What Lies Behind Successful Regulation? A Qualitative Evaluation of Pilot Implementation of Kenya’s Health Facility Inspection Reforms

Document Type : Original Article


1 Institute of Healthcare Management, Strathmore University Business School, Strathmore University, Nairobi, Kenya

2 Department of Global Health and Development, London School of Hygiene and Tropical Medicine, University of London, London, UK

3 World Bank Group, Nairobi, Kenya


Health facility regulation in low- and middle-income countries (LMICs) is generally weak, with potentially serious consequences for safety and quality. Innovative regulatory reforms were piloted in three Kenyan counties including: a Joint Health Inspection Checklist (JHIC) synthesizing requirements across multiple regulatory agencies; increased inspection frequency; allocating facilities to compliance categories which determined warnings, sanctions and/or time to re-inspection; and public display of regulatory results. The reforms substantially increased inspection scores compared with control facilities. We developed lessons for future regulatory policy from this pilot by identifying key factors that facilitated or hindered its implementation.
We conducted a qualitative study to understand views and experiences of actors involved in the one-year pilot. We interviewed 77 purposively selected staff from the national, county and facility levels. Data were analyzed using the framework approach, identifying facilitating/hindering factors at the facility, inspection system, and health system levels.
The joint health inspections (JHIs) were generally viewed as fair, objective and transparent, which enhanced their perceived legitimacy. Interactions with inspectors were described as friendly and supportive, in contrast to the punitive culture of previous inspections when bribery had been common. Inspector training and use of an electronic checklist were strongly praised. However, practical challenges with transport, route planning and budgets highlighted the critical nature of strong logistical management. The effectiveness of inspection in improving compliance was hampered by limitations in related systems, particularly facility licensing, enforcement of closures and, in the public sector, control of funds. However, an inclusive reform development process had led to high buy-in across regulatory agencies which was key to the system’s success.
Effective facility inspection involves more than “hardware” such as checklists, protocols and training. Cultural, relational and institutional “software” are also crucial for legitimacy, feasibility of implementation and enforceability, and should be carefully integrated into regulatory reforms.



Commentaries Published on this Paper

  •  What Might Be Required for Inspections to Be Considered Fair?; Comment on “What Lies Behind Successful Regulation? A Qualitative Evaluation of Pilot Implementation of Kenya’s Health Facility Inspection Reforms”

        Abstract | PDF


  • Regulatory Reforms for Health Facilities: Can These Suffice?; Comment on “What Lies Behind Successful Regulation? A Qualitative Evaluation of Pilot Implementation of Kenya’s Health Facility Inspection Reforms”

        Abstract | PDF


  • Interest Groups and Health Facility Regulation – Future Directions for Health Policy and Systems Research; Comment on “What Lies Behind Successful Regulation? A Qualitative Evaluation of Pilot Implementation of Kenya’s Health Facility Inspection Reforms”

