Laboratory accreditation and monitoring: An urgent necessity for strengthening diagnostics in Africa

Efforts to combat HIV, tuberculosis and malaria in sub-Saharan Africa in the past two decade have underscored the inadequacy of laboratory systems in most African countries, as they were not equipped to perform vital testing for HIV care and prevention programmes. In more recent years, the critical need for a truly functional diagnostics system in Africa has been brought to full light by the Covid-19 pandemic, with concerted efforts being made to strengthen diagnostics across the continent. Perhaps more investment needs to be made in the lab space. Over these years, billions of US dollars have been invested in these programmes with only a small fraction going into the laboratory stream.

Laboratory testing is essential for the diagnosis and management of several communicable and non-communicable diseases endemic to the African region. Therefore, addressing the factors responsible for weak laboratory systems in Africa is critical to the successful reduction of the global burden of disease on the continent.

Therefore, addressing the factors responsible for weak laboratory systems in Africa is critical to the successful reduction of the global burden of disease on the continent

However, the challenges confronting Africa’s diagnostic system are multifaceted, with factors ranging from limited human, financial and technical resources to poor laboratory monitoring and accreditation systems.

Laboratory accreditation/monitoring critical to strengthening diagnostics in Africa

A key priority in laboratory medicine is the improvement of quality management systems. Quality in healthcare is closely linked to the level of excellence of healthcare provided in relation to the current level of knowledge and technical development. Accreditation, which is a tool to recognise laboratories globally, effectively demonstrates the competence of laboratories, as it is linked to periodical audits that stimulate the maintenance and improvement of quality, and hence, a high standard of services for patients and healthcare providers.

Accreditation essentially establishes a system of standard procedures with the goal of improving quality and patient safety. Laboratory accreditation facilitates accurate and rapid diagnostics, efficient treatment, and a reduction of errors in the laboratory process.

The gold standard of accreditation for diagnostic laboratories – ISO 15189:2012

The ISO 15189:2012 is the gold standard for medical laboratory accreditation. It contains requirements for diagnostic labs to demonstrate competence to deliver timely, accurate, and reliable results. The accreditation involves an independent assessment of the medical laboratory by a qualified, authoritative body, such as the American-based ANAB. ANAB is the largest accreditation body in the western hemisphere, and has accredited over 2,500 organizations in about 80 countries. There are several other accrediting bodies across the world, including some national accrediting bodies such as NiNAS in Nigeria and SANAS in South Africa.

ISO 15189 accreditation requires the accreditation body to evaluate all the factors affecting the production of test data. This involves an examination of the qualifications and competence of the laboratory staff, as well as the assessment of equipment, reagents and supplies, quality assurance, amongst other factors. Even after achieving accreditation, to ensure continued compliance, medical laboratories regularly undergo reassessment to ensure they maintain their technical expertise.

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Challenges in achieving, maintaining laboratory accreditation in Africa

Achieving laboratory accreditation in Africa is enormously challenging due to factors such as inadequate funding, lack of suitably skilled personnel, poor equipment maintenance/servicing, and poor procurement systems.

The accreditation process requires massive funding, which is typically unavailable to most labs except government or donor-funded laboratories. A lack of in-country suppliers for specialist equipment and stringent and complex procurement regulations can cause very long lead times, which negatively affects the accreditation process.

Equipment maintenance and servicing is also a huge barrier, as many countries in Africa lack in-country expertise needed to service laboratory equipment and have to source expertise internationally, which is expensive and can lead to delays in servicing. Also, adequate skilled staff is a necessity for laboratory accreditation, as the process is highly labour intensive, requiring the involvement of many staff in the development of documentation and increased time spent on recording requirements and other procedures.

Strategies to build capacity for laboratory accreditation in Africa

Building the capacity for laboratory accreditation in Africa will require massive investment and strong technical support, which can be achieved through strategic partnerships in health financing within the laboratory space. Bloom Public Health, Katchey Laboratories and ND Western partnership that gave rise to Delta Plus Diagnostics still stands out. This role model partnership is one that should be emulated by other stakeholders and deployed across the entire laboratory space in Africa, for the strengthening and accreditation of diagnostic laboratories.

Another strategy is to have a paradigm and start seeing the diagnostics space as one that needs investment. If a significant fraction of the investment made in the health space in Africa were channelled to diagnostics, we would have made significant progress with more laboratory accreditation achieved.

In conclusion

Although accreditation is a capital-intensive investment, through strategic partnerships and the concerted efforts of committed stakeholders, laboratories in Africa can be accredited and upgraded to world-class status. The impact of this will be a tremendous increase in patient safety through accurate test results and prompt treatment. This will also give rise to the building of a critical mass of highly skilled medical laboratory scientists.