Access to diagnostics remains sub-optimal in Africa due to limited human, financial and technical resources that affect various components of the health system.
The failure of diagnostics to reach a large proportion of the population in need of it can partly be linked to implementation approaches that are designed for the site level, with oversight of the tiered laboratory network requirements and insufficient attention given to the underlying laboratory systems (e.g. supply chain, workforce, finance, etc.). Complementing the Maputo Declaration of 2008,
Apart from selected disease-dedicated investments (e.g. HIV, tuberculosis), national tiered laboratory networks generally remain grossly underfunded with mild to critical dysfunctions in the underlying laboratory systems. In addition to falling short in the provision of optimal access to essential clinical diagnostics, the current sub-optimal capacity of tiered laboratory networks translates into weaknesses in the detection component of the ‘prevent, detect, respond’ framework of health security
Despite the call for more attention in building effective public health laboratory systems,
In this report, the African Society for Laboratory Medicine (ASLM) and the Africa Centres for Disease Control and Prevention (Africa CDC) share a unique insight into some of the most critical areas for improvement to bridge the gap between the capacity of laboratory networks and the promises of diagnostic technologies.
Actionable data on integrated laboratory network functionality are scarce. The WHO Joint External Evaluation
Proportion of African countries (
Overall level of laboratory network functionality in eight countries assessed.
Most critical gaps in laboratory network core capabilities were identified through the laboratory network assessment of eight sub-Saharan African countries between 2017 and 2019, and their implications for diagnostic services.
Core capabilities assessed | Most critical common weaknesses (score 0–1) | Implication on diagnostic services |
---|---|---|
Policy, legal and regulatory framework | The nine essential public health functions No national system for licensing laboratories No dedicated budget for laboratory services for both routine and emergency situations |
Inconsistent compliance of diagnostic services to the principles of biosafety, biosecurity, waste management, and the protection of the environment. Inconsistent application of diagnostic services to outbreak response, food safety and disease notification Facilities with low capacities are allowed to deliver diagnostic services Diagnostic services cannot be optimally organised and coordinated, also during situations of disease outbreaks |
Structure of the tiered network | The network does not incorporate testing activities at community level |
Results of rapid and point-of-care testing at community level are not supervised and quality controlled |
Network coverage and rapid response | Lack of updated data on the geographic information system location of laboratory capacity Minimal testing packages are not defined at all tiers Diagnostic services are not accessible at points of entry No national plan to mobilise laboratories in case of health emergencies |
Implementation of diagnostics unlikely to cover optimal testing needs and to ensure cost-effectiveness of services Diagnostics are not used at the most relevant levels, reducing the public health impact of diagnostics strategies Diagnostics cannot contribute to control the spread of diseases across borders Diagnostics cannot optimally contribute to the response to health emergencies |
Laboratory information management system | No standardised test request and result return forms at national level No central unit for health data analysis No systems to ensure confidentiality and anonymity of test results |
Test demand and result utilisation are compromised even when diagnostics are available Diagnostics cannot optimally inform public health interventions Clients do not trust the diagnostic services, which undermines the demand for testing |
Infrastructure, reagents and supplies | Building norms not applied for the construction of testing facilities Testing facilities are not maintained, with frequent interruption of water, electricity and Internet supply Insufficient system to forecast and adequately supply reagent in routine and emergency situations |
Diagnostic testing is done in unsafe, unsecured or illegal locations Diagnostics in place are not used according to biosafety and biosecurity requirements. Instruments cannot be operated Diagnostic services are interrupted, even in situations of emergency |
Workforce | Insufficient training for laboratory management Incomplete, inadequate or no staffing plan Overall shortage of staff to deliver testing services No human resources strategy specifically and comprehensively addressing the laboratory workforce |
Overall diagnostic services are ineffective at both facility and national level The correct execution of diagnostics is compromised |
Quality management systems | Inconsistent internal quality control procedures Quality focal point not in place in all laboratories No national norms for laboratory certification and accreditation |
Unreliable test results Quality of test results cannot be verified |
Biosecurity | Insufficient availability of biosecurity of adequate level No systems to store and archive samples, including dangerous pathogens Gaps in waste management systems |
Unreliable test results (e.g. AST) Unsafe diagnostic testing for staff and environment Missed opportunities for in-house or external validation of diagnostics |
Priority diseases | Poor capacity for isolating AMR bacteria Insufficient reporting of AMR |
AMR testing does not feed into representative AMR surveillance systems List of pathogens and antibiotics of importance are not updated and many irrelevant AST are conducted |
AMR, antimicrobial resistance; AST, antibiotic susceptibility test.
