title: Harmonization in hemolysis detection and prevention. A working group of the Catalonian Health Institute (ICS) experience.
abstract: BACKGROUND
  Hemolysis is the main cause of non-quality samples in clinical laboratories, producing the highest percentage of rejections in the external assurance programs of preanalytical quality. The objective was to: 1) study the agreement between the detection methods and quantification of hemolysis; 2) establish comparable hemolysis interference limits for a series of tests and analytical methods; and 3) study the preanalytical variables which most influence hemolysis production.
  
  
  METHODS
  Different hemoglobin concentration standards were prepared using the reference method. Agreement was studied between automated methods [hemolytic indexes (HI)] and reference method, as well as the interference according to hemolysis degree in various biochemical tests was measured. Preanalytical variables which could influence hemolysis production were studied: type of extraction, type of tubes, transport time, temperature and centrifugation conditions.
  
  
  RESULTS
  Good agreement was obtained between hemoglobin concentrations measured using the reference method and HI, for the most of studied analyzers, particularly those giving quantitative HI. The hemolysis interference cut-off points obtained for the majority of tests studied (except LDH, K) are dependent on the method/analyzer utilized. Furthermore, discrepancies have been observed between interference limits recommended by the manufacturer. The preanalytical variables which produce a lower percentage of hemolysis rejections were: centrifugation at the extraction site, the use of lower volume tubes and a transport time under 15 min at room temperature.
  
  
  CONCLUSIONS
  The setting of interference limits (cut-off) for each used test/method, and the study of preanalytical variability will assist to the results harmonization for this quality indicator.
authors.forename: Pilar
authors.initials: P
authors.lastname: Fernandez
authors.forename: María Antonia
authors.initials: MA
authors.lastname: Llopis
authors.forename: Carmen
authors.initials: C
authors.lastname: Perich
authors.forename: Maria Jesús
authors.initials: MJ
authors.lastname: Alsina
authors.forename: Virtudes
authors.initials: V
authors.lastname: Alvarez
authors.forename: Carmen
authors.initials: C
authors.lastname: Biosca
authors.forename: Gloria
authors.initials: G
authors.lastname: Busquets
authors.forename: Maria Vicenta
authors.initials: MV
authors.lastname: Domenech
authors.forename: Rubén
authors.initials: R
authors.lastname: Gómez
authors.forename: Isabel
authors.initials: I
authors.lastname: Llovet
authors.forename: Joana
authors.initials: J
authors.lastname: Minchinela
authors.forename: Rosa
authors.initials: R
authors.lastname: Pastor
authors.forename: Rosa
authors.initials: R
authors.lastname: Ruiz
authors.forename: Ester
authors.initials: E
authors.lastname: Tarrés
authors.forename: Mercè
authors.initials: M
authors.lastname: Ibarz
authors.forename: Margarita
authors.initials: M
authors.lastname: Simón
authors.forename: Mercè
authors.initials: M
authors.lastname: Montesinos
mesh_terms: D001331:Automation; D006403:Hematologic Tests / Q000295:instrumentation / Q000379:methods*; D006454:Hemoglobins / Q000032:analysis*; D006461:Hemolysis; D006801:Humans; D007753:Laboratories / Q000592:standards*; D016017:Odds Ratio
chemical_list: D006454:Hemoglobins