MEASUREMENT UNCERTAINTY
Unseen risks: how MU affects much more than just assays
In this final article in his latest series, Stephen MacDonald concludes by focusing on the importance of uncertainty measurement outside the narrow boundary of analytical process, into the wider realm of equipment calibration, monitoring and performance.
Throughout this latest series, our changing understanding of measurement uncertainty (MU) and its applications have been addressed. When the first series came out in 2017, MU was very much in its infancy when it came to being used in medical laboratories. Since then, we have learnt much from new guidelines, peer-reviewed publications and from a few of years of implementing it in all of our laboratories.
The aim of this series was to update what we now know. Central to this is our improved understanding of metrological traceability and analytical performance specifications. The landscape of laboratories has also changed in this time with an emphasis on pathology networks, and, along with many other challenges, MU across multiple platforms and laboratories presents a modern challenge we are still trying to approach. Although our understanding has come so far, there is no doubt there remains some aspects we haven’t completely conquered. A satisfactory method for handling of bias, its correction and the impact on uncertainty still remains elusive. This remains a topic of sometimes heated discussion between those that follow the MU paradigm and those that argue the case for Total Error.
Semi-quantitative and qualitative assays are also still not completely
Periodically reviewing methods, including MU performance, is vital and doing so in the context of risk of harm to patients is a focus of ISO 15189:2022.
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covered, even by more recent guidelines. These types of test are becoming more and more common so the need to address performance specifications and MU assessment in them is still going to be an area of interesting research moving forward.
Periodically reviewing our methods,
including MU performance, is as vital as ever, and doing so in the context of risk of harm to patients is a focus of ISO 15189:2022. While we have a good feel for that in the laboratory, the need to formalise review of our processes is becoming of paramount importance – as it should. But, and there is always a but, having come so far, we still need to make sure our application of MU is not limited only to what the QC is doing. There are a host of other aspects of laboratory practice where MU comes into play, and it is often these applications that will present challenges during audits and compliance assessments. Overlooking MU in these areas can lead to compromised quality and potential patient safety risks. This article will explore how MU should be applied in
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