Abstract
BackgroundLaboratory services are essential at all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment. Enabling access to quality services is a challenge in low-resource settings. Implementation of a strong quality management system (QMS) and laboratory accreditation are key to improving patient care.ObjectivesThe study objective was to determine the status of QMS implementation and progress towards accreditation of National Tuberculosis Reference Laboratories (NTRLs) in the African Region.MethodAn online questionnaire was administered to NTRL managers in 47 World Health Organization Regional Office for Africa member states in the region, between February and April 2015, regarding the knowledge of QMS tools and progress toward implementation to inform strategies for tuberculosis diagnostic services strengthening in the region.ResultsA total of 21 laboratories (43.0%) had received SLMTA/TB-SLMTA training, of which 10 had also used the Global Laboratory Initiative accreditation tool. However, only 36.7% of NTRLs had received a laboratory audit, a first step in quality improvement. Most NTRLs participated in acid-fast bacilli microscopy external quality assurance (95.8%), although external quality assurance for other techniques was lower (60.4% for first-line drug susceptibility testing, 25.0% for second-line drug susceptibility testing, and 22.9% for molecular testing). Barriers to accreditation included lack of training and accreditation programmes. Only 28.6% of NTRLs had developed strategic plans and budgets which included accreditation.ConclusionGood foundations are in place on the continent from which to scale up accreditation efforts. Laboratory audits should be conducted as a first step in developing quality improvement action plans. Political commitment and strong leadership are needed to drive accreditation efforts; advocacy will require clear evidence of patient impact and cost-benefit.
Highlights
The burden of tuberculosis in Africa remains high
Five National Tuberculosis Reference Laboratories (NTRLs) reported knowing all of the quality management system (QMS) tools mentioned, all of which had either achieved accreditation or were known to be actively working toward accreditation
Progress has been made in implementing QMS in laboratories in the African Region
Summary
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. 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]. Laboratory services are essential at all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment. Implementation of a strong quality management system (QMS) and laboratory accreditation are key to improving patient care
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