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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?

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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.