Objective To analyze the unqualified items that occurred in the operation of the quality management system of Wuhu Blood Center, identify key issues and weak links, and provide a basis for continuous improvement of the quality management system.

Methods Data on the unqualified items identified in routine inspections, internal audits and external audits of Wuhu Blood Center from 2021 to 2025 were collected. The unqualified items were classified and statistically analyzed based on clauses, nature, responsible departments, identification methods and identification entities. The Mann‑Kendall trend test was used to analyze the annual change trend, and the Pearson χ² test was adopted to compare the differences in the nature composition of unqualified items among different departments.

Results A total of 1 194 unqualified items were identified. The number of unqualified items decreased overall from 2021 to 2025. According to the distribution by clauses, the unqualified items mainly concentrated in blood donation services (289 items, 24.20%), materials (184 items, 15.41%) and documentation (134 items, 11.22%). According to the nature classification, effectiveness (562 items, 47.07%) and implementation (467 items, 39.11%) unqualified items were predominant. According to the department distribution, the department of blood collection and supply service had the largest number of unqualified items (651 items, 54.52%). According to the classification by identification route, routine inspections was the main identification route (826 items, 69.18%). According to the classification by identification subject, downstream departments identification (345 items, 28.89%) and self-department identification (267 items, 22.36%) were the two main identification subjects. The results of Pearson's χ² test indicated that there was a statistically significant difference in the nature composition of unqualified items among different departments (χ²=615.16,P < 0.01).

Conclusion The overall operation of the quality management system of Wuhu Blood Center is effective, but there are problems such as details management loopholes in key links and insufficient execution. Future work should focus on strengthening the training of front-line personnel, optimizing core business processes, in order to drive the quality management system of the blood station to a higher level.

1. 张晓霞, 李晓龙. 持续质量改进对血站采血护理质量及血液质量的影响[J]. 中国卫生标准管理, 2023, 14(5): 165-168.ZhangXX, LiXL. The impact of continuous quality improvement on the quality of blood collection care and blood quality in blood banks[J]. China Health Standard Management, 2023, 14(5): 165-168. DOI: 10.3969/j.issn.1674-9316.2023.05.036.

2. GammonRR, DubeyR, GuptaGK, et al. Patient blood management and its role in supporting blood supply[J]. J Blood Med, 2023, 14: 595-611. DOI: 10.2147/JBM.S387322.

3. ShiJ. Status analysis and evaluation of the blood scrap rate from 2015-2017 for a blood center in China[J]. Transfus Clin Biol, 2020, 27(3): 109-114. DOI: 10.1016/j.tracli.2020.06.010.

4. 中华人民共和国卫生部.卫生部关于印发《血站质量管理规范》的通知[EB/OL]. (2006-04-25) [2026-04-27]. https://www.nhc.gov.cn/wjw/gfxwj/200607/bb4ad624b49a4495a3948de6966bd5fd.shtml.

5. 郭丽玮. 不符合项的识别、报告及调查处理[J].中国社区医师, 2014, 30(7): 71-72.GuoLW. Identify, report and investigation and handling of non-conformance term[J]. Chinese Community Doctors, 2014, 30(7): 71-72. DOI: 10.3969/j.issn.1007-614x.2014.7.48.

6. 李雪梅, 付海忠, 董菲, 等. 基于外部审核模式的血站质量管理体系评价与持续改进[J].中国输血杂志, 2023, 36(11): 1040-1045.LiXM, FuHZ, DongF, et al. Evaluation and improvement of blood station quality management system: based on external audit[J]. Chinese Journal of Blood Transfusion, 2023, 36(11): 1040-1045. DOI: 10.13303/j.cjbt.issn.1004-549x.2023.11.017.

7. 周静宇, 孙俊. 2015年度江苏省采供血机构联合内审情况分析[J]. 临床输血与检验, 2017, 19(3): 304-305.ZhouJY, SunJ. Analysis of joint internal audit of blood collection and supply institutions in Jiangsu Province in 2015[J]. Journal of Clinical Transfusion and Laboratory Medicine, 2017, 19(3): 304-305. DOI: 10.3969/j.issn.1671-2587.2017.03.027.

8. 张春梅. 临沂市中心血站质量管理体系不合格项的统计分析[J]. 中国输血杂志, 2019, 32(3): 307-309.ZhangCM. Statistical analysis of the unqualified items in the quality control system of Linyi Blood Center[J]. Chinese Journal of Blood Transfusion, 2019, 32(3): 307-309. DOI: 10.13303/j.cjbt.issn.1004-549x.2019.03.029.

9. 王绒和, 孙蕊娟. 咸阳血站质量管理不合格项统计分析[J]. 临床输血与检验, 2015, 17(5): 453-455.WangRH, SunRJ. Statistical analysis of non-conformities in quality management of Xianyang Blood Station[J]. Journal of Clinical Transfusion and Laboratory Medicine, 2015, 17(5): 453-455. DOI: 10.3969/j.issn.1671-2587.2015.05.024.

10. 袁海涛. 2015-2019年血站质量管理不合格项回顾性分析[J]. 江苏卫生事业管理, 2021, 32(6): 775-778, 782.YuanHT. Retrospective analysis of non-conformities in blood station quality management from 2015 to 2019[J]. Jiangsu Health System Management, 2021, 32(6): 775-778, 782. DOI: 10.3969/j.issn.1005-7803.2021.06.022.

