Abstract
Summary Laboratory medicine, as a specialty that had prioritised quality control, has always been at the forefront of error reduction. In the last decades, a dramatic decrease of analytical errors has been experienced, while a relatively high frequency of errors has been documented in the pre-analytical phase. Most pre-analytical errors, which account for up to 70% of all mistakes made in laboratory diagnostics, arise during patient preparation, and sample collection, transportation, preparation for analysis and storage. However, while it has been reported that the pre-analytical phase is error-prone, only recently has it been demonstrated that most of these errors occur in the »pre-pre-analytical phase«, which comprises the initial procedures of the testing process performed outside the laboratory walls by healthcare personnel outside the direct control of the clinical laboratory. Developments in automation and information technologies have played a major role in decreasing some pre-analytical errors and, in particular, the automation of repetitive, errorprone and bio-hazardous pre-analytical processes performed within the laboratory walls has effectively decreased errors in specimen preparation, centrifugation, aliquot preparation, pipetting and sorting. However, more efforts should be made to improve the appropriateness of test request, patient and sample identification procedures and other pre-analytical steps performed outside the laboratory walls.
Highlights
Laboratory medicine has a long histor y of careful attention to quality assurance, standar d setting and performance monitoring
Most pr e-analytical errors, which account for up to 70% of all mistakes made in laborator y diagnostics, arise during patient pr eparation, and sample collection, transportation, preparation for analysis and storage
While it has been r eported that the pr e-analytical phase is error-prone, only r ecently has it been demonstrated that most of these errors occur in the »pre-pre-analytical phase«, which comprises the initial procedures of the testing process performed outside the laboratory walls by healthcare personnel outside the dir ect control of the clinical laborator y
Summary
Laboratory medicine has a long histor y of careful attention to quality assurance, standar d setting and performance monitoring. According to the ISO 1518 9: 2007 Inter national Standard for laborator y accreditation, the pre-analytical phase should be defined as »steps starting, in chronological order, from the clinician’s request and including the examination r equisition, preparation of the patient, collection of the primar y sample, and transportation to and within the laborator y, and ending when the analytical examination pr ocedure begins« [8] This definition clearly r ecognizes the need to evaluate, monitor and impr ove all the pr ocedures and processes in the initial phase of laborator y testing, the pr ocedures performed within the laboratory walls. The pr e-analytical phase should be subdivided into a »pre-pre-analytical phase« and a »true«
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