关注临床实验室质量控制结果满意与检验结果“准确可比”的差异  

Pay attention to the differences between clinical quality control results and the goals about “accurate and comparable″ in quality management

作　　者：陈宝荣[1] 

机构地区：[1]北京航天总医院检验科,100076

出　　处：《中华临床实验室管理电子杂志》2017年第3期129-134,共6页Chinese Journal of Clinical Laboratory Management(Electronic Edition）

基　　金：国家质检总局公益项目(201210066);国家重点研发计划项目(2017YFF0205401);国家标准物质资源共享平台项目(APT1702-1);首发项目资助课题(2016-2-2096)

摘　　要：以1例人绒毛膜促性腺激素(human chorionic gonadotropin,HCG)检验结果投诉为例,通过回顾分析质量管理、质控的概念、室内质控的含义、目前临床实验室质控的现状,找出现阶段我国各级临床实验室的质控结果与患者、医生的需求与要求和临床实验室质量管理中检验结果"准确可比"目标的差距。探讨检验医学技术与学科发展中的管理经验、持续改进并建立实验室质量管理体系,以解决临床实验室检验结果"准确可比"问题的可行性。另外,以部分临床生化检验项目测量质量研究数据为例,说明临床实验室通过紧跟学科发展,正确评价现有测量技术水平与能力;并通过标准化/一致化的路径与方法改进存在瑕疵的技术;同时发展临床实验室适宜技术以保证质控结果满意,使患者获得"准确可比"的检验结果。而通过建立质量管理体系助力临床实验室实现检验结果"准确可比"的质量管理目标。A case study of human chorionic gonadotropin （HCG） results is taken as an example in this paper. By reviewing the concept of quality management and quality control, the meaning of internal quality control and the present situation of quality control in clinical laboratory, the differences between the quality control results of clinical laboratory at all levels in China, the requirements and needs of patients and doctors and the goals about ＇accurate and comparable＇ in quality management are found. The feasibility of solving the ＇accurate and comparable＇ problem of clinical laboratory test by keeping up with the development of discipline, constantly summing up experience in management, and continuously improving and establishing the laboratory quality management system is explored. Taking the data of some clinical biochemical tests as an example, the clinical laboratory can correctly evaluate the level and ability of the existing measurement technology by keeping up with the development of the discipline. The defective technology through the standardized / homogenized path and method is improved. Developing the laboratory＇s appropriate technique allows patients to obtain ＇accurate and comparable＇ test results. Clinical laboratories can achieve ＇accurate and comparable＇ quality management objectives by establishing the quality management system.

关 键 词：临床实验室 质量管理 质量控制 标准化 一致化 

分 类 号：R446[医药卫生—诊断学]