Best Practices for Conducting an RCA: Are There Any?
Best Practices for Conducting an RCA: Are There Any?
By Shea Polancich, PhD, RN; Linda Roussel, DSN, RN; and Patricia Patrician, PhD, RN
Patient safety has been a priority in the healthcare industry for 15 years. Despite the call to action provided by the Institute of Medicine (IOM) in 1999 (Kohn, Corrigan & Donaldson, 2000), studies 5 and 10 years later revealed that while improvements in safety have been made, there is still considerable work and attention needed in this domain (Wachter, 2004; Wachter, 2010).
During these years of studying safety in the healthcare environment, methods for examining adverse events from industries such as engineering and aviation have been borrowed and applied. Incident analysis has become a standard for risk mitigation and proactive patient safety, and several tools have been developed to examine or critically analyze a patient safety failure or adverse event.
Purpose of the Review
The Root Cause Analysis (RCA) is one such tool that has been used in a variety of settings to understand flaws in systems or processes. The RCA has been used by quality and safety professionals since the 1997 mandate by The Joint Commission (TJC) as a means of understanding causation of events and a basis for making system or process changes that mitigate risks (Percarpio, 2008). It is important that the information obtained from the RCA process is reliable and valid. However, it has been noted that the definition of what constitutes an adverse event, variation in the components of RCA reports, and inconsistency in RCA action plan follow up exists despite the call to a more standardized approach to the process (Wu, Lipshutz, & Pronovost, 2008).
After more than a decade of only minor to modest improvement in healthcare quality (Wachter, 2010), the question, “Why there is less than desirable progress?” is a subject for examination. One could argue that with a greater focus on medical error there is more awareness and perhaps, better reporting. However, from an improvement perspective, one could counter argue that after an event was recognized and causes were identified there was a failure to “fix” the underlying problem. An alternative hypothesis is that the analysis of the event did not produce the appropriate or most correct factors contributing to causation. This last proposition could depend on the tool or technique used to examine the event, and to produce the causative factors.
The purpose of this review is to examine the current literature specific to the technical performance or conduct of the RCA, and to identify any knowledge gaps or variations that may limit the utility of the findings from an event review to make improvements. Opportunities for improving the RCA process will also be explored.
Methods for Incident Analysis or Event Review
There are several methods that may be used in analyzing events. These methods may include, but are not limited to the following analyses:
- Inferential
- Failure Modes and Effects Analysis (FMEA)
- Fault Tree
- Ishikawa (Fishbone)
- Pareto
- Barrier
- Root Cause
Some of these methods have specific uses. For example, mathematical models such as inferential techniques have been used to assign probability to factors that may result in a negative outcome or event. The FMEA is typically a proactive process to identify failure points prior to an event, and to use those failure points to proactively mitigate risk. And, Ishikawa diagrams have been used as a tool for visually depicting factors considered to be causal components of an event.
However, no matter the technique or method used to examine an event or failure, the objective remains the same. The purpose of incident analysis or RCA is to gain a comprehensive understanding of an event, typically in sequence of steps, to examine any gaps or failures that occurred during the steps, to ask “why” the failure or failures occurred, and then to critically explore and recommend action items to prevent the identified cause(s) from reoccurring. One of the most common methods or tools used to examine a patient safety event within the healthcare environment is the Root Cause Analysis (RCA).
History of Root Cause Analysis
The RCA is a method of problem identification that ultimately helps in problem solving. The RCA process is a systematic method of examining events in order to determine root causes or factors that precipitated the event. The process is retrospective or reactive in nature, meaning it is performed after an event has occurred. The process focuses not only on the apparent factors associated with an incident, but also seeks to explore any hidden or latent factors for causation with the ultimate goal of developing strategies to mitigate the risk for future occurrence.
The earliest uses of the RCA were in examining industrial accidents and in engineering. The method was advanced by Sakichi Toyoda, the founder of Toyota Industries. Toyoda used the “5 Whys” to understand factors associated with failures (Toyota, 2005). The 5 Whys is simply to repeat “why” at least five times until the root cause of an incident or failure is discovered.
From the work of Toyoda, the RCA process grew, and other industries adopted and evolved this problem solving method. Occupational health and safety used the process to examine events through accident analysis. Manufacturing developed the process of quality management and used the RCA for production failures. In addition, manufacturing and business used the RCA for process-based failures. The RCA process has continued to evolve into various forms as a result.
