Risk Management in Clinical Laboratory Based on ISO 15189:2022 for Plasma-based Testing of Prothrombin Time and Activated Partial Thromboplastin Time

Introduction: In the new ISO 15189:2022 standard, risk management in the clinical laboratory has been hugely emphasized. The purpose of detailed risk analysis and management is to eliminate the known risk factors as much as possible and to minimize the residual risk to an acceptable level. We chose to give precedence to plasma-based tests for Prothrombin time (PT) and activated partial thromboplastin time (aPTT) to conduct a more thorough risk analysis. These tests involve multiple sensitive steps and are overly critical for patient care as test results are self-sufficient to start the treatment. Methods: We applied risk control measures using FMEA (failure mode and effects analysis) based risk analysis process in every step including all phases of the testing process. Results: Many risk factors were identified; control measures and continuous surveillance processes were put in place to avoid recurrence of high-risk events that could affect the test results. Conclusion: It was concluded that with stringent risk management processes in place, risk could be reduced significantly thus minimizing the impact on patient results.