The Art and Science of Infusion Nursing Rachel L. Zastrow, MSN, RN, CCRN, CPPS, LSSBB

Root Cause Analysis in Infusion Nursing Applying Quality Improvement Tools for Adverse Events

ABSTRACT The application of root cause analysis (RCA) to health care began in the Veteran’s Administration system and spread to Joint Commissionaccredited organizations when it became a requirement for accreditation. The success of this valuable quality improvement tool relies on understanding the principles of patient safety, assembling a team, and producing and completing action items aimed at correcting root causes of adverse events. This article describes optimal RCA techniques based on published literature and expert opinion and then provides a sample RCA for a fictitious but common adverse event: catheter-associated bloodstream infection. Key words: adverse events, catheter-related bloodstream infection, CLABSI, performance improvement, patient safety, quality improvement, RCA, root cause analysis

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ore than a decade ago, the Institute of Medicine (IOM) released 2 groundbreaking reports revealing that harm to patients was devastating and prevalent, with as many as 98 000 deaths related to medical errors annually, but preventable through a focus on systems improvement.1,2 The American health care system lacked the tools to address this need and looked to outside industries for successful quality improvement methodologies. Root cause analysis (RCA) originated in engineering but was adapted to health care by the US Department Author Affiliation: Cadence Health, Winfield, Illinois. Rachel L. Zastrow, MSN, RN, CCRN, CPPS, LSSBB, is Director, Patient Safety, Advocate Lutheran General Hospital, Park Ridge, Illinois. The author has no conflicts of interest to disclose. Corresponding Author: Rachel L. Zastrow, MSN, RN, CCRN, CPPS, LSSBB, Advocate Lutheran General Hospital, 1775 Dempster St., Park Ridge, IL 60068 (Rachel.zastrow@advocate health.com). DOI: 10.1097/NAN.0000000000000104

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of Veterans Affairs (VA) and spread rapidly when The Joint Commission (TJC) began to require RCA in 1997 as a condition for accreditation.3 Despite widespread use of RCA in health care, few quantitative data provide practitioners with expected measurable improvements from RCA use. Much of the content of this review will include qualitative data from research and published expert opinion.

SAFETY SCIENCE Before delving into the mechanics of an RCA, a basic understanding of safety science is essential. Without appreciation for fundamental concepts of human and system error, an investigator or participant would experience difficulty identifying root causes. James Reason4 developed a model of accident causation, commonly referred to as the Swiss Cheese model, speculating that errors in health care, like those in other industries, arise from a combination of human errors and system failures. In this model, although the clinician on the “sharp end,” or closest to the patient, might make a mistake or violate a rule, this would only lead to patient harm after the error passed through many layers of defenses. Focus on the sharp end yields little long-term improvement. Human failure will not end. Improvement in safety requires examination of the entire environment in which the error occurred, from the board room to the bedside. What is a latent failure? This term is not often heard in patient care, but understanding latent failure has the potential to change the patient care environment for the better. This refers to “blunt-end” factors that have an impact on patient care, setting the stage for an error that eventually reaches the patient and causes harm. This includes organizational culture and processes that affect bedside care. An illustration of how several factors could come together to cause patient harm should improve understanding of this concept (Figure 1). In the example, the care provider at the sharp end clearly violated a rule. However, many layers of defenses—using clearly marked vials, designing for human factors, and using a manufacturer or familiar product consistently, to name a few—failed the nurse and the patient. In contrast to our historic response to

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Figure 1 The “Swiss Cheese” model.

error, which focuses on the person, new knowledge about safety science would guide our efforts toward a system focus. After all, human beings will continue to fail. Without an understanding of this model, efforts to improve are likely doomed to failure, as indicated by health care’s abysmal record on patient safety. As stated above, the IOM estimated more than a decade ago that health care-attributed harm contributes to deaths equivalent to a 747 aircraft crashing every day. More recently, in 2013, James confirmed that health care not only continues to harm patients but that the estimated volume of patients harmed also has quadrupled, with as many as 400 000 patients now victims of health carerelated harm.5 Armed with knowledge about human error, a reviewer can conduct an RCA more effectively and address root causes, likely preventing a recurrence of the harmful incident.

