(a) Hospitals must report all major adverse incidents involving a patient to the Department within 10 calendar days. (1) A major adverse incident is a patient safety event (not primarily related to the natural course of the patient's illness or underlying condition) that reaches a patient. The Department shall define "major adverse incident" and provide further clarification in regulation. (2) Major adverse incidents must be investigated by the hospital. (3) A summary of the hospital's investigative findings will be forwarded to the Department within a timeframe agreeable to both parties. (b) Hospitals must notify the Department immediately of any event occurring within the hospital that jeopardizes the health or safety of patients or employees including: (1) An unscheduled interruption for 3 or more hours of physical plant or clinical services impacting the health or safety of patients or employees. (2) A fire, disaster or accident which results in evacuation of patients out of the hospital. (3) An alleged or suspected crime which endangers the life or safety of patients or employees, which is also reportable to the police department, and which results in an immediate on-site investigation by the police. (4) An alleged incident of medication diversion, as defined under § 1131 of this title. (c) Information submitted as a major adverse incident is considered peer review information and not subject to public disclosure except as aggregate data.
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