This assignment is about providing recommendations on how to prevent central line associated blood-stream infections.

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ABSTRACT The creation of a consistent culture of safety and quality in an intensive care unit is challenging. We applied the Six Sigma Define-Measure-Analyze-Improve-Control (DMAIC) model for quality improvement (QI) to develop a long-term solution to improve outcomes in a high-risk neurotrauma intensive care unit. We sought to reduce central line utilization as a cornerstone in preventing central line- associated bloodstream infections (CLABSIs). This study describes the successful application of the DMAIC model in the creation and implementation of evidence-based quality improvement designed to reduce CLABSIs to below national benchmarks.

Key Words Central venous catheter, DMAIC, Infection, Neurotrauma, Quality

Author Affiliations: Carilion Roanoke Memorial Hospital, Roanoke, Virginia (Mrs Loftus, Dr Bradburn, and Dr Harvey); Carilion New River Valley Medical Center, Christiansburg, Virginia (Mrs Tilley); and Carilion Medical Center, Roanoke, Virginia (Dr Hoffman).

The authors declare no conflicts of interest.

Correspondence: Ellen Harvey, DNP, RN, ACNS-BC, CCRN, Carilion Roanoke Memorial Hospital, 1906 Belleview Ave, Roanoke, VA 24014 ([email protected]).

Use of Six Sigma Strategies to Pull the Line on Central Line-Associated Bloodstream Infections in a Neurotrauma Intensive Care Unit

Kelli Loftus, BSN, RN, CCRN ■ Terry Tilley, MSN, RN ■ Jason Hoffman, PharmD, BCPS ■ Eric Bradburn, DO, MS, FACS ■ Ellen Harvey, DNP, RN, ACNS-BC, CCRN

namic instability, may require multiple blood product transfusions, and have multiple wounds and invasive lines, placing them at greater risk for CLABSIs.2,3 Emergent placements of CVCs are common in trauma patients, and historically higher central line utilization ratios in trauma/ surgical ICUs contribute to additional risk for CLABSIs.4,5

A greater focus on the reduction in the number of hos- pital-associated infections (HAIs), such as CLABSIs, has emerged within the medical community in recent years. HAI prevention was identified as 1 of the 20 priority areas in the Institute of Medicine’s 2003 report Transforming Health Care Quality.6 The Joint Commission has also confronted this challenge through its National Patient Safety Goals, which are designed to improve patient safety. National Pa- tient Safety Goal 07.04.01 requires hospitals to “use proven guidelines to prevent infection of the blood from central lines.”7 Catheter-associated infections are considered pre- ventable, and the Center for Medicare and Medicaid Ser- vices will no longer reimburse additional costs associated with these events.8 In addition, multiple organizations have established clinical practice guidelines pertaining to the prevention of CLABSIs.2,9,10 Several campaigns have also highlighted the success of preventing CLABSIs through adherence to evidence-based practices.11,12 Furthermore, a multidisciplinary approach has been shown to be effective in dramatically reducing HAIs.13,14

Despite numerous published guidelines and initiatives, an estimated 80 000 CLABSIs occur each year in ICU pa- tients in the United States, and this number increases to an estimated 250 000 infections hospital-wide.2,15 Blood- stream infections represent 10% to 20% of HAIs.16 These infections have been shown to increase hospital costs, morbidity, and mortality.5 The estimated mortality rate as- sociated with CLABSI is 23.8%, with an average increase in hospital length of stay of 7 to 21 days and an estimated cost of $29 156 per case.17,18

Process improvement tools have been effectively used in the healthcare setting to decrease errors,19 reduce length of stay,20 and improve patient satisfaction.20 The Six Sigma is an effective strategy that focuses on identifying errors and improving processes, using measurable results to demonstrate time and cost savings, and establishing DOI: 10.1097/JTN.0000000000000111

