Quality Management
Determined from Risk Assessment
Bruce Thomadsen
University of Wisconsin
and
The Center for the
Assessment
of Radiological Sciences
Disclosure
I am the President of the Center for the
Assessment of Radiological Sciences, a nonprofit Patient Safety Organization listed with
the Agency for Heathcare Research and
Quality. The Center is dedicated to
improving patient safety in radiotherapy and
radiology.
Learning Objectives
To understand how to approach developing a QM
program from a risk analysis:
1.
Redesign to eliminate potential failures,
2.
Ensure resources and key core components,
3.
Fix environment and technical problems
4.
Commission well and add QC and QA
So, What to Do
After making the fault tree. What now?
n  Address the potential failures.
n
What to Do?
Start with the branches of the fault tree with either
highest PRN or S.
n  Wherever you start, you will consider all the possible
failure modes until prevention is not worth the
resources.
n  So, if you are off in your values for the FMEA, not a
big deal.
n  Pay particular attention to common causes.
n
Patient
misidentified
Human error:
Omission – Timeout not performed
Or
Training – patient
identified
incorrectly
US images
inadequate
Or
Human Failure:
Inattention/Poor
performance Temp/ate not
seated properly
US probe
misaligned
Incorrect dose,
dose
distribution,
location
Human Failure:
Inattention/Poor
performance Probe cover not
correctly filled
US images
inadequate – QA
failure
Or
RO fails to match
the volume study
images
Fault Tree for
Prostate
Implants with
Loaded
Needles
Training – Probe
cover not correctly
filled
Or
Or
Human Failure:
Poor performance
Changes in
prostate
Training failure
RO fails to align
images along the
range
Or
Human Failure:
Inattention/Poor
performance
US images
inadequate – QA
failure
RO fails to image
adequately
Or
Training failure:
US images
inadequate –
Needle order
Human failure: US
images inadequate
– Needle order
Human Failure:
Inattention/Poor
performance
MP fails to hand
the correct needle
to RO
Or
Confusion between
packages
Poor demarcation
of needles
Poor room layout
MP drops needle
Or
Human failure: MP
slips
Human Failure:
Inattention
RO fails to insert
into correct hole
RO fails to insert
needle properly
Or
Bad viewing
conditions
Confusion
between holes
Or
Training Failure
Sources placed in
wrong location
RO fails to insert
needle to correct
depth
Or
RO fails to hold
stylet stable during
retraction
Or
US images
inadequate – QA
failure
Human failure: RO
fails to hold stylet
Or
Confusion
between planes
Human failure: RO
pushes on stylet
RO selects next
needle that
obscures
subsequent
needles
RO erroneously
modifies source
distribution
Human Failure:
Inattention/Poor
performance
Training Failure
Or
Human Failure:
Inattention/Poor
performance
RO adds
unnecessary
sources
Or
RO fails to add
necessary
additional sources
Or
US images
inadequate – QA
failure
Training Failure
Or
US images
inadequate – QA
failure
Training Failure
Don’t worry
about reading
it, this is for
scale.
Generalization about Fixes
The prevention of events can be by:
n  Eliminating progenitor causes,
OR
n  By interrupting the propagation.
Patient
Misidentified
X
Human error:
Omission - Time
out not performed
Or
X
Training - patient
identified
incorrectly
Example of a Common
Progenitor Cause
Incorrect activity
calculation
Failure selecting
date and time for
treatment
Or
Misread
spreadsheet
Incorrect activity
taken to procedure
Or
Incorrect activity
received
AND
AND
Incorrect activity
shipped
Or
Incorrect activity
ordered
Vendor error
Failure to check
order verification
Or
Transcription error
from spreadsheet
to ordered activity
Or
MP error reading
spreadsheet
Misunderstanding
of spreadsheet.
