1. science
2. medicine
3. oncology

Learning Objectives
§  To learn how to determine the “true” root cause of
a nonconforming event.
§  To learn how to identify corrective actions needed
and ensure improvements are sustained.
§  To develop immediate strategies to address
common pitfalls within the participant’s
organization.
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What is Root Cause Analysis?
Root cause analysis (RCA) is a collective term used
to describe a wide range of methods and tools used
to uncover the underlying or “root” causes of
problems. Root causes are eliminated by identifying
factors that contribute to the problem and finding
solutions.
RCA focuses primarily on systems and processes,
not individual performance.
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Common Causes of Errors
Question:
Are these
root causes?
Individual
Responsibilities
Unclear
Equipment
Not Properly
Maintained
No Written
Procedures
Common
Causes of
Error
QC, EQA
Not
Performed
Written
Procedures
Not Followed
Training
Not Done
or
Not Completed
Test Kits
Not Stored
Properly
Transcription
Errors
Checks
Not Done
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“Swiss Cheese” Model of Error
Failed or
Absent Defenses
Accident or
Error
Reference: CLSI Guideline GP32-A, pgs. 3-5.
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Determining the “True” Root Cause
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When to Perform an RCA
§  RCA is performed for any significant NCE.
§  A detailed RCA should be done on high-risk or
high-cost NCEs.
§  Each RCA needs to result in an action plan.
Common tools used in RCA include:
Process
Map
Cause-andEffect (C-E)
Diagram
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Five Whys
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RCA Primary Stages
1.  Problem Understanding
2.  Problem Cause Brainstorming
3.  Problem Cause Data Collection
4.  Problem Cause Data Analysis
5.  Root Cause Identification
6.  Root Cause Elimination
7.  Solution Implementation
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The Case Study Example
§  71-year-old female (DMW) had lump on neck surgically
removed by an oncologist.
§  Oncologist informed patient the lump was cancerous and
recommended radiation treatment.
§  Patient received 15 radiation treatments, 5 per week for 3
weeks, then was informed there was an error, she did not
have cancer.
§  Patient’s treatment side effects:
§ 
Right arm paralysis – took 1 year to regain feeling.
§ 
Loss of salivary glands – dry mouth for rest of life.
§ 
Loss of hair under arms – patient happy with this one!
How can this happen?
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What Happened?
Root Cause Analysis of Patient DMW
Oncology
Pathology
Radiology
Tissue collected by Oncologist
First step in
an RCA
investigation
is to
understand
the sequence
of events.
Tissue processed, slide prepared for Pathologist review
Oncologist requests Histotech pull patient slide for review
Oncologist reviews slide, discovers cancerous tissue
Histotech pulls slide, gives to Oncologist
Pathologist review, final diagnosis benign
Oncologist diagnosis cancer, dictates findings for discharge notes
Radiologist, reviews discharge summary determines course of treatment
Oncologist discusses patient treatment with Radiologist
ABC Hospital -­‐ Confidential and Privileged Information
Tool:
Process Map
Frozen section results indicated tissue benign
Tissue sent to Pathology
3 weeks of radiation treatment given to patient
Radiologist prepares for Tumor Board, reviews Pathology report, discovers error, contacts Ongologist
Oncologist and Radiologist inform patient of medical error, radiation cancelled
Report available in EMR
RCA Conducted
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What Could Have Caused This?
Management
Process
Histotech misread
slide case #
Slide labeling
Lack of Radiologist
Back-up
Case Review
delayed due to
training program
People
Case number
difficult to read
Radiologist
used discharge Dx
Lack of 2
critical patient
identifiers
Oncologist and
Radiologist did not
read Path report
prior to treatment
Specimen
mix-up
High patient census
Hand labeled slide
Stainer smudges writing
Stainer adds artifact to slide
Electronic pathology report
Hard copy sent to
primary physician
Materials & Equipment
Excessive Histology
workload
DMW received
15 radiation
treatments in error,
tissue was benign
Excessive Radiologist
case load
Tumor Board
case schedule
not defined
Environment
Second step is to brainstorm possible causes
then identify the primary “pain points.”
Tool: Cause-and-Effect (C-E) Diagram
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Sources of Error
Root Cause Analysis of Patient DMW
Oncology
Pathology
Radiology
Tissue collected by Oncologist
Tissue sent to Pathology
Frozen section results indicated tissue benign
Tissue processed, slide prepared for Pathologist review
Oncologist requests Histotech pull patient slide for review
Oncologist reviews slide, discovers cancerous tissue
Histotech pulls slide, gives to Oncologist
Pathologist review, final diagnosis benign
Oncologist diagnosis cancer, dictates findings for discharge notes
Radiologist, reviews discharge summary determines course of treatment
Oncologist discusses patient treatment with Radiologist
ABC Hospital -­‐ Confidential and Privileged Information
Review
process map
to identify
process steps
that could be
the source of
error.
