Dynamic benchmarking strategy combined with Six Sigma metrics for quality improvement in the total testing process

doi:10.3877/cma.j.issn.2095-5820.2026.02.006

Abstract

Abstract:

Objective

To explore the practical value of integrating the dynamic indicator limits derived from national clinical laboratory quality specifications with Six Sigma in driving the continuous improvement of quality indicators across the total testing process in medical laboratories.

Methods

Data of 15 quality indicators from the clinical laboratory of a tertiary hospital between 2023 and 2025 were analyzed. Using the 2023 national quality specifications as the baseline and the 2025 specifications as the evaluation standard, 8 quality indicators requiring improvement were included. Based on the root causes of errors, they were divided into process-dependent (n=5) and operation-dependent (n=3) indicators. A dynamic benchmarking management strategy was adopted to implement a stepwise PDCA cycle of "benchmarking, reaching the standard, and setting a new standard," and the improvement effects during 2023 to 2025 were evaluated.

Results

By 2025, the process-dependent indicators improved significantly: Error rates for specimen type, container, and collection volume decreased substantially, with corresponding σ values increasing to 5.4σ (P＜0.01)、5.3σ (P＜0.001)、5.3σ (P＜0.01), respectively. The σ value for the IQC CV failure rate rose to 6.0σ (P＜0.001), and the σ value for the incorrect laboratory report rate increased to 5.3σ (P＜0.001). Among the operation-dependent indicators, the σ values for the blood culture contamination rate and specimen hemolysis rate improved to 4.6σ (P＜0.001) and 4.7σ (P＜0.05), respectively, while the improvement in the anticoagulated specimen coagulation rate was not statistically significant.

Conclusion

The dynamic benchmarking management strategy combined with Six Sigma metrics, through stepwise goal setting and focusing on indicators requiring improvement, can significantly enhance the quality level of the total testing process, with the intervention effect on process-dependent indicators.

Key words: dynamic benchmarking management, Six Sigma, quality indicators, PDCA cycle, continuous improvement

Lili Wei, Shibing Li, Shengming Lai, Xianghui Wang, Huofeng Meng, Shutao Cai, Ziqing Feng, Zihuan Yang. Dynamic benchmarking strategy combined with Six Sigma metrics for quality improvement in the total testing process[J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2026, 14(02): 127-133.

