Measurement Uncertainty in the Hemostasis Laboratory

Area of Science:

• Clinical laboratory science
• Metrology
• Analytical chemistry

Background:

• Clinical laboratory results exhibit inherent variability.
• Measurement uncertainty (MU) is a framework to quantify this variability for accurate clinical interpretation.
• In hemostasis assays, MU is crucial for result comparison within and between patients.

Purpose of the Study:

• To review the implementation of different measurement uncertainty (MU) approaches in hemostasis laboratories.
• To assess the applicability of the ISO/TS 20914:2019 standard in specialist areas like hemostasis.
• To explore the balance between statistical rigor and operational feasibility in MU estimation.

Main Methods:

• Review of existing metrological frameworks for MU estimation, including the Guide to the Expression of Uncertainty in Measurement (GUM).
• Analysis of the ISO/TS 20914:2019 technical specification for a top-down MU approach.
• Exploration of challenges and considerations for implementing MU in hemostasis testing.

Main Results:

• The GUM provides a statistically rigorous but complex method for MU estimation.
• ISO/TS 20914:2019 offers a more operationally feasible top-down approach, supporting ISO 15189 compliance.
• Applicability of ISO/TS 20914:2019 to specialist fields like hemostasis requires further investigation.

Conclusions:

• Implementing MU in hemostasis laboratories involves navigating complex metrological frameworks.
• The ISO/TS 20914:2019 standard presents a promising, feasible approach but needs validation in specialized areas.
• Effective MU implementation enhances the reliability and interpretability of hemostasis test results.