Welcome!

Virtual Root Cause Analysis Workshop:

Managing Patient Safety Events

July 2025 1
© 2025 Joint Commission International. All Rights Reserved.
Objectives
At the end of this workshop, you will be able to:
• Describe 7 organizational requirements to effectively
manage patient safety events
• Interpret relevant Joint Commission International
standards
• Apply the 4-phase approach to root cause analysis
• Illustrate the use of 5 essential tools

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References GLD Governance Role

 Root Cause Analysis in Health Care, 7th Ed

Joint Commission Resources, 2020

JCI Accreditation Standards

 JCI Framework for Root Cause Analysis

and Corrective Actions

3
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Publications and Record Restrictions
- Copyright © 2025 by Joint Commission
International, Inc. All rights reserved. No part of
this publication may be reproduced in any form or by
any means without written permission from the
publisher. Request for permission to make copies
of any part of this work should be addressed to
[email protected]. However, the use of
these materials for commercial purposes is
restricted to JCI and may not be used by any other
party or entity.
- These slides should not be distributed to
individuals outside registered program attendees.
© 2025 Joint Commission International. All Rights Reserved.
Current State

© 2025 Joint Commission International. All Rights Reserved.

Current State
 1/10 patients may be harmed while in the
hospital
 Up to 10/100 patients hospitalized will acquire a
healthcare-associated infection
 50% of harm could be avoided
 Average one patient harm incident every 35
second in the United Kingdom
 15% of hospital costs attributed to safety failures

World Health Organization

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The Goal: High Reliability
Zero Harm

© 2025 Joint Commission International. All Rights Reserved.

High Reliability
A High Reliability Organization (HRO) is
involved in a complex and high-risk
environment, that delivers exceptionally
safe and consistently high-quality
service/care over time.

1. Preoccupation with failure

2. Reluctance to Simplify
3. Sensitivity to Operations
4. Commitment to Resilience
5. Deference to Expertise
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WHO Global
Patient Safety
Action Plan. 2021

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How do we manage safety events?

Source: The Joint Commission,

(US-based reported SE, CY2023)
© 2025 Joint Commission International. All Rights Reserved.
Organizational Requirements

Leadership

Systems
Data-Driven Thinking/
Improvement Human
Factors

Safety
Second
Victim
Program Safety
Culture

Patient/
Reporting
Family
System
Engagement

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 GLD Leadership for Quality
Leadership

Leaders – including the governing entity- are

responsible for the quality and safety program.

1 Participate in developing, implementing quality and

safety program
2 Select improvement process; provide staff education
3 Ensure management and resources
4 Implement structure and process for coordination of
quality program
5 Define the Sentinel Event (SE) Policy
6 Conducts RCA on SE
7 Provide support systems to staff involved in SE

© 2025 Joint Commission International. All Rights Reserved.

Leadership GLD Leadership for Quality

Governing
Body

Quality
Committee of
BOD

CEO

Chief Quality Chief Financial Chief Nurse Chief Medical

Officer Officer Officer Officer

Patient Safety
Committee

Accreditation

Risk Management

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Leadership
Three Core Areas Operations
• Set vision
Strategy • Establish performance expectations, accountability
• Promote a safe culture
• Focus on systems

• Define patient safety events

• Define the structure
Operations • Assure resources are available (financial, staff)
• Maintain regulatory and accreditation requirements

• Transparent communication
• Share results of analyses
• Model safety behaviors
Engagement • Active participation in projects and committees
• Listen
• Recognize and reward
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 Glossary

Definitions Patient Safety (PS)

Sentinel Events (SE)

Patient Safety
Event

Hazardous or Close call, Adverse event

“unsafe” “near miss,” or No-harm event Sentinel
condition “good catch” Event
Did not reach the patient Reached the patient

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Definitions
Term Also known as Example
Unsafe condition
Hazardous
(not related to a Out-of-date medication is found on the shelf
Condition
specific patient)
The wrong medication is dispensed from the
Good Catch
Near Miss pharmacy, but the nurse identifies the incorrect
Close call
medication before administering to the patient
No Harm Nurse gives patient the wrong medication but there
No harm incident
event is no physiologic response

