Article(id=1153016483778125827, tenantId=1146029695717560320, journalId=1146119944283992078, issueId=1153016476459066182, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1752830151743, onlineDateStr=2025-07-18, pubDate=null, pubDateStr=null, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1752830151743, onlineIssueDateStr=2025-07-18, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1752830151743, creator=13701087609, updateTime=1752830151743, updator=13701087609, issue=Issue{id=1153016476459066182, tenantId=1146029695717560320, journalId=1146119944283992078, year='2025', volume='3', issue='1', pageStart='1', pageEnd='160', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1752830149998, creator=13701087609, updateTime=1753700684032, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1156667760873693905, tenantId=1146029695717560320, journalId=1146119944283992078, issueId=1153016476459066182, language=EN, specialIssueTitle=, coverIllustrator=, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1156667760873693906, tenantId=1146029695717560320, journalId=1146119944283992078, issueId=1153016476459066182, language=CN, specialIssueTitle=, coverIllustrator=, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=49, endPage=51, ext={CN=ArticleExt(id=1153016487058071655, articleId=1153016483778125827, tenantId=1146029695717560320, journalId=1146119944283992078, language=CN, title=60 理论在改进常规临床化学检验室内质控的应用效果评估, columnId=1152194692222432247, journalTitle=实验室检测, columnName=实验室管理, runingTitle=null, highlight=null, articleAbstract=
目的 将6σ质量管理标准引入临床生化检验质量控制,评估其在改进常规临床化学检验室内质控的效果,提升结果的准确性和可靠性。方法 选取贝克曼 AU5800 检测系统的24个常规化学检验项目,采用6σ 质量管理理论,计算各项目的σ值,分析正确度和精密度,并与传统的 Westgard 多规则质控方法比较。结果 6σ标准能有效选择适宜的质控规则,降低失控发生率,减少“假失控”,在提高检验质量和管理效率方面优于传统方法。结论 6σ质量管理标准可显著提升临床生化检验质量管理水平,确保结果的准确性和可靠性,优化质控管理程序。
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1 浙江大学医学院附属第二医院 杭州 310009, bio={"content":"
龚丽文，技师，研究方向为临床检验基础形态学工作。
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龚丽文，技师，研究方向为临床检验基础形态学工作。
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1 浙江大学医学院附属第二医院 杭州 310009)])]), Author(id=1154798131293311114, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, orderNo=1, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={CN=AuthorExt(id=1154798131435917454, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, authorId=1154798131293311114, language=CN, stringName=王宁, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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2 上海市崇明区新河社区卫生服务中心 上海 202156, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1154798130622222451, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, xref=2, ext=[AuthorCompanyExt(id=1154798130630611060, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, companyId=1154798130622222451, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
2 上海市崇明区新河社区卫生服务中心 上海 202156)])]), Author(id=1154798131544969359, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, orderNo=2, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=472359982@qq.com, emailSecond=null, emailThird=null, correspondingAuthor=1, authorType=1, ext={CN=AuthorExt(id=1154798131876319384, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, authorId=1154798131544969359, language=CN, stringName=张旭, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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3 上海健康医学院附属崇明医院 检验科 上海 202150, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1154798131058430080, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, xref=3, ext=[AuthorCompanyExt(id=1154798131066818689, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, companyId=1154798131058430080, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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1 浙江大学医学院附属第二医院 杭州 310009)]), AuthorCompany(id=1154798130622222451, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, xref=2, ext=[AuthorCompanyExt(id=1154798130630611060, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, companyId=1154798130622222451, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
2 上海市崇明区新河社区卫生服务中心 上海 202156)]), AuthorCompany(id=1154798131058430080, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, xref=3, ext=[AuthorCompanyExt(id=1154798131066818689, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, companyId=1154798131058430080, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
3 上海健康医学院附属崇明医院 检验科 上海 202150)])], figs=[ArticleFig(id=1154798134229324001, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, language=EN, label=null, caption=null, figureFileSmall=zscxUzwb9w4yToEYzmAl+g==, figureFileBig=jVZjc1wHRb5xvaJ3annPjg==, tableContent=null), ArticleFig(id=1154798134313210083, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, language=CN, label=图 1, caption=