C entral venous catheters (CVCs) play an important role in the treatment of hospitalized patients, espe- cially those who are critically ill. These devices allow for administration of intravenous fluids, medi- cations, parenteral nutrition, and blood products, in

addition to hemodynamic monitoring and renal replace- ment therapy. It is estimated that more than 3 million CVCs are inserted each year.1 This practice is not without risk. One serious complication is the development of a central line-associated bloodstream infection (CLABSI). Critically ill patients in the trauma intensive care unit (ICU) are immunosuppressed, experience periods of hemody-

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long-term sustainable goals. Motorola originally devel- oped Six Sigma in the 1990s. Although originally designed for manufacturing processes, it has been embraced by many healthcare organizations.20-24 The Define-Measure- Analyze-Improve-Control (DMAIC) process, a Six Sigma strategy, is a 5-step sequence used to reduce variability and remove errors or defects. The 5 steps are as follows: (1) define the project goal and identify the issues that need to be addressed; (2) measure the current issues to obtain baseline data; (3) analyze the root cause(s) of the problems; (4) improve the process and remove barriers; and (5) control the process through periodic monitoring. The purpose of this article is to describe use of the DMA- IC model by a multidisciplinary team to improve quality outcomes related to CLABSI in a high-risk neurotrauma intensive care unit (NTICU).

A LOCAL PROBLEM: DMAIC USE TO IMPROVE NEUROTRAUMA ICU CARE Significant changes in the NTICU multidisciplinary team occurred when 7 trauma surgeons, including the unit medical director, left the facility in the spring of 2011. An influx of locum tenen surgeons, new surgical in- terns, and new graduate nursing staff occurred in the summer of 2011. These changes led to a lack of nurs- ing and surgical resident staff engagement, with knowl- edge deficits contributing to inconsistent application of evidence-based prevention of CLABSIs. A significant in- crease in CLABSI rate during this transition period pro- vided the motivation to form a multidisciplinary team to enhance processes for prevention. This team sought to implement the Six Sigma DMAIC model to acquire information on the barriers to following evidence-based guidelines, implement solutions for prevention of future CLABSIs, and decrease the overall central line utilization in our NTICU.

METHODS

Design This project was determined as quality improvement by the facility Institutional Review Board. A pre- and post- intervention design using the DMAIC model for quality improvement was used.

Setting The project setting is a 12-bed NTICU located in a 767- bed, level I trauma center, in Southwest Virginia. Originally awarded American Nurse Credentialing Center Magnet designation in 2003, the facility received Magnet redesig- nation in 2013. Admission patterns for the NTICU include 60% multisystem trauma, 90% of those with blunt injury, and 40% acute neurosurgical injury other than traumatic brain injury.

Planning The DMAIC framework, the performance improvement model formally adopted by our facility, was applied us- ing a systematic approach by the multidisciplinary team to eliminate and control the occurrence of CLABSI in our NTICU. The CLABSI team was formed to include project champions composed of local experts in the care and maintenance of CVCs, including surgery, medicine, phar- macy, infection control, and nursing representation. With CLABSI recognized as a nurse-sensitive indicator,25 the selected project team leader was a frontline staff nurse mentored by the unit nursing director and trauma clinical nurse specialist. Neurotrauma ICU frontline nurse repre- sentation was included from day and night shift staffs. Comprising a team of 10 allowed for rapid cycle tests of change, evaluation of impacts, and concentrated re- inforcement to support adoption of improvements into practice.

Performance improvement training utilizing the DMA- IC model occurred for team members through comple- tion of web-based educational activities, shared govern- ance council DMAIC education sessions, and consultation with facility Six Sigma engineers. In addition, the team attended the Virginia Hospital and Healthcare Association Comprehensive Unit Safety Program seminar where they were given a toolkit that included instructions on how to engage a team and promote a culture of change uti- lizing structured models for performance improvement. Our team, in order to structure the quality of improve- ment and evaluation process, sequentially applied each element of the DMAIC model.

