Transforming central line associated blood stream infection prevention in neonates: Results from a multimodal quality improvement initiative

Abstract

BACKGROUND

Central line-associated bloodstream infections (CLABSI) are a major cause of morbidity and mortality among neonates in intensive care units. Quality improvement (QI) initiatives targeting CLABSI prevention can significantly enhance patient outcomes.

AIM

To evaluate the impact of a multimodal QI initiative on reducing CLABSI incidence in a level-3 neonatal intensive care unit (NICU) and sustaining the improvement over time. The goal was to achieve a 50% reduction in CLABSI rates within 12 months and maintain results for an additional 18 months.

METHODS

This prospective interventional study was conducted in a level-3 teaching NICU in Western India. All neonates with central venous access during NICU stay were included. Baseline CLABSI rates were measured over a pre-intervention period. The intervention bundle comprised strengthening hand hygiene practices, customizing and updating CLABSI prevention bundles, revising environmental cleaning protocols, conducting regular audits of line insertion and maintenance practices, and implementing structured nursing education sessions. Multiple Plan-Do-Study-Act cycles were used to refine interventions and monitor compliance.

RESULTS

The baseline CLABSI rate was 6.4 per 1000 central line days, which decreased to 1.1 per 1000 central line days post-intervention; an 83% reduction. During the 18-month sustainability phase, rates remained low at 0.96 per 1000 central line days. Hand hygiene compliance, adherence to central line bundles, and nursing education coverage improved significantly throughout the intervention and maintenance phases.

CONCLUSION

Implementation of a structured, multimodal QI bundle emphasizing hand hygiene, tailored central line care bundles, regular audits, and nursing education resulted in a substantial and sustained reduction in CLABSI rates. This approach is feasible, cost-effective, and replicable in similar resource-constrained NICU settings.

Key Words: Quality improvement; Plan-Do-Study-Act cycle; Neonatal sepsis; Prevention bundle; Infection control; Central line-associated bloodstream infections

Core Tip: A structured, multimodal quality improvement initiative led to a substantial and sustained reduction in neonatal central line associated blood stream infection rates in a level-3 neonatal intensive care unit. By strengthening hand hygiene, customizing central line care bundles, reinforcing environmental cleaning, conducting regular audits, and providing ongoing nursing education through iterative Plan-Do-Study-Act cycles, central line associated blood stream infection rates fell by over 80% and remained low for 18 months. This low-cost, pragmatic approach is feasible and reproducible in resource-constrained neonatal intensive care unit settings, including low- and middle-income countries.

INTRODUCTION

Neonatal sepsis remains a leading cause of morbidity and mortality worldwide, particularly in low- and middle-income countries (LMICs), where access to advanced neonatal care is often limited. Sepsis accounts for a substantial proportion of neonatal intensive care unit (NICU) admissions, leading to prolonged hospitalization, increased antibiotic exposure, and elevated healthcare costs[1,2]. According to the Global Burden of Disease database, neonatal sepsis was the third most common cause of neonatal mortality globally, responsible for an estimated 336300 deaths annually[3,4]. Beyond its immediate threat to survival, neonatal sepsis contributes to long-term neurodevelopmental impairment, growth restriction, and chronic health challenges among survivors, imposing lasting consequences on families and health systems alike[5,6].

Critically ill and premature neonates frequently require prolonged central venous access for administration of intravenous fluids, medications, and parenteral nutrition. While central venous catheters are essential for optimal neonatal care, their use carries a significant risk of central line-associated bloodstream infection (CLABSI)[7,8]. CLABSI represents the most common healthcare-associated infection in NICUs and serves as an important indicator of healthcare quality and safety[9,10]. Data from the International Nosocomial Infection Control Consortium (INICC) highlight the global burden of CLABSI, with reported rates as high as 18.3 per 1000 central line days among infants weighing < 750 g, compared with 7.7 per 1000 line days in those weighing 1501-2500 g[11]. These figures underscore the heightened vulnerability of the smallest and most premature infants.

