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Understanding Measurement Error in Metrology

The document discusses the differences between measurement error and measurement uncertainty in the context of metrology and laboratory practices. It highlights the inconsistencies in CLSI guidelines regarding total measurement error and the lack of ISO guidelines for measuring total error. Additionally, it critiques the CLSI's approach to monitoring performance characteristics and the implications for laboratory accreditation processes.

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34 views1 page

Understanding Measurement Error in Metrology

The document discusses the differences between measurement error and measurement uncertainty in the context of metrology and laboratory practices. It highlights the inconsistencies in CLSI guidelines regarding total measurement error and the lack of ISO guidelines for measuring total error. Additionally, it critiques the CLSI's approach to monitoring performance characteristics and the implications for laboratory accreditation processes.

Uploaded by

r2035m
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© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Metrology 2025, 5, 18 6 of 12

tive to a known reference value, allowed by the specifications or regulations for a given
measurement, measuring instrument, or measurement system.
Only in ISO 14644-1:2015 (clean rooms) do we find the entry as in VIM 4.26 in the
health sector. “Analytical error” appears in an older ISO document (ISO 18158:2016, linked
to EN 1540:2011, Workplace exposure—Terminology) concerning air in the workplace, even
as a synonym for “uncertainty”.
In contrast, CLSI adopts the term “measurement error” in several guides. CLSI EP35
and CLSI EP31 use the concept in the context of the comparison of methods, incorporated
in the headword “total allowable error (ATE)”. CLSI EP21 and CLSI EP46 make it the
center around which recommendations are developed on how to estimate the measurement
error and the identification of its limit of acceptability. In discussions with the committee
developing the two documents, numerous critical points and inconsistencies were noted
on the operational level. From the metrological point of view, we can point out that in the
EP21 definition itself, “total error” includes what occurs in the pre-examination processes
(from sampling to receipt) and in the post-examination processes (from presentation of
the result to its clinical use). Thus, all processing of the result, regardless of its correctness,
only concerns the measurement. One should, therefore, speak of “total measurement
error (TME)” and “total acceptable measurement error (ATME)”. For errors in pre- and
post-examination processes, no guidelines are available at the moment.
But, above all, one notices the approach of CLSI documents that adopt measurement
error and the resulting statistics as an alternative to the measurement uncertainty demanded
by ISO 15189 and driven by ISO 20914. An embarrassing situation for both laboratories
and those involved in their ISO accreditation processes.
The surveillance of performance characteristics seems at first sight to be an operational
rather than a metrological issue. From another point of view, it can be placed alongside
performance estimation activities. VIM3 2.22 (intermediate accuracy conditions) gives as an
example measurement results obtained on quality-control materials to monitor the quality
of measurements. We can, therefore, ask which metrological concepts lend themselves well
to monitoring and which less so. CLSI EP31 (comparability) uses the word “monitoring”
frequently, more than 40 times. The tendency in CLSI to propose method comparison
procedures with a fairly high frequency is evident despite its conceptual weaknesses, i.e.,
the precarious relationship with calibration, the statistics of comparison data, the costs
of procedures, the risks of false positives and false negatives, the weak connection with
accreditation requirements. Clearly, the metrological concept VIM 5.26 (comparability
based on calibration) does not lend itself to monitoring. But VIM 2.27 (compatibility on the
basis of measurement pairs) also lends itself to monitoring in the form of interlaboratory
programs, in which costs and frequency are carefully managed, much less for in-house
laboratory activities, as if it were a kind of alternative to in-house quality control.
For CLSI EP21, “total error” includes all random and systematic errors throughout
the examination process and includes the combined effect of all precision and systematic
errors that may affect the accuracy of a result. The total error incorporates sources of error
from the pre-examination, examination, and post-examination phases of a measurement
procedure, but no CLSI guidelines are available for measuring total error. Neither are there
any ISO guidelines for the error so defined.
VIM does not have a definition of “variability” but uses the term “coefficient of
variation under the specified conditions of measurement” in “precision” (VIM3 2.15). CLSI
only defines “variability” in M23 (antibiogram). CLSI EP21 (measurement error), EP46
(maximum acceptable error), and EP31 (method comparison) often use “variability” in
their abbreviations. They consider the concept of so-called “analytical” variability (CVA),
i.e., that of measurement, alongside biological variability between subjects (CVG) and

Common questions

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Interlaboratory programs offer a structured and external mechanism for quality control that can supplement or substitute in-house processes by providing a broader basis for assessment across different settings. Managed costs and frequencies make these programs particularly effective, ensuring measurement comparability and compatibility (per VIM 2.27). This alternative is useful in maintaining consistent standards and avoiding the isolation that can result from relying solely on in-house quality controls .

