Applying Reliable Design to ICU Clinical Bundle Work

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Applying Reliable Design  to ICU Clinical Bundle
Work

• Frank Federico

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Objectives

• Describe why we do not have reliable processes
• Describe the three step process of reliable
  design
• Identify an area within your ICU where you will
  be able to apply reliable design.

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Outline

• Review reasons why we do not have reliable
  processes.
• Describe a method that allows for less than
  perfect design yet reaches high levels of
  reliability
• Walk through the process of developing processes
  for non-catastrophic events

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What does this line graph tell you?
Standardization
Education
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Improvement

• Improvement requires change
• Doing the same thing and expecting different
  results is insanity (Einstein)
• All improvement requires change not all change
  is improvement.

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Example of a Project
(Baptist Memorial, Memphis)
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Framework for Reliable Design

• Reliability occurs by design not by accident
• Process is the action point of all improvement
  methodologies
• Segmentation allows the perfection of the design

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Starting Labels of Reliability

• Chaotic process Failure in greater than 20 of
  opportunities
• 80 to 90 (10-1) 1 or 2 failures out of 10
  opportunities
• 95 or better (10-2) 5 failures or less out of
  100 opportunities
• (These are IHI definitions and are not meant to
  be the true mathematical equivalent)

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Non-Catastrophic Processes

• Definition Failure of the process does not lead
  to death or severe injury within hours of the
  failure
• Less than 95 performance or worse is most
  commonly seen in these processes (hand-washing as
  an example)
• Poor outcomes do not occur with each defect due
  to either to biologic or system resilience
• Can be applied to Ventilator Care, and CLI Care

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Reasons for the Reliability Gap in Healthcare

• Current improvement methods in healthcare are
  highly dependent on vigilance and hard work
• The focus on benchmarked outcomes tends to
  exaggerate the reliability within healthcare
  hence giving both clinicians and leadership a
  false sense of security
• Permissive clinical autonomy creates and allows
  wide performance margins
• The use of deliberate designs to achieve
  articulated reliability goals seldom occurs

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Improvement Concepts Associated with lt 95
Performance (Primarily can be described as
intent, vigilance, and hard work)

• Common equipment, standard order sheets, multiple
  choice protocols, and written policies/procedures
  
• Personal check lists
• Feedback of information on compliance
• Suggestions of working harder next time
• Awareness and training

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The Three Buckets James Reason
Custodial attention Discretional energy
(extra mile) Experience Knowledge Fitness Self
awareness limited commodities eroded by
bad stuff
Clear instructions Good briefing Good
teamwork Available time Good rapport Able to
question Good kit, etc
Forcing functions Standardization Alerts
reminders
Preoccupation Inexperience Lack of
knowledge Under the weather Fatigue Emotional
state Life events
Distractions Interruptions Change Harassment Hand-
offs Authority gradient Poor workplace
Multiple steps
SELF
CONTEXT
TASK
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Focus on BenchmarksBiology Protects Us

• All defects in process do not lead to bad
  outcomes
• Healthcare tends to look at outcomes and not the
  reliability of the process leading to outcomes
  (hand washing is an example)
• Benchmark to best practice not aggregate averages

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Focus on Clinical Autonomy in Health Care
Processes
Desired - variation based on clinical criteria,
no individual autonomy to change the
process, process owned from start to finish, can
learn from defects before harm occurs, constantly
improved by collective wisdom - variation
Current - Variable, lots of autonomy not
owned, poor if any feedback for improvement,
constantly altered by individual changes,
performance stable at low levels
Terry Borman, MD, Mayo Health System
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Use of Deliberate DesignThe Reliability Design
Strategy

• Prevent initial failure using intent,
  simplification and standardization
• Identify defects (using redundancy) and mitigate
• Measure and then communicate learning from
  defects back into the design process

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Preventing Errors...The Role of Complexity
Probability of Success, Each Element

