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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 / Schlattmann, Peter / Tate, Jillian R. / Tsongalis, Gregory J.

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Implementing the Stockholm Conference hierarchy of objective quality criteria in a routine laboratory

Gurdeep S. Dhatt1 / Mukesh M. Agarwal2 / Bassam Bishawi3 / Janice Gill4

1Department of Pathology and Laboratory Medicine, Tawam Hospital, Al Ain, United Arab Emirates

2Department of Pathology, Faculty of Medicine, UAE University, Al Ain, United Arab Emirates

3Department of Pathology and Laboratory Medicine, Tawam Hospital, Al Ain, United Arab Emirates

4RCPA Quality Assurance Programs Pty Ltd., Flinders Medical Center, Bedford Park, SA, Australia

Corresponding author: Dr. Gurdeep Singh Dhatt, Department of Pathology and Laboratory Medicine, Tawam Hospital, P.O. Box 15258, Al Ain, United Arab Emirates Phone: +971-3-7072417, Fax: +971-3-7072418,

Citation Information: Clinical Chemical Laboratory Medicine. Volume 45, Issue 4, Pages 549–552, ISSN (Online) 14346621, ISSN (Print) 14374331, DOI: 10.1515/CCLM.2007.105, April 2007

Publication History

Received:
2006-11-14
Accepted:
2007-01-08

Abstract

Background: Analytical performance of clinical laboratory testing should be evaluated against objective quality specifications. The Stockholm Conference consensus recommendation states that from a hierarchy of quality models, the highest-ranking model should be used. This study reports the performance of a routine clinical laboratory using these quality recommendations. Quality standards recommended for use in manufacturers' package inserts are also compared against the objective criteria.

Methods: Imprecision of 22 analytes was monitored by analyzing three levels of commercial quality control (QC) material daily over a 6-month period. The performance for each analyte was evaluated against defined quality specifications based on biological variation and the National Cholesterol Education Panel (NCEP) criteria.

Results: Overall, objective quality specifications were met by the laboratory for 18/22 (82%) analytes. The performance for analytes not meeting the criteria was assessed against quality targets based on a model lower in the hierarchy, i.e., interlaboratory imprecision data derived from an accredited EQA program. All analytes met these quality targets. When quality targets set by the manufacturer were applied to biological variation and NCEP criteria, results for only 8/22 (36 %) analytes met the targets.

Conclusions: Objective quality specifications can be consistently achieved in a routine laboratory. The hierarchy model of the Stockholm Conference should be promoted for global adoption.

Clin Chem Lab Med 2007;45:549–;52.

Keywords: biological variation; imprecision; objective; quality; specifications

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