Neonatal sepsis is defined as a systemic inflammatory response to infection in a newborn, supported by clinical features and microbiological evidence. It remains a major cause of neonatal morbidity and mortality worldwide [3]. Early-onset and late-onset sepsis require prompt identification, appropriate investigations, and timely evidence-based antimicrobial therapy. International guidelines, including the NICE Neonatal Infection Guideline (NG195), outline essential management steps, such as obtaining a blood culture before starting antibiotics, assessing red-flag indicators, and reviewing treatment at 36 hours [1]. Quality standards such as NICE QS75 further define expectations for sepsis recognition, timely antibiotic delivery, parental communication, and documentation [2]. Despite clear guidance, many NICUs struggle with staff turnover, limited resources, and inconsistent clinical workflows. Our NICU demonstrated similar challenges, prompting this audit and QI intervention. Aims and Objectives The primary aim of this initiative was to strengthen how neonatal sepsis is managed in our unit, especially by ensuring that blood cultures are collected before antibiotics are started. To support this, we set out to achieve at least 90% compliance with blood culture collection prior to treatment. We also focused on empowering the team by training all NICU nurses, interns, and junior residents in sepsis protocols and correct sampling techniques. Improving the everyday culture of infection prevention was another priority, with a goal of maintaining hand-hygiene adherence above 95%. In addition, we introduced a standardized NICU sepsis workflow based on NICE guidelines, with the broader purpose of reducing sepsis-related morbidity and improving the quality of care for newborns.

Study Design Retrospective clinical audit followed by QI intervention using PDSA methodology. Setting Tertiary-care Neonatal Intensive Care Unit in Punjab Institute of Medical Sciences, Jalandhar. Audit Periods • Pre-audit: August–November 2024 • Post-audit: December 2024–March 2025 Sample Size • Pre-audit: 87 neonates • Post-audit: 98 neonates Standards Used Audit criteria were derived from: • NICE NG195 [1] • NICE QS75 [2] • Institutional NICU Sepsis Protocol [4] Data Collection • Blood culture before antibiotics • CRP baseline and repeat (18–24 hrs) • Documentation of red flags • Antibiotic type and timing • Lumbar puncture when indicated • Availability of culture vials • Staff competency (questionnaires) • Adherence to infection-prevention practices Interventions Implemented • Structured staff training sessions • Demonstration of blood culture technique • Display of redesigned NICE-based flowcharts • Ensuring vial availability 24/7 • Restricting antibiotic decisions to JR/Consultant • Improved lab coordination for timely CRP reporting • Daily huddles for realtime feedback Quality Improvement Interventions (PDSA Cycles) PDSA Cycle 1: Ensuring Availability of Blood Culture Vials The pre-audit revealed that cultures were often omitted due to unavailability of vials—particularly during night duty. A standardized supply protocol was implemented, including daily stock checks, sealed emergency kits, and assignment of responsibility to the shift nursing supervisor. This ensured consistent availability of culture bottles across all shifts. PDSA Cycle 2: Standardizing Blood Culture Collection Technique Observations and staff questionnaires revealed variable technique in hand hygiene, skin preparation, and labelling. A stepwise protocol based on NICE NG195 was implemented, covering proper antisepsis, minimum 1 mL sampling, needle change before inoculation, and aseptic handling. Posters were placed at sampling stations, and staff practiced under supervision. PDSA Cycle 3: Comprehensive Education and Competency Training Knowledge gaps were identified in: red-flag indicators, when to repeat CRP, sampling outborn babies on prior antibiotics, indications for lumbar puncture, and ET cultures. A structured education package—including demonstrations, orientation modules, and competency checklists—was delivered to all NICU nursing staff, interns, and JRs from August to November 2024. Post-training assessments showed significant improvement. PDSA Cycle 4: Implementing a Standardized Sepsis Workflow (Flowchart) Comparison of actual NICU practice with NICE guidelines showed major deviations such as antibiotics started before cultures, delayed LP, missed ET cultures, and incomplete documentation. A unified flowchart integrating maternal risk factors, red-flag indicators, culture-before-antibiotics, CRP timing, and 36-hour review was implemented across NICU workstations. PDSA Cycle 5: Improving CRP Reporting and Documentation CRP reporting delays due to late printing and lack of notifications contributed to treatment lag. Coordination with the laboratory resulted in timely electronic result updates and designated staff assigned to print and document results promptly. PDSA Cycle 6: Clarifying Responsibility for Antibiotic Initiation Interns frequently initiated antibiotics without complete assessment or cultures. A policy was introduced mandating that antibiotic decisions be made only by the JR/Consultant after evaluating red-flag indicators and ensuring sample collection.

