摘要
目的探讨建立采供血机构血液检测关键设备维修后性能验证方案。方法把维修的设备分为3种情况,参考美国临床和实验室标准协会(CLSI)的标准,验证顺序设计为精密度、准确度、携带污染率、室内质控4个验证步骤。验证的内容结合中国合格评定国家认可委员会(CNAS)于2012年9月发布的临床免疫学、临床化学和输血医学领域的应用说明5.3.1.5条款。根据检测设备的系统属性,全自动样品处理系统和全自动酶免分析系统为定性试验,全自动生化分析仪为定量试验,全自动血型仪为鉴别试验,选择可行性方法制作维修后性能验证流程图。结果关键设备维修后的性能验证,定性试验的设备全自动样品处理系统和全自动酶免分析系统可通过设备的校准。定量试验的设备全自动生化分析仪可以通过项目定标,质控品检测结果在允许范围内。鉴别试验的设备全自动血型仪通过留样再测。结论实验室应指定专人对设备进行确认工作,根据所用设备的现状和存在的问题实施相适应的方法进行性能验证。
Objective To discuss the establishment of a performance verification plan after maintenance of the key equipment for blood test in blood transfusion services.Methods According to standards of CLSI,the equipments that needed maintenance were divided into three situations.The sequence of authentication was designed as followed：precision,accuracy,residual contamination rate,internal quality control verification.The contents of verification were referenced to 5.3.1.5 clause in the Application of Accreditation Criteria in the field of Clinical Immunology and Clinical Chemistry and Transfusion Medicine by China National Accreditation Service for Conformity Assessment（CNAS）.According to the attributes of test equipment,Freedom EVO Clinical DITI and Microlab FAME system are qualitative experiments,while automatic biochemistry analyzer is a quantitative experiment and hemotype analyser instrument is differential experiment.A feasible method was chosen from a method flowchart.Results Calibration of Freedom EVO Clinical DITI and Microlab FAME system can help complete verification.Item calibration and detection of quality control materials within allowable range could help automatic biochemistry analyzer to finish verification.Hemotype analyser could finish verification by re-detecting samples.Conclusion In laboratory,specific professionals were assigned to be in charge of performance verification of their equipments.Depending on the type of challenges and the status of their equipments,they can apply appropriate method to complete verification.
出处
《中国输血杂志》
北大核心
2017年第6期645-648,共4页
Chinese Journal of Blood Transfusion
关键词
血液筛查实验室
关键设备
性能验证
blood screening laboratory
key equipment
performance verification
