监测和改善分析阶段外的质量是检验医学面临的挑战

Monitoring and improving the quality of the extra-analytical phase is the challenge for laboratory medicine

国际医学实验室认可准则明确要求要监测检验全程（TTP）的质量。目前分析阶段的误差得到了有效控制；而分析前、后阶段的误差成为影响质量的主要因素。因而，监测与改善分析阶段外的质量将是我们面临的任务。监测TTP的质量，将促使临床实验室从过去局限于实验室中各阶段的管理而扩展到实验室外各环节的管理。同时，也促使我国室问质评组织机构开展分析阶段外的质量保证计划。国际临床化学和检验医学联合会已制定了临床实验室质量指标的模式。美国病理学家学会的质量探查和质量追踪计划为分析阶段外的质量监测提供了一个理想的方法。卫生部临床检验中心也依据国内外相关指南文件，并结合我国的基本国情制定了临床实验室质量控制指标体系，为分析阶段外质量保证计划的开展提供了依据。

International Standard for Medical Laboratories Accreditation demanded monitoring the quality of the total testing process （TTP）. Recently, the errors in the analysis phase had been effectively controlled, while the errors in pre- and post-analytical phases still remained comparably high, and became the major factors influencing the TTP quality. Thus, monitoring and improving the quality of the extra- analytical phases became the major challenge. Monitoring the TFP quality required the laboratory staff to extend the quality management to the influential elements outside the laboratory. In addition, it also prompted the organizers of external quality assessment （ EQA ） in China to provide a quality assurance program for extra-analytical phases. The International Federation of Clinical Chemistry and Laboratory Medicine （ IFCC ） had developed a model of quality indicators. The Q-Probes and Q-Tracks programs of the College of American Pathologists provided a good practice of monitoring and improving quality for the extra- analytical phases. Based on the related international guidelines, the QIs system was established for quality management and control in clinical laboratory, so as to manage EQA of extra-analytical phases.