Abstract

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 TTP 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.(Chin J Lab Med, 2015, 38: 786-788) Key words: Laboratories, hospital; Quality assurance, health care; Quality control

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