Jump to ContentJump to Main Navigation
Show Summary Details
In This Section

Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

12 Issues per year


IMPACT FACTOR 2016: 3.432

CiteScore 2016: 2.21

SCImago Journal Rank (SJR) 2015: 0.873
Source Normalized Impact per Paper (SNIP) 2015: 0.982

Online
ISSN
1437-4331
See all formats and pricing
In This Section
Volume 48, Issue 1 (Jan 2010)

Issues

Managing quality vs. measuring uncertainty in the medical laboratory

James O. Westgard
  • Department of Pathology and Laboratory Medicine, University of Wisconsin Medical School, and Westgard QC, Inc, Madison, WI, USA
Published Online: 2009-11-18 | DOI: https://doi.org/10.1515/CCLM.2010.024

Abstract

ISO 15189's particular requirements for quality management in medical laboratories provide guidance for (a) relating performance specifications to the intended use of a test or examination procedure, (b) designing internal quality control (IQC) procedures to verify the attainment of the intended quality of test results, as well as (c) determining the uncertainty or results, where relevant and possible. This guidance has particular implications for analytical quality management, specifically for validating method performance relative to quality goals or requirements (intended use), designing statistical quality control procedures on the basis of the quality required for a test and the precision and bias observed for a method, and characterizing the quality achieved in practice by calculating measurement uncertainty. There already exists an error framework that provides practical tools and guidance for managing analytical quality, along with an existing concept of total error that can be used to characterize the quality of laboratory tests, thus there is considerable concern and debate on the merits and usefulness of measurement uncertainty. This paper argues that total error provides a practical top-down estimate of measurement uncertainty in the laboratory, and that the ISO/GUM model should be primarily directed to and applied by manufacturers.

Clin Chem Lab Med 2010;48:31–40.

Keywords: analytical quality management; measurement uncertainty; quality; total error

About the article

Corresponding author: James O. Westgard, 7614 Gray Fox Trail, Madison, WI 53717, USA Phone: +1-608-833-4718, Fax: +1-608-833-0640,


Received: 2009-07-30

Accepted: 2009-07-30

Published Online: 2009-11-18

Published in Print: 2010-01-01



Citation Information: Clinical Chemistry and Laboratory Medicine, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2010.024. Export Citation

Citing Articles

Here you can find all Crossref-listed publications in which this article is cited. If you would like to receive automatic email messages as soon as this article is cited in other publications, simply activate the “Citation Alert” on the top of this page.

[1]
Kendal E. Harr, Bente Flatland, Mary Nabity, and Kathleen P. Freeman
Veterinary Clinical Pathology, 2013, Volume 42, Number 4, Page 424
[3]
R. G. Gullberg
Journal of Analytical Toxicology, 2012, Volume 36, Number 3, Page 153
[4]
Therese Koal, Diane Schmiederer, Hai Pham-Tuan, Cornelia Röhring, and Manfred Rauh
The Journal of Steroid Biochemistry and Molecular Biology, 2012, Volume 129, Number 3-5, Page 129
[5]
Elvar Theodorsson
Bioanalysis, 2012, Volume 4, Number 3, Page 305
[6]
Anna Carobene, Carlo Franzini, and Ferruccio Ceriotti
Clinical Chemistry and Laboratory Medicine, 2011, Volume 49, Number 7
[7]
E. Rozet, R.D. Marini, E. Ziemons, Ph. Hubert, W. Dewé, S. Rudaz, and B. Boulanger
TrAC Trends in Analytical Chemistry, 2011, Volume 30, Number 5, Page 797
[8]
Per Hyltoft Petersen, Sverre Sandberg, and Callum G. Fraser
Clinical Chemistry and Laboratory Medicine, 2011, Volume 49, Number 4

Comments (0)

Please log in or register to comment.
Log in