Establishment of routine dry biochemical test IQC rules based on six sigma quality management method

doi:10.3969/j.issn.1673-8640.2020.01.014

Abstract

Abstract:

Objective To apply the six sigma（σ） quality management method designing internal quality control（IQC） rules of routine dry biochemical test. Methods The 16 dry biochemical tests’ IQC data under control were collected from December 2017 to May 2018,and the imprecision was calculated. The bias was calculated using the external quality assessment of Jiangsu Province. The coefficient of variation（CV） was used as allowable total error（TEa）,and the design of IQC rules conformed to the actual IQC. By the quality control index,the performance characteristics of the tests that needed to be improved were found. Results The alanine aminotransferase（ALT）,urea（Urea） and creatine kinase（CK） IQC rules were designed to be 1₃s（N=2,R=1）,and the total bilirubin（TB） IQC rules were designed as 1₃s/2₂s/R₄s（N=2,R=1）. Total protein（TP）,creatinine（Cr）,uric acid（UA）,glucose（Glu）,K,Cl and Ca IQC rules were designed as 1₃s/2₂s/R₄s/4₁s（N=2,R=2）,and albumin（Alb）,aspartate aminotransferase（AST）,lactate dehydrogenase（LDH）,Na and amylase（AMY） IQC rules were designed as 1₃s/2₂s/R₄s/4₁s/8x（N=2,R=4）. All tests were needed to be optimized the performance characteristics of imprecision. Conclusions The IQC method meeting the actual requirements and the clinical quality requirements has been established.

Key words: Dry biochemical, Internal quality control, Six sigma, Quality control index

CLC Number:

R446.1

WANG Xinqin, QIU Wei, CHEN Sumei, LIU Dongsheng. Establishment of routine dry biochemical test IQC rules based on six sigma quality management method[J]. Laboratory Medicine, 2020, 35(1): 66-69.

Figures/Tables 2

References 7

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分析项目	生物学变异质量规范			方法学性能		σ水平
分析项目	适当（%）	最佳（%）	最低（%）	Bias（%）	CV（%）	适当	最佳	最低
TB	31.1	15.5	46.6	3.14	5.47	5.11	2.26	7.94
TP	3.4	1.7	5.2	1.10	2.12	1.08	0.28	1.93
Alb	3.9	1.9	5.8	0.88	2.36	1.28	0.43	2.08
ALT	32.1	16	48.1	4.19	3.91	7.15	3.02	11.24
AST	15.2	7.6	22.8	2.59	3.77	3.34	1.33	5.36
Urea	15.7	7.8	23.5	0.59	2.42	6.24	2.98	9.46
Cr	8.2	4.1	12.2	1.80	2.55	2.51	0.91	4.08
UA	12.4	6.2	18.6	1.98	2.52	4.13	1.67	6.59
Glu	6.9	3.5	10.4	0.89	2.24	2.68	1.17	4.25
K	5.8	2.9	8.7	0.87	1.95	2.53	1.04	4.02
Na	0.9	0.4	1.3	0.81	1.39	0.06	0.30	0.35
Cl	1.5	0.7	2.2	1.04	1.87	0.25	0.18	0.62
Ca	2.4	1.2	3.6	1.27	2.99	0.38	0.02	0.78
LDH	11.4	5.68	17.03	1.62	3.11	3.15	1.31	4.96
CK	30.3	15.2	45.5	1.26	4.56	6.37	3.06	9.70
AMY	14.6	7.3	21.9	4.66	4.43	2.25	0.60	3.89

分析项目	生物学变异质量规范			方法学性能		σ水平
分析项目	适当（%）	最佳（%）	最低（%）	Bias（%）	CV（%）	适当	最佳	最低
TB	31.1	15.5	46.6	3.14	5.47	5.11	2.26	7.94
TP	3.4	1.7	5.2	1.10	2.12	1.08	0.28	1.93
Alb	3.9	1.9	5.8	0.88	2.36	1.28	0.43	2.08
ALT	32.1	16	48.1	4.19	3.91	7.15	3.02	11.24
AST	15.2	7.6	22.8	2.59	3.77	3.34	1.33	5.36
Urea	15.7	7.8	23.5	0.59	2.42	6.24	2.98	9.46
Cr	8.2	4.1	12.2	1.80	2.55	2.51	0.91	4.08
UA	12.4	6.2	18.6	1.98	2.52	4.13	1.67	6.59
Glu	6.9	3.5	10.4	0.89	2.24	2.68	1.17	4.25
K	5.8	2.9	8.7	0.87	1.95	2.53	1.04	4.02
Na	0.9	0.4	1.3	0.81	1.39	0.06	0.30	0.35
Cl	1.5	0.7	2.2	1.04	1.87	0.25	0.18	0.62
Ca	2.4	1.2	3.6	1.27	2.99	0.38	0.02	0.78
LDH	11.4	5.68	17.03	1.62	3.11	3.15	1.31	4.96
CK	30.3	15.2	45.5	1.26	4.56	6.37	3.06	9.70
AMY	14.6	7.3	21.9	4.66	4.43	2.25	0.60	3.89

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