In the 1980s and 1990s, as industries began to adopt Six Sigma, the RCA process was incorporated into the examination of defects or failures in production (Pande, Neuman, Cavanagh, 2000). Since the goal of attaining Six Sigma level performance is to decrease defects to a level of 3.4 per million, understanding how defects are translated to failures is important to the healthcare industry. One key milestone in the healthcare industry occurred in 1999 when the Institute of Medicine began to publish information on the excessive number of deaths that resulted from inappropriate medical care or clinical errors (IOM, 1999). Subsequently, the use of the RCA became a preferred method of examining failures for the healthcare system.
Review of Literature
The majority of evidence in the literature regarding the performance of the RCA process comes from descriptive studies and systematic reviews on certain aspects or components of the RCA. Using the most recent five years of literature available, very limited evidence specific to the technical performance of the RCA was found. Therefore, this literature review focuses on specific common themes that were noted from the small subset of articles on the technical performance or conduct of an RCA.
Data Sources and Literature Searches
The primary strategy used to search the literature was to identify published studies associated with the use of RCA process. The MeSH heading of “root cause analysis” was used to examine the literature.
The first database search was completed using PubMed for information from Medline. The search in PubMed began with the use of the terms “Root Cause Analysis” with an additional set of qualifying terms connected through the Boolean AND “Patient Safety.” The reason for the additional qualifier was to limit the search to use for patient safety events and not for the global use of root cause analysis.
The second search was completed using the Cumulative Index of Nursing and Allied Health Literature (CINAHL) database to examine the nursing literature. CINAHL contains article citations with abstracts, when available, from nursing and allied health disciplines. Again, the search strategy was the same as for Medline through PubMed.
Using the MeSH heading of “Root Cause Analysis” AND “Patient Safety” the initial PubMed and CINAHL searches combined identified over 300 articles. However, the search was further refined using the search function limitation to include only the most recent five years and human subjects. The result of this search yielded 76 articles from PubMed and 54 articles from CINAHL meeting these criteria.
The second step was to identify from each of these search strategies articles relevant to the technical performance of the RCA. Once these articles were identified, the third step was to read and comprehensively examine the relevant papers, looking for commonalities and consistent themes among them.
Data Synthesis and Analysis
The authors manually reviewed the 130 articles identified by the search. The majority of the articles were related to the use of the RCA tool for incident analysis in a specific patient population or for a specific type of clinical event, such as for patient falls or transfusion errors. The remaining articles reviewed were specific to global discussion of incident analysis or the resulting outcomes. Out of this latter group, eight articles were identified that specifically addressed some component of the technical performance of the RCA. However, after manual review, two articles were excluded falling outside the 5-year publication time window, and one was excluded as unrelated. See Table 1 for the results of the review process for these six articles.
Setting and Country of Origin
All of the studies were conducted in the healthcare environment or related to the healthcare environment. Of the six studies, three originated in the United States, two in the United Kingdom, and one in the Netherlands.
Results
There were very few articles that were specific to the topic of the technical performance of the RCA process, and there was very little consistency among them. In fact, only two of the articles specifically discussed the steps for conducting the RCA process, and this was done from a broad perspective, but did not provide the specific details for each step in the process. The themes from these articles focused on a specific aspect of the process, such as the implementation of an action plan, the outcomes or resulting improvement, and/or the training competencies of the facilitator.
The only consistent theme in this literature was the lack of improvement resulting from the RCA process, a finding found in the literature from both the United States and the United Kingdom. This theme was further expanded to concepts such as organizational factors impacting improvement, the lack of evaluation from the improvement intervention, and a perceived limitation of the current RCA process to produce results. Essentially, the RCA process seemed to be a “given” method to investigate untoward events, however, the results of the action or improvement interventions may not always achieve the desired results.
The work by Card, et al. (2012), Hettinger, et al. (2013), and Pham, et al. (2010) examined the most common risk control strategies implemented as a result of the RCA process. In these studies, risk mitigation strategies relied significantly on administrative controls such as changes or development of policies, procedures, and training as opposed to design controls or engineering controls, such as human factors engineering or process redesign. According to these authors, the ability to achieve sustained improvement is impacted by the type and strength of the “control” prescribed for the solution or intervention to the causes identified. In addition, the organizational attention or willingness to accept and support the “control” selected will impact the success of the solution. Pham, et al. (2010) have even proposed a new method to address the lack of improvement achieved using the traditional RCA process. They recommended prioritization of RCA findings using a Likert rating scale, limiting the need to address all problems at once.
