Article(id=1320389046765998644, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388968923902012, articleNumber=null, orderNo=null, doi=10.11876/mimt202505010, 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=1792734880390, onlineDateStr=2026-10-23, pubDate=1760025600000, pubDateStr=2025-10-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792734880390, onlineIssueDateStr=2026-10-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792734880390, creator=13701087609, updateTime=1792734880390, updator=13701087609, issue=Issue{id=1320388968923902012, tenantId=1146029695717560320, journalId=1319373289681944729, year='2025', volume='31', issue='5', pageStart='1', pageEnd='108', issueExtLink='null', onlineDate='null', pubDate='1760025600000', pubDateStr='2025-10-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792734861832, creator='13701087609', updateTime=1792746392297, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1320437331253900271, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388968923902012, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1320437331253900272, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388968923902012, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=64, endPage=69, ext={EN=ArticleExt(id=1320389046988296757, articleId=1320389046765998644, tenantId=1146029695717560320, journalId=1319373289681944729, language=EN, title=The application of quality control circle to improve the standard usage rate of indentation needle in Phase I clinical trials, columnId=null, journalTitle=Modern Instruments & Medical Treatment, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective

To carry out Quality Control Circle (QCC) activities aiming to improve the standardized utilization rate of intravenous indwelling needles in Phase I clinical trials.

Methods

A total of 120 subjects enrolled in the trial from February 2 to 9, 2023, were assigned to the control group, with 144 blood sample collections performed. Separately, 134 subjects enrolled in the trial from August to October 2023 were assigned to the observation group, with 160 blood sample collections performed. QCC management tools (e.g., Pareto charts, fishbone diagrams) were used for root cause analysis to identify the causes of non-standard practices in the use of indwelling needles, and corresponding improvement measures were formulated and implemented. The standardized utilization rate of indwelling needles before and after the QCC activities was compared, and the application effect of the QCC activities was analyzed.

Results

The standardized utilization rate of indwelling needles increased from 43.75% before the activities to 75.63% (χ2=32.23, P<0.05), with a target achievement rate of 105.49% and an improvement rate of 72.87%. In terms of intangible effects, the circle members' abilities in QCC technique application, teamwork, professional knowledge mastery, communication and coordination, sense of responsibility, and problem-solving capabilities were significantly improved.

Conclusion

Conducting QCC activities improved the standardized utilization rate of indwelling needles in Phase I clinical trials, ensured blood collection safety, enhanced nursing quality, and maintained a balance between subject protection and compliance with the research protocol.

, authors=Zhujun Shao, Yan Zong*, Xiaoju Wang, Wenwen Cao, authorsList=Zhujun Shao, Yan Zong, Xiaoju Wang, Wenwen Cao, authorCompany=null, correspAuthors=Yan Zong, authorNote=null, correspAuthorsNote=null, copyrightStatement=All copyrights in 2025 belong to the sponsor of the journal.Not content published by the journal may be reproduced or abridged without authorization., copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1320389047214789174, articleId=1320389046765998644, tenantId=1146029695717560320, journalId=1319373289681944729, language=CN, title=品管圈在提升Ⅰ期临床试验留置针规范使用率中的应用, columnId=1320381058969883180, journalTitle=现代仪器与医疗, columnName=临床研究, runingTitle=null, highlight=null, articleAbstract=
目的

开展品管圈活动,以提高留置针在Ⅰ期临床试验中的规范使用率。

方法

将2023年2月2日—9日纳入试验的120例受试者作为对照组,采集血样144例次;2023年8月—10月纳入试验的134例受试者作为观察组,采集血样160例次。运用品管圈管理工具如柏拉图、鱼骨图等进行根因分析,探讨留置针使用过程中不规范现象的原因,制定改进措施并实施,比较品管圈活动开展前后的留置针规范使用率,分析品管圈活动的应用效果。

结果

留置针规范使用率从活动前的43.75%上升至75.63%,差异有统计学意义(χ2=32.23,P<0.05);目标达成率为105.49%,改善幅度为72.87%。无形效果方面,圈员在品管圈手法应用、团队合作、专业知识、沟通协调、责任心及解决问题能力等方面都得到显著提升。

结论

通过开展品管圈活动提升了Ⅰ期临床试验留置针规范使用率,保障采血安全,提升护理质量,确保受试者保护与研究方案依从之间的平衡。

, authors=邵竹君, 宗岩*, 王小菊, 曹雯雯, authorsList=邵竹君, 宗岩, 王小菊, 曹雯雯, authorCompany=null, correspAuthors=宗岩, authorNote=

邵竹君,女,本科,主管护师,研究方向:皮肤科护理

, correspAuthorsNote=
宗岩,女,本科,主管护师,研究方向:护理管理
, copyrightStatement=2025年版权归本刊主办单位所有未经本刊书面许可, 不得转载、摘编本刊所有文章内容。, copyrightOwner=中国科学器材公司, extLink=null, articleAbsUrl=null, sourceXml=ElmYqavilMdS/7c3MOXICg==, magXml=rzhQPF0pV1kaVd4DtZWPeg==, pdfUrl=null, pdf=Jk0Gu2gHRNmPAubfXmxyUw==, pdfFileSize=2156126, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=HA63/jImyYDjTtjsAj+cLA==, mapNumber=null, fund=null)}, authors=[Author(id=1320389047567110715, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320389046765998644, orderNo=0, 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={EN=AuthorExt(id=1320389047646802493, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320389046765998644, authorId=1320389047567110715, language=EN, stringName=Zhujun Shao, firstName=Zhujun, middleName=null, lastName=Shao, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Hospital for Skin Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1320389047713911358, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320389046765998644, authorId=1320389047567110715, language=CN, stringName=邵竹君, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=中国医学科学院 北京协和医学院皮肤病医院,南京 210042, bio={"content":"