, Essential public health functions are: Disease prevention, control and surveillance; Integrated data management; Reference and specialized testing; Environmental health and protection; Food safety; Laboratory improvement and regulation; Policy development; Public health preparedness and response; Public health related research; Training and Education; Partnership and communication. The NRL or NPHL does not have to perform them all but must ensure that they are in place.
Two countries with strong laboratory governance include Ethiopia, through the Ethiopian Public Health Institute, and Uganda, through the Directorate of Laboratory Services of Uganda. They offer good examples of best practices in the management of the laboratory systems and networks. These countries report updated national policies and strategic plans, budget lines earmarked for laboratory functions and regulations defining and enforcing laboratory clinical and public health functions from the reference level to the community level:
Strengthening of integrated quality management and specimen referral systems are the most urgent interventions needed, the outcomes of which should be evaluated against the advancement of Joint External Evaluation scores. Various initiatives funded by global stakeholders are ongoing (e.g. United States Agency for International Development, United States President’s Emergency Plan for AIDS Relief, Global Fund) with the potential to be transitioned to and sustained by stronger and empowered national laboratory leadership with the political support of Africa CDC. The ASLM and their partners can work together at formulating clearer guidance on the respective mandates of directorates of laboratories and national public health institutes (including the monitoring and evaluation framework for laboratory network functions) as well as advocating to empower the laboratory sector. These efforts align with the recommendations of the Maputo and the Freetown Declarations. Assisting countries to define tier-specific testing packages that address the needs of clinical diagnostics and disease surveillance is another important intervention with the potential to guide the introduction of diagnostics at the levels where they are most needed and cost-effective. We recommend that every country conduct an external or self-evaluation of their laboratory systems once a year or once every two years as part of a continuous quality improvement cycle for their national tiered laboratory network. While the Joint External Evaluation tool provides high-level dashboards for a set of four indicators, the LABNET scorecard is designed to guide countries in selecting specific and feasible interventions most likely to tackle the root causes of the identified dysfunctions across a comprehensive set of indicators.
Mutualising scarce resources for most cost-effective health services is (or should be) a constant concern in low-resource settings. A data-driven configuration of a national laboratory network can support the design of faster and more affordable sample transportation routes towards testing hubs. From the specimen referral landscape, assessments that were performed during 2015 and 2016 in eight countries by ASLM under the Global Health Security Agenda laboratory strengthening effort revealed that a certain level of integration of the specimen transport system (STS) can exist, often between HIV and tuberculosis programmes. The STSs are generally fragmented, working in parallel, using different transport mechanisms depending on the disease programme, are funded by various donors and have challenges in terms of cost-effectiveness, turnaround time and coverage. A few countries, such as Ethiopia, Rwanda and Uganda, have highly integrated specimen referral networks that cater to any disease programme and span across diagnosis to surveillance, detection and response. Ideally, this disease-agnostic approach should be developed such that individual STSs are effectively and efficiently networked, and that any type of specimen can be easily and seamlessly moved from where it originates to the appropriate diagnostic equipment.
Addressing the common problem of fragmented and disease-specific STSs, ASLM coordinated the development of a standardised STS assessment and development toolkit,
The availability of up-to-date geo-localised information about laboratory network capacity provides evidence on which to base the process of defining optimal service configurations, including the shortest routes for sample transportation, maximum population coverage for testing services, cost-effective supply chains, or opportunities for testing integration. Initiatives aimed at collecting geographical information system data on laboratory capacity are gaining momentum to improve the performance of HIV and tuberculosis control programmes.
Gaps between actual diagnostic capacity and World Health Organization recommendations for minimal testing package in 101 level 4 and level 3 laboratories in 12 African countries (data from 2018 to 2019).
Data-driven optimisation of laboratory networks is an important management activity that can support essential public health and clinical functions. Key considerations of any optimisation exercise should include at least: the structure of the tiered laboratory networks, (essential) testing needs for both clinical diagnosis and disease surveillance, and opportunities for test integration. Specimen referrals are important systems underlying national laboratory networks. Taking a network approach for developing integrated STSs may provide greater cost savings, efficiencies, increased coverage and increased access. This approach can begin by mapping and optimising the overall referral network based on the existing diagnostics network (or any upcoming changes), reducing redundancies where possible and leveraging existing or new systems to create economies of scale, clearly planning and budgeting for the optimised network and implementing the new approach. Any potential benefits should be clearly estimated and used to convince governments of the approach and gain buy-in from other stakeholders as well.
