To address these issues, Centers for Disease Control and Prevention (CDC) through the US PEPFAR program supported the implementation of Quality Management Systems (QMS) in Kenya in 2010.
The Situation & Challenge
For years, Kenya has endured some of the world's highest rates per capita of HIV, tuberculosis, hepatitis, malaria, and other infectious diseases. In addition, between 8000 and 10 000 children under the age of 5 are hospitalized with severe acute respiratory illness associated with influenza every year.
Although accurate diagnosis and testing are essential for identifying and managing infectious disease, Kenya had only three accredited medical laboratories serving its population of 41 million in 2010. One example of the need: a lack of trained personnel had caused the time for receiving test results of viral load (the amount of HIV in a person's blood) to exceed 33 days. And still, most physicians did not feel confident in their accuracy.1
The Kenyan government and CDC set out to greatly increase the number of laboratories in Kenya that could achieve and maintain accreditation aligned with ISO 15189. Several clinical laboratory organizations, including CLSI, were selected to participate in this effort.
Of the 10 labs originally assigned to CLSI, seven had achieved accreditation by 2016. • Due to the local mentoring and auditing capacity instituted by CLSI, several of the laboratories it served achieved accreditation for consecutive years. To date, 311 clinicians and laboratory staff have been trained through CLSI’s hands-on instruction, train-the-trainer education, and ongoing mentoring and monitoring.