Reliability Theory and its Application to Healthcare

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Reliability Theory and its Application to
Healthcare
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Aims of session

• Introduction to reliability theory the
  framework and the three step model
• Highly reliable organisations who are they? Can
  we learn from them?
• Healthcare as a highly reliable industry
  designing reliable systems of care
• Care bundles a reliability approach

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Reliability in healthcare

• Healthcare is a high hazard industry
• We are not able to reliably deliver healthcare to
  all of our patients all of the time.
• Approx. 10 (900,000) of patients admitted to
  hospital experience an incident.
• 72,000 of these incidents/adverse events
  contribute to the death of patients
• Many go unrecognised

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Patient safety a global issue
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Impact

• Direct costs
• in England healthcare associated infections are
  estimated to cost over 1 billion pounds per year
• on average, preventable drug events resulted in
  an additional 4.6 days in length of stay
• estimated cost of preventable adverse events in
  USA is 10.1 billion (Leape et al 1993)

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Is medicine a high-reliability industry?

• The practice of medicine involves complex systems
  in which humans play a key role
• Procedures are very technical and sometimes risky
• Medicine should be a high-reliability industry
• Unfortunately literature shows that it is fraught
  with error, can be unsafe, and at times is not
  effective
• The potential for error and system failure is
  always there
• Things happen on a daily basis staff go off
  sick, equipment doesnt work, people forget to do
  something - we are all human no matter how
  diligent
• This is a normal part of a complex healthcare
  system

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What is reliability science?

• Reliability principles are used successfully in
  industries such as manufacturing and air travel
  to help evaluate, calculate and improve the
  overall reliability of complex systems
• These can be used to design systems that
  compensate for the limits of human ability, can
  improve safety and the rate at which a system
  consistently produces the desired outcomes

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How is it measured?

• Reliability is measured as the inverse of the
  systems failure rate
• A system that has a defect rate of one in ten or
  10 performs at a level of 10 1
• Reliability is defined as failure-free operation
  over time
• Reliability number of actions that achieve the
  intended result, divided by total number of
  actions taken

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A reliability framework

• 10 1 performance on process measures indicates
  no articulated common process and an emphasis on
  training and reminders (international studies of
  adverse events in hospitals shows an error rate
  of 10 suggesting a level at which most
  organisations currently perform)
• 10 2 performance on process measures indicates
  processes intentionally designed with tools and
  concepts based on the principles of human factors
  engineering
• 10 3 or better performance on process measures
  indicates a well designed system with attention
  to processes structure and their relationship to
  outcomes

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Examples

• 10-1 80 or 90 success, 1 or 2 failures out of
  10 opportunities ( A chaotic process)
• B-blockers after acute MI
• 10-2 5 failures or less out of 100
  opportunities
• Mortality in general surgery
• 10-3 5 failures or less out of 1000
  opportunities
• - Mortality in routine anaesthesia
• 10-4 5 failures or less out of 10,000
  opportunities
• A chaotic process is failure in greater than 20
  of opportunities
• Almost all studies that investigate the
  reliability of the application of clinical
  evidence conclude that it is 10-1

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Improving reliability

• Level I Intent, vigilance hard work
• Level II Design systems for reliability
• constraints, decision aids,
• reminders, checklists, bundles
• Level III Prevent design for reliability
• Identify make failures visible
• Mitigate prevent / treat harm
  due to
• failures

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How to reduce variability

• Standardisation
• Care bundles
• ICPs
• Guidelines
• Checklists
• Improve access to information
• Reduce reliance on memory
• Constraints
• Reduce handovers
• Simplify processes

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Standardisation concepts

• Standardisation is done to provide the
  appropriate infrastructure
• The what we are standardising based on good
  medical evidence
• The how does not need to be based on good
  medical evidence but rather on systems knowledge

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In a broader context

• Aviation passenger safety is measured at 10-6
• Nuclear power plants must demonstrate a design
  capable of operating at 10-6 before they can be
  built

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IHI three-tiered strategy for designing reliable
care systems

• 1. Prevent failure
• 2. Identify and mitigate failure identify
  failure when it occurs and intercede before harm
  is caused, or mitigate the harm caused by
  failures that are not detected
• 3. Redesign the process based on the critical
  failures identified

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Designing effective and reliable systems

• Have simple rules complex systems best handled
  by this
• Feature redundancy offers multiple layers of
  defence from error
• Incorporate forcing functions a mechanism that
  makes it easy to do the right thing and hard to
  do the wrong thing (i.e. on a plane the toilet
  light cannot be turned on without locking the
  door first)
• Ensure people cannot work around the system first
  understand why people develop workarounds
• Minimise reliance on human memory
• Allow the expertise of the people performing the
  work to be used standardised protocols provide
  a systematic approach
• Incorporate technology where possible
• Communicate the advantages of the system to
  clinicians if staff do not see this they will
  develop workarounds
• Consider what happens if the system fails be
  prepared

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How Hazardous Is Healthcare?(Leape and Amalberti)
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Highly reliable organisations?

