Application of Nucleic Acid Laboratory Risk Management in Blood Station Based on ISO 15189 Quality System
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)xseverity of consequence(S),and risk levels are divided according to risk val-ue.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.
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维普
