The Safety Assessment score, based on the frequency and severity of the type of event, can be assigned to assist with the determination of whether or not the Root Cause Analysis needs to be performed.
Score = 3 Requires a Root Cause Analysis
Score = 2 Root Cause Analysis is optional.
Score = 1 Root Cause Analysis is not required.
However, if a trend has been noticed that multiple similar events with SA scores of 1 and 2 have been occurring over a period, a root cause analysis can be performed for the group of events. For example, a single event related to a hemolyzed specimen may not require a root cause analysis, but if many hemolyzed specimen events are occurring, a root cause analysis should be performed with the aggregate data from all of the events.