Clinical Risk Management Health is a Risky Business

1. Clinical Risk ManagementHealth is a Risky Business Elizabeth J Haxby Lead Clinician in Clinical Risk Royal Brompton and Harefield NHS Trust

2. Department of Health • The New NHS: Modern , dependable (1997) • A first class service:Quality in the new NHS (1998) • The NHS Plan: A plan for investment , a plan for reform (2000)

3. The new NHS- modern, dependable • 10 year modernisation strategy • Focus on the quality of care • Clinical Governance

4. Clinical Governance DOH 1997 ‘…this central plank of government policy will transform the health service putting ‘quality’ at its ‘heart’. Its adoption will ‘assure and improve clinical standards’ throughout the service providing that ‘good practice is disseminated and systems in place to ensure constructive improvements in clinical care’

5. Prof Liam Donaldson CMO 98/99 ‘ This is probably the most important development in the NHS for 30 years and will have profound implications for every hospital and primary care service as well as individual doctors and other healthcare professionals’ ‘The introduction of clinical governance, aimed as it is at improving the quality of clinical care at all levels of healthcare provision is by far the most ambitious quality improvement initiative that will ever have been implemented in the NHS.

6. Clinical Governance ‘ A framework through which NHS Trusts are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish’ Scally G, Donaldson LJ Clinical governance and the drive for quality improvement in the NHS in England BMJ 1998:61-64

7. New NHS – a First Class service – Quality in the NHS (1998) • Clear National Quality Standards • NSFs, NICE • Dependable local delivery • Risk management, ACE reporting • Strong monitoring mechanisms • CHI • NPSA www.doh.gov.uk/nnhsind.htm

9. Strategy • Arrangements for setting clear national quality standards through NSFs and NICE • Mechanisms for ensuring local delivery of high quality clinical services through clinical governance reinforced by a new statutory duty of quality and supported by programmes of life-long learning and local delivery of professional self regulation • Effective systems for monitoring delivery of quality standards in the form of a new statutory CHI and an NHS performance assessment framework together with national surveys of patient and user experience.

10. Clinical Governance

11. Clinical Governance

12. Clinical Governance • NHS culture change • Openness and participation • Education and research valued • Learning from failure • ‘Just blame’ • Good practice and new approaches shared

15. Clinical Governance -as assessed by CHI • Patient involvement • Risk Management • Clinical Audit • Staffing and management • Education and training • Clinical Effectiveness • Use of information www.chi.nhs.uk

17. Quality • Setting clear standards • Accountability for service quality • Measures to ensure quality assured practice by NHS staff • Effective systems of ACE reporting . Analysis, learning and risk management to enhance patient safety • Robust inspection system • Spread good practice • Active participation and information for patients

18. Standards for Risk Management • NHS plan • RPST • CNST/NHSLA • Controls assurance • HSE • National Inquiries (Bristol) • (Human Rights Act 1998)

19. Risk Pooling Scheme for Trusts (RPST) • Development and promotion of good risk management systems • Framework to focus risk management systems • improve patient care • organisational safety • Compliance ensures • fewer claims • reduced scheme contributions

20. CNST Requires as a condition of discounted premiums, the development of clinical incident reporting systems for compliance with its risk management standards.

21. Controls assurance ‘…..Controls assurance project requires that boards of health authorities, NHS Trusts and Primary Care Trusts satisfy themselves that systems are in place to ensure that risks are assessed and properly managed…, www.casu.org.uk May 2001

22. Controls assurance ‘…..Controls assurance project requires that boards of health authorities, NHS Trusts and Primary Care Trusts satisfy themselves that systems are in place to ensure that risks are assessed and properly managed…, www.casu.org.uk May 2001

23. Bristol Inquiry • CPD • Appraisal • Revalidation ‘ should be compulsory for all healthcare professionals’

24. Fundamentals of Risk Management • Improve quality and safety • Identify improvements in processes and outcomes • Minimise the cost of failure

25. Definition of Risk ‘ a risk is the likelihood of potential harm from a hazard being realised. The extent of that risk will depend on the likelihood of that harm occurring, the potential severity of that harm and the population which might be affected by the hazard’ ‘..risk is the chance, high or low, that somebody will be harmed by a hazard’ Health and Safety Executive

26. Risk Management A systematic process for the identification,analysis and control of actual and potential risks and their resource implications. This will include risks to people, structure, reputation and any other issues which could impact upon or compromise the ability of the Trust to carry out is normal activities

27. Clinical Risk ManagementAims • Improve quality of care by reducing number of occasions when harm occurs • Identification of causes (‘root cause analyses’) • Local or trust-wide action to improve quality • Need to encourage ‘blame free’ culture • Reduce costs of clinical negligence claims • Early identification of potential claims • Active claims management

28. Patients ‘…..with that complexity comes an inevitable risk that at times things will go wrong……..the stakes are higher than in almost any other sphere of human activity’ ‘….the challenge is to ensure that the modern NHS is as safe as possible for patients.’ Secretary of State for Health

31. Clinical Adverse Events • Harvard Medical Practice study (1984) 3.7% • Australian Healthcare Study (1994) 16.6% • English pilot study (2001) 10.8%

