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UNC Medical Center
Root Cause Analysis (RCA)
Program Guide
Patient Safety Subcommittee
Updated 7/2020
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Welcome to the UNC Medical Center (UNCMC) RCA Program!
You have been identified as a key individual to assist UNCMC in improving patient
safety, reducing risk and identifying improvement methods and measurements. The
following information is offered to assist you in learning common RCA terms and
understanding the process and your role. We appreciate your involvement and
encourage active participation.
Contents
1. RCA Process Steps Page 3
2. RCA Charter and Team Mandate Page 4
3. Roles and Responsibilities Page 5
4. RCA Timeline Plan – Facilitator Checklist Page 6
5. RCA Ground Rules Page 7
6. Just-in-Time Training Page 8
a. Interview Guide Page 8
b. Comparison of Tools Page 12
c. Five Rules of Causation Page 16
d. Contributing Factors Framework Page 18
e. Developing and Choosing Action Items Page 21
f. Action Hierarchy Page 23
g. Selecting Outcome Measures Page 24
The contents of this Program Guide are a combination of the following RCA programs: VA
National Center for Patient Safety, ASHRM, RCA², The Joint Commission and CMS.
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RCA Process Steps
Getting
Started
Analysis
Taking
Action
What happened?Why did it happen?What action can we take to prevent it from happening again?How will we know if the action we took made a difference?
PSO Notified of SSE
Charter drafted and RCA Team assigned
Clinical Team implements immediate
actions if needed
Just in Time Training -
RCA Program Guide
Initial RCA Team Meeting
-Initial Sequence of
Events
RCA Team begins
investigation
Information Collection (Timeline,
Chart review)
Fact Finding(Interviews, Policy and Literature review)
RCA Team Meeting – Synthesize information; identify root cause and
contributing factors
Develop Action Plan including Metrics and
Measures
Develop Communication Plan (What was learned
and who needs to know)
Final Sign-off and Action Plan
Facilitator Follows-up
Action Plan Status Report out to Patient
Safety Subcommittee
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RCA Team Charter and Mandate
The Root Cause Analysis (RCA) committee forms in response to the need to conduct a
review of an adverse event. The RCA committee function is to conduct this review as a
medical review/peer review activity pursuant to the Medical Staff and Hospital Staff
Peer Review Processes, and described in bullet 1 of Appendix A.
RCA committee members have responsibility for reviewing the event including relevant
parts of the medical record (limited to UNC School of Medicine and UNC Medical
Center team members), interviewing staff and when appropriate patient and family,
examining equipment, review of policies, procedures, other documented guidelines
and observation of the work environment and work flow.
The objectives of this RCA committee is to identify contributing factors and cause(s) of
the event and address them to ensure the event does not recur.
This RCA committee has formed on ________ to review the event reported in SAFE #
______.
The members of this committee are:
Member Role
Executive Sponsor
Facilitator
Process Owner
SME
Team Member (interviewer)
Team Member (Chart review,
policy/literature)
Patient Safety Officer (PSO)
Risk Liaison
Formed under the direction of:
__________________________________
Patient Safety Officer
__________________________________
Vice President, Risk Management
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Roles and Responsibilities
Role Responsibilities
PSO Notifies Executive Sponsor of event, assists in creating
charter, chooses appropriate Facilitator and collaborates
with Executive Sponsor to choose appropriate Process
Owner. Performs other functions as described in the RCA
Timeline and Plan. Works with Process Owner to ensure all
RCA process items are completed. Schedules report-outs for
Patient Safety Subcommittee (PSS).
Facilitator Schedules and facilitates the RCA meetings, assigns
responsibilities, sends Training Guide to Team Members,
schedules meetings, creates meeting agendas, and creates
final report. Works with the PSO, Executive Sponsor and
Process Owner to create RCA timeline and plan. Other duties
as assigned in the RCA Timeline and Plan
Executive Sponsor Provides leadership oversight with authority to approve and
disapprove action items. Collaborates with PSO and Process
Owner to choose Facilitator and RCA Team. Other duties as
assigned in RCA Timeline and Plan
SME Provides expert opinion and support – Clinical Expert
Process Owner Works with PSO and Executive Sponsor to choose Facilitator
and assign RCA Team. Ultimately responsible for the
implementing the action items and auditing. Reports out to
the Patient Safety Subcommittee. Assists with duties as
assigned in the RCA Timeline and Plan.
