目的:探讨冷沉淀凝血因子质量情况,分析不合格项目及原因,为采供血机构制备高质量冷沉淀提供理论依据。方法:回顾性分析2013-01-2015-06质管科对采用离心法制备的冷沉淀凝血因子其容量、纤维蛋白原、FⅧ及无菌试验共4项质控抽检结果,从各个环节探讨影响冷沉淀质量的因素。结果:每月随机抽检4袋,连续30批次,共抽检120袋,合格品114袋,合格率为95.0%;不合格品6袋,不合格率为5.0%,不合格原因均为Ⅷ因子含量不足。结论:冷沉淀凝血因子符合血液质量控制项目要求,但仍有少部分产品Ⅷ因子含量不足,主要原因是由于个别工作人员质量意识淡薄,违反操作规程造成,通过加强全过程关键点控制,减少人为差错,其质量可以得到保证。 Objective: To investigate the quality of cryoprecipitate clotting factor, analyze unqualified items and causes, and provide theoretical basis for preparation of high quality cryoprecipitate for blood collection and blood supply. Methods: A retrospective analysis of 2013 QCQQQQQQQQQQFBQQQHQQHQQHQQHQQHQQHQQQQQQQHQQQQHQQQQHQQQQQQQHQQQQHQQJQJQJ (4) Cold precipitation quality factors. Results: 4 bags were randomly sampled every month for 30 batches, a total of 120 bags were selected and 114 bags were qualified, the pass rate was 95.0%; 6 bags were unqualified, the unqualified rate was 5.0%. The unqualified causes were all Ⅷ factors Insufficient content. Conclusion: Cold coagulation factor is in line with the requirements of blood quality control project, but there is still a small part of product Ⅷ factor content is not enough, mainly due to the weak quality awareness of individual staff, in violation of operating procedures caused by strengthening the key points throughout the process control, reducing human Error, its quality can be guaranteed.