Impact of Individualized Hemolysis Management Based on Biological Variation Cut-offs in a Clinical Laboratory
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Background: Hemolysis is the most common type of preanalytical interference. Cut-offs based on the hemolysis index level can be established using different approaches. The Working Group for Preanalytical Phase of the European Federation of Laboratory Medicine has developed a protocol for hemolysis management based on cut-offs estimated from biological variation (BV) and the use of interpretative comments. We developed and assessed the implementation of the protocol in our laboratory. Methods: Hemolysates from whole blood were prepared following the Meites method, and pooled serum samples with known Hb concentrations were prepared. For each analyte (42 ), interferograms were generated and used to establish cut-offs: desirable analytical quality specification and reference change value. This protocol was assessed, both pre- and post-implementation, according to expert rules in the Laboratory Information System. Results: Among the analytes evaluated, we selected those that showed the highest degree of hemolysis interference: lactate dehydrogenase (LDH), aspartate aminotransferase, direct bilirubin, potassium, and folic acid. The cut-offs for LDH and direct bilirubin were the lowest. Only 28.16% of all LDH values were adequately reported in the pre-implantation retrospective study, but this percentage improved in the post-implementation stage. Conclusions: The development and implementation of a harmonized protocol for hemolysis management based on BV cut-offs and result reporting significantly improve hemolysis detection and lead to a decrease in the number of hemolyzed samples over time.
Abstract
Background: Hemolysis is the most common type of preanalytical interference. Cut-offs based on the hemolysis index level can be established using different approaches. The Working Group for Preanalytical Phase of the European Federation of Laboratory Medicine has developed a protocol for hemolysis management based on cut-offs estimated from biological variation (BV) and the use of interpretative comments. We developed and assessed the implementation of the protocol in our laboratory. Methods: Hemolysates from whole blood were prepared following the Meites method, and pooled serum samples with known Hb concentrations were prepared. For each analyte (42 ), interferograms were generated and used to establish cut-offs: desirable analytical quality specification and reference change value. This protocol was assessed, both pre- and post-implementation, according to expert rules in the Laboratory Information System. Results: Among the analytes evaluated, we selected those that showed the highest degree of hemolysis interference: lactate dehydrogenase (LDH), aspartate aminotransferase, direct bilirubin, potassium, and folic acid. The cut-offs for LDH and direct bilirubin were the lowest. Only 28.16% of all LDH values were adequately reported in the pre-implantation retrospective study, but this percentage improved in the post-implementation stage. Conclusions: The development and implementation of a harmonized protocol for hemolysis management based on BV cut-offs and result reporting significantly improve hemolysis detection and lead to a decrease in the number of hemolyzed samples over time.
참고문헌 (24)
- Goyal T, "Validation of hemolysis index thresholds optimizes detection of clinically significant hemolysis", Am J Clin Pathol, 143, pp.579~583 (2015)
- Lippi G, "Haemolysis : an overview of the leading cause of unsuitable specimens in clinical laboratories", Clin Chem Lab Med, 46, pp.764~772 (2008)
- Plebani M, "The detection and prevention of errors in laboratory medicine", Ann Clin Biochem, 47, pp.101~110 (2010)
- Plebani M, "Closing the brain-to-brain loop in laboratory testing", Clin Chem Lab Med, 49, pp.1131~1133 (2011)
- Farrell CJ, "Serum indices : managing assay interference", Ann Clin Biochem, 53, pp.527~538 (2016)
- Marqués-García F, "Methods for hemolysis interference study in laboratory medicine-a critical review", EJIFCC, 31, pp.85~97 (2020)
- Minović Isidor, "Interpretation of Folate Results in Hemolytic Plasma Samples: A Practical Approach", Annals of Laboratory Medicine, 41(5), pp.485~488 (2021), 대한진단검사의학회[DOI]
- Howanitz PJ, "Clinical laboratory quality practices when hemolysis occurs", Arch Pathol Lab Med, 139, pp.901~906 (2015)
- Luksic AH, "Visual assessment of hemolysis affects patient safety", Clin Chem Lab Med, 56, pp.574~581 (2018)
- Dupuy AM, "Determination of hemolysis cut-offs for biochemical and immunochemical analytes according to their value", Clin Chem Lab Med, 58, pp.1232~1241 (2020)
- Gils C, "Verification of the hemolysis index measurement: imprecision, accuracy, measuring range, reference interval and impact of implementing analytically and clinically derived sample rejection criteria", Scand J Clin Lab Invest, 80, pp.580~589 (2020)
- Turbidity Indices as Indicators of interference in Clinical Laboratory Analysis: Approved Guideline, "Haemolysis, Icterus, and Lipemia", pp.2012, CLSI
- Lippi G, "Practical recommendations for managing hemolyzed samples in clinical chemistry testing", Clin Chem Lab Med, 56, pp.718~727 (2018)
- Meites S, "Letter: Reproducibly simulating hemolysis, for evaluating its interference with chemical methods", Clin Chem, 19, pp.1319~ (1973)
- Glick MR, "Graphical comparisons of interferences in clinical chemistry instrumentation", Clin Chem, 32, pp.470~475 (1986)
- Pum JKW, "Evaluating sample stability in the clinical laboratory with the help of linear and non-linear regression analysis", Clin Chem Lab Med, 58, pp.188~196 (2020)
- Aarsand AK, "Harmonization initiatives in the generation, reporting and application of biological variation data", Clin Chem Lab Med, 56, pp.1629~1636 (2018)
- "Biological variation database and quality specifications for imprecision, bias and total error (desirable and minimum). The 2014 update" (2020)[URL]
- "The EFLM Biological Variation Database" (2021)[URL]
- Wan Azman WN, "Hemolyzed specimens : major challenge for identifying and rejecting specimens in clinical laboratories", Oman Med J, 34, pp.94~98 (2019)
- CLSI, "Interference testing in clinical chemistry" (2021), Clinical and Laboratory Standards Institute
- Plebani M, "Corrigendum to : Performance criteria and quality indicators for the pre-analytical phase", Clin Chem Lab Med, 53, pp.1653~ (2015)
- Sciacovelli L, "Quality indicators in laboratory medicine : the status of the progress of IFCC working group"Laboratory Errors and Patient Safety"project", Clin Chem Lab Med, 55, pp.348~357 (2017)
- Zaninotto M, "Effects of sample transportation on commonly requested laboratory tests", Clin Chem Lab Med, 50, pp.1755~1760 (2012)