我国血站细菌污染防控措施及质控实验室现况调查

Current status of bacterial contamination control and prevention measures and construction of quality control laboratory in Chinese blood stations

  • 摘要:
    目的  评估我国血站细菌污染防控措施及质控实验室工作现状, 分析问题并提出改进建议。
    方法  2024年5-6月由中国采供血机构执业比对工作组秘书处发放调查问卷41份, 收到40份(14家血液中心、26家中心血站)问卷反馈, 其中有效问卷39份。问卷涵盖消毒与监测、质控实验室建设、成分血无菌试验和输血反应监测四方面, 数据采用分项统计与描述性分析。
    结果  84.62%的血站使用含碘消毒剂进行献血者手臂消毒, 监测频率以每月为主;质控实验室中, 43.59%备案为生物安全二级, 35.90%未备案;实验室压力设置:64.10%常压、15.38%负压、17.95%正压;无菌试验中, 超净工作台与生物安全柜使用率均为48.72%, 79.49%未设室内质控, 仅35.90%参与室间质评。阳性结果确认方式:25.64%重复试验, 15.38%结合阳性培养瓶确认。资金不足为无菌试验主要限制因素, 阳性确认是核心难题。53.85%的血站反馈医院输血反应报告不足, 25.64%曾遇疑似细菌性输血反应但培养阴性。
    结论  我国血站细菌污染防控及质控实验室建设差异较大, 生物安全备案缺失、无菌试验操作不规范、输血反应监测薄弱为主要问题。建议加大投入, 推动标准化, 完善实验室生物安全体系, 建立医院-血站闭环协作机制, 以提升血液安全。

     

    Abstract:
    OBJECTIVE  To evaluate the current status of bacterial contamination control and prevention measures and construction of quality control laboratory in Chinese blood station, and find out the problems and put forward the improvement suggestions.
    METHODS  A total of 41 questionnaires were sent out for performance comparison by secretariat of working group of Chinese blood collection and supply institutions from May 2024 to Jun. 2024, and 40 questionnaires were received (14 blood centers and 26 central blood stations), 39 of which were valid. The questionnaire survey covered four aspects, including disinfection and surveillance, construction of quality control laboratory, sterility test for blood component and monitoring of blood transfusion reactions. The data were processed through itemized statistics and descriptive analysis.
    RESULTS  Totally 84.62% of the blood stations used iodine-containing disinfectants for arm disinfection of the blood donors, and the monthly monitoring was the primary frequency. Among the quality control laboratories, 43.59% were registered as biosafety level 2, while 35.90% lacked biosafety registration. As for the pressure settings of the laboratories, 64.10% were under normal pressure, 15.38% under negative pressure and 17.95% under positive pressure. In the sterility test, the utilization rate of ultra clean operating tables and biological safety cabinets was 48.72%, the blood stations that did not have the indoor quality control accounted for 79.49%, and only 35.90% participated the external quality assessment. Regarding the approaches to confirm the positive result, 25.64% of the blood stations adopted the repeated tests, and 15.38% adopted the combination with positive culture bottle. The shortage of fund was the major restricted factor for the sterility test, and the confirmation of positive result was the fundamental difficulty. The blood stations with the feedback of insufficient transfusion reactions reported from hospitals accounted for 53.85%, while the blood stations that encountered suspected bacterial transfusion reactions with negative culture results accounted for 25.64%.
    CONCLUSIONS  The infeciton control and prevention measures and the construction of quality control laboratory vary significantly in Chinese blood stations. The incomplete biosafety registration, non-standardized sterility test operation and weak surveillance of blood transfusion reactions are the major existing problems. It is suggested that the investment should be increased to push forward the standardization and complete the laboratory biosafety system, and a hospital-blood station closed loop coordination mechanism should be established so as to raise the blood safety.

     

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