Team Member Conducts the investigation interviews. Assists with duties as
assigned (Timeline, literature review, policy review).
Risk Liaison Clinical Risk Manager who provides support and is an
additional resource as set forth in the RCA Timeline and Plan.
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RCA Timeline and Plan – Facilitator Checklist
Elements Responsible party
Initial Steps
Notification Received from PSO to begin RCA Exec Sponsor
Facilitator, Risk Liaison and Process Owner Identified Exec Sponsor and PSO
RCA Team and necessary coaches and SMEs identified PSO and Process Owner
(Risk Liaison Assist)
Charter created
PSO, Process Owner
(Facilitator/Risk Liaison
Assist)
RCA Team appointed and roles assigned (Chart reviewers,
Interviewers, SMEs) Exec Sponsor
RCA High Level Project Timeline developed Exec Sponsor, Process
Owner (Facilitator Assist)
Just in Time Training completed – For coaches (Self Review) Facilitator
UNCMC RCA Process Team Packet Sent Facilitator
Just in Time Training completed - Team (Self Review) RCA Team
Initial RCA Team Meeting Scheduled and Held Facilitator
Final RCA meeting scheduled within 45 days of event Facilitator
Information Collection
Chart review performed Chart Reviewers
Interviews conducted Interviewers
Create Timeline about the SAFE/Sentinel Event
Chart Reviewer, Interviewer
(if guidance needed –
facilitator can assist)
Policies and literature review SME (Risk Liaison assist)
RCA Meeting Agenda created Facilitator
RCA Meeting - (1 or 2 meetings depending upon complexity)
Goals, purpose, timeline and expectations for RCA outlined
Executive Sponsor,
Facilitator and Process
Owner
Contributing Factors are determined Team – Facilitator Leads
discussion
Causes determined utilizing one of the following methods:
Fishbone, 5 Whys, Change analysis, barrier analysis
Team – Facilitator Leads
discussion
Action Plans developed Team – Facilitator Leads
discussion
•Identify Action Item owner(s) Team – Facilitator Leads
discussion
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•Develop implementation timeline Team – Facilitator Leads
discussion
•Develop measure of success Team – Facilitator Leads
discussion
•Assign audit owner Team – Facilitator Leads
discussion
•Assign/evaluate action strength Team – Facilitator Leads
discussion
Identify other areas utilizing similar processes at similar risk PSO (input from team)
Communication plan developed and action items shared with
other areas with similar risk PSO
Post RCA Meeting Actions
Final report is completed and submitted to the PSO Facilitator
Track and trend for reoccurrences of similar events/close
calls/near misses Process Owner
For the other areas identified with same risk, were the actions
items implemented in those areas? PSO
Feedback provided to those involved as appropriate on the
action items Process Owner
RCA scheduled to present at PSS PSO
All actions implemented? Process Owner – PSS report
out to oversee
Reconvene RCA Team if measures unsuccessful
PSO and/or Executive
Sponsor to Decide Next
Steps (Start Process Over –
Reassess Team Members,
take to PSS, refer to another
process
Peer Review referral needed? If yes, Risk Task Chairs of MCPEC? Risk Liaison
RCA Ground Rules
□ All voices are equal – job titles are left at the door
□ All participants will be provided equal audience and respond by all participants
□ Different opinions are welcome
□ Respect each other’s ideas
□ Confidentiality is absolute
□ Attendance is imperative – if you cannot attend, find an informed replacement
□ All assignments will be completed on time
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Just-in-Time Training
Interview Guide
Overview:
The goal of the interview process is to discover information about what happened and
why that will lead to the identification of system issues and ultimately to effective and
sustainable corrective actions. A fundamental question of this process is not “where did
people go wrong?” but “why did their action make sense to them at the time?”
After reviewing the initial timeline of the event, identify and document all questions
team members have about the adverse event or close call. Additional “triggering”
questions are provided at the end of this document as examples of important
‘categories’ of information to consider obtaining either during the interview process or
review of documentation, regulatory requirements, guidelines, or publications - or a
combination of all of the above.
