NY Pub Health L § 2805-L (2021)
2021 New York Laws PBH - Public Health Article 28 - Hospitals 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.