According to the Centers for Disease Control and Prevention, central line–associated bloodstream infections (CLABSIs) are considered the deadliest healthcare-associated infection (HAI).1 Patients who require central venous line (CVL) access for treatments are often the sickest and most vulnerable to HAIs. Patients in the intensive care unit (ICU) are at an even greater risk of CLABSIs due to the emergent circumstances under which CVLs are often placed, the frequency they are accessed, and an extended number of device days.2 Vital statistics indicate that one in four patients who acquire a CLABSI will die, making this the most devastating consequence of hospital-acquired infections.1,3
Central line–associated bloodstream infections not only negatively impact patient safety, but they are also a tremendous financial burden for healthcare organizations. Central line–associated bloodstream infections per case costs are estimated at $49,201.4 This financial impact is even more significant to organizations because CLABSIs are included in the Center for Medicare and Medicaid Services' value-based purchasing and hospital-acquired conditions pay-for-performance reimbursement programs.5 In addition, individual hospital CLABSI rates are compared with other organizations and are visible to the public through the Medicare.gov Hospital Compare web site with the potential to significantly impact the consumer perception of an organization.5 The financial and reputational impact of poor performance in this area has increased the nation's healthcare industries' attention on improvement efforts.
To improve patient safety and positively impact the financial burden associated with CLABSIs, organizations should strive to achieve a culture of high reliability. The culture of high reliability is not an individual performance improvement project, but rather a continuous commitment toward ongoing patient safety and high-quality care.6 High-reliability organizations (HROs) consistently maintain a high level of organizational safety. A key aspect of HROs is their ability to eliminate safety deficiencies through robust process improvement that creates constant awareness and a collective mindfulness for high-quality care.6 Creating a HRO culture may be an effective method for preventing CLABSIs. The purpose of this article is to describe the process of using high-reliability methodology to maintain zero tolerance for CLABSIs in an acute care patient setting.
Conceptual Framework of High Reliability
The science of high reliability has been used successfully for many years in high-risk industrial organizations such as aviation and nuclear power plants; however, the use of high reliability in healthcare has only recently been considered and evaluated.6 The concept of high reliability is defined as consistently maintaining a high level of organizational safety. High-reliability organizations develop a collective mindfulness and maintain a culture that encourages every employee to continually look for unsafe conditions before a problem occurs. This proactive approach to high reliability often prevents major adverse events from ever happening. High-reliability organizations share five similar principles, which consist of (1) a preoccupation with failure, (2) a resistance to simplify observations or experiences, (3) a sensitivity to operations, (4) a commitment to resilience, and (5) a deference to expertise.6 Each of these principles will be described highlighting examples for translation (Figure 1).
The first HRO principle, a preoccupation with failure, is a mindfulness process in which an individual approaches each day with a purposeful watch for unsafe conditions within an organization, while never becoming complacent or satisfied with the current level of safety. Staff members of HROs are continually striving for improvement from the status quo. Performing a failure mode effect analysis (FMEA) helps staff identify potential process failures that have the greatest risk of failure. A FMEA is a proactive approach that not only identifies where a process may fail but also identifies the degree of impact the failed process will create.7,8 Staff are then able to proactively make process changes that improve safety and highlight opportunities for improvement by limiting practice variations.
The second HRO principle involves resisting the urge to simplify observations or experiences. This resistance to simplify is an essential principle for process improvement in order for an organization to achieve and maintain a high level of consistent reliability and patient safety. A methodology using a process flow diagram to identify subtle practice variations helps staff identify isolated versus widespread knowledge deficits that involve clinical practice guidelines and standardized patient care bundles. This methodology results in an organization's continued focus on prevention and assessment emphasizing each step of a practice process, which creates a state of ever alertness for subtle threats that may compromise patient safety.
