OBJECTIVE: Central lines in NICUs have long dwell times. Success in reducing central line–associated bloodstream infections (CLABSIs) requires a multidisciplinary team approach to line maintenance and insertion. The Perinatal Quality Collaborative of North Carolina (PQCNC) CLABSI project supported the development of NICU teams including parents, the implementation of an action plan with unique bundle elements and a rigorous reporting schedule. The goal was to reduce CLABSI rates by 75%.
METHODS: Thirteen NICUs participated in an initiative developed over 3 months and deployed over 9 months. Teams participated in monthly webinars and quarterly face-to-face learning sessions. NICUs reported on bundle compliance and National Health Surveillance Network infection rates at baseline, during the intervention, and 3 and 12 months after the intervention. Process and outcome indicators were analyzed using statistical process control methods (SPC).
RESULTS: Near-daily maintenance observations were requested for all lines with a 68% response rate. SPC analysis revealed a trend to an increase in bundle compliance. We also report significant adoption of a new maintenance bundle element, central line removal when enteral feedings reached 120 ml/kg per day. The PQCNC CLABSI rate decreased 71%, from 3.94 infections per 1000 line days to 1.16 infections per 1000 line days with sustainment 1 year later (P = .01).
CONCLUSIONS: A collaborative structure targeting team development, family partnership, unique bundle elements and strict reporting on line care produced the largest reduction in CLABSI rates for any multiinstitutional NICU collaborative.
- quality improvement
- central line–associated bloodstream infection
- family-centered care
- enteral feeding
- CDC —
- Centers for Disease Control and Prevention
- CLABSI —
- central line–associated bloodstream infection
- LCL —
- lower control limit
- LS —
- learning session
- NHSN —
- National Health Surveillance Network
- PDSA —
- Plan Do Study Act
- PQCNC —
- Perinatal Quality Collaborative of North Carolina
- QI —
- quality improvement
- SPC —
- statistical process control
- VLBW —
- very low birth weight
Central line–associated bloodstream infection (CLABSI) is a significant source of hospital morbidity and mortality. Quality improvement (QI) projects have attempted to spread central line best practices in multiple clinical environments.1–4 The concept of bundles has developed, which defines compliance as an all or none phenomenon for all recommended-care elements. The most notable successes in CLABSI reduction have occurred in adult ICUs, where lines have shorter dwell times and the major emphasis has been on insertion bundles. Neonatal and pediatric central lines have longer dwell times, and line maintenance likely plays a critical role in the prevention of CLABSIs.5–7 Miller et al clearly demonstrated the importance of maintenance bundle compliance in PICUs and NICUs, but significant variation in central line care practice exists.8 The variable success in QI initiatives to reduce CLABSIs and nosocomial infection in PICUs and NICUs highlights the challenges of developing best collaborative structures, supporting multidisciplinary hospital team formation, identifying best line care bundles, and tracking compliance with those bundles.10–14
State collaboratives have gained increasing prominence in efforts to improve neonatal care and offer tremendous advantages as quality laboratories.15 Collaboratives offer the opportunity for shared learning. Although in large part due to payment, each state has developed unique networks of care. Collaboration amongst stakeholders within these unique laboratories offers the opportunity to improve care across the continuum of multiple systems. The Perinatal Quality Collaborative of North Carolina (PQCNC) aimed to unite these stakeholders in a collaborative offering hospital teams structured facilitation as they implemented and measured the deployment of insertion and maintenance bundles to reduce NICU CLABSIs for all infants by 75%.
In March 2009 the PQCNC general membership identified NICU CLABSI prevention as a statewide initiative. A general proposal for a PQCNC CLABSI project was approved. A neonatologist volunteered to lead the CLABSI Expert Team in developing the PQCNC CLABSI action plan. The action plan would include an aim statement, insertion and maintenance bundles, and process and outcome metrics that would guide hospitals in efforts to reduce CLABSIs for all infants in all types of NICUs. The expert team was composed of PQCNC members who reviewed background materials and attended webinars in which the action plan would be developed.16,17 In March of 2009 an expert team assembled that included neonatologists, parents, nurses, neonatal nurse practitioners, and infection control specialists.
