Harmonization in hemolysis detection and prevention. A working group of the Catalonian Health Institute (ICS) experience

Pilar Fernandez; María Antonia Llopis; Carmen Perich; Maria Jesús Alsina; Virtudes Alvarez; Carmen Biosca; Gloria Busquets; Maria Vicenta Domenech; Rubén Gómez; Isabel Llovet; Joana Minchinela; Rosa Pastor; Rosa Ruiz; Ester Tarrés; Mercè Ibarz; Margarita Simón; Mercè Montesinos

doi:10.1515/cclm-2013-0935

Article

Harmonization in hemolysis detection and prevention. A working group of the Catalonian Health Institute (ICS) experience

Pilar Fernandez , María Antonia Llopis , Carmen Perich , Maria Jesús Alsina , Virtudes Alvarez , Carmen Biosca , Gloria Busquets , Maria Vicenta Domenech , Rubén Gómez , Isabel Llovet , Joana Minchinela , Rosa Pastor , Rosa Ruiz , Ester Tarrés , Mercè Ibarz , Margarita Simón and Mercè Montesinos

Published/Copyright: June 4, 2014

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 52 Issue 11

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.

Keywords: hemolysis index; preanalytical errors; quality specifications; quality indicators

Corresponding author: Carmen Perich, Laboratori Clínic Bon Pastor, Mollerusa s/n, Barcelona 08030, Spain, E-mail: cperich.bcn.ics@gencat.cat

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Received: 2013-10-31

Accepted: 2014-4-25

Published Online: 2014-6-4

Published in Print: 2014-11-19

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Articles in the same Issue

https://doi.org/10.1515/cclm-2013-0935

Keywords for this article

hemolysis index; preanalytical errors; quality specifications; quality indicators