title: Harmonization of automated hemolysis index assessment and use: Is it possible?
abstract: The major source of errors producing unreliable laboratory test results is the pre-analytical phase with hemolysis accounting for approximately half of them and being the leading cause of unsuitable blood specimens. Hemolysis may produce interference in many laboratory tests by a variety of biological and analytical mechanisms. Consequently, laboratories need to systematically detect and reliably quantify hemolysis in every collected sample by means of objective and consistent technical tools that assess sample integrity. This is currently done by automated estimation of hemolysis index (HI), available on almost all clinical chemistry platforms, making the hemolysis detection reliable and reportable patient test results more accurate. Despite these advantages, a degree of variability still affects the HI estimate and more efforts should be placed on harmonization of this index. The harmonization of HI results from different analytical systems should be the immediate goal, but the scope of harmonization should go beyond analytical steps to include other aspects, such as HI decision thresholds, criteria for result interpretation and application in clinical practice as well as report formats. With regard to this, relevant issues to overcome remain the objective definition of a maximum allowable bias for hemolysis interference based on the clinical application of the measurements and the management of unsuitable samples. Particularly, for the latter a recommended harmonized approach is required when not reporting numerical results of unsuitable samples with significantly increased HI and replacing the test result with a specific comment highlighting hemolysis of the sample.
authors: Clinical Chemistry Laboratory, University Hospital "Luigi Sacco", Milan, Italy. Electronic address: dolci.alberto@hsacco.it.
authors: Alberto
authors: A
authors: Dolci
authors: Clinical Chemistry Laboratory, University Hospital "Luigi Sacco", Milan, Italy; Centre for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan, Milan, Italy.
authors: Mauro
authors: M
authors: Panteghini
mesh_terms: D001331:Automation; D003627:Data Interpretation, Statistical; D006405:Hematology / Q000592:standards*; D006461:Hemolysis; D006801:Humans; D019300:Medical Errors; D011786:Quality Control; D012015:Reference Standards
keywords: Hemolysis; Maximum allowable bias; Pre-analytical phase; Serum indices