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

Ana Maria Simundic, 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, Tomas Zima

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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.

Original languageEnglish
Pages (from-to)215-228
Number of pages14
JournalClinical Chemistry and Laboratory Medicine
Volume49
Issue number2
DOIs
Publication statusPublished - Feb 1 2011

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Keywords

  • errors
  • extra-analytical quality
  • laboratory testing
  • quality
  • survey

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

Simundic, A. M., Bilic-Zulle, L., Nikolac, N., Supak-Smolcic, V., Honovic, L., Avram, S., Beregovaja, E., Dobreanu, M., Guimaraes, J. T., Kovacs, G. L., Singh, N. M., Sierra-Amor, R. I., Sypniewska, G., & Zima, T. (2011). The quality of the extra-analytical phase of laboratory practice in some developing European countries and Mexico - A multicentric study. Clinical Chemistry and Laboratory Medicine, 49(2), 215-228. https://doi.org/10.1515/CCLM.2011.034