Application of Westgard sigma rules in selecting internal quality control rules for clinical hematology tests

doi:10.3969/j.issn.1673-8640.2016.011.015

Abstract

Abstract:

Objective To use Westgard sigma rules in selecting suitable internal quality control rules for clinical hematology tests. Methods A laboratory which participated complete blood count external quality assessment and internal quality control of the National Center for Clinical Laboratories in 2013 was enrolled. Accumulated coefficient of variation（CV） in internal quality control was regarded as the estimation value of imprecision,and the percentage difference in external quality assessment was chosen to be the estimation value of bias. The allowable total errors（TEa） based on biological variation, the Clinical Laboratory Improvement Amendments of 1988（CLIA'88） and national health industry standard WS/T406-2012 were adopted as quality specification. σ value was calculated,and suitable internal quality control rules were selected by Westgard sigma rules. Results When using TEa based on biological variation,1₃_s/2₂_s/R₄_s/4₁_s/8_x multi-rules were selected for all complete blood counts whose σ values were < 4. If TEa in CLIA'88 was employed,1₃_s/2₂_s/R₄_s multi-rules were selected for hemoglobin and platelet whose σ values were 5.20 and 5.13. When TEa in national health industry standard was used,1₃_s/2₂_s/R₄_s/4₁_s multi-rules were suitable for hemoglobin and hematocrit whose σ values were 4.35 and 4.62. Conclusions Westgard sigma rules are convenient and feasible,and laboratories can use them for selecting internal quality control rules correctly.

Key words: Internal quality control, Quality management, Westgard sigma rules

CLC Number:

R446.1

FEI Yang, WANG Wei, WANG Zhiguo. Application of Westgard sigma rules in selecting internal quality control rules for clinical hematology tests[J]. Laboratory Medicine, 2016, 31(11): 993-996.

Figures/Tables 4

References 10

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分析物	CV（%）		偏移（%）	生物学变异导出要求			美国CLIA'88能力验证评价限				我国卫生行业标准
分析物	CV（%）		偏移（%）	TEa		σ值	TEa		σ值		TEa		σ值
红细胞	1.63		0.86	4.4		2.17	6.0		3.15		6.0		3.15
血红蛋白	1.17		0.91	4.1		2.73	7.0		5.20		6.0		4.35
血细胞比容	1.73		1.00	4.1		1.79	6.0		2.89		9.0		4.62
血小板	3.72		5.90	13.4		2.02	25.0		5.13		20.0		3.79
白细胞	2.66		7.28	14.6		2.75	15.0		2.90		15.0		2.90
Sysmex质控品批号		红细胞（×10¹²/L）			血红蛋白（g/L）			血细胞比容（%）		血小板（×10⁹/L）		白细胞（×10⁹/L）
30260810		2.34			59.48			17.84		56.43		2.81
30270811		0.05			121.26			34.93		222.91		0.18

分析物	CV（%）		偏移（%）	生物学变异导出要求			美国CLIA'88能力验证评价限				我国卫生行业标准
分析物	CV（%）		偏移（%）	TEa		σ值	TEa		σ值		TEa		σ值
红细胞	1.63		0.86	4.4		2.17	6.0		3.15		6.0		3.15
血红蛋白	1.17		0.91	4.1		2.73	7.0		5.20		6.0		4.35
血细胞比容	1.73		1.00	4.1		1.79	6.0		2.89		9.0		4.62
血小板	3.72		5.90	13.4		2.02	25.0		5.13		20.0		3.79
白细胞	2.66		7.28	14.6		2.75	15.0		2.90		15.0		2.90
Sysmex质控品批号		红细胞（×10¹²/L）			血红蛋白（g/L）			血细胞比容（%）		血小板（×10⁹/L）		白细胞（×10⁹/L）
30260810		2.34			59.48			17.84		56.43		2.81
30270811		0.05			121.26			34.93		222.91		0.18

血小板质控品批号	靶值（×10⁹/L）	偏移（%）	生物学变异导出要求σ值	美国CLIA'88能力验证评价限σ值	我国卫生行业标准σ值
201311	160	6.25	1.92	5.04	3.70
201312	187	6.42	1.88	4.99	3.65
201313	207	5.8	2.04	5.16	3.82
201314	241	6.64	1.82	4.94	3.59
201315	206	4.37	2.43	5.55	4.20

血小板质控品批号	靶值（×10⁹/L）	偏移（%）	生物学变异导出要求σ值	美国CLIA'88能力验证评价限σ值	我国卫生行业标准σ值
201311	160	6.25	1.92	5.04	3.70
201312	187	6.42	1.88	4.99	3.65
201313	207	5.8	2.04	5.16	3.82
201314	241	6.64	1.82	4.94	3.59
201315	206	4.37	2.43	5.55	4.20

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