[1]张楠楠a,李淮淮b,王绪山a.6σ 质量管理在凝血酶原时间室间质量评价与室内质量控制分析应用[J].现代检验医学杂志,2020,35(03):149-152.[doi:10.3969/j.issn.1671-7414.2020.03.040]
　ZHANG Nan-nana,LI Huai-huaib,WANG Xu-shana.Application of 6 σ Theory on Prothrombin Time Quality Management Through the Data from External Quality Assessment and Internal Quality Control[J].Journal of Modern Laboratory Medicine,2020,35(03):149-152.[doi:10.3969/j.issn.1671-7414.2020.03.040]
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6σ 质量管理在凝血酶原时间室间质量评价与室内质量控制分析应用 ()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第35卷
期数:
2020年03期
页码:
149-152
栏目:
质量控制·实验室管理
出版日期:
2020-07-20

文章信息/Info

Title:
Application of 6 σ Theory on Prothrombin Time Quality Management Through the Data from External Quality Assessment and Internal Quality Control
文章编号:
1671-7414（2020）03-149-04
作者:
张楠楠a;  李淮淮b;  王绪山a
（江苏省灌云县人民医院a. 检验科；b. 心血管内科，江苏灌云　222200）
Author(s):
ZHANG Nan-nana;  LI Huai-huaib; WANG Xu-shana
（a. Department of Clinical Laboratory; b.Cardiovascular Medicine,Guanyun County People’s Hospital, Jiangsu Guanyun 222200,China ）
关键词:
六西格玛; 凝血酶原时间; 室间质量评价; 室内质量控制
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2020.03.040
摘要:
目的　探讨6σ 质量管理在持续监控凝血酶原时间（prothrombin time，PT）的室间质量评价（external quality assessment，EQA）和室内质量控制（internal quality control，IQC）中的应用。方法　收集灌云县人民医院检验科2017 年、2018 年PT 的省EQA 结果和IQC 数据，分别获得偏倚（Bias）、差值占允许差值的百分比和半年IQC 平均变异 系数（coefficient of variation，CV），以允许总误差（total allowable error，TEa），Bias 和CV 计算σ 值：σ=(TEa- |Bias|)/CV，当σ ＜ 6 时，通过计算质量目标指数（Quality goal index，QGI）：QGI=|Bias|/(1.5×CV)，分析性能不佳 的原因。结果　2017(1)EQA 五组样本差值占允许差值的百分比平均值为-31.55%，σ 水平为4.23，其QGI 为1.29； 2017(2)EQA 五组样本差值占允许差值的百分比平均值为-10.88%，其绝对值低于2017(1)，差异具有统计学意义。室内 质控CV 为2.04%，σ 水平为6.55。2018(1) 及2018(2)EQA 五组样本差值占允许差值的百分比平均值分别为18.57% 和 11.07%，室内质控CV 分别为2.62% 和2.82%，σ 水平为4.66 和4.73，QGI 为0.71 和0.39。结论　应用6σ 质量管理 综合分析PT 连续的EQA 结果、IQC 数据可达到全面监控和持续改进其检测质量的作用。
Abstract:
Objective　To explor the effectiveness of six sigma(6σ) theory on continuous monitoring the external quality assessment (EQA) and internal quality control(IQC) of prothrombin time (PT). Methods　Based on data from EQA and IQA of PT between 2017 and 2018， the Bias, the percentage of the difference as the allowable difference and coefficient of variation(CV) in 2017(1), 2017(2), 2018(1) and 2018(2) were obtained, respectively. Sigma (σ) value was calculated using total allowable error (TEa), Bias, and CV, σ= (TEa-|Bias|)/CV. When σ<6, the quality goal index (QGI) was calculated using the formula: QGI=|Bias|/(1.5×CV),by which the factors for poor performance was analyzed. Results　In the EQA of 2017(1), the average value of the percentage of the difference in the allowable difference was -31.55%, the σ value was 4.23, and the QGI was 1.29. In 2017(2), the average value of the percentage of the difference in the allowable difference was -10.88%, which was significantly lower than 2017(1). The CV of IQC was 2.04%, and the σ level was 6.55. The average value of the percentage of the sample difference in the allowable difference of 2018(1) and 2018(2) was 18.57% and 11.07%, respectively, while the CV of IQC was 2.62% and 2.82%, respectively. The σ value was 4.66 and 4.73, and QGI was 0.71 and 0.39, respectively. Conclusion　 Applying six σ theory on the management of EQA and IQC in PT could comprehensively monitor and continuously improve its experimental quality.