The clinical and economic impact of CLABSI is considerable. Each episode is associated with increased morbidity and mortality, prolonged NICU stay, and substantial additional treatment costs[12,13]. Management typically requires extended antibiotic therapy, which not only heightens the risk of antimicrobial resistance but also interrupts enteral nutrition and growth trajectories[14]. Consequently, CLABSI prevention has become a central focus of global neonatal safety initiatives and a critical target for quality improvement (QI) programs[15,16].

Baseline surveillance in our level III NICU between October 2019 and March 2020 demonstrated a CLABSI rate of 6.4 per 1000 central line days, highlighting a significant opportunity for improvement. Recognizing that the majority of CLABSIs are preventable, our team initiated a structured QI project aimed at reducing CLABSI incidence by 50% within 12 months. The intervention focused on implementing evidence-based central line care bundles, strengthening infection prevention and control practices, and enhancing nursing competence through structured education, standardized protocols, and continuous audit-feedback mechanisms. In addition to achieving initial reduction, the project aimed to sustain improvements over an additional 18-month period to ensure durable impact on patient safety and clinical outcomes. Through this initiative, we sought not only to lower CLABSI rates but also to foster a culture of safety, accountability, and continuous learning within the NICU team. This manuscript describes the design, implementation, and outcomes of this QI project, contributing to the growing evidence that systematic, multidisciplinary efforts can meaningfully reduce preventable infections and improve neonatal care quality in resource-limited settings[17,18].

MATERIALS AND METHODS

Study design and setting

This prospective QI initiative was conducted in the Level III NICU in Mumbai, serving both inborn and outborn neonates from Maharashtra and neighboring states. The NICU admits approximately 1000 neonates annually and comprises 25 level III beds, 35 level II beds, and 45 Kangaroo Mother Care beds. The multidisciplinary team includes three full-time consultant neonatologists, 60 trained staff nurses, and 14 fellows/residents. Nurse-to-patient ratios are maintained at 1:2 for level III and 1:3 for level II care, in accordance with national and international standards.

Study population

All neonates admitted to the NICU between April 2020 and March 2021 who required central venous access via umbilical venous catheter, peripherally inserted central catheter, or surgically placed central line, at any time during their NICU stay were eligible for inclusion. Central line days represented the total number of days that the neonate had one or more central lines in place during the surveillance period. Neonates with a documented bloodstream infection prior to line insertion were excluded to avoid misattribution of infection source.

Root cause analysis and key driver diagram

A multidisciplinary QI team was constituted, including neonatologists, infection control nurses, NICU staff nurses, fellows, and housekeeping personnel. The team conducted a root cause analysis to identify modifiable factors contributing to CLABSI. Potential causes were broadly categorized under five domains: Personnel, practices and protocols, equipment modification, NICU environment and documentation.

Findings from the analysis informed the development of a key driver diagram following the Institute for Healthcare Improvement methodology. The key driver diagram delineated the overall project aim - reducing CLABSI rates in the NICU - along with primary drivers (such as adherence to insertion and maintenance bundles, strict aseptic technique, and staff education), secondary drivers, and specific change ideas (Figure 1). This framework served as the operational blueprint for phased intervention planning, implementation, and evaluation throughout the study period.

Figure 1 Key driver diagram outlining aim and change ideas. CLABSI: Central line associated blood stream infection; NICU: Neonatal intensive care unit; SOPs: Standard operating procedure; q8h: Every 8 hourly; q24h: Every 24 hourly.

Intervention phases

The QI initiative was implemented over a 12-month period and divided into three iterative phases. Each phase incorporated Plan-Do-Study-Act cycles to facilitate systematic implementation, evaluation, and refinement of interventions.

Phase 1: Protocol revision and capacity building

During the initial phase, existing central line insertion and maintenance protocols were reviewed and revised in accordance with the Centers for Disease Control and Prevention and INICC guidelines (Supplementary Figures 1 and 2). Standardized procedures were introduced for the aseptic preparation of intravenous fluids and medications, all of which were performed under laminar airflow hoods to minimize contamination risk. Environmental hygiene protocols were concurrently updated, encompassing regular disinfection of incubators, radiant warmers, syringe pumps, infusion stands, and other high-touch surfaces. Comprehensive orientation sessions were conducted for medical, nursing, and housekeeping staff to sensitize them to the revised protocols and emphasize their role in infection prevention.

