Background to Clinical Risk Management and Root Cause Analysis

1. Background to Clinical Risk Management and Root Cause Analysis Dr Lee Gruner BSc, MBBS, BHA, FRACMA, MBA (Executive) GAICD Dr Lee Gruner 2004

2. Major medical error studies • Harvard Medical Practice Study (1984) • Reviewed medical charts of 30,121 patients admitted to 51 acute care hospitals in New York state in 1984 • In 3.7% an adverse event led to prolonged admission or produced disability at the time of discharge • 69% of injuries were caused by errors Dr Lee Gruner 2004

3. Major medical error studies • Australian Quality in Healthcare study (1995) • Investigators reviewed the medical records of 14,179 admissions to 28 hospitals in New South Wales and South Australia in 1995. • An adverse event occurred in 16.6% of admissions, resulting in permanent disability in 13.7% of patients and death in 4.9% • 51% of adverse events were considered to have been preventable. Dr Lee Gruner 2004

4. Results of medical error • In Australia medical error results in 18,000 unnecessary deaths and more than 50,000 disabled patients per year • In the USA, medical error results in at least 44,000 unnecessary deaths and over 1,000,000 excess injuries per year Dr Lee Gruner 2004

5. Origins of Clinical Risk Management “Most people view medical mistakes as an individual provider issue rather than a failure in the process of delivering care in a complex delivery system. When asked about possible solutions to prevent medical mistakes actions rated effective by respondents were “keeping health professionals with bad track records from providing care” and “better training of health professionals” ( To Err is Human, 1999) Dr Lee Gruner 2004

6. Developing a systems approach • Research into adverse events in the aviation industry have supported the systems approach • Don Berwick contends the “bad apples” approach is inappropriate: • worst mistakes often made by the best people • error provoking states of mind are the last and least manageable in the error sequence Dr Lee Gruner 2004

7. Developing a systems approach • A systems approach is based on: • same situations lead to the same errors regardless of who is involved • no single best way to prevent error • fallibility is part of being human • important features are the chain of events, actions of individuals, conditions of work and contextual issues • blame lies with the system at least 60% of the time Dr Lee Gruner 2004

8. Why does medical error rate continue to be so high? • Lack of awareness of the extent of the problem • major errors are uncommon and regarded as outliers • most errors do not harm the patient • Professional staff have great difficulty in dealing with human error when it does occur • powerful emphasis in medicine on perfection • error is regarded as a failure of character “you weren't careful enough” “ you didn’t try hard enough” • error = negligence • role models enforce concept of infallibility Dr Lee Gruner 2004

9. Why does medical error rate continue to be so high? • Learnings are not shared • errors covered up • mistakes not evaluated • learn from mistakes in a vacuum • Realities of medico-legal action • incentives against disclosure Dr Lee Gruner 2004

10. Standard approaches • If professionals were properly trained and motivated there would be no errors • Training and/or punishment will fix the problem • The individual is at fault- “bad apple” theory • Underlying causes of error not explored • More emphasis on inspection and quality control Dr Lee Gruner 2004

11. Evidence from human factor and psychological research • Human performance is classified into: • skill based • rule based • knowledge based • Errors are classified as: • Active failures • Slips • Mistakes • Violations • Latent failures • Provide conditions in which unsafe acts occur, usually stemming from decisions of those not directly involved in the workplace Dr Lee Gruner 2004

12. Evidence from human factor and psychological research • Slips: • errors of action • due to break in routine when attention is diverted • influenced by sleep loss, drugs, illness, anxiety Dr Lee Gruner 2004

13. Example of an error • Car accident while fiddling with the radio • Affixing wrong drug label while talking to someone • Picking up the wrong ampoule while in a hurry Dr Lee Gruner 2004

14. Evidence from human factor and psychological research • Mistakes • rule or knowledge based errors • use the wrong rule • lack of knowledge or misinterpretation of the problem • bias may play a significant part- paradigm theory Dr Lee Gruner 2004

15. Example of a mistake • Methotrexate prescribed for patient admitted for elective surgery at a dosage of 15 mg per day • Prescribed by a junior doctor • Actual dose should have been 15 mg per week • Patient died a week later of neutropaenia Dr Lee Gruner 2004

16. Evidence from human factor and psychological research • Violations • Deviations from safe operating practice usually associated with motivational problems eg poor morale/ poor riole modelling/ deficient management Dr Lee Gruner 2004

17. Example of a violation Dr Lee Gruner 2004

18. Example of a violation Dr Lee Gruner 2004

19. Relationship to adult learning theory SELF AWARENESS • LOW HIGH LOW HIGH Conscious Incompetence Unconscious Incompetence LOW COMPETENCE Unconscious Competence Conscious Competence HIGH LOW Dr Lee Gruner 2004

