MEASUREMENT UNCERTAINTY
Reviewing and reporting measurement uncertainty in medical laboratories
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? The simple answer is everyone. However, different aspects of MU review apply to different stakeholders responsible for the quality performance of the methods. Quality managers and leads oversee
the review of MU, with the ultimate goal of ensuring that all procedures align with accreditation standards and quality protocols. They coordinate with other personnel to ensure that MU reviews are conducted systematically and that corrective actions are implemented as needed. Typically, this may be through regular audits but is also an essential part of the periodic review of examinations as part of ISO 15189:2022 compliance. This periodic review is overseen by laboratory leads, in collaboration with the service clinical lead, and customarily occurs annually.
Daily operations, more realistically,
A critical question is how do we confirm that the assumption of adequate IQC and EQA performance is valid?
WWW.PATHOLOGYINPRACTICE.COM SEPTEMBER 2024
are managed by the scientists in the laboratory, who play a central role in the regular assessment of deviations from expected performance. Using the top-down method according to ISO/TS 20914:2019, the management of internal quality control is crucial to deriving long-
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