During the interview process, recall the following “5 Rules for Identifying Root
Causes/Contributing Factors”:
Root cause statements need to include the cause and effect
Negative descriptions about people are not to be used
Each human error has a proceeding cause
Violations of procedure or policy are not root causes, but must have a preceding
cause
Failure to act is only a root cause when there is a pre-existing duty to act
Interview Tips:
Ideally, have only one or two members of the team conduct the interviews.
Interview only one individual at a time, which will permit information to be
compared and weighed. Expect differences between descriptions given by
different staff when they describe what happened, and use additional
information gathered by the team to support the final conclusions.
The preferred method is to conduct interviews in person. In some cases, it may
be necessary to conduct an interview via telephone. This may be acceptable if
the individuals involved know and trust each other.
Explain the purpose of the interview. Stress that the RCA review team is seeking
to identify system issues and not to assign blame to any individuals. If the staff
member/employee was involved in the adverse event, be sensitive to this. Let
them know that the goal is to identify and implement systems-level sustainable
corrective actions, so a similar event does not happen again.
When possible, conduct the interview in the staff member’s/employee’s area or
in an area that may help them relax. Avoid the appearance of summoning them
to a deposition or administrative review. If practical, match your attire to that of
the interviewee, while maintaining a level of professionalism. The goal is to avoid
having them feel intimidated.
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Request permission to take notes and explain what the notes will be used for.
Start with broad, open-ended questions and then narrow them down; move
from general interrogatories, to specific clarifying questions, and then where
appropriate, to closed questions to clarify your understanding of what has been
shared.
Effective interview skills help make fact finding easier and the staff involved more
comfortable with the process. Start with broad, open-ended questions and then
narrow them down; move from general interrogatories, to specific clarifying
questions, and then where appropriate, to closed questions to clarify your
understanding of what has been shared.
Use active listening and reflect what is being said. Build confidence by restating
and summarizing what you have heard. Keep an open body posture, good eye
contact, and nod appropriately. Demonstrate empathy and be patient.
Thank the interviewee at the conclusion of the process, provide your contact
information in case they have additional information that they remember.
Trigger Questions by Category:
Communication
1. Was information from various patient assessments shared and used by members
of the treatment team on a timely basis?
2. Did existing documentation provide a clear picture of the work-up, the
treatment plan, and the patient’s response to treatment? (e.g., Assessments,
consultations, orders, progress notes, medication administration record, x-ray,
labs, etc)
3. Were policies and procedures communicated adequately?
4. Was the correct technical information adequately communicated to and
understood by the people who needed it?
5. Were there methods for monitoring the adequacy of staff communications?
(e.g., Read back, repeat back, confirmation messages, debriefs)
6. Were the patient and their family/significant others actively included in the
assessment and treatment planning?
7. Did the overall culture of the department/work area encourage or welcome
observations, suggestions, or “early warnings” from staff about risky situations and
risk reduction
Training
1. Was training provided on the work process in question?
a. Was the training adequate? If not, consider the following factors:
supervisory responsibility, procedure omission, flawed training, and flawed
rules/policy/procedure.
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Environment/Equipment
2. Were the levels of vibration, noise, or other environmental conditions
appropriate?
3. Was the work area/environment designed to support the function it was being
used for?
4. Had appropriate safety evaluations been conducted in that area/work
environment?
5. Was the equipment designed to properly accomplish its intended purpose?
a. Was the equipment designed such that usage mistakes would be unlikely
to occur?
b. Did the design of the equipment enable detection of problems and make
them obvious to the operator in a timely manner?
6. Did the equipment work smoothly in the context of: staff needs and experience;
existing procedures, requirements, and workload; and physical space and
location?
7. Was the medical equipment or device used in accordance with its design and
manufacturer’s instructions?
8. Were personnel involved in the adverse event/close call trained appropriately
to operate the equipment?
9. Did staff utilize any workarounds related to use of the equipment or technology?
10. Was there adequate equipment to perform the work processes?
11. Was there a maintenance program in place to maintain the equipment
involved?
Personnel
1. Was there sufficient staff on-hand for the workload at the time? (i.e., Workload
too high, too low, or wrong mix of staff.)
2. Did fatigue play a role?
Rules/Policies/Procedures
1. Was required care for the patient within the scope of the facility’s mission, staff
expertise and availability, technical and support service resources?
2. Had a previous investigation been done for a similar event?
3. Was the staff involved in the adverse event or close call properly qualified and
trained to perform their function/duties?