Nurse gives patient the wrong medication, causing

Adverse
Harm incident the patient’s blood pressure to drop, requiring
Event
additional monitoring. Patient recovers.
Nurse give patient the wrong medication, causing
Sentinel
Never Event the patient to have a cardiac arrest and the patient
Event (SE)
dies

Adapted from www.ahrq.gov 16

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Organizational Requirements

Leadership

Systems
Data-Driven Thinking/
Improvement Human
Factors

Safety
Second
Victim
Program Safety
Culture

Patient/
Reporting
Family
System
Engagement

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Systems Thinking

From RCA in Health Care, 7th Ed. JCR, 2020 18

© 2025 Joint Commission International. All Rights Reserved.
Systems Thinking

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Human Factors
Cognitive Physical and Organizational
Environmental
Factors Factors Factors

Physical:
Perception Fatigue; Posture; Culture
Motion

Environment:
Attention Light; Noise; Teamwork
Climate

Decision
Management
Making

Training
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Human Factors
Cognitive Types of Human Error

Error


Planning
Execution
Failure
Failure
(Mistake)

Rule-based Knowledge-
Slip Lapse
(2 causes) based

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Organizational Requirements

Leadership

Data-Driven
Improvement
Systems
Thinking/
Human

Factors

Safety
Second
Victim
Program Safety
Culture

Patient/
Reporting
Family
System
Engagement

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© 2025 Joint Commission International. All Rights Reserved.
What is Organizational Culture?

Values,
Belief,
Norms Behaviors OUTCOMES
(actions)
Ways of
Thinking

•  Patient Outcomes
•  Staff Outcomes

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Traditional health care culture

 Autonomy of physicians
 Leadership prioritizes productivity over safety
 Analyses focus on “blame-and-shame” of individuals
– Failure to evaluate system or process causes
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Safety Culture GLD Leadership creates safety culture

Uses data for learning, willing to

Learning Culture implement major
reforms/adjustments

Trusting, with clear defined lines

Just Culture between acceptable and
unacceptable behavior

Safety Nimble, responsive, innovative

Flexible Culture approach to continuous
Culture improvement

Active, robust reporting of events

Reporting Culture and near misses

Recognition of system
Informed Culture
(systems thinking)
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Adapted from James
© 2025 Joint Reason
Commission International. All Rights Reserved.
Safety Culture
Psychological Safety
– an individual’s “sense of being able to show and
employ oneself without fear of negative consequences
to self-image, status or career” and
– at the group level as “a shared belief that the team is
safe for interpersonal risk taking.”

From: Agency for Healthcare Research and Quality at psnet.AHRQ.gov

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Safety Culture
 Organizations must evaluate and
monitor their safety culture
 Validated Survey tools and
assessments:
– Oro 2.0 High Reliability
Assessment
– Safety Attitudes Questionnaire
(SAQ)
– AHRQ Survey on Patient Safety
Culture (SOPS)
– Physician Practice Patient Safety
Assessment (PPPSA)

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 QPS Data gathering, encourage reporting
GLD Define events
Event Reporting Systems PS, SE

Purpose: to identify and analyze patient safety events, in

order to prevent them from occurring
Process: effective Incident Report Systems include:
– Collect uniform data
– Centralize data analysis
– Increase awareness of patient safety
– Identify opportunities for improvement
– Provide Feedback to staff involved
– Improve efficiency
– May include public reporting

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Event Reporting Systems
Types of Reporting systems
 Voluntary, self-report
– Incident reporting systems
– Example: Patient falls, error reports
 Trigger tools
– Selected triggers identify potential events
– Example: Sedation reversal agents
– Requires chart review
 Indicators
– Administrative data analysis

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Just Culture
Recognize that:
 There is risk everywhere
 Humans make mistakes
 Errors are usually due to system failures
 We will drift from what we have been taught
 Everyone is accountable for their actions

Adapted from James Reason 30

© 2025 Joint Commission International. All Rights Reserved.
 Just Culture

Human Error At-Risk Behavior Reckless Behavior

A Choice: Risk not Conscious
Inadvertent action:
recognized or disregard of
Slip, lapse, mistake
believed justified unreasonable risk

Manage through
Manage through:
changes in:
- Remove incentives for
- Processes
at-risk behavior
Manage through
- Procedures
- Training
- Create incentives for - Disciplinary
healthy behaviors action
- Design
- Increase situation
- Environment
awareness
- Choices

Adapted from David Marx 31

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Just Culture

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From Meadows. The Incident Decision Tree.

