Statistical process monitoring of WBC-reduced blood components assessed by two types of software

Statistical process control is required for monitoring of the WBC-reduction process. This study focused on some factors that may influence the outcomes of statistical process monitoring, such as WBC-reduction technologies, the anticoagulant used, and WBC-counting technologies, by using two types of software.

Data were collected from January to September 1999, before the implementation of universal WBC reduction. The effects of three major factors were investigated: methods of preparation, the addition of EDTA to the sample, and the WBC-counting technologies used (microvolume fluorimetry, flow cytometry, and Nageotte chamber). The WBC-reduction process capability was assessed by two types of software, EZQC (Gambro BCT) and NWA (Northwest Analytical). In addition, the differences between various sets of results were compared by the t test or ANOVA.

There was no statistical difference (at the 0.05 level of significance) in WBC content when the three types of platelets in citrate samples were compared with EDTA samples. In general, the Nageotte chamber appeared to count the lowest, and microvolume fluorimetry appeared to count lower than flow cytometry. There were minor but significant methodologic differences between the software packages. However, these differences had negligible effects on the percentage of conforming components at both <1 x 10(6) and <5 x 10(6) WBCs per unit.

Only the counting technologies were sufficiently different to warrant consideration. This difference may make unacceptable the interchange of results obtained from various counting methods.