4. Were all staff involved oriented to the job, department, and facility policies
regarding: safety, security, hazardous material management, emergency
preparedness, life safety management, medical equipment, and utilities
management?
5. Did management have an audit or quality control system to inform them how
key processes related to the adverse event were functioning?
6. Were there written up-to-date policies and procedures that addressed the work
processes related to the adverse event or close call?
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a. Were relevant policies/procedures clear, understandable, and readily
available to all staff?
b. Were relevant policies/procedures and guidelines consistent with best
practices/standards/regulatory guidelines?
c. Were the relevant policies and procedures actually used on a day-to-day
basis?
i. If the policies and procedures were not used, what got in the way
of their usefulness to staff?
7. Is or could this process be standardized?
8. Is there or could there be clinical decision support?
Barriers
(Barriers protect people and property from adverse events and can be physical or
procedural. Negative/positive pressure rooms are an example of a physical barrier that
controls the spread of bacteria/ viruses. The “surgical time out” is an example of a
procedural barrier that protects patients from wrong site, wrong patient, wrong
procedure surgeries.)
1. What barriers and controls were involved in this adverse event or close call and
why did they fail?
2. Are there forcing functions in place so that the safest thing to do is the easiest
thing to do?
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Selection and Comparison of Analysis Tools
Tool Method + Δ
Fault tree analysis Ask how, then why Evidence based Complicated to
use at first
Barrier analysis Review detection
barriers – human
and system
Identifies causal
factors and actions
Doesn’t recognize
al barriers of failed
barriers
Change analysis Used on single
problems,
compares actual
process to ideal
Simple and quick,
supplement to the
ECF chart
More questions
than answers
Cause and effect Shows cause and
effect
Simple to use, team
collaboration
Assumption based
Event and causal
factor chart
A story line with
graphical display
Incorporates the
results of other
techniques and is
most flexible
Time consuming
and confusing for
novice
Fault Tree Analysis – A failure analysis in which an undesired state of a system is
analyzed using logic to combine a series of lower-level events. This analysis
method is mainly used in the field of safety engineering to quantitatively
determine the probability of a safety hazard.
Fractured hip
Up to Bathroom
unassistedUsed bedside
No order No fall assessment No monitoring
WHY?
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Barrier Analysis – Focuses on what administrative or physical control is designed
to prevent or inhibit, in terms of an undesirable event affecting a patient. There
are generally three modes of barrier failure:
1. Barrier fails to protect
2. Barrier not in place
3. Barrier was circumvented
Another purpose for this analysis is to establish what barriers should have been in
place to prevent a particular accident or what barriers could be installed to
increase safety.
Detection Barrier Example Worked
Yes/No
Comments
Surgical Scheduling policy No Surgery was scheduled without laterality being
specified
Surgical Consent Form No Laterality was not specified on the consent form
Pre-op checklist – no area
designated for indicating that
the surgical site was marked
No Discussions have addressed adding this to the
checklist, but has not been implemented
Surgical site marking policy No Policy not followed – site not marked prior to
making incision
Change Analysis – Compares the accident situation with a similar but accident-
free situation. The assumption is that change generally signals trouble. The
mishap situation is compared to a similar mishap-free situation to determine
differences. The tool/method is useful when the accident is obscure and a quick
answer is required, though it may produce more questions than answers and
trends and corresponding changes may be overlooked.
Factors that
influence
performance
Describe the
event
Describe the
ideal or event
free situation
Describe
policy and
procedure
What is the
difference?
What is the
effect of this
difference?
What
When
Where
Who
How
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Five Whys – The Five Whys strategy involves looking at any problem and drilling
down by asking: "Why?" or "What caused this problem?" While you want clear
and concise answers, you want to avoid answers that are too simple and
overlook important details. Typically, the answer to the first "why" should prompt
another "why" and the answer to the second "why" will prompt another and so
on; hence the name Five Whys. This technique can help you to quickly
determine the root cause of a problem. It's simple, and easy to learn and apply.
Problem Statement: One sentence description of event or problem
Why?
Why?
Why?
Why?
Why?
Root Cause(s) 1.
2.
3.
To validate root causes, ask the following: If you removed this root
cause, would this event or problem have been prevented?
Example: Problem statement – your car gets a flat tire on your way to work.