 Code of Conduct GLD Ethics

Define Professional Conduct

Expectations including:
 Acceptable Behaviors
 Disruptive or Inappropriate Behavior

Types of Disruptive behavior

 Overt actions
 Passive activities

Intimidating and disruptive behaviors

can foster:
 Medical errors
 Poor patient satisfaction
 Preventable adverse outcomes
 Increase costs of care
 Staff resignations
© 2025 Joint Commission International. All Rights Reserved.
Patient/Family Engagement

Structure Process Outcomes

Shared Decision-
Advisory Making Patient
Councils experience data
Structured
Patient on Communication Staff
Quality/Safety Performance
Committee Complaints evaluations
management
EMR patient Patient reported
portal Patient outcomes
sensors/monitors

© 2025 Joint Commission International. All Rights Reserved.

 PCC Patients engaged in care

Patient/Family Engagement:
Disclosure
 Patients have right to know:
– unanticipated outcome or
event
– who is responsible for
informing them
– Clinical errors
 Unanticipated outcomes:
– Hospital-acquired infections
– Pressure ulcers
– Postoperative infections
 Clinical Errors:
– Wrong medication
– Wrong-site surgery
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Patient/Family Engagement:
Disclosure Conversation

 Prepare team
 Set the stage
 Listen and empathize
 Explain the facts
 Apologize
 Close the discussion with next steps

Adapted from Disclosure Checklist, AHRQ

Tool 1-3. Disclosure Checklist. Page 41, RCA in Health Care. JCR 36
© 2025 Joint Commission International. All Rights Reserved.
 GLD Staff support
Second Victim

“This is the worst day of my

life.”
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Data-Driven Improvement GLD Data-based decisions

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Summary
 Prepare your
organization for an
effective incident
analysis program
 Leadership plays an
essential role
 Follow the “Safety
Culture Actions
Checklist” to assure all
elements are
implemented
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The Analysis Process

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What Is a Root Cause Analysis?
Comprehensive systematic analysis to identify the causes
that lead to variation from our performance expectation
A process that (at a minimum) seeks to answer:
1. What happened?
2. Why did it happen?
3. How can it be prevented?
4. How will we know if our actions worked?

 Focus on systems and processes

– Less focus on WHO did it

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 Analysis Strategies
Analysis Required Examples
Wrong site surgery: operation
Comprehensive Systematic Analysis incorrectly performed on left side)
SE
“Intense Analysis”
4 Blood transfusion reactions
(Common Cause Analysis/ Undesirable in past 3 months
Aggregate Review) Trend
Concise Incident Analysis/
Apparent Cause Analysis Near-Miss Events Order for Insulin
1000 units stopped
No Harm Event by Pharmacy

Proactive
Risk Analysis
(FMEA)
Hazardous Condition Infusing
chemotherapy

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 Analysis Frameworks
Type of Event Description Time Frame

• Multidisciplinary team
• Identify contributing
Comprehensive − Sentinel Events
factors 45-60 days
Systematic Analysis − Complex
• Recommend
improvements
• Multidisciplinary team
Common Cause • Identify COMMON
− Similar events
Analysis or contributing factors Long timeline
− Trends
Aggregate Review • Recommend
improvements
Apparent Cause
Analysis or • 1 trained staff
− No or low harm Hours to days
Concise Incident • Focus on key factors
Analysis
− Hazardous • Multidisciplinary team
Proactive Risk conditions • Identify potential
Long timeline
Analysis − High risk areas failures
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or procedures • Recommend controls
© 2025 Joint Commission International. All Rights Reserved.
Tools for Analysis

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 Prioritization Matrix
Safety Assessment Code (SAC) Matrix
Severity
Catastrophic Major Moderate Minor
Probability

Frequent 3 3 2 1

Occasional 3 2 1 1

Uncommon 3 2 1 1

Rare 3 2 1 1
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Immediate Response to an Event

Patient Staff Organization

Appropriate
Communication Preserve
care
evidence
Psychological
Contain risk
support
Event
Disclosure Documentation investigation

