六西格玛质量管理方法在内分泌项目质量控制中的应用  

Application of Six Sigma Quality Management Approach in Quality Control of Endocrine Index Detection

作　　者：陶春妃 陈欣 黄潇苇[1] 王娴[1] 赵如翠 Tao Chunfei;Chen Xin;Huang Xiaowei;Wang Xian;Zhao Rucui(Department of Clinical Laboratory,Chengdu Third People's Hospital,Chengdu 610031,China)

机构地区：[1]成都市第三人民医院检验科,成都610031

出　　处：《成都医学院学报》2023年第6期721-726,共6页Journal of Chengdu Medical College

基　　金：四川省中医药管理局科学技术研究专项课题(No:2020CP0003)。

摘　　要：目的探究六西格玛(6σ)质量管理方法在医院内分泌项目中的实践和应用。方法以成都市第三人民医院2022年参与国家卫生健康委员会临床检验中心(NCCL)室间质量评价(EQA)所选择的20个内分泌相关指标作为质量评估标准,结合获得数据,使用4种不同来源的性能标准作为具体的评价目标,借助6σ计算公式获得较详细的σ值,并进行性能验证、评价分析,设计进行质量控制的具体方案。统计σ<6的项目,计算相应项目的质量目标指数(QGI),对性能不佳的主要原因进行分析,提出优先改进措施。结果采用NCCL EQA标准时,10个项目达到6σ;采用生物学变异适当标准时,孕酮(P)、维生素B12(VB12)、总25-羟维生素D(25-OHVD)、促肾上腺皮质激素(ACTH)无参考标准,6个项目达到6σ;采用美国临床实验室标准化协会(CLIA)质量目标(2024)标准时,游离三碘甲状原氨酸(FT3)、C-肽(C-P)、胰岛素(INS)、25-OHVD、ACTH、甲状腺球蛋白(TG)无参考标准,6个项目达到6σ;采用澳大利亚皇家病理学院分析质量(RCPA ALP)标准时,25-OHVD无参考标准,1个项目达到6σ。结合项目的具体性能情况,进行质控方案的有效设计。三碘甲状原氨酸(T3)、促甲状腺刺激激素(TSH)、皮质醇(CORT)、卵泡刺激素(FSH)、催乳素(PRL)、C-P、INS、VB12、甲状旁腺激素(PTH)、ACTH采用13s(N=2,R=1)质量控制规则;FT3、游离甲状腺素(FT4)、黄体生成素(LH)、睾酮(T)、TG采用13s/22s/R4s(N=2,R=1)质量控制规则;甲状腺素(T4)、雌二醇(E2)、P、叶酸(FA)、25-OHVD采用13s/22s/R4s/41S(N=4,R=1或N=2,R=2)。根据QGI值,FT3、FT4、T4、E2、LH、P、T、FA、25-OHVD和TG需优先改进精密度。结论通过6σ质量管理对内分泌项目进行性能客观评价,能及时发现需优化改进的项目,最大限度提升实验室质量管理的有效性。Objective To explore the practice and application of six Sigma(6σ)quality management approach in hospital detection of endocrine indexes.Methods The 20 endocrine-related indexes selected by the Third People's Hospital of Chengdu when participating in the external quality assessment(EQA)of the National Center for Clinical Laboratories(NCCL)in 2022 were used as the quality assessment criteria.Combined with the data obtained,four quality specifications of different sources were used as the specific evaluation objectives.The more detailedσvalues were obtained by using the 6σcalculation formula.The performance verification,evaluation and analysis were carried out.And the specific scheme for quality control was designed.The quality goal index(QGI)for indexes withσ<6 were calculated.The main reasons for their poor performance were analyzed,and the improvement measures were put forward.Results Under EQA of NCCL,theσvalues of 10 of the 20 endocrine indexes reached 6σ;Under the Appropriate Criteria for Biological Variation,6 indexes reached 6σ,and there were no reference standards for progesterone(P),Vitamin B 12(VB12),total 25-hydroxyvitamin D(25-OHVD),and adrenocorticotrophic hormone(ACTH);Under the criteria of Quality Objec tives(2024)of American Clinical Laboratory Improvement Amendments(CLIA),6 indexes reached 6σ,and there were no reference standards for free triiodothyronine(FT3),C-peptide(C-P),insulin(INS),25-OHVD,ACTH,and thyroglobulin(TG);And under the criteria of Royal College of Pathologists of Australasia Allowable Limits of Performance(RCPA ALP),1 index reached 6σ,and there was no reference standard for 25-OHVD.Quality control schemes were designed according to the specific performance of the indexes.Triiodothyronine(T3),thyroid stimulating hormone(TSH),cortisol(CORT),follicle stimulating hormone(FSH),prolactin(PRL),C-P,INS,VB12,parathyroid hormone(PTH),and ACTH were subjected to 13s(N=2,R=1)quality control rules;FT3,free thyroxin(FT4),luteinizing hormone(LH),testosterone(T),and TG were subjected to 1

关 键 词：六西格玛 室间质量评价 内分泌 质量控制 

分 类 号：R197.32[医药卫生—卫生事业管理]