and closed claims and the nature of the incident which led to, the persons involved in, and the status and disposition of each claim. Each report shall update status and disposition for all prior reports.

(b) The information reported to the department pursuant to subsection (a) that relates to persons licensed under chapter 448, 453, or 463E shall be reviewed by the department. The department shall determine whether any of the incidents potentially involved conduct by a health care professional who is subject to disciplinary action, in which case the professional shall forward this information to the appropriate regulatory agency for disciplinary proceedings, including license sanctions and other civil and criminal sanctions as appropriate.

(c) The report submitted to the department also shall contain the name of the risk manager of the health care facility, a copy of its policy and procedures that govern the measures taken by the facility and its risk manager to reduce the risk of injuries and adverse incidents, and the results of those measures. The annual report is confidential and is not available to the public pursuant to chapter 92, 92F, or any other law providing access to public records. The annual report is not discoverable or admissible in any civil or administrative action, except in disciplinary proceedings by the department or the appropriate regulatory agency. The annual report is not available to the public as part of the record of investigation for and prosecution in disciplinary proceedings made available to the public by the department or the appropriate regulatory board. However, upon written request by a health care professional against whom probable cause has been found, the department or the appropriate regulatory agency shall make available any such records that form the basis of the determination of probable cause.

(d) The first annual report from each health care facility shall be filed no later than August 1, 2004, and shall reflect the period July 1, 2003 to June 30, 2004. The deadlines and reporting period for all subsequent annual reports shall be as established by the department.

§   -4 Notification; one business day. (a) The health care facility shall notify the department no later than one business day after the risk manager or the risk manager's designee has received an incident report pursuant to section    -2(a)(4) and can determine within one business day that any of the following adverse incidents has occurred, whether occurring in the health care facility or arising from health care prior to admission in the facility:

(1) The death of a patient;

(2) Brain or spinal damage to a patient;

(3) The performance of a surgical procedure on the wrong patient;

(4) The performance of a wrong-site surgical procedure; or

(5) The performance of a wrong surgical procedure.

(b) The notification in subsection (a) shall be made in writing and be provided by facsimile device or overnight mail delivery. The notification shall include information regarding the identity of the affected patient, the type of adverse incident, the initiation of an investigation by the facility, and whether the events causing or resulting in the adverse incident represent a potential risk to other patients.

§   -5 Notification; fifteen calendar days; extensions. (a) Any of the following adverse incidents, whether occurring in the health care facility or arising from health care prior to admission in the facility, shall be reported by the facility to the department within fifteen calendar days after its occurrence:

(1) The death of a patient;

(2) Brain or spinal damage to a patient;

(3) The performance of a surgical procedure on the wrong patient;

(4) The performance of a wrong-site surgical procedure;

(5) The performance of a wrong surgical procedure;

(6) The performance of a surgical procedure that is medically unnecessary or otherwise unrelated to the patient's diagnosis or medical condition;

(7) The surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage is not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process; or

(8) The performance of procedures to remove unplanned foreign objects remaining from a surgical procedure.

(b) The department may grant extensions to this reporting requirement for more than fifteen days upon justification submitted in writing by the facility administrator to the department. The department may require an additional, final report. These reports shall not be available to the public pursuant to chapter 92, 92F, or any other law providing access to public records, nor be discoverable or admissible in any civil or administrative action, except in disciplinary proceedings by the department or the appropriate regulatory agency, nor shall they be available to the public as part of the record of investigation for and prosecution in disciplinary proceedings made available to the public by the department or the appropriate regulatory board. However, upon written request by a health care professional against whom probable cause has been found, the department or the appropriate regulatory board shall make available any such records that form the basis of the determination of probable cause. The department, as it deems appropriate, may investigate any such incident and prescribe measures that must or may be taken in response to the incident. The department shall review each incident and determine whether it potentially involved conduct by the health care professional who is subject to disciplinary action, in which case the professional shall be subject to appropriate disciplinary proceedings, including license sanctions and other civil and criminal sanctions as appropriate.

§   -6 Access to records. The department shall have access to all health care facility records necessary to carry out this chapter. The records obtained by the department under section    -3,    -4, or    -5 are not available to the public under chapter 92 or 92F, nor shall they be discoverable or admissible in any civil or administrative action, except in disciplinary proceedings by the department or the appropriate regulatory agency, nor shall records of investigation for and prosecution in disciplinary proceedings involving health care professionals be made available to the public by the department or the appropriate regulatory board. However, the department or the appropriate regulatory board, upon written request by a health care professional against whom probable cause has been found, shall make available any such records that form the basis of the determination of probable cause, except that, with respect to peer review committee or quality assurance committee records, section 663-1.7 controls.

§   -7 Meetings. The meetings of the committees and governing board of a health care facility held solely for the purpose of achieving the objectives of risk management as provided by this chapter shall not be open to the public under chapter 92. The records of these meetings are confidential and exempt from inspection, examination, and duplication, except as provided in section -6.

§   -8 Review. The department shall periodically review the program at each health care facility to determine whether the program meets standards established in statutes and rules, whether the program is being conducted in a manner designed to reduce adverse incidents, and whether the program is appropriately reporting incidents under this chapter.

§   -9 Department reports. (a) If the department, through its receipt of the annual reports required by section    -3 or through any investigation, has a reasonable belief that conduct by a staff member or employee of a health care facility is grounds for disciplinary action by the appropriate regulatory agency, the department shall report this fact to the appropriate regulatory agency.

(b) The department shall annually publish a report summarizing the information contained in the annual reports submitted by health care facilities pursuant to section    -3 and disciplinary actions reported to the department pursuant to section 663-1.7. The report, at a minimum, shall summarize:

(1) Adverse incidents, by category of reported incident, and by type of professional involved; and

(2) Types of malpractice claims filed, by type of professional involved.

§   -10 Violations. The department shall require a written plan of correction from the facility. For a single incident or series of isolated incidents that are not wilful violations of the reporting requirements of this chapter, the department shall first seek to obtain corrective action by the facility. If the correction is not demonstrated by the deadline established by the department or if there is a pattern of violations of this chapter that are not wilful, the department may impose an administrative fine not to exceed $5,000 for any violation of the reporting requirements of this chapter. The administrative fine for repeated violations that are not wilful shall not exceed $10,000 for any violation. The administrative fine for each intentional and wilful violation may not exceed $25,000 per violation, per day. The fine for an intentional and wilful violation of this chapter may not exceed $250,000. This section does not apply to the notice requirements under section      -4."

SECTION 3. This Act does not affect rights and duties that matured, penalties that were incurred, and proceedings that were begun, before its effective date.

SECTION 4. This Act shall take effect upon its approval.

INTRODUCED BY:

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