参考文献/References:

[1]　刘彦明，何坤，刘熙君，等．6σ 理论在激素类项 目检验质量精益管理中的应用[J]．现代检验医学杂 志，2019, 34（1）: 148-153．LIU Yanming, HE Kun, LIU Xijun, et al. Application of 6σtheory for quality promotion in the detection of endocrinology project inspection [J]. Journal of Modern Laboratory Medicine, 2019, 34(1):148-153.
[2]　王治国．临床检验质量控制技术[M]．3 版．北京： 人民卫生出版社，2004：466-477． 　　 WANG Zhiguo. Laboratory quality control technology[M]. 3th Ed. Beijing: People’s Medical Publishing House, 2014:466-477．
[3]　费阳，王薇，王治国．Westgard 西格玛规则在临床 血液学检验项目室内质量控制规则选择中的应用 [J]. 检验医学, 2016, 31（11）: 993-996. 　　 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．
[4]　靳冰，赵强元，刘敏，等．应用六西格玛质量管理 方法评价实验室质量水平[J]．国际检验医学杂志， 2015, 36（6）: 743-744． 　　 JIN Bing, ZHAO Qiangyuan, LIU Min, et al. Evaluation of quality level in clinical laboratory by six sigma quality management method [J]. International Journal of Laboratory Medicine, 2015, 36(6):743-744.
[5]　WESTGARD J O.The six sigma calculators [Z]. http:// www.westgard.com/ six-sigma-calculators.htm.
[6]　赵海建，张传宝，汪静，等．质量控制规则软件在 定量检测室间质量评价数据分析中的应用[J]．检验 医学，2016, 31（4）: 319-323． 　　 ZHAO Haijian, ZHANG Chuanbao, WANG Jing, et al. Quality control rule softwares for datum analysis in external quality assessment of quantitative assays [J]. Laboratory Medicine, 2016, 31(4):319-323.
[7]　　刘佳丽，王薇，何法霖，等．全国566 家临床实验 室血清降钙素原室内质量控制不精密度调查与分析 [J]．现代检验医学杂志，2018，33（2）：139-142. 　　 LIU Jiali, WANG Wei, HE Falin, et al. Investigation and analysis of the coefficient of variation of internal quality control of the serum procalcitonin in 566 laboratories in China [J]. Journal of Modern Laboratory Medicine，2018，33（2）：139-142．
[8]　　费阳，王薇，王治国．临床检验室内质量控制规则 设计新工具-Westgard 西格玛规则[J]．现代检验医 学杂志，2015, 30（1）: 149-152． 　　 FEI Yang, WANG Wei, WANG Zhiguo. A new internal quality control rules design tool in clinical laboratory- Westgard sigma rules [J]. Journal of Modern Laboratory Medicine, 2015, 30(1): 149-152.
[9]　　冯仁丰．临床实验室检测系统分析性能采用σ 验 证的必要性[J]．检验医学，2017，32（10）：837- 843． 　　 FENG Renfeng. Role of sigma validation for the analysis performance of determination systems among clinical laboratories [J]. Laboratory Medicine, 2017, 32(10):837-843.

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备注/Memo

备注/Memo:
收稿日期：2019-12-15 修回日期：2020-01-22作者简介：张楠楠（1988-），女，本科，中级检验技师，研究方向：临床基础检验，E-mail：znlh0052@126.com。 通讯作者：王绪山，男，硕士研究生，主任技师，E-mail：wxs1970@126.com
更新日期/Last Update: 2020-07-20