Regular collection and updating of (geo-located) laboratory capacity information is necessary to inform network optimisation exercises. Such activities could be enforced as part of laboratory registration or licensing and re-licensing processes under the coordination of the directorate of laboratories.
Unreliable diagnostic tests can compromise the quality of healthcare delivery. A laboratory quality management system (LQMS) is a formalised system that documents processes, procedures and responsibilities for achieving an international standard of quality. The implementation of LQMS was identified as a priority to strengthen laboratory services in Africa
Stepwise Laboratory Quality Improvement Process Towards Accreditation coverage of facilities in the public and private sector in 17 African countries (as of August 2019).
Country | Estimated number of laboratories in the public sector | Estimated number of laboratories in the private sector | Number of laboratories engaged in SLIPTA in the public and private sectors |
---|---|---|---|
Botswana | 53 | NA | 23 |
Burkina Faso | 107 | 112 | 3 |
Burundi | 624 | 489 | 15 |
Cameroon | 3279 | NA | 16 |
Côte d’Ivoire | 420 | 113 | 11 |
Ethiopia | 3949 | 1797 | 34 |
Ghana | 2280 | NA | 21 |
Kenya | 2245 | NA | 37 |
Malawi | 1026 | NA | 19 |
Namibia | 44 | 40 | 15 |
Niger | 335 | 73 | 1 |
Nigeria | 34423 | NA | 50 |
South Africa | 221 | NA | 31 |
Tanzania | 6213 | NA | 53 |
Uganda | 1625 | NA | 60 |
Zambia | 1608 | NA | 4 |
Zimbabwe | 1630 | NA | 35 |
SLIPTA, Stepwise Laboratory Quality Improvement Process Towards Accreditation; NA, not available.
In addition to the poor coverage of LQMS implementation, most countries do not have systems in place to ensure that all testing sites comply with the basic components of quality assurance such as external quality assessments, proficiency testing schemes
To overcome these challenges, the ASLM and WHO regional office for Africa launched SLIPTA version 2.0,
This strategic approach is currently being implemented through regional collaborations where the West African Health Organization and East, Central and Southern Africa Health Community are providing leadership to advance LQMS using the SLIPTA programme in West, Central East and Southern Africa, with ASLM serving as a high-level coordinator. According to this model, ASLM and its partners work at generating a sufficient pool of local SLIPTA auditors and laboratory mentors who can be mobilised to advance LQMS and conduct SLIPTA audits upon regional or national request. The efforts of Africa CDC to establish The Regional Integrated Laboratory Network (RISLNET) is also contributing to the extension of SLIPTA version 2.0, through the implementation of LQMS in national public health institutes, with subsequent deployment of the system in lower tiers of the national laboratory networks and across the private sector.
A couple of African countries like Ethiopia have stepped forward to ‘franchise’ the SLIPTA model as national programmes aiming to cover all laboratory facilities from the public and the private sector. The foundation of a country-led SLIPTA programme is the definition of national quality standards for diagnostic services at each level of service delivery, clearly describing which laboratory has the vocation to be accredited or certified and against which set of minimum quality standards.
Clinical pathologists are physicians trained in various disciplines of laboratory medicine, such as haematology, medical microbiology, transfusion medicine, clinical biochemistry or cytopathology.
Overview of numbers, coverage and needs of pathologists in nine surveyed countries of Africa (data from August 2019).
Countries surveyed | Total number of pathologists | Number of pathologists per 100 000 population | Times lower than United States ratio |
Number of pathologists needed |
---|---|---|---|---|
Ethiopia | 61 | 0.05 | 70 | 4209 |
Sierra Leone | 7 | 0.01 | 350 | 2443 |
Eswatini | 1 | 0.09 | 39 | 38 |
Zambia | 13 | 0.07 | 50 | 637 |
Rwanda | 51 | 0.41 | 9 | 384 |
Nigeria | 350 | 0.18 | 19 | 6456 |
Burkina Faso | 42 | 0.21 | 17 | 658 |
Gabon | 15 | 0.71 | 5 | 59 |
Kenya | 131 | 0.25 | 14 | 1703 |
South Africa | 216 | 0.37 | 9 | 1827 |
, 3.5/100 000.
