[1]张 莉,蒙立业,杨 培,等.临床检验室内质量控制策略设计新工具-分析批长度Westgard西格玛规则[J].现代检验医学杂志,2019,34(02):137-139.[doi:10.3969/j.issn.1671-7414.2019.02.035]
　ZHANG Li,MENG Li-ye,YANG Pei,et al.New Internal Quality Control Rules Design Toolin Clinical Laboratory -Westgard Sigma Rules with Run Size[J].Journal of Modern Laboratory Medicine,2019,34(02):137-139.[doi:10.3969/j.issn.1671-7414.2019.02.035]
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临床检验室内质量控制策略设计新工具-分析批长度Westgard西格玛规则()

《现代检验医学杂志》[ISSN:/CN:]

卷:
第34卷
期数:
2019年02期
页码:
137-139
栏目:
质量控制·实验室管理
出版日期:
2019-05-11

文章信息/Info

Title:
New Internal Quality Control Rules Design Toolin Clinical Laboratory -Westgard Sigma Rules with Run Size
文章编号:
1671-7414(2019)02-137-03
作者:
张 莉1,蒙立业2,杨 培2,黄亨建2
(1.四川大学华西临床医学院医学检验系,成都 610041; 2.四川大学华西医院实验医学科,成都 610041)
Author(s):
ZHANG Li1,MENG Li-ye2,YANG Pei2,HUANG Heng-jian2
(1.Department of Medical Examination,West China School of Medicine,Sichuan University Chengdu 610041,China; 2.Department of Laboratory Medicine,West China Hospital,Sichuan University,Chengdu 610041,China)
关键词:
患者风险;  分析批长度Westgard西格玛规则
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2019.02.035
文献标志码:
A
摘要:
为高通量连续工作分析仪建立限定区间统计质量控制计划时,分析批长度(或质量控制频率)的优化是一项重要内容。合理的分析批长度有助于及时检出误差,降低系统误差所致的不可接受患者结果数,从而最小化患者风险。但目前缺乏简单实用的工具帮助实验室优化分析批长度,导致实验室的质控实践与理论间存在明显的差异。对此,Westgard以不可接受患者结果最大预期数目[MaxE(Nuf)]为基础,将Sigma度量分析批长度列线图与Westgard西格玛规则流程图相结合,建立了分析批长度Westgard西格玛规则流程图。该工具图简单直观,实验室根据检测方法的Sigma度量值即可选择适当的质控规则、每次质控测定数量以及分析批长度,以此为连续工作分析仪建立科学客观的限定区间质控策略,达到患者风险最小化的目标。
Abstract:
For the bracketed statistical quality control(SQC)of high-volume continuous production analyzers,it is important to optimize the run size or the freque- ncy of QC.The run size appropriate for the different SQC procedures can detect error condition timely,which will reduce thenumber of unacceptable patient results during the existene of an undetected error condition and minimize the patient risk〉However,the lack of simple and practical tools to optimize run size makes it difficult for laboratory practice〉Based on the maximum expected number of unacceptable final patient results [MaxE(Nuf)],Westgard created a diagram called Westgard Sigma Rules with Run Size,which combines Sigma-Metric Run Size Nomogram and Westgard Sigma Rules.Once the sigma quality of the tests and methods in laboratories were calculated.Thesimple practical tools can help laboratory to select the right control rules,the right number of control measurements and the right run size for bracketed SQCof continuous production analyzers so as to realize the patient risk minimization〉

参考文献/References:

[1] Clinical and Laboratory Standards Institute.Statisticalquality control for quantitative measurement procedures:principles and definitions[S].4th ed.Wayne:PA,CLSI C24-A3,2016.
[2] WESTGARD J O, GROTH T.Power functions for statistical control rules[J].Clinical Chemistry,1979,25(6):863-869.
[3] Clinical and Laboratory Standards Institute.Statistical quality control for quantitative measurement procedures:principles and definitions[J].3rd ed.Wayne:PA,CLSI C24-A3,2016.
[4] WESTGARD J O.Charts of operational process specifications(“OPSpecs charts”)for assessing the precision,accuracy,and quality control neededto satisfy proficiency testing performance criteria[J].Clinical Chemistry,1992,38(7):1245-1250.
[5] WESTGARD J O. Basic quality control practices:training in statistical quality control for medical laboratories[J].4th ed.Madison(WI):Westgard QC,Inc,2016:148-151.
[6] WESTGARD J O,BAYAT H,WESTGARD S A.Planning risk-based SQC schedules for bracketed operation of continuous production analyzers[J].ClinicalChemistry,2018,64(2):289-296.
[7] 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.
[8] WESTGARD J O, WESTGARD S A.Establishing evidence-based statistical quality control practices[J].Am J Clin Pathol,2019,151(4):364-370.

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备注/Memo

备注/Memo:
作者简介:张 莉(1998-),女,四川大学华西临床医学院医学检验系2016级,E-mail:2138477196@qq.com。 通讯作者:黄亨建,主要从事临床检验质量方法研究工作,E-mail:huanghenjian@sina.com。 收稿日期:2019-01-01 修回日期:2019-01-27
更新日期/Last Update: 2019-04-30