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References 31

1	PLEBANI M. Quality in laboratory medicine: 50 years on[J]. Clinical biochemistry, 2017, 50(3): 101-104.
2	INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. Medical laboratories-Requirements for quality and competence: ISO 15189:2022[S]. Geneva: International Organization for Standardization, 2022.
3	CHEN M, ZHENG Y, XU J, et al. Quality checks to promote patient safety: A 10-year retrospective study of adverse events in an emergency laboratory[J]. NEJM Catalyst innovations in care delivery, 2025, 6(s1).
4	LI Y, CHEN F L, CHEN X J. The surveys on quality indicators for the total testing process in clinical laboratories of Fujian Province in China from 2018 to 2023[J]. Clinical chemistry and laboratory medicine, 2025, 63(1): 118-128.
5	杜雨轩, 王治国, 张志新, 等. 2024年全国临床检验专业15项质量指标室间质量评价结果分析[J]. 中华检验医学杂志, 2026, 49(1): 84-94.
6	XIA Y, WANG X X, YAN C L, et al. Risk assessment of the total testing process based on quality indicators with the Sigma metrics[J]. Clinical chemistry and laboratory medicine, 2020, 58(8): 1223-1231.
7	段敏, 王薇, 赵海建, 等. 2018年全国临床检验质量指标室间质量评价结果分析及初步质量规范的制定[J]. 临床检验杂志, 2018, 36(12): 931-936.
8	DE GUIRE V, GALORO C A O, IBARZ M, et al. Recommendations from the IFCC Working Group on laboratory errors and patient safety for the global adoption of an essential quality indicators panel in laboratory medicine[J]. Clinical chemistry and laboratory medicine, 2025, 64(4):806-812.
9	ZUBANOV P S, TREGUB P P, GOLDBERG A S, et al. Comprehensive assessment of medical laboratory performance: A 4D model of quality, economics, velocity, and productivity indicators[J]. Clinical chemistry and laboratory medicine, 2025, 63(10): 1928-1940.
10	KANG F, LI W, XIA X, et al. Three years' experience of quality monitoring program on pre-analytical errors in China[J]. Journal of clinical laboratory analysis, 2021, 35(4): e23699.
11	APOSTU S A, VASILE V, VERES C. Externalities of lean implementation in medical laboratories. Process optimization vs. adaptation and flexibility for future[J]. International journal of environmental research and public health, 2021, 18(23): 12309.
12	中华医学会检验医学分会. 不合格静脉血标本管理中国专家共识[J]. 中华检验医学杂志, 2020, 43(10): 956-963.
13	CHERIE N, BERTA D M, TAMIR M, et al. Improving laboratory turnaround times in clinical settings: A systematic review of the impact of lean methodology application[J]. PLoS One, 2024, 19(10): e0312033.
14	GETAWA S, AYNALEM M, MELKU M, et al. Blood specimen rejection rate in clinical laboratory: A systematic review and meta-analysis[J]. Practical laboratory medicine, 2022, 33: e00303.
15	董敏, 程萌, 刘宁, 等. 鱼骨图与柏拉图及PDCA循环分析法在病案管理中的应用[J]. 国际护理学杂志, 2024, 43(21): 4010-4015.
16	王治国, 费阳, 康凤凤. 临床检验质量指标[M]. 1版. 北京 : 人民卫生出版社, 2016.
17	吴宗勇, 张晓煜, 张丽, 等. 检验与临床沟通方式探讨[J]. 检验医学与临床, 2022, 19(5): 712-714.
18	阚丽娟, 张丽军, 张秀明. 正确理解和应用15项临床检验质量控制指标[J]. 检验医学, 2022, 37(10): 907-914.
19	SCIACOVELLI L, PADOAN A, AITA A, et al. Quality indicators in laboratory medicine: state-of-the-art, quality specifications and future strategies[J]. Clinical chemistry and laboratory medicine, 2023, 61(4): 688-695.
20	PLEBANI M. Quality indicators: An evolving target for laboratory medicine[J]. Clinical chemistry and laboratory medicine, 2025, 63(10): 1889-1890.
21	CAI X, LIN Y, ZHAN L, et al. Optimizing clinical laboratory efficiency through digital shadow and lean Six Sigma integration: A real-time monitoring approach to reduce intra-laboratory turnaround time[J]. Digital health, 2025, 11:20552076251375939.
22	刘文静, 秦绪珍, 孙丹丹, 等. 北京协和医院检验科报告不正确率分析及持续改进[J]. 国际检验医学杂志, 2021, 42(10): 1271-1273, 1280.
23	LIU B, SUN Z, CHEN K, et al. Evaluation of a Six Sigma-based dynamic quality control strategy for hematology analysis: A multicenter study[J]. Journal of clinical laboratory analysis, 2026, 40(2): e70138.
24	HAROUN A, AL-RUZZIEH M A, HUSSIEN N, et al. Using failure mode and effects analysis in improving nursing blood sampling at an international specialized cancer center[J]. Asian Pacific journal of cancer prevention, 2021, 22(4): 1247-1254.
25	刘会玲, 赵滨, 李萍, 等. 基于多学科团队的行动研究法在血标本检验前质量控制中的应用[J]. 中华现代护理杂志, 2019, 25(18): 2291-2295.
26	欧阳能良, 王伟佳, 黄福达, 等. 多措并举提升检验前质量的实践与体会[J]. 中华医院管理杂志, 2020, 36(06): 500-503.
27	ORHAN B, SONMEZ D, CUBUKCU H C, et al. The use of preanalytical quality indicators: A Turkish preliminary survey study[J]. Clinical chemistry and laboratory medicine, 2021, 59(5): 837-843.
28	JOHN G K, FAVALORO E J, AUSTIN S, et al. From errors to excellence: The pre-analytical journey to improved quality in diagnostics. A scoping review[J]. Clinical chemistry and laboratory medicine, 2025, 63(7): 1243-1259.
29	ZHANG L, JIANG K, CHEN J, et al. Quality indicators in laboratory medicine: A 2020—2023 experience in a Chinese province[J]. Clinical chemistry and laboratory medicine, 2025, 63(8): 1573-1581.
30	MOONLA K, WIRIYAPRASIT R, APIRATMATEEKUL N, et al. Novel blood collection tubes improve sample preservation in a multicenter study in Thailand[J]. Diagnostics(Basel, Switzerland), 2025, 15(18): 2398.
31	LIPPI G, MATTIUZZI C, FAVALORO E J. Artificial intelligence in the pre-analytical phase: State-of-the art and future perspectives[J]. Journal of medical biochemistry, 2024, 43(1): 1-10.