Define the Problem The first phase of the DMAIC model focuses on defining the process you want to improve, identifying the custom- ers, and setting the project improvement activity goals. For this project, the problem scope was defined as pa- tients with a CVC in the NTICU at risk for development of a CLABSI. Process customers included nurses, phar- macists, physicians, trauma clinical nurse specialists, and infection prevention staff providing care to patients in the NTICU. The NTICU patients and their families were established as the end customers who would benefit greatly through reduced risk of infection and ultimately reduced mortality and morbidity. Defined project qual- ity improvement objectives were the following: (1) uti- lize a multidisciplinary systematic and evidence-based approach to control the rate of CLABSIs in the NTICU through maintenance of the central line device utiliza- tion ratio below the national benchmark for like units (National Hospital Safety Network [NHSN] 0.56)26; (2) improve system assessment documentation in the elec- tronic health record (EHR) for central line bundle com- pliance; and (3) share our lessons learned and outcomes

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with internal colleagues and broadly with health care cli- nicians regionally and nationally.

Measure the Problem The second DMAIC phase aims to objectively establish baseline information about the targeted process. This data is used to help identify problem areas and recognize the gap between current performance and customer expecta- tions. Project measurements were delineated to include the monitoring of all CLABSIs as rate/1000 line days as defined by the Centers for Disease Control2 and month- ly central line device utilization ratio data in the NTICU 2008 through 2013. The central line utilization ratio trend was tested for statistical significance using significance of trend. The level of statistical significance was established as α = .05. Analyses were conducted using Tableau 8.1 (Tableau Software, Seattle, Washington).

Three patients met the Centers for Disease Con- trol and Prevention definition for CLABSI during this 6-month period preceding implementation of the NTICU quality improvement initiative. Of those CLABSI cases, 2 were multisystem trauma patients, age range 20 to 40 years, 1 male and 2 female. The third case was a neurosurgical nontrauma patient. These CLABSI events resulted in the May 2011 NTICU CLABSI rate of 18.7/1000 line days at more than 9 times the NHSN pooled mean of 1.9 (P = .0184) and in the Septem- ber 2011 CLABSI rate of 14.7 at more than 7 times

the NHSN pooled mean of 1.9 (P = .0286).26 Month- ly CLABSI rates for the NTICU in 2011 in comparison to the NHSN pooled mean for like units are found in Figure 1.

Analyze the Problem This phase of the DMAIC process is concerned with identifying the root causes of problems. Detailed process maps can be used to locate the source of a problem and what might be contributing to that problem. Systematic analysis by the multidisciplinary team included review of the latest evidence for care of CVCs and prevention of CLABSIs. The team identified barriers to consistent application of evidence-based strategies for prevention of CLABSIs in the NTICU. Barriers were subcategorized into patient, environment of care, and multidisciplinary staff elements of care. Patient-related barriers included limited staff awareness of patients with femoral lines be- ing at higher risk for potential CLABSI. Also, significant variability in care and maintenance of central lines were identified through direct team observation of care prac- tices and analysis of documentation of care in the EHR. Environment of care barriers primarily stemmed from inconsistent location of equipment and supplies needed for sterile insertion of central lines. Contributory multi- disciplinary factors encompassed the following: (1) lack of empowerment of nursing staff to hold team members accountable for adherence to evidence-based insertion of

Figure 1. Baseline neurotrauma ICU CLABSI rates per 1000 line days.

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central lines; (2) knowledge deficits in nursing, resident, and surgeon staff regarding evidence-based insertion and care of central lines; (3) limited clinician awareness of unit-based CLABSI rates in comparison with national benchmarks and impact on patient outcomes; and (4) poor documentation of central line bundle compliance, procedure notes, and “time-outs” consistent with univer- sal protocols.

