When is a Root Cause Analysis (RCA) typically initiated in relation to medication safety incidents?

• A. For every minor discrepancy
• B. Only after a documented incident with harm
• C. After a staff member reports something informally
• D. When an incident is identified for formal review, including near-misses, regardless of harm level

Answer: (D)

Root Cause Analysis is triggered when an event is selected for formal review, and this includes near-misses as well as events with harm. The aim is to uncover underlying system factors that allowed the error to occur and to develop actions that prevent recurrence, not to chase every minor discrepancy or only study incidents that caused harm. Informal reports or minor issues typically don’t meet the threshold for a formal RCA, whereas a flagged incident or near-miss prompts a structured investigation to improve processes and safety. So, initiating an RCA whenever an incident is identified for formal review, including near-misses, regardless of harm level, is how safety programs typically proceed.