By Elias Chipofya
A high percentage of all clinical decisions depend on the results from clinical laboratory investigations (lab tests). These investigations support the diagnosis, management and treatment of almost all human diseases.
There are more than 1,000 different laboratory investigations based on human biological samples (blood, urine, tissue and other fluids). The investigations apply to both infectious diseases (e.g. HIV and Covid-19) and non-communicable diseases (e.g. heart disease, cancer, diabetes).
Investigations include chemical, microbiological, immunological, haematological, genetic, molecular and histopathological testing. Techniques vary from simple manual testing to complex biological and chemical analyses that involve sophisticated instrumentation and computer technology.
Advances in clinical laboratory services are progressing rapidly, often linked to our growing understanding of the molecular basis of disease processes.
It follows that clinical laboratory science (laboratory medicine) professionals, often called medical laboratorians, are vital healthcare professionals who are trained in technical, scientific and clinical aspects of the investigation of human disease.
Quality control procedures are developed to ensure that the correct result that truly represents the status of the individual patient is obtained on the correct specimen, for the correct patients, in the correct clinical setting.
Clinical laboratories provide a consultant advisory service covering all aspects of laboratory investigation including the interpretation of results and advice on further appropriate investigation.
The impact of Clinical Laboratory Services in patient care is unquestioned by those working in Clinical Medicine. Sadly, however, laboratory testing is something of a ‘Cinderella’ profession in the eyes of politicians, donors and the public, perhaps because it is ‘taken for granted’ or not fully understood. This under-appreciation of the profession of Clinical Laboratory Services is more evident in resource-poor countries like Malawi.
The Clinical Laboratory Science profession has more than one career track based on the level of education: Medical Laboratory Assistant (two years), Medical Laboratory Technician (three years) and Medical Laboratory Technologist (four to five years).
Careers in the Clinical Laboratory Science profession are perfect if you are analytical, enjoy problem solving and are interested in the science of healthcare.
In Malawi, the following institutions train Clinical Laboratory Science professionals: University of Malawi, College of Medicine; Malawi Adventist University, Malamulo College of Health Sciences; Mzuzu University and Malawi College of Health Sciences. Malawi University of Science and Technology trains Medical Microbiologists and Immunologists at undergraduate level.
After graduation, clinical laboratory professionals register with the Medical Council of Malawi and are given licences to practise and they are renewed annually. Debate is still going on whether graduates that have never been employed or unemployed continue renewing their licences or not.
Apart from being registered by the Medical Council of Malawi, clinical laboratory professionals apply to and become members of the Malawi Association of Medical Laboratory Scientists (MAMLS), which is the national professional body for the profession.
Clinical laboratories are categorised into Biological Safety Levels (BSL) 1, 2, 3 or 4. A biological level is assigned to a biological lab as a safeguard to protect laboratory personnel, as well as the surrounding environment and community. BSL-1 is the lowest of the four, biosafety level 1, and applies to a lab setting in which lab professionals work with low-risk microorganisms that pose little to no threat of infection in healthy adults-for example, non-pathogenic strains of Escherichia coli.
Clinical laboratories categorised as work with agents associated with human diseases that pose moderate health hazards. Access to a BSL-2 laboratory is restrictive. Outside personnel or those with an increased risk of contamination are often restricted from entering when work is being conducted.
Airborne transmissible diseases like Covid-19 are typically categorised as BSL- 3. These laboratories are almost always purpose constructed containment laboratories, outfitted with specialised equipment and heating, ventilation and air conditioning systems designed to ensure no airborne particles can exit the contained space. Access to a BSL-3 laboratory is restricted and controlled at all times.
BSL-4 labs are rare. They work with highly dangerous and exotic microbes such as Ebola and Marburg viruses. A BSL-4 lab is extremely isolated- often located in a separate building or in an isolated and restricted zone of the building.
The quality of clinical laboratory operations is driven by technical skills, quality management systems and the motivation of human resources. Clinical laboratory quality is defined as the reliability, accuracy and timeliness of the result, supported by quality control procedures which involve frequent analysis of specimens of known composition to ensure that the laboratory procedures are working properly.
To our customers who are nurses, clinicians, patients and environment experts, quality is defined only in relationship to time taken from sample collection to when they have received the results from the laboratory (timeliness, turnaround time).
The technical competency of laboratory technicians, technologists and scientists plays a critical role in ensuring strict adherence to the requirements of the total testing process as defined by the quality management system. To achieve proficiency, laboratory professionals must have both targeted training and an appropriate working environment to turn acquired knowledge into technical skills.
During the past decade there has been a renewed focus on laboratories with the agenda largely driven by the surge in funding for HIV/Aids, tuberculosis (TB), and malaria. As a result, there has been a boost in training opportunities for laboratory professionals, upgrading of facilities and an introduction of new technologies for prompt and accurate diagnosis.
There has been a growing recognition of the broader importance of laboratories and several calls for action. The main regional consensus was embodied in the 2008 Maputo Declaration on strengthening of Laboratory Systems which underscored the importance of putting in place appropriate institutional, policy and strategic frameworks and called for action to address the broader laboratory human resources agenda.
A similar policy statement was made during the 59th meeting of African Ministers of Health which called for strengthening public health laboratories, tackling the spread of drug resistance to Aids, TB and malaria.
International health regulations not only require the establishment of integrated disease surveillance systems and alerting neighbouring countries of disease outbreak, they also require well trained laboratory professionals and well-functioning laboratory systems.
As governments face numerous challenges and financial constraints, their main focus has been on addressing human resource shortages of clinicians and nurses. Laboratory staffing and workforce planning have not figured prominently in discussions of human resources at national or global level with these workers being among the neglected cadres in Africa.
Testing outside of a clinical laboratory is possible for a few diagnostic procedures like HIV rapid testing, HIV viral load testing and TB diagnosis. However, quality assurance of such point of care testing requires oversight and management by trained clinical laboratory professionals.
Today, Malawi faces the challenge of the global Covid-19 pandemic. The management of this potentially catastrophic viral infection will depend heavily on clinical laboratory services. Two tests will be required to be performed in large numbers and to a high quality.
Firstly, measurement of viral genetic material in respiratory swabs is required to determine which patients are infected. Secondly, measurement of the antibody to Sars-CoV2 in blood may determine which patients are immune to further infection and so safe to circulate in society and work. Perhaps this major health challenge will help to highlight why clinical laboratory services are an essential part of modern healthcare.
Let us celebrate Medical Laboratory Professional Week, April 19-25 to respect all laboratory professionals who are working to fight against Covid-19.
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