Improvement Strategies The fourth DMAIC phase aims to implement creative solutions for improving the process. These solutions ad- dress the problems identified during the analysis phase. Solutions are tested within the process on a trial basis and evaluated for possible risk associated with the im- provement. Finally, an implementation plan is developed before enacting the improvements. Evidence-based strat- egies for improvement in the provision of CVC care tar- geted the subcategories of patient, environment of care, and multiprofessional staff. Figure 2 shows the systematic application of targeted improvement strategies and the significant impact on reduction of the central line utiliza- tion ratio over time.

The NTICU CLABSI team joined the hospital collaborate as part of the national cohort Comprehensive Unit Based Safety Program (CUSP),27 to support a culture of safety change within the NTICU. In an effort to improve out- comes for those patients requiring CVCs, NTICU frontline nurses were engaged, educated, and empowered to pro- vide safe and reliable care and implement new processes on the basis of the most current evidence. Central to the culture change was articulating the project as nurse-driven with the frontline nurse vital to elimination of CLABSIs.

Transforming Care at the Bedside (TCAB) was formed in 2003 by the Robert Woods Johnson Foundation, in conjunction with the Institute for Healthcare Improve- ment, as an initiative to engage frontline staff and man- agers in change processes to promote safe reliable care, increase team vitality and teamwork.28 Transforming Care at the Bedside promotes value-added care in a patient- centered care environment through “test of change” to pilot changes using rapid cycle processes.28 The NTICU joined the TCAB national cohort team in August 2010. As a TCAB unit, the NTICU utilized the “snorkel” process, a brainstorming exercise in which the entire team partici- pates, to develop ideas for improvement and innovation

Figure 2. Impact of improvement interventions on the neurotrauma intensive care unit central line utilization ratio.

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in CVC care. In addition, NTICU nurses and physicians participated in a safety assessment survey to assess unit- based cultural perspectives on safety. The survey and “snorkel” indicated a need to create teams to address CLABSIs and improve patient outcomes. Neurotrauma ICU clinical team leader-led subteams were formed to au- dit documentation and compliance with our central line care and maintenance policy.

Core members of the multiprofessional team attended a state CUSP CLABSI conference, resulting in the devel- opment and implementation of a central line cart, a cath- eter insertion checklist, and an evidence-based practice bundle. Having a cart, which contains all the necessary supplies for insertion of a central line, allows the nurse to be present and assist if necessary with placement. Use of the insertion checklist helps to ensure adherence to sterile technique and execution of line placement accord- ing to policy. The insertion checklist helps to empower the nurse to stop the insertion if necessary because of poor preparation or practice. An evidence-based prac- tice bundle implemented included patient bathing with chlorhexidine gluconate every 24 hours, a set schedule for central line dressing changes, use of a biopatch with central line dressings, marking of intravenous tubing for every 96-hour changes, use of “scrub the hub” when ac- cessing a line, removal of femoral lines within 24 hours of admission, and daily evaluation of the line necessity. In addition, pharmacy supported an essential function to address antibiotic stewardship in daily rounds.

Knowledge deficits were addressed with frontline mul- tiprofessional staff during “movie nights,” which included popcorn and the showing of “On the CUSP: Stop BSI.” Education focused on insertion and line maintenance, evidence-based guidelines for appropriate antibiotic use, and prompt removal of lines that are no longer indicated. Frontline nursing and resident staffs were also educated on fever management, new Centers for Disease Control and Prevention Hospital-Associated Infection guidelines and criteria for HAIs, including CLABSIs and evidence- based culturing procedures. New NTICU resident orienta- tion was implemented to educate and train physician staff regarding unit-based protocols.

Bedside nurse handoff reporting, use of daily goal boards, and the incorporation of frontline nurses in daily interdisciplinary rounds helped to empower nurses to take ownership in eradicating CLABSI. Implementation of bedside nurse handoff reporting allows for monitoring of sensitive care issues including necessity of indwelling lines, appropriate care and maintenance, and education of patients and families regarding the plan of care. The use of daily goal boards in patient rooms tracks indwell- ing line days, and participating in daily interdisciplinary rounds allows for discussion of CUSP and unit-based ev- idence-based practice protocols. Commitment to patient

and family education and participation in daily multidis- ciplinary rounds remains essential. Patient and family orientation to the daily goal boards and the importance of hand washing to reduce the risk of infection for their loved one is emphasized in the NTICU.

