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Table of Contents

Chapter 1 INTRODUCTION

Chapter 2 WHAT IS ROOT CAUSE ANALYSIS (RCA)?

Chapter 3 WHY HEALTHCARE HAS MIXED RESULTS IN RCA?

Chapter 4 ADOPT SYSTEMS AND RISK-BASED APPROACHES

Chapter 5 TAKE ACTIONS AFTER THE ANALYSIS

Chapter 6 MEASURE RCA EFFECTIVENESS

Chapter 7 CONCLUSION

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 CHAPTER 01

Introduction

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Introduction
You have spent a lot of time and effort
conducting RCA on incidents. Pause
and ask: How many formal action plans
have you or your team initiated and
implemented? Are the control measures
taken effective in improving patient
safety? Why similar adverse events are
recurring after RCA has been
conducted?
If your own experience on RCA reviews
and the outcome are mixed, you are not
alone. Numerous studies have shown
that the RCA process has had
inconsistent success in healthcare.
There are challenges and limitations on
using RCA, and its potential has
remained under-utilized in healthcare.
The purpose of this e-book is to provide
guidance on conducting effective RCA.
This Guide starts with an introduction.
Chapter 2 briefly describes the concept
of RCA and key steps in the RCA
process. Chapter 3 discusses the
challenges of RCA and reasons for the
lack of effectiveness of RCA in
healthcare. Key takeaways are in
Chapter 4, 5 and 6, which outline three
key approaches and considerations to
improve the effectiveness of RCA.
This Guide is intended for Patient Safety,
Quality and Risk Managers. The goal is
to help you identify and implement
effective systems-based actions to
improve patient safety and bring
measurable results.
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 CHAPTER 02

What is Root Cause Analysis (RCA)?

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 What is Root Cause Analysis?

Root Cause Analysis is a structured and robust investigation process to identify the
original cause of failure or inefficiency that ultimately leads to a problem, such as a
clinical incident, occurring within the health system. It is one of the most widely used
analysis tools in healthcare to analyze patient safety issues. In some countries, RCA is
mandatory for clinical incidents which result in serious harm or death.

RCA attempts to answer three questions about an incident:

1. What happened?
2. Why did it happen?
3. How can we prevent it from happening again?

RCA review focuses on systems and processes, not on individual’s performance or to

assign blame. It uses various methods to examine and understand how systems,
processes and human factors may have contributed to an incident taking place.

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 What is Root Cause Analysis?
Step 1 - Identify incident and investigation level

○ Take a risk-based prioritization approach (more on Chapter 4)

○ Use risk matrix, such as Severity Assessment Code (SAC) Matrix
○ Prioritize resources

Step 2 - Select investigation team

○ Team size of 4-6

○ Team leader who is well-versed with RCA process
○ Team members should include subject matter expert on the event, senior
management (Medical Director, CNO), Quality/Risk Manager, staff with some
understanding of human factors

Step 3 - Investigate and gather information

○ Tabulate sequence of events

○ Visit the site, review physical evidence, conduct interviews
○ Gather feedback from responsible manager/supervisor

Step 4 - Identify contributing factors

○ Systematically categorize contributing factors.

○ Make it easier to prioritize, implement and follow up on actions
○ The London Protocol (7 categories) is widely used

Step 5- Determine root causes

○ Root cause is the fundamental reason for an incident to occur.

○ It may be one of the contributing factors which have been identified
○ Use established RCA methods such as Fishbone, Five Whys and Cause and Effect
Diagram

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Step 6 - Develop and implement action plans
○ This is the most important step in the RCA process
○ Design actions to prevent incident from recurring. If that is not possible,
reduce the probability and severity of harm to patient should it occur (more
on Chapter 5)
○ Identify at least one stronger or intermediate strength action

Step 7 - Measure the effectiveness of actions and RCA process

○ Assign each action to a responsible individual, not a committee, and set
deadlines
○ Each action must be measurable, either a process measure or outcome
measure
○ RCA programs to be reviewed annually by senior leadership for
effectiveness and sustainability (more on Chapter 6)

Step 8 - Feedback and leadership support

○ Essential to create a culture of safety, reporting and feedback from staff and
patients/families
○ Leadership support from all levels of organization is critical for RCA
processes to be successful

Adopted Source: Guidelines on Implementation - Incident Reporting and Learning Systems 2.0 for
Ministry of Health Malaysia Hospitals

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 CHAPTER 03

Why Healthcare Has Mixed Results in RCA?

