New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter V - Medical Facilities › Subchapter A - Medical Facilities-minimum Standards › Article 2 - Hospitals › Part 405 - Hospitals-Minimum Standards › Section 405.8 - Adverse event reporting

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Any
					 adverse event required to be reported pursuant to subdivision (b) of this
					 section shall be reported to the department. Hospitals shall report such
					 adverse events, as defined in subdivision (b) of this section, within 24 hours
					 or one business day of when the adverse event occurred or when the hospital has
					 reasonable cause to believe that such an adverse event has occurred. This
					 report to the department shall be submitted in a format specified by the
					 department and shall at a minimum include: the date, the nature, classification
					 and location of the adverse event; and medical record numbers of all patients
					 directly affected by the adverse event.
(b) Adverse events to be reported are:
(1) patients' deaths in circumstances other
					 than those related to the natural course of illness, disease or proper
					 treatment in accordance with generally accepted medical standards;
(2) injuries and 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 that necessitate additional or more complicated treatment
					 regimens or that result in a significant change in patient status;
(3) equipment malfunction or equipment user
					 error during treatment or diagnosis of a patient which results in death or
					 serious injury of a patient;
(4)
					 patient elopements resulting in death or serious injury;
(5) abduction of a patient of any
					 age;
(6) sexual abuse/sexual
					 assault on a patient or staff member within or on the grounds of a general
					 hospital;
(7) physical assault of a
					 patient or staff member within or on the grounds of a general
					 hospital;
(8) discharge or release
					 of a patient of any age, who is unable to make decisions, to other than an
					 authorized person;
(9) patient or
					 staff death or serious injury associated with a burn incurred from any source
					 in the course of a patient care process;
(10) patient suicide, attempted suicide or
					 self harm resulting in serious injury;
(11) poisoning occurring within the
					 hospital;
(12) fires or other
					 internal disasters in the hospital which disrupt the provision of patient care
					 services or cause harm to patients or staff members;
(13) disasters or other emergency situations
					 external to the hospital environment which affect hospital
					 operations;
(14) termination of any
					 services vital to the continued safe operation of the hospital or to the health
					 and safety of its patients and staff members, including but not limited to the
					 termination of telephone, electric, gas, fuel, water, heat, air conditioning,
					 rodent or pest control, laundry services, food, or contract services;
					 and
(15) strikes by staff
					 members.