Application of Six Sigma in evaluating the analytical performance of endocrine project

doi:10.3877/cma.j.issn.2095-5820.2020.01.007

Abstract

Abstract:

Objective

To investigate the application value of Six Sigma in the evaluation of endocrine project analysis performance.

Methods

The data of internal quality control (IQC) from October 2018 to March 2019 and the data of external quality assessment (EQA) from second time in 2018 and first time in 2019 were collected respectively. Four different sources of performance specifications were used as quality goals, and the long-term cumulative coefficient of variation of IQC were used as precision and the percentage difference of EQA were used as bias to evaluate σlevels of endocrine items and σvalues of endocrine items with different quality objectives. Meanwhile, individualized IQC scheme was formulated. In addition, the quality target index (QGI) of items with σvalue below 6 were evaluated and the plan for laboratory quality improvement was provided.

Results

According to the national EQA evaluation standard, biological variation, "appropriate" quality standard and quality standard recommended by CLSI are derived. The proportion of projects with σvalue ≥ 6 is between 20.0% and 35.4%; While, according to the Spanish EQA standard, no analytes with σvalue more than 6 were found. According to the analytical performance of each project, a personalized IQC scheme was developed: total triiodothyronine (TT3), thyroid stimulating hormone (TSH), luteinizing hormone (LH) and testosterone (T) were selected for single rule 1_3s for quality control, prolactin (PRL) was selected multiple rule 1_3s/2_2s/R_4s for quality control, free thyroxine (FT4) was selected multiple rule 1_3s/2_2s/R_4s/4_1s for quality control, free triiodothyronine (FT3), total thyroxine (TT4), estradiol (E2), follicle stimulating hormone (FSH) and progesterone (P) were selected multiple rule 1_3s/2_2s/R_4s/4_1S/8_X for quality control. According to the Chinese EQA standard, the precision of FT3, FT4, TT4, E2, FSH, P and PRL should be improved firstly.

Conclusion

Six Sigma can reasonably evaluate the analytical performance of the endocrine project and promote the continuous improvement of laboratory test quality.

Key words: Six Sigma, Endocrine analyte, Quality goal, Quality control

Qian Liu, Xizhen Wang, Ziling Zhang, Li Chen, Wei Liang, Fumeng Yang. Application of Six Sigma in evaluating the analytical performance of endocrine project[J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2020, 08(01): 36-40.

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References 16

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项目	CV	Bias	TEa
项目	CV	Bias	中国EQA评价标准	"适当的"生物学变异	美国CLIA质量目标(2019)	西班牙EQA评价标准
FT3	5.73	3.36	25.00	11.34	NA	24.00
TT3	3.65	2.98	25.00	12.00	30.00	24.00
FT4	5.18	1.23	25.00	8.05	15.00	16.00
TT4	4.83	3.56	20.00	7.03	20.00	24.00
TSH	3.65	2.45	25.00	23.74	20.00	15.00
E₂	7.38	2.09	25.00	26.86	30.00	26.00
FSH	6.13	2.06	25.00	21.19	18.00	14.00
LH	3.97	0.98	25.00	27.92	20.00	17.00
P	6.21	4.09	25.00	NA	25.00	26.00
PRL	4.43	1.12	25.00	29.45	20.00	22.00
T	3.45	3.03	25.00	13.61	30.00	23.00

项目	CV	Bias	TEa
项目	CV	Bias	中国EQA评价标准	"适当的"生物学变异	美国CLIA质量目标(2019)	西班牙EQA评价标准
FT3	5.73	3.36	25.00	11.34	NA	24.00
TT3	3.65	2.98	25.00	12.00	30.00	24.00
FT4	5.18	1.23	25.00	8.05	15.00	16.00
TT4	4.83	3.56	20.00	7.03	20.00	24.00
TSH	3.65	2.45	25.00	23.74	20.00	15.00
E₂	7.38	2.09	25.00	26.86	30.00	26.00
FSH	6.13	2.06	25.00	21.19	18.00	14.00
LH	3.97	0.98	25.00	27.92	20.00	17.00
P	6.21	4.09	25.00	NA	25.00	26.00
PRL	4.43	1.12	25.00	29.45	20.00	22.00
T	3.45	3.03	25.00	13.61	30.00	23.00

项目	中国EQA评价标准	"适当的"生物学变异	美国CLIA质量目标(2019)	西班牙EQA评价标准
FT3	3.78	1.39	NA	3.60
TT3	6.03	2.47	7.40	5.76
FT4	4.59	1.32	2.66	2.85
TT4	3.40	0.72	3.40	4.23
TSH	6.18	5.83	4.81	3.44
E₂	3.10	3.36	3.78	3.24
FSH	3.74	3.12	2.60	1.95
LH	6.05	6.79	4.79	4.04
P	3.37	NA	3.37	3.53
PRL	5.39	6.39	4.26	4.71
T	6.37	3.07	7.82	5.79

项目	中国EQA评价标准	"适当的"生物学变异	美国CLIA质量目标(2019)	西班牙EQA评价标准
FT3	3.78	1.39	NA	3.60
TT3	6.03	2.47	7.40	5.76
FT4	4.59	1.32	2.66	2.85
TT4	3.40	0.72	3.40	4.23
TSH	6.18	5.83	4.81	3.44
E₂	3.10	3.36	3.78	3.24
FSH	3.74	3.12	2.60	1.95
LH	6.05	6.79	4.79	4.04
P	3.37	NA	3.37	3.53
PRL	5.39	6.39	4.26	4.71
T	6.37	3.07	7.82	5.79

项目	TEa (%)	σ值	QGI	改进措施
FT3	25.00	3.74	0.39	优先改进精密度
FT4	25.00	4.59	0.16	优先改进精密度
TT4	20.00	3.40	0.50	优先改进精密度
E₂	25.00	3.10	0.19	优先改进精密度
FSH	25.00	3.74	0.22	优先改进精密度
P	25.00	3.37	0.44	优先改进精密度
PRL	25.00	5.39	0.17	优先改进精密度

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