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 Why Healthcare Has Mixed Results In RCA?
Challenges of RCA in Healthcare
Healthcare sector has adopted the RCA practice from high-risk industries such as
aviation during the patient safety movement in the late 1990s. While RCA is now
widely used in healthcare for the investigation of adverse events, there are
challenges in its application. Numerous studies show that RCA has had
inconsistent success in improving patient safety.

Wider Systems Approach, Skills Required

Several reasons are cited. Firstly, a key problem with RCA is its name, which implies
a singular and linear cause. Sentinel events and serious incidents often involve
multiple and interacting contributing factors. Therefore, a wider systems approach
in RCA is required to identify root causes and bring sustained improvement.
Secondly, multi-disciplinary skills such as proficiency in systems thinking, human
factors and safety science, and hands-on experiences in staff engagement and
data analytics are required in RCA reviews. Hospitals may lack such internal
resources and expertise.

Stronger Measures Needed

Thirdly, risk control strategies and corrective actions taken are often not strong
enough to bring about sustained improvement. Studies have shown that there is a
tendency for investigators to recommend administrative and perhaps “weaker”
action, rather than addressing latent causes such as poorly designed processes or
defective operating systems. This requires strong management commitment and
support.

Failure to Act and Learn

Next, the general lack of emphasis on follow-up actions and timely implementation
after RCAs are conducted. RCA does not end with analysis and will be a waste of
time and effort if no necessary actions are taken. Finally, failure to learn from
incidents and share control measures due to poorly functioning feedback loops and
communication channels.

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 Why Healthcare Has Mixed Results In RCA?

Reasons Cited by NPSF

National Patient Safety Foundation of the US cited the lack of standardized and explicit
processes and techniques are reasons why RCA in healthcare has had mixed results.
Specifically, NPSF recommended the following:

● Identify hazards and vulnerabilities that impact patient safety and then
prioritize them to determine if action is required
● Identify systems-based corrective actions
● Ensure the timely execution of an RCA and formulation of effective
sustainable improvements and corrective actions
● Ensure follow-through to implement recommendations
● Measure whether corrective actions were successful
● Ensure that leadership at all levels of the organization support and
participate in RCA reviews and corrective actions are implemented

Source: NPSF, RCA2 – Improving Root Cause Analyses to Prevent Harm, 2015

Three Key Approaches to Improve Effectiveness of RCA

The next three chapters elaborate on three key approach and considerations to
improve the effectiveness of RCA, namely:

● Adopt systems and risk-based approaches in prioritizing RCA and actions

● Take improvement actions after the analysis
● Develop outcome measures to determine the effectiveness of actions

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 CHAPTER 04

Adopt Systems And Risk-Based

Approaches

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 Adopt Systems and Risk-Based Approaches

Uncover System Weaknesses

A systems-based approach in RCA refers to assessing incidents from a systems
perspective to uncover the underlying root and contributing causes. This is
consistent with the purpose of conducting RCA - to identify, and eliminate or
mitigate, system weaknesses. RCA reviews should not focus on individual
performance or failure and lead to individual punitive actions. Healthcare
organizations can benefit the most when they adopt a systems approach and view
human errors as a symptom of broader issues within a poorly designed system or
process flaws. This is essential to cultivate trust and just culture, where staff do
not hesitate to report incidents to improve safety.

Risk-based SAC Matrix

RCA review is a robust investigation process that requires tremendous effort and
time. As such, it may not be practical to conduct RCA for all incidents given the
limited resources. How do you determine and prioritize which incident warrants
RCA?

Organizations should adopt a risk-based approach to RCA. One of the methods

used to evaluate incidents and determine the need for RCA is Severity Assessment
Code (SAC) Matrix. SAC Matrix helps you to rate incidents based on the severity or
consequences of the incident and the likelihood of its recurrence. A commonly
used matrix is a 5 x 5 matrix, which is then translated into SAC rating of 1 to 3 or 1
to 4. Priorities can be assigned based on SAC rating. By having a clearly defined
matrix, this approach enables your organization to credibly and objectively
determine incidents that should be prioritized.

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 Adopt Systems and Risk-Based Approaches

Near Misses and Aggregated RCA

Near misses should also be prioritized using the risk matrix by evaluating the
potential severity or consequence of the event, and the likelihood or probability of the
event occurring. Some may believe that since there was no patient harm, near misses
do not need to be reported or investigated. This view is unmerited as near misses are
leading indicators of system vulnerabilities and safety issues. They provide
organizations the opportunity to identify and correct system vulnerabilities before
incidents occur.

Aggregated review is a process of analyzing similar events to look for

common causes.