From April through June 2009, 3 expert team webinars were attended by 30 to 55 members. The expert team identified its primary goal as the reduction in CLABSIs by 75%. Insertion and maintenance bundles were developed, as well as process measures to reflect bundle adherence (Table 1). NICUs would be asked to report on process indicators for every line insertion. Maintenance indicators would be reported by staff for all lines for 7 shifts per week. In reporting maintenance indicators, centers were required to include at least 1 weekend shift and 1 night shift per week. All NICU centers used 12-hour nursing shifts. NICUs were free to establish their own reporting schedule within these constraints.
The insertion bundle included recommended elements in Centers for Disease Control and Prevention (CDC) line insertion guidelines as well as a “unit time out” (Table 2). The unit time out included checking patient identification and announcing the procedure, the type of line to be inserted, and the site of line insertion. The maintenance bundle included CDC recommendations and 2 additional elements18: first was a recommendation that central lines be discontinued when an infant’s enteral feedings reached 120 mL/kg per day; second was the requirement that teams evaluate lines daily with the added question, “If a line was not in place today, would one be placed?”
Enrollment and Roll Out
PQCNC CLABSI was approved at all site institutional review boards, or it was determined that the study was exempt from review. In June of 2009 PQCNC invited all hospitals in the state with an NICU and on-site neonatologist to join PQCNC CLABSI. Centers agreeing to participate formed an NICU team (recommended to include a neonatologist, nurse, executive leader, parent, and infection control specialist), obtained senior executive support, reviewed the action plan, and received a start-up kit including guidance on implementation, data management, and prework. Prework for the first face-to-face learning session (LS) included identifying an executive sponsor, formal review of 2 local CLABSI cases, and review of current line practice.
Three quarterly LSs were 1- to 2-day in-person events that included presentations by teams and parents, data review, and QI education. Monthly 1-hour Web conferences were held and focused on staff engagement, NICU culture and leadership, progress reports, local Plan Do Study Act (PDSA) rapid-improvement intervention cycles, and sharing successes and challenges. Weekly e-mail newsletters supplemented key learning elements. Teams received data reports for all metrics on a quarterly basis.
Data and Analysis
The expert team identified process and outcome measures. The outcome measure identified for this initiative was CLABSIs per 1000 line days for all NICU patients. CLABSI during the intervention was defined by using CDC National Health Surveillance Network (NHSN) criteria. NHSN data for CLABSIs and line days were supplied by centers. Any centers not participating in the NHSN would review hospital records to identify infections and report on line days on the basis of internal data. A Web-based commercial data entry system was identified (StudyTrax) to collect process measures. Process measures were elements of the insertion and maintenance bundles. These were aggregated. Insertion data were reported by a member of the team performing line insertion. Maintenance data were reported by bedside nurses engaged in patient care. All hospitals collected paper copies of data forms for later entry by a team member. Our data system would only accept forms with all bundle elements completed.
Statistical process control (SPC) charts were used to track process and outcome changes.19,20 For the primary outcome of CLABSIs per 1000 line days, baseline NHSN data were obtained for the period January 2008 through September 2009. The mean (center line) and upper and lower control limits (LCLs) were calculated and displayed as ±3 SEs of the mean using QI macros for Excel (Microsoft Corporation, Redmond, WA). The mean was carried forward and displayed throughout the intervention (October 2009 through June 2010). Evaluation of the intervention occurred for 1 quarter after the intervention and 1 year later in July through September 2011 by using baseline data for PQCNC CLABSI NICUs entering a national CLABSI project.
There were no baseline data for process measures, and compliance measures were limited to 9 points. SPC guidelines suggest a minimum of 12 data points to determine significant changes in control limits on the basis of trends of ≥7 points, but that would not limit our ability to detect signals of change and draw conclusions.
Adjustments to control limits were made by using SPC guidelines including 1 point outside the upper control limits or LCLs, 2 of 3 successive points in the outer third of the control limit, 8 successive points above or below the center line, or 6 consecutive points on an increasing or decreasing trend line.20
Thirteen NICUs participated in PQCNC CLABSI. Their characteristics are presented in Table 1. Ten of the 13 centers were reporting NHSN data from January 2008 onward. The other 3 centers were lower volume NICUs with a mean of 105 line days per quarter. Chart and laboratory review at these centers from January 2008 through September 2009 revealed no infections based on NHSN criteria. At the time of PQCNC CLABSI initiation in October 2009, all centers were reporting NHSN data.
