Serious Incident Reports

(A) A clinic shall immediately report to the Department, pursuant to Department guidelines, any of the following incidents occuring on premises covered by its license: (1) death that is unanticipated, not related to the natural course of the patient’s illness or underlying condition, or that is the result of an error or other incident as specified in guidelines of the Department; (2) full or partial evacuation of the facility for any reason; (3) fire; (4) suicide; (5) serious criminal acts; (6) pending or actual strike action by its employees, and contingency plans for operation of the clinic; (7) reports on surgery-related and anesthesia-related complications that result in serious morbidity or death of a patient; or (8) any other serious incident or accident as specified in guidelines of the Department. (B) A clinic shall immediately report to the Department, for any patient treated at the clinic, any suspected instance(s) of abuse, neglect, mistreatment of that patient, or misappropriation of that patient’s property, at or by a nursing home, rest home, home health, home maker or hospice. (C) A clinic shall report to the Department any other serious incident occurring on premises covered by the clinic’s license that seriously affects the health and safety of a patient(s) or that causes serious physical injury to a patient(s) within seven calendar days of the date of occurrence of the event. (D) If an ambulatory surgery center makes a report of any incident pursuant to 105 CMR 140.307(A), (B) or (C), and the incident meets the definition of Serious Reportable Event in 105 CMR 140.308(A) or a medication error within the definition of a Serious Adverse Drug Event (SADE) pursuant to 105 CMR 140.308(A), the ambulatory surgery center also shall comply with the requirements of 105 CMR 140.308.