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Risk Management and Patient Safety
      Evolution and Progress
                       Madrid
                    February 2005


                   Charles Vincent
          Professor of Clinical Safety Research
      Department of Surgical Oncology & Technology
                Imperial College London
                     www.csru.org.uk
Terminology
   Health and Safety
   Risk management
   – Legal and financial issues
   – Protecting the organisation
   Clinical risk management
   – Understanding and prevention of harm
   – Support for staff and patients
   Patient Safety
Consequences of serious adverse
events for patients & families
   Death of neonates, children, adults
   Loss of womb in young women
   Untreated cancer, mastectomy
   Blindness
   Disability and handicap, children and adults
   Chronic pain, scarring, incontinence
   Profound effects on all aspects of their lives

                                  Vincent, Young & Phillips, 1994
In their own words

   Hysterectomy left me in pain and incontinent ... later I had
   ovaries removed and bladder repair op ...unable to empty my
   bladder completely as my urethra had been stitched almost
   closed ... major bowel problems , left with life-threatening
   condition and completely incontinent
   While under anaesthetic they apparently cut a blood vessel in
   my womb, which led to severe haemorrhage .. could only be
   stopped by giving me a hysterectomy so they say
   A swelling on my cheek was diagnosed as a malignant tumour
   and part of my jaw and extensive tissue was removed without
   my consent. The lab. test showed that it was not a tumour,
   malignant or benign

                                        Vincent et al, Lancet 1994
Facing up to the problem
1980s
– Quality initiatives & monitoring of care
– Rising litigation, financial and legal solutions
– Little research: a case of negligence?
Early 1990s -
– Epidemiology
– Analysis of claims
– Awareness of underlying clinical problems
From risk management to
      patient safety
Mid 1990s.
– Clinical risk management
– Human factors and understanding errors
Late 1990s to present
– Major reports in US, UK and Australia
– UK National Patient Safety Agency
World Health Organisation Resolutions
– World Alliance for Patient Safety
An Organisation with a Memory
Learning from adverse events in the NHS

   Every year in Britain:
      400 people die or are seriously injured in events
      involving medical devices
      10,000 reported serious adverse drug reactions
      1,150 suicides by people in recent contact with
      mental health services
      NHS pays £400 million in litigation
      Hospital acquired infections cost nearly
      £1billion and 15% are regarded as preventable
Risk Management and Patient Safety Evolution and Progress
“Medicine used to be simple,
ineffective and relatively safe.
Now it is complex, effective and
potentially dangerous”


                    Chantler, Lancet 1999, 353:1178-81
The Epidemiology of Harm
Harvard Medical Practice Study
   An unintended injury caused by medical
   treatment
   Two stage record review
   3.7% of admissions involve adverse event
    – 13% of adverse events involve death
    – 7% lead to long term disability
    – 16 times as many negligent adverse events as
      paid claims
London Pilot Study
Percentage of patients who experienced an AE


                            5.7%
                                          5.1%




 89.2%

    Patients with unpreventable AE    Patients with preventable AE
    No adverse event

                                     Vincent, Neale, Woloshynowych 2001
Cost of adverse events
   8 million admissions per year in England
   856,000 adverse events
   Average of 8.7 extra days in hospital
    – Specialty costs £171 - 305 per day
   Cost in extra days in hospital
    – £2 billion per annum
    – £1 billion for preventable AEs
International Perspective
   Australia (1995)           16.6%
   United Kingdom (2001)      10.8%
   Denmark (2002)             9.0%
   New Zealand                11.2%
   Canada (2004)              7.5%

   `In effect a new public health risk’
Understanding Adverse Events
Person versus System
      explanations
Person Centred View
– Focuses on those at the `sharp end’
– Individual responsibility and blame
– Countermeasures aimed at changing
  individuals’ behaviour
System View
– Human beings fallible, errors to be expected
– Focus on factors influencing errors
– Countermeasures aimed at conditions of work
|Obstetric example
Care delivery problems

