Adverse event reporting

§ 2805-l. Adverse event reporting. 1. (a) All hospitals shall be
required to report events described by subdivision two of this section
to the department in a manner and within time periods as may be
specified by regulation of the department.

(b) For purposes of this section, "hospital" means any general
hospital or diagnostic and treatment center.

2. The following adverse events shall be reported to the department:

(a) patients' deaths or impairments of bodily functions in
circumstances other than those related to the natural course of illness,
disease or proper treatment in accordance with generally accepted
medical standards;

(b) fires in the hospital which disrupt the provision of patient care
services or cause harm to patients or staff;

(c) equipment malfunction during treatment or diagnosis of a patient
which did or could have adversely affected a patient or hospital
personnel;

(d) poisoning occurring within the hospital;

(e) strikes by hospital staff;

(f) disasters or other emergency situations external to the hospital
environment which affect hospital operations; and

(g) termination of any services vital to the continued safe operation
of the hospital or to the health and safety of its patients and
personnel, including but not limited to the anticipated or actual
termination of telephone, electric, gas, fuel, water, heat, air
conditioning, rodent or pest control, laundry services, food or contract
services.

3. Notwithstanding any provision of this section to the contrary, the
commissioner is authorized, as appropriate in the interest of promoting
patient safety, and after consulting with clinicians, hospital
administrators, researchers, and consumers with expertise in the area of
patient safety and quality improvement, to add, modify or eliminate one
or more adverse events set forth in subdivision two of this section, by
regulation, consistent with national consensus standards endorsed by the
consensus-based entity selected for the purpose of pursuing certain
activities relating to healthcare performance measurement by the U.S.
Department of Health and Human Services pursuant to the Medicare
Improvements for Patients and Providers Act (Pub. L. 110-275).

4. The hospital shall conduct an investigation of events described in
paragraphs (a) through (d) of subdivision two of this section within
thirty days of obtaining knowledge of any information which reasonably
appears to show that such an event has occurred, provided that, if the
hospital reasonably expects such investigation to extend beyond such
thirty day period, the hospital shall notify the department of such
expectation and the reason therefor, and shall inform the department of
the expected completion date of the investigation. The hospital shall
provide to the department a copy of the investigation report within
twenty-four hours of completion. Nothing herein shall limit the
authority of the department to conduct an investigation of events
occurring in hospitals.

5. The department shall:

(a) analyze event reports, findings of the investigations, their root
cause analyses, and corrective action plans to determine patterns of
systemic failure in the health care system and identify successful
methods to correct these failures; and

(b) communicate to facilities the department's conclusions, if any,
regarding event reports, patterns of systemic failure, and
recommendations for corrective action resulting from the analysis of
submissions from facilities; and may release, in a format that does not
identify specific patients and does not provide reasonable basis to
believe that the information can be used to identify a patient; (i)
analyses and findings derived from the adverse event data to hospitals
or the public and (ii) adverse event data to researchers for patient
safety research projects approved by the commissioner, subject to any
terms and conditions imposed by the commissioner concerning the security
and confidentiality of the data and their use; and provided that no such
data, record, documentation or action subject to subdivision two of
section twenty-eight hundred five-m of this article, shall be subject to
disclosure under article six of the public officers law nor article
thirty-one of the civil practice law and rules.

6. The commissioner shall establish protocols for hospital personnel
where a patient under the age of eighteen years dies during
transportation to the hospital or while at the hospital, under
circumstances other than those related to the natural course of illness,
disease or proper treatment in accordance with generally accepted
medical standards. Such protocols shall address matters including, but
not limited to, the following:

(a) medical and social history, and examination of the patient;

(b) preservation of evidence and chain of custody;

(c) questioning of the patient's family, guardian or person in
parental authority;

(d) circumstances surrounding the injury resulting in death;

(e) determination of the cause of death;

(f) notification of law enforcement personnel; and

(g) reporting requirements under title six of article six of the
social services law.

In developing such protocols, the commissioner shall consult with the
office of children and family services, local departments of social
services, coordinators of child fatality review teams established
pursuant to section four hundred twenty-two-b of the social services
law, law enforcement agencies, pediatricians preferably with expertise
in the area of child abuse and maltreatment or forensic pediatrics, and
such other persons as the commissioner deems necessary.

7. The commissioner shall make, adopt, promulgate and enforce such
rules and regulations as he may deem appropriate to effectuate the
purposes of this section.