N.Y. Public Health Law § 2805-l: 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.