Phase 2: Staff education and process standardization

The second phase focused on strengthening compliance with aseptic practices through targeted education and structured audits. Hand hygiene monitoring was intensified, with infection control nurses conducting regular audits. Structured educational modules were developed for nursing staff, covering topics such as neonatal sepsis, CLABSI prevention, aseptic technique, and adherence to bundle components. Training workshops and demonstration sessions were organized for fellows and nurses to reinforce correct techniques for line insertion, maintenance, and handling. Continuous supervision and feedback promoted uniform adherence to the updated bundles across shifts.

Phase 3: Bundle implementation and feedback

In the final phase, full implementation of the central line insertion and maintenance bundles was undertaken across the NICU. Bedside “central line alert cards” were introduced to prompt daily assessment of line necessity and adherence to best practices for line access and maintenance (Supplementary Figure 3). Regular audit and feedback sessions were conducted to monitor compliance with insertion and maintenance checklists, identify deviations, and address performance gaps through immediate corrective action. Ongoing discussions during multidisciplinary review meetings reinforced accountability, facilitated knowledge translation, and supported sustainability of the achieved improvements.

Phase 4: Sustainability phase

Following the 12-month implementation period, a sustainability phase was conducted from April 2021 to September 2022 to ensure long-term adherence to best practices and consolidation of gains achieved during the intervention period. This phase emphasized continuous learning, reinforcement of standardized protocols, and institutionalization of safe line-care practices through three key strategies.

Simulation-based training: Periodic simulation and role-play sessions were introduced to strengthen procedural competence and team coordination. Scenarios focused on correct central line insertion and maintenance techniques, aseptic handling, and troubleshooting of potential contamination or breach events. These interactive sessions facilitated experiential learning and promoted consistent performance across staff members and shifts.

Reflective learning: Structured case-based debrief sessions were conducted following each CLABSI episode. These sessions allowed multidisciplinary teams to review event timelines, identify contributing factors, and discuss targeted preventive strategies. The reflective learning format encouraged self-assessment, accountability, and reinforcement of a safety-oriented culture within the unit.

Periodic re-audits and feedback: Compliance with hand hygiene and central line bundle components was monitored through twice-monthly audits conducted by infection control personnel. Findings were shared in real time with the entire care team through feedback meetings and visual dashboards, ensuring transparency and collective ownership of outcomes. The regular audit-feedback cycle supported early detection of deviations and maintained high standards of practice over time. The study timeline and phases are described in Figure 2.

Figure 2 Study timeline and intervention phases. CLABSI: Central line associated blood stream infection; CI: Central line insertion.

Outcome and intervention measures

The primary outcome was the CLABSI rate, expressed as the number of CLABSI episodes per 1000 central line days, and compared with baseline data collected between October 2019 and March 2020. CLABSI was defined according to the Centers for Disease Control and Prevention/National Healthcare Safety Network (CDC/NHSN) criteria, ensuring standardization and comparability with international benchmarks. To evaluate fidelity of implementation and monitor adherence to infection prevention practices, the process measures included hand hygiene compliance, compliance to insertion/maintenance bundle and staff education coverage.

Data collection and analysis

Prospective data were collected by trained members of the QI team throughout the intervention and sustainability phases. Process audits were performed three times per week using a standardized observation tool developed in alignment with institutional infection control protocols. All data were entered into a secure, password-protected electronic database, with periodic validation to ensure accuracy and completeness.

Monthly QI team meetings were convened to review audit findings, identify gaps, and plan corrective actions. Analysis of the temporal trends in CLABSI rates was done using the Statistical Process Control charts. Upper and lower control limits were calculated to distinguish random variation from special cause variation, allowing real-time assessment of intervention impact and sustainability.

