Application of failure mode and effects analysis to minimize quality failures in clinical biochemistry laboratory

Introduction: Quality failures in the clinical laboratories should be analyzed to improve patient safety in hospital. Purpose of this study is to apply failure mode and effects analysis (FMEA) for prospective risks of quality failures and appropriate corrective actions to reduce/prevent errors in clinical biochemistry laboratory. Materials and Methods: Members of multidisciplinary team were trained to notify quality failures. Each quality failures assigned value from 1 to 5 based on severity, occurrence and detection of failure modes. Risk priority number (RPN) was calculated from severity, occurrence and detection scores (RPN = SI x OI x DI). For highest risk failure modes, FMEA tool was applied in two stages: before and after action plan. Results: A total 14 high risk failure modes were found and arranged based on their RPN values from high to low score. In 5 highest risk failure modes RPN values before action plan were as follows: Transcription error (RPN=100), Malfunction of reagent (RPN=75), Malfunction of calibrator (RPN=48), Samples taken in wrong tubes (RPN=36) and Sample misplaced in laboratory (RPN=36). After corrective actions taken, we found decrease in RPN values for 5 highest risk failure modes. Conclusion: FMEA is an effective tool to reduce quality failures in clinical biochemistry laboratories.