1. Why did you get a flat tire?
• You ran over nails in your garage
2. Why were there nails on the garage floor?
• The box of nails on the shelf was wet; the box fell apart and nails fell from
the box onto the floor.*
3. Why was the box of nails wet?
• There was a leak in the roof and it rained hard last night. (Root
cause=leak in the roof)
*If you stopped here and “solved” the problem by sweeping up the nails, you
would have missed the root cause of the problem.
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Cause and Effect – Used to identify the causes, factors or sources of variation
that led to the event. It is often used in concert with brainstorming and the five
whys. This diagram groups causes into categories with an arrow indicating how
they cascade toward the event. This approach is called fishbone.
Event and Causal Factor Chart – Similar to fishbone but is displayed a bit
differently and highlights the occurrence(s). It describes the event(s) as action
step(s) rather than as conclusions. It asks “why” at each step. All direct and
contributing factors are identified. Use the ECF chart throughout the
investigation as a visual trigger of events to solicit thinking and input.
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5 Rules of Causation
Rule 1 – Clearly show and describe the “cause and effect."
Incorrect: A resident was fatigued.
Correct: Residents are scheduled 80 hours per week, which led to increased
levels of fatigue, increasing the likelihood that dosing instructions would be
misread.
Cause and Effect Statement:
1. Cause (something)
2. Effect (leads to something)
3. Event (which increases the likelihood that something will occur)
Example: A high volume of activity and noise in the ED led to the resident being
distracted when entering medication orders which increased the likelihood that
the wrong dose would be ordered.
Rule 2 – Use specific and accurate descriptors for what occurred. Negative or
derogatory words should not be included in causal statements.
Incorrect: The manual is poorly written.
Correct: The pumps user manual had 8 point font and no illustrations; as a result
nursing staff rarely used it, increasing the likelihood that the pump would be
programmed incorrectly.
Rule 3 – Each human error or mistake must have a preceding cause.
Incorrect: The resident selected the wrong dose, which led to the patient being
overdosed.
Summary:
1. Show cause and effect
2. Use specific and accurate descriptors;
avoid vague and negative words
3. Human errors must have a preceding
cause
4. Violations of policy are not root causes
5. Failure to act is only casual when there
is a pre-existing duty to act
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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.
Rule 4 – Violations of policy/procedures are not root causes, they must have a
preceding cause.
Incorrect: The techs did not follow the procedure for CT scans, which led to the
patient receiving an air bolus from an empty syringe, resulting in a fatal air
embolism.
Correct: Noise and confusion in the prep area, coupled with production
pressures, increased the likelihood that steps in the CT scan protocol would be
missed, resulting in the injection of an air embolism from using an empty syringe.
Rule 5 – Failure to act is only causal when there was a pre-existing duty to act.
Task or role expectations must be clearly communicated and understood.
Incorrect: The nurse did not check for STAT orders every half hour, which led to a
delay in the start of anticoagulation therapy, increasing the likelihood of a blood
clot.
Correct: The absence of an assignment for designated RNs to check orders at
specified times increased the likelihood that STAT orders would be missed or
delayed, which led to a delay in therapy.
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Contributing Factors Framework Investigation Tool
Human Indicator Factors
□ Knowledge-based violation
□ Chose incorrect goal or strategy, lacks competence
□ Skill based violation
□ Slip, lapse, mistake in executing an action, action triggered by info in the
environment, haste, inattention
□ Rule based violation
□ Mistake- chose incorrect procedure or violated procedure, standard guideline,
failed to act on available information
□ Physical or mental health
□ Stress, fatigue, work relationships
□ Violations of procedure – Check all that apply
□ Did not know procedure
□ Not aware of or took short cut
□ Situation dictated deviation
□ Procedure not practiced or out of date
□ Education/experience
□ Training lacking or novice
□ Not seeking help when should have
□ Other ___________________________________________
Task/Procedural Factors
□ Clarity and design of structure lacking
□ Availability and use of protocols lacking
□ Availability and/or accuracy of tests, results (etc.) lacking
□ Decision making aids lacking or wrong
□ Lack of monitoring or assessment
□ Other _________________________________________________
Teamwork Related Factors
□ Supervision
□ Lacking, inadequate, did not seek out
□ Communication (gaps, omissions, misunderstandings, or a lack of a safe
environment to communicate)
□ Written
□ Verbal
□ Culture and teamwork
□ Lack of teamwork
□ Breakdown, management style, hierarchical structure
□ Team structure
□ Consistency, leadership, intimidation, disruptive behavior
□ Other _________________________________________________
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Technology/Equipment/Supplies Factors
□ Design lacking
□ Availability lacking
□ Maintenance issue
□ Failure/malfunction
□ Improper use
□ Outdated
□ Other _________________________________________________
Management Factors
□ Constraints
□ Organizational Structure
□ Policy, standards, goals
□ Safety culture and priorities
□ Planning
□ Other _________________________________________________
Work/Environmental Factors
□ Staffing
□ Levels, skill mix
□ Workload
□ Shift patterns, influx of patients
□ Time delays
□ Environment
□ Distractions, interruptions
□ Administrative/managerial support issues
□ Other _________________________________________________
Patient Factors
□ Condition
□ Complexity, severity of illness
□ Communication
□ Language barrier, interpretation
□ Psychosocial
□ Personality or social factors
□ Other _________________________________________________
Detection Barriers in Place
□ Physical barriers (bar coding, locked cabinets, etc.)