The third HRO principle includes maintaining a sensitivity to operations, regardless of how small or insignificant it may seem. Assumptions are never made, and robust process improvement efforts are used to guide assessments. Developing a validation tool from a process flow diagram and FMEA outlines and delineates each step in a patient care process. Often, it is the smallest process failure that poses the greatest threat to an organization's safety. High-reliability organizations do not claim to be error-free, but instead they recognize errors can and will occur. Maintaining this heightened level of sensitivity identifies process variations that threaten an organization's safety. This ongoing sensitivity to operations prepares staff to be preemptively aware of unsafe conditions before they become impossible to manage.
The fourth principle of HROs is a commitment to resilience. High-reliability organizations demonstrate resilience when front-line staff demonstrate early recognition of process variations. Leaders at HROs encourage and expect their front-line staff to speak up when they see a potential threat to patient safety. High-reliability organization leaders and staff are extremely aware of resilience and continually maintain a commitment to zero harm regardless of previous organizational success. Implementing a process that creates an environment where front-line staff can safely provide feedback is vital. Performing interprofessional bedside huddles that are led by organizational leadership for the purpose of reviewing patients' plan of care has demonstrated improved outcomes in the healthcare industry.9 Bedside huddles create a real-time learning laboratory, and when performed on a consistent basis, they create a level of trust between the front-line staff and their organizational leadership. This heightened sense of awareness means that both front-line staff and leadership rarely experience a false sense of security, which is essential in maintaining a level of safety that is expected at HROs.
The fifth and final principle of HROs is a deference to front-line staff expertise. A consistent presence by organizational leadership through the utilization of bedside huddles provides an excellent opportunity for front-line staff to voice their concerns. Leaders must in turn provide closed-loop communication related to improvements that were created as a result of the information obtained from the frontline during these huddles. Leadership follow-through with real-time changes based on the recommendations of front-line staff builds a relationship of trust and respect, and fosters continuous improvement.6 This enhanced communication creates a process of continuous improvement reflective of a deference to front-line staff expertise. Whenever trust is broken, it becomes increasingly difficult to create a HRO. Deference to front-line staff expertise promotes transformational leadership placing the decision-making responsibility into the hands of those who are ideally positioned to proactively prevent an adverse event.
Although the Centers for Disease Control and Prevention cites an overall 46% decrease in CLABSIs nationwide, there continues to be increasing national attention on the sustainability of CLABSI reduction.5 At the organization of study for this article, the CLABSI rates appeared to increase between 2012 and 2016 in contrast to the national trend. Sensing an opportunity, nursing leadership at the organization analyzed these data and found that overall HAI rates and specifically, CLABSI rates were on the rise. In 2015, the ICU CLABSI rate was 3.15 infections per 1,000 device days, with a 2.10 National Healthcare Safety Network (NHSN) Standardized Infection Ratio (SIR). During the first 2 quarters of 2016, the rate continued to increase to 5.88 infections per 1,000 device days and a preliminary SIR of 3.9. Both rates were considerably higher than the national benchmark and posed a cause for concern. On further analysis, each CLABSI occurred approximately 10–12 days after the insertion date of the device demonstrating that the infection was not caused during the insertion process but rather during the daily maintenance.
Nursing leadership analysis found an increase in nurse turnover ranging from 8.57% to 55.17% between 2012 and 2016, which coincided with the increase in CLABSI rates. This rise in nursing turnover created instability in the ICU contributing to a decrease in Registered Nurse (RN) experience and an increased knowledge deficit surrounding the key aspects of the CVL maintenance care bundle. Further analysis indicated the higher turnover rate created a deficient onboarding program for newly hired nurses, and a failure to ensure initial or continued CVL competence and maintenance education.
Improvement Project Design
The purpose of the improvement project discussed in this article was to establish the principles of high reliability in the ICU as a method for developing and maintaining a zero tolerance culture for CLABSIs. Using the model for improvement and plan-do-study-act cycle, the leadership team developed and implemented a bundled intervention approach based on the principles of high reliability. Starting in April 2017, the organization's improvement aim was to achieve a 50% decrease in the ICU CLABSI rate by July 1, 2017, and to maintain the reduction consistently over time. Objectives were measured to determine that an improvement had occurred and included an increase in RN awareness and reliable compliance of the components of an evidence-based CVL maintenance bundle and a decrease in CVL device utilization ratio. Following approval by an Institutional Review Board, the intervention bundle was developed and tested to align with high-reliability principles.
