External quality assessment of automated hematology analyzer performance using fresh human blood samples in Shanghai.

We set out to assess the performance and degree of agreement for the different automated hematology analyzers (AHAs) currently used within the Shanghai region. Analyzers from 5 different manufacturers were represented within the 114 hospitals that participated in this project: Abbott, ABX, Beckman Coulter, Nihon Kohden, and Sysmex. We determined the results obtained on 115 hematology analyzers in the 114 different hospitals for hemoglobin (HGB), red blood cell count (RBC), white blood cell count (WBC), hematocrit (HCT), and platelet count (PLT) from fresh anticoagulated blood samples from healthy donors. The maximum coefficients of variation (CV%) among instruments of the 3 main manufacturers (Abbott, Beckman Coulter, and Sysmex) for RBC, HGB, HCT, WBC, and PLT were 3.2%, 3.8%, 3.6%, 9.3%, and 10.8%, respectively. The maximum deviations observed among these parameters from the 5 major instrument groups were 0.74% (RBC), 2.24% (HGB), 6.37% (HCT), 6.97% (WBC), and 21.06% (PLT). Implementation of the regular, local external quality assessment program in the Shanghai region using fresh blood samples has resulted in a reduction of CV% values for the major clinically important CBC parameters (RBC, HGB, HCT, WBC, and PLT) within the instrument groups over time. An important result was that the CBC parameter CVs were also well within established US Clinical Laboratory Improvement Amendments of 1988 guidelines for AHA performance. Combined with a comprehensive education program, the Shanghai external fresh blood quality assessment program has resulted in closer agreement among the various AHA manufacturers, with only very small differences for RBC, HGB, HCT, WBC, and PLT counts. The success of this program has given us increased confidence in the comparability of results and subsequent patient management using the various types of AHAs currently in use in the hospitals within the Shanghai region.