Accessible Requires Authentication Published by De Gruyter September 30, 2015

Croatian laboratories have a good knowledge of the proper detection and management of hemolyzed, icteric and lipemic samples

Nora Nikolac, Ivana Celap, Petra Filipi, Marina Hemar, Marija Kocijancic, Marijana Miler, Ana-Maria Simundic, Vesna Supak Smolcic and Alen Vrtaric

Abstract

Background: Endogenous interferences are an important source of biased laboratory results. Hemolysis, lipemia and icteria are the main source of endogenous interference in laboratory medicine. Accreditation according to ISO 15189 improves the overall quality of the laboratory procedures. The aim of our study was i) to assess the level of knowledge of Croatian medical biochemists about the proper detection and management of hemolysis, lipemia and icteria; and ii) to identify possible differences in the level of knowledge respective to the laboratory accreditation status.

Methods: An on-line self-report survey was carried out by the Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine during April to May 2015. Survey included 14 statements (Q1–Q14) about procedures for samples with interferences and participants were asked to assess the degree of agreement with the statement using a 4-point Likert scale.

Results: The lowest level of knowledge was observed for statements Q10 (dealing with icteric sample; 40.9% participants agreed with the correct procedure), Q12 (allowable error for interference; 47.2%) and Q11 (dealing with lipemic sample; 60.1%). Almost all participants (97.4%) agreed that laboratories in Croatia should have a harmonized protocol for management of samples with interferences. Participants from accredited laboratories showed higher knowledge of hemolysis detection (p=0.031), rejection of hemolyzed sample (p<0.001), management of icteric samples (p=0.038) and allowable error for interferences (p=0.040).

Conclusions: Croatian laboratories have a good knowledge of the proper detection and management of hemolyzed, icteric and lipemic samples. Accreditation is associated with higher knowledge about management of samples with interferences.


Corresponding author: Ivana Celap, University Department of Chemistry, Sestre Milosrdnice University Hospital, Vinogradska 29, Zagreb, Croatia, Phone/Fax: +385-1-3768-280, E-mail: ; and Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia

References

1. Hallworth MJ. The ‘70% claim’: what is the evidence base? Ann Clin Biochem 2011;48:487–8. Search in Google Scholar

2. Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem 2002;48:691–8. Search in Google Scholar

3. Kroll MH, Elin RJ. Interference with clinical laboratory analyses. Clin Chem 1994;40:1996–2005. Search in Google Scholar

4. Agarwal S, Vargas G, Nordsrtom C, Tam E, Buffone GJ, Devaraj S. Effect of interference from hemolysis. Icterus and lipemia on routine pediatric clinical chemistry assays. Clin Chim Acta 2015;438:241–5. Search in Google Scholar

5. Ji JZ, Meng QH. Evaluation of the interference of haemoglobin, bilirubin, and lipids on Roche Cobas 6000 assays. Clin Chim Acta 2011;412:1550–3. Search in Google Scholar

6. Simundic AM, Nikolac N, Vukasovic I, Vrkic N. The prevalence of preanalytical errors in Croatian ISO 15189 accredited laboratory. Clin Chem Lab Med 2010;48:1009–14. Search in Google Scholar

7. Simundic AM, Topic E, Nikolac N, Lippi G. Hemolysis detection and management of hemolyzed specimens. Biochem Med (Zagreb) 2010;20:154–9. Search in Google Scholar

8. Lippi G, Salvagno GL, Blanckaert N, Giavarina D, Green S, Kitchen S, et al. Multicenter evaluation of the hemolysis index in automated clinical chemistry systems. Clin Chem Lab Med 2009;47:934–9. Search in Google Scholar

9. Clinical Laboratory Standards Institute. Interference testing in clinical chemistry; approved guideline. CLSI EP7-A2 document. Wayne, PA: Clinical Laboratory Standards Institute, 2005. Search in Google Scholar

10. Clinical Laboratory Standards Institute. Hemolysis, icterus, and lipemia/turbidity indices as indicators of interference in clinical laboratory analysis; approved guideline. CLSI C56-A document. Wayne, PA: Clinical Laboratory Standards Institute, 2012. Search in Google Scholar

11. Čvorišćec D. [Hemoliza]. Available from: http://www.hkmb.hr/povjerenstva/strucna-pitanja.html#11. Accessed: 10 Jun, 2015. [In Croatian]. Search in Google Scholar

12. Dukić L, Simundić AM. Institutional practices and policies in acid-base testing: a self reported Croatian survey study on behalf of the Croatian society of medical biochemistry and laboratory medicine Working Group for acid-base balance. Biochem Med (Zagreb) 2014;24:281–92. Search in Google Scholar

