Risk Management and Patient Safety
      Evolution and Progress
                       Madrid
                    February...
Terminology
   Health and Safety
   Risk management
   – Legal and financial issues
   – Protecting the organisation
   Cl...
Consequences of serious adverse
events for patients & families
   Death of neonates, children, adults
   Loss of womb in y...
In their own words

   Hysterectomy left me in pain and incontinent ... later I had
   ovaries removed and bladder repair ...
Facing up to the problem
1980s
– Quality initiatives & monitoring of care
– Rising litigation, financial and legal solutio...
From risk management to
      patient safety
Mid 1990s.
– Clinical risk management
– Human factors and understanding error...
An Organisation with a Memory
Learning from adverse events in the NHS

   Every year in Britain:
      400 people die or a...
“Medicine used to be simple,
ineffective and relatively safe.
Now it is complex, effective and
potentially dangerous”


  ...
The Epidemiology of Harm
Harvard Medical Practice Study
   An unintended injury caused by medical
   treatment
   Two stage record review
   3.7% o...
London Pilot Study
Percentage of patients who experienced an AE


                            5.7%
                       ...
Cost of adverse events
   8 million admissions per year in England
   856,000 adverse events
   Average of 8.7 extra days ...
International Perspective
   Australia (1995)           16.6%
   United Kingdom (2001)      10.8%
   Denmark (2002)       ...
Understanding Adverse Events
Person versus System
      explanations
Person Centred View
– Focuses on those at the `sharp end’
– Individual responsibil...
|Obstetric example
Care delivery problems

     The significance of the decelerations on the
     CTG trace were not given...
Wider features of the unit
Contributory factors
No clear demarcation of roles and responsibilities and
no agreed line of c...
Stages of development of organisational accident
                       Contributory
Organisational &                     ...
Framework for the analysis of risk and
safety in medicine
   Patient factors
   Task factors
   Individual staff factors
 ...
A Window on the System
 Systems analysis of clinical incidents
  –   Root cause terminology highly misleading
  –   Comple...
Enhancing safety
Incident reporting: local systems
   Assume massive under-reporting
   It’s communication not counting
   Incident reports...
Beyond reporting
   Record review
    – Now feasible at local level
    – Systematic review of error and harm
   Executive...
UK National Patient Safety Agency
   National Reporting & Learning System
   – Frequency and contributory factors
   – Cul...
Safety in practice: generic issues
   Are the foundations in place?
   – Safety awareness
   – Safety culture
   Leadershi...
Culture and leadership
    Culture important but evidence weak
   No blame culture?
   `Open and fair’ culture
    – To en...
Safety paradigms
   Clinical innovations
   Standardisation and process improvement
    – Automation
    – Information tec...
Specific Clinical Interventions
(Agency for Healthcare Research and Quality)

      Prophylaxis to prevent venous
      th...
Prophylaxis to prevent venous
thromboembolism
    VTE frequent, painful, dangerous, wastes
    resources and is sometimes ...
Conflicting Visions of Safety?



 Replace or             Practitioners
 support human
                        create safe...
How is safety achieved?
   Contrasting visions
Replace or support      Practitioners create
human beings            safety...
Reducing medication error
Multi-level interventions:
Compliance with hand hygiene in Geneva

    Senior management backing
     – Funding and safety...
Multi-level interventions:
Reducing medical errors at Wimmera Hospital
     Senior management backing
      – Executive ch...
The Aftermath
   Caring for patients
   – Explanations, apology, making sure it does not
     happen again
   – Longer ter...
Sources & Information
   Research, books, papers and downloads of case
   analysis methods
    – www.csru.org.uk
   Nation...
Risk Management and Patient Safety Evolution and Progress
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Risk Management and Patient Safety Evolution and Progress

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Risk Management and Patient Safety Evolution and Progress. Charles Vincent. Match Safety critical component of quality (Madrid, Ministry of Health and Consumer Affairs, 2005)

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Risk Management and Patient Safety Evolution and Progress

  1. 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. 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. 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. 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. 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. 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. 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
  8. 8. “Medicine used to be simple, ineffective and relatively safe. Now it is complex, effective and potentially dangerous” Chantler, Lancet 1999, 353:1178-81
  9. 9. The Epidemiology of Harm
  10. 10. 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
  11. 11. 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
  12. 12. 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
  13. 13. 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’
  14. 14. Understanding Adverse Events
  15. 15. 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
  16. 16. |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
  17. 17. 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
  18. 18. 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
  19. 19. 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
  20. 20. 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
  21. 21. Enhancing safety
  22. 22. 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
  23. 23. 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
  24. 24. 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
  25. 25. Safety in practice: generic issues Are the foundations in place? – Safety awareness – Safety culture Leadership – Clinical – Management – National Regulatory pressure may assist
  26. 26. 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?
  27. 27. Safety paradigms Clinical innovations Standardisation and process improvement – Automation – Information technology People create safety – Individuals – Teams
  28. 28. 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
  29. 29. 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
  30. 30. Conflicting Visions of Safety? Replace or Practitioners support human create safety beings
  31. 31. 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
  32. 32. Reducing medication error
  33. 33. 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.
  34. 34. 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.
  35. 35. 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
  36. 36. 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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