Implementation of quality management systems and progress towards accreditation of National Tuberculosis Reference Laboratories in Africa

Introduction

The burden of tuberculosis in Africa remains high. The World Health Organization (WHO) reported 1 342 000 tuberculosis cases in the region in 2014; 28% of the global caseload. The region suffers from the highest per-capita burden; 281 cases per 100 000 population, more than double the global average. Despite meeting the Millennium Development Goal target of a falling tuberculosis incidence rate, the African region failed to meet the targets for 50% reduction in tuberculosis prevalence and mortality. Furthermore, the attainment of these targets varied among countries, with 40 countries achieving the Millennium Development Goal tuberculosis incidence target and only 18 countries achieving the 50% reduction in tuberculosis mortality target. Rates of multi-drug resistant tuberculosis vary across the continent, with average rates of 2.1% (0.5-3.7) among new cases and 11% (6.7-16) among previously-treated cases.¹

High-quality laboratory services are an essential component of all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment.^2,3 However enabling access to quality tuberculosis diagnostic services for populations in need is a major challenge in low-resource settings. The End TB Strategy calls for universal access to drug susceptibility testing (DST).⁴ However, the WHO reported that only 6.4% of new bacteriologically-confirmed tuberculosis cases and 33% of previously-treated cases received DST in 2014.¹

Laboratory services on the continent are known to suffer many challenges, including poor infrastructure, inadequate human resource capacity, and weak underlying health systems.³ A number of recent regional initiatives have emphasised the need for strengthening quality systems of laboratories in the region, including the World Health Organization (WHO) Regional Office for Africa 58th session (AFR/RC58/R6, Yaoundé, September 2008),⁵ the Maputo Declaration (January 2008),⁶ the Kigali Declaration on Strengthening Laboratory Management Towards Accreditation (July 2009),² and the African Society for Laboratory Medicine’s Ministerial Call for Action (December 2012).⁷

A strong laboratory quality management system (QMS) is critical to ensuring the quality of testing. A weak QMS may result in laboratory errors that can lead to both over- and under-diagnosis of tuberculosis, interruptions in service, and delayed reporting of results, leading to a negative impact on patient care. Failure to meet minimum safety standards may put laboratory workers, patients and the community at risk.