[1]王 麟,成景松,胡雪竹.应用统计质量控制(SQC)和诺曼图相结合方法对临床血液学常规检验项目风险管理[J].现代检验医学杂志,2019,34(03):148-150,155.[doi:10.3969/j.issn.1671-7414.2019.03.038]
　WANG Lin,CHENG Jing-song,HU Xue-zhu.Applying Statistical Quality Control(SQC)and Norman Diagram tothe Risk Management of Clinical Hematology Routine Test Items[J].Journal of Modern Laboratory Medicine,2019,34(03):148-150,155.[doi:10.3969/j.issn.1671-7414.2019.03.038]
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应用统计质量控制(SQC)和诺曼图相结合方法对临床血液学常规检验项目风险管理()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第34卷
期数:
2019年03期
页码:
148-150,155
栏目:
质量控制·实验室管理
出版日期:
2019-06-20

文章信息/Info

Title:
Applying Statistical Quality Control(SQC)and Norman Diagram tothe Risk Management of Clinical Hematology Routine Test Items
文章编号:
1671-7414(2019)03-148-04
作者:
王 麟1; 成景松2; 胡雪竹1
(1.成都郫都区中医医院检验科,成都 611730; 2.安康市白河县人民医院检验科,陕西安康 725800)
Author(s):
WANG Lin1; CHENG Jing-song2; HU Xue-zhu1
(1.Department of Clinical Laboratory,PiDistrict Hospital of Traditional Chinese Medicine,Chengdu 611730,China; 2.Department of ClinicalLaboratory,Baihe County People's Hospital in Ankang City,Shaanxi Ankang725800,China)
关键词:
患者风险;  统计质量控制;  σ值;  Sigma-SQC诺曼图
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2019.03.038
文献标志码:
A
摘要:
目的 应用统计质量控制(Statistical quality control,SQC)和诺曼图相结合的方法对实验室高通量连续检测的临床血液学检验常规项目设计符合质量控制的方案。方法 根据实验室血细胞分析仪各常规项目的σ度量值的大小与风险管理的应用图形工具Sigma-SQC诺曼图相结合,设计实验室临床血液学检验常规项目的起始及过程监控程序。结果 对6σ度量值以上的项目白细胞(WBC)和血红蛋白(Hb)采用:起始质控计划采用MR2:13s/22s/R4s多规则,分析样本量为300,PED=0.94; 过程监测计划采用:SR1W2.5s,分析批长度300,Pfr=0.01。对σ度量值为4.7的红细胞(RBC)和4.6的血小板(PLT)起始质控计划采用MR4:13s/22s/R4s/41s多规则,分析样本量=300,误差检出率(PED)=1.00; 过程监测质控计划:SR2W3s,分析批长度=80,Pfr=0.00。结论 本着以起始质控误差检出率最大,过程监测质控的假失控率最低的原则,对实验室临床血液学检验常规项目采用起始质控计划:MR2多规则,分析批长度为80,过程监测质控计划:SR2W3S就可以最大限度减少患者风险,实现实验室质量持续性改进。
Abstract:
Objective Statistical quality control(SQC)andNorman diagram were combined to design a quality control scheme for clinical hematology routine items of high-throughput continuous laboratory tests.Methods According to the sigma metric value of the routine itemsof the laboratory blood cell analyzer and the Sigma-SQC Norman diagram of the risk management application tool,the initial and process monitoring procedures of the routine clinical hematology test were designed.Results For white blood cells(WBC)and hemoglobin(Hb)above the 6σ metric,theinitial QC plan was:MR2:13s/22s/R4s multi-rule,analysis sample size was 300,PED=0.94.Process monitoring quality control plan adopts was:SR1W2.5s,and analysis batch Length 300,Pfr=0.01.For red blood cells(RBC with σ metric of 4.7 and platelets(PLT)with σ metric of 4.6,the initial QC plan uses was:MR4:13s/22s/R4s/41s multi-rule,and analysis sample size=300,error detectionrate(PED)=1.00.Process monitoring quality control plan adopts was:SR2W3s,and analysis batch length= 80,Pfr=0.00.Conclusion Based on the principle that the initial quality control error detection rate is the largest and the false loss of control rate is the lowest in quality control monitoring process,initial quality control plan:MR2 multi-rules,analysis batch length of 80,process monitoring quality control plan:SR2W3s can minimize the risk of patients and achieve continuous improvement of laboratory quality.

参考文献/References:

[1] International Organization for Standardization.IS-O 15189:2012,Medical laboratories-requirements for quality and competence[EB/OL].http://www.iso.org/standard/56115.html.
[2] 孔丽蕊,王华丽,吴 风.基于风险管理设计临床生物化学酶类检测项目质量控制策略[J].现代检验医学杂志,2019,34(1):154-156. KONG Lirui,WANG Huali,WU Feng.Quality control strategy of clinical biochemical enzymes detection project based on risk management[J].Journal of Modern Laboratory Medicine,2019,34(1):154-156.
[3] Clinical Laboratory Standards Institute.CLSI C24A3.Statistical qualitycontrol for quantitative measurement procedures:principles and defnitions,4thEdition[S].Wayne:PA,CLSI C24A3,2016.
[4] 曾玉萍,黄亨建.基于风险管理的统计质量控制策略研究进展[J].中华临床实验室管理(电子杂志),2018,6(4):229-233. ZENG Yuping,HUANG Hengjian.Advances of statistical quality controlplan based on risk management[J].Chinese Journal of Clinical Laboratory Management(Electronic Edition),2018,6(4):229-233.
[5] Clinical and Laboratory Standardtions Institute.CLSI EP23-4.Laboratoryquality control hased on risk management; approved quideline[S].Wayne:PA,CLSI EP23-4,2011.
[6] YUNDT-PACHECO J,PARVIN C A.Validating the performance of QC procedures[J].Clin Lab Med,2013,33(1):75-88.
[7] PARVIN C,YUNDT-PACHECO J.System and method for analyzing a QC strategyfor releasing results:United States Patent 8397302[P/OL].2015-01-20,http://www.free patentson line.com /8397302.html.
[8] YAGO M,ALCOVER S.Selecting statistical procedures for quality control planning based on risk management[J].Clin Chem 2016,62(7):959-965.
[9] BAYAT H.Selecting multi-rule quality control procedures based on patient risk[J].Clin Chem Lab Med,2017,55(11):1702-1708.
[10] WESTGARD J O,BAYAT H,WESTGARD S A.Planning risk-based SQC schedules for bracketed operation of continuous production analyzers[J].Clinical Chemistry,2018,64(2):289-296.

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备注/Memo

备注/Memo:
作者简介:王 麟(1971-),男,副主任技师,主要从事临检及分子生物学研究,E-mail:820922621@qq.com。 收稿日期:2019-03-23 修回日期:2019-04-15
更新日期/Last Update: 2019-06-20