Quality of Medical Laboratories: Proficiency test for laboratories: Down syndrome

The Laboratory Quality Department (Sciensano) was created in 1978 by the publication of the first decree approving clinical biology laboratories. Until 1988, the department was concerned only with the accreditation of laboratories as regards their inspection, the secretariat of the Clinical Biology Commission and the Appeal Board and the purely administrative management of external quality control. The evaluation of quality control was then entrusted to control laboratories recognized for this purpose. The second version of the Order for the Accreditation of Clinical Biology Laboratories (1989) provided for a national programme of external quality control fully coordinated by Sciensano. As a result, the department's activities became increasingly important and allowed for more uniform supervision of laboratory quality. For the organization of external quality programs, the Quality department of medical laboratories has an ISO/EIC 17043 accreditation. Since 1993, laboratories have prepared themselves for the obligation to work within the framework of a quality assurance system, as laid down in the Accreditation Order of 3 December 1999. This project concerns the QML proficiency test for Down syndrome.实验室质量部（Sciensano）于1978年随首部批准临床生物实验室的法令正式设立。直至1988年，该部门仅负责实验室认可相关的现场检查、临床生物学委员会及申诉委员会的秘书处工作，以及外部质量控制的纯行政管理事务。此后，质量控制评估工作交由经专项认可的质控实验室承担。1989年出台的《临床生物实验室认可令》第二版，确立了由Sciensano全面统筹的国家级外部质量控制计划。自此，该部门的职能范畴持续拓展，实验室质量监管的统一性也得到显著提升。为统筹外部质量计划的组织实施，医学实验室质量部已获得ISO/EIC 17043资质认可。自1993年起，各实验室便开始为落实1999年12月3日《认可令》中规定的质量保证体系工作要求做准备。本项目围绕唐氏综合征的QML能力验证试验展开。