Loyola University Chicago School of Law, JD 2017
Over the past decade, risk management and compliance professionals have moved away from asking “what happened” and “who did it” to asking “why” the error occurred in hopes of developing effective safeguards to prevent reoccurrence of those errors. As a result of this “why” approach, many risk and compliance professionals have turned to Root Cause Analyses (RCA) to investigate failures that caused, or could cause, unfavorable outcomes.
The problem is often easy to identify. Sales are down. A data breach occurred. A patient was harmed due to medication error. Perhaps the government conducted an audit and identified an issue with billing procedures. But identifying the underlying cause(s), and differentiating those cause(s) from contributing factors may not always be so straightforward as spotting the issue. Human and systematic errors affect performance and cause mistakes, errors and failures, which may result in significant risks and compliance issues for any industry.
Ultimately RCA is a collective term that describes a wide range of approaches, tools, and techniques used to uncover the root causes of problems, that is, the factors that cause nonconformance and should be permanently eliminated through process improvement. The Centers for Medicare and Medicaid Services (CMS) defines RCA as “a structured facilitated team process to identify root causes of an event that resulted in an undesired outcome and develop corrective actions” in their Guidance for Performing Root Cause Analysis (RCA) with Performance Improvement Projects (PIPs). The Joint Commission defines RCA as “a process for identifying the basic or causal factor(s) underlying variation in performance, including the occurrence or possible occurrence of a sentinel event” in the Root Cause Analysis in Health Care: Tools and Techniques (sample available here). But no matter how you define RCA, analyzing an error to determine the underlying cause is the first step in correcting for potential non-compliance.
There are many case studies available, particularly in healthcare, regarding RCA and patient safety improvement. For example, an internal study at Nationwide Children’s Hospital in Columbus, OH found that in 2004, only 64 percent of patients with acute appendicitis received the correct antibiotic at the right time. Concerned, the hospital took a systems approach to root cause analysis, launching “Operation Takeoff,” which involved 1) standardizing patient verification and timeout process to include surgeon presence before prep/drape, 2) revising policies, 3) redesigning the surgical site verification checklist, 4) using timeout placards in instrument sets, 5) redesigning operating room marker boards and 6) a large scale marketing and education campaign. The project eventually expanded to address all forms of errors associated with surgical procedures. Importantly, in the first year of Operation Takeoff, 98.2 percent of acute appendicitis patients received antibiotics correctly, a 1.8 percent error rate, and there were no surgical errors and only two near misses.
But RCA can also assist in the improvement of business functions. For example, individuals at St. Mary’s/Duluth Clinic Health System (SMDC) in Duluth, Minnesota, noticed that dollars in accounts receivable (A/R) had increased, particularly in the discharged, not final billed portion of active A/R over 12 months old. Using brainstorming techniques, the 5 Whys Methodology and a PICK chart, SMDC identified insufficient weekend staffing, missing records on the floor, inadequate cross-training, and unnecessary charting steps as significant causes of delays. By reducing delays in documentation, coding, and billing, SMDC found that gross A/R could be reduced by two gross days revenue outstanding. Ultimately, lead time was improved 44 percent from 8 days to 4.6 days resulting in a reduction in gross days revenue outstanding by 2.75 days and improving cash on hand by over $5 million. The financial benefit on interest income annually totaled $152,831.
There are many methodologies, approaches, and techniques for conducting RCA and some people believe the process is so complicated that several methods should be used for each. Some common methods include:
- Events and Causal Factor Analysis is widely used for major, single-event problems, like a refinery explosion. The process begins by identifying a sequence of events and aligning the events with the conditions that caused them. This process uses evidence gathered quickly and methodically to establish a timeline for the activities leading up to the accident and once the timeline has been established, the causal and contributing factors can be identified by “walking” the chart and asking if the problem would be different if the events or conditions were changed.
- Change Analysis is applicable in situations where a system’s performance has shifted significantly. This analysis focuses on changes made in people, equipment, information, and more that may have contributed to the change in performance. The analysis begins by describing the event or problem, then describing the same situation without the problem, comparing the two situations, documenting all the differences, analyzing the differences, and finally identifying the consequences of the differences. Change analysis is nearly always used in conjunction with another RCA method to provide a specific cause, not necessarily a root cause.
- Barrier Analysis focuses on what controls are in place in the process to either prevent or detect a problem, and determine whether the barriers held, failed, or were compromised in some way by tracing the path to the threat from the harmful action to the target. A simple example is a knife in a sheath where the knife is the threat, the sheath is the barrier, and the target is a human. If the sheath fails and a human is injured, the barrier analysis would attempt to determine why the barrier failed. The cause of this failure is then identified as the root cause. While the Barrier Analysis can provide an excellent tool for determining where to start your root cause analysis, it is not a method for finding effective solutions because it does not identify why a barrier failed or was missing.
- Tree Diagrams are very common and recognized as one of the more effective formed of RCA. The Ishikawa Fishbone Diagram, Management Oversight and Risk Tree (MORT) Analysis, and Human Performance Evaluation Systems (HPES) are three common Tree Diagram approaches. These analyses use predefined lists of causal factors, for example Ishikawa uses manpower, methods, machinery and environment as the top-level categories each with subcategories, to arrange factors like a fault tree.
- Why-Why Chart or the “Five Whys Method” is one of the most simplistic brainstorming methods whereby the question “why” is posed repeatedly until the investigator can no longer answer the question. This method produces a linear set of causal relationships and uses the experience of the problem owner to determine the root cause and corresponding solutions.
- Pareto Analysis is a statistical approach to problem solving that uses a database of problems to identify the number of predefined causal factors that have occurred in the business or system. It is based on the Pareto principle, also known as the 80-20 rule, which presumes that 80% of your problems are caused by 20% of the causes. Pareto analysis is best used as a tool for determining where you should start your analysis, not truly determining root causes.
- Failure Modes and Effect Analysis is primarily used in the design of engineered systems rather than root cause analysis because it identifies a component, subjectively lists all the possible failures (modes) that could happen, and then makes an assessment of the consequences (effect) of each failure.
No matter what the failure and no matter what type of RCA is used, it is vital to identify the source of the failure. As the teams at Nationwide Children’s Hospital, St. Mary’s/Duluth Clinic Health System and so many more have discovered, correcting the root cause for any given error often results in significant improvements for many other functions.
For training videos, tutorials, diagrams, roles/responsibilities lists, guides, checklists/templates and information in implementing RCA in your compliance program, see the Minnesota Department of Health, CMS’s How to Use the Fishbone Tool for Root Cause Analysis, the American Society for Quality and more.