Also of significance, this review has highlighted the lack of evidence-based articles published in the last five years on the “best practice” methodology for conducting the RCA or the technical performance. This finding is possibly related to the view of the conduct of the RCA as a toolbox approach as opposed to a prescribed method (Nicolini, Waring, & Mengis, 2011). From the review, it appears that variation in the tools used to conduct an RCA is the current state globally. In the United States, The Joint Commission provides a toolkit for the performance of the RCA process and action plan development (http://www.jointcommission.org/Framework_for_Conducting_a_Root_Cause_Analysis_and_Action_Plan/). However, this approach is not consistently applied across all hospitals, nor is it prescribed by TJC for their accredited facilities. In countries with national healthcare, such as the United Kingdom (UK), the training and education for RCA facilitation also exists at the national level. The UK National Health Service has trained more than 8000 individuals through the National Patient Safety Agency (Nicolini, Waring, & Mengis, 2011). This approach is also not a prescribed method, but promotes a variety of tools, including barrier analysis, brainstorming, brain writing, change analysis, 5 Whys, narrative chronology, nominal group technique, tabular timeline, time person grid, and simple timeline.
In all of the articles examined, the authors identified some degree of variation in the traditional use of the RCA process. Whether the variation existed in the education and competency assessment of the personnel who performed the RCA, the actual technical performance of the process, the tools used, the findings, the outcomes, the evaluation, or the follow up, there was some aspect of the RCA process that was inconsistent across the articles reviewed (Bowie, Skinner, de Wet, 2013; Smits et al, 2009). These variations exist at a local level, a system level, or a national level and could explain the lack of expected outcomes of the RCA process.
Table 1. Articles that Address Technical Performance of Root Cause Analysis
Author(s) |
Date of Publication |
Location of Study |
Objective of Study |
Methods |
Discussion/Findings |
|
Smits, |
2009 |
Netherlands; 30 hospital units |
Determination of inter-rater reliability in constructing causal trees and classifying root causes |
Cross sectional, 2 rater comparison, descriptive study |
|
|
Nicolini, |
2011 |
United 2 large |
Review the process of incident investigation, reporting, and translation of |
Ethnographic study |
|
|
Bowie, |
2013 |
United Single territorial health board, Scotland |
Follow up and evaluation of |
Cross-sectional, online survey of health professionals, Descriptive study |
|
|
Author(s) |
Date of Publication |
Location of Study |
Objective of Study |
Methods |
|
|
Pham, Kim, Natterman, Cover, |
2010 |
United States |
Propose adapting a risk prioritization and reduction process modeled after the Commercial Aviation Safety Team (CAST). |
|
|
|
Card, Ward, Clarkson |
2012 |
United States
|
To determine what tools were being used to generate risk controls after completion of an RCA |
Systematic review |
|
|
Zachary, |
2013 |
United States; Multi-healthcare institution database review
|
To introduce evidenced based model for assisting hospital based RCA teams in developing sustainable solutions |
Qualitative analysis |
|
Conclusions
The results of the literature review and synthesis provided insight into the finding that the RCA process is not a prescribed method and that the approach will vary. In addition the improvement that results from the RCA process may be limited by a variety of factors. These factors range from aspects of organizational culture to the strength of the improvement intervention.
Whether the improvement is related to the process itself or specific aspects associated with the process is not clear. However, it is clear that there is a lack of current information on the process and methods for conducting an RCA and that the results of the current processes that are being utilized are not producing the desired effects in outcomes.
Given the findings supported in the literature of variation specific to the analysis of events or clinical incidents, the lack of evidence to guide standardization around the technical aspects of performing event analysis, and limited evidence to support improved RCA processes, there is sufficient impetus for examining the RCA process in more detail, as well as improving the results obtained from the process in order to achieve more systemic and sustainable improvements.
Shea Polancich is currently an assistant professor at the University of Alabama at Birmingham School of Nursing with a joint appointment in quality and patient safety at the University of Alabama at Birmingham Medical Center. 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 the NQF Patient Safety Reporting Framework Steering Committee and may be contacted at polancs@uab.edu.
Linda Roussel is a professor at University of Alabama at Birmingham, School of Nursing. She is the DNP program director and works in the clinical nurse leader and nursing health systems administration graduate programs. Roussel has worked with the Robert Wood Johnson Initiative Transforming Care at the Bedside and Frontline Engagement through the Improvement Science Research Network Quality and safety are cornerstone to her practice and educating graduate students.
Pat Patrician is the Donna Brown Banton Endowed Professor at the University of Alabama at Birmingham (UAB). Previously, she served 26 years in the US Army Nurse Corps, where she held clinical, administrative, educational, and research positions. At UAB, she teaches in the nursing and health systems administration program and supervises PhD and Doctorate of Nursing Practice students. In addition, she is a senior nurse faculty/scholar in the Veteran’s Administration Quality Scholars (VAQS) fellowship program that focuses on the science of quality improvement, and a national consultant in the quality and safety education for nurses program. She is also scientist at the Center for Outcomes and Effectiveness Research and Education and Scholar at the Lister Hill Center for Health Policy at UAB.
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