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The application of quality control circle to improve the standard usage rate of indentation needle in Phase I clinical trials
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Zhujun Shao, Yan Zong*, Xiaoju Wang, Wenwen Cao
Modern Instruments & Medical Treatment | 2025, 31(5) : 64 - 69
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Modern Instruments & Medical Treatment | 2025, 31(5): 64-69
The application of quality control circle to improve the standard usage rate of indentation needle in Phase I clinical trials
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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
Published: 2025-10-10 doi: 10.11876/mimt202505010
Outline
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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
Year 2025 volume 31 Issue 5
55
12
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doi: 10.11876/mimt202505010
  • Online Date:2026-10-23
  • Published:2025-10-10
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    Hospital for Skin Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
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
栓菌属 Trametes 5 2.39
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