Electronic health record improvements targeted the enhancement of central line documentation to include evidence-based care and maintenance interventions. Vari- ous disciplines had different EHR screen views, impairing clear communication among clinicians regarding central line insertion dates, care, and maintenance. As a result of the DMAIC process, a surgical rounding tool was devel- oped for the EHR for use by all disciplines, subsequently improving team tracking of all line, drain and airway in- sertion dates, and consecutive CVC line days.

The unit-based CLABSI team monitors evidence-based CVC care compliance monthly and publishes results to NTICU nursing, residents, and physician staff. Unit CLAB- SI never events are displayed simply as a “yellow alarm” symbol on a 52-week circular display in the NTICU unit. In the event a CLABSI is called, a “deep dive,” or in-depth evaluation of how it might have been avoided, is con- ducted with members of the specific patient multidisci- plinary care team and the infection control preventionist of the unit. With consistent reinforcement of the evidence by the multiprofessional leadership team, including the clinical team leader, registered nurse project lead, unit nursing director, trauma clinical nurse specialist, clinical pharmacist, and unit medical director, the NTICU culture transformed over an 18-month period to embrace the be- lief that the CLABSI is no longer an inevitable part of be- ing sick, and in the hospital, it can and must be avoided.

Control the Problem The last phase of the DMAIC process involves making the new process the standard of practice. This is ac- complished by modifying existing policies, procedures, or systems and training of all new staff on the current process. Performance results are periodically monitored to ensure results are sustained. Evidence-based controls to sustain improvements in CVC care and prevention of CLABSIs have been effective in our NTICU setting. Pull- ing the Line is discussed everyday for every patient in multidisciplinary rounds. Updates on the CLABSI bundle education program are presented to NTICU nursing, resi- dents, and physician staff. All new resident and registered nurse staff receive this education. Central line-associated bloodstream infection rates and central line utilization ra- tios in monthly staff meetings have been added to the quarterly facility Trauma Performance Improvement Sys- tems meeting. An executive summary (Figure 3) was dis- seminated widely to share lessons learned throughout the integrated health care system. Reviews of CLABSI never events are incorporated into monthly Surgical Mortality

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Figure 3. Executive summary pulling the line on central line-associated bloodstream infections in a neurotrauma intensive care unit.

and Morbidity Conference. The deep-dive drill down pro- cess remains in place in the event of a CLABSI. Of great importance successes are celebrated! For example, staff receives a zero candy bar at the 6-month intervals for no CLABSIs in the NTICU. Celebrations support meaningful recognition of the concerted efforts of staff to promote high-quality outcomes for neurotrauma patients.

Outcomes Results of this nurse-driven quality improvement initiative include a sustained reduction in the NTICU central line utilization ratio trend significantly lower than the NHSN pooled device mean of 0.55 for national benchmark trau- ma units (P < .0001) (Figure 4). NTICU CLABSI rates of 1.46 in 2012 and 1.2 in 2013, respectively, are below the NHSN pooled mean of 1.6 for like units (Figure 5). After a 12-month zero CLABSI rate, a single NTICU CLABSI rate spike of 15.5 in October 2012 was followed by an ad- ditional 8 consecutive CLABSI free months. A fiscal cost avoidance of $204 092 (estimated cost of $29 156 per case) associated with CLABSI,18 and cost savings associated with the decreased LOS in the NTICU of $75 600 for fiscal year 2010 to 2011 (7 cases in 2011 at a cost of $1500 per day × 7.2 days), was projected. An estimated 2 lives saved was achieved.17 Results highlight the tremendous efforts of a dedicated NTICU multidisciplinary team to sustain a remarkable 26 of the 28 months’ CLABSI free culture in a high-risk NTICU. The project culminated in receipt of the integrated health system annual MVP award in 2012 and the Hold the Gains award in 2013.