During the intervention period, there were 1308 line insertions reported. The majority of NICUs chose to report maintenance activities for all weekdays, including 1 night, and for 1 weekend shift. This regimen represented a maximal opportunity to report on line maintenance 6 days per week. Maintenance reports were received for 17 801 line days. There were a total of 30 587 catheter days reported during the intervention. On the basis of a maximal number of maintenance reports of 26 217, we achieved a response rate of 68%.
Insertion and maintenance bundles were analyzed for all or none compliance. Baseline insertion compliance was relatively high at 76%, peaked at 93%, and showed an overall trend to increasing insertion compliance (Fig 1). Baseline maintenance compliance was initially low at 32% and ranged as high as 56%. There was a trend to an increase in answering “yes” to the query, “If a central line were not already present one would be placed that day.” The maintenance bundle element of line removal when enteral feedings reached 120 mL/kg per day showed a significant change with reporting dropping consistently below the 3-σ LCL. This special cause variation directs adjustment of control limits for this bundle element despite only 9 data points (Fig 2 A–C).
There were a total of 57 CLABSIs during the intervention. The primary outcome measure, CLABSI rate, was evaluated by measuring changes in quarterly collaborative CLABSI rates with a baseline starting in January 2008 and ending in July 2011. Twelve of 13 NICUs showed a reduction in CLABSI rates. The CLABSI rate for the collaborative showed a significant decline during the initiative. The mean was adjusted from a baseline mean of 3.94 infections per 1000 line days to a mean of 1.16 infections per 1000 line days through July 2010, which was a reduction of 71% in the collaborative CLABSI rate (Fig 3). The CLABSI reduction was analyzed by using Mann-Whitney U test and was significant at P = .01.
PQCNC CLABSI used rigorous collaborative building efforts over a 12-month period to reduce CLABSIs by 71% in 13 North Carolina NICUs caring for 62% of North Carolina’s very low birth weight (VLBW) infants. To our knowledge, this is the largest CLABSI reduction ever reported by an NICU collaborative. Whereas insertion and maintenance bundle compliance showed clear indications of improvement, the length of the intervention period limited our ability to definitively report that increased compliance with insertion and maintenance bundles led to the significant improvements we noted for CLABSI rates during the period. Despite this limitation, we speculate that the success of this initiative relates to at least 4 factors.
First, formal education, training of hospital teams in QI, and shared learning were vital to PQCNC CLABSI success. The face-to-face LSs and webinars included QI education regarding the role of rapid cycles of change and PDSAs, parent presentations, team time to discuss initiative execution, evaluation of culture and leadership, discussion of challenges, and sharing of innovations developed by teams. Innovations were achieved via intensive campaigns to apprise staff of the impact of CLABSI in their NICUs and target specific areas of practice using PDSA methodology. Examples of such interventions included creation of g-charts reporting days between infection, deployment of line insertion carts, family members monitoring provider hand hygiene, using videography to spread the concept of the infant’s sterile “sacred space,” spreading methods to ensure that line hubs were properly scrubbed, role-playing unit time outs, and stealth assessments of practice by local NICU teams.
Second, PQCNC CLABSI required formation of committed teams that regularly interacted with the purpose of increasing compliance with insertion and maintenance bundles. Daily reporting by bedside providers on adherence to maintenance bundle elements has not been reported previously and required engagement of multiple providers. We required reporting for at least 1 weekend and 1 night shift to increase the likelihood that all nursing rotations would engage in the initiative. PQCNC CLABSI had as a short-term goal improving measured compliance with bundles as the initial step to incorporation of bundles into practice. We believed bundle compliance reporting would represent true adherence, but speculated that rigorous documentation requirements would make best line care a daily focus for providers. Significant effort was required by teams to meet reporting goals. Observations were captured by the bedside nurse on paper forms with data later entered online. In an NICU with 300 line days per month, there was 7 hours of monthly data entry time. PQCNC CLABSI NICUs are to be lauded for a reporting rate of 68%.
