This study sought to investigate the factors affecting the sustainability of ISO 15189:2012 medical laboratory accreditation programs in Kenya. Specifically, the study focused on the challenges medical laboratories go through on their ISO 15189:2012 accreditation journey and factors affecting the sustainability of ISO 15189:2012 medical laboratory accreditation in Kenya. The research utilized an exploratory study methodology. Structured questionnaires were used to gather data from senior laboratory managers from twenty accredited county referral hospitals in Kenya. Face-to-face interviews were also held with hospital management for the accredited hospitals. The study concluded that the major challenges are the cost of the accreditation process, the cost of a yearly subscription, and the cost of proficiency testing. Other challenges are huge documentation requirements, lack of senior management support, reagent stock-outs, and poor laboratory equipment maintenance schedules. The study also concluded that the high turnover of laboratory personnel as a result of successive county government policies where qualified and trained officers on quality management systems are transferred to other facilities or demoted is a major challenge in the sustainability of ISO 15189:2012.

Keywords : Accreditation, ISO 15189, Laboratory Quality, Quality of Service, Sustainability, Quality Management Systems.