Kenya shows how clear regulations and regular inspections improve quality of health care

Recent research in Kenya has identified a powerful and cost-effective tool to help improve the quality of health care in low- and middle-income countries: strict quality and safety regulations combined with regular inspections based on a clear checklist.

The research provides the first robust evidence from a randomized control trial that regulating health facilities combined with regular and transparent inspections can improve care.

“Health regulations are an underutilized and misunderstood tool for improving health outcomes in LMICs,” said Agya Mahat, a technical officer at the World Health Organization and expert on regulations who was not involved in the research. “Too often regulation models in LMICs are replicated from high-income countries without an understanding of what the goal is, whether it's to improve the quality of care or improve access to care. While on the ground, there is no enforcement.”

Health care decision makers looking for levers for improving the delivery of care and health outcomes should consider the role of regulations, said Mahat.

Consider the fact that unsafe medical care, often taking place at unlicensed health facilities – which make up a majority of health facilities in many LMICs – leads to an estimated 2.6 million deaths in those countries each year.

“Historically, we’ve given regulations such a short shift,” said Jishnu Das, one of the study’s lead researchers and a professor of public policy at Georgetown University. “This research will hopefully change that. With this research we can say we have two key pieces of valuable evidence. First, regulations can improve key factors that then impact patient outcomes. And second, regulations can improve those factors across all health facilities, public and private, by increasing competition between facilities.”

The research was made possible by a critical window of opportunity – a decision by health leaders in Kenya to re-evaluate their existing regulatory structure and policies, said Amy Dolinger, an analyst with the World Bank research team that conducted the study. “Kenya is a pioneer in health sector regulations in the region,” said Dolinger. “Only one out of five countries in Africa have regular de facto inspections of health facilities.”

As Kenyan government officials were discussing revisions and reforms to their health regulations to improve health outcomes, they invited leading researchers to join the discussion, said Dolinger. The group decided on a randomized control trial to test a transparent and clear regulatory system.

The researchers collaborated for more than five years with ministry of health officials, leaders of public and private health facilities, and facility inspectors, to design and implement new minimum quality standards for patient safety in both public and private health facilities. The outcome was the Joint Health Inspection Checklist, a 471-item checklist of minimum quality standards used to assess a facility's compliance with safety protocols.

Researchers received permission from the government to experimentally implement the new regulations for 13 months from November 2016 to December 2017 in 1,348 health facilities across three Kenyan counties. The health facilities were grouped into 273 markets, and the markets were then randomly assigned to either the treatment or control groups.

All of the health facilities were provided with the 471-item checklist. In the treatment facilities, the checklist was used by government inspectors to assess performance during two unannounced inspections during the study period.

Following the inspections, as part of their regulatory enforcement actions, unlicensed facilities were reported for closure. Licensed facilities that fell below minimum quality standards were given a warning but allowed to stay open and given a timeline for re-inspection to demonstrate they had improved their performance versus the checklist.

Finally, in a subset of randomly chosen health facilities, inspectors publicly posted the results of these new inspections in “report cards” with letter grades of A through D assigned to the facility. Others were not required to post their inspection score.

Meanwhile, facilities in the control group were not subject to ramped-up inspections, warnings, or sanctions. Inspections in these control areas were made, as per usual, only in response to a complaint – in reality, this inspection rate, researchers found, was close to zero. Previously only 4% of health facilities were inspected in a given year.

Researchers found that the increased regulation of health facilities in Kenya based on the 471-item checklist with regular inspections improved patient safety scores – at low cost and without reducing health facility utilization. In fact, visits to public health facilities increased by 19% over the course of the research period.

Interestingly, researchers noted that the facilities didn’t just invest in the cheapest or easiest items on the inspection checklist. “They aren’t just painting walls and posting standard operating procedures on walls,” said Das. “Instead, they are investing in key infrastructure that impacts quality of care.”

There was no significant difference in the performance of the health facilities that posted the results of their inspection and those that did not. The key difference was between the treatment facilities, which were subject to inspections with the checklist as the key measure of compliance, and the control facilities, which were not.

Dolinger noted that the tenor of inspections changed as part of this research. Under the old system, regulations were sometimes viewed as ambiguous and requiring some interpretation. That often left the door open to complaints of discriminatory practices. Health facility operators complained that the system was adversarial and government responses were punitive.

But under the new system, with transparent and unambiguous regulations and a checklist preprogrammed into inspectors’ tablets, the inspections were often viewed as helpful, said Guadalupe Bedoya, an economist in the Development Impact department in the World Bank's Development Research Group and one of the study’s authors.

Dr. Charles Kandie, the head of health standards for Kenya’s ministry of health at the time of the research, told researchers that the clear and transparent checklist removed discretion from the inspector’s role. The new system allowed inspectors to be objective in their evaluations and better reflect and respond to public health risks, said Dr. Kandie.

Removing discretion also reduced opportunities for corruption, the authors and the national leaders noted.

“We believe that the checklist helps the health facility staff prioritize their investments,” said Das. “And the knowledge that other facilities in the area were making similar improvements to meet the checklist standards in advance of or in response to inspections drove broad improvements across facilities both public and private.”

Indeed, the researchers found that the checklist and enforcement prompted the best performing facilities to make investments to maintain their position as the highest quality facility in their area. The researchers suggested that the checklist helped health facility staff prioritize their investments in improving facility conditions and protocols. The checklist may also have served as an advocacy tool to support staff requests for key equipment.

Kenyan health authorities are now preparing to roll out the new checklist and ramped-up inspection protocols across the country. “This shows what can happen when researchers are at the table, when there is political will and openness,” said Dolinger.