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. 2016 Feb 9;27(1):30-6.
eCollection 2016 Feb.

The International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR) - A Pathway for Harmonization

Gary L Myers  1 , W Greg Miller  2
Affiliations

The International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR) - A Pathway for Harmonization

Gary L Myers et al. EJIFCC. .

Abstract

Results from clinical laboratory measurement procedures must be equivalent to enable effective use of clinical guidelines for disease diagnosis and patient management. Analytical results that are harmonized and independent of the measurement system, time, and location of testing is essential for providing adequate patient care. The key to generating harmonized results is establishing traceability to an accepted reference standard where available. Awareness of the benefits of having traceable measurement results that are harmonized has increased along with efforts to develop approaches to enable and facilitate the implementation of harmonization. Although several organizations are addressing harmonization of test procedures, centralized and cooperative global oversight is needed to ensure that the most important tests are being addressed and resources are optimally used. Working with its domestic and international partners, the American Association for Clinical Chemistry (AACC) has created an International Consortium for Harmonization of Clinical Laboratory Results. Advances in this area will improve the quality of patient care.

Keywords: comparable test results; harmonization; harmonization consortium; measurand; traceability.

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Figures

Figure 1
Figure 1
Traceability scheme Source: ISO 17511
Figure 2
Figure 2
An infrastructure for harmonization
Figure 3
Figure 3
Harmonization website resources page
See this image and copyright information in PMC

References

    1. Little RR, Rohlfing CL, Wiedmeyer HM, Myers GL, Sacks DB, Goldstein DE for the NGSP Steering Committee The National Glycohemoglobin Standardization Program: A five-year progress report. Clin Chem 2001;47:1985–1992. - PubMed
    1. Warnick GR, Kimberly MM, Waymack PP, Leary ET, Myers GL. Standardization of measurements for cholesterol, triglycerides and major lipoproteins. LABMEDICINE 2008;39:481–490.
    1. ISO. In vitro diagnostic medical devices – measurement of quantities in biological samples – metrological traceability of values assigned to calibrators and control materials. 1st ed. ISO17511:2003(E). Geneva: ISO; 2003.ISO 17511
    1. Miller WG, Myers GL, Rej R. Why commutability matters. Clin Chem 2006;52:553–554. - PubMed
    1. Miller WG, Myers GL, Gantzer ML, Kahn SE, Schönbrunner ER, Thienpont LM, Bunk DM, Christenson RH, Eckfeldt JH, Lo SF, Nübling CM, Sturgeon CM. Roadmap for harmonization of clinical laboratory measurement procedures. Clin Chem 2011;57:1108–1117. - PubMed

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