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The quality of the extra-analytical phase of laboratory practice in some developing European countries and Mexico – a multicentric study

  • Ana-Maria Simundic EMAIL logo , Lidija Bilic-Zulle , Nora Nikolac , Vesna Supak-Smolcic , Lorena Honovic , Sanja Avram , Elena Beregovaja , Minodora Dobreanu , Joao-Tiago Guimaraes , Gabor L. Kovacs , Nada Majkic Singh , Rosa Isabel Sierra-Amor , Grazyna Sypniewska and Tomas Zima
Published/Copyright: December 1, 2010

Abstract

Background: This cross-sectional multicentric survey study aimed to assess the quality of the extra-analytical phase of laboratory activities in some developing European countries and Mexico. We assessed the quality of the extra-analytical practices in participating laboratories regarding the: a) sample acceptance criteria; b) phlebotomy procedures; c) test results reporting and d) recording non-conformities.

Methods: A survey was performed during the April–May 2009. A total of 15 clinical laboratories from the following countries were included: Bosnia, Croatia, Czech Republic, Hungary, Mexico, Poland, Portugal, Romania, Serbia and Ukraine. Questions were scored (scores from 1–4) and average scores was calculated for each category.

Results: The overall score for all respondents (n=443) was 3.10±0.33. The average score was 3.11±0.56 for sample acceptance criteria, 2.76±0.58 for phlebotomy and 3.34± 0.53, for test results reporting (F=116.49; p<0.001). Laboratory accreditation was associated with better practices and higher overall quality of the extra-analytical procedures (F=16.62; p<0.001). Moreover, the highest scores for sample acceptance criteria (F=8.32; p<0.001), phlebotomy procedures (F=13.28; p<0.001) and for reporting non-conformities (F=33.62; p<0.001) were observed for accredited laboratories or laboratories under preparation for accreditation.

Conclusions: The overall quality of the extra-analytical practices in countries in this survey is not satisfactory. Phlebotomy practices are the most critical extra-analytical activity. Since laboratory accreditation was associated with better practices and higher overall quality of the extra-analytical procedures, we believe that the most significant improvement could be made by implementing the total quality management system and standardizing laboratory procedures.


Corresponding author: Assist. Prof. Ana-Maria Simundic, PhD, University Department of Chemistry, Emergency Laboratory Department, University Hospital “SESTRE MILOSRDNICE”, Zagreb, Croatia

Received: 2010-6-10
Accepted: 2010-8-4
Published Online: 2010-12-1
Published in Print: 2011-02-01

©2011 by Walter de Gruyter Berlin New York

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