(a) Definitions.  As used in this section, the following terms shall have the following meanings:

(1)  “Adverse event” means injury to a patient resulting from a medical intervention, and not to the underlying condition of the patient.

(2)  “Checklist of care” means predetermined steps to be followed by a team of healthcare providers before, during, or after a given procedure to decrease the possibility of adverse effects and other patient harm by articulating standards of care.

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(b)  Reportable events as defined in subsection (c) shall be reported to the department of health division of facilities regulation on a telephone number maintained for that purpose. Hospitals and freestanding emergency-care facilities shall report incidents as defined in subsection (c) 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 or freestanding emergency-care facility to believe that a reportable event has occurred.

(c)  Reportable events are defined as follows:

(1)  Fires or internal disasters in the facility that disrupt the provisions of patient-care services or cause harm to patients or personnel;

(2)  Poisoning involving patients of the facility;

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

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

(5)  Strikes by personnel;

(6)  Disasters or other emergency situations external to the hospital or freestanding emergency-care facility environment that adversely affect facility operations; and

(7)  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.

(d)  Any hospital or freestanding emergency-care facility 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. § 301 et seq., shall be forwarded to the department of health within the time specified in the federal law.

(e)  Any reportable incident in a hospital that results in patient injury, as defined in subsection (f), 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 (f), has occurred. The department of health shall promulgate rules and regulations to include the process whereby healthcare 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 (f). 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 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;

(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.

(f)  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.

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

(h)  Nothing in this section shall prohibit the department from investigating any event or incident.

(i)  All reports to the department under this section shall be subject to the provisions of § 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 § 23-17-25.

(j)  The department shall issue an annual report by March 31 each year providing aggregate, summary information on the events and incidents reported by hospitals and freestanding emergency-care facilities 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 § 23-17.17-6.

(k)  The director shall review the list of incidents to be reported in subsection (f) 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.