To reverse this trend, in 2008 the US Centers for Disease Control and Prevention initiated a program for limited-resource countries that was aimed at developing quality laboratory systems that would lead to accreditation aligned with ISO 15189 standards.
The Situation & Challenge
In 2005, Tanzania faced widespread outbreaks of HIV, AIDS, tuberculosis, malaria, and other infectious diseases. To compound the crisis, laboratory testing—used to confirm diagnosis and monitor treatment—was found to be severely inadequate.
Misdiagnoses occurred regularly. Clinicians viewed laboratory results as unreliable. And in one study of 4,670 hospital patients treated for malaria, fewer than 50% had their diagnosis confirmed by blood smear.1 The conclusion: inaccurate laboratory tests posed a significant threat to the nation's health.
In a pilot study, the Tanzanian Ministry of Health commissioned CLSI to bring its six largest laboratories to international accreditation standards, upgrading their capabilities and training lab personnel in acknowledged best practices.
At the end of the pilot test, all six government laboratories were accredited, a first for any nation in the region. The success of the initial phase led to the program's implementation in 23 other laboratories around the country. To date, ten laboratories have been fully accredited, and 820 technicians have been trained through hands-on instruction, train-the-trainer education, and ongoing follow-through and monitoring.