M.S.A. §144.7065

Facility Requirements to Report, Analyze, and Correct

All hospitals or outpatient surgical centers must report any adverse health care event to the Commissioner of Health as soon as possible.  Surgical adverse health care events that must be reported include surgeries performed on the wrong body part not consistent with documentation, but do not include surgeries performed in urgent situations.  Other adverse surgical events that must be reported are surgeries performed on the wrong person, the wrong surgery being performed, a foreign object retained in the surgical area, or death during or right after surgery in a localized area of a patient with no other complications. 

Product adverse events that must be reported include death or disability due to the use of contaminated drugs or devices, death or disability due to a device being used in a way it was not intended to be used, or death or disability related to intravascular air embolism.  Additional adverse events that are required to be reported are instances of an infant being discharged to the wrong parents, death or disability associated with a patient’s disappearance, and patient suicide or attempted suicide.  Other reportable adverse care events are medication errors, reactions to incompatible blood  death or disability during child birth in a low risk pregnancy, death or disability due to hypoglycemia, or artificial insemination using the wrong specimen. 

Environmental adverse events that must be reported include death or disability from an electric shock, delivery of incorrect gas or lack of oxygen, death or disability due to a burn, death or disability associated with a fall in the hospital, and death or disability due to the use or lack of use of restraints. 

Criminal events may also be considered adverse events in hospital settings.  Those that must be reported include care ordered by an individual impersonating a physician, nurse or other hospital staff, abduction of a patient, sexual assault on the facility’s grounds, and death or injury of any individual due to an assault within the facility. 

After any such adverse event occurs, the facility must conduct an analysis to determine the root cause of the adverse event. The facility must take corrective action.  The reporting for adverse events must be done electronically.  The data contained in the reports to the Commissioner are not public and must remain confidential.

Related Laws:  M.S.A. §144.7067; M.S.A. §144.7068