     The significance of the decelerations on the
     CTG trace were not given sufficient weight
     The midwife did not reduce the syntocinon
     as soon as she saw the deteriorating trace
     The consultant overrode the decision of the
     team without considering their arguments
     The sister was ‘forced’ to induce more
     evident signs of fetal distress
Wider features of the unit
Contributory factors
No clear demarcation of roles and responsibilities and
no agreed line of communication in a crisis
Inadequate training for CTG interpretation
Staff assumed faults in machines rather than fetal
distress
General acceptance of faulty equipment
No system to ensure lessons learnt from serious
incidents
Stages of development of organisational accident
                       Contributory
Organisational &                                            Defence
                    factors influencing   Care Management
Corporate Culture                                           Barriers
                      clinical practice       Problems




                           Error
                                                                       Accident/Incident
                                               Errors
                         Producing
                         Conditions
 Management
 Decisions and
 Organisational
 Processes

                         Violation
                                             Violations
                         Producing
                         Conditions
Framework for the analysis of risk and
safety in medicine
   Patient factors
   Task factors
   Individual staff factors
   Team Factors
   Work environment
   Organisation and management
   Institutional context
A Window on the System
 Systems analysis of clinical incidents
  –   Root cause terminology highly misleading
  –   Complexity of events and contributory factors
  –   Moving away from blame
  –   Looking to the future and
  –   Generating plans for action
Enhancing safety
Incident reporting: local systems
   Assume massive under-reporting
   It’s communication not counting
   Incident reports act to flag issues and to
   provide warnings
   Analysis of incidents often neglected but
   can be very informative
Beyond reporting
   Record review
    – Now feasible at local level
    – Systematic review of error and harm
   Executive walk rounds
   Case analysis
   Process analysis
    – Failure, modes and effects analyses
   Observation
UK National Patient Safety Agency
   National Reporting & Learning System
   – Frequency and contributory factors
   – Cultural importance
   Patient Safety Observatory
   Development of solutions
   Training in root cause analysis
   Open disclosure policy
Safety in practice: generic issues
   Are the foundations in place?
   – Safety awareness
   – Safety culture
   Leadership
   – Clinical
   – Management
   – National
   Regulatory pressure may assist
Culture and leadership
    Culture important but evidence weak
   No blame culture?
   `Open and fair’ culture
    – To encourage reporting
    – To encourage discussion of error and harm
    – To support injured patients and staff
   High reliability culture?
Safety paradigms
   Clinical innovations
   Standardisation and process improvement
    – Automation
    – Information technology
   People create safety
    – Individuals
    – Teams
Specific Clinical Interventions
(Agency for Healthcare Research and Quality)

      Prophylaxis to prevent venous
      thromboembolism
      Perioperative betablockers to prevent
      morbidity
      Sterile barriers while placing central
      intravenous catheters
      Antibiotic prophylaxis in surgical patients
Prophylaxis to prevent venous
thromboembolism
    VTE frequent, painful, dangerous, wastes
    resources and is sometimes fatal
    – Without prophylaxis occurs in 20% of surgical
      operations, 50% orthopaedic
    – In US 10% of surgeons never use prophylaxis
    Focus of patient safety is on the omissions
    rather than the clinical intervention
Conflicting Visions of Safety?



 Replace or             Practitioners
 support human
                        create safety
 beings
How is safety achieved?
   Contrasting visions
Replace or support      Practitioners create
human beings            safety
– Design and            – New & enhanced skills
  standardisation       – High reliability
– Protocols &             organisations
  guidelines            – Mindfulness & hazard
– Information             awareness
  technology            – Studying success and
– Technical solutions     recovery
Reducing medication error
Multi-level interventions:
Compliance with hand hygiene in Geneva

    Senior management backing
     – Funding and safety culture
    Working conditions
     – Availability of cleaning solution
    Team based interventions
    Educational campaign for individual staff
    Task
     – Design of new containers


                                     Pittet et al. Lancet (2000), 356, 1307-12.
Multi-level interventions:
Reducing medical errors at Wimmera Hospital
     Senior management backing
      – Executive champions and dedicated staff
     Working conditions
      – Reviewing working hours and workload
     Multidisciplinary action team
      – Addressing levels of supervision
     Training in risk management and patient safety
     Task
      – Simplifying systems
      – Standardising procedures
      – Reminders and checklists


