卫生行业标准《献血不良反应分类指南》实施效果初步评价

Preliminary evaluation on the implementation of the health standard Guidelines on Classification of Adverse Reactions to Blood Donation

目的评价卫生行业标准《献血不良反应分类指南(WS/T 551-2017)》(简称《指南》)实施1年后的效果。方法将《指南》与国际输血协会(ISBT)《献血相关并发症监测标准(2014版)》及国内《血站管理办法》、《血站质量管理规范》、《血站技术操作规程》、《献血场所配置要求》、《献血相关迷走神经反应预防与处置指南》等采供血相关法规、规程以及其他标准做对比分析;调研全国101家省、市两级血站实施《指南》的情况;统计并比较各血站在《指南》实施前3年与实施1年来报告的献血不良反应数据。结果《指南》与《献血相关并发症监测标准(2014版)》献血不良反应分类的一致率为71.43%(15/21),与《血站管理办法》《血站质量管理规范》《血站技术操作规程》《献血场所配置要求》《献血相关迷走神经反应预防与处置指南》等采供血相关法规、规程和其他标准的符合率100%(5/5);参与调研的血站对《指南》的采用率为79.21%(80/101)。《指南》实施前3年每年报告的献血不良反应平均为(9786±985)例、实施后1年跃升至18375例,增加率(18375-9786)/9786×100%=87.77%。其中采用《指南》作为监测依据的血站在实施指南后报告的献血不良反应增加率(16112-7726)/7726×100%=108.54%,未采用指南的血站同时仅增加了(2263-2061)/2061×100%=9.80%。《指南》实施1年来被引用次数为5次。结论《指南》与相关国际标准之间基本一致,但还存在一些差异(距),与现行采供血相关法规、规程及其他标准有较好的协调性。《指南》实施1年来已为大多数血站所采用,有效提升了采供血机构监测献血不良反应的效果。

Objective To evaluate the efficacy of the health standard Guidelines on Classification of Adverse Reactions to Blood Donation(WS/T 551-2017)(referred to as the Guidelines)one year after the implementation.Methods The Guidelines were compared with relevant regulations,laws,and other standards of blood collection and supply,such as ISBT’s Standard for Surveillance of Complications Related to Blood Donation(2014 revision),Management of Blood Stations,Regulations on Quality Management of Blood Stations,Regulations on Operation Technologies in Blood Stations,Requirement for Blood Donation Settings,Guidelines on the Interventions for Donation Related Vasovagal Reaction,etc.A total of 101 provincial and municipal blood service institutions were investigated for the implementation of the Guidelines.Average data of adverse reactions reported by each blood institution 3 years before and one year after the implementation of Guidelines were collected and compared.Results The consistency rate of the sub-category between the Guidelines and the ISBT standard was 71.43%(15/21),while the coincidence rate was 100%(5/5)with other regulations or standards mentioned above.The adoption rate of the Guidelines in these institutions was 79.21%(80/101).The average number of adverse reactions increased from 9786±985(3 years before guideline-implementation)to 18375(one year after implementation),with an increase rate of 87.77%.Notably,the increase rate in Guideline-based institutions was 108.54%,in contrast to 9.80%from Guideline-omitted institutions.Meanwhile,the Guideline has been cited 5 times in publication in the past year.Conclusion Despite of the minor variation or difference,the Guidelines has showed a good consistency with relevant international standards,which are in good coordination with the current laws,regulations and other standards related to blood collection and supply.The Guidelines has been adopted in most blood service institutions in the past year and effectively promotes adverse reaction surveillance in blood collection and supply institutions.