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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

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

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Volume 49, Issue 5


Quality Indicators in Laboratory Medicine: from theory to practice

Preliminary data from the IFCC Working Group Project “Laboratory Errors and Patient Safety”

Laura Sciacovelli / Maurice O’Kane / Younis Abdelwahab Skaik
  • Department of Laboratory Medicine, Faculty of Applied Medical Sciences, Al-Azhar University, Gaza, Palestine
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Patrizio Caciagli / Cristina Pellegrini / Giorgio Da Rin / Agnes Ivanov / Timothy Ghys / Mario Plebani
  • Department of Laboratory Medicine and Center of Biomedical Research, University Hospital of Padova, Padova, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2011-02-23 | DOI: https://doi.org/10.1515/CCLM.2011.128


Background: The adoption of Quality Indicators (QIs) has prompted the development of tools to measure and evaluate the quality and effectiveness of laboratory testing, first in the hospital setting and subsequently in ambulatory and other care settings. While Laboratory Medicine has an important role in the delivery of high-quality care, no consensus exists as yet on the use of QIs focussing on all steps of the laboratory total testing process (TTP), and further research in this area is required.

Methods: In order to reduce errors in laboratory testing, the IFCC Working Group on “Laboratory Errors and Patient Safety” (WG-LEPS) developed a series of Quality Indicators, specifically designed for clinical laboratories. In the first phase of the project, specific QIs for key processes of the TTP were identified, including all the pre-, intra- and post-analytic steps. The overall aim of the project is to create a common reporting system for clinical laboratories based on standardized data collection, and to define state-of-the-art and Quality Specifications (QSs) for each QI independent of: a) the size of organization and type of activities; b) the complexity of processes undertaken; and c) different degree of knowledge and ability of the staff. The aim of the present paper is to report the results collected from participating laboratories from February 2008 to December 2009 and to identify preliminary QSs.

Results and conclusions: The results demonstrate that a Model of Quality Indicators managed as an External Quality Assurance Program can serve as a tool to monitor and control the pre-, intra- and post-analytical activities. It might also allow clinical laboratories to identify risks that lead to errors resulting in patient harm: identification and design of practices that eliminate medical errors; the sharing of information and education of clinical and laboratory teams on practices that reduce or prevent errors; the monitoring and evaluation of improvement activities.

Keywords: errors reporting system; laboratory errors; patient safety; quality assurance; quality indicators

About the article

Corresponding author: Laura Sciacovelli, Dipartimento di Medicina di Laboratorio e Centro di Ricerca Biomedica, Azienda Ospedaliera Universita, Via Giustiniani 2, 35128 Padova, Italy Phone: +39 0498218708, Fax: +39 049663240

Received: 2010-09-27

Accepted: 2010-11-26

Published Online: 2011-02-23

Published in Print: 2011-05-01

Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 49, Issue 5, Pages 835–844, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2011.128.

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