                                    Wolff & Bourke Med J Aust 2000; 173:247-251.
The Aftermath
   Caring for patients
   – Explanations, apology, making sure it does not
     happen again
   – Longer term support for some
   Supporting staff
   – Understanding of error
   – Professional and personal support
   – Potential long term effects
Sources & Information
   Research, books, papers and downloads of case
   analysis methods
    – www.csru.org.uk
   National Patient Safety Agency
    – www.npsa.nhs.uk
   Agency for Healthcare Research & Quality
    – www.ahcpr.gov/clinic/ptsafety
   Institute for Healthcare Improvement
   www.qualityhealthcare.org

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Risk Management and Patient Safety Evolution and Progress

  • 1. Risk Management and Patient Safety Evolution and Progress Madrid February 2005 Charles Vincent Professor of Clinical Safety Research Department of Surgical Oncology & Technology Imperial College London www.csru.org.uk
  • 2. Terminology Health and Safety Risk management – Legal and financial issues – Protecting the organisation Clinical risk management – Understanding and prevention of harm – Support for staff and patients Patient Safety
  • 3. Consequences of serious adverse events for patients & families Death of neonates, children, adults Loss of womb in young women Untreated cancer, mastectomy Blindness Disability and handicap, children and adults Chronic pain, scarring, incontinence Profound effects on all aspects of their lives Vincent, Young & Phillips, 1994
  • 4. In their own words Hysterectomy left me in pain and incontinent ... later I had ovaries removed and bladder repair op ...unable to empty my bladder completely as my urethra had been stitched almost closed ... major bowel problems , left with life-threatening condition and completely incontinent While under anaesthetic they apparently cut a blood vessel in my womb, which led to severe haemorrhage .. could only be stopped by giving me a hysterectomy so they say A swelling on my cheek was diagnosed as a malignant tumour and part of my jaw and extensive tissue was removed without my consent. The lab. test showed that it was not a tumour, malignant or benign Vincent et al, Lancet 1994
  • 5. Facing up to the problem 1980s – Quality initiatives & monitoring of care – Rising litigation, financial and legal solutions – Little research: a case of negligence? Early 1990s - – Epidemiology – Analysis of claims – Awareness of underlying clinical problems
  • 6. From risk management to patient safety Mid 1990s. – Clinical risk management – Human factors and understanding errors Late 1990s to present – Major reports in US, UK and Australia – UK National Patient Safety Agency World Health Organisation Resolutions – World Alliance for Patient Safety
  • 7. An Organisation with a Memory Learning from adverse events in the NHS Every year in Britain: 400 people die or are seriously injured in events involving medical devices 10,000 reported serious adverse drug reactions 1,150 suicides by people in recent contact with mental health services NHS pays £400 million in litigation Hospital acquired infections cost nearly £1billion and 15% are regarded as preventable
  • 9. “Medicine used to be simple, ineffective and relatively safe. Now it is complex, effective and potentially dangerous” Chantler, Lancet 1999, 353:1178-81
  • 11. Harvard Medical Practice Study An unintended injury caused by medical treatment Two stage record review 3.7% of admissions involve adverse event – 13% of adverse events involve death – 7% lead to long term disability – 16 times as many negligent adverse events as paid claims
  • 12. London Pilot Study Percentage of patients who experienced an AE 5.7% 5.1% 89.2% Patients with unpreventable AE Patients with preventable AE No adverse event Vincent, Neale, Woloshynowych 2001
  • 13. Cost of adverse events 8 million admissions per year in England 856,000 adverse events Average of 8.7 extra days in hospital – Specialty costs £171 - 305 per day Cost in extra days in hospital – £2 billion per annum – £1 billion for preventable AEs
  • 14. International Perspective Australia (1995) 16.6% United Kingdom (2001) 10.8% Denmark (2002) 9.0% New Zealand 11.2% Canada (2004) 7.5% `In effect a new public health risk’
  • 16. Person versus System explanations Person Centred View – Focuses on those at the `sharp end’ – Individual responsibility and blame – Countermeasures aimed at changing individuals’ behaviour System View – Human beings fallible, errors to be expected – Focus on factors influencing errors – Countermeasures aimed at conditions of work
  • 17. |Obstetric example Care delivery problems The significance of the decelerations on the CTG trace were not given sufficient weight The midwife did not reduce the syntocinon as soon as she saw the deteriorating trace The consultant overrode the decision of the team without considering their arguments The sister was ‘forced’ to induce more evident signs of fetal distress
