RRML - Quality Control Strategy for Automated CBC: A Laboratory Point of View Deducted from an Internal Study Organised in an Emergency Laboratory
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Concept, Design & Programming
Dr. Adrian Man

   
 
Nr. 28(1)/2020 DOI:10.2478/rrlm-2020-0012
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Original professional paper

Quality Control Strategy for Automated CBC: A Laboratory Point of View Deducted from an Internal Study Organised in an Emergency Laboratory

Oana Roxana Oprea, Adina Hutanu, Oana Pavelea, David Robert Kodori, Minodora Dobreanu

Correspondence should be addressed to: Adina Hutanu

Abstract:

Introduction: The aim of this study was to determine the performance of the total testing process of complete blood count (CBC) on two different instruments in an emergency setting of a county hospital, and to design an appropriate internal quality control plan. Materials and method: Two models of Statistical Quality Control (SQC) were evaluated on Sysmex XT-1800i and Cell-Dyne Ruby: 3 levels of commercial blood every 8 hours (N=9) and an alternative model using 3 levels every 12 hours (N=6) as shift changes. Total Error (TE) was calculated using the formula: TE=Bias%+1.65xCV%; Sigma score was calculated using the formula: Sigma=[(TEa%–Bias%]/CV%. Values for coefficient of variation (CV%) and standard deviation (SD) were obtained from laboratory data and Bias% from proficiency testing. For the pre-analytical phase Sigma score was calculated, while for post-analytical phase the turnaround time (TAT) was assessed. Results: TE for all directly measured parameters, for both instruments, had lower values than Total Error allowable (TEa). CV% for almost all parameters had lower values than CV% derived from biological variation except for platelets (PLT) at low level on Sysmex XT-1800i and red blood cells (RBC) on Cell-Dyne Ruby. Sigma score ranged from as low as 2 to 10. Sigma score for pre-analytical phase was 4.2 and turnaround time was 36 minutes on average. Conclusions: Given the performances of the total testing process implemented for CBC in our laboratory, performing the internal control after every 50 samples/batch seems to fulfill both the Health Ministry Order (HMO) 1301/2007 and International Organization for Standardization ISO 15189:2013 recommendation. All quality instruments must work together to assure better patient results and every laboratory should design its own control plan that is appropriate for better quality achievement.

Keywords: quality control, Six-Sigma, moving average, Total Error, Bull’s algorithm

Received: 5.9.2019
Accepted: 22.1.2020
Published: 23.1.2020

 
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How to cite
Oprea OR, Hutanu A, Pavelea O, Kodori DR, Dobreanu M. Quality Control Strategy for Automated CBC: A Laboratory Point of View Deducted from an Internal Study Organised in an Emergency Laboratory. Rev Romana Med Lab. 2020;28(1):19-27. DOI:10.2478/rrlm-2020-0012