Title: Section 405.8 - Adverse Event Reporting

405.8 Adverse Event Reporting

(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.

(c) The hospital shall conduct an investigation of adverse events described in paragraphs (1-10) of subdivision (b) of this section. Such investigations shall be thorough and credible and occur within thirty days of when the adverse event occurred or when the hospital has reasonable cause to believe that such an adverse event occurred or upon determination by the department that an investigation is warranted in order to protect patient health and safety. If the hospital reasonably expects such investigation to extend beyond the thirty day period, the hospital shall notify the department electronically of such expectation and the reason(s) and shall inform the department of the expected date of completion, not to exceed sixty days. For adverse events described in paragraphs (1- 10) of subdivision (b) of this section, the hospital shall submit its investigative report electronically, in a format prescribed by the department. The investigative report shall document all hospital efforts to identify and analyze the circumstances surrounding the adverse event and to develop and implement appropriate measures to prevent recurrence and improve the overall quality of patient care. This report shall be credible and thorough and contain all information in a format specified by the department.

(d) The requirements of this section shall be in addition to and shall not replace other reporting required by this Part.

(e) Nothing in this section shall prohibit the department from investigating any adverse event occurring in general hospitals.