Our measured maintenance compliance rates were lower than those reported by others.8,12,13 We speculate that large-scale anonymous reporting by bedside nurses led to a more accurate estimate of bundle compliance than higher estimates reported in other studies. Whereas overall compliance rates for both insertion, and especially maintenance, showed improving trends, these trends did not achieve SPC significance. One limitation in establishing significance was our 9-month observation period. Based on the trend line and significant reduction in PQCNC CLABSI rates, a longer period of observation might have revealed a significant relationship between bundle compliance and CLABSI reduction. The significance of the actual data aside, centers confirmed that the process of bedside provider reporting was critical in daily engaging multiple bedside providers in the initiative and contributed to the reduction in CLABSI rates.
Third, the inclusion of family members as expert team and local team members was critical in building powerful teams. Four hospitals (30%) had a parent as a team member. At LSs and webinars these parents offered a unique perspective on CLABSI and the deployment of bundles. A powerful motivator was the “Gabby” video produced by a parent team member and PQCNC staff.21 In “Gabby” a father recounts the birth, life, and death by a methicillin-resistant staphylococcus aureus (MRSA) CLABSI of his premature daughter, Gabby, in a PQCNC NICU. “Gabby” pointedly brings urgency to the case for NICUs to improve central line practices.
Fourth, the expert team based PQCNC CLABSI bundles on others’ toolkits16–18 but added 2 unique maintenance elements that were key factors in CLABSI reduction. The vast majority of infants in NICUs with central lines are premature infants receiving parenteral nutrition as they advance enteral feedings. Although there is no best evidenced recommendation for the point at which a central line should be discontinued in these cases, the expert team identified enormous variation. Line removal was occurring at feeding volumes from 100 to 150 mL/kg per day in participating NICUs. The expert team agreed to standardize this practice and established a recommendation for line removal at enteral feedings of 120 ml/kg per day. There was a statistically significant adoption of this guideline. The expert team also recommended that teams assess the need for a central line with the question “Do we need the line today?” and a second question, “If a line was not in place today, would one be placed?” This phrasing reframes the real necessity for a central line.
The addition of these elements to our maintenance bundle accounts for our relatively low maintenance compliance. When we removed these elements, PQCNC CLABSI maintenance compliance at intervention end increased from 56% to 72%. It is likely that for neonatal central lines a focus on reliable implementation of neonatal specific bundles that includes standardization of practices related to line removal offers the greatest opportunity to reduce CLABSIs.22 These 2 new elements required providers to daily consider line necessity in a more standardized fashion. We believe adding these elements to the standard maintenance bundle on the basis of the trend to state positively that “if a line were not in place today one would be placed” and the significant adoption of our enteral feeding guideline made the bundle a key factor in the reduction we report in CLABSI rates.
The concern in any successful QI project is sustainability. On the basis of 1 planned quarter of follow-up data, PQCNC CLABSI sustained its gains. We achieved a mean reduction to 1.16 infections per 1000 line days. CLABSI rates in the quarter after PQCNC CLABSI decreased to 0.87 per 1000 line days, and we are also able to report that baseline data obtained for a national CLABSI prevention project in the July quarter of 2011 revealed that our 13 PQCNC CLABSI centers had an aggregate CLABSI rate of 0.67 infections per 1000 line days.
The impact of PQCNC CLABSI on the burden of NICU infection in North Carolina cannot be overstated. In the year after PQCNC CLABSI (July 2010 to June 2011), based on a sustained mean CLABSI rate of 1.16 per 1000 line days and an annual number of line days based on the average of our 12 quarters of observation (41 110), the 13 PCQCNC CLABSI centers avoided 114 CLABSIs. The financial impact of nosocomial bloodstream infection has been analyzed by Donovan et al.23 Most CLABSIs observed in PQCNC CLABSI were in VLBW infants, but modifying the observed 30% mortality rate reported by Donovan et al for VLBW infants in Ohio to 15% for our collaborative, which included all infants, and applying their cost differential of $16 800 for hospital charges in infected infants, we can estimate that PQCNC CLABSI saved 17 lives and $1 915 2000 in hospital charges.
