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Clin Chem. 2002 May;48(5):691-8.

Errors in laboratory medicine.

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Università Vita-Salute San Raffaele, Cattedra di Biochimica Clinica, Via Olgettina 58, 20132 Milan, Italy.



The problem of medical errors has recently received a great deal of attention, which will probably increase. In this minireview, we focus on this issue in the fields of laboratory medicine and blood transfusion.


We conducted several MEDLINE queries and searched the literature by hand. Searches were limited to the last 8 years to identify results that were not biased by obsolete technology. In addition, data on the frequency and type of preanalytical errors in our institution were collected.


Our search revealed large heterogeneity in study designs and quality on this topic as well as relatively few available data and the lack of a shared definition of "laboratory error" (also referred to as "blunder", "mistake", "problem", or "defect"). Despite these limitations, there was considerable concordance on the distribution of errors throughout the laboratory working process: most occurred in the pre- or postanalytical phases, whereas a minority (13-32% according to the studies) occurred in the analytical portion. The reported frequency of errors was related to how they were identified: when a careful process analysis was performed, substantially more errors were discovered than when studies relied on complaints or report of near accidents.


The large heterogeneity of literature on laboratory errors together with the prevalence of evidence that most errors occur in the preanalytical phase suggest the implementation of a more rigorous methodology for error detection and classification and the adoption of proper technologies for error reduction. Clinical audits should be used as a tool to detect errors caused by organizational problems outside the laboratory.

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