Six sigma quality management for choosing appropriate quality control rules in automatic hematological analyzer

doi:10.3969/j.issn.1673-8640.2018.01.014

Abstract

Abstract:

Objective To evaluate the performance of automatic hematological analyzer by six sigma（6σ） quality management,and to choose appropriate quality control rules with OPSpecs charts,monitor analyzer's performance and ensure determination quality. Methods Sigma（σ） values were calculated,according to imprecisions,biases （Bias） and allowable total error （TEa） by SYSMEX XE-2100D automatic hematological analyzer. The parameters included white blood cell （WBC） count,red blood cell （RBC） count,hemoglobin （Hb）,hematocrit （HCT）,platelet （PLT） count,neutrophil （NEUT）,lymphocyte （LYMPH）,monocyte （MONO）,eosinophil （EOS） and basophil （BASO）. Appropriate quality control rules were chosen with OPSpecs charts. Results The parameters achieving 6σ accounted for 80%,those achieving 5σ accounted for 10%,and the other 10% parameters did not achieve 5σ. For WBC count,RBC count,Hb,HCT,PLT count,Neut,LYMPH and BASO,quality control rule 1_3.5_s, N=3,R=1 should be used. For EOS,quality control rule 1₃_s, N=3,R=1 should be used. For MONO,quality control rule 1_2.5_s, N=3,R=1 should be used. These rules can meet 90% requirements for ensuring determination quality.Conclusions Clinical laboratories may choose appropriate quality control rules according to different parameters,in order to ensure determination quality.

Key words: Sigma value, OPSpecs chart, Imprecision, Bias

CLC Number:

R195.1

MIAO Yingbo, SONG Ying, XU Lei, ZHU Peichao, WANG Qing. Six sigma quality management for choosing appropriate quality control rules in automatic hematological analyzer[J]. Laboratory Medicine, 2018, 33(1): 72-75.

Figures/Tables 2

References 10

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项目	检测值	TEa（%）	CV（%）	斜率	截距	Bias（%）	σ值
WBC计数	7.07×10⁹/L	15.0	1.23	1.022 8	0.017 3	2.46	>6.0
RBC计数	4.51×10¹²/L	6.0	0.46	0.994 0	0.023 6	0.08	>6.0
Hb	127 g/L	7.0	0.39	0.994 1	-0.038 3	0.63	>6.0
HCT	36.5%	6.0	0.84	0.985 7	0.204 4	0.88	>6.0
PLT计数	234×10⁹/L	25.0	1.59	0.968 9	-0.960 9	3.65	>6.0
NEUT	3.36×10⁹/L	22.4	1.80	1.027 8	0.011 8	3.03	>6.0
LYMPH	2.29×10⁹/L	16.0	2.25	0.969 9	0.040 7	1.25	>6.0
MONO	0.70×10⁹/L	27.9	4.11	1.080 0	0.011 7	8.82	4.6
EOS	0.72×10⁹/L	37.1	6.44	0.981 8	0.016 5	0.48	5.7
BASO	4.58×10⁹/L	38.5	1.80	1.027 9	0.001 1	2.74	>6.0

项目	检测值	TEa（%）	CV（%）	斜率	截距	Bias（%）	σ值
WBC计数	7.07×10⁹/L	15.0	1.23	1.022 8	0.017 3	2.46	>6.0
RBC计数	4.51×10¹²/L	6.0	0.46	0.994 0	0.023 6	0.08	>6.0
Hb	127 g/L	7.0	0.39	0.994 1	-0.038 3	0.63	>6.0
HCT	36.5%	6.0	0.84	0.985 7	0.204 4	0.88	>6.0
PLT计数	234×10⁹/L	25.0	1.59	0.968 9	-0.960 9	3.65	>6.0
NEUT	3.36×10⁹/L	22.4	1.80	1.027 8	0.011 8	3.03	>6.0
LYMPH	2.29×10⁹/L	16.0	2.25	0.969 9	0.040 7	1.25	>6.0
MONO	0.70×10⁹/L	27.9	4.11	1.080 0	0.011 7	8.82	4.6
EOS	0.72×10⁹/L	37.1	6.44	0.981 8	0.016 5	0.48	5.7
BASO	4.58×10⁹/L	38.5	1.80	1.027 9	0.001 1	2.74	>6.0

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