Guidance for Establishing a National Laboratory Quality Framework

Preface

The African continent faces disproportionately high burden of diseases and experiences frequent outbreaks that can be detrimental to the lives of its citizens and bottleneck for social and economic development. The health systems in most Member States, even though there are recent improvements, remain extremely weak. This was witnessed during the current Corona Virus Disease (COVID-19) outbreak which claimed thousands of lives. One of the weakest links is limited quality assured laboratory services at all levels of the national health care system. Although many African countries have made progress in strengthening laboratory capacity and improving quality of laboratory services, much of the focus has been on specific disease control programs, leaving general laboratory services fragmented and without adequate resources. Lack of laboratory capacity is one of the major challenges contributing to delayed or inadequate responses to epidemics/pandemics.
National laboratory systems have faced significant hurdles in advancing the deployment of Laboratory Quality Management System (LQMS) at all levels of the laboratory network. A national laboratory quality framework document has been prepared to guide and facilitate country-level efforts of strengthening national laboratory systems and networks. The framework will support laboratories in implementing and continued maintenance of laboratory quality management systems. Moreover; the document will be used by the policy makers and health service regulators in the establishment and amendment of national policies aimed at facilitating the implementation of laboratory quality management systems.
This document also serves as practical guide for Member States during the development or updating of the national laboratory quality policies and strategic plans.