For example, close call events (near misses) in high frequency event
categories that would typically require root cause analysis (e.g., falls,
medication adverse events) are collected as it occurs and reviewed as
a group on a quarterly or semi-annual basis. The review team looks for
trends or recurring issues in the data to identify system issues needing
correction.

Source: NPSF, RCA2 – Improving Root Cause Analyses to Prevent Harm, 2015

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 CHAPTER 05

Take Actions After The Analysis

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 Take Actions After The Analysis
A critical step in the RCA process is the identification and implementation of actions to
address system vulnerabilities that have been identified. Investigation team should
design actions to prevent incidents from recurring. If that is not possible, reduce the
probability and severity of harm to the patient should it occur. According to the NPSF,
the lack of emphasis on actions is one of the main reasons for RCAs not yielding the
desired results.

The Concept of RCA2

To improve the effectiveness of RCA, NPSF introduced the concept of RCA2 (RCA and
Action or RCA squared) in 2015. RCA2 methodology emphasizes on actions after the
analysis is done, as the ultimate objective of RCA is to prevent future harm by
implementing corrective and preventive actions.

Action Hierarchy
Action Hierarchy is a tool that will assist investigation teams in identifying stronger
actions that provide effective and sustained system improvement. It is recommended
that investigation teams should identify at least one stronger or intermediate strength
action for each RCA.

The Action Hierarchy, developed by the US Department of Veterans Affairs

National Center for Patient Safety in 2001, was modeled on the National
Institute for Occupational Safety and Health Administration’s Hierarchy of
Controls. It has been used for decades in many other industries to improve
worker safety.

Source: NPSF, RCA2 – Improving Root Cause Analyses to Prevent Harm, 2015

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 Take Actions After The Analysis

To be sure, all levels of actions are important. Weaker actions may be important to
support stronger actions. Weaker actions can also be used as temporary measures until
stronger actions can be implemented. Intermediate actions, such as replacing aging
equipment, can be effective at reducing hazards but can be costly to implement.
Examples of stronger actions are major renovation of a nursing unit to move the nursing
station to a more central location for better visibility and accessibility by nurses, staff, and
patients/families.

Source: Modified from VHA National Center for Patient Safety (NCPS), Guide to Performing a Root Cause Analysis,
published on Feb 5,2021 and presentation slides.

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 CHAPTER 06

Measure RCA Effectiveness

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 Measure RCA Effectiveness
Organizations should ensure that there are follow up actions for every RCA, and the
actions and outcomes should be monitored and tracked for completion and
effectiveness.

After the action plan has been developed, it is necessary to develop outcome
measures to determine the effectiveness of an action. Outcome measures involve
two aspects - measuring specific steps in a process and high-level outcome. Each
action identified by the review team requires at least one measure. For the overall
RCA process, it is better to have both process measure and outcome measure.
Process measures confirm the action has been implemented, while outcome
measures determine if the action is effective.

Examples for measuring RCA effectiveness are:

● % of RCA review with actions being implemented

● % of RCA review with at least one stronger or intermediate strength action
● % of actions classified as stronger or intermediate strength
● Process measures such as % of nurses will do intentional rounding 4 weeks
after receiving training
● Outcome measures such as surgical mortality rates will decrease by x% by the
end of the quarter compared with the previous quarter
● Staff and patient satisfaction with the RCA review process (through surveys)

To ensure that actions are implemented, assign an individual, not a committee, to be

responsible for each action, and set a deadline for the action to be completed. It is
recommended that the RCA program be reviewed annually by senior leadership and
the board for effectiveness and continued improvement.

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 CHAPTER 07

Conclusion

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 Conclusion
RCA is a proven and widely used incident investigation technique. But it must not be
an exercise that does little more than showing investigation on an incident has been
done. To realize the full benefits of RCA, adopting systems and risk-based
approaches, and taking improvement actions need to be key features of the RCA
process. It is also necessary to develop outcome measures to determine the
effectiveness of actions. The ultimate objective of RCA is to prevent future harm by
taking corrective and preventive actions. Digitalizing incident management
processes, including investigation, RCA and actions, can further help to improve the
efficiency and effectiveness of RCA in healthcare.

References:
1. National Patient Safety Federation, RCA2 – Improving Root Cause Analyses to Prevent Harm,
2015
2. US Department of Veteran Affairs, VHA National Center for Patient Safety (NCPS), Guide to
Performing a Root Cause Analysis, published on Feb 5, 2021 and presentation slides.
3. The Problem with Root Cause Analysis, Dr Mohammad Farhad Peerally, SAPPHIRE,
Department of Health Sciences, University of Leicester, Centre for Medicine
4. Ministry of Health Malaysia, Guidelines on Implementation – Incident Reporting & Learning
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