The project took place in an 18 bed ICU of a 191 bed acute care community hospital located in the southeastern United States. The bundled intervention consisted of the implementation of interprofessional daily device rounds, development of an evidence-based CVL maintenance bundle, implementation of a daily device rounding checklist validation tool, and the development of a real-time learning laboratory. An evaluation plan was developed to measure the bundled interventions. The CLABSI rate metric (infections per 1,000 device days) was used as an internal benchmark for performance comparison preintervention and postintervention. The ICU CVL device utilization ratio was calculated using the number of catheter days divided by the total number of patient days. The overall target was determined to be at or below the NHSN benchmark of 0.34.
A comparative analysis of the RN CVL bundle knowledge and utilization was performed on a weekly basis. A tool was created and used by the interprofessional team during daily device rounds. This tool was implemented as a validation checklist to determine the level of RN knowledge and reliable CVL maintenance bundle utilization. The front-line RN must either have demonstrated knowledge of the bundle or have used each step of the bundle indicated on the tool. When the RN did not complete or demonstrate knowledge of one or more aspects of the bundle, the RN was considered to have not completed the bundle and was given no partial credit on the validation tool. The ICU nurse manager completed this validation process during each interprofessional daily device round. These rounds were performed Monday through Friday for a total of eight consistent weeks. At minimum, two of the daily rounds each week were performed during the nightshift with a primary focus on the newly hired RNs and new graduate nurses.
A data comparison of preintervention and postintervention analysis included the number of CVL infections from the second quarter of 2017 (April, May, and June) compared with the second quarter of 2016 (April, May, and June). The CLABSI rate for the second quarter of 2017 was 0.0 infections per 1,000 device days compared with 5.85 infections per 1,000 device days in 2016. The yearly ICU CLABSI rate decreased from 3.95 infections per 1,000 device days in 2016 to 2.83 infections per 1,000 device days in 2017. The CVL intervention resulted in an overall improvement of the facility-wide CLABSI rate from 2.93 infections per 1,000 device days in 2016 to 1.04 infections per 1,000 device days in 2017. The improvement aim of a 50% reduction in the ICU CLABSI rates was met by the second quarter of 2017. However, CLABSI reduction remains a focus of the leadership team to ensure sustainability.
Baseline RN knowledge and reliable CVL bundle utilization improved from 75% at Week 1 to 100% at Week 8. Weeks 3 and 6 demonstrated lower rates than the initial baseline result at 33% and 69%, respectively. Ninety-one percent of the fulltime RN staff were evaluated, whereas 100% of the newly hired new graduates were included in this evaluation process.
Analysis of preintervention and postintervention data indicated a decrease in the ICU's device utilization ratio from 0.34 in the baseline period of 2016 to 0.27 in 2017. The month of June 2017 (0.22) demonstrated the greatest improvement from the baseline period in 2016 (Figure 2).
During this project, front-line nursing staff in the ICU demonstrated a strong desire to prevent patient harm. This focus on harm prevention was identified early on during the daily device rounds, which were led by nursing leadership (the ICU Nurse Manager, Director of Quality and Infection Prevention, and the Chief Nurse Executive). At the conclusion of this project, several nursing practice changes were identified. These process changes included an improved communication mechanism, proactive removal of unnecessary CVLs, and a sense of urgency to remove CVLs placed in the femoral area. The front-line staff independently began incorporating additional preventative measures to improve patient outcomes within their unit, such as catheter-associated urinary tract infection, pressure ulcer injury, and early recognition of severe sepsis.
