Pre-analytical errors management in the clinical laboratory: A five-year study

Biochemia Medica

Volumn 24, Issue 2, 2014, Pages 248-257

  Giménez Marín, Angeles ^a   Rivas Ruiz, Francisco ^b   del Mar Pérez Hidalgo, Maria ^a   Molina Mendoza, Pedro ^a  

^a HOSPITAL DE ANTEQUERA   (Spain)

^b HOSPITAL COSTA DEL SOL   (Spain)

Author keywords

Health care; Laboratories; Patient safety; Quality indicators; Total quality management

Indexed keywords

ANALYTICAL ERROR; ARTICLE; BLOOD SAMPLING; CLINICAL INDICATOR; CLINICAL LABORATORY; DIAGNOSTIC ERROR; HUMAN; INFORMATION PROCESSING; LABORATORY PERSONNEL; MEDICAL PERSONNEL; OUTCOME VARIABLE; PATIENT SAFETY; QUALITY CONTROL; RATING SCALE; SAMPLING ERROR; SIX SIGMA SCALE; URINALYSIS;

CLINICAL CHEMISTRY TESTS; CLINICAL LABORATORY TECHNIQUES; FALSE NEGATIVE REACTIONS; FALSE POSITIVE REACTIONS; HEMOLYSIS; HUMANS; QUALITY CONTROL; SPECIMEN HANDLING;

EID: 84902149443     PISSN: 13300962     EISSN: None     Source Type: Journal    
DOI: 10.11613/BM.2014.027     Document Type: Article

References (36)

