• 王 贝,刘佳惠.基于ISO 15189质量体系的血站核酸实验室的风险管理[J].江苏卫生事业管理,2024,35(5):737-742.
  • 基于ISO 15189质量体系的血站核酸实验室的风险管理
  • Application of Nucleic Acid Laboratory Risk Management in Blood Station Based on ISO 15189 Quality System
  • 王 贝  刘佳惠
    徐州市红十字血液中心检验科
  •   
  • DOI:
  • 中文关键词:

    核酸检测  风险评估  质量管理

  • 英文关键词:

    Blood Nucleic Acid Testing  Risk Assessment  Quality Management

  • 基金项目:

  • 摘要点击次数: 96    全文下载次数: 79
  • 中文摘要:

    目的:依据ISO 15189质量管理体系,针对血液核酸检测全过程实施风险管理,达到有效控制和预防潜在风险的目的。方法:风险识别:按照核酸检验过程步骤流程,构建质量风险鱼骨图;风险分析与评价:应用风险矩阵法,风险值(R)=发生可能性(L)×后果严重程度(S),依据风险值划分风险等级;风险应对:实施风险应对措施后进行回顾性验证,评价残余风险可接受性。结果:有10项风险点评估为不可接受风险,对其采取相应控制措施后,经回顾性验证,风险发生的可能性显著降低,残余风险在可接受范围,达到了有效的风险规避效果。结论:风险管理在血站核酸实验室质量管理中具有重要的作用和意义,可帮助有效评估实验室检测过程中的潜在风险因素,提高血液检测质量水平,保证了核酸检测工作高质、高效地运行。

  • 英文摘要:

    Objective:According to ISO 15189 quality management system,risk management is implemented for the whole process of blood nucleic acid testing to achieve effective control and prevention of potential risks. Methods:Risk identification:According to the nucleic acid test process step flow chart,build the quality risk fishbone diagram;Risk analysis and evaluation:Risk matrix method is applied,risk value(R)=probability of occurrence(L)×severity of consequence(S),and risk levels are divided according to risk value. Risk control:Retrospective validation after the implementation of risk control measures to evaluate the acceptability of residual risks. Results:There are 10 risk points assessed as unacceptable risks. After taking corresponding control measures,the retrospective verification showed that the possibility of risk occurrence was significantly reduced and the residual risk was within the acceptable range,achieving effective risk avoidance effect. Conclusions:Risk management plays an important role and significance in the quality management of nucleic acid laboratory in blood stations,which can help the laboratory to effectively identify and evaluate potential risk factors in the detection process. After taking intervention measures,the quality level of blood detection can be significantly improved,and the high-quality and efficient operation of nucleic acid detection can be ensured.