1. Document the Event
- Adverse Event form intitiated
- 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
- 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.