• No. Elements 0.95 0.990 0.999 0.9999
• 1 0.95 0.990 0.999 0.9999
• 25 0.28 0.78 0.98 0.998
• 50 0.08 0.61 0.95 0.995
• 100 0.006 0.37 0.90 0.99

Probability of Performing Perfectly
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The Set Up for Reliability

• Select a topic whose outcome you want to improve
• Determine a high volume segment for initial
  design testing
• Build a high level flow chart for that segment
• Determine where the defects occur in the current
  system
• Determine where your design work will begin with
  by identifying where the commonest defects occur
• Your goal is always 95

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Using Segments

• Allows for the control of some variables
• Defines the boundaries around which sequential
  expectations for success can be found
• More likely to test the validity of the design
  rather than deal with barriers
• Fosters a deeper understanding of the design
  complexity required for the project
• Forces understanding of the differences between
  segments as design strategies
• Allows the formation of more predictable timelines

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Topic Ventilator Care
Segment Patient Population/ nursing unit
Patient on ventilator
Order for head of the bed elevation
Head of the bed elevation maintained
Patient taken off ventilator
Head of bed elevation not maintained
Our aim is to achieve a reliability of 95 with
ensuring that the head of the bed is elevated to
agreed upon level
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The Reliability Design Strategy

• Prevent initial failure using intent and
  standardization
• Identify defects (using redundancy) and mitigate
• Measure and then communicate learning from
  defects back into the design process

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Why Standardize?

• Contributes to building an infrastructure (who
  does what, when, where, how and with what)
• Support training and competency testing to
  sustain the process
• Achieve front line articulation of key processes
  by staff
• Allows the appropriate application of Evidence
  Based Medicine consistently
• Feedback about defects and application of
  learning to design is possible

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New Standardization Concepts

• Critical failure modes drive customization
• Organizational maturity drives the complexity of
  the standardization
• Leadership must drive expectation of
  standardization
• Model shifts
• From hope for clinicians to opt in
• To requirement of an explanation if opt out
• Opt Out reasons used to remodel process
• Designated process owner

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Human Factor Concepts
Human Factors and Reliability Science (Designing
sophisticated failure prevention, failure
identification and mitigation)

• Decision aids and reminders built into the system
• Desired action the default (based on evidence)
• Redundant processes
• Use fixed current scheduling in design
• Take advantage of habits and patterns
• Standardization of process based on clear
  specification and articulation

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Characteristics of Redundancy Tools

• Require careful consideration since they do
  represent a form of waste
• Needs to be connected to the process almost all
  the time (at least 80 reliability)
• Requires a good standardization functions be in
  place before implementing a redundancy
• Need to be truly independent
• Need to be used or will no longer function as a
  good filter
• Must follow with a mitigation strategy

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Mitigate

• Measure and then communicate learning from
  defects back into the design process
• Measurement should take place at each step
• Measurement should be as close to real time as
  possible
• If the system is not performing as designed must
  make changes

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Redundancy in the form of a check by RT built
into 1 hour scheduled vent checks as a 10-2
change concept (step 2)
Integrate daily goals with MDR to identify
defects as a 10-2 change concept (step 1)
Feedback on compliance as a 10-1 concept
Education as a 10-1 concept
Baseline
Example of using 10-1 and 10-2 change concepts
to initially reach a reliability of 10-1 then
additionally using a robust 10-2 change concept
(redundancy) to reach 10-2 reliability in the 4
elements of the ventilator bundle (Baptist
Memorial, Memphis)
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Examine Your Own Process

• What is the level of reliability of the process?
• Does the success of the process depend on a
  person?
• Is our main effort to improve the process
  training and education?
• Is it truly standardized?
• What will you do to improve the level of
  reliability?

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When to Re-design

• If you have a process and it is not reliable ask
• Is it truly standardized?
• Why are staff not using the process?
• What is failing?
• Is it time to develop a totally new process?

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Why not 95 or better for your patients?