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Clinical governance

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Is there a problem?
Studies based on retrospective analysis of medical records :
Harvard study 1991 (Lucien Leape) – adverse event rate in ‘hospitalisations’ of 3.7% of which two
thirds were ‘errors’
Australian study 1995 (Ross Wilson) – adverse event rate 16.6%
British study 2001 (Charles Vincent) – adverse event rate of 10.8%
To Err is Human (Institute of Medicine 1999)
As many as 98,000 people die each year in USA from medical errors that occur in hospitals. That is
more than die in RTAs or from breast cancer or AIDS. Medical error is fifth leading cause of death in
USA
An Organisation with a Memory (CMO, 2000)
The NHS is doomed to make the same mistakes over and over again as we have no way of learning
from when things go wrong
Disasters in other industries
Herald of Free Enterprise
Hillsborough
Sinking of Marchioness on Thames
Bhopal
Learning from when disasters happen
Complex set of interactions
No single causal factor
Combination of local conditions, human behaviours, social factors, organisational weaknesses
Human Error (Reason, 1990)
Humans are fallible and errors are inevitable
Systems approach takes holistic view of causes of failure
Cannot change the human condition but can change conditions in which people work and minimise
opportunities for error
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Reason’s Swiss Cheese Model
An Example
Systems Approach in Healthcare
As many as 70% of adverse incidents are preventable
Errors can be minimised, but never completely eliminated
Rarely single, isolated cause of error – attempts to prevent errors need to address systems as a
whole
Safety Critical Industries with Safety Approach
Aviation
Railways
Oil and Gas
Construction
Nuclear
Military
15 Learning from failure
“The NHS is not unique: other sectors have experience of learning from failures which is of relevance
to the NHS”
Sir Liam Donaldson in
‘Organisation with a Memory’
16 Systems for Learning from Experience :
Aviation
Accident and serious incident investigations
Confidential Human factors Incident Reporting Programme (CHIRP)
Company Safety Information Systems
Crew Resource Management
17 The Need for Action in Healthcare
Unified mechanisms for reporting and analysing examples of when things have gone wrong
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Development of a more open culture in which errors or service failures can be admitted
Lessons must be identified, active learning must take place and necessary changes must be put into
practice
Healthcare professionals must appreciate the need to ‘think systems’ in learning from errors, as well
as in prevention through risk management
18 The National Patient Safety Agency
Established in 2001
Relates to England and Wales
Responsible for National Reporting and Learning System (NRLS)
Previously produced Patient Safety Alerts
Now is developing systems of ‘Rapid Responses’
Produced guidance to the NHS on patient safety – ‘Seven Steps to Patient Safety’
19 Reported incidents by type (NPSA, April 2006 – March 2007)
20 Reported degree of harm
21 Seven Steps to Patient Safety
22 The Steps Step 7 - Solutions to reduce harm
Step 6 - Learn and Share Lessons
Step 5 - Patient involvement
Step 4 - Promote Reporting and Learning
Step 3 - Integrated Risk Management
Step 2 - Lead and support your staff
Step 1 - Build a Safety Culture that is open and fair
23 Step 1 - Build a Safety Culture that is Open and Fair
Organisations, practices, teams and individuals have constant and active awareness of potential for
things to go wrong
Being open and fair means sharing information freely with patients and families balanced by fair
treatment for staff when things go wrong
Incidents are linked to the system in which an individual works
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24 Safety Culture
NPSA – A safety culture is where organisations, practices, teams and individuals have a constant and
active awareness of the potential for things to go wrong. Both the individuals and the organisation
are able to acknowledge mistakes, learn from them, and take action to put things right.
Confederation of British Industry – The way we do things around here
25 Step 1 – Best Practice
Don’t expect perfection from humans – use systems to support human decision making
Establish reporting systems for errors and adverse events (practice; local; national)
Assess your culture by undertaking a practice safety culture audit, eg MaPSaF
26 Step 2 - Lead and Support Staff
Delivering patient safety needs motivation and commitment from clinical and managerial staff
everyone has a responsibility for safety
Leaders must be visible and active in leading patient safety improvements
Staff and teams should be able to say if they do not feel that care is safe – regardless of their
position
Some ideas – patient safety champions; safety briefings; team briefings; safety walkabouts
27 Step 2 – Best practice
Leadership – GPs and practice leaders have to own safety. Walk the walk
Reflection – ‘How are we doing on safety?’
Training – Run in-house and seek out external provision
Promotion – standing agenda item in clinical and business meetings
28 Step 3 – Integrate risk management activity
Proactive
Training in safety and risk
Use risk assessment in major change management projects
Review controls for minimising risk
Reactive
Incident reporting and analysis
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Significant event audit at team or unit level
Root cause analysis at organisational level
All of the above methods can be integrated
29 Step 3 – Best Practice Regular and embedded SEA in practice
Sharing the learning from SEA
Active and willing participation in other reactive methods, eg RCA
Active participation in reporting systems ‘Should we report this?’
Embrace risk assessment methodology – identify and manage your risks
30 Step 4 – Promote reporting
Reporting of patient safety incidents provides the opportunity to ensure that learning from what
happened to one patient can reduce the risk of the same thing happening to another patient
Reporting should be simple, timely, confidential (?anonymous), and have feedback mechanisms
31 Step 4 – Best Practice Report locally Learn and share locally
Report nationally
Involve patients and public in reporting and learning
32 Step 5 – Involve and communicate with patients and the public
Patients’ expertise and experience can be used to identify risks and devise solutions to patient safety
problems
Staff need to include patients in identifying risks and in helping to protect themselves from harm
Being open when things have gone wrong can help patients cope better afterwards
33 Step 5 – Best Practice
Actively involve patients in safety culture and activity eg section on safety in annual reports, patient
reps in risk assessments
Seek patient views and comments
Be open when things go wrong (‘Being open’ tool from NPSA available online)
34 Step 6 – Learn and share safety lessons
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Root cause analysis
Intensive technique
Usually for most serious incidents (deaths or multiple cases of harm)
Normally at organisational level
Requires trained facilitators
Learning can be shared
Significant Event Audit
Developed in general practice and promoted by RCGP
Team based
Can link to conventional audit
Can be themed
Powerful driver for change
Learning can be shared
35 Step 6 – Best Practice Regular structured SEA meetings
Respond quickly when there are important events or when high risks are identified
Involve patients
Learn lessons and put learning into practice – don’t be doomed to see the same event happening
over and over again
36 Step 7 – Implement solutions to prevent harm
Design systems that make it easy for people to do the right thing and difficult for them to do the
wrong thing
Solutions that rely on physical barriers are far more effective than those that rely on human
behaviour and action
Solutions should be risk assessed, evaluated and sustainable in the long term
37 Step 7 – Best Practice Actively consider solutions in SEA meetings
What have others done?
What ideas can we get from staff and patients?
Formal risk assessment of solutions
Share your solutions with others
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38 Where are we now? Increased awareness Enlistment of stakeholders
Safety campaigns – 100,000 Lives in USA
Leadership - ‘Safety First’, Dec 2006
Translating to action?
What are they actually doing?
WHO – Safer Surgery
What is happening in New Zealand?
39 From ‘Seven steps’ to ‘Next steps’
Need safety culture to tackle safety problems, e.g. Infection control needs ALL Seven Steps
Professional understanding and ownership – especially safety culture and human factors
Work with safety professionals – a pilot or an engineer on every Healthcare Board?
Research and evaluation to demonstrate clinical and financial benefits
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