        Abstract | PDF



  1. Mackintosh M, Channon A, Karan A, Selvaraj S, Cavagnero E, Zhao H. What is the private sector? understanding private provision in the health systems of low-income and middle-income countries. Lancet. 2016;388(10044):596-605. doi:10.1016/s0140-6736(16)00342-1
  2. Saksena P, Xu K, Elovainio R, Perrot J. Utilization and expenditure at public and private facilities in 39 low-income countries. Trop Med Int Health. 2012;17(1):23-35. doi:10.1111/j.1365-3156.2011.02894.x
  3. World Bank Group. Healthy Partnerships: How Governments Can Engage the Private Sector to Improve Health in Africa. Nairobi: World Bank Group; 2011.
  4. Olivier J, Tsimpo C, Gemignani R, et al. Understanding the roles of faith-based health-care providers in Africa: review of the evidence with a focus on magnitude, reach, cost, and satisfaction. Lancet. 2015;386(10005):1765-1775. doi:10.1016/s0140-6736(15)60251-3
  5. Montagu D, Goodman C. Prohibit, constrain, encourage, or purchase: how should we engage with the private health-care sector? Lancet. 2016;388(10044):613-621. doi:10.1016/s0140-6736(16)30242-2
  6. Ensor T, Weinzierl S. Regulating health care in low- and middle-income countries: broadening the policy response in resource constrained environments. Soc Sci Med. 2007;65(2):355-366. doi:10.1016/j.socscimed.2007.03.021
  7. Baldwin R, Cave M, Lodge M. Understanding Regulation: Theory, Strategy, and Practice. Oxford University Press on Demand; 2012.
  8. Doherty JE. Regulating the for-profit private health sector: lessons from East and Southern Africa. Health Policy Plan. 2015;30(Suppl 1):i93-i102. doi:10.1093/heapol/czu111
  9. Morgan R, Ensor T. The regulation of private hospitals in Asia. Int J Health Plann Manage. 2016;31(1):49-64. doi:10.1002/hpm.2257
  10. Braithwaite J. Responsive regulation and developing economies. World Dev. 2006;34(5):884-898. doi:10.1016/j.worlddev.2005.04.021
  11. Flodgren G, Gonçalves-Bradley DC, Pomey MP. External inspection of compliance with standards for improved healthcare outcomes. Cochrane Database Syst Rev. 2016;12(12):CD008992. doi:10.1002/14651858.CD008992.pub3
  12. Chalker J, Ratanawijitrasin S, Chuc NT, Petzold M, Tomson G. Effectiveness of a multi-component intervention on dispensing practices at private pharmacies in Vietnam and Thailand--a randomized controlled trial. Soc Sci Med. 2005;60(1):131-141. doi:10.1016/j.socscimed.2004.04.019
  13. Sheikh K, Saligram PS, Hort K. What explains regulatory failure? analysing the architecture of health care regulation in two Indian states. Health Policy Plan. 2015;30(1):39-55. doi:10.1093/heapol/czt095
  14. Wafula F, Molyneux C, Mackintosh M, Goodman C. Protecting the public or setting the bar too high? understanding the causes and consequences of regulatory actions of front-line regulators and specialized drug shop operators in Kenya. Soc Sci Med. 2013;97(100):220-227. doi:10.1016/j.socscimed.2013.08.020
  15. Barnes J, O'Hanlon B, Feeley F, McKeon K, Gitonga N, Decker C. Private Health Sector Assessment in Kenya. The World Bank; 2010.
  16. G.o.K MoH. Kenya Master Health Facility List. 2020; http://kmhfl.health.go.ke/#/facility_filter/results. Accessed May 11, 2020.
  17. Ministry of Health, World Bank Group. Kenya Patient Safety Impact Evaluation (KePSIE) Operation Manual. Nairobi: Ministry of Health, World Bank Group; 2016.
  18. Kenya Ministry of Health (MoH) IFCI, World Health Organization (WHO). Kenya National Patient Safety Survey. 2012.
  19. Ministry of Health, World Bank Group. Kenya Patient Safety Impact Evaluation (KePSIE) Brief. Nairobi: Ministry of Health, World Bank Group; 2016.
  20. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi:10.1136/bmj.a1655
  21. De Silva MJ, Breuer E, Lee L, et al. Theory of change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions. Trials. 2014;15:267. doi:10.1186/1745-6215-15-267
  22. Marchal B, Westhorp G, Wong G, et al. Realist RCTs of complex interventions - an oxymoron. Soc Sci Med. 2013;94:124-128. doi:10.1016/j.socscimed.2013.06.025
  23. Moore GF, Audrey S, Barker M, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350:h1258. doi:10.1136/bmj.h1258
  24. Government of Kenya. 2019 Kenya Population and Housing Census. 2019.
  25. Commission for Revenue Allocation (CRA) Government of Kenya. Kenya County Fact Sheets. 2013.
  26. Government of Kenya MoH. County Health Fact Sheets. Nairobi, Kenya; 2015.
  27. Pope C, Ziebland S, Mays N. Qualitative research in health care. Analysing qualitative data. BMJ. 2000;320(7227):114-116. doi:10.1136/bmj.320.7227.114
  28. Leslie HH, Sun Z, Kruk ME. Association between infrastructure and observed quality of care in 4 healthcare services: a cross-sectional study of 4,300 facilities in 8 countries. PLoS Med. 2017;14(12):e1002464. doi:10.1371/journal.pmed.1002464
  29. Sheikh K, Gilson L, Agyepong IA, Hanson K, Ssengooba F, Bennett S. Building the field of health policy and systems research: framing the questions. PLoS Med. 2011;8(8):e1001073. doi:10.1371/journal.pmed.1001073
  30. Barasa EW, Cloete K, Gilson L. From bouncing back, to nurturing emergence: reframing the concept of resilience in health systems strengthening. Health Policy Plan. 2017;32(Suppl 3):iii91-iii94. doi:10.1093/heapol/czx118
  31. Elloker S, Olckers P, Gilson L, Lehmann U. Crises, routines and innovations: the complexities and possibilities of sub-district management. S Afr Health Rev. 2012;2012(1):161-173. doi:10.10520/ejc133690
  32. Bloom G, Henson S, Peters DH. Innovation in regulation of rapidly changing health markets. Global Health. 2014;10:53. doi:10.1186/1744-8603-10-53
  33. Hovlid E, Braut GS, Hannisdal E, et al. Mediators of change in healthcare organisations subject to external assessment: a systematic review with narrative synthesis. BMJ Open. 2020;10(8):e038850. doi:10.1136/bmjopen-2020-038850
  34. Smithson R, Richardson E, Roberts J, et al. Impact of the Care Quality Commission on Provider Performance: Room for Improvement? King's Fund; 2018.
  35. Bagonza A, Peterson S, Mårtensson A, et al. Regulatory inspection of registered private drug shops in East-Central Uganda-what it is versus what it should be: a qualitative study. J Pharm Policy Pract. 2020;13:55. doi:10.1186/s40545-020-00265-9
  36. Pring C, Vrushi J. Global corruption barometer: Africa 2019. Transparency International; 2019.
Volume 11, Issue 9
September 2022
Pages 1852-1862
  • Receive Date: 17 December 2020
  • Revise Date: 04 July 2021
  • Accept Date: 19 July 2021
  • First Publish Date: 25 August 2021