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RCA Phases

Phase 4
Phase 1 Phase 2 Phase 3
Organize Implement,
Team; Define Determine Identify Root Monitor
Problem Causes Causes Corrective
Actions

47
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RCA Team
 Regularly scheduled RCA Team meetings
 Membership limited to less than 10
– Leader
– RCA/human factors specialist
– Front line staff (subject matter experts)
– Physician (Residents, Trainees)
– Person with decision-making authority
– Quality Improvement
– Patient Representative
** Not the patient involved in the event

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RCA Team
 Strategies to encourage open discussion
– Follow standardized process for meeting
– Emphasize “learning” rather than “assigning
fault/blame”
– Share an example of a personal mistake
– Thank team members for speaking up
– Provide examples of previous lessons learned
from events
– Communicate clearly and frequently

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Document Security and Confidentiality

All documents generated

as the result of a sentinel
or other serious reportable
events, including but not
limited to initial report and
findings and root cause
analysis, should be
maintained in a
confidential manner that is
consistent with local laws.

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© 2025 Joint Commission International. All Rights Reserved.
Define the Problem
 Define the problem
– Simple statement

 Gather information including:

– Witness or Observation statements
– Physical evidence
– Documentation
– Medical records
– Maintenance logs
– Policies and procedures

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Interviews
 Who
– Staff involved in event
– Patients, family members
 What to discuss
– Sequence of events
– Ask about special causes in the clinical process and common
causes in the organization process
– Inquiry into all areas appropriate to the specific type of event
(nothing “off limits”)
 How
– Focus on facts, not opinions
– Focus on process and system, not individual blame

52
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RCA Cycle

Phase 4
Phase 1 Phase 2 Phase 3
Organize Implement,
Team; Define Determine Identify Root Monitor
Problem Causes Causes Corrective
Actions

53
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Determine WHAT Happened

Order
Communicate Review Prep Transport Verify Administer
med

 Process Factors to consider

– Risk points in a process step or linkage
– Flawed process
– Failure to follow process

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Determine WHAT Happened
What Should
What Analysis of
Date/Time have Differences
Happened Impact
Happened

Timeline
of event Gaps
Work-as-
Planned
Work-as-
Done

Adapted from: Change Analysis Worksheet (JCR); 55

Comparative Timeline © 2025 Joint Commission International. All Rights Reserved.
Measures
 Process Measures  Outcome Measures
– Reflects the process – Reflects the results of
that is under analysis the process
– Types: Clinical, – Types: Clinical,
Administrative Functional, perceived

 Percentage A X 100
A+B
 Rates # persons with an event
Persons exposed to the event in a time period
 Count (discrete or continuous number)
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© 2025 Joint Commission International. All Rights Reserved.
RCA Cycle

Phase 4
Phase 1 Phase 2 Phase 3
Organize Implement,
Team; Define Determine Identify Root Monitor
Problem Causes Causes Corrective
Actions

57
© 2025 Joint Commission International. All Rights Reserved.
Understand WHY It Happened
Types of Causes
 Direct (proximate) Cause
– Closest to the event
– Most apparent cause
– Tip of the iceberg
 Contributing Cause
– Contribute to, but did not cause, the event
– Existing conditions
 Root (latent or underlying) cause
– System factor
– Underwater part of the iceberg
– Usually, there are more than 1 root cause
– “Human error” is NOT a root cause!
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Understand WHY It Happened

Higham H., Vincent C. (2021) Human Error and Patient Safety.

In: Donaldson L. (eds) Textbook of Patient Safety and Clinical 59
© 2025 Joint Commission International. All Rights Reserved.
Risk Management.
Root Cause Categories
 Communication factors
 Environmental factors
 Equipment/device/IT factors
 Process/Task factors
 Staff Performance factors
 Team factors
 Management/supervisory/workforce factors
 Organizational culture/leadership

Adapted from Department of Defense, Patient Safety Program.

PSR Contributing Factors List – Cognitive Aid, Version 2.0. May 2013;
Joint Commission Framework for RCA, 2017 60
© 2025 Joint Commission International. All Rights Reserved.
Communication Factors
 Communication breakdowns between and among
teams, staff, and providers
 Communication during handoff, transition of care
 Language or literacy
 Availability of information
 Misinterpretation of information
 Presentation of information

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Sentinel Events: Leading Causes

62
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Environmental Factors

 Noise, lighting, flooring condition, etc.

