title: [Overview of Proficiency Testing and External Quality Assessment Programs of Laboratory Tests from the Standpoint of International Standardization].
abstract: In Japan, laboratory comparison, by means of proficiency testing or external quality assessment, has been conducted with separate programs on a nationwide basis, markedly contributing to quality improvement of clinical laboratory testing. However, from the standpoint of international standardization, there are issues to be addressed. Performance is evaluated once a year in each program, with time-consuming studies and different methods for data collection, analysis, and its assessment among programs, thus not leading to real-time monitoring and correction of the performance. Only the examination procedure of routine laboratory testing is focused on, while the entire process of the examination needs to be properly performed from the pre-examination down to the post-examination procedures. The development of proficiency testing for esoteric tests is needed, since both routine and esoteric ones have been provided by most medical laboratories, and a combination of them is used for decision-making in patient care. As molecular-genetic tests have been widely used, demand for the development of laboratory comparison programs has increased. In order to comprehensively evaluate the performance of laboratory, medical imaging and biophysical examination are also necessary. The overall performance of the medical laboratory must be assured along with the availability of proficiency testing or external quality assessment programs for each test to be performed, in order to contribute to optimal patient care.
authors.forename: Hayato
authors.initials: H
authors.lastname: Miyachi
mesh_terms: D005820:Genetic Testing; D006801:Humans; D059021:Laboratory Proficiency Testing / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000592:standards*; D011786:Quality Control; D015203:Reproducibility of Results