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.