The nursing staff developed and implemented a mechanism for improving communication around the CVL maintenance bundle, focusing specifically on reliable utilization of the maintenance process. The communication process included the use of communication boards located in each patient room as a mechanism for improving patient communication and for holding staff accountable for completing the daily CVL maintenance bundle. Completion of the communication boards is now being reliably performed on a daily basis. This communication technique has been further refined to not only include CVL maintenance bundle interventions but also other various patient devices that require specific care interventions to improve patient outcomes (i.e., Foley catheters, ventilator intubations, arterial lines, and feeding tubes).
Evaluating CVL necessity has also become part of the nurses' daily assessment. The front-line nurses work collaboratively with the interprofessional patient care team to remove any unnecessary CVLs. During this project, it was found that unnecessary CVL removal was expedited when the ICU nurse had taken the initiative and started a peripheral Intravenous (IV) access proactively before requesting a CVL access removal. This practice change solidified the notion that RNs are aware of circumstances that make having a CVL access no longer necessary.
Most attending providers have worked collaboratively with the ICU nurses and support prompt CVL removal when CVL access is no longer necessary. Since the completion of this project, the medical staff members have initiated a hospital-wide policy that any CVL placed outside of the facility, placed under emergent circumstances, or placed in the femoral area shall be removed within 48 hours of insertion. When the patient continues to require CVL access, the attending provider assures that the femoral line is removed and is then placed in a more acceptable insertion site to prevent infection. Intensive care unit nurses work collaboratively within the interprofessional patient care team to make certain that line assessment is completed in a timely manner. When there is push back from an attending provider, the front-line RN will approach nursing leadership to assist in these conversations.
Since the completion of this project, the interprofessional device rounds have continued and are now being led independently with the ICU Nurse Manager taking charge and having consistent project ownership. The Director of Quality and Infection Prevention and Chief Nursing Executive continue to participate in the device rounds two to three times weekly. In addition, this leadership device rounding methodology has been implemented in various patient care units within the organization. Since the beginning of this improvement project (April 2017), to date, this facility has experienced only one facility-wide CLABSI (August 2017).
The principles of high reliability may be used to improve quality and patient safety in healthcare. This improvement project demonstrates how each of the high-reliability principles discussed may be used to develop sustainable improvements in a clinical problem within the hospital setting such as CLABSIs. Table 1 provides measures addressing high-reliability principles to establish interventions used in this project. The outcomes and results are provided for each of the bundled interventions.
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Beth McCraw, DNP, APRN, is the Vice President of Nursing and Clinical Services at Jennie Stuart Medical Center, Hopkinsville, Kentucky, and is also an Adjunct Instructor in Nursing at Vanderbilt University School of Nursing. Before her current executive role, which she has held for over 7 years, she served as the Adult Health Clinical Nurse Specialist at Jennie Stuart Medical Center with a focus on process improvement, evidence-based practice, and change.
Terri Crutcher, DNP, RN, is an Assistant Professor and Assistant Dean for Clinical and Community Partnerships at Vanderbilt University School of Nursing. She is currently the interim director of the Nursing and Health Care Leadership master's degree program at Vanderbilt.
Shea Polancich, PhD, RN, is a column editor for the Journal of Healthcare Quality Department titled: Translation of Research into Healthcare Quality Practice. Dr. Polancich has been practicing in quality and patient safety for over a decade. She is currently an Assistant Professor and Assistant Dean at the University of Alabama at Birmingham (UAB) School of Nursing with a primary practice at the UAB Medical Center, Birmingham, Alabama, as a director specializing in nursing improvement, innovation, and analytics. Formerly, her roles included the Director for Quality and Patient Safety at Vanderbilt University Medical Center, Director of Data Analysis and Measurement at Texas Health Resources, NIH/NINR research intern, and health policy fellow at George Mason University. She served on an NQF advisory group specific to patient safety and adverse events.
Pam Jones, DNP, RN, NEA-BC, is the Senior Associate Dean for Clinical and Community Partnerships at the Vanderbilt University School of Nursing. Before her appointment at the School, she served as the Chief Nursing Officer for the Vanderbilt University Hospital.