DISCUSSION Quality improvement is a dynamic process, and success depends upon a multidisciplinary system approach to continue identifying and implementing evidence-based solutions to complex factors affecting practice and NTICU patient outcomes. Grima and colleagues note the DMAIC framework is particularly useful for complex problems, which are chronic or interdepartmental, with contribut- ing causes poorly defined and solutions unknown.24(pp. 203) The NTICU CLABSI prevention improvement project met these criteria and proved to be well suited for improve- ment with the DMAIC approach. As reported in prior studies,29-32 a multimodal approach, incorporating the central line bundle and multidisciplinary education, was effective in reducing CLABSI rates in our NTICU. How- ever, the DMAIC structured approach in particular as an improvement framework led to barrier identification and locally relevant innovative solutions. Use of the DMAIC model, combined with the TCAB “test of change” strategy, created synergy that engaged frontline clinicians to adopt a culture of safety within our unit. The DMAIC framework directed the team not to ignore the obvious; reduction of central line device utilization is the cornerstone of CLABSI prevention. Ongoing commitment to reduction of CVC line days despite rising Injury Severity Scores (ISS) in our neurotrauma intensive care population (ie, 2011, average ISS 11.413; 2012, average ISS 11.645; and 2013, average ISS 11.795) has sustained our low CLABSI rates.

Several key lessons were learned through the CLABSI quality improvement DMAIC process. Multidisciplinary

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staff must become process owners and take pride in their practice. Creating a sense of urgency and communicating early wins in improvement built pride and motivated clini- cians. Education is most effective when it addresses the needs of all levels of care providers (eg, nursing assistants, medical students, residents, and nurses) and is provided to all new staff members. Cultivation of multiprofessional

internal expertise is essential. Our team gained leadership expertise through its membership in the national CUSP co- hort, which provided access to external experts in CLABSI reduction. The change in culture empowered the nursing staff to hold the line on adherence to evidence-based in- sertion and care of centrally placed lines. The participation of patients and families as central members of the CLABSI

Figure 4. Central line utilization ratios in the neurotrauma intensive care unit by month (July 2008 through June 2013).

Figure 5. CLABSI rate by year in the neurotrauma intensive care unit (2008 through 2013).

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8. Centers for Medicare and Medicaid Services. Hospital acquired conditions. http://www.cms.gov/Medicare/Medicare-Fee-for- Service-Payment/HospitalAcqCond/Hospital-Aquired_Conditions .html. Accessed May 24, 2013.

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care team nurtures multidisciplinary team accountability for care. Celebration of improved outcomes is vital. We found that one of the best ways to do this is to support multiprofessional members in presentation of project suc- cesses on a local, regional, and national level. The lessons learned are the strengths of the project.

Limitations to this quality improvement project in- clude several changes made, making it difficult to iden- tify which interventions made the greatest improvement impact. Additionally, the project was implemented in an academic medical center with more than 700 beds and interventions used may not be applicable to community hospitals or ambulatory settings.

CONCLUSIONS A multidisciplinary team approach to identify root causes and process defects through the use of the DMAIC mod- el was effective to reduce CLABSIs in our neurotrauma ICU. The model’s framework supported creativity and collaboration, reinforcing changes in care delivery, and improved clinical outcomes in a high-risk setting. Cultural adoption of evidence-based practice at the unit-based level occurred after 18 months of daily reinforcement by the project leadership team and requires ongoing multi- professional education. Multiprofessional teams pursing improved outcomes of care across the trauma care con- tinuum may also find the DMAIC model useful for ad- dressing quality improvement challenges.

ACKNOWLEDGMENTS We thank Karen Baker, RN, Carilion Medical Center, Infection Preventionist Department of Infection Control, for her support.

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