List: __________________________________________________
Effective? Yes/No
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□ Human action detection barriers (patient identity check, surgical site marking,
etc.)
List: __________________________________________________
Effective? Yes/No
□ Administrative detection barriers (procedures, checklists, alert notices, etc.)
List: __________________________________________________
Effective? Yes/No
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Developing and Choosing Action Items
Risk reduction actions can be weak, intermediate or strong impact actions. The
components of actions include the following:
Approval by the Executive Sponsor
Actions are specifically assigned, complete with timeline, to a specific individual
Formal approval by executive sponsor of any extension of action due dates
Complete actions are verified
Unit/Department Manager leads the implementation of the actions
Resources allocated or adjustments are made if actions are behind schedule
Roles and accountability need to be determined in relation to actions and
implementation as follows:
RCA Team determines who is responsible for implementation of actions (usually
the unit manager)
RCA Team Facilitator supports the units manager in ensuring the actions are
implemented as intended within the timeline established
RCA Team Facilitator will also take the lessons learned from the event and the
share the lessons learned throughout the organization as determined in the
communication plan.
Steps to Developing Actions
1) Map the actions to the root causes
a) Identify actions that focus on those root cause categories from the
questions that were answered or identified as potential issues for the system.
Note: There may be need for more than one action to address one root cause
category.
i. Rules (Policies and Procedures)
ii. Safeguards (Barriers and Controls)
iii. Environment
iv. Equipment
v. Information Technology
vi. Fatigue and Scheduling
vii. Training
viii. Communication
2) Brainstorm and identify ways to enhance, enforce, redesign or homogenize the
process for everyone
a) Is there something missing? Working improperly? Are there distractions in
the environment? Miscommunicated information? Is the process out of order or
easy to do incorrectly or misunderstand?
22 | P a g e
b) What is influencing staff to rely on personal or clinical judgment instead of
the policy? Are there things in place to manage unexpected or busy
circumstances?
c) What tools and resources will the user need to fulfill the action correctly?
3) Write the actions as SPECIFIC, CONCRETE and CLEAR as possible:
a) The actions may be shared throughout UNCMC –Other units/areas may
have the same issue and they will want to know HOW, specifically, the action will
be carried out.
b) The most well thought out action/intention is not helpful if it is not written
or communicated well and in detail. Things to include: who, what, where, when,
why, and how.
Example: A facility has an issue with contraband on the unit and they develop a
process to control for contraband.
i) Who will be doing it? Nursing staff.
ii) What will they be doing? Implement a room safety check.
iii) Where will it be done? In the patient’s room (bedding, bathroom,
closets, etc.).
iv) When will this occur? Beginning and end of every shift.
v) Why are they doing this? Prevent patient harm resulting from
contraband.
vi) How is it going to be accomplished? Staff will wear gloves and
manually search the bed and use a metal detector wand around the
perimeter of the room.
4) Identify and consult the person responsible (process owner) for completing the
action
a) Have them read and evaluate feasibility of the action. Ask them about
what has been tried in the past and whether it made things better or worse. Ask
them for their best suggestions/ideas for making care safer. Finally, ask them how
they would know if things got safer (this piece of information will help you design
outcome measures).