32. Harvard Medical Practice Study Incidence of adverse events and negligence in hospitalised patients Brennan TA, Leape L et al NEJM 1991;324:370-6

33. HMPS • To develop more current and reliable estimates of the incidence of ACEs and negligence in hospitalised patients • ACE – injuries caused by medical management that prolonged hospitalisation, produced a disability at time of discharge or both • 51 acute hospitals in NYS in 1984 • 30,121 randomly selected records

34. HMPS • Two-stage screening process • Initial screen by trained nurses / medical records analysts • If positive reviewed by two doctors independently • Causation score • Disability score • Negligence factor • Specialists available for consultation • Reliability and validity tested

35. HMPS • ACEs occurred in 3.7% of hospitalisations • 27.6% of ACEs due to negligence • 70.5% of ACEs resulted in disability <6/12 • 2.6% ACEs resulted in permanent disabling injuries • 13.6% of ACEs resulted in death • 50.3% of deaths from ACEs due to negligence • 69% human error • ACE rate increased with age

36. QAHS Quality in Australian Health Care Study Wilson RM, Runciman et al Med J Aust 1995;163:458-471

37. QAHS • Goal to estimate patient injury and its direct consequences caused by healthcare in Australian hospitals • Quality improvement, measure of preventability to replace negligence in HMPS • 28 hospitals in NSW & SA in 1992 • 14,129 randomly selected records

38. QAHS • ACE – an unintended injury or complication which results in disability, death or prolongation of hospital stay and is caused by healthcare management rather than the patient’s disease • Two stage screening process • Presence on ACE (18 explicit criteria) • Disability • Causation • Preventability • Association with complexity, urgency and expected benefits • Type of error

39. Unplanned admission before index admission Unplanned readmission Hospital incurred injury Adverse drug reaction Unplanned transfer to ITU Unplanned transfer to other unit Unplanned return to theatre Unplanned organ injury/removal Other complications MI/CVA/PE Development of neurological deficit Unexpected death Inappropriate discharge Cardiac / Resp arrest / low APGAR Delivery / abortion injury Hospital acquired sepsis Documented dissatisfaction with care Litigation correspondence Any other undesirable outcome QAHS ACE criteria

40. QAHS • 16.6% of admissions associated with an ACE • 77.1% disability resolved within 12 months • 13.7% resulted in permanent disability • 4.9% resulted in death • 51% of ACEs were considered preventable • ACEs accounted for 7.1 additional days in hospital • ‘decision –making’ ACEs associated with increased preventability, permanent disability and death

41. QAHS • A high proportion of ACEs resulting in permanent disability or death occurred among; • Complex cases • Urgent cases • Cases in which management was considered life saving • Cases in which management was expected to provide major improvement in quality of life • Nearly half of all deaths occurred in association with life-saving interventions • 46.8% of all ACEs occurred in the OR • 10.8% of ACEs were drug related

42. QAHS Preventability • Failure to take precautions to prevent accidental injury • Failure in technical performance • Failure to employ indicated tests • Avoidable delays in treatment • Failure to act on results of tests or findings • Failure to take adequate history / examination • Practice outside area of expertise • Errors of omission 52% of ACEs • Errors of commission 27% • ACEs accounted for 8% of bed days at a cost of $4.7Bn

43. QAHS • Areas to which efforts should be redirected to prevent recurrence of ACEs • Quality assurance / peer review • Education • System Change • Communication Human error is a prominent cause of adverse clinical events. The implication in terms of preventable adverse outcomes for patients are substantial.

44. British Study Adverse Events in British Hospitals:preliminary retrospective review Vincent C, Neale G,Woloshynowych M BMJ 2001;322:517-19

45. British Study • Goal – to examine the feasibility of detecting ACEs through record review in British hospitals and make preliminary estimates of the incidence and cost of ACEs • 500 randomly drawn records from 2 acute trusts in north London • HMPS screening procedure and criteria

46. British Study • 10.8% of patients experienced an ACE • A third of these lead to moderate or greater impairment • In 8% ACE contributed to death • 48% of ACEs judged preventable • Preventable ACEs cost the NHS £1 bn per year in terms of additional bed days.

47. Why are they different? • Worse health care in Australia? • Availability of information? • Different definitions of ACEs • Different inclusion criteria • Discrepancies between 1st and 2nd stage reviews • Timing • Multicentre studies with pooling of data • No post-mortem data

48. Retrospective Review • Quality of documentation and availability of notes • ACE definition • Recording of events • Context of event • Timing of review • Subjective • New treatments • Balance of risks • Assessment of Causation and Preventability is complex • Life expectancy / Limited care • No near miss data

49. What is known • 400 people die or are seriously injured in ACEs involving medical devices • Almost 1000 people experience serious adverse reactions to drugs • Approximately 1150 people who have recent contact with MHS commit suicide

50. What is known • 28,000 written complaints are received which related to clinical care • 400 million is paid in compensation for clinical negligence claims (potential liability 2.4 billion) • Hospital acquired infection costs an estimated 1 billion