Poor training
And
Physicist/dosimetrist
check images failure
Post-procedure
CT imaging
error
Or
Or
Non-Positional
Failure Modes
Poor quality/
incomplete
images
Channel numbering
error: marking or
recording
25
Catheter indicators
not inserted fully
26
Sounding
measurement error
26
Wrong catheter
position Marked
25
23,24
51
Distal-most dwell
location
inaccurately
digitized
Dwell position
construction
failure
Or
Unit step size
inaccurate
Applicator in
wrong location
52
53
Treatment length
incorrect (wrong
transfer tube
length, wrong
sounding
information, wrong
dwell spacing)
Physicist check
plan failure
Or
50
Or
Channel
Mismatch
Units length
distance is
incorrect
Or
Or
Treatment
planning
Error
Catheter trajectory
inaccurately
localized
Or
Single or multiple
catheter failure
Adequate QM program for
planning and afterloader
systems
Inadequately
trained personal
Poor images
Default distances
used
Equipment failure
52
And
Dose in wrong
location due to
source position
And
Intricate
Common
Cause
Catheter
localization
failure
Assisting therapist
misses errors
46
Systematic offset
Commissioning
failure
Wrong catheter
slice images
Or
Inadequately
trained personal
Or
Incorrect catheter
number asssigned
Or
48
Poor labeling on
photographs
Poor image quality
49
Operator check
failure: imported
parameters vs.
plan
Initial treatment
failure
And
Wrong data file
imported
Program
treatment unit
failure
Or
Inconsistency
between treatment
program and
default operating
parameters
72, 70, 71
Or
73
And
Non-Positional
Failure Modes
Or
Connect transfer
tubes to
applicator failure
Tree from Jeff Williamson
Failure:
Physicist & MD
final setup check
Or
Wrong length
transfer tube
75
Channel and
applicator numbers
not matching when
connecting transfer
tubes to applicator
76
Incorrect Catheter
Polar rotation
Non-Positional
Failure Modes
86
Software failure
Innatention
Which of the following is true
about common cause?
20%
1.
20%
20%
2.
20%
3.
20%
4.
5.
It is a cause for a potential failure that
is common in everyday life.
It is a left-wing political action group.
It is a cause that produces a common
potential failure.
It is a cause that is not very interesting
or difficult to fix.
It is a cause that can produce potential
failures along more than one pathway.
10
Which of the following is true
about common cause?
20%
1.
20%
20%
2.
20%
3.
20%
4.
5.
It is a cause for a potential failure that
is common in everyday life.
It is a left-wing political action group.
It is a cause that produces a common
potential failure.
It is a cause that is not very interesting
or difficult to fix.
It is a cause that can produce
potential failures along more than
10
one pathway.
Reference
Slides 8 and 9.
n  B. Thomadsen. Elements of Quality and Safety in
Healthcare. Cognella Academic Publishing (2015).
n
Redesign
n
The best way to avoid potential errors at some
step is to redesign the procedure so that error is
not possible (i.e., what leads to it no longer
exists).
Redesign
The best way to avoid potential errors at some
step is to redesign the procedure so that error is
not possible.
n  Re-evaluate after a redesign because new
possible errors may have been produced.
n
Possible Interventions
•
•
•
First correct any environmental
problems.
Fix technical problems.
Both usually are relatively inexpensive
but effective operations that managers
understand.
Possible Interventions 2
Then consider the key core components identified by
AAPM TG 100:
§
Standardized procedures
§
Adequate staff, physical and IT resources
§
Adequate training of staff
§
Maintenance of hardware and software resources
§
Clear lines of communication among staff
Possible Interventions 3
n  As
you start with the highly ranked potential
failures, it is useful to consider all the given
branch of the fault tree at once.
n  It is also efficient to work though all the
branch of the process tree at once.
n  Work down through the rankings until you get
to potential failures that you don’t care if they
happen given your resources.
Commissioning
n  Identify
those potential failures that can be
eliminated through commissioning.
n  This is likely to be many.
n  Commissioning is when the limits of
reliability for equipment operation are found
and all data needed for its use gathered.
n  BUT, commissioning is for more than
equipment.
