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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 / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

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Point-of-care testing, medical error, and patient safety: a 2007 assessment

Sharon S. Ehrmeyer1 / Ronald H. Laessig2

1Departments of Pathology and Laboratory Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA

2Departments of Pathology and Laboratory Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA, Population Health Sciences, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA and State Laboratory of Hygiene, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA

Corresponding author: Sharon Ehrmeyer, PhD, MT(ASCP) Professor, Pathology and Laboratory Medicine Director, MT/CLS, University of Wisconsin School of Medicine and Public Health, Madison, WI 53706, USA Phone: +1-608-2620859, Fax: +1-608-2629520,

Citation Information: Clinical Chemical Laboratory Medicine. Volume 45, Issue 6, Pages 766–773, ISSN (Online) 14374331, ISSN (Print) 14346621, DOI: 10.1515/CCLM.2007.164, June 2007

Publication History

Published Online:


Point-of-care testing (POCT) is the fastest growing segment of a US$30 billion worldwide market. “Errors” in the testing process, as well as medical data interpretation and treatment associated with POCT, are recognized as leading to major compromises of patient safety. In today's environment, most testing errors (pre-analytical, analytical and post-analytical) can be virtually eliminated by proper design of testing systems. We cite examples of two systems that have made exceptional progress in this respect. It has been recently suggested that the basic errors associated with the testing process are amplified in the POC setting. Two of the amplifiers – incoherent regulations and failure of clinician/caregivers to respond appropriately to POCT results – lead us to recognize additional changes in today's POCT environment. The first is a willingness of manufacturers, not laboratories, to take responsibility for the quality of test results – an outgrowth of an industrial philosophy called autonomation. The second is a need to substantially modify the clinician/caregiver test utilization paradigm to take full advantage of POCT results, available on site in real time. Both have already begun to take place.

Clin Chem Lab Med 2007;45:766–73.

Keywords: Clinical Laboratory Improvement Amendments (CLIA) regulation; clinical laboratory testing; errors; patient safety; point-of-care testing; quality

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