The frequent use of the term "monitoring" in CLSI documents, like EP31, which references it over 40 times, indicates an emphasis on continuous assessment of method comparability and measurement quality. It suggests a proactive approach to ensuring laboratories align with established performance parameters. This focus on monitoring implies the need for diligent performance evaluation and consistent quality assurance, potentially leading to improved operational standards and more reliable diagnostic results .

To effectively apply metrological concepts like VIM3 2.22, which involves using measurement results obtained on quality-control materials, laboratories could integrate these results into ongoing monitoring systems. Programs that use VIM 2.27 compatibility through measurement pairs could standardize interlaboratory programs, optimizing costs and frequency, especially when conducted as a form of quality control. Incorporating these structured programs could mitigate some CLSI method comparison weaknesses, providing a more robust framework aligned with ISO standards .

The CLSI's frequent proposal of method comparison procedures faces conceptual weaknesses, including a tenuous relationship with calibration standards, issues with comparison data statistics, procedural costs, and risks associated with false positives and negatives. These challenges highlight a weak connection with accreditation requirements, and the metrological concept VIM 5.26 (comparability based on calibration) does not effectively support monitoring in this context. Furthermore, the use of VIM 2.27 (compatibility on the basis of measurement pairs) in interlaboratory programs highlights these weaknesses for in-house laboratory activities .

The absence of guidelines for addressing errors in pre- and post-examination processes presents a challenge for laboratories seeking accreditation. It could result in gaps in overall error management frameworks that accreditation bodies like ISO expect to be thoroughly addressed. Such omissions may particularly affect the laboratories' ability to meet specific quality benchmarks, leading to potential discrepancies during accreditation evaluations where comprehensive error management is sought .

Adopting "total measurement error (TME)" offers a comprehensive view of all potential error sources throughout the measurement process. It emphasizes accountability not only for examination-related errors but also for the effects arising during pre- and post-examination phases. This holistic approach enables laboratories to improve their overall accuracy and reliability by targeting and minimizing the totality of relevant errors, fostering enhanced diagnostic confidence and operational efficiency .

CLSI guidelines, such as EP21, EP35, and EP46, focus on "measurement error" and incorporate it into concepts like "total allowable error (ATE)" and "total measurement error (TME)." This is contrasted with ISO's preference for "measurement uncertainty," as seen in ISO 15189 and ISO 20914. A key challenge is that CLSI's approach can be inconsistent with metrological standards, potentially leading to conflicts during ISO accreditation. Moreover, this focus might overlook errors from pre- and post-examination processes, which aren't covered by CLSI's guidelines .

According to CLSI EP21, "total error" encompasses all random and systematic errors occurring throughout the pre-examination, examination, and post-examination phases. It reflects the combined impact of precision and systematic errors, affecting the accuracy of a result. However, while acknowledging these errors, neither CLSI nor ISO provides specific guidelines for measuring this comprehensive total error .

By incorporating "variability" into its standard terminology, as seen in CLSI documents, variability is split into analytical (CVA) and biological (CVG) components. This nuanced perspective allows laboratories to discern between instrument-related measurement fluctuations and natural biological differences among samples. Consequently, a comprehensive understanding of measurement constancy is achieved by separating and addressing these distinct sources of variability, thereby improving precision and accuracy of laboratory results .

VIM does not explicitly define "variability" but refers to it in the context of "coefficient of variation under specified conditions of measurement" related to precision (VIM3 2.15). Conversely, CLSI defines "variability" more specifically in documents like M23 (regarding antibiogram) and uses variations like "analytical variability (CVA)" alongside biological variability as part of its measurement error context. This reflects a broader use of "variability" that encompasses both inherent measurement fluctuations and biological differences in the CLSI standards .

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