5) Pilot test or simulate prior to system-wide implementation
a) Can these tools/actions be accurately used in the “real world setting”:
i) Will people have time to do this?
ii) Will people have the information needed to do this?
iii) Will there be support for people to fulfill this action?
iv) Do people clearly understand what they need to do and how?
v) Will something help people remember and enforce this action?
vi) Is this of value to the patient, staff and organization?
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vii) Will the patient, staff or process be penalized by the action in any
way?
viii)Will people be provided with feedback about whether or not the
action was done correctly?
Action Hierarchy
Action Primary Analysis Categorization Glossary
Stronger
Actions
Architectural/physical plant changes
New devices with usability testing before purchasing
Engineering control, interlock, forcing functions
Simplify the process and remove unnecessary steps
Standardize on equipment or process or care maps
Tangible involvement and action by leadership in
support of patient safety
Intermediate
Actions
Redundancy/back-up systems
Increase in staffing/decrease in workload
Software enhancements/modifications
Eliminate/reduce distractions
Checklist/cognitive aid
Eliminate look- and sound-alikes
Enhanced documentation/communication
Weaker
Actions
Double checks
Warnings and labels
New procedure/memorandum/policy
Training
Additional study/analysis
Skilled, rule and knowledge-based actions
Skill Based Rule Based Knowledge Based
Limiting memory
requirements
Training by SMEs in specific
areas
Oversight by more
experienced individuals
Standardization of the
process
Accountability measures Creation of assignments
with understanding of
individuals’ previous
knowledge
Reducing distractions
during critical parts of a
process
Establishment of rule-
based procedures that are
also evidence based
Problem solving training
Reducing time constrains
when appropriate
Scripting of
communication
Familiarization with work
process
Structured communication
(SBAR)
Orientation training and
validation (testing) of
knowledge
Close supervision
Safety culture training
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Action Plan Template
Cause/Contributing
Factor
Action Action
Owner
Due
Date
Action
Strength
Outcome
Measure
Measure
Date
Executive
Sponsor
Concurs
Status
Selecting Outcome Measures
How will we know if the action we took made a difference? Measurement determines
the effectiveness of an action to prevent reoccurrence of the process that
necessitated the RCA. It is critical to risk reduction efforts.
Two measures per action will help prevent additional workarounds. Process measures
may be easier to observe than outcome measures but both should be considered.
The Monitoring Phase includes the following components:
Periodic reports of actions implemented are sent by the unit manager (owner of
the process) to the Executive Sponsor and/or Patient Safety Subcommittee.
Internal audits of actions are conducted
A sampling audit is conducted with ability to transition to 100% audit if significant
issues of non-compliance are identified
Measures are set up in a way that will allow determination of whether or not
actions are effective in preventing a repeat incident
o Quantitative and qualitative event trend rate is only one measure (any
repeat incidents)
Validation of measures is conducted by a staff person outside of the unit
Determination of effectiveness is formal and plan is adjusted if not effective
Common cause analysis of all events is conducted at least once a year
RCA is conducted on trends from common cause analysis above
Best practice: All actions should be less than six months and 90% of all actions need to
be completed before due date.
Basic Requirements
1. Numerator: What specific group/event/cause/outcome is being
measured/monitored/changed for improvement?
2. Denominator: Out of what population/total group is the numerator being
sampled?
3. Threshold: What is the realistic expected level of compliance (percent)/result of
the numerator?
4. Date/Timeframe: How long it will be measured?
Example:
N = number of collected specimens with proper labeling
D = Total number of specimens collected on the nursing unit
Threshold = 98% of the specimens will have the proper labeling
Date = the collection will be monitored for three months
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Types of Outcome Measures
Measurement Definition Example
Adverse Event Measure Demonstrate that the
action reduced or
prevented the adverse
event from happening
again. Measures the
improvement the action
will have on eliminating
the adverse event.
3 months following staff
training, the # of incidents
will be reduced by 50%.
The numerator will be the
# of incidents on the unit.
Root Cause Measure Preventing the root cause
from happening again.
Measures the impact of
the action will have on the
root cause.
Hourly rounds will show
that 90% of patients at
high risk for falls will not
ambulate independently
for the next six months.
Action/Process Measure Least preferred. These
measures just bookkeep
that an action was done,
not its effect.
95% of staff on the unit will
have completed the
training by June 13th.
Recommended