  • 18. Wider features of the unit Contributory factors No clear demarcation of roles and responsibilities and no agreed line of communication in a crisis Inadequate training for CTG interpretation Staff assumed faults in machines rather than fetal distress General acceptance of faulty equipment No system to ensure lessons learnt from serious incidents
  • 19. Stages of development of organisational accident Contributory Organisational & Defence factors influencing Care Management Corporate Culture Barriers clinical practice Problems Error Accident/Incident Errors Producing Conditions Management Decisions and Organisational Processes Violation Violations Producing Conditions
  • 20. Framework for the analysis of risk and safety in medicine Patient factors Task factors Individual staff factors Team Factors Work environment Organisation and management Institutional context
  • 21. A Window on the System Systems analysis of clinical incidents – Root cause terminology highly misleading – Complexity of events and contributory factors – Moving away from blame – Looking to the future and – Generating plans for action
  • 23. Incident reporting: local systems Assume massive under-reporting It’s communication not counting Incident reports act to flag issues and to provide warnings Analysis of incidents often neglected but can be very informative
  • 24. Beyond reporting Record review – Now feasible at local level – Systematic review of error and harm Executive walk rounds Case analysis Process analysis – Failure, modes and effects analyses Observation
  • 25. UK National Patient Safety Agency National Reporting & Learning System – Frequency and contributory factors – Cultural importance Patient Safety Observatory Development of solutions Training in root cause analysis Open disclosure policy
  • 26. Safety in practice: generic issues Are the foundations in place? – Safety awareness – Safety culture Leadership – Clinical – Management – National Regulatory pressure may assist
  • 27. Culture and leadership Culture important but evidence weak No blame culture? `Open and fair’ culture – To encourage reporting – To encourage discussion of error and harm – To support injured patients and staff High reliability culture?
  • 28. Safety paradigms Clinical innovations Standardisation and process improvement – Automation – Information technology People create safety – Individuals – Teams
  • 29. Specific Clinical Interventions (Agency for Healthcare Research and Quality) Prophylaxis to prevent venous thromboembolism Perioperative betablockers to prevent morbidity Sterile barriers while placing central intravenous catheters Antibiotic prophylaxis in surgical patients
  • 30. Prophylaxis to prevent venous thromboembolism VTE frequent, painful, dangerous, wastes resources and is sometimes fatal – Without prophylaxis occurs in 20% of surgical operations, 50% orthopaedic – In US 10% of surgeons never use prophylaxis Focus of patient safety is on the omissions rather than the clinical intervention
  • 31. Conflicting Visions of Safety? Replace or Practitioners support human create safety beings
  • 32. How is safety achieved? Contrasting visions Replace or support Practitioners create human beings safety – Design and – New & enhanced skills standardisation – High reliability – Protocols & organisations guidelines – Mindfulness & hazard – Information awareness technology – Studying success and – Technical solutions recovery
  • 34. Multi-level interventions: Compliance with hand hygiene in Geneva Senior management backing – Funding and safety culture Working conditions – Availability of cleaning solution Team based interventions Educational campaign for individual staff Task – Design of new containers Pittet et al. Lancet (2000), 356, 1307-12.
  • 35. Multi-level interventions: Reducing medical errors at Wimmera Hospital Senior management backing – Executive champions and dedicated staff Working conditions – Reviewing working hours and workload Multidisciplinary action team – Addressing levels of supervision Training in risk management and patient safety Task – Simplifying systems – Standardising procedures – Reminders and checklists Wolff & Bourke Med J Aust 2000; 173:247-251.
  • 36. The Aftermath Caring for patients – Explanations, apology, making sure it does not happen again – Longer term support for some Supporting staff – Understanding of error – Professional and personal support – Potential long term effects
  • 37. Sources & Information Research, books, papers and downloads of case analysis methods – www.csru.org.uk National Patient Safety Agency – www.npsa.nhs.uk Agency for Healthcare Research & Quality – www.ahcpr.gov/clinic/ptsafety Institute for Healthcare Improvement www.qualityhealthcare.org