• A definition of a HRO is one that is known to be
  complex and risky, yet safe and effective
• These organisations acknowledge the complexity of
  their systems create an environment in which
  individuals can communicate openly about concerns
  and design systems that make it difficult for
  failures to occur
• HROs ask what happens when the system fails?,
  not What if the system fails?

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Examples of highly reliable organisations

• Aviation
• Nuclear power plants
• Air traffic control centre
• Nuclear aircraft carriers

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Learning from highly reliable organisations

• Other highly technical industries bear a
  similarity to medicine
• Airline industry - thousands of flights take
  place every day in varying weather conditions. If
  a significant error occurred the consequences
  would be dire
• So why is the error rate in aviation not the
  subject of public and media interest?

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Lessons learned the hard way!
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The airline industry

• Aviation industry recognised years ago that human
  error is an inevitable part of doing business
• The industry chose to address error prevention
  and safety by improving communication, flattening
  team hierarchy and implementing fail safe systems
• These actions have made aviation a highly
  reliable industry

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High reliability organisations

• Strong organisational culture of reliability
• Continuous learning
• Effective and varied patterns of communication
• Human resource management practices that support
  reliability
• Adaptable decision-making dynamics
• Managing technology
• System and human redundancy

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The need to apply a Systems Approach

• Failure is predictable and can be detected
• Failure arises out of systematic and
  organisational factors not just erratic
  behaviour of individuals
• High reliability departments create safety by
  anticipating and planning for unexpected events
  and future surprises

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Can reliability be applied to healthcare?

• Although healthcare is not currently highly
  reliable, it has the potential to be
• IHI and others believe that applying reliability
  principles to healthcare has the potential to
  reduce defects in care or care processes,
  increase the consistency with which appropriate
  care is delivered, and improve patient outcomes
• To move in that direction we must overcome one of
  the largest barriers the culture of medicine

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There is hope

• One bright light in the field of healthcare with
  regard to high reliability anaesthetics
• No other medical discipline has come as close
• Realisation that the weak link in the process was
  the people not the technology (1984 Cooper
  published his study review of 329 incidents
  involving anaesthesia in a Massachusetts Hospital
  identified that nearly 70 of these incidents
  related to human error
• They have learned lessons and implemented changes
  that the rest of the healthcare field are just
  beginning to acknowledge
• In 1954, one out of every 1,500 patients died as
  a result of problems with their anaesthetic
• In 2001 that risk has dropped to one in every
  250,000

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Using care bundles to improve reliability

• Bundles demand all or none thinking and
  measurement
• Bundles facilitate identifying failures
• Failures are actively used to redesign the
  process
• Team work and communication proven to improve

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What are they?

• A series of interventions relating to a treatment
  or intervention
• - ventilator bundle
• - central Line bundle
• - tracheostomy bundle etc
• When implemented together will achieve
  significantly better outcomes than when
  implemented individually (IHI 2005)

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Why?

• A way of reducing the gap between research and
  practice in clinical areas
• Promotes evidence-based change
• The bundle of care will have a greater effect on
  the positive outcome of the patient than if used
  in isolation
• Reduces variation from unit to unit or clinician
  to clinician

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Care bundles

• Based on reliability principles all or nothing
  compliance
• Plane takes off ok, one engine fails during
  flight, descends ok, lands ok 75
• Plane takes off ok, one engine fails during
  flight, descends badly, crashes on landing 25
• Plane takes off ok, engines ok during flight,
  descends ok, lands ok 100
• Overall flight compliance 66
• Would you want to travel on this airline?

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Evidence

• IHI estimates that it could be possible to
  achieve an 80 reduction in Surgical Site
  Infections (of which 3 could be fatal) and a 50
  reduction in deaths from Acute Myocardial
  Infarction
• They also estimate that an average bed sized U.S.
  hospital could save 18 lives from SSI and 108
  lives from AMI each year as a result of
  implementing care bundles

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An example

• Reduction of Ventilator Acquired Pneumonia
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• 59

• Level of reliability of all 4 elements
  of ventilator bundle
• lt 95 compliance
• gt 95 compliance

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Outcomes

• Evidence that the unit is achieving quality care
  and doing the right thing for the right patient
• Average length of stay is reducing
• Sedation costs reduced financial savings

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Central line bundle
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Central line infection rate
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Making the move

• Need to move towards a culture focused on safety
  and reliability
• Leadership driven with staff focused on safe and
  reliable care
• Adoption of standardised methods of communication
  and in the creation of an environment in which
  people interact collaboratively and feel free to
  speak up if they see something worrying
• Engineer systems with redundancy and safeguards
  that make doing the wrong thing difficult
• Create a learning environment in which little
  problems are seen as indicators of deeper
  potential faults to be addressed proactively