The results demonstrate that a Model of Quality Indicators managed as an External Quality Assurance Program can serve as a tool to monitor and control the pre-, intra- and post-analytical activities. It might also allow clinical laboratories to identify risks that lead to errors resulting in patient harm: identification and design of practices that eliminate medical errors; the sharing of information and education of clinical and laboratory teams on practices that reduce or prevent errors; the monitoring and evaluation of improvement activities.
The Sysmex XS-1000i is a compact new, fully automated haematology analyser, designed to generate complete blood counts with five-part leucocyte differential. In our study, a Sysmex XS-1000i instrument was evaluated according to Clinical Laboratory Standards Institute (CLSI) and International Council for Standardization in Haematology (ICSH) guidelines. Precision, carry-over and linearity were determined. Using a total of 700 patient samples, results from the Sysmex XS-1000i were compared with those from a Sysmex XE-2100, an Abbott Cell Dyn 4000 and the manual reference leucocyte differential. Using quality control material, total and within-run imprecision was less than 3% except for platelets. The system demonstrated good linearity over the entire reporting range and no carry-over (<0.5%). The Sysmex XS-1000i showed good correlation with XE-2100, CD-4000 and the manual reference leucocyte differential. Overall flagging sensitivity and specificity were 91% and 48%, respectively. In conclusion, the Sysmex XS-1000i demonstrated good analytical performance, is able to generate a complete blood count with five-part differential on low blood volumes and has considerable back-up capacity.
In the context of diagnosing cytopenia due to myelosuppressing agents or leukocytosis due to infection, the XP-300 showed good analytical performance. However, in the thrombocytopenic range, precision was suboptimal. In follow-up of hematological malignancies with the occurrence of abnormal cells, we advise verification with a more advanced analyzer or with microscopic review, although further studies with a higher prevalence of abnormal cells are needed.
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