 Space availability, design, locations, storage
 Maintenance, housekeeping
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Equipment/Devices
 Equipment, device, or product
supplies problems or availability
 Health information technology
issues such as display/interface
issues (including display of
information), system
interoperability
 Availability of information
 Malfunction, incorrect selection,
misconnection
 Labeling instructions, missing
 Alarms silenced, disabled,
overridden

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© 2025 Joint Commission International. All Rights Reserved.
Task/Process
 Lack of process
redundancies,
interruptions, or lack
of decision support
 Lack of error
recovery
 Workflow inefficient
or complex

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Staff Performance Factors

 Fatigue, inattention,
distraction, or workload
 Staff knowledge deficit
or competency
 Criminal or intentionally
unsafe act

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Team

 Speaking up,
disruptive behavior,
lack of shared mental
model
 Lack of
empowerment
 Failure to engage
patient

67
© 2025 Joint Commission International. All Rights Reserved.
Management/Supervision
 Disruptive or intimidating
behaviors
 Staff training
 Appropriate
rules/policies/procedures
or lack thereof
 Failure to provide
appropriate staffing or
correct a known problem
 Failure to provide
necessary information

68
© 2025 Joint Commission International. All Rights Reserved.
Organizational Culture
 Organizational-level
failure to correct a
known problem and/or
provide resource
support including
staffing
 Workplace
climate/institutional
culture
 Leadership
commitment to patient
safety

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Cause-and-Effect Diagram

(Problem Statement)

70
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Cause-and-Effect Diagram - Process

Med Order Pharmacy Review Prepare Med

Process Step 1 Process Step 2 Process Step 3

Problem
Statement

Process Step 4 Process Step 5

Transport Verify

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© 2025 Joint Commission International. All Rights Reserved.
 5 Whys

Problem Why?  WHY: physicians say

Statement: they forget to use the
Physicians are not hand soap dispenser
washing their  WHY: The soap
hands Why? dispenser dries out
their hands
 WHY: the current
Why?
hand gel has no
moisturizers

72
© 2025 Joint Commission International. All Rights Reserved.
Note on human error

Rule 3. Human errors must have a preceding cause.

INCORRECT: The resident selected the wrong dose, which

led to the patient being overdosed.

CORRECT: Drugs in the Computerized Physician Order Entry

(CPOE) system are presented to the user without sufficient
space between the different doses on the screen, increasing
the likelihood that the wrong dose could be selected, which
led to the patient being overdosed

Five Rules of Causation. VA.2001

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Confirming a Root Cause
Confirm as a Root Cause if the answer is NO to all 3
questions:
1. Would the problem have occurred if this cause had
not been present?
2. Will the problem recur due to the same causal factor if
this cause is corrected or eliminated?
3. Will similar conditions recur if this cause is corrected
or eliminated?

74
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 RCA Cycle

Phase 4
Phase 1 Phase 2 Phase 3
Organize Implement,
Team; Define Determine Identify Root Monitor
Problem Causes Causes Corrective
Actions

75
© 2025 Joint Commission International. All Rights Reserved.
 QPS
Select Improvement Actions
Identify improvement interventions that
address the root cause.

Solutions may include:

 Human factors engineering
 Health information technology
 Standardized processes
 Red rules
 Checklists
 Patient-Centered Care

76
© 2025 Joint Commission International. All Rights Reserved.
 Select Solutions

Category Example
Less Reliance on Humans

Physical plant changes Fire doors

Stronger Actions Forcing function (engineering control) IV Tubing connectors

Standardize Equipment IV medication pumps

Redundancy 2 Nurses for Med dose calculation

Intermediate Actions
Software programs Alerts for drug-drug interaction
More Reliance on Humans

Warnings Alarms on IV pumps

Training Staff Education on new procedure

Weaker Actions
1 nurse calculate med dose; 2nd
Double checks
nurse reviews it

Rescue Resuscitation equipment available

Source: Modified from VA National Center for Patient Safety 77

© 2025 Joint Commission International. All Rights Reserved.
Human Factors Engineering
Human factors engineering is about designing the
workplace and the equipment in it to accommodate for
limitations of human performance.

