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Accreditation and Quality Assurance

, Volume 18, Issue 5, pp 429–434 | Cite as

Quality management of preanalytical phase: impact of lithium heparin vacuum tubes changes on clinical chemistry tests

  • Gabriel Lima-OliveiraEmail author
  • Gian Luca Salvagno
  • Giuseppe Lippi
  • Giorgio Brocco
  • Monica Voi
  • Martina Montagnana
  • Geraldo Picheth
  • Gian Cesare Guidi
Practitioner's Report

Abstract

The validation process is essential in accredited laboratory medicine, but is rarely regarded as an issue in the preanalytical management. The aim of this study was to validate five kinds of lithium heparin vacuum tubes for routine clinical chemistry laboratory testing. Blood specimens from 100 volunteers in five different plasma vacuum tubes (Tube I: VACUETTE®, Tube II: LABOR IMPORT®, Tube III: S-Monovette®, Tube IV: PST® and Tube V: PST II®) were collected by a single expert phlebotomist. The routine clinical chemistry tests were performed on a Cobas® 6000 <c501> module. The significance of the differences between samples was statistically assessed at p < 0.005. The biases from the different tubes were compared with the current desirable quality specifications. Basically, significant differences could be confirmed by RM ANOVA for the results of the clinical chemistry tests on the following components: glucose, urea, creatinine, alkaline phosphatase, amylase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, phosphate, Ca, Mg, Fe and K. Clinically significant variations as compared with the current desirable quality specifications were found for glucose, creatinine, amylase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, Ca, Mg and K. In conclusion, our results do not support arbitrary interchange among brands of plasma vacuum tubes. Future investigations are needed to understand the reasons of these observations; in the meantime, we suggest that laboratory managers standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices.

Keywords

Laboratory variability Blood collection devices Plasma samples Patient safety Validation process Interference 

Notes

Conflict of interest

No potential conflicts of interest relevant to this article were reported.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • Gabriel Lima-Oliveira
    • 1
    • 2
    • 3
    • 4
    Email author
  • Gian Luca Salvagno
    • 1
  • Giuseppe Lippi
    • 5
  • Giorgio Brocco
    • 1
  • Monica Voi
    • 1
  • Martina Montagnana
    • 1
  • Geraldo Picheth
    • 2
  • Gian Cesare Guidi
    • 1
    • 2
  1. 1.Department of Life and Reproduction Sciences, Laboratory of Clinical BiochemistryUniversity of VeronaVeronaItaly
  2. 2.Post-Graduate Program of Pharmaceutical Sciences, Department of Medical PathologyFederal University of ParanaCuritibaBrazil
  3. 3.MERCOSUL: Sector Committee of Clinical Analyses and in Vitro Diagnostics—CSM 20Rio de JaneiroBrazil
  4. 4.Brazilian Society of Clinical Analyses on Sao Paulo StateSao PauloBrazil
  5. 5.Department of Pathology and Laboratory Medicine, U.O. Laboratory of Clinical Chemistry and HematologyAcademic Hospital of ParmaParmaItaly

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