1. De la Fuente Capdevila B, García Vitoria M, Ricós Aguilá C, Ventura Solà MC, Gimferrer Campmajó M, Berlanga Caro R, et al. [Laboratory medicine and process quality management]. Quim Clin 2003; 22: 44-7. (In Spanish).
2. ISO 15189: 2007. Medical laboratories. Particular requirements for quality and competence.
3. The European Health Committee. Committee of experts on management of safety and quality in healthcare. [Prevention of adverse effects in healthcare: a system approach]. Council of Europe CDSP (2004) 41. Strasbourg, 2004. (In Spanish).
4. AENOR. [Quality control and quality assurance UNE 8402: 1995]. Madrid: AENOR, 1995. (In Spanish).
5. Westgard JO. Historical perspective on laboratory QC: Where we've been and where we're going. Available at: http://www. westgard. com/history-and-future-of-qc/pdf. htm. Accessed July 25, 2012.
6. CLSI. Laboratory Quality Control Based on Risk Management; Approved Guideline. CLSI document. EP23-A. Wayne, PA: Clinical and Laboratory Standards Institute, 2011.
7. Nichols JH. Laboratory quality control based on risk management. Ann Saudi Med 2011; 31: 223-8. http://dx. doi. org/10. 4103/0256-4947. 81526.
8. Malone B. A new approach to quality control-How can risk management help labs? Clinical Laboratory News 2011; 37: 11. Available at: http://www. aacc. org/publications/cln/2011/november/Pages/ANewApproachtoQualityControl. aspx. Accessed October 30, 2012.
9. Technical Specification ISO/TS 22367: 2008. Medical Laboratories-Reduction of error through risk management and continual improvement.
10. Kenny D, Fraser CG, Petersen PH, Kallner A. Strategies to set global analytical quality specifications in laboratory medicine-consensus agreement. Scand J Clin Lab Invest 1999; 59: 585.
11. Buño A, Calafell R, Morancho J, Ramón F, Ricos C, Salas A. [Consensus on minimum specifications for analytic quality]. Lab Cli 2008; 1: 35-9. (In Spanish).
12. Calafell R, Gutierrez G, Jou JM, Morancho J, Ramón F, Ricós C, et al. [Consensus on the minimum analytical quality specifications for haematology and special biochemistry parameters]. Lab Cli 2010; 3: 87-93. (In Spanish).
13. Plebani M, Carraro P. Mistakes in a stat laboratory: types and frequency. Clin Chem 1997; 43: 1348-51.
14. Wiwanitkit V. Types and frequency of preanalytical mistakes in the first Thai ISO 9002: 1994 certified clinical laboratory, a 6 month monitoring. BMC Clin Pathol 2001; 1: 5. http://dx. doi. org/10. 1186/1472-6890-1-5.
15. Carraro P, Plebani M. Errors in a Stat Laboratory: Types and Frequencies 10 Years Later. Clin Chem 2007; 53: 1338-42. http://dx. doi. org/10. 1373/clinchem. 2007. 088344.
16. Lippi G, Blanckaert N, Bonini P, Sol G, Kitchen S, Palicka V, et al. Causes, consequences, detection, and prevention of identification errors in laboratory diagnostics. Clin Chem Lab Med 2009; 47: 143-53. http://dx. doi. org/10. 1515/CCLM. 2009. 045.
17. Giménez A, Molina P, Ruiz JJ, Acosta F, López M, Jiménez M, et al. [Application of failure mode and effects analysis of the pre-analytical phase in a clinical laboratory]. Lab Cli 2010; 3: 161-70. (In Spanish).
18. ISO 9000: 2005. Quality management systems. Fundamentals and vocabulary.
19. Westgard JO. Six Sigma Calculators. Available at: http://www. westgard. com/six-sigma-calculators-2. htm. Accessed July 25, 2012.
20. Westgard JO. Six Sigma Quality Design and Control: Desirable precision and requisite QC for laboratory measurement processes. 2nd ed. Madison, WI: Westgard QC Inc; 2006, 338 pp.
21. Govindarajan, R. [Healthcare disorder can be cured: from patient safety to the sustainability of the healthcare system through process-focused management]. 1st Ed. Barcelona: Marge Médica Books; 2009. (In Spanish).
22. Boone DJ. How can we make laboratory testing safer? Clin Chem Lab Med 2007; 45: 708-11. http://dx. doi. org/10. 1515/CCLM. 2007. 169.
23. Plebani M, Ceriotti F, Messeri G, Ottomano C, Pansini N, Bonini P. Laboratory network of excellence: Enhancing patient safety and service effectiveness. Clin Chem Lab Med 2006; 44: 150-60. http://dx. doi. org/10. 1515/CCLM. 2006. 028.
24. Shahangian S, Snyder SR. Laboratory medicine quality indicators: A review of the literature. Am J Clin Pathol 2009; 131: 418-31. http://dx. doi. org/10. 1309/AJCPJF8JI4ZLDQUE.
25. Wagar EA, Tamashiro L, Yasin B, Hilborne L, Bruckner DA. Patient safety in the clinical laboratory. A longitudinal analysis of specimen identification errors. Arch Pathol Lab Med 2006; 130: 1662-8.
26. Ricós C, García Victoria M, De la Fuente B. Quality indicators and specifications for the extra-analytical phases in clinical laboratory management. Clin Chem Lab Med 2004; 42: 578-82. http://dx. doi. org/10. 1515/CCLM. 2004. 100.
27. Llopis MA, Trujillo G, Llovet MI, Tarrés E, Ibarz M, Biosca C et al. Quality indicators and specifications for key analytical-extranalytical processes in the clinical laboratory. Five years' experience using the Six Sigma concept. Clin Chem Lab Med 2011; 49: 463-70. http://dx. doi. org/10. 1515/CCLM. 2011. 067.
28. Carraro P, Zago T, Plebani M. Exploring the initial steps of the testing process: Frequency and nature of pre-preanalytic errors. Clin Chem 2012; 58: 638-42. http://dx. doi. org/10. 1373/clinchem. 2011. 175711.
29. Beletic A, Sumarac Z, Milinkovic N, Ignjatovic S, Majkic-Singh N. Experience in introduction of quality indicators in pre-analytical phase. 2nd EFLM-BD European Conference on Preanalytical Phase. Biochem Med 2013; 23: A46.
30. Gras JM, Philipe M. Application of the Six Sigma concept in clinical laboratories: a review. Clin Chem Lab Med 2007; 45: 786-96. http://dx. doi. org/10. 1515/CCLM. 2007. 135.
31. Iren Emekli D, Aslan D, Zorbozan N. Six Sigma in the preanalytical phase for continuous quality improvement in clinical laboratories. 2nd EFLM-BD European Conference on Preanalytical Phase. Biochem Med 2013; 23: A11.
32. Sciacovelli L, O'Kane M, Skaik YA, Caciagli P, Pellegrini C, Rin GD, et al. 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. http://dx. doi. org/10. 1515/CCLM. 2011. 128.
33. Carraro P, Servidio G, Plebani M. Hemolyzed Specimens: A Reason for Rejection or a Clinical Challenge? [Letter] Clin Chem 2000; 46: 306-7.
34. Lippi G, Bassi A, Brocco G, Montagnana M, Salvagno GL, Guidi GC. Preanalytic error tracking in a laboratory medicine department: results of a 1-year experience. Clin Chem 2006; 52: 1442-3. http://dx. doi. org/10. 1373/clinchem. 2006. 069534.
35. Lippi G, Guidi GC. Risk management in the preanalytical phase of laboratory testing. Clin Chem Lab Med 2007; 45: 720-7. http://dx. doi. org/10. 1515/CCLM. 2007. 167.
36. Plebani M, Chioza ML, Sciacovelli L. Towards harmonization of quality indicators in laboratory medicine. Clin Chem Lab Med 2013; 51: 187-95. http://dx. doi. org/10. 1515/cclm-2012-0582.