2005 -- S 0555 SUBSTITUTE A

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LC01764/SUB A

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STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2005

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A N A C T

RELATING TO HEALTH AND SAFETY -- LICENSING OF HEALTH CARE FACILITIES

     Introduced By: Senators Roberts, Goodwin, C Levesque, Pichardo, and Polisena

     Date Introduced: February 10, 2005

     Referred To: Senate Health & Human Services

It is enacted by the General Assembly as follows:

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     SECTION 1. Section 23-17-40 of the General Laws in Chapter 23-17 entitled "Licensing

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of Health Care Facilities" is hereby amended to read as follows:

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     23-17-40. Hospital events reporting. -- (a) Reportable events as defined in subsection

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(b) shall be reported to the department of health division of facilities regulation on a telephone

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number maintained for that purpose. Hospitals shall report incidents as defined in subsection (b)

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within twenty-four (24) hours of when the accident occurred or if later, within twenty-four (24)

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hours of receipt of information causing the hospital to believe that a reportable event has

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occurred.

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      (b) (1) Reportable events are defined as follows:

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      (i) Fires or internal disasters in the facility which disrupt the provisions of patient care

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services or cause harm to patients or personnel;

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      (ii) Poisoning involving patients of the facility;

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      (iii) Infection outbreaks as defined by the department in regulation;

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      (iv) Kidnapping and inpatient psychiatric elopements and elopements by minors;

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      (v) Strikes by personnel;

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      (vi) Disasters or other emergency situations external to the hospital environment which

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adversely affect facility operations; and

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      (vii) Unscheduled termination of any services vital to the continued safe operation of the

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facility or to the health and safety of its patients and personnel.

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      (2) Any hospital filing a report with the attorney general's office concerning abuse,

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neglect and mistreatment of patients as defined in chapter 17.8 of this title shall forward a copy of

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the report to the department of health. In addition, a copy of all hospital notifications and reports

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made in compliance with the federal Safe Medical Devices Act of 1990, 21 U.S.C. section 301 et

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seq., shall be forwarded to the department of health within the time specified in the federal law.

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      (c) Any reportable incident in a hospital that results in patient injury as defined in

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subsection (d) shall be reported to the department of health with seventy-two (72) hours or when

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the hospital has reasonable cause to believe that an incident as defined in subsection (d) has

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occurred. The department of health shall promulgate rules and regulations outlining to include the

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process whereby health care professionals with knowledge of an incident shall report it to the

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hospital, requirements for the hospital to conduct a root cause analysis of the incident or other

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appropriate process for incident investigation and to develop and file a performance improvement

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plan, and additional incidents to be reported that are in addition to those listed in subsection (d).

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In its reports, no personal identifiers shall be included. The hospital shall require the appropriate

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committee within the hospital to carry out a peer review process to determine whether the

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incident was within the normal range of outcomes, given the patient's condition. The hospital

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shall notify the department of the outcome of the internal review, and if the findings determine

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that the incident was within the normal range of patient outcomes no further action is required. If

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the findings conclude that the incident was not within the normal range of patient outcomes, the

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hospital will shall conduct a root cause analysis or other appropriate process for incident

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investigation to identify causal factors that may have lead to the incident and develop a

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performance improvement plan to prevent similar incidents from occurring in the future. The

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hospital shall also provide to the department of health the following information:

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      (1) An explanation of the circumstances surrounding the incident;

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      (2) An updated assessment of the effect of the incident on the patient;

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      (3) A summary of current patient status including follow-up care provided and post-

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incident diagnosis; and

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      (4) A summary of all actions taken to correct identified problems to prevent recurrence

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of the incident and/or to improve overall patient care and to comply with other requirements of

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this section.

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      (d) Incidents to be reported are those causing or involving:

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      (1) Brain injury;

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      (2) Mental impairment;

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      (3) Paraplegia;

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      (4) Quadriplegia;

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      (5) Any type of paralysis;

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      (6) Loss of use of limb or organ;

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      (7) Hospital stay extended due to serious or unforeseen complications;

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      (8) Birth injury;

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      (9) Impairment of sight or hearing;

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      (10) Surgery on the wrong patient;

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      (11) Subjecting a patient to a procedure other than that ordered or intended by the

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patient's attending physician;

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      (12) Any other incident that is reported to their malpractice insurance carrier or self-

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insurance program;

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      (13) Suicide of a patient during treatment or within five (5) days of discharge from an

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inpatient or outpatient unit (if known);

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      (14) Blood transfusion error; and

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      (15) Any serious or unforeseen complication, that is not expected or probable, resulting

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in an extended hospital stay or death of the patient.

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      (e) This section does not replace other reporting required by this chapter.

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      (f) Nothing in this section shall prohibit the department from investigating any event or

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incident.

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      (g) All reports to the department under this section shall be subject to the provisions of

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section 23-17-15. In addition, all reports under this section, together with the peer review records

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and proceedings related to events and incidents so reported and the participants in the proceedings

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shall be deemed entitled to all the privileges and immunities for peer review records set forth in

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section 23-17-25.

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      (h) The department shall issue an annual report by March 31 each year providing

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aggregate summary information on the events and incidents reported by hospitals as required by

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this chapter. A copy of the report shall be forwarded to the governor, the speaker of the house, the

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senate president and members of the health care quality steering committee established pursuant

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to section 23-17.17-6.

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     (i) The director shall review the list of incidents to be reported in subsection (d) above at

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least biennially to ascertain whether any additions, deletions or modifications to the list are

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necessary. In conducting the review, the director shall take into account those adverse events

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identified on the National Quality Forum's List of Serious Reportable Events. In the event the

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director determines that incidents should be added, deleted or modified, the director shall make

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such recommendations for changes to the legislature.

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     SECTION 2. This act shall take effect upon passage.

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LC01764/SUB A

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N A C T

RELATING TO HEALTH AND SAFETY -- LICENSING OF HEALTH CARE FACILITIES

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     This act would amend the requirements for the reporting of certain hospital events and

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incidents.

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     This act would take effect upon passage.

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LC01764/SUB

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