In this penultimate article in his current series, Stephen MacDonald focuses on the vital role that each stakeholder plays in ensuring compliance with measurement uncertainty limits and enhancing the overall quality of laboratory services.
For medical laboratory scientists, managing and understanding measurement uncertainty (MU) is not just a matter of compliance but also essential for managing risk and ensuring the clinical appropriateness of the results produced. An often-neglected topic is how to review and report MU. Previous articles have highlighted the importance of determining acceptable performance initially. However, once assays are in clinical use, the focus shifts to managing deviations from acceptable levels and understanding the roles of different stakeholders in this process.
There needs to be a distinction between reviewing and re-estimating MU. According to ISO/TS 20914:2019, section 6.8, MU does not need to be re-estimated if the measurement procedure is under stable control based on internal quality control (IQC) and external quality assessment (EQA) performance. This assumes that the top-down method is being applied. The critical question, therefore, is how do we confirm that the assumption of adequate IQC and EQA performance is valid? This circles back to analytical performance specifications and uncertainty budgeting, as discussed in earlier articles.
Who should review measurement uncertainty?
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