Chapter 05-059

2005 -- S 0555 SUBSTITUTE A

Enacted 06/23/05

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

It is enacted by the General Assembly as follows:

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

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

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

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

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

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

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

occurred.

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

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

services or cause harm to patients or personnel;

      (ii) Poisoning involving patients of the facility;

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

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

      (v) Strikes by personnel;

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

adversely affect facility operations; and

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

incident diagnosis; and

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

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

this section.

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

      (1) Brain injury;

      (2) Mental impairment;

      (3) Paraplegia;

      (4) Quadriplegia;

      (5) Any type of paralysis;

      (6) Loss of use of limb or organ;

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

      (8) Birth injury;

      (9) Impairment of sight or hearing;

      (10) Surgery on the wrong patient;

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

patient's attending physician;

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

insurance program;

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

inpatient or outpatient unit (if known);

      (14) Blood transfusion error; and

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

in an extended hospital stay or death of the patient.

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

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

incident.

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

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

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

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

section 23-17-25.

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

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

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

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

to section 23-17.17-6.

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

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

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

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

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

such recommendations for changes to the legislature.

     SECTION 2. This act shall take effect upon passage.

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LC01764/SUB A

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