11. 段云霞. 采供血服务中实施差错管理对提高血站管理规范化及血液质量的影响[J]. 中国标准化, 2022, (20): 257-260.DuanYX. The influence of implementing error management in blood collection and supply service on improving the standardization of blood station management and blood quality[J]. China Standardization, 2022, (20): 257-260. DOI: 10.3969/j.issn.1002-5944.2022.20.054.

12. 李鹏飞, 袁红, 高钰然, 等. 吉林省采供血机构质量管理体系不符合项调查及改进分析[J]. 生命科学仪器, 2025, 23(5): 144-146.LiPF, YuanH, GaoYR, et al. Investigation and improvement analysis of nonconformities in quality management system of blood collection and supply institutions in Jilin Province[J]. Life Science Instruments, 2025, 23(5): 144-146. DOI: 10.11967/2025231047.

13. ReasonJ. Human error: models and management[J]. BMJ, 2000, 320(7237): 768-770. DOI: 10.1136/bmj.320.7237.768.

14. JuskewitchJE, BriggsL, KhanJ, et al. How do we leverage data through replication and warehousing to meet blood collection and transfusion service needs[J]. Transfusion, 2024, 64(6): 969-978. DOI: 10.1111/trf.17845.

15. 王园园, 王珍, 张韦, 等. 血站典型不良事件案例分析与防范策略[J]. 国际输血及血液学杂志, 2025, 48(3): 273-276.WangYY, WangZ, ZhangW, et al. Case analysis and prevention strategies of typical adverse events in blood station[J]. International Journal of Blood Transfusion and Hematology, 2025, 48(3): 273-276. DOI: 10.3760/cma.j.cn511693-20240927-00143.

16. 代华友, 刘开强, 刘晓杰, 等. 2020～2021年全国部分地区采供血不良事件哨点监测情况分析[J]. 临床输血与检验, 2023, 25(1): 56-62.DaiHY, LiuKQ, LiuXJ, et al. Analysis of haemovigilance of adverse events in blood establishments from 2020 to 2021[J]. Journal of Clinical Transfusion and Laboratory Medicine, 2023, 25(1): 56-62. DOI: 10.3969/j.issn.1671-2587.2023.01.010.

17. SheeranP, WebbTL. The intention-behavior gap[J]. Social and Personality Psychology Compass, 2016, 10(9): 503-518. DOI: 10.1111/spc3.12265.

18. 刘丽, 庄文韬. 血站检验科质量控制关键点的质量管理[J]. 中国卫生产业, 2021, 18(16): 67-70.LiuL, ZhuangWT. The quality management of the key points of the quality control of the blood laboratory[J]. China Health Industry, 2021, 18(16): 67-70. DOI: 10.16659/j.cnki.1672-5654.2021.16.067.

19. 杨晨曦. 如何充分发挥质管科的质量管理职能[J]. 中国卫生质量管理, 2011, 18(6): 74-76.YangCX. How to develop quality management function of the quality control department[J]. Chinese Health Quality Management, 2011, 18(6): 74-76. DOI: 10.3969/j.issn.1006-7515.2011.06.023.

20. 贾璐, 石洁, 郑建勇. 血站质量管理体系不合格项回顾性分析[J]. 中国卫生质量管理, 2019, 26(6): 119-121.JiaL, ShiJ, ZhengJY. The unqualified items in the quality management system of blood station:a retrospective analysis[J]. Chinese Health Quality Management, 2019, 26(6): 119-121. DOI: 10.13912/j.cnki.chqm.2019.26.6.32.

21. 杨丹蓉, 代华友, 杨俊鸿, 等. 利用日巡查提高血站质量管理水平[J]. 中国卫生质量管理, 2022, 29(2): 95-97.YangDR, DaiHY, YangJH, et al. Improving the quality management level of blood station by daily inspection[J]. Chinese Health Quality Management, 2022, 29(2): 95-97. DOI: 10.13912/j.cnki.chqm.2022.29.2.22.

22. 程卫芳. 血站质量管理体系内部审核结果分析[J]. 中国输血杂志, 2010, 23(10): 826-827.ChengWF. Analysis of internal audit results of blood station quality management system[J]. Chinese Journal of Blood Transfusion, 2010, 23(10): 826-827. DOI: 10.13303/j.cjbt.issn.1004-549x.2010.10.019.

23. ChaudharyR, DasSS, OjhaS, et al. The external quality assessment scheme: five years experience as a participating laboratory[J]. Asian J Transfus Sci, 2010, 4(1): 28-30. DOI: 10.4103/0973-6247.59388.

24. 王锦, 邱艳, 崔爽, 等. 溯源性审核在采供血机构质量内部审核中的运用[J]. 临床输血与检验, 2020, 22(4): 405-407.WangJ, QiuY, CuiS, et al. Application of traceability audit in internal audit quality of blood collection and supply organization[J]. Journal of Clinical Transfusion and Laboratory Medicine, 2020, 22(4): 405-407. DOI: 10.3969/j.issn.1671-2587.2020.04.017.