There have been press reports recently regarding who between the Pharmacy and Poisons Board (PPB) and Kenya Medical Laboratory Technicians and Technologists’ Board (KMLTTB) has the capacity to validate and verify Covid-19 testing equipment and test kits, and approve them.
This unnecessary confusion would not have arisen had the then Health Cabinet Secretary Cleophas Mailu not usurped the authority of regulators in the Ministry of Health and issued circulars that are not backed by law.
The PPB has its legislation, Cap 244 of the Laws of Kenya, establishing it, while KMLTTB is established under Cap 253A. These two laws are not in conflict. Whereas PPB has issued guidelines on handling of medical devices, KMLTTB published a legal gazette notice number 113 of 2011 that stipulates regulations for validation of in vitro diagnostics, namely medical laboratory equipment and reagents.
The medical laboratory training and practice is controlled by the later Act and is about the only medical profession in the world that is accredited vide an international standard, namely ISO/IEC 15189:2012. It is imperative to note that in matters competency, it is not the person who does the test that proclaims it but rather an accreditation body like our Kenya Accreditation Service (KENAS) that engages the services of qualified and retained medical laboratory assessors following regulatory assessment and licensure by KMLTTB.
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The qualified and registered medical laboratory personnel are trained and competent to verify manufacturer claims on equipment and reagents they use in the course of their work because they understand quality management systems in as far clinical testing is concerned.
Testing laboratories provide vital services to their clients who expect accurate results produced at the appropriate time and at a reasonable cost. However, when making measurements, there is always some level of inaccuracy. The challenge is to reduce the level of inaccuracy as much as possible, given the complexity of analytical testing laboratories that, like any type of complex system, exhibit an inherent variability. Therefore, the Quality Management System model (QMS), is very important for assessing and controlling the laboratory complexity and achieving good performance.
Outbreaks and pandemics
The set of operations that occur in testing is usually called ‘path of workflow’: it begins with the sample collection and ends in reporting. The concept of the path of workflow is a key to the QM and should be considered when developing quality practices. For this reason promoting a culture of quality should be an everyday effort and medical laboratories must remember that many factors should be addressed to assure quality not only during outbreaks and pandemics.
In as much as medical laboratory accreditation around here is still a voluntary affair, there is need to make it mandatory to minimise to acceptable levels testing errors because it is about human life. There are 12 quality systems essentials, but the one in which we have not done so well as a country is information management, which is a system that incorporates all the processes needed for effectively managing data. Data, and in particular test results, are the final product of the laboratory and for this reason, laboratory directors/managers need to ensure there is an effective information management system in place to achieve accuracy, timeliness, security and privacy of information.
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During this time of global distress, we hope that all medical laboratory personnel are well. The world is struggling because of the pandemic, and healthcare resources are stretched. From our perspective, the quality of laboratory results is especially important now as they play an important role both in securing patient safety and overcoming this global challenge. We are doing our best to assist clinicians and governments manage patients better using medical laboratory-validated equipment and consumables in maintaining good quality levels.
The writer is secretary-general, Association of Kenya Medical Laboratory Assessors.