The Root Cause Analysis Toolkit is for healthcare facilities seeking additional resources to strengthen their existing adverse event review process. The toolkit acknowledges the inherent risks associated with healthcare delivery and helps facilities identify system-level root causes and solutions with the intention of preventing future harm.

Section 1: Overview of Adverse Event Basics

Preventing adverse events requires a strong patient safety culture, the ability to identify system-level contributing factors and action plans, and a willingness to review close calls in addition to more serious adverse events. This section elaborates on these concepts and provides additional resources to help get started.

• What are adverse events? Adverse events are events resulting in unintended harm or creating the potential for harm that is related to any aspect of a patient’s care, rather than to the underlying disease or condition of the patient.

• What is the systems approach? The systems approach encourages you to focus on identifying systems or factors that contribute to human errors with the intention of changing the underlying system of care in order to reduce the likelihood of the error from recurring. It takes the focus away from individual blame and shame.

• What is a culture of safety? A culture of safety fosters open communication and mutual respect among staff and leadership with an emphasis on learning from past mistakes to enhance patient safety.

• What is a root cause analysis? A structured team approach to identify the underlying cause(s) involving practices, processes and procedures in order to decrease the likelihood of future errors. It helps to identify what happened, why it happened and what changes need to be made.

Resources

Patient Safety Network, Agency for Healthcare Research and Quality
An extensive collection of resources, articles, and information related to patient safety. Also offers a free newsletter with recent publications, articles trade journal articles, news, and events.

Patient Safety Primers, Agency for Healthcare Research and Quality
A collection of commonly used patient safety definitions.

Surveys on Patient Safety Culture, Agency for Healthcare Research and Quality
Patient safety culture assessment tools developed to help identify strengths and areas for improvement as well as raise awareness about patient safety in your organization.

Institute for Healthcare Improvement Open School, Institute for Healthcare Improvement
Online educational programs that teach the foundation of patient safety improvement (some programs require subscription).

Section 2: Reviewing Adverse Events

Conducting a review of an adverse event is an important step to reduce the likelihood of the event from happening again. This section highlights specific tools and resources that will help your team create event timelines, identify contributing factors, and define the system-level root cause of the event.

• What should I investigate? Any unanticipated, usually preventable event that results in patient harm or has the potential to cause harm should be investigated. Specific event type lists for each reporting entity are available on the Commission’s website. Recent resources include risk matrices to help to prioritize which events should be scheduled for an root cause analysis.

• How to select your review team. Choose review team members with personal knowledge of the processes and systems involved in the event as well as those who will need to be engaged in the action plan.

• How to gather data. Collect and organize the facts surrounding the event to understand what happened. Interview those involved including the patient/resident or family members and staff. Include pictures or drawings of the scene or inspections of the environment as well as any relevant policies and procedures, devices, supplies or equipment involved.

• How to create an event timeline. Map out an event by starting with the event and then reflect backwards as to what occurred prior to the event to help you review potential contributing factors and root causes.

• How to identify contributing factors and root cause(s). Identify system level contributing factors such as communication, device/supply, human, environmental, organizational, policy/procedure and patient/resident management. Then, use the “5 Whys” to drill down and explore the cause and effect relationship.

Resources

Guidance for Performing RCA with Performance Improvement Projects, Centers for Medicare and Medicaid Services
A step-by-step process for conducting successful RCAs.

RCA2: Improving Root Cause Analyses and Actions to Prevent Harm, Institute for Healthcare Improvement
Guidelines to help healthcare organizations improve the way they investigate medical errors, adverse events, and near misses.

How to Use the Fishbone Tool for RCA, Centers for Medicare and Medicaid Services
A resource for identifying contributing factors through the use of the Ishikawa (Fishbone, Cause-Effect) diagram.

Root Cause Analysis, Veterans Affairs National Center for Patient Safety
Information about RCAs as well as tools and resources to help support investigations.

Human Factors Matrix, Oregon Patient Safety Commission
A matrix of human factors principles that, when applied during a root cause analysis, can help your team identify strong strategies to improve patient safety.

Section 3: Developing Action Plans

Once your team has identified the cause(s) of an adverse event, you should develop system-level action plans prevent future harm from occurring. This section elaborates on the development of strong action plans.

• What is an action plan? An action plan is a strategy based on contributing factors and root cause(s) you have identified in your adverse event review to reduce the likelihood of the event from recurring.

• What is a strong action plan? Plans that change processes and practices, not the individual, are considered strong action plans. While education and training is a necessary component of many action plans, it does not address system issues

• How to create strong action plans. Both the spread of the action plan and its strength are important. “Spread” addresses how wide an impact the action plan will have. “Strength” refers to the likelihood that the action plan will result in decreased risk of future events.

Resources

TeamSTEPPS, Agency for Healthcare Research and Quality
A teamwork system for healthcare professionals to improve patient safety implemented in diverse healthcare settings.

Section 4: Action Plan Implementation

Teams can implement action plans through small tests of change using the Model for Improvement. This section elaborates on the concept of Plan-Do-Study-Act (PDSA) and how PDSA cycles can support rapid improvement at your facility.

• What is of the Model for Improvement? The Model for Improvement is a process improvement framework that starts with three fundamental questions (what am I trying to accomplish, how will I measure progress, and what will I change) and a series of small tests to determine if the change will result in improvement.

• How to identify meaningful aims, measures, and potential changes. Organizations looking to make change need to identify clear, specific, and time-sensitive goals (aims), measures that will help track progress as the organization tests changes, and changes that are likely to lead to improvement. 

• How to conduct plan-do-study-act (PDSA) cycles. PDSA cycles should start small and build on knowledge gained during each test. Groups plan the activity, carry it out, study the results and decide appropriate actions. Once the tests yield positive results, the team can work on implementation.

Resources

How to Improve, Institute for Healthcare Improvement
An introduction to the Model for Improvement including how to form teams, set aims, establish measures, and select and test changes.

Plan-Do-Study-Act Worksheet, Institute for Healthcare Improvement
A tool to help document PDSA tests.

System-Focused Event Investigation and Analysis Guide, AHRQ Communication and Optimal Resolution (CANDOR) Toolkit
The "Solutions Meeting" section of this guide (and Appendix F) offer a walk-through on how to run an action planning meeting. It includes brainstorming, evaluating solutions for effectiveness and sustainability, measurement, and a description of the expected outputs.