质量指标分类与名称	2023年（基线期）		2024年（过渡期）		2025年（评价期）		P值^*	2025规范对标（σ值比较）
质量指标分类与名称	均值/%	σ值	均值/%	σ值	均值/%	σ值	P值^*	2025规范对标（σ值比较）
检验前干预指标
标本类型错误率	0.028	5.000	0.011	5.200	0.006	5.400	0.002	＞适当（5.300）＜最佳（5.600）
标本容器错误率	0.030	4.900	0.024	5.000	0.007	5.300	＜0.001	=适当（5.300）＜最佳（5.600）
标本采集量错误率	0.047	4.800	0.045	4.800	0.009	5.300	0.004	＞适当（5.100）＜最佳（5.400）
血培养污染率	0.660	4.000	0.424	4.100	0.110	4.600	＜0.001	＞最佳（4.500）
抗凝标本凝集率	0.015	5.100	0.043	4.800	0.036	4.900	0.128	＞适当（4.800）＜最佳（5.100）
标本溶血率	0.115	4.600	0.097	4.600	0.067	4.700	0.015	＜最低（5.000）
检验中干预指标
室内质控CV不合格率	0.015	5.100	0.000	6.000	0.000	6.000	＜0.001	最佳（6.000）
检验后干预指标
检验报告不正确率	0.034	4.900	0.012	5.200	0.007	5.300	＜0.001	＞最低（5.000）＜适当（5.800）
常态化监测指标
标本丢失率	0.000	6.000	0.000	6.000	0.000	6.000	N/A	最佳（6.000）
室内质控项目开展率	93.600	3.000	95.500	3.200	93.500	3.000	N/A	＞最佳（2.900）
EQA参加率	100.000	6.000	100.000	6.000	100.000	6.000	N/A	最佳（6.000）
EQA不合格率	0.500	4.100	0.000	6.000	0.000	6.000	N/A	最佳（6.000）
检验项目替代评价方法使用率	100.000	6.000	100.000	6.000	100.000	6.000	N/A	＞最佳（1.200）
危急值通报率	100.000	6.000	100.000	6.000	100.000	6.000	N/A	最佳（6.000）
危急值通报及时率	100.000	6.000	100.000	6.000	100.000	6.000	N/A	最佳（6.000）

质量指标分类与名称	2023年（基线期）		2024年（过渡期）		2025年（评价期）		P值^*	2025规范对标（σ值比较）
质量指标分类与名称	均值/%	σ值	均值/%	σ值	均值/%	σ值	P值^*	2025规范对标（σ值比较）
检验前干预指标
标本类型错误率	0.028	5.000	0.011	5.200	0.006	5.400	0.002	＞适当（5.300）＜最佳（5.600）
标本容器错误率	0.030	4.900	0.024	5.000	0.007	5.300	＜0.001	=适当（5.300）＜最佳（5.600）
标本采集量错误率	0.047	4.800	0.045	4.800	0.009	5.300	0.004	＞适当（5.100）＜最佳（5.400）
血培养污染率	0.660	4.000	0.424	4.100	0.110	4.600	＜0.001	＞最佳（4.500）
抗凝标本凝集率	0.015	5.100	0.043	4.800	0.036	4.900	0.128	＞适当（4.800）＜最佳（5.100）
标本溶血率	0.115	4.600	0.097	4.600	0.067	4.700	0.015	＜最低（5.000）
检验中干预指标
室内质控CV不合格率	0.015	5.100	0.000	6.000	0.000	6.000	＜0.001	最佳（6.000）
检验后干预指标
检验报告不正确率	0.034	4.900	0.012	5.200	0.007	5.300	＜0.001	＞最低（5.000）＜适当（5.800）
常态化监测指标
标本丢失率	0.000	6.000	0.000	6.000	0.000	6.000	N/A	最佳（6.000）
室内质控项目开展率	93.600	3.000	95.500	3.200	93.500	3.000	N/A	＞最佳（2.900）
EQA参加率	100.000	6.000	100.000	6.000	100.000	6.000	N/A	最佳（6.000）
EQA不合格率	0.500	4.100	0.000	6.000	0.000	6.000	N/A	最佳（6.000）
检验项目替代评价方法使用率	100.000	6.000	100.000	6.000	100.000	6.000	N/A	＞最佳（1.200）
危急值通报率	100.000	6.000	100.000	6.000	100.000	6.000	N/A	最佳（6.000）
危急值通报及时率	100.000	6.000	100.000	6.000	100.000	6.000	N/A	最佳（6.000）

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