Manual handling of hemolyzed samples is not standardized and is vulnerable to errors. This study aimed to evaluate laboratory errors due to manual handling of hemolyzed samples and to assess the risk they might have for patient safety.
Data were retrospectively obtained from a laboratory information system for 25 emergency tests from hemolyzed samples. Hemolysis (concentration of free hemoglobin >0.5 g/L) was visually assessed by comparison with a color chart. The reference person reestimated the routinely assessed degree of hemolysis to all samples (n=3185) received in the laboratory in a 1-week period. For each test, the correct and incorrect way of handling results was determined. Risk assessment was performed according to ISO 14971 standard with five categories of risk (S1–S5) and error occurrence (O1–O5).
In the studied period, the emergency laboratory received 495 hemolyzed samples (15.5%) with a total of 2518 laboratory test requests (15.5%): 102 (20.6%) of the reports from hemolyzed samples had a comment on hemolysis; 31% of the test results were handled incorrectly (20.7% due to the incorrect release of the test result despite hemolysis interference and 10.3% due to unnecessary suppression), accounting for 4.8% of the total test volume. Tests with the highest combination of risk and occurrence rate were troponin T, potassium and total bilirubin.
Manual handling of hemolyzed samples may lead to risk of errors in reporting results for troponin T, potassium and total bilirubin, which may have an effect on clinical decision. In addition, unnecessary suppression of the sample results unaffected by hemolysis could affect patient outcome.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
1. Milutinovic D, Andrijevic I, Licina M, Andrijevic LJ. Confidence level in venipuncture and knowledge on causes of in vitro hemolysis among healthcare professionals. Biochem Med 2015;25:401–9.10.11613/BM.2015.040Search in Google Scholar PubMed PubMed Central
2. Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem 2007;53:1338–42.10.1373/clinchem.2007.088344Search in Google Scholar PubMed
3. Lippi G, Blanckaert N, Bonini P, Green S, Kitchen S, Palicka V, et al. Haemolysis: an overview of the leading cause of unsuitable specimens in clinical laboratories. Clin Chem Lab Med 2008;46:764–72.10.1515/CCLM.2008.170Search in Google Scholar PubMed
4. Lippi G, Plebani M, Di Somma S, Cervellin G. Hemolyzed specimens: a major challenge for emergency departments and clinical laboratories. Crit Rev Clin Lab Sci 2011;48:143–53.10.3109/10408363.2011.600228Search in Google Scholar PubMed
5. Simundic AM, Nikolac N, Ivankovic V, Ferenec-Ruzic D, Magdic B, Kvaternik M, et al. Comparison of visual vs. automated detection of lipemic, icteric and hemolyzed specimens: can we rely on a human eye? Clin Chem Lab Med 2009;47:1361–5.10.1515/CCLM.2009.306Search in Google Scholar PubMed
6. Jeffery J, Sharma A, Ayling RM. Detection of haemolysis and reporting of potassium results in samples from neonates. Ann Clin Biochem 2009;46:222–5.10.1258/acb.2009.008241Search in Google Scholar PubMed
7. Dolci A, Panteghini M. Harmonization of automated hemolysis index assessment and use: is it possible? Clin Chim Acta 2014;15:38–43.10.1016/j.cca.2013.10.012Search in Google Scholar PubMed
8. Lippi G, Banfi G, Church S, Cornes M, De Carli G, Grankvist K, et al. Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE). Clin Chem Lab Med 2015;53:357–70.10.1515/cclm-2014-1051Search in Google Scholar PubMed
9. BSI British Standards. BS EN ISO 14971: Medical devices—application of risk management to medical devices, 2009.Search in Google Scholar
10. Hrvatska komora medicinskih biokemicara. Povjerenstvo za strucna pitanja. Available at: http://www.hkmb.hr/povjerenstva/strucna-pitanja/. Accessed 17 May 2016.Search in Google Scholar
11. Glick MR, Ryder KW, Glick SJ, Woods JR. Unreliable visual estimation of the incidence and amount of turbidity, hemolysis, and icterus in serum from hospitalized patients. Clin Chem 1989;35:837–9.10.1093/clinchem/35.5.837Search in Google Scholar
12. Hawkins RC. Discrepancy between visual and spectrophotometric assessment of sample hemolysis. Ann Clin Biochem 2002;39:521–2.10.1258/000456302320314575Search in Google Scholar PubMed
13. Asirvatham JR, Moses V, Bjorson L. Errors in potassium measurement: a laboratory perspective for the clinician. N Am J Med Sci 2013;5:255–9.10.4103/1947-2714.110426Search in Google Scholar PubMed PubMed Central
14. Bilic-Zulle L, Simundic AM, Supak-Smolcic V, Nikolac N, Honovic L. Self reported routines and procedures for the extraanalytical phase of laboratory practice in Croatia – crosssectional survey study. Biochem Med 2010;20:64–74.10.11613/BM.2010.008Search in Google Scholar
15. Nikolac N, Lenicek Krleza J, Simundic AM. Preanalytical external quality assessment of the Croatian Society of Medical Biochemistry and Laboratory Medicine and CROQALM: finding undetected weak spots. Biochem Med 2017;27:131–43.10.11613/BM.2017.017Search in Google Scholar PubMed PubMed Central
16. Lyon ME, Ball CL, Krause RD, Slotsve GA, Lyon AW. Effect of hemolysis on cardiac troponin T determination by the Elecsys 2010 immunoanalyzer. Clin Biochem 2004;37:698–701.10.1016/j.clinbiochem.2004.03.002Search in Google Scholar PubMed
17. Sodi R, Darn SM, Davison AS, Stott A, Shenkin A. Mechanism of interference by haemolysis in the cardiac troponin T immunoassay. Ann Clin Biochem 2006;43:49–56.10.1258/000456306775141687Search in Google Scholar PubMed
18. Algeciras-Schimnich A, Cook WJ, Milz TC, Saenger AK, Karon BS. Evaluation of hemoglobin interference incapillary heel-stick samples collected for determination of neonatal bilirubin. Clin Biochem 2007;40:1311–6.10.1016/j.clinbiochem.2007.08.003Search in Google Scholar PubMed
19. Simundic AM, Topic E, Nikolac N, Lippi G. Hemolysis detection and management of hemolysed specimens. Biochem Med 2010;20:154–9.10.11613/BM.2010.018Search in Google Scholar
20. Nikolac N, Celap I, Filipi P, Hemar M, Kocijancic M, Miler M, et al. Croatian laboratories have a good knowledge of the proper detection and management of hemolyzed, icteric and lipemic samples. Clin Chem Lab Med 2016;54:419–25.10.1515/cclm-2015-0650Search in Google Scholar PubMed
©2018 Walter de Gruyter GmbH, Berlin/Boston