Sysmex Journal International

2005Vol.15 No.1


Comparison of Technical Validation before and after Implementation of the Work Area Manager SIS 2.0 with Standard Rule Package



*1 Division of Haematology and Central Haematology Laboratory
*2 Sysmex Europe GmbH


Objectives : To evaluate the work area manager “ Sysmex Information System ( SIS ) 2.0 standard rules ” for standardizing technical validation of the SYSMEX automated haematology analyser XE-2100 results in a medium sized hospital.

Methods : First we compared the validation time of the results ( turn-around time, TAT ) for 2 months before ( previous validation ) and 2 months after implementation ( current validation ) of the SIS standard rule package. The validation time is defined as “ time of the results in laboratory information system ( LIS ) ” minus “ time of measurement in XE-2100 ”. Then we compared the decisions made automatically in SIS with the decisions that were made with the previous validation criteria and we observed the quality of previous and current workflow actions and results. Finally we checked the satisfaction of the medical technologist employees after 3 months working with the SIS 2.0 standard rules work area manager.

Results : The validation time of the results was significantly ( p < 0.0001 ) lower in the two months following introduction of the SIS 2.0 standard rules work area manager. There was a decrease in validation time with SIS which averaged 8.5 minutes for CBC ( complete blood cell count ) results and 37.7 minutes for CBC+DIFF ( complete blood cell count plus leucocyte differential ). Ninety-five percent ( 95% ) of total validated samples were 27.8 minutes faster validated with SIS for CBC and 179.8 minutes for CBC+DIFF. The total decreased time per month with SIS was more then 700 hours for CBC and over 500 hours for CBC+DIFF. The total positive data checks and actions ( repeat sample, nucleated red blood cell count, platelet optical count and smear ) were clearly decreased to clinically relevant actions, with more specific information about the cause of the unreliable results. Only NRBC ADD ( additional NRBC count ) order was increased with the SIS rules. The quality of actions and results decided by SIS standard rules are in general at least as good as with the previous procedure. Shortly after SIS introduction acceptance of the SIS standard rules was very high. The SIS standard rules were found in general helpful both in night and day shifts, fast, safe and, most importantly, they were standardized.

Conclusions : The SIS software shows improvements in turn-around time ( TAT ) of validated results, and shows very user-friendly, standardized, specific positive results and actions with no loss of quality. It is interesting that very soon after introduction almost all laboratory technicians accepted the SIS software.

We will continue our studies to suggest further improvements ( NRBC rule ) and adapt our parameters to satisfy our requirements.


Work Area Manager SIS, Standard Rules, Technical Validation Criteria, Standardization, Automated Hematology Analyzer, XE-2100