Improving quality and patient safety in the medical biochemistry laboratory accredited according to the International Standard Organization (ISO 15189:2012) requires the patient-centered evaluation of errors based on the implementation of quality indicators (QIs) across the total testing process. Our main goal was to achieve quality improvement of the preanalytical process in an emergency laboratory which had the highest error rate using risk management principles.
Failure mode and effects analysis (FMEA) was applied to analyze predefined preanalytical QIs and score laboratory failures for the failure demerit value (FDV), probability of failure (PF) and probability of failure remedy (PFR). Based on obtained scores (on a 10-point scale) risk priority numbers (RPNs) were calculated.
A total of five failure modes were identified in the preanalytic process. The calculated risks were “sample hemolysis” (RPN, 168),“misidentified samples” (RPN, 108),“samples clotted” (RPN, 90),“sample volume error” (RPN, 72) and “samples transported at inappropriate temperature” (RPN, 24). The activation of corrective risk-reducing measures for failure modes with RPN≥30 resulted in quality improvement with the significant decrease in reevaluated RPNs.
The implementation of a preanalytical quality monitoring system based on observation of evidence-based QIs and patient-centered evaluation of errors through risk analysis with regular tailored education as well as implementing process improvements can effectively reduce preanalytical errors in the emergency laboratory and improve patient safety.
Plebani M, Sciacovelli L, Marinova M, Marcuccitti J, Chiozza ML. Quality indicators in laboratory medicine: a fundamental tool for quality and patient safety. Clin Biochem 2013;46:1170–4.2321974410.1016/j.clinbiochem.2012.11.028)| false
Plebani M, Astion ML, Barth JH, Chen W, de Oliveira Galoro CA, Escuer MI, et al. Harmonization of quality indicators in laboratory medicine. A preliminary consensus. Clin Chem Lab Med 2014;52:951–8.24622792)| false
Flegar-Meštrić Z, Nazor A, Perkov S, Šurina B, Kardum Paro MM, Šiftar Z, et al. Accreditation of Medical Laboratories in Croatia-Experiences of the Institute of Clinical Chemistry, University Hospital Merkur, Zagreb. Coll Antropol 2010;34:181–6.
Flegar-Meštrić Z, Nazor A, Perkov S, Šurina B, Kardum Paro MM, Šiftar Z, et al. Accreditation of Medical Laboratories in Croatia-Experiences of the Institute of Clinical Chemistry, University Hospital Merkur, Zagreb. Coll Antropol 2010;34:181–6.20437640)| false
Sciacovelli L, Sonntag O, Padoan A, Zambon CF, Carraro P, Plebani M, et al. Monitoring quality indicators in laboratory medicine does not automatically result in quality improvement. Clin Chem Lab Med 2011;50:463–9.
Sciacovelli L, Sonntag O, Padoan A, Zambon CF, Carraro P, Plebani M, et al. Monitoring quality indicators in laboratory medicine does not automatically result in quality improvement. Clin Chem Lab Med 2011;50:463–9.22149744)| false
Romero A, Cobos A, Gómez J, Muñoz M. Role of training activities for the reduction of pre-analytical errors in laboratory samples from primary care. Clin Chim Acta 2012;413:166–9.2196446110.1016/j.cca.2011.09.017)| false
Leniček Krleza J, Dorotic A, Grzunov A, Maradin M. Capillary blood sampling: national recommendations on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine. Biochem Med (Zagreb) 2015;25:335–58.
Nikolac N, Supak-Smolcic V, Simundic AM, Celap I. Croatian Society of Medical Biochemistry and Laboratory Medicine: national recommendations for venous blood sampling. Biochem Med 2013;23:242–54.
Clinical Laboratory Standards Institute. Procedures for collection of diagnostic blood specimens by venipuncture; approved guideline, 6th ed. CLSI document H3-A6. Wayne, PA: CLSI, 2007.
World Health Organization. WHO guidelines on drawing blood: best practices in phlebotomy. Geneva, Switzerland: WHO, 2010.
Clinical Laboratory Standards Institute. Accuracy in patient and sample identification; approved guideline. CLSI document GP33-A. Wayne, PA: CLSI, 2010.
Dongen-Lases EC, Cornes MP, Grankvist K, Ibarz M, Kristensen GB, Lippi G, et al. Working Group for Preanalytical Phase (WG-PRE), European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Patient identification and tube labelling – a call for harmonisation. Clin Chem Lab Med 2016;54:1141–45.
Plebani M. The quality indicator paradox. Clin Chem Lab Med 2016; 54:1119–22.
Sciacovelli L, O’Kane M, Skaik YA, Caciagli P, Pellegrini C, Da Rin G, et al. IFCC WG-LEPS. Quality Indicators in Laboratory Medicine: from theory to practice. Preliminary data from the IFCC Working Group Project “Laboratory Errors and Patient Safety”. Clin Chem Lab Med 2011;49:835–44.
Chiozza ML, Ponzetti C. FMEA: a model for reducing medical errors. Clin Chim Acta 2009;404:75–8.
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