邵竹君,女,本科,主管护师,研究方向:皮肤科护理

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品管圈在提升Ⅰ期临床试验留置针规范使用率中的应用
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邵竹君 , 宗岩 * , 王小菊 , 曹雯雯
现代仪器与医疗 | 临床研究 2025,31(5): 64-69
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现代仪器与医疗 |临床研究 2025 , 31 (5) : 64 -69
品管圈在提升Ⅰ期临床试验留置针规范使用率中的应用
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邵竹君, 宗岩*, 王小菊, 曹雯雯
作者信息
  • 中国医学科学院 北京协和医学院皮肤病医院,南京 210042
通讯作者:
宗岩,女,本科,主管护师,研究方向:护理管理
作者简介:

邵竹君,女,本科,主管护师,研究方向:皮肤科护理

The application of quality control circle to improve the standard usage rate of indentation needle in Phase I clinical trials
Zhujun Shao, Yan Zong*, Xiaoju Wang, Wenwen Cao
Affiliations
  • Hospital for Skin Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, China
出版时间: 2025-10-10 doi: 10.11876/mimt202505010
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目的

开展品管圈活动,以提高留置针在Ⅰ期临床试验中的规范使用率。

方法

将2023年2月2日—9日纳入试验的120例受试者作为对照组,采集血样144例次;2023年8月—10月纳入试验的134例受试者作为观察组,采集血样160例次。运用品管圈管理工具如柏拉图、鱼骨图等进行根因分析,探讨留置针使用过程中不规范现象的原因,制定改进措施并实施,比较品管圈活动开展前后的留置针规范使用率,分析品管圈活动的应用效果。

结果

留置针规范使用率从活动前的43.75%上升至75.63%,差异有统计学意义(χ2=32.23,P<0.05);目标达成率为105.49%,改善幅度为72.87%。无形效果方面,圈员在品管圈手法应用、团队合作、专业知识、沟通协调、责任心及解决问题能力等方面都得到显著提升。

结论

通过开展品管圈活动提升了Ⅰ期临床试验留置针规范使用率,保障采血安全,提升护理质量,确保受试者保护与研究方案依从之间的平衡。

留置针  /  Ⅰ期临床试验  /  品管圈活动
Objective

To carry out Quality Control Circle (QCC) activities aiming to improve the standardized utilization rate of intravenous indwelling needles in Phase I clinical trials.

Methods

A total of 120 subjects enrolled in the trial from February 2 to 9, 2023, were assigned to the control group, with 144 blood sample collections performed. Separately, 134 subjects enrolled in the trial from August to October 2023 were assigned to the observation group, with 160 blood sample collections performed. QCC management tools (e.g., Pareto charts, fishbone diagrams) were used for root cause analysis to identify the causes of non-standard practices in the use of indwelling needles, and corresponding improvement measures were formulated and implemented. The standardized utilization rate of indwelling needles before and after the QCC activities was compared, and the application effect of the QCC activities was analyzed.

Results

The standardized utilization rate of indwelling needles increased from 43.75% before the activities to 75.63% (χ2=32.23, P<0.05), with a target achievement rate of 105.49% and an improvement rate of 72.87%. In terms of intangible effects, the circle members' abilities in QCC technique application, teamwork, professional knowledge mastery, communication and coordination, sense of responsibility, and problem-solving capabilities were significantly improved.

Conclusion

Conducting QCC activities improved the standardized utilization rate of indwelling needles in Phase I clinical trials, ensured blood collection safety, enhanced nursing quality, and maintained a balance between subject protection and compliance with the research protocol.

Intravenous indwelling needle  /  Phase I clinical trial  /  Quality control circle activity
邵竹君, 宗岩, 王小菊, 曹雯雯. 品管圈在提升Ⅰ期临床试验留置针规范使用率中的应用. 现代仪器与医疗, 2025 , 31 (5) : 64 -69 . DOI: 10.11876/mimt202505010
Zhujun Shao, Yan Zong, Xiaoju Wang, Wenwen Cao. The application of quality control circle to improve the standard usage rate of indentation needle in Phase I clinical trials[J]. Modern Instruments & Medical Treatment, 2025 , 31 (5) : 64 -69 . DOI: 10.11876/mimt202505010
  • 江苏省自然科学基金(BK20210049)
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doi: 10.11876/mimt202505010
  • 首发时间:2026-10-23
  • 出版时间:2025-10-10
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江苏省自然科学基金(BK20210049)
作者信息
    中国医学科学院 北京协和医学院皮肤病医院,南京 210042

通讯作者:

宗岩,女,本科,主管护师,研究方向:护理管理
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
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