常规临床化学检验项目标准化${6\sigma }$ 性能决定图, figureFileSmall=zscxUzwb9w4yToEYzmAl+g==, figureFileBig=jVZjc1wHRb5xvaJ3annPjg==, tableContent=null), ArticleFig(id=1154798134384513253, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
| 项目 | CV(%) | Bias(%) | TEa(%) | σ值 | QGI 值 | 优先改进 | QC 方案 | 性能 |
| K | 4.49 | 1.27 | 10 | 1.94 | 0.19 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| NA | 1.62 | 1.85 | 4 | 1.33 | 0.76 | 精密度 | 13S/22S/R4S/41S/8 | 不可接受 |
| CL | 1.72 | 0.57 | 5 | 2.58 | 0.22 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 欠佳 |
| CA | 2.06 | 1.16 | 5 | 1.86 | 0.38 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| P | 3.36 | 2.33 | 10 | 2.28 | 0.46 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 欠佳 |
| GLU | 5.82 | 1.96 | 10 | 1.38 | 0.22 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| UN | 7.07 | 7.47 | 9 | 0.22 | 0.70 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| UA | 5.7 | 8.24 | 17 | 1.54 | 0.96 | 精密度 + 准确度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| CRE | 4.59 | 5.12 | 12 | 1.50 | 0.74 | 精密度 + 准确度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| TP | 3.02 | 1.27 | 10 | 2.89 | 0.28 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 欠佳 |
| ALB | 4.52 | 1.94 | 10 | 1.78 | 0.29 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| TCH | 3.25 | 2.42 | 9 | 2.02 | 0.50 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 欠佳 |
| TG | 1 | 4.03 | 25 | 20.97 | 2.69 | - | 13s | 一流 |
| TBIL | 8.99 | 8.61 | 20 | 1.27 | 0.64 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| AST | 5.71 | 6.76 | 20 | 2.32 | 0.79 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 欠佳 |
| ALT | 6.53 | 3.49 | 20 | 2.53 | 0.36 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 欠佳 |
| AKP | 5.57 | 8.5 | 30 | 3.86 | 1.02 | 精密度 + 准确度 | 13S/22S/R4S/41S | 临界 |
| AMY | 3.55 | 5.22 | 30 | 6.98 | 0.98 | - | 13s | 一流 |
| CK | 5.01 | 10.26 | 30 | 3.94 | 1.37 | 准确度 | 13S/22S/R4S/41S | 临界 |
| LDH | 3.8 | 0.99 | 30 | 7.63 | 0.17 | - | 13s | 一流 |
| GGT | 4.9 | 0.72 | 20 | 3.93 | 0.098 | 精密度 | 13S/22S/R4S/41S | 临界 |
| $\alpha$ -HBDH | 3.67 | 16.66 | 30 | 3.63 | 3.03 | 准确度 | 13S/22S/R4S/41S | 临界 |
| FE | 4.33 | 2.49 | 25 | 5.20 | 0.38 | 精密度 | 13S/22S/R4S | 优秀 |
| MG | 4.41 | 12.09 | 25 | 2.93 | 1.83 | 准确度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 欠佳 |
), ArticleFig(id=1154798134468399334, tenantId=1146029695717560320, journalId=1146119944283992078, articleId=1153016483778125827, language=CN, label=表 1, caption=
常规临床化学项目的性能评估及 GPI 值计算批号 L1/L3, figureFileSmall=null, figureFileBig=null, tableContent=
| 项目 | CV(%) | Bias(%) | TEa(%) | σ值 | QGI 值 | 优先改进 | QC 方案 | 性能 |
| K | 4.49 | 1.27 | 10 | 1.94 | 0.19 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| NA | 1.62 | 1.85 | 4 | 1.33 | 0.76 | 精密度 | 13S/22S/R4S/41S/8 | 不可接受 |
| CL | 1.72 | 0.57 | 5 | 2.58 | 0.22 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 欠佳 |
| CA | 2.06 | 1.16 | 5 | 1.86 | 0.38 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| P | 3.36 | 2.33 | 10 | 2.28 | 0.46 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 欠佳 |
| GLU | 5.82 | 1.96 | 10 | 1.38 | 0.22 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| UN | 7.07 | 7.47 | 9 | 0.22 | 0.70 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| UA | 5.7 | 8.24 | 17 | 1.54 | 0.96 | 精密度 + 准确度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| CRE | 4.59 | 5.12 | 12 | 1.50 | 0.74 | 精密度 + 准确度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| TP | 3.02 | 1.27 | 10 | 2.89 | 0.28 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 欠佳 |
| ALB | 4.52 | 1.94 | 10 | 1.78 | 0.29 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| TCH | 3.25 | 2.42 | 9 | 2.02 | 0.50 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 欠佳 |
| TG | 1 | 4.03 | 25 | 20.97 | 2.69 | - | 13s | 一流 |
| TBIL | 8.99 | 8.61 | 20 | 1.27 | 0.64 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 不可接受 |
| AST | 5.71 | 6.76 | 20 | 2.32 | 0.79 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 欠佳 |
| ALT | 6.53 | 3.49 | 20 | 2.53 | 0.36 | 精密度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 欠佳 |
| AKP | 5.57 | 8.5 | 30 | 3.86 | 1.02 | 精密度 + 准确度 | 13S/22S/R4S/41S | 临界 |
| AMY | 3.55 | 5.22 | 30 | 6.98 | 0.98 | - | 13s | 一流 |
| CK | 5.01 | 10.26 | 30 | 3.94 | 1.37 | 准确度 | 13S/22S/R4S/41S | 临界 |
| LDH | 3.8 | 0.99 | 30 | 7.63 | 0.17 | - | 13s | 一流 |
| GGT | 4.9 | 0.72 | 20 | 3.93 | 0.098 | 精密度 | 13S/22S/R4S/41S | 临界 |
| $\alpha$ -HBDH | 3.67 | 16.66 | 30 | 3.63 | 3.03 | 准确度 | 13S/22S/R4S/41S | 临界 |
| FE | 4.33 | 2.49 | 25 | 5.20 | 0.38 | 精密度 | 13S/22S/R4S | 优秀 |
| MG | 4.41 | 12.09 | 25 | 2.93 | 1.83 | 准确度 | 13S/22S/R4S/41S/8 $\bar{X}$ | 欠佳 |
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