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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

Editorial Board Member: Gillery, Philippe / Kazmierczak, Steven / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Whitfield, John B.

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IMPACT FACTOR 2013: 2.955
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The role of in vitro diagnostic companies in reducing laboratory error

Ana K. Stankovic1 / Peter Romeo2

1Medical and Clinical Affairs, BD Diagnostics, Preanalytical Systems, Franklin Lakes, NJ, USA

2Global Product Development System, BD Diagnostics, Preanalytical Systems, Franklin Lakes, NJ, USA

Corresponding author: Ana K. Stankovic, MD, PhD, MSPH, World Wide Vice President, BD Diagnostics, Preanalytical Systems MC310, 1 Becton Drive, Franklin Lakes, NJ 07417, USA Phone: +1-201-8474376, Fax: +1-201-8474851,

Citation Information: Clinical Chemical Laboratory Medicine. Volume 45, Issue 6, Pages 781–788, ISSN (Online) 14374331, ISSN (Print) 14346621, DOI: 10.1515/CCLM.2007.175, June 2007

Publication History

Published Online:


Laboratory errors have a significant impact on patient safety. The manufacturers of in vitro diagnostic (IVD) products play an important role in the reduction of laboratory errors by ensuring the highest possible safety and efficacy of their products. In order to achieve this, the IVD industry has implemented rigorous product development and manufacturing processes. Many IVD companies apply Six Sigma principles in order to minimize variability within the whole product life cycle, starting with customer requirements, through product design and manufacture, as well as management of the potential issues that occur after the products have been released for use. A closer look into this process is presented here, using an evacuated blood collection tube as a model device.

Clin Chem Lab Med 2007;45:781–8.

Keywords: design for Six Sigma; Define-Measure-Analyze-Improve-Control (DMAIC); evacuated tubes; in vitro diagnostic (IVD) products; laboratory errors; New Product Development; patient safety; preanalytical variables; product development; Six Sigma

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