A Quality Improvement Initiative to Control a Gram-negative Sepsis Outbreak in a Resource-limited Neonatal Intensive Care Unit Using Systems Engineering Initiative for Patient Safety and a Modified Donabedian Framework

Introduction: Each year, 2.6 million newborns die globally, making up 46% of mortality in children younger than 5 years. Most of these deaths (96%) occur in low- and middle-income countries, with India accounting for approximately 25% of global neonatal mortality. Healthcare-associated infections (HCAIs) are a major cause of morbidity and mortality in neonatal intensive care units across low- and middle-income countries, with incidence rates ranging from 15.2 to 62.0 per 1,000 patient-days. A simplified and scalable framework is required to reduce neonatal mortality from sepsis. Methods: We experienced a Gram-negative sepsis outbreak in our neonatal intensive care unit beginning in July 2021, with HCAI peaks reaching 30–40 per 1,000 patient-days and a case fatality of approximately 30%. The outbreak was contained through a strategic combination of the Modified Donabedian approach and the application of the Systems Engineering Initiative for Patient Safety model. Results: HCAIs decreased from a mean of 14 and a peak of 38.7 per 1,000 patient-days to a sustained mean of 2.9, and antibiotic use decreased by 50%. Late-onset sepsis–related mortality fell from 27.3% in 2021 and 40% in 2022 to 12% in 2023 and 0% in 2024. Conclusions: Effective outbreak control requires a holistic, structured approach that encompasses all components of the Systems Engineering Initiative for Patient Safety model, namely studying the work system (structure), processes, and outcomes. Activating agency and fostering psychological safety transform healthcare workers from being recipients of policy into active participants in implementing solutions. Strong leadership galvanizes teams toward a shared purpose and overcomes significant challenges to improve care.