Ethical considerations

The study was approved by the Institutional Ethics Committee of Surya Children’s Hospital, approval No. EC-05/12/2020. A waiver of informed consent was granted as the project constituted a minimal-risk QI initiative, did not involve deviation from standard care practices, and aimed to enhance patient safety. Access to identifiable information was restricted to authorized personnel only, and all datasets were de-identified prior to analysis and reporting to ensure participant privacy and data integrity.

RESULTS

Demographics

During the 12-month implementation period (April 2020-March 2021), 683 neonates were admitted to the level III NICU, including 77 extremely low birth weight infants. A total of 1816 central line days were recorded. In comparison, the pre-intervention surveillance period (October 2019-March 2020) included 457 admissions and 1249 central line days. The proportion of extremely low birth weight infants and total catheter days was comparable between the study periods, minimizing potential confounding due to case-mix variation (Table 1).

Table 1 Demographics of study population, n (%).

Characteristics	Pre-intervention period (6 months)	Implementation period (12 months)	Sustainability period (18 months)
Total number of admissions	457	683	1218
No. of ELBW	46 (10)	77 (11.2)	160 (13.1)
Central line days	1249	1816	4145
No. of CLABSI cases	8	2	4
CLABSI rates/1000 central line days	6.4	1.1	0.96
Compliance to hand hygiene (%)	97.9%	98.1%	97.7%
Compliance to insertion bundle (%)	-	100%	97%
Compliance to maintenance bundle checklist (%)	-	Nurses 86%	Nurses 94%
		Doctors 82%	Doctors 93%
Compliance to nurses education (% staff coverage)	-	62%	81%

ELBW: Extremely low birth weight; CLABSI: Central line associated blood stream infection.

Primary outcome

Baseline CLABSI incidence was 6.4 per 1000 central line days, corresponding to eight confirmed episodes during the pre-intervention period. Following implementation of the multimodal QI bundle, the rate declined to 1.1 per 1000 central line days; with only two CLABSI episodes reported during the intervention period. Statistical process control charts demonstrated a sustained downward shift in the center line after phase 2, signifying special cause variation attributable to the intervention. During the subsequent 18-month sustainability phase, CLABSI rates remained low at 0.96 per 1000 central line days, confirming sustained improvement (Figure 3).

Figure 3 Statistical process control charts demonstrating a sustained downward shift in central line associated blood stream infection rates. CLABSI: Central line associated blood stream infection; LCL: Lower control limit; UCL: Upper control limit.

Process measures

Baseline hand hygiene compliance was high (97.9%), and remained consistently above 97% throughout the intervention and sustainability phases. The lowest adherence (88%) was observed for the “after contact with patient surroundings” moment, which improved following targeted reminders and reinforcement through ongoing education. Following implementation of the revised insertion bundle and structured training, compliance improved rapidly to 100% by the end of phase 1 and remained sustained for the remainder of the study period. The compliance to maintenance bundle was poor, ranging from 60%-70% during phase 1. Through regular audits, feedback during clinical rounds, and continuous reinforcement, adherence increased progressively, achieving over 90% by phase 3. Compliance rates were comparable between nurses and physicians. Staff educational modules introduced in phase 2 achieved progressive uptake, with 88% of nursing staff completing all sessions by end of phase 2. During the sustainability phase, simulation-based training and case-based reflective exercises were incorporated to reinforce learning and promote long-term behavioural change.

DISCUSSION

This project demonstrated a sustained and clinically meaningful reduction in CLABSI within a busy, level 3 NICU in a LMIC. By implementing a pragmatic, multimodal bundle, the CLABSI rates reduced by 83% in the unit. The incidence of CLABSI may be influenced by multiple factors including gestational age, birth weight, severity of illness, nurse-to-patient ratio, and total number of catheter days[7]. In our study population, these baseline demographics remained similar during all the study phases. These findings underscore the power of a systems-based approach that combines evidence-based technical interventions with behavioural and cultural change strategies.