1. Blood Culture Compliance Period Total Neonates Blood Cultures Sent Compliance (%) Pre-audit (Aug–Nov 2024) 87 12 13.7% Post-audit (Dec 2024–Mar 2025) 98 63 64.3% Compliance improved 4.6-fold following intervention. 2. Reasons for Non-Compliance (Pre-Audit) From documented observations and staff feedback, reasons included: • Lack of vials (20%) • Untrained staff (20%) • Ignorance/oversight (15%) • Unclear responsibility (15%) • Delayed CRP reports (10%) • No ET cultures (10%) • LP not done when indicated (10%) 3. Workflow Deviations Ideal Workflow Based on NICE Guidelines (Supported by NG195 [1] and QS75 [2]) • Complete clinical assessment • Send blood culture before antibiotics • Baseline CRP • Start antibiotics immediately after sampling • Repeat CRP at 18–24 hours • Stop antibiotics at 36 hours if criteria met Actual Pre-Audit Workflow (before QI intervention) • Partial assessment • Early start of antibiotics without cultures • CRP delays • ET cultures not performed • LP delayed or omitted • Vital signs not monitored routinely 4. Improvements After Intervention • Significant improvement in correct sampling • Better recognition of red-flag indicators • More consistent documentation • Clearer delegation of decisions • Reduced unnecessary antibiotic duration • Increased consultant involvement • Improved hand-hygiene adherence

The audit identified significant gaps in neonatal sepsis management. Only 13.7% of neonates underwent blood culture collection before antibiotics in the pre-audit period—well below NICE expectations [1,2]. This increases the risk of misdiagnosis, antibiotic overuse, and delays in escalation or de-escalation. Root causes included lack of supplies, inadequate training, unclear workflow, and poor inter-team communication. These findings align with challenges reported by WHO regarding newborn infection management in low-resource settings [3]. After targeted interventions, compliance increased to 64.3%. Our findings are consistent with a UK audit published in Clinical Medicine assessing compliance with NICE QS75 [5]. Both identified discrepancies between recommended and actual sepsis management pathways, underscoring that guideline adoption remains an international challenge. Like their report, our QI intervention resulted in significant improvement, demonstrating that structured education and system redesign are effective across settings. Findings from our audit also align with the QI study by Allen et al., [6] which demonstrated that standardized procedures and staff education significantly improved the quality of blood culture collection in neonates. While their focus was on contamination and ours on compliance, both projects identified similar root causes which includes training gaps, inconsistent aseptic technique, and workflow variation and showed substantial improvement following PDSA-based interventions. This reinforces that structured QI approaches are effective across diverse neonatal units. This highlights that structured education, logistic support, and workflow standardization can significantly improve clinical practice. However, achieving the ≥90% target requires continuous training, monitoring, and periodic re-audits.

This audit demonstrated important gaps between recommended and actual neonatal sepsis management practices. A structured QI intervention led to substantial improvements, increasing blood-culture compliance from 13.7% to 64.3%. Ongoing reinforcement, protocol adherence, and re-audit cycles are required to sustain progress and further improve outcomes.

1. NICE. Neonatal infection: antibiotics for prevention and treatment. NICE guideline NG195; 2021. 2. NICE. Neonatal infection (early onset): Quality Standard QS75; 2014. 3. World Health Organization. Newborn infections. WHO Newborn Health Guidelines; Accessed June 2025. 4. Institutional NICU Sepsis Management Protocol, Pediatrics Department, 2024. 5. Dalvi S, Gawlowski Z. Closing the clinical gap: an audit of clinical compliance for early-onset neonatal sepsis management. Clin Med. 2025;25(4 Suppl):100374. 6. Allen E, Cavallaro A, Keir AK. A quality improvement initiative to reduce blood culture contamination in the neonatal unit. Pediatr Qual Saf. 2021;6(3):e413. doi:10.1097/pq9.0000000000000413