RCA RESEARCH As previously stated, few quantitative data on the longterm success of RCA use in health care exist. RCA typically represents 1 tool in an arsenal of safety improvements. For example, Muething et al combined an enhanced, robust RCA program with behavioral error prevention technique instruction, restructured patient safety governance, a robust “lessons learned” program, and tactics for high-risk areas (specifically, intensive care and perioperative services) to achieve an impressive reduction of more than 50% in serious safety events over several years.6 Of course, not all of the improvement can be attributed to the use of RCAs, given the simultaneous implementation of other interventions. In addition, RCAs are performed in diverse situations, making measurement of outcomes across RCAs difficult. The VA, a leader in RCA use, provides compelling evidence for potential improvements in patient care using RCAs. A research team reviewed all medication errors, also known as adverse drug events, for an entire year throughout the VA system, encompassing more 226 Copyright © 2015 Infusion Nurses Society

than 200 reports from member hospitals.7 Of 993 actions taken throughout the system, 75% were fully implemented at the time of the study. Interestingly, reports of substantial improvement in root causes correlated with improvements in equipment and clinical care, which included such interventions as alerts, forcing functions in order entry, drug storage changes, and process changes. However, interventions based on training and education were statistically significantly correlated with a lack of improvement. This reinforces the value of making changes to the system versus focusing on human beings. Earlier research from the VA illustrates a potential pitfall in conducting RCAs. Bagian et al found in a small random sample of RCAs that 7% included only training and another 7% included only policy changes, the least effective interventions.8 A variety of qualitative research further illuminates potential barriers to improvement in the RCA process. An RCA training program including an immediate and 6-month follow-up test illustrates common barriers to RCAs. Newly trained participants cited time and resources as the most problematic issues in conducting RCAs. After 6 months of practice conducting RCAs, organizational barriers moved from the bottom of the list, at number 19, in immediate postteaching testing to a ranking of 2.9 Lack of time remained a major theme, but failure to implement recommendations from RCAs rose to nearly the top of the 21-item list rapidly after practitioners developed real-world experience. The importance of organizational commitment to learn from failures cannot be overstated. Given the scarcity of resources, time in particular, failure to implement team recommendations represents inefficiency, at least. This potential for bureaucracy to override the goals of an RCA is echoed by Nicolini et al.10 The qualitative study examined many barriers, but researchers mention several symptoms of a dysfunctional organizational response to RCA. A need to produce an action plan may override full examination of root causes. Production of a report may be seen as more important than achieving meaningful improvement. In addition, lack of sharing RCA results across divisions or institutions also lessens the impact an RCA might otherwise have. RCAs continue to contribute to quality outside health care, and barriers described in other industries may guide health care practice. Carroll et al remind RCA practitioners that the way in which RCAs are conducted directly influences the quality of the outcome and the benefits achieved.11 One additional discussion item when determining root causes is the potential to identify a root cause far outside the capability of the improvement team members or one far outside its scope.12 RCA teams frequently suffer from a self-limiting attitude, seeing interventions as potentially too costly or difficult in the institution in question.9 Although it’s important to challenge the institution to correct difficult and time-consuming Journal of Infusion Nursing

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TABLE 1

TABLE 1

Outline and Tips for Successful RCAs

Outline and Tips for Successful RCAs (Continued)

Organizational Recommendations • The senior executive is accountable for the action plan.

• Focus on causes, not problems.

• Systematically learn across RCAs. • Involve physicians and hospital leadership. • Conduct more RCAs, including RCAs on near misses and chronic problems. • Include the hospital attorney, if necessary. • Safe culture is essential to successful RCAs.

• Conduct an investigation before meeting and as soon as possible after an event. • Collect all possible facts.

• Build a timeline from documentation. • Use tools, such as a flowchart, to facilitate understanding. • Have staff-level persons involved in the RCA process.

• Do not neglect controversy in your action plan or report out.

• Share the intent of the RCA—to improve the system—with anyone you interview. • Make a commitment and a plan to share the results of the RCA with any involved party. Assembling a Team • The initial meeting should include the timeline/process map, especially if it’s complex. • Staff involvement is essential, and all roles must be involved. • A diverse team will see the same situation in different ways and improve communication. • Expect discomfort and defensiveness; develop a plan in advance to deal with this. • Guard against the influence of professional status. • When possible, have a clinician lead the team who is knowledgeable about both the area in question and conducting an RCA. This leads to better focus on systemic and organizational factors. Determining Root Causes • The lack of something is not a cause. A common error is citing “lack of knowledge” or determining that a staff member did not complete a required action. This should be followed with asking “why” or ending the sentence with “because”; ie, “The nurse did not follow all 5 rights of medication administration, because.…” • Do not look for a single “most important” root cause; complexity dictates that there will be more than 1 root cause in virtually every situation. • If you can answer the question “why,” you have not reached the root cause. • Use an RCA tool to aid examination of all potential barriers and contributors. (continues)

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• Engage staff members to implement actions related to safety improvement. Tell the story, and be transparent about why you’re asking them to engage. • Always measure your action plan implementation.

• Interview involved individuals 1-on-1 before the RCA.

