Health systems in low and middle income countries (LMIC) are increasingly pluralistic, involving a wide mix of public, not-for-profit and for-profit providers. Regulation should be a key foundation of the Government's stewardship role of these heterogeneous facilities, but performance of this function is generally weak, with serious consequence for patient safety and quality of care.
There has been little evaluation of strategies to strengthen regulation in LMIC, a notable exception being the Kenya Patient Safety Impact Evaluation (KePSIE), a collaboration between the Kenyan Ministry of Health and the World Bank. This randomised controlled trial is assessing the impact of a set of innovative regulatory interventions in public and private facilities in three Kenyan counties. These comprise the use of the Joint Health Inspections Checklist (JHIC), which synthesises the areas covered by all the regulatory Boards and Councils; increased inspection frequency; risk-based inspections where warnings, sanctions and time to re-inspection depend on inspection scores; and display of regulatory results outside facilities.
The KePSIE trial will provide a rigorous quantitative assessment of these regulatory strategies.
The results are expected to make an important contribution to the limited evidence base on regulation and regulatory reform. The findings will be of substantial benefit to those concerned with regulatory reform and the improvement of quality and safety more generally in Kenya and other LMIC settings.
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