Example 2 Event Process

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Example 2 Event Process

1. Document the Event

  • Adverse Event form intitiated

2. Investigate

  • Transfusion Reaction Workup performed.
  • Administrative Review conducted. Classification determined to be a Sentinel Event. Situation to be reported to FDA within 7 days, and to the Joint Commission within 45 days.
  • Severity/Probability - SAC score 3 (Potentially Catastrophic/Remote)
  • Immediate actions -
    • Life-saving measures to treat hemolysis in patient
    • Freeze patient bill for adjustment of charges

3. Root Cause Analysis - Required

Tools Used:

  • Process Flow Diagram
  • Cause and Effect Diagram

Root cause/contributing factors identified:

  • Deviation from protocol to verify two identifiers prior to venipuncture
  • Deviation from protocol to label the sample in the presence of the patient

4. Develop Action Plan

  • Implement a patient ID band scanning system for bedside ID verification and specimen labels

5. Implement Action Plan

  • Reports sent to FDA and TJC
  • Case presented at Transfusion Committee meeting
  • Assign responsibilities and completion dates

6. Evaluate Effectiveness of Actions

  • Audit compliance with the patient identification verification protocol for 4 months, with a goal of 95% or better compliance.