The findings of this QI initiative are consistent with previously published studies demonstrating the effectiveness of bundled interventions in reducing CLABSIs in NICUs[12,16,17,19,20]. Fisher et al[21] reported a 71% reduction in CLABSI rates, following a QI project conducted over 13 NICUs in North Carolina by performing monthly webinars and learning sessions regarding unique CLABSI bundle elements. They reported a reduction in CLABSI rates from 3.94 to 1.16 per 1000 line days following implementation of the care bundle[21]. Likewise, Balla et al[19] documented an 89% reduction in CLABSI, although the unit had a very high baseline CLABSI incidence of 31.7 per 1000 line days. The baseline CLABSI rate in our unit (6.4 per 1000 line days) was comparable to rates reported by the INICC for middle-income countries, where infection burdens are often significantly higher than those reported in high-income settings[22]. These results demonstrate that high-quality infection prevention outcomes are attainable even in resource-constrained environments when a structured, multidisciplinary, and data-driven approach is employed.

Despite the successful implementation and sustained reduction in CLABSI rates, several operational and contextual challenges were encountered during the course of the QI initiative. The multidisciplinary team proactively identified these barriers and employed context-specific mitigation strategies to ensure uninterrupted progress and long-term sustainability. The implementation bundles were designed to be adaptable to the dynamic NICU environment, allowing improvisation based on workflow demands, staff availability, and periodic audit findings. One major challenge was the rapid staff turnover, as ours was a training centre in neonatology with frequent rotation of resident doctors and nursing staff. A structured orientation and training program was institutionalized for all new staff, supplemented by quarterly simulation-based refresher sessions by the senior staff. Many staff also reported documentation fatigue, due to the introduction of multiple checklists and audit tools. Based on this feedback, redundant forms were consolidated, and electronic data entry via a simplified digital dashboard as introduced. The challenges and mitigation strategies are summarized in Table 2. Consistent with evidence that adherence to hand hygiene and maintenance protocols is a major determinant of CLABSI risk[7,23,24] our QI team instituted rigorous hand hygiene audits using the World Health Organization “Five Moments” framework. Importantly, both physicians and nurses were required to complete the checklist during each shift change promoted shared ownership, a critical cultural shift that aligns with prior literature emphasizing interprofessional teamwork as a determinant of sustained infection prevention[25,26].

Table 2 Challenges and mitigation strategies.

Challenge	Description	Mitigation strategy
Variable adherence to maintenance bundle during initial phases	Early audits revealed inconsistent compliance with maintenance checklists, particularly during night shifts and high-workload periods	Real-time feedback during bedside rounds, peer mentoring, and reinforcement of accountability through shared nurse-physician responsibility for checklist completion improved compliance to > 90% by phase 3
High staff turnover and rotational postings	Frequent rotation of fellows and nursing staff led to variability in familiarity with protocols and compromised consistency in central line care practices	A structured orientation and modular training program was institutionalized for all new staff, supplemented by quarterly simulation-based refresher sessions to reinforce core competencies
Competing clinical priorities during the COVID-19 pandemic	Redeployment of personnel, heightened infection control demands, and restricted group gatherings challenged consistent implementation and training schedules	Smaller, repeated training sessions adhering to infection control norms were conducted using audiovisual aids and virtual platforms. Dedicated infection control nurses ensured continuity of audit and feedback processes
Resistance to change and behavioral inertia	Initial reluctance among some staff members to adopt revised aseptic protocols and documentation requirements hindered early compliance	Continuous engagement through inclusive team meetings, sharing of infection data trends, and recognition of high-performing individuals fostered ownership and motivation. Behavioral reinforcement through feedback overcome resistance
Documentation fatigue and checklist overload	The introduction of multiple checklists and audit tools increased perceived workload among nurses and fellows	Redundant forms were consolidated, and electronic data entry via a simplified digital dashboard was introduced to streamline documentation and facilitate real-time data visualization
Environmental hygiene and equipment cleaning gaps	Inconsistent disinfection of high-touch equipment (syringe pumps, infusion stands) contributed to occasional breaches in asepsis	Daily cleaning schedules and visual reminder posters were implemented. Infection control nurses conducted unannounced spot checks, and cleaning logs were reviewed weekly in QI meetings
Maintaining sustainability beyond the active intervention phase	Post-implementation, the risk of gradual decline in compliance and attention to line care was recognized	Sustainability was ensured through periodic re-audits, case-based debrief sessions after any CLABSI event, and integration of bundle adherence metrics into the unit’s routine performance dashboard

COVID-19: Coronavirus disease 2019; QI: Quality improvement; CLABSI: Central line associated blood stream infection.

