1. Reliability Theory and its Application to Healthcare

2. 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
A brief overview of what the presentation will attempt to cover.
How we can learn from other industries that are more reliable than ours.

3. This slide shows the Institute of Medicine’s recommended model for all patients taken from The Institute of Medicine’s Report, 2001.
Reliability is closely linked with the effective and safe part in this model.
Reinforce the point – how can we ensure that 100 % of patients get the right treatment every time?
You can suggest that maybe reliability should feature in this model too.

4. 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
This slide highlights that healthcare is a high hazard industry, and that evidence shows (nationally and internationally) that 10% of patients admitted to hospital suffer an adverse event.
This supports the fact that our hospitals are not as reliable as they should be in delivering care. The references for the statistics for adverse events are from The Institute of Medicines report and from Department of Health report – An Organisation with a Memory.

5. Patient safety – a global issue
This slide demonstrates patient safety statistics internationally and demonstrates that the issues are worldwide.
This slide is about contextualising the problem of patient safety which is also demonstrating that our current healthcare systems are not reliable

6. 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)
This slide demonstrates some of the direct costs caused by adverse events.
Evidence demonstrates that staff only wash their hands on average 40% of the time.
However if staff reliably washed their hands 100% of the time, the impact on hospital acquired infections would be at least a 50% reduction.
If we were able to reliably do the right thing for all our patients all of the time the impact on adverse events, reductions in infections and length of stay as well as a reduction in cost would be phenomenal.

7. This slide shows that what we tend to see in healthcare is the tip of the iceberg – the accidents.
If we want to make healthcare more reliable and safe we need to concentrate improvement efforts on the near misses, dangerous situations, errors and deviations .

8. 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 doesn’t work, people forget to do something - we are all human no matter how diligent
This is a normal part of a complex healthcare system
Discussion point - start by asking the audience the question ‘Is medicine a high reliability industry?’
The text then describes how complex and risky healthcare is, and why things at times go wrong with our systems and processes.
People will always make mistakes regardless of how competent a professional they are. Many of our systems in healthcare are currently reliant on individuals remembering to do the right thing. This is not how to be a reliable industry.
We need to design systems and processes that are not reliant on individuals remembering to do specific things.
It is important to reinforce with this slide that medicine should be a highly reliable industry and that what we are attempting to do is to learn from other industries and experts in this field as to how we can change our healthcare system to one that is more reliable and safe, so that each patient gets the right care at the right time and in the right place.

9. 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
An example of other industries that have used reliability principles in designing safe and reliable systems and processes to achieve the right outcomes

10. 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
This slide explains an operational definition and definition of how reliability is measured.

11. 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
This slide defines the reliability framework that is recommended by the Institute of Healthcare Improvement and gives examples of each level.

12. 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
Here are some examples that demonstrate the framework at each level
We are currently at 10 – 1 in most healthcare settings. Many reliability experts would argue that our healthcare systems and processes are chaotic. ( Roger Rezar- IHI MD expert in Reliability)
Anaesthesia is the most reliable form of healthcare.

13. 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
Currently in healthcare most organisations are at Level 1 and when things go wrong they expect the staff to work harder and be more diligent to prevent the problem from occurring again – this is not the behaviour of a highly reliable organisation.
Level 2 is where some hospitals are now working at - they are redesigning their systems and processes to make them more reliable.
The implementation of care bundles, checklists and reminders built into the system will enable organisations to improve the reliability of their systems and processes
However to become a highly reliable organisation hospitals need to focus on Llevel 3 and start to concentrate improvement efforts, on redesigning to prevent error from occurring and if errors do occur to make them highly visible for staff to see.

14. How to reduce variability
Standardisation
Care bundles
ICPs
Guidelines
Checklists
Improve access to information
Reduce reliance on memory
Constraints
Reduce handovers
Simplify processes
Standardisation is an important aspect of designing reliable healthcare. It is important to make that link in the presentation.
Standardisation makes care safer and ensures that all staff are doing the same.
Takes out the variation from Doctor to Doctor or unit to unit.
Evidence demonstrates that standardisation is key to improving reliability.

15. 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
A few concepts thrown in to explain what we mean by standardisation. It is always based on best evidence base.

16. 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
Some examples of highly reliable industries and their framework level.
Reinforce at this point that healthcare systems and processes tend to be at 10 – 1. We have a long way to go to increase our reliability to where we should be.
So how can we learn from them?

