体外诊断试剂检验报告风险管理的探讨

On Risk Management of the Test Reports for in Vitro Diagnostic Reagent

目的:将风险管理理念引入体外诊断试剂检验报告质量控制过程中,以保障检验报告的科学、有效。方法:通过对体外诊断试剂检验报告中的问题进行梳理、汇总,剖析检验过程中潜在的质量问题,提出解决问题的建议,保障检验工作质量。结果与结论:检验报告是检验过程质量控制的集中体现,对检验过程进行规范、有序的管理,是保证检验报告科学有效的基础。从事诊断试剂检测的实验室应重视风险管理,采取多种措施防控风险,提升质量管理体系的有效性。

Objective： To ensure the scientificity and effectiveness of the test reports for in vitro diagnostic reagent by introducing the concept of risk management in quality control. Methods： The problems in the test reports for in vitro diagnostic reagent were sorted out and summarized. The potential quality problems in the testing process were analyzed in order to put forward some suggestions for solutions and quality improvement. Results and Conclusion： A test report is a main expression of the quality control of the testing process. The standardized and orderly management of the testing process is the basis for ensuring the scientificity and effectiveness of the test reports. Laboratories engaged in in vitro diagnostic reagents should attach importance to the risk management and take various measures to improve the effectiveness of the quality management system.