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Licensed Unlicensed Requires Authentication Published by De Gruyter June 19, 2007

Risk management in the preanalytical phase of laboratory testing

  • Giuseppe Lippi and Gian Cesare Guidi
From the journal


The clinical laboratory is no longer its own limited ecosystem, as it is increasingly integrated with patient care, assisting diagnosis, monitoring therapies and predicting clinical outcomes. Although efforts and resources are continuously focused to achieve a satisfactory degree of analytical quality, there is clear evidence that the preanalytical phase is much more vulnerable to uncertainties and accidents, which can substantially influence patient care. Most errors within the preanalytical phase result from system flaws and insufficient audit of the operators involved in specimen collection and handling responsibilities, leading to an unacceptable number of unsuitable specimens due to in vitro hemolysis, clotting, insufficient volume, wrong container, contamination and misidentification. A reliable approach to overcome this problem entails prediction of accidental events (exhaustive process analysis, reassessment and rearrangement of quality requirements, dissemination of operating guidelines and best-practice recommendations, reduction of complexity and error-prone activities, introduction of error-tracking systems and continuous monitoring of performances), an increase in and diversification of defenses (application of multiple and heterogeneous systems to identify non-conformities), and a decrease in vulnerability (implementation of reliable and objective detection systems and causal relation charts, education and training). This policy, which requires integration between requirements and design, full commitment and interdepartmental cooperation, should make laboratory activity more compliant to the inalienable paradigm of total quality in the testing process.

Clin Chem Lab Med 2007;45:720–7.

Corresponding author: Prof. Giuseppe Lippi, MD, Sezione di Chimica e Microscopia Clinica, Dipartimento di Scienze Morfologico-Biomediche, Università degli Studi di Verona, Ospedale Policlinico G.B. Rossi, Piazzale Scuro, 10, 37134 Verona, Italy Phone: +39-045-8124308, Fax: +39-045-8201889,

Published Online: 2007-06-19
Published in Print: 2007-06-01

©2007 by Walter de Gruyter Berlin New York

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