title: Recommendations for detection and management of unsuitable samples in clinical laboratories.
abstract: A large body of evidence attests that quality programs developed around the analytical phase of the total testing process would only produce limited improvements, since the large majority of errors encountered in clinical laboratories still prevails within extra-analytical areas of testing, especially in manually intensive preanalytical processes. Most preanalytical errors 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 misidentification, in vitro hemolysis, clotting, inappropriate volume, wrong container or contamination from infusive routes. Detection and management of unsuitable samples are necessary to overcome this variability. The present document, issued by the Italian Inter-society SIBioC-SIMeL-CISMEL (Society of Clinical Biochemistry and Clinical Molecular Biology-Italian Society of Laboratory Medicine-Italian Committee for Standardization of Hematological and Laboratory Methods) Study Group on Extra-analytical Variability, reviews the major causes of unsuitable specimens in clinical laboratories, providing consensus recommendations for detection and management.
authors.affiliation: Sezione di Chimica Clinica, Dipartimento di Scienze Morfologico-Biomediche, Università degli Studi di Verona, Verona, Italy. ulippi@tin.it
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lippi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Banfi
authors.forename: Mauro
authors.initials: M
authors.lastname: Buttarello
authors.forename: Ferruccio
authors.initials: F
authors.lastname: Ceriotti
authors.forename: Massimo
authors.initials: M
authors.lastname: Daves
authors.forename: Alberto
authors.initials: A
authors.lastname: Dolci
authors.forename: Marco
authors.initials: M
authors.lastname: Caputo
authors.forename: Davide
authors.initials: D
authors.lastname: Giavarina
authors.forename: Martina
authors.initials: M
authors.lastname: Montagnana
authors.forename: Valentino
authors.initials: V
authors.lastname: Miconi
authors.forename: Bruno
authors.initials: B
authors.lastname: Milanesi
authors.forename: Andrea
authors.initials: A
authors.lastname: Mosca
authors.forename: Margherita
authors.initials: M
authors.lastname: Morandini
authors.forename: Gian Luca
authors.initials: GL
authors.lastname: Salvagno
mesh_terms: D017408:Guidelines as Topic; D007753:Laboratories / Q000458:organization & administration*; D015203:Reproducibility of Results; D013048:Specimen Handling