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• Determine whether the interventions decided on have really improved safety with data.

• Use change management and/or performance improvement techniques when implementing action plans (PDSA, DMAIC, etc.).

• Do not include conjecture.

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• Review all potential barriers, and ask as many questions as possible. It is much easier to miss barriers or conduct a shallow investigation than to make the opposite mistake. Developing and Executing the Action Plan

Conducting the Investigation

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• Review facts and base questions in situational needs. Rather than asking “was environment a problem?” ask, “What challenges existed in the environment? What was needed?”

• Ensure sustainability. This is by far, in RCA action plans and in change management in general, the most common stumbling block. • Share your findings across and outside the organization! Abbreviations: RCA, root cause analysis; PDSA, Plan-Do-Study-Act; DMAIC, Define, Measure, Analyze, Improve, and Control. Note: The recommendations above are based on expert opinion and research findings.6,7,10-12,14-18

contributors to adverse events, such as poor culture, some root causes may stem from outside sources, such as a manufacturer. For example, many serious events in health care stem from the ubiquitous use of luer lockstyle devices for various nonrelated devices. Readers may be familiar with the risks of accidentally connecting venous tubing to an epidural catheter, or vice versa. In this case, the team should refer concerns to the manufacturer, but the long-term solution truly rests with industry. The medical device industry, although slow to respond, has made strides toward addressing this type of concern.13 Additional recommendations from literature and experts for conducting effective RCAs are listed in Table 1. Table 1 also includes a broad outline of the steps to conduct an RCA.6,7,10-12,14-18

CONDUCTING A FICTIONAL RCA RCA is not a single approach to discovering a cause for an adverse outcome but, instead, a set of tools to guide investigation, analysis, and action, ultimately aimed at preventing future errors. This example uses the method

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Figure 2 Timeline.

outlined in Table 1 to walk through an RCA of a bloodstream infection using tools and techniques typical of RCAs. TJC provides a thorough tool on their Web site that allows teams to systematically review an event and answer questions about potential barriers and causes.17 For the purposes of providing an example, the following situation will be used: a patient has been diagnosed with a central line-associated bloodstream infection in the intermediate care unit after a 2-week stay in the intensive care unit, and receives positive initial blood cultures in the intermediate unit. The ICU achieved a 0 infection rate for the preceding 12 months, and the hospital board has committed to the elimination of health care-acquired infections. The patient is diagnosed with

sepsis. Comorbidities include diabetes and advanced age of 78. Investigation Where would an investigator begin to hunt for root causes? The first step would be to create a timeline of the event and investigate any point of potential contamination (Figure 2). In this instance, the investigation would attempt to uncover any deviations from expectations during insertion and maintenance. Because this investigation encompasses a wider time frame than a typical “event,” the team may benefit from examining common practices in general. For example, how would a line be accessed in the ICU? Would the nurse or

Documentaon

Maintenance Lack of Knowledge of Hub Scrub

Missing Dressing Changes

Role Confusion No Communicaon from IV team

Dressing changes not Completed

CLABSI Locaon not recorded (Peripheral vs. Central) Sample not labeled (Peripheral vs. Central) Policy does not reflect evidencebased pracce re: ming

Blood Culture Figure 3 Causes of recent catheter-related bloodstream infection.

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Figure 4 Root cause question example from the Joint Commission RCA tool.

technician scrub the hub? For how long? These questions should be asked, and answers should be based on objective data whenever possible, rather than reviewing policies or asking management or staff. The importance of investigation taking place in the area in which an adverse event occurs cannot be overstated. Team members must view the environment to understand the event. After completion of the event timeline, a team meeting would be called.

Figure 4. Keep in mind that root-cause statements should be statements of fact, not opinion; focus on the situation rather than an individual; and be clearly related to the event. All root causes should be identified, but the team may not be able to work on every root cause. Because of limitations on time, the most relevant root causes should be selected for intervention. Keep in mind that the most relevant and easiest are rarely synonymous. If a poor safety culture largely contributed to an event, it should be the priority for action planning.

Team Formation and Root Cause Determination The team should include members from any discipline potentially involved in the event. In this case, the team should include at a minimum nurses, physicians, and infusion therapists. Although the temptation to involve only management representatives is great given time constraints, involvement of clinical staff will yield benefits in understanding bedside care issues and realities. In an event such as this, the team might engage in brainstorming potential root causes using a tool, such as the fish bone (Figure 3). The team should also use an RCA tool, such as the one available from TJC, which includes 24 domains.17 An example of one of the questions, along with the associated text from the tool, appears in

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Figure 5 Strength of corrective actions.

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Figure 6 Root cause statment and action plans. ©The Joint Commission, 2014. Reprinted with permission.