Psychomotor I Input Devices

N
- Hands - Buttons
T
E
Senses R Output
F
- Vision A - Display
- Hearing C - Sound
E
78
US Department of Veteran Affairs
© 2025 Joint Commission International. All Rights Reserved.
 79
© 2025 Joint Commission International. All Rights Reserved.
Risk Reduction Strategies for Human
Performance
 Reduce reliance on memory
– Checklists
– Standardization
 Reduce reliance on vigilance
– Forcing Functions
– Bar coding
– Color coding
 Simplify tasks and procedures
 Reduce handoffs
 Reduce the requirement for calculations
 Manage fatigue
80
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Proactive Risk Assessment

81
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Implement Actions
 Use SMART Objectives
 Specific: the targeted area; simple
 Measurable: quantifiable; can be measured
 Achievable (attainable); knowledge, skills, ability to
meet the goal are available
 Realistic (Relevant): worthwhile; aligned with the
goals
 Time-bound: timeframe is defined and practical

82
© 2025 Joint Commission International. All Rights Reserved.
Implement Actions
 Develop an Action Plan What Who When Measure

 Pilot test the change Actions/ Responsible

Tasks Staff
Due
Date
 Measure and analyze
1
 Develop control and
sustainability plan 2

 Disseminate successful 3
improvements

D
P
D

S
P S
D S A

S P A
D A
P

A
A

P
S P
A P D

S D

83
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Change Management

Technical Human
Solution Element

84
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Monitor with Data

85
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Monitor with Data

From: Walters. Ambulatory Antimicrobial Stewardship and UTI. JC Jour 86

QPS.2019 © 2025 Joint Commission International. All Rights Reserved.
 GLD Communicate QPS data
Communicate
 Internal and External Stakeholders
 Hospital leadership reports to the
governing entity:
– At least quarterly
– Number and type of sentinel events
– Whether the patients and families were
informed of the event
– Actions taken to improve safety, both
proactively and in response to actual
occurrences
– Follow-up of actions taken, when necessary

87
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Joint Commission
Office of Quality and Patient Safety (OQPS)
All accredited health care organizations are encouraged to
voluntarily self-report potential sentinel events

Contacting JCI after a sentinel event allows the health

care organization to use the OQPS patient safety staff’s
expertise and experience.

JCI can help analyze root causes, redesign processes, and

monitor performance improvement practices and other
aspects of the sentinel event process.

© 2025 Joint Commission International. All Rights Reserved.

Joint Commission
Office of Quality and Patient Safety (OQPS)

OQPS will evaluate the comprehensive systematic analysis based on

the following criteria:

Thorough
• The analysis results in identifying root causes, focused on
improving and redesigning processes and systems

Credible
• The process of the analysis is clear, systematic, accurate, complete,
and data-based

Acceptable
• Action plan outlines a comprehensive plan (i.e., what, who, when,
how) for implementing changes

© 2025 Joint Commission International. All Rights Reserved.

 GLD External Report
Communicate with JCI SE

FRAMEWORK FOR ROOT CAUSE ANALYSIS AND

CORRECTIVE ACTIONS

90
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Sentinel Event Policy SE Chapter

• Define sentinel events

• Must include all JCI-designated sentinel events
• Notification of organization leaders
• Final RCA plan is approved by the CEO or other
high-level leadership.
• Quarterly reports of SE to Governance
• Complete a comprehensive systematic analysis
• Prepared within 30 business days
• Corrective action plan
• Implemented within 45 business days
• Systemic improvement with Measures of Success
• Monitored for 4 months
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Challenges
 Lack of leadership support and safety culture
 Premature jump to the cause before conducting the
analysis
 Failure to define the problem in detail
 Failure to go beyond the proximate cause
– HUMAN ERROR IS NOT A ROOT CAUSE
 Limited analysis identifies only one cause
 Weak actions selected for improvement
– TRAINING IS NOT A SOLUTION
 Failure to follow through on actions
 Failure to monitor using data
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Conclusions
 Prepare your
organization
 Follow a
standardized
approach to incident
analyses
 Focus on systems

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Questions?

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Thank you!

© 2025 Joint Commission International. All Rights Reserved.