Staff education program used a combination of didactic instruction, simulation-based practice, and case-based reflective learning, which facilitated cognitive and behavioural integration of best practices. Staff training was challenged by operational constraints inherent to the unit; including a shift-based work structure, limited protected time for education during busy clinical schedules, and staff turnover. These factors affected the uniformity and continuity of education, as not all personnel could attend scheduled sessions. To address these concerns, training was conducted through staggered sessions, with brief bedside demonstrations and reinforcement during routine clinical rounds ensuring wider coverage without disrupting patient care. By December 2020, 88% of nursing staff had completed all modules, and the program was subsequently institutionalized as part of new staff orientation to ensure long-term sustainability. Reflective case discussions, simulation-based refresher training and ongoing audits helped maintain staff engagement, reinforce accountability, and ensure long-term adherence to infection prevention practices. A systematic review for CLABSI prevention strategies identified education and training (100%), use of checklists (67%), and audit-feedback mechanisms (63%) as the most consistently effective interventions in the neonatal unit[27]. Similarly, other programs have demonstrated that sustained nurse-led training and performance auditing yielded durable CLABSI reductions in intensive care settings[28,29].

This QI initiative demonstrated methodological and implementation strengths that enhance its credibility and replicability. The prospective design, systematic data collection, and use of iterative Plan-Do-Study-Act cycles enabled continuous adaptation of interventions based on real-time performance data. The implemented bundle was low-cost, pragmatic, and scalable, relying primarily on standard infection control practices, bedside visual prompts, and team-based accountability rather than expensive technological solutions. Methods such as simulation-based refresher training, periodic re-audits, and post-CLABSI episode debriefing sessions were institutionalized to maintain adherence. This approach offers a practical framework for developing CLABSI prevention protocols for NICUs across LMIC. Our study had several limitations that warrant consideration. Although the sustainability period extended beyond that of many comparable studies, longer-term follow-up is necessary to confirm enduring low CLABSI rates, particularly in the context of high staff turnover. Inclusion of neonatal-specific outcome measures, such as the impact on neurodevelopmental outcomes and patterns of antibiotic exposure, would have further strengthened the clinical relevance and depth of the study. The coronavirus disease 2019 pandemic (2020-2021) coincided with the implementation phase and may have influenced outcomes indirectly through reduced patient census, altered workflow, and improved nurse-to-patient ratios. The multifaceted nature of the intervention precludes attribution of impact to any single component, a common limitation in bundle-based QI approaches. Despite these limitations, the findings of this study hold significant relevance for neonatal units globally, particularly in LMICs where resource constraints and staffing challenges often hinder infection prevention efforts.

CONCLUSION

This QI initiative achieved a sustained 83% reduction in CLABSI rates in a high-volume, resource-limited NICU. The success of the intervention stemmed from an integrated, evidence-based bundle encompassing standardized clinical protocols, bedside prompts, continuous audit and feedback, and structured nurse education. These findings demonstrate that meaningful and durable reductions in healthcare-associated infections are achievable in resource-constrained settings through a systems-oriented, multidisciplinary approach. Sustained impact will require ongoing surveillance, periodic staff retraining, and strong institutional commitment to infection prevention.

ACKNOWLEDGEMENTS

The authors sincerely acknowledge the efforts of the neonatal intensive care unit team, including nurses, resident doctors, consultants, and housekeeping staff, whose commitment to infection prevention practices made this quality improvement initiative successful.