Action Planning In the given example, 2 communications-related root causes were identified. What would best address the use of a checklist and communication about line removal? Writing a policy or reeducation about the use of a checklist tempts even experienced change managers. However, Figure 5 provides an overview of the strongest and weakest techniques to reduce risk. Whenever possible, choose a stronger option. Policies and procedures must be maintained and accurate but should never really be viewed as a correction. Think of the policy as the written record of an identified best practice. The work of designing, testing, refining, and sustaining the best practice is the true improvement and differs from rewriting a policy. Figure 6 provides possible action plans related to the identified root causes. RCA is a valuable tool in the arsenal of quality improvement instruments. Although required for sentinel events, relegating this powerful tool to the closet, only to be dusted off in extreme circumstances, leaves many potential gains unrealized. Consider using RCAs for complex, recurrent problems, such as the one described above, and for “near misses.” If your job does not place you in a position to conduct formal RCAs, begin questioning events and near misses in your daily practice. Finding why something happened is the first step in correcting a broken system. RCA, thoughtfully

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applied with corresponding measurable and sustained improvements and institutional support, can radically improve care for future patients and by practitioners. ACKNOWLEDGMENTS Special thanks to Sallie Jo Rivera and Laurel Ann Peterson for their assistance in the development of the content of this article. REFERENCES 1. Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, DC: Institute of Medicine, Committee on Quality Health Care in America; 2000. 2. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: Institute of Medicine, Committee on Quality Health Care in America; 2001. 3. The Joint Commission. Sentinel event policy and procedures. http://www.jointcommission.org/Sentinel_event_policy_and_ procedures. Updated November 19, 2014. Accessed January 12, 2015. 4. Reason J. Safety in the operating theatre. Part 2: human error and organisational failure. Qual Saf Health Care. 2005;14(1):56-60. 5. James JT. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Saf. 2013;9(3):122-128. 6. Muething SE, Goudie A, Schoettker PJ, et al. Quality improvement initiative to reduce serious safety events and improve patient safety culture. Pediatrics. 2012;130(2):e423-e431. 7. Mills PD, Neily J, Kinney LM, Bagian J, Weeks WB. Effective interventions and implementation strategies to reduce adverse

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8.

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drug events in the Veterans Affairs (VA) system. Qual Saf Health Care. 2008;17(1):37-46. Bagian JP, Gosbee J, Lee CZ, Williams L, McKnight SD, Mannos DM. The Veterans Affairs root cause analysis system in action. Jt Comm J Qual Improv. 2002;28(10):531-545. Wallace LM, Spurgeon P, Adams S, Earll L, Bayley J. Survey evaluation of the National Patient Safety Agency’s Root Cause Analysis training programme in England and Wales: knowledge, beliefs and reported practices. Qual Saf Health Care. 2009;18(4): 288-291. Nicolini D, Waring J, Mengis J. The challenges of undertaking root cause analysis in health care: a qualitative study. J Health Serv Res Policy. 2011;16(suppl 1):34-41. Carroll JS, Rudolph JW, Hatakenaka S. Lessons learned from non-medical industries: root cause analysis as a culture change at a chemical plant. Qual Saf Health Care. 2002;11(3):266-269. Wu AW, Lipshutz AM, Pronovost PJ. Effectiveness and efficiency of root cause analysis in medicine. JAMA. 2008;299(6):685-687.

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13. Brown J. The life and death of the luer. Medical Device and Diagnostic Industry. 2012. http://www.mddionline.com/article/ life-and-death-luer. Accessed January 12, 2015. 14. Thompson American Health Consultants. Root-cause analysis might be shallow-cause analysis. Healthc Risk Manage. 2006;28(4):37-39. 15. Thompson American Health Consultants. Six ways to improve your root cause analysis. Healthc Risk Manage. 2013;35(7):76. http://www.highbeam.com/doc/1G1-340759899.html. Accessed January 12, 2015. 16. McDonald A, Leyhane T. Drill down with root cause analysis. Nurs Manage. 2005;36(10):26-32. 17. The Joint Commission. Framework for Conducting a Root Cause Analysis and Action Plan. http://www.jointcommission.org/ Framework_for_Conducting_a_Root_Cause_Analysis_and_ Action_Plan. Published March 22, 2013. Accessed April 12, 2014. 18. Williams PM. Techniques for root cause analysis. Proc (Bayl Univ Med Cent). 2001;14(2):154-157.

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Root cause analysis in infusion nursing: applying quality improvement tools for adverse events.

The application of root cause analysis (RCA) to health care began in the Veteran's Administration system and spread to Joint Commission-accredited org...
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