四步法制备冷沉淀模式及其电子信息化管理的建立

Establishment of a four-step model of electronic information management for cryoprecipitate preparation

目的建立连续采用4个步骤(简称四步法)并实现全程电子信息化管理的制备冷沉淀模式,以提高制备冷沉淀的人均工作效率。方法将240袋(230 mL/袋)新鲜冰冻血浆(FFP)随机平分成四步法制备冷沉淀模式组(四步法组):FFP经4℃恒温连续水浴振荡摇摆融化、大容量低温离心机离心、自动分离机制备冷沉淀后,低温速冻机速冻,应用设备管理软件及血站信息管理系统将不同设备在制备冷沉淀过程中的数据明细、分类、汇总以及跟踪、追溯;常规法制备组(虹吸法组):4℃水浴虹吸法制备冷沉淀。结果四步法和虹吸法所制备的冷沉淀凝血因子Ⅷ(FⅧ)含量分别为(131.5±20.6)和(96.6±25.4)IU(P<0.05),纤维蛋白原(Fg)含量分别为和(265.8±71.5)和(221.6±69.3)mg(P<0.05);人均制备冷沉淀效率分别为(7.00±3.12)和(5.28±4.19)袋/(h·人)(P<0.05)。对设备的全程信息化监控,使四步法制备冷沉淀实现了全程的电子明细记录、监测关键控制点以及汇总统计报表。结论四步法制备的冷沉淀符合国家质量标准,而且制备过程中的电子信息化管理提高了制备效率,并实现了冷沉淀制备全程的人、机、料、法、环的信息可追溯。

Objective To establish cryoprecipitate preparation model of electronic information management for promoting more efficiency. Methods We soughed to compare the efficacy of these 2 methods of cryoprecipitate preparation. The first was 4 steps method through electronic information system and data collection platform,including water thawing,gravity centrifugation,automatic separation and low-temperature fast frozen to prepare cryoprecipitate; the second was conventional method by using an inverted siphon. Results The levels of FⅧ in the cryoprecipitate through 2 methods were（ 131. 5 ± 20. 6） IU and（ 96. 6 ± 25. 4） IU（ P 0. 05）,respectively. The fibrinogen levels were（ 265. 8 ± 71. 5） mg and（ 221. 6 ± 69. 3） mg（ P 0. 05）,respectively. Similarly,the working efficiency for 4-step model and conventional method were（ 7. 00 ± 3. 12） and（ 5. 28 ± 4. 19） bag·h-1·person-1（ P 0. 05）,respectively. So we achieved the following functions： electronic detail record,monitoring of critical control and constructing through four steps method. Conclusion The efficiency of cryoprecipitate preparation is improved by 4 steps method,which conforms to the quality standards and achieve the whole traceability function of person,machine,material,method and environment.