Introduction of quality management in a National Reference Laboratory in Germany.

ABSTRACT: BACKGROUND:High quality diagnostic services are crucial for tuberculosis (TB) diagnosis, treatment and control. A strong laboratory quality management system (QMS) is critical to ensuring the quality of testing and results. Recent initiatives to improve TB laboratory quality have focused on low and middle-income countries, but similar issues also apply to high-income countries. METHODS AND FINDINGS:Using a multipronged approach reviews of facilities, equipment, processes (purchasing, pre-analytic, analytic and post-analytic), staff, health and safety, documentation, information management and organization based on the ISO 15189 and the twelve quality system essentials were conducted between October 2015 and January 2016 at the National TB Reference Laboratory in Germany. Outcome assessment

SUBMITTER: Homolka S 

PROVIDER: S-EPMC6793863 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature