Harmonization Of Quality Indicators In Laboratory Medicine. A Preliminary Consensus

Quality indicators (QIs) are fundamental tools for enabling users to quantify the quality of all operational processes by comparing it against a defined criterion. QIs data should be collected over time to identify, correct, and continuously monitor defects and improve performance and patient safety by identifying and implementing effective interventions. According to the international standard for medical laboratories accreditation, the laboratory shall establish and periodically review QIs to monitor and evaluate performance throughout critical aspects of pre-, intra-, and post-analytical processes. However, while some interesting programs on indicators in the total testing process have been developed in some countries, there is no consensus for the production of joint recommendations focusing on the adoption of universal QIs and common terminology in the total testing process. A preliminary agreement has been achieved in a Consensus Conference organized in Padua in 2013, after revising the model of quality indicators (MQI) developed by the Working Group on "Laboratory Errors and Patient Safety" of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The consensually accepted list of QIs, which takes into consideration both their importance and applicability, should be tested by all potentially interested clinical laboratories to identify further steps in the harmonization project.527951958Plebani, M., Laposata, M., Lundberg, G.D., The brain-to-brain loop concept for laboratory testing 40 years after its introduction (2011) Am J Clin Pathol, 136, pp. 829-833Epner, P.L., Gans, J.E., Graber, M.L., When diagnostic testing leads to harm: A new outcomes-based approach for laboratory medicine (2013) BMJ Qual Saf, 22 (SUPPL. 2), pp. 6-10Mainz, J., Krog, B.R., Bjornshave, B., Nationwide continuous quality improvement using quality indicators: The Danish national indicator project (2004) Int J Qual Health Care, 16 (SUPPL. 1), pp. 45-50Mainz, J., Defining and classifying clinical indicators for quality improvement (2003) Int J Qual Health Care, 15, pp. 523-530Plebani, M., Sciacovelli, L., Marinova, M., Marcuccitti, J., Chiozza, M.L., Quality indicators in laboratory medicine: A fundamental tool for quality and patient safety (2013) Clin Biochem, 46, pp. 1170-1174Plebani, M., The detection and prevention of errors in laboratory medicine (2010) Ann Clin Biochem, 47, pp. 101-110(2012) Medical Laboratories - Requirements for Quality and Competence, , ISO 15189:2012 Geneva, Switzerland: International Organization for StandardizationKhoury, M., Burnett, L., Mackay, M., Error rate in australian chemical pathology laboratories (1996) Med J Aust, 165, pp. 128-130Shcolnik, W., Plebani, M., Burnett, D., De Oliveira, C.A., De São José, A.S., De Oliveira Galoro, C.A., Brazilian laboratory indicators program (2012) Clin Chem Lab Med, 50, pp. 1923-1934Kirchner, M.J., Funes, V.A., Adzet, C.B., Clar, M.V., Escuer, M.I., Girona, J.M., Quality indicators and specifications for key processes in clinical laboratories: A preliminary experience (2007) Clin Chem Lab Med, 45, pp. 672-677Barth, J.H., Selecting clinical quality indicators for laboratory medicine (2012) Ann Clin Biochem, 49, pp. 257-261Barth, J.H., Clinical quality indicators in laboratory medicine (2012) Ann Clin Biochem, 49, pp. 9-16Simundic, A.M., Topic, E., Quality indicators (2008) Biochem Med, 18, pp. 311-319Plebani, M., Sciacovelli, L., Lippi, G., Quality indicators for laboratory diagnostics: Consensus is needed (2011) Ann Clin Biochem, 48, p. 479Sciacovelli, L., O'Kane, M., Skaik, Y.A., Caciagli, P., Pellegrini, C., Da Rin, G., Quality indicators in laboratory medicine: From theory to practice (2011) Clin Chem Lab Med, 49, pp. 835-844. , IFCC WG-LEPS. Preliminary data from the IFCC Working Group Project Laboratory errors and patient safetyMainz, J., Developing evidence-based clinical indicators: A state of the art methods primer (2003) Int J Qual Health Care, 15 (SUPPL. 1), pp. 5-11Plebani, M., Chiozza, M.L., Sciacovelli, L., Towards harmonization of quality indicators in laboratory medicine (2013) Clin Chem Lab Med, 51, pp. 187-195Plebani, M., Sciacovelli, L., Aita, A., Padoan, A., Chiozza, M.L., Quality indicators to detect pre-analytical errors in laboratory testing (2013) Clin Chim Acta, , Sep 5. [Epub ahead of print](2008) Medical Laboratories - Reducing Error through Risk Management and Continual Improvement, , ISO/PDTS 22367:2008. Geneva, Switzerland: International Organization for StandardizationTate, J.R., Johnson, R., Barth, J., Panteghini, M., Harmonization of laboratory testing - current achievements and future strategies (2013) Clin Chim Acta, , Aug 31. [Epub ahead of print]Plebani, M., Sciacovelli, L., Aita, A., Chiozza, M.L., Harmonization of pre-analytical quality indicators (2014) Biochem Med, 24, pp. 105-11