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目的了解《血液储存要求》和《临床输血技术规范》在上海市采供血机构和临床用血医疗机构血液安全监管中的应用状况,为加强血液储存安全监管提供参考。方法通过问卷调查和回顾性研究,对全市9家采供血机构及301家开展临床用血的医疗机构的血液储存监管情况进行调查分析。结果 2008—2015年共对9家采供血机构及301家临床用血医疗机构血液安全监督检查2 574户次,共作出血液安全行政处罚12件,处罚率为0.47%。在处罚应用方面,卫生计生行政部门更偏重使用《临床输血技术规范》,在血液安全监管的应用方面,卫生计生监督机构更偏重使用《临床输血技术规范》,在能否满足监管需要方面,卫生计生监督机构认为《临床输血技术规范》更能满足于血液安全监管。结论应明确《血液储存要求》和《临床输血技术规范》的优先等级及适用范围,完善《血液储存要求》及《临床输血技术规范》的标准。
Objective To understand the application of “blood storage requirements” and “clinical blood transfusion technical specifications” in the blood safety supervision of blood collection and supply institutions and clinical blood medical institutions in Shanghai, so as to provide reference for strengthening the safety supervision of blood storage. Methods Through the questionnaire survey and retrospective study, the regulation of blood storage in 9 blood collection and delivery agencies and 301 medical institutions that carried out clinical blood tests in the city was investigated. Results A total of 2 574 blood safety inspections were conducted among 9 blood collection and delivery agencies and 301 clinical blood medical institutions from 2008 to 2015. A total of 12 administrative sanctions were made against blood safety, with a penalty rate of 0.47%. In terms of the application of sanctions, the administrative departments of public health and family planning put more emphasis on using the “Technical Specifications for Clinical Blood Transfusion”. In terms of the application of blood safety regulation, the health and family planning supervisory agencies place more emphasis on using the “Clinical Transfusion Technical Code”, and in meeting the regulatory needs, Family planning supervisory body that “clinical blood transfusion technical specifications” to better meet the blood safety regulations. Conclusion The priorities and scope of “Blood Storage Requirements” and “Clinical Transfusion Technical Specifications” should be clearly defined, and the standards of “Blood Storage Requirements” and “Clinical Transfusion Technical Specifications” should be improved.