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