13. Biljak VR, Honović L, Matica J, Knežević B, Vojak SŠ. Laboratory diagnostics of chronic kidney disease in Croatia: state of the art. Biochem Med (Zagreb) 2015;25:73–83. Search in Google Scholar

14. Simundic AM, Church S, Cornes MP, Grankvist K, Lippi G, Nybo M, et al. Compliance of blood sampling procedures with CLSI H3-A6 standard for the collection of diagnostic blood specimens by venipuncture and risk assessment analysis: an observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE). Clin Chem Lab Med 2015;53:1321–31. Search in Google Scholar

15. Plebani M, Sciacovelli L, Aita A, Chiozza ML. Harmonization of pre-analytical quality indicators. Biochem Med (Zagreb) 2014;24:105–13. Search in Google Scholar

16. 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. Search in Google Scholar

17. Simundic AM, Cornes M, Grankvist K, Lippi G, Nybo M, Kovalevskaya S, et al. Survey of national guidelines, education and training on phlebotomy in 28 European countries: an original report by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PA). Clin Chem Lab Med 2013;51:1585–93. Search in Google Scholar

18. Zima T. Accreditation in clinical laboratories. Biochem Med (Zagreb) 2010;20:215–20. Search in Google Scholar

19. Ho B, Ho E. The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria. Biochem Med (Zagreb) 2012;22:247–57. Search in Google Scholar

20. Simundic AM, Nikolac N, Ivankovic V, Ferenec-Ruzic D, Magdic B, Kvaternik M, et al. Comparison of visual versus automated detection of lipemic, icteric and hemolyzed specimens: can we rely on a human eye? Clin Chem Lab Med 2009;47:1361–5. Search in Google Scholar

21. Lippi G, Avanzini P, Campioli D, Da Rin G, Dipalo M, Aloe R, et al. Systematical assessment of serum indices does not impair efficiency of clinical chemistry testing: a multicenter testing. Clin Biochem 2013;46:1281–4. Search in Google Scholar

22. Kocak FE, Meral A, Kocak H. Assessment of serum indices implementation on Roche Cobas 6000 analyzer. Eur J Med Sci 2014;1:43–52. Search in Google Scholar

23. Dolci A, Panteghini M. Harmonization of automated hemolysis index assessment and use: Is it possible? Clin Chim Acta 2014;432:38–43. Search in Google Scholar

24. Fliser E, Jerkovic K, Vidovic T, Gorenjak M. Investigation of unusual high serum indices for lipemia in clear serum samples on siemens analysers dimension. Biochem Med (Zagreb) 2012;22:352–62. Search in Google Scholar

25. Fernandez P, Llopis MA, Perich C, Alsina MJ, Alvarez V, Biosca C, et al. Harmonization in hemolysis detection and prevention. A working group of the Catalonian Health Institute (ICS) experience. Clin Chem Lab Med 2014;52:1557–68. Search in Google Scholar

26. Nikolac N, Simundic AM, Miksa M, Lima-Oliveira G, Salvagno GL, Caruso B, et al. Heterogeneity of manufacturers’ declarations for lipemia interference – An urgent call for standardization. Clin Chim Acta 2013;426:33–40. Search in Google Scholar

27. Nikolac N. Lipemia: causes, interference mechanisms, detection and management. Biochem Med 2014;24:57–67. Search in Google Scholar

28. Dimeski G. Interference testing. Clin Biochem Rev 2008;29(Suppl 1):S43–8. Search in Google Scholar

29. Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G, Oosterhuis W, et al. Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med 2015;53:833–5. Search in Google Scholar

30. Szoke D, Braga F, Valente C, Panteghini M. Hemoglobin, bilirubin, and lipid interference on Roche Cobas 6000 assays. Clin Chim Acta 2012;413:339–41; author reply 342–3. Search in Google Scholar

31. Plebani M, Sciacovelli L, Aita A, Pelloso M, Chiozza ML. Performance criteria and quality indicators for the pre-analytical phase. Clin Chem Lab Med 2015;53:943–8. Search in Google Scholar

32. Allen LC. Role of a quality management system in improving patient safety – laboratory aspects. Clin Biochem 2013;46:1187–93. Search in Google Scholar

33. Lippi G, Chance JJ, Church S, Dazzi P, Fontana R, Giavarina D, et al. Preanalytical quality improvement: from dream to reality. Clin Chem Lab Med 2011;49:1113–26. Search in Google Scholar

34. ISO 15189:2012. Medical laboratories – Requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization, 2012. Search in Google Scholar

Received: 2015-7-9
Accepted: 2015-8-28
Published Online: 2015-9-30
Published in Print: 2016-3-1

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