§ 2805-L — Adverse event reporting

§ 2805-l. Adverse event reporting. 1. (a) All hospitals shall be\nrequired to report events described by subdivision two of this section\nto the department in a manner and within time periods as may be\nspecified by regulation of the department.\n (b) For purposes of this section, "hospital" means any general\nhospital or diagnostic and treatment center.\n 2. The following adverse events shall be reported to the department:\n (a) patients' deaths or impairments of bodily functions in\ncircumstances other than those related to the natural course of illness,\ndisease or proper treatment in accordance with generally accepted\nmedical standards;\n (b) fires in the hospital which disrupt the provision of patient care\nservices or cause harm to patients or staff;\n (c) equipment malfunction during treatment or diagnosis of a patient\nwhich did or could have adversely affected a patient or hospital\npersonnel;\n (d) poisoning occurring within the hospital;\n (e) strikes by hospital staff;\n (f) disasters or other emergency situations external to the hospital\nenvironment which affect hospital operations; and\n (g) termination of any services vital to the continued safe operation\nof the hospital or to the health and safety of its patients and\npersonnel, including but not limited to the anticipated or actual\ntermination of telephone, electric, gas, fuel, water, heat, air\nconditioning, rodent or pest control, laundry services, food or contract\nservices.\n 3. Notwithstanding any provision of this section to the contrary, the\ncommissioner is authorized, as appropriate in the interest of promoting\npatient safety, and after consulting with clinicians, hospital\nadministrators, researchers, and consumers with expertise in the area of\npatient safety and quality improvement, to add, modify or eliminate one\nor more adverse events set forth in subdivision two of this section, by\nregulation, consistent with national consensus standards endorsed by the\nconsensus-based entity selected for the purpose of pursuing certain\nactivities relating to healthcare performance measurement by the U.S.\nDepartment of Health and Human Services pursuant to the Medicare\nImprovements for Patients and Providers Act (Pub. L. 110-275).\n 4. The hospital shall conduct an investigation of events described in\nparagraphs (a) through (d) of subdivision two of this section within\nthirty days of obtaining knowledge of any information which reasonably\nappears to show that such an event has occurred, provided that, if the\nhospital reasonably expects such investigation to extend beyond such\nthirty day period, the hospital shall notify the department of such\nexpectation and the reason therefor, and shall inform the department of\nthe expected completion date of the investigation. The hospital shall\nprovide to the department a copy of the investigation report within\ntwenty-four hours of completion. Nothing herein shall limit the\nauthority of the department to conduct an investigation of events\noccurring in hospitals.\n 5. The department shall:\n (a) analyze event reports, findings of the investigations, their root\ncause analyses, and corrective action plans to determine patterns of\nsystemic failure in the health care system and identify successful\nmethods to correct these failures; and\n (b) communicate to facilities the department's conclusions, if any,\nregarding event reports, patterns of systemic failure, and\nrecommendations for corrective action resulting from the analysis of\nsubmissions from facilities; and may release, in a format that does not\nidentify specific patients and does not provide reasonable basis to\nbelieve that the information can be used to identify a patient; (i)\nanalyses and findings derived from the adverse event data to hospitals\nor the public and (ii) adverse event data to researchers for patient\nsafety research projects approved by the commissioner, subject to any\nterms and conditions imposed by the commissioner concerning the security\nand confidentiality of the data and their use; and provided that no such\ndata, record, documentation or action subject to subdivision two of\nsection twenty-eight hundred five-m of this article, shall be subject to\ndisclosure under article six of the public officers law nor article\nthirty-one of the civil practice law and rules.\n 6. The commissioner shall establish protocols for hospital personnel\nwhere a patient under the age of eighteen years dies during\ntransportation to the hospital or while at the hospital, under\ncircumstances other than those related to the natural course of illness,\ndisease or proper treatment in accordance with generally accepted\nmedical standards. Such protocols shall address matters including, but\nnot limited to, the following:\n (a) medical and social history, and examination of the patient;\n (b) preservation of evidence and chain of custody;\n (c) questioning of the patient's family, guardian or person in\nparental authority;\n (d) circumstances surrounding the injury resulting in death;\n (e) determination of the cause of death;\n (f) notification of law enforcement personnel; and\n (g) reporting requirements under title six of article six of the\nsocial services law.\n In developing such protocols, the commissioner shall consult with the\noffice of children and family services, local departments of social\nservices, coordinators of child fatality review teams established\npursuant to section four hundred twenty-two-b of the social services\nlaw, law enforcement agencies, pediatricians preferably with expertise\nin the area of child abuse and maltreatment or forensic pediatrics, and\nsuch other persons as the commissioner deems necessary.\n 7. The commissioner shall make, adopt, promulgate and enforce such\nrules and regulations as he may deem appropriate to effectuate the\npurposes of this section.\n