Commissioning 2
Commissioning is also for procedures.
n  Walk though the procedure with all principles.
n  Make sure all equipment and instruments are
where they need to be and operators know how
they work.
n  Establish the lines of communication:
n  Who
passes what information to whom and how.
n  Everyone understands what everyone else does when.
n
Start slowly and work up to clinical speed.
Inadequate or lack
of procedures /
practices
Defective
materials/tools/
equipment (2.1,
2.2, 2.3)
Commissioning
>3*sigma error
contouring errors:
wrong organ,
wrong site, wrong
expansions (1)
Don’t try to read!
User Error (2.5,
2.6)
366
Or
250
Inadequate design
specification (3.2)
Inadequate
assessment of
operational
capabilities (3.5)
Inadequate
programming (3.6)
Inattention,
Rushed process,
lack of time or
staff, fatigue,
failure to review
work
Inadequate or lack
of procedures /
practices
Taken care of by the generally complete
training, establishing clear communication
modalities (possibly forms) and
establishing protocols, policies and
procedures
255
Availability of
defective
materials/tools/
equipment (2.1,
2.2)
Materials/tools/
equipment used
incorrectly or
inadequate
assessment of
materials/tools/
equipment for task
(2.5, 2.6)
Excessive
delineation errors
resulting in <3*
sigma
segmentation
Errors (2)
Key item for commissing
326
Inadequate design
specification (3.2)
Or
Inadequate
assessment of
operational
capabilities (3.5)
Inadequate
programming (3.6)
260
Inadequate
training /
orientation (6.1)
Key item for facility managerial changes
Inattention,
Rushed process,
lack of time or
staff, fatigue,
failure to review
work
Inadequate or lack
of procedures /
practices
Availability of
defective
materials/tools/
equipment (2.1,
2.2)
Taken from TG 100
Error in
delineating
GTV/CTV (MD)
and other
structures for
planning and
optimization
Materials/tools/
equipment used
incorrectly or
inadequate
assessment of
materials/tools/
equipment for task
(2.5, 2.6)
Or
Poorly drawn
contours (spikes,
sloppy, etc) (3)
265
Inadequate design
specification (3.2)
212
Or
Inadequate
assessment of
operational
capabilities (3.5)
Inadequate
programming (3.6)
Inadequate
training /
orientation (6.1)
Inattention,
Rushed process,
lack of time or
staff, fatigue,
failure to review
work
270
After Checking Resources
Identify those potential failures that can be
eliminated through commissioning.
n  This is likely to be many.
n  For the remaining, consider QC and QA.
n
Quality Management
Quality Management – All activities designed to
achieve the desired quality in treatments.
Quality Control – Activities that force specific
quality on a process.
Quality Assurance – Activities that demonstrate
the level of quality of a process.
Organiza(onal Difference between QC and QA Input
1
Input
2
Input
3
Input
4
QC
QC
Process
QA
QC
QC
After Checking Resources
Identify those potential failures that can be
eliminated through commissioning.
n  This is likely to be many.
n  For the remaining, consider QC and QA.
n  All fault tree branches eventually need to be
covered somewhere before the far left box.
n  Let’s consider some examples.
n
Which of the following is true
about commissioning?
20% 1.
20% 2.
20% 3.
20%
20% 4.
5.
It is the preparations for a procedure.
It is only for equipment.
It is where the operation of equipment is
compared with the order specifications.
It doesn’t need to be done if there is
only one person who performs a
procedure.
It is when the values for the FMEA are
determined.
10
Which of the following is true
about commissioning?
20% 1.
20% 2.
20% 3.
20%
20% 4.
5.
It is the preparations for a procedure.
It is only for equipment.
It is where the operation of equipment is
compared with the order specifications.
It doesn’t need to be done if there is
only one person who performs a
procedure.
It is when the values for the FMEA are
determined.
