title: Performance criteria and quality indicators for the pre-analytical phase.
abstract: The definition, implementation and monitoring of valuable analytical quality specifications have played a fundamental role in improving the quality of laboratory services and reducing the rates of analytical errors. However, a body of evidence has been accumulated on the relevance of the extra-analytical phases, namely the pre-analytical steps, their vulnerability and impact on the overall quality of the laboratory information. The identification and establishment of valueable quality indicators (QIs) represents a promising strategy for collecting data on quality in the total testing process (TTP) and, particularly, for detecting any mistakes made in the individual steps of the pre-analytical phase, thus providing useful information for quality improvement projects. The consensus achieved on the developed list of harmonized QIs is a premise for the further step: the identification of achievable and realistic performance targets based on the knowledge of the state-of-the-art. Data collected by several clinical laboratories worldwide allow the classification of performances for available QIs into three levels: optimum, desirable and minimum, in agreement with the widely accepted proposal for analytical quality specifications.
authors.forename: Mario
authors.initials: M
authors.lastname: Plebani
authors.forename: Laura
authors.initials: L
authors.lastname: Sciacovelli
authors.forename: Ada
authors.initials: A
authors.lastname: Aita
authors.forename: Michela
authors.initials: M
authors.lastname: Pelloso
authors.forename: Maria Laura
authors.initials: ML
authors.lastname: Chiozza
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D006801:Humans; D019300:Medical Errors / Q000517:prevention & control; D061214:Patient Safety; D019984:Quality Indicators, Health Care / Q000592:standards*; D012015:Reference Standards