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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter

IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

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Source Normalized Impact per Paper (SNIP) 2018: 1.205

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Volume 44, Issue 12


National survey on the pre-analytical variability in a representative cohort of Italian laboratories

Giuseppe Lippi
  • Sezione di Chimica e Microscopia Clinica, Dipartimento di Scienze Morfologico Biomediche, Università degli Studi di Verona, Verona, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Martina Montagnana
  • Sezione di Chimica e Microscopia Clinica, Dipartimento di Scienze Morfologico Biomediche, Università degli Studi di Verona, Verona, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Davide Giavarina
  • Laboratorio di Chimica Clinica ed Ematologia, Dipartimento di Patologia Clinica, Ospedale San Bortolo, Vicenza, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2011-09-21 | DOI: https://doi.org/10.1515/CCLM.2006.274


Background: Owing to remarkable advances in automation, laboratory technology and informatics, the pre-analytical phase has become the major source of variability in laboratory testing. The present survey investigated the development of several pre-analytical processes within a representative cohort of Italian clinical laboratories.

Methods: A seven-point questionnaire was designed to investigate the following issues: 1a) the mean outpatient waiting time before check-in and 1b) the mean time from check-in to sample collection; 2) the mean time from sample collection to analysis; 3) the type of specimen collected for clinical chemistry testing; 4) the degree of pre-analytical automation; 5a) the number of samples shipped to other laboratories and 5b) the availability of standardised protocols for transportation; 6) the conditions for specimen storage; and 7) the availability and type of guidelines for management of unsuitable specimens. The questionnaire was administered to 150 laboratory specialists attending the SIMEL (Italian Society of Laboratory Medicine) National Meeting in June 2006.

Results: 107 questionnaires (71.3%) were returned. Data analysis revealed a high degree of variability among laboratories for the time required for check-in, outpatient sampling, sample transportation to the referral laboratory and analysis upon the arrival. Only 31% of laboratories have automated some pre-analytical steps. Of the 87% of laboratories that ship specimens to other facilities without sample preparation, 19% have no standardised protocol for transportation. For conventional clinical chemistry testing, 74% of the laboratories use serum evacuated tubes (59% with and 15% without serum separator), whereas the remaining 26% use lithium-heparin evacuated tubes (11% with and 15% without plasma separator). The storage period and conditions for rerun/retest vary widely. Only 63% of laboratories have a codified procedure for the management of unsuitable specimens, which are recognised by visual inspection (69%) or automatic detection (29%). Only 56% of the laboratories have standardised procedures for the management of unsuitable specimens, which vary widely on a local basis.

Conclusions: The survey highlights broad heterogeneity in several pre-analytical processes among Italian laboratories. The lack of reliable guidelines encompassing evidence-based practice is a major problem for the standardisation of this crucial part of the testing process and represents a major challenge for laboratory medicine in the 2000s.

Clin Chem Lab Med 2006;44:1491–4.

Keywords: errors; laboratory testing; pre-analytical variability; standardisation; survey


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About the article

Corresponding author: Prof. Giuseppe Lippi, M.D., Sezione di Chimica e Microscopia Clinica, Dipartimento di Scienze Morfologico-Biomediche, Università degli Studi di Verona, Ospedale Policlinico G.B. Rossi, Piazzale Scuro, 10, 37121 Verona, Italy Phone: +39-045-8074517, Fax: +39-045-8201889, ;

Received: 2006-08-16

Accepted: 2006-09-26

Published Online: 2011-09-21

Published in Print: 2006-12-01

Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 44, Issue 12, Pages 1491–1494, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2006.274.

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