10
Reference
Slide 19.
n  The Report of Task Group 100 of the AAPM:
Application of Risk Analysis Methods to Radiation
Therapy Quality Management. Medical Physics In
press (2015).
n  B. Thomadsen. Elements of Quality and Safety in
Healthcare. Cognella Academic Publishing (2015).
n
One Example
Patient
Misidentified
Human error:
Omission - Time
out not performed
Or
Training - patient
identified
incorrectly
Systemic
corrections
One Example
Quality assurance
Quality control
Managerial
changes
Human error:
Omission – Timeout not performed
Procedural
changes
AND
Patient
misidentified
Or
Training – patient
identified
incorrectly
QC failure: Time
out form
Another Example
Human failure:
Inattention/Poor
performance
MP fails to hand
correct needle to
RO
Confusion
between
packages
Or
Poor demarcation
of needles
Poor room layout
MP drops needle
Or
Human failure:
MP slips
Systemic
corrections
Another Example
Quality assurance
Quality control
AND
Managerial
changes
Procedural
changes
MP fails to hand
the correct needle
to RO
Or
Human Failure:
Inattention/Poor
performance
Failure of call and
response
Confusion between
packages
Poor demarcation
of needles
Poor room layout
MP drops needle
Or
Human failure: MP
slips
Another Example
Training Failure
RO fails to align
images along the
range
Or
Human Failure:
Inattention/Poor
performance
US images
inadequate
Systemic
corrections
Quality assurance
Another Example
Quality control
Managerial
changes
Procedural
changes
Or
Human Failure:
Inattention/Poor
performance
AND
RO fails to align
images along the
range
Training failure
US images
inadequate
US QA failure
Some Thoughts on Human Errors
You can never eliminate human error except by
eliminating the humans.
n  You need to design the system to be resilient to
human error. There are ways to address some
factors that increase the likelihood of human error.
n  Protect it downstream with interventions.
n  Best if these are automatic.
n
Or
Training failure
QC failure:
Prostate image
time out
RO fails to align
images along the
range
Add some QC
down stream
Or
Human Failure:
Inattention/Poor
performance
AND
AND
No Preventing Human Error
US images
inadequate
US QA failure
A Note on Equipment Failure
Equipment failure is not entirely under your
control because sometimes equipment just fails.
You cannot eliminate that possibility.
n  You can do things to influence equipment failure:
n
n  Thorough
commissioning
n  PMI, a resource and procedural issue
n  QA
Ranking of QM Tools
The strength of actions varies:
1. Forcing functions and constraints
2. Automation and computerization
3. Protocols and standard order forms
4. Independent check systems and other redundancies
5. Rules and policies
6.  Education and Information
From the Institute for Safe Medical Practices toolbox
(ISMP, 1999)
Which of the following is the
weakest intervention?
20% 1.
20%
20% 2.
20% 3.
20%
4.
5.
Policies because they may not be
followed.
Automation because it might not work.
Forcing functions because an action
may not be anticipated.
Education because it can be forgotten.
Checklist because it might be omitted.
10
Which of the following is the
weakest intervention?
20% 1.
20%
20% 2.
20% 3.
20%
4.
5.
Policies because they may not be
followed.
Automation because it might not work.
Forcing functions because an action
may not be anticipated.
Education because it can be
forgotten.
Checklist because it might be omitted.
10
Reference
Slide 37.
n  Institute for Safe Medical Practices toolbox
(ISMP, 1999).
n  The Report of Task Group 100 of the AAPM:
Application of Risk Analysis Methods to Radiation
Therapy Quality Management. Medical Physics In
press (2015).
n  B. Thomadsen. Elements of Quality and Safety in
Healthcare. Cognella Academic Publishing (2015).
n
Summary
To prevent the effect of a failure requires either
preventing the progenitor cause OR interrupting the
propagation.
n  First, look at redesign and reassess.
n  Ensure resources, environment and key core
components.
n  Commission well.
n  Organize the QM steps by QC and QA.
n  Often it is most efficient and effective to consider
complete branches of the fault tree and process tree
at the same time.
n