, Using United States ratio as a reference.
In-country capacity for pathology training is commonly reported, with efforts by the College of Pathologists in East, Central and Southern Central Africa and other organisations to advocate for training of more pathologists and the laboratory workforce. However, the magnitude of the gaps highlighted here and by others demands that many more resources be deployed to produce higher numbers of pathologists at a faster pace in the disciplines associated with the most severe disease burdens, and to provide acceptable solutions for task shifting at each tier of the laboratory network. Key interventions to reduce the shortage of clinical pathologists include: the formulation of staffing norms in national laboratory strategic plans and healthcare human resources development strategies by defining the number and profile of pathologists at each relevant tier of the laboratory network and increasing opportunities for education, training and mentorship at the regional level, including innovative digital, remote training options. This could be done as part of the objective of the Workforce Development Institute of Africa CDC,
The past decade has seen the introduction of game-changing technologies for major public health diseases such as HIV, tuberculosis and malaria, which promise easier access, use and impact of diagnostics at the community level where most patients seek care. The WHO’s IVD prequalification process is a standardised procedure to determine whether products meet requirements for safety, quality and performance. The findings of this prequalification are used to provide guidance to countries in selecting laboratory diagnostics to be implemented at the programme level. The WHO prequalification represents the ‘ticket’ for any IVD to penetrate national markets, and is a process that takes 2–3 years. Additionally, national regulatory frameworks often foresee additional evaluations to verify that the prequalified diagnostic is adapted to specific contexts. However, the relevance of multiple, in-country evaluations is not always clear, represents unnecessary repetition, and has no additional value compared to WHO prequalification results or to a well-designed single evaluation conducted in one centre of excellence located in a region with similar disease epidemiology. Delayed registration of IVDs in-country prevents access to reliable existing diagnostics for many priority diseases including those associated with outbreaks. Regulatory bottlenecks for IVDs during country registration compromise the implementation of essential diagnostics, and prevent universal health coverage and African health security.
An innovative approach to facilitate the swift evaluation and registration of useful and performant IVD and support the advancement of the diagnostic agenda in African regions is needed. Leveraging existing networks of excellence that can quickly conduct the standardised evaluation of IVDs and support collaborative registration procedures on behalf of entire regions of Africa can lead to critical benefits in access to IVD, while waiting for or to complement WHO prequalification. The Africa Collaborative to Advance Diagnostics, led by Africa CDC, was launched in Abuja during the biannual ASLM conference in 2018
In addition to advancing the development of increasingly relevant, reliable, specific and affordable IVD products, the future of diagnostics in Africa also depends on our collective ability to comprehensively and swiftly address the systemic weaknesses in national laboratory networks. Under the leadership of the Africa CDC and WHO regional office for Africa, African technical agencies at the continental or regional level (e.g. ASLM, the West African Health Organization and East Central and Southern Africa Health Community) or national level (e.g. Nigeria CDC) have a critical role to play in providing direct technical assistance and vision for advancing national laboratory network diagnostic capacity and on setting adequate priorities for international cooperation. Implementing the African Union recommendations on domestic investment in healthcare
The authors thank the African Society for Laboratory Medicine and the Africa Centres for Disease Control and Prevention team members Samba Diallo, Edwin Shumba and Anafi Mataka for their input in data collection and analysis. We thank Dr Kameko Nichols for her contribution to the section on sample transportation systems. We thank Dr Ali Elbireer for his contribution to the initial design of the manuscript. We thank Professor Oni Emmanuel Idigbe for his support in collecting data on African pathologists. We thank the Ministries of Health of Niger, Cameroon, Congo, Ethiopia, Democratic Republic of Congo, Chad, Zambia, Zimbabwe, Sao Tome and Principe, Gabon, Central African Republic and Malawi for sharing data on laboratory mapping.
We thank the Ministries of Health of Ethiopia, Uganda, Burkina Faso, Senegal, Cameroon, Tanzania, Democratic Republic of Congo and Nigeria for sharing data on the LABNET scorecard assessment.
The authors declare that they have no conflicts of interest.
All authors contributed equally to the work.
Ethical approval is not required for this opinion article.
This work would not have been possible without funding from the Bill and Melinda Gates Foundation, the President Emergency Plan for AIDS Relief, The Global Health Security Agenda, UNITAID and Vital Strategies.
Data sharing is not applicable to this article as no new data were created or analysed in this study.
The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of any affiliated agency of the authors.