17. 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
This slide shows the Institute of Healthcare Improvement’s three tiered recommended strategy for the design of reliable healthcare.
It’s a model that should be applied when redesigning our processes and systems
Start by trying to prevent failure - to do this we need to have an understanding of what can go wrong and learn from cases when things have gone wrong
Identify and mitigate is having staff that are always aware that things may go wrong and will be on the look-out for opportunities when things may go wrong and then act before they do.
Example – badly written prescription – nurse thinks it says one thing but instead of going ahead with the administration she contacts the Doctor to rewrite it so it is clear. Another individual may have just given the medication.
Critical failure redesign is about identifying the failure opportunities and then redesigning to prevent them from happening

18. 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
Here are some examples that you can talk through of how we can start to implement some changes to increase our reliability of systems and processes.

19. How Hazardous Is Healthcare? (Leape and Amalberti)
This slide is taken from Lucian Leape and Renee Amalberti’s work. Both are experts from America in the field of human factors and reliability.
The slide is showing that healthcare is as hazardous as mountain climbing and bungee jumping and you can make the point that we need to move healthcare to the ultra safe end of the chart along with nuclear power, airlines etc.

20. 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?’

21. Examples of highly reliable organisations
Aviation
Nuclear power plants
Air traffic control centre
Nuclear aircraft carriers

22. 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?
You can mention that some people may say that healthcare is very different from the airline industry and that we should not be compared.
However we are not wanting to compare but to learn from how they have managed to become more reliable and safe to see if their lessons learnt and achievements made can be tested out and transferred to healthcare.

23. Lessons learned the hard way!
Slide to highlight that even the airline industry, similar to healthcare, has learnt lessons the hard way too.

24. 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
So what did the airline industry do?
In healthcare we have many systems and processes that are reliant on individuals and we are not building in human factors knowledge when redesigning our systems and processes
Humans will always make mistakes and the airline industry acknowledged this a long time ago.
In healthcare we seem not to accept that errors are part of life, and that things will go wrong when you put people in complex and risky systems.
We need to make everyone aware that this is the environment in which we work and try to plan for when things go wrong.
Team work and communication in the airline industry have played a huge part in making the industry more reliable. They implemented crew resource management which has played a significant role in increasing reliability .
In the airline industry staff are all empowered to question and challenge. The hierarchy has been flattened out to enable this to work effectively.
Unfortunately in healthcare we have many staff who do not feel able to question and challenge even though it may be to the benefit of the patient

25. 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
These are the characteristics of highly reliable organisations.

26. 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
A few systems approach concepts.

27. 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
This slide is trying to highlight that reliability principles can be applied to healthcare. However it links the need to tackle the current organisational culture of medicine.

28. 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
Anaesthetics is the nearest example of high reliability in healthcare today and an example is shared of where they came from back in 1954 to where they are today.
The learning from this again is the same as the airline industry learning - human factors are a key element to improving safety and reliability.
Good people unfortunately make mistakes. If anaesthetists can increase their reliability then why can’t other specialities / fields?

29. 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
Care bundles are a tool for increasing reliability and evidence has shown that when reliably is applied this will make a significant impact on patient outcomes.
Further reading: Modernisation Agency – 10 High Impact Changes, Critical Care Networks, Department of Health.

30. 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)

31. 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

32. 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?
Slide shows an example of reliability principles – all or nothing compliance.
In healthcare we previously thought that an audit showing 80% of patients getting a given treatment was good.
However in all or nothing / reliability principles this means 2 out of 10 patients didn’t get.
Would you want to be one of those two patients?

33. 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
Taken from the Institute of Healthcare Improvement’s White Paper on Reliability, 2004.

34. An example Reduction of Ventilator Acquired Pneumonia
Level of reliability of all 4 elements of ventilator bundle
< 95% compliance
> 95 % compliance
Reduction of Ventilator Acquired Pneumonia
46 %
59 %
Evidence of the outcome benefits for reliable implementation of the ventilator care bundle.

35. Compliance with care bundle – will update with more up-to-date chart.

36. 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

37. Central line bundle
This slide shows compliance with the implementation of a central line bundle.
Evidence shows that if reliably is applied this will reduce / eradicate central line related infections. This is taken from the work of the Safer Patients Initiative.

38. Central line infection rate

39. 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
Slide highlights some ideas of changes that can be taken to increase our reliability in healthcare.