基于患者数据的实时质量控制程序建立与性能验证专家共识  

Expert consensus on the procedure establishment and performance verification of patient-based real-time quality control

作　　者：中华医学会检验医学分会 中国中西医结合学会检验医学专业委员会 王传新 杨曦明[3] 陈捷[4] 苗强[4] 张玫[4] 曾玉萍[4] Chinese Society of Laboratory Medicine;Laboratory Medicine Committee of Chinese Association of Integrative Medicine;Wang Chuanxin;Yang Ximing

机构地区：[1]不详 [2]山东大学第二医院检验医学中心 [3]北京中医药大学东直门医院检验科 [4]四川大学华西医院实验医学科

出　　处：《中华检验医学杂志》2024年第1期35-48,共14页Chinese Journal of Laboratory Medicine

摘　　要：基于患者数据的实时质量控制(PBRTQC)具有连续监控、低成本、无基质效应、分析前和中误差敏感、体现患者风险等优势,与传统室内质量控制联合应用,可及时有效地检测出系统误差,保证检验结果的准确性。由于PBRTQC算法、参数选择和程序建立的复杂性,目前国内尚缺乏PBRTQC程序建立的方法原则以及优化性能参数设置的共识和标准指南。该共识从PBRTQC项目选择、参数设置、程序建立、参数优化与验证、以及报警处理全流程的应用给出指导建议,以进一步提升实验室质量管理水平,减少患者风险。Patient-based real-time quality control(PBRTQC)has the advantages of continuity,low cost,no matrix effect,sensitivity to pre-analysis and analysis errors,and the ability to monitor patient risk.It can timely and effectively detect system errors by combining with traditional internal quality control.However,due to the complexity of the algorithm and parameters of PBRTQC,there is no consensus and standard guidelines on the establishment of testing procedures and the optimization of PBRTQC performance parameters.This consensus provides suggestions on the selection of testing items,parameter settings,process establishment,parameter optimization and validation,and alarm handling in PBRTQC to further enhance the level of laboratory quality management and minimize patient risk.

关 键 词：质量控制 临床实验室技术 质量管理 程序建立 共识 

分 类 号：R197.323[医药卫生—卫生事业管理]