基于培养基灌装试验的无菌操作技能验证体系构建与临床应用

Construction of validation system and clinical application for aseptic technique based on media fill test

  • 摘要:
    目的 构建基于培养基灌装试验的无菌操作技能评估方法,以降低因操作污染导致的医院感染风险。
    方法 模拟临床静脉用药调配场景,采用双倍胰酪大豆胨液体培养基替代真实药液,设计5种不规范操作场景,通过人为减少无菌操作程序验证方法灵敏度与可靠性;对8名调配人员采用建立的MFT方法进行无菌操作技能评估,每人各完成3组试验,同时对操作过程进行无菌技术评分,并在培养基灌装过程中监测环境卫生学指标,以样品无菌生长、评分≥90分和环境监测达标作为评估通过标准。
    结果 灵敏度验证中违规操作导致的样品污染率最高(86.67%),证明了试验对无菌操作缺陷的敏感性;调配人员无菌操作技能验证制备的24个样品仅1例污染,5人通过评估(62.50%),2人因技术评分不足90分未通过。
    结论 本研究建立的基于培养基灌装试验的无菌操作技能验证体系,可有效识别操作中微生物污染风险、量化评估调配人员无菌技术能力,在降低医院感染风险方面具有显著价值。

     

    Abstract:
    OBJECTIVE  To establish an aseptic technique evaluation method based on the media fill test to reduce the risk of hospital-associated infections caused by operational contamination.
    METHODS  Simulating clinical intravenous drug preparation scenarios, double-strength tryptic soy broth was used as a substitute for actual medication. Five non-compliant operation scenarios were designed to validate the sensitivity and reliability of the method by intentionally reducing aseptic technique procedures. Eight preparation personnel were evaluated the established MFT method for aseptic operation skills, with each completing three test sets. Their performance was scored for aseptic technique, and environmental hygiene indicators were monitored during the media fill process. The evaluation pass criteria included no microbial growth in samples, a score ≥90, and compliance with environmental monitoring standards.
    RESULTS  In sensitivity validation, the highest contamination rate (86.67%) occurred in samples subjected to non-compliant operations, demonstrating the test's sensitivity to aseptic technique flaws. Among the 24 samples prepared by personnel during aseptic technique validation, only one showed contamination, with five individuals passing the evaluation (62.50%) and two failing due to scores below 90.
    CONCLUSIONS  The MFT-based aseptic technique validation system developed in this study effectively identifies microbial contamination risks, quantitatively assesses personnel competency in aseptic techniques, and holds significant value in reducing hospital-associated infection risks.

     

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