There are several possible limitations to our report. First, our baseline NHSN data extend back only to January 2008. As a result, 7 points establish our stable baseline infection rate. Although a longer baseline period would offer more convincing evidence of a stable baseline, our baseline extended over 21 months and included 113 000 line days in 13 NICUs. We are confident that this baseline is representative given the dramatic change over the course of the initiative. Second, this initiative was undertaken without the opportunity to record baseline activity for adherence to bundles. Although October 2009 serves as our baseline for process indicators, this initiative was intensively developed with expert team members from all centers over the preceding 3 months. Some facilities began early adoption of bundle elements, but it is impossible to assess the extent of early adoption in the July through September development period. Third, all bundle and NHSN data were self-reported with no requirement to validate NHSN or process data accuracy. The potential inaccuracies of NHSN data have been described by others.24 Schulman et al13 performed chart review on a small sample of records from each reporting facility in their state collaborative, but PQCNC CLABSI did not have this capability. Finally, of great interest in NICUs are not only CLABSI rates but the impact of CLABSI prevention efforts on non-CLABSI and overall nosocomial infection rates. Although we did not measure these directly in PQCNC CLABSI, we do have Vermont Oxford Network PQCNC data, which reveal a 28% decrease in all nosocomial infection rates for VLBW infants at participating centers from 2009 to 2010.
PQCNC CLABSI demonstrated that, although an ambitious timeline was used, it was possible to execute a successful NICU collaborative with a well-designed action plan, committed hospital leadership, structured team support, and an effective data system that supported the largest repository of reporting on central line maintenance care. Keys to PQCNC CLABSI success were the engagement of multiple providers on broad-based teams in NICUs, active partnership with families, the inclusion of bundle elements that focused the teams on line maintenance care and reduction in catheter dwell time, and a data-reporting system that required multiple NICU providers daily to review line maintenance care. Although we did not achieve a 75% CLABSI reduction rate, our 71% reduction rate is the largest CLABSI reduction reported in a neonatal collaborative.
As CLABSI rates decrease due to ongoing QI efforts, large collaboratives will be needed to identify methods to further reduce, and possibly eliminate, increasingly rare NICU CLABSIs. The success of PQCNC CLABSI should inspire investigators to intensify efforts to assess the individual elements and role of maintenance checklists in reducing CLABSIs, evaluate the impact of CLABSI reduction on nosocomial infection rates, further define the impact of dwell times on CLABSI rates for different line types, measure the impact of NICU culture on CLABSI reduction, enhance methods to improve the development of truly multidisciplinary hospital QI teams, and strengthen partnerships with parents. Our reported experience with checklists, and our appreciation for the manpower requirements of secondary data entry, should further be a call to all interested in QI to pursue methods that support bedside data entry and real-time clinical decision support tools applicable within and across health care systems to support health care improvements. Such advances will allow us to make QI efforts aimed at reducing the burden of NICU infection an opportunity to not only prevent infection in future infants but to avoid infections in the infants we care for today.
PQCNC participating hospitals and key perinatal QI team members included Betty H. Cameron Women and Children’s Hospital: Brandi Page, Brandy Garris, Felisa Perkins-Lewis, and Sheri Carroll; Brenner Children’s Hospital: Tammy Haithcox, Cherrie Welch, and Patricia Harold; Caromont Regional Medical Center: Laura Magennis, Millie Home, and Kevin Coppage; Catawba Valley Medical Center: Andrea Flynn, Trish Beckman, Rachel Wetz, Lori McNeely, Michelle Mace, and David Berry; Cone Health Women’s Hospital: Tina Hunsucker, Helen Mabe, Nancy Micca, Lisa Maxson, Amanda French, and John Wimmer; Duke Children’s Hospital and Health Center: Martha Schaub-Bordeaux, Nicole Castle, Mary Laura Smithwick, and Mike Cotten; First Health of the Carolinas Moore Regional Hospital: Nicholas Lynn, Maryellen Lane, Lisa Valverdes, Jayne Lee, Maggie Craft, and Nicholas Lynn; Jeff Gordon’s Children’s Hospital at Carolinas Medical Center Northeast: Christie Baggarly, Brandi Newman, Charlene Head, Tinky Whittington, and Robert Silver; Levine Children’s Hospital: Callie Dobbins, Pamela Spivey, Gail Harris, Lori Erwin, Julie Barfield, and Andrew Hermann; North Carolina Children’s Hospital: Carol Manenti, Joebeth Bongares-Brown, Linda Denton, Joanne Kilb, Jean-Paul Dame, Karen Wood, and Wayne Price; Novant Health Forsyth Medical Center: Ann Smith, David Lambert, Jane Aghai, and Robert Dillard; Vidant Children’s Hospital: Rhonda Creech, Sharon Buchwald, and Jim Cummings; and WakeMed Children’s: Heidi Gallart, Susan Gutierrez, and Tom Young.
