Clinical laboratory tests ensure approximately 70% of the medical decisions, so that the time until the release of the results and its accuracy are critical for the diagnosis and the efficiency of the treatment . Risk management involves both the anticipation of what could happen erroneous and the assessment of errors’ frequency as well as the consequences or the severity of the effects caused by it, and finally to decide what can be done in order to reduce the risk to an acceptable clinical level. For this reason, organizations should not see the risk management as a compliance issue, but as an integral part of the decision-making process. EP23-A is a guideline of CLSI that introduces the risk management principles in the clinical laboratory and encourages the laboratories to develop plans of risk management which are addressed to the risks of each laboratory. EP18-A2 proposes 2 techniques for identifying and controlling the errors in the laboratory: FMEA (Failure Mode and Effects Analysis) and FRACAS (Failure Reporting, Analysis and Corrective Action System). The European Committee of Experts and Management of Safety and Quality in Health Care proposed to use the quality indicators to identify the critical stages of each process, thus being possible to assess continuously the medical processes with the aim of identifying the errors when they occur. This review summarizes the principles of the risk management in the clinical laboratory, thus it can achieve its aims to report valid, accurate and reliable test results
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1. Mendes ME Persio de Almeida RE Romano P and al. Practical aspects of the use of FMEA tool in clinical laboratory risk management. J Bras Patol Med. 2013; 49(3): 174-181.
2. The Orange BooK. Management of Risk – Principles and Concepts. Norwich. HM Treasury on behalf of the Controller of Her Majesty’s Stationery Office. 2004
3. Asociația de Standardizare din România (ASRO). SR Ghid ISO 73:2010. Managementul riscului – Vocabular. Acest standard este identic cu ghidul internațional ISO GUIDE 73:2009. 2010
4. International Organization for Standardization ISO/IEC GUIDE 51:2014. Safety aspects – Guidelines for their inclusion in standards. Geneva. Published in Switzerland. 2014
5. Njoroge WS Nichols HJ. Risk Management in the Clinical Laboratory. Ann Lab Med. 2014;34:274-278.
6. Lippi G Guidi GC. Risk management in the preanalytical phase of laboratory testing. Clin Chem Lab Med. 2007; 45(6):720-727.
7. International Organization for Standardization. SR ISO 31000:2010. Managementul riscului. Principii și linii directoare. 2010
8. International Organization for Standardization. SR BS 31100:2013. Managementul riscului. Cod de practică și îndrumare pentru implementarea standardului SR ISO 31000. 2013
9. Clinical and Laboratory Standards Institute (CLSI). EP23-A-WB: A Practical Guide for Laboratory Quality Control Based on Risk Management. USA
10. Clinical and Laboratory Standards Institute (CLSI). EP23-A-WS: A Sample Form for Laboratory Quality Control Based on Risk Management. USA
11. Clinical and Laboratory Standards Institute (CLSI). EP23-ATM: Laboratory Quality Control Based on Risk Management; Approved Guideline. USA. 2011
12. Asociația de Standardizare din România (ASRO). SR EN 31010 CEI/ISO 31010. Managementul riscului. Tehnici de evaluare a riscurilor. Acest standard este identic cu standardul european EN 31010:2010. 2011
13. Clinical and Laboratory Standards Institute (CLSI). EP18-A2: Risk Management Technigues to Identify and Control Laboratory Error Sources; Approved Guideline – Second Edition. USA. 2009
14. Plebani M. Errors in clinical laboratories or errors in laboratory medicine?. Clin Chem Lab Med. 2006;44(6):750-759.
15. International Organization for Standardization. ISO 15189:2012. Medical laboratories – Requirements for quality and competence. 2012
16. International Organization for Standardization. ISO/TS 22367:2008. Medical laboratories – Reduction of error through risk management and continual. Geneva. Published in Switzerland. 2008
17. Gimenez-Marin A Rivas-Ruiz F Perez-Hidalgo MM and all. Pre-analytical errors management in the clinical laboratory: a five-year study. Biochemia Medica. 2014; 24:248-257.
18. Plebani M Sciacovelli L Chiazza ML. Harmonization of the pre-analytical quality indicators. Biochemia Medica. 2014; 24:105-103.
19. Plebani M Sciacovelli L Chiazza ML. Towards harmonization of quality indicators in laboratory medicine. Clin Chem Lab Med. 2013;51:187-195.
20. Plebani M Astion ML Barth JH and al. Harmonization of quality indicators in laboratory medicine. A preliminary consensus. Clin Chem Lab Med. 2014;52:951-958.
21. Working Group: Laboratory Errors and Patient Safety of IFCC – Education and Management Division. Membership: Laura Sciacovelli Mario Plebani Isabel Garcia del Pino Castro Giuseppe Lippi Zorica Sumarac Keila Furtado Veira Jamie West Agnes Ivanov.
22. International Organization for Standardization. ER EN ISO 14971:2009. Dispozitive medicale. Aplicarea managementului de risc la dispozitivele medicale. 2011