SIX SIGMA APPLICATION IN EVALUATING THE EFICACY OF PERIPHERAL BLOOD CELL TESTS ON THE DXH-800 HEMATOLOGY ANALYZER AT THE NATIONAL HOSPITAL ENDOCRINOLOGY PERIOD 2019-2021

Bùi Minh Hằng1,, Đỗ Tiến Dũng1, Nguyễn Thu Hà2
1 National Hospital of Endocrinology
2 Hanoi University of Public Health

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Abstract

Introductions: the application of Six sigma method in quality control is very important to enhance test quality. Objectives: to evaluate the performance of peripheral blood cell testing method on DxH-800 hematology analyzer by Six sigma when TEa according to CLIA standards and biological variation range at the National Hospital of Endocrinology period 2019-2021. Subjects and research methods: cross-sectional description on subjects including: 2437 IQC results of 5 indicators in peripheral blood cell test: WBC, RBC, HGb; HCT, PLT at 3 concentration levels, 36 EQC results of 5 indicators above; allowable total error value TEa. Results: most of the sigma results according to CLIA criteria are higher than those calculated according to the biological variation range; all values ​​of low sigma are in the HCT index (TEa according to HCT is the lowest 1.69; TEa according to CLIA sigma is the lowest at 2.96). With the specificity, once performed for all blood cell indicators, other indicators still have to be controlled like HCT with Westgard's rule of 1:2S/2:2S/R:4S/4 :1S/8X with N=4, R=2. Conclusions: the laboratory needs to review the method, controlling IQC by Westgard multi-rule is 1:2S/2:2S/R:4S/4:1S/8X with N=4, R=2. Recommendations: Regarding the method performance according to sigma, TEa should be used as recommended by CLIA because the standard of biological variation range is quite tight, making it difficult for the laboratory to achieve the quality goal.

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References

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