3 weeks of radiation treatment given to patient
Radiologist prepares for Tumor Board, reviews Pathology report, discovers error, contacts Ongologist
Oncologist and Radiologist inform patient of medical error, radiation cancelled
RCA Conducted
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Report available in EMR
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Why Did This Happen?
1.  Why was radiation given to DMW?
§ 
Because patient discharge notes stated cancer.
2.  Why did discharge notes state cancer?
§ 
Because oncologist discovered cancer on patient slides in lab.
3.  Was the slide DMW’s?
§ 
No, the slide was another patient’s.
4.  How do you know the slide was another patient’s?
§ 
Because DMW’s pathology report stated tissue was benign,
consistent with frozen section preliminary results.
5.  Why was the oncologist given the wrong slide?
§ 
Because the number “8” looked like the number “3” to the
histotech. Only one critical patient identifier was on the slide.
Third step is to determine root cause.
Tool: 5 Whys
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Commonly Identified Root Causes
Random Event—No
Process Problem
Identified
Employee
Performance Issue
Equipment
Problem
Root
Cause
Human Factor Issues:
Supply Problem
(includes reagents
and medications)
§  Fatigue
§  Lack of communication
§  Lack of or ineffective training
§  Lack of policies, processes, and
procedures
Software
Problem
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What Needs to Change?
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What Corrective Actions Were Taken?
§  Pathology:
§ 
Two critical patient identifiers were added to all slides.
§ 
Slide and writing tool changed to improved products.
§ 
Preliminary report printed for all physician slide review
requests.
§  Oncology:
§ 
Discrepancy in diagnosis discussed with pathologist.
§ 
Final pathology report reviewed with discharge summary.
§  Radiology:
§ 
Final pathology report reviewed prior to start of treatment.
§ 
Case review within one week of treatment start, published
schedule, back-up radiologist used if needed.
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Assessing Effectiveness
OP Imaging Center Average Wait Time (min)
Major Patient
Dissatisfaction
80.700
70.700
“Leaned” Patient
Registration Process
Average Wait Time (min)
60.700
50.700
UCL
45.982
40.700
“Leaned” Physician
Order Process
CL
30.700
20.700
LCL
33.082
20.182
1O
ct
3O
ct
5O
ct
7O
ct
9O
ct
11
-O
ct
13
-O
ct
15
-O
ct
17
-O
ct
19
-O
ct
21
-O
ct
23
-O
ct
25
-O
ct
27
-O
ct
29
-O
ct
31
-O
ct
9Se
p
11
-S
ep
13
-S
ep
15
-S
ep
17
-S
ep
19
-S
ep
21
-S
ep
23
-S
ep
25
-S
ep
27
-S
ep
29
-S
ep
7Se
p
5Se
p
3Se
p
1Se
p
10.700
Date
Outcome: Reduced Outreach Imaging Center Patient Wait Time
Most corrective actions involve multiple solutions.
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Developing Immediate Strategies to Address Common Pitfalls
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Creating a “Just Culture”
§  Just culture recognizes that most NCEs should
not lead to employee discipline.
§  Just culture classifies behavior in three
categories:
§ 
Unintended, honest human error.
§ 
At-risk behavior.
§ 
Reckless behavior.
Without a “Just Culture,”
root cause identification may not occur.
Reference: CLSI Guideline QMS11-A, pgs. 5-6.
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Pitfalls to Avoid
§  Address staff FEAR:
§ 
§ 
§ 
“I don’t want to rat on my co-worker!”
“Will I lose my job?”
Keep people informed of investigation.
§  Avoid using negative descriptors in communication
(e.g., “poor,” “inadequate,” “bad”).
§  Use a systematic approach to RCA.
§ 
Need to understand all the details.
Caution: analysis by paralysis.
§  Assess effectiveness of corrective action and monitor
compliance over time if needed.
Focus on process, not people!
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Essential Steps Summarized
1.  Identify series of steps (Process Map).
2.  Brainstorm possible causes that could create the error
(Cause-and-Effect Diagram).
3.  Investigate the possible causes, identifying the most
probably causes.
4.  Analyze the most probable causes (5 Whys).
5.  Repeat steps 3 and 4 until root cause is identified.
6.  Determine corrective action.
7.  Implement.
8.  Assess effectiveness; repeat steps 3 to 8 if needed.
9.  Trend and track performance to ensure correction is
sustained.
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General Discussion
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Twenty Years Later, the Rest of the DMW Story…
Celebrating 70 years of marriage at 95 and 91!
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Anne Daley
Senior Consultant
Chi Solutions, Inc.
(734) 662-6363, ext. 414
[email protected]
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