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Updated: Feb 26, 2026
A Neonatal Imaging Model of Gram-Negative Bacterial Sepsis
Published on: August 12, 2020
A Quality Improvement Initiative to Control a Gram-negative Sepsis Outbreak in a Resource-limited Neonatal Intensive
Kedar Sawleshwarkar1,2, Mahtab Singh3, Ramesh Bajaj1
1From the Department of Neonatology, Deogiri Children's Hospital, Chhatrapati Sambhajinagar, Maharashtra, India.
Insights
A structured approach combining the Modified Donabedian and Systems Engineering Initiative for Patient Safety models significantly reduced healthcare-associated infections and sepsis mortality in a neonatal intensive care unit. This improved patient safety and outcomes.
Area of Science:
- Neonatal Intensive Care
- Infectious Disease Control
- Patient Safety
Background:
- Neonatal mortality remains a critical global health issue, particularly in low- and middle-income countries, with healthcare-associated infections (HCAIs) contributing significantly to neonatal sepsis.
- Incidence rates of HCAIs in neonatal intensive care units (NICUs) are high, ranging from 15.2 to 62.0 per 1,000 patient-days, leading to substantial morbidity and mortality.
- A simplified and scalable framework is essential to mitigate neonatal mortality stemming from sepsis.
Purpose of the Study:
- To describe the successful containment of a Gram-negative sepsis outbreak in a NICU.
- To evaluate the effectiveness of a combined Modified Donabedian approach and the Systems Engineering Initiative for Patient Safety (SEIPS) model in controlling HCAIs and reducing sepsis-related mortality.
- To highlight the importance of a holistic, structured approach in improving patient safety and outcomes in NICUs.
Main Methods:
- Implementation of a strategic combination of the Modified Donabedian approach and the SEIPS model to address a Gram-negative sepsis outbreak.
- Monitoring of HCAI incidence rates and case fatality rates during the outbreak.
- Assessment of changes in antibiotic use and sepsis-related mortality following the intervention.
Main Results:
- Healthcare-associated infections (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.
- Antibiotic use was reduced by 50%.
- Late-onset sepsis-related mortality significantly decreased from 27.3% in 2021 and 40% in 2022 to 12% in 2023 and 0% in 2024.
Conclusions:
- Effective control of HCAI outbreaks in NICUs necessitates a holistic and structured approach, integrating work system components (structure, processes, outcomes) as outlined by the SEIPS model.
- Empowering healthcare workers and fostering psychological safety are crucial for successful implementation of patient safety initiatives.
- Strong leadership is vital for uniting teams, overcoming challenges, and driving improvements in neonatal care and patient safety.
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.
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