- Accepted August 21, 2013.
- Address correspondence to Martin J. McCaffrey, MD, CAPT USN (Ret), Division of Neonatal-Perinatal Medicine, Department of Pediatrics, CB 7596, 4th Floor, UNC Hospitals, Chapel Hill, NC 27599-7596. E-mail:
Dr Fisher led the Perinatal Quality Collaborative of North Carolina (PQCNC) Central Line–Associated Bloodstream Infection (CLABSI) Expert Team, which developed the collaborative action plan. He was the principal speaker for 3 of 6 monthly webinars and led the 3 face-to-face learning sessions (LSs). He contributed to and reviewed manuscript development and assisted Dr McCaffrey in the primary drafting of the manuscript and in data analysis. Mr Cochran assisted in the development of the initial action plan outline. He was a member of the PQCNC CLABSI Expert Team, developed the data collection system for the project, was responsible for triaging questions and day-to-day support of teams participating in the collaborative, and contributed to and reviewed the final manuscript. Mr Provost was responsible for regularly reviewing data and analyzing outcomes and process indicators using statistical process control (SPC) analysis. His expertise in SPC was vital in delineating the impact of PQCNC CLABSI. He reviewed the manuscript and suggested revisions that were incorporated into the final manuscript. Ms Bristol was responsible for developing family participation at all levels in PQCNC CLABSI. She recruited family members from 4 centers to support the larger collaborative work. She identified and mentored families presenting at all LSs. She coproduced, in conjunction with Mr Cochran, the “Gabby” video, reviewed manuscript drafts, and made suggestions that were incorporated as revisions in the final manuscript. Dr Patterson was responsible for collecting and analyzing data for PQCNC CLABSI. She cleaned the enormous data set, identified inconsistencies, was responsible for regularly contacting facilities to retrieve missing data and to assist facilities with questions regarding data submission, and reviewed and contributed to revisions of the final manuscript. Ms Metzguer was the quality improvement advisor for the project. She assisted in the development of the action plan and helped facilitate the PQCNC CLABSI Expert Team. She assisted in the development of teams at all hospitals, facilitated LSs and reviewed the final manuscript. Dr Testoni conducted statistical analysis on all PQCNC CLABSI data. She reviewed the manuscript, made suggestions regarding data presentation in the final manuscript, and approved the final submission. Dr Smith reviewed the manuscript, the complete PQCNC CLABSI data set, and made key suggestions regarding data analysis. He made suggestions for revisions to manuscript drafts that were incorporated into the final manuscript. Dr McCaffrey championed the selection of CLABSI as this first PQCNC project. He oversaw the development of the project outline and facilitated the formation of the expert team. He led recruitment of teams statewide, led 3 monthly webinars, presented at all LSs, and conducted the initial data analysis, which was refined with the critical assistance of Mr Provost and Drs Testaroni and Smith. He was the primary draft author with support from all of the above-mentioned authors.
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
FUNDING: Funding for PQCNC CLABSI was provided by a Center for Medicare and Medicaid Services Neonatal Outcomes Improvement Project Transformation grant administered by the North Carolina Division of Medical Assistance (1UOCMS030303-NC MTG grant); an Investments for the Future (IFF) grant administered by the Dean of the University of North Carolina School of Medicine, Chapel Hill, NC; and legislative funds directed by the North Carolina General Assembly to the Perinatal Quality Collaborative of North Carolina.
POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.
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- Copyright © 2013 by the American Academy of Pediatrics