Abstract
BackgroundThe National HIV Reference Laboratory (NHRL) serves as Kenya’s referral HIV laboratory, offering specialised testing and external quality assessment, as well as operating the national HIV serology proficiency scheme. In 2010, the Kenya Ministry of Health established a goal for NHRL to achieve international accreditation.ObjectivesThis study chronicles the journey that NHRL took in pursuit of accreditation, along with the challenges and lessons learned.MethodsNHRL participated in the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme from 2010–2011. Improvement projects were undertaken to address gaps in the 12 quality system essentials through development of work plans, team formation, training and mentorship of personnel. Audits were conducted and the scores used to track progress along a five-star grading scale. Standard quality indicators (turn-around time, specimen rejection rates and service interruptions) were measured. Costs of improvement projects and accreditation were estimated based on expenditures.ResultsNHRL scored 45% (zero stars) at baseline in March 2010 and 95% (five stars) after programme completion in October 2011; in 2013 it became the first public health laboratory in Kenya to attain ISO 15189 accreditation. From 2010–2013, turn-around times decreased by 50% – 95%, specimen rejections decreased by 93% and service interruptions dropped from 15 to zero days. Laboratory expenditures associated with achieving accreditation were approximately US $36 500.ConclusionInternational accreditation is achievable through SLMTA, even for a laboratory with limited initial quality management systems. Key success factors were dedication to a shared goal, leadership commitment, team formation and effective mentorship. Countries wishing to achieve accreditation must ensure adequate funding and support.
Highlights
International accreditation is achievable through Strengthening Laboratory Management Toward Accreditation (SLMTA), even for a laboratory with limited initial quality management systems
The burden of HIV in Kenya is high, with 1.6 million people living with the infection as of December 2011, including 621 813 patients who had been placed on antiretroviral therapy (ART) by 2010
Laboratory test results play a crucial role in medical decision making; and accurate and reliable diagnostic testing and monitoring are critical to the successful management of HIV
Summary
The burden of HIV in Kenya is high, with 1.6 million people living with the infection as of December 2011, including 621 813 patients who had been placed on antiretroviral therapy (ART) by 2010. In order to support diagnostic testing and laboratory monitoring of HIV patients, there is a high demand for quality laboratory services, as 5.7 million HIV tests were performed in 2012 alone.[1]. Gershy-Damet et al pointed out that high-quality laboratory testing is critical for patient care, disease prevention and surveillance.[2] Laboratory test results play a crucial role in medical decision making; and accurate and reliable diagnostic testing and monitoring are critical to the successful management of HIV. Because most HIV diagnostic testing is done by non-laboratory staff, reference laboratories play a critical role in monitoring field testing.[2,5] To ensure quality results at every level, the World Health Organization (WHO) recommends that national reference laboratories seek accreditation to international standards.[6]. In 2010, the Kenya Ministry of Health established a goal for NHRL to achieve international accreditation
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