20. Latent errors • Three Mile Island incident 1979 • Chernobyl 1986 / Bhopal 1984 • poor system design implicated • operator error only part of the explanation- proximal cause • root causes present in the system for a long time i.e. accidents waiting to happen Dr Lee Gruner 2004

21. Accident Prevention • Must focus on: • Root causes- systems errors in design and implementation • don’t develop solutions to the unsafe acts themselves • developing methods of error reduction at each stage of system development • design features that correct for human and mechanical errors and minimise errors • simplification, use of constraints, standardisation Dr Lee Gruner 2004

22. Systems changes to reduce hospital injuries • Discovery of errors • Prevention of errors • Absorption of errors • Psychological precursors Dr Lee Gruner 2004

23. Discovery of errors • Efficient routine identification of errors as part of normal practice • Routine investigation of all errors that cause injury • Collect relevant data as this will reduce expenses in the longer term Dr Lee Gruner 2004

24. Error prevention in hospitals • Reduce reliance on memory • check lists/ protocols/ decision aids • Improve information access • creative ways to provide information where and when needed • Error proofing • “forcing functions” • Standardisation • Training • How to prevent errors/ problem solving techniques • Better supervision of junior staff • Safe practice is as important as effective practice Dr Lee Gruner 2004

25. Turn the swiss cheese into a solid cheddar Dr Lee Gruner 2004

26. Absorption of errors • Impossible to prevent all errors • Need to build barriers into the system to prevent harm to patients Dr Lee Gruner 2004

27. Psychological precursors • Assess work schedules, division of responsibilities,task descriptions, management decisions • These can lead to time pressure and fatigue with an impact on safety • Develop a supportive environment • Eliminate fear Dr Lee Gruner 2004

28. Lessons from King Edward Memorial Hospital • Issues relating to poor child and maternal outcomes dating back over 10 years • Three reviews in 3 years culminating in the Douglas Enquiry in 1999 • Douglas Enquiry focused on areas for improvement and high risk cases • Findings related to management / medical staff and clinical practice issues Dr Lee Gruner 2004

29. Lessons from King Edward Memorial Hospital • Management failed to: • Make important decisions • Create an open and transparent culture • Monitor safety and quality • Ensure proper supervision/ training of staff • Define accountability and reporting responsibility • Address serious issues relating to adverse pt outcomes • Respond adequately to complaints Dr Lee Gruner 2004

30. Lessons from King Edward Memorial Hospital • Senior doctor procedures deficient: • Insufficient involvement in complex cases • Inadequate decisions • Inadequate credentialling and appointment procedures • Inadequate performance management • Inadequate supervision of junior staff • Failed to provide timely analysis of staffing needs Dr Lee Gruner 2004

31. Lessons from King Edward Memorial Hospital • Junior doctor work practices: • Did much of the complex work • Poorly supervised • Requests for help ignored • Blamed for errors • Sink or swim culture • Inadequate orientation and training Dr Lee Gruner 2004

32. Lessons from King Edward Memorial Hospital • Clinical practice issues: • Little best practice • Poor outcomes • No benchmarking Dr Lee Gruner 2004

33. Clinical governance • A framework through which organisations are accountable for continually improving the quality of services and safeguarding standards of care by creating an environment in which clinical care will flourish Dr Lee Gruner 2004

34. Clinical governance Aims to ensure that: • systems to monitor the quality of clinical practice are in place and functioning properly • clinical practices are reviewed and improved • clinical practitioners meet standards set by regulatory bodies Dr Lee Gruner 2004

35. Elements of clinical governance • Human resource systems • Review of clinical practice • External assessment of practice • Commitment to ongoing education Dr Lee Gruner 2004

36. Human resource systems • Medical appointments and credentialing systems • Effective management of poorly performing colleagues • Management of the clinical performance of colleagues , developing guidelines and protocols Dr Lee Gruner 2004

37. Review of clinical practice • Clinical audit • Evidence based clinical practice • Implementation of clinical effectiveness evidence • Risk management Dr Lee Gruner 2004

38. Commitment to ongoing education • Continuing education for all clinical staff • Development of clinical leadership skills • Continuing professional development for all staff Dr Lee Gruner 2004

39. Use of root cause analysis • To uncover latent errors (errors of system design) underlying an adverse (sentinel) event • Structured, process focused approach • Avoids individual blame • Identifies and addresses systems and organisational issues Dr Lee Gruner 2004

40. Limitations of RCA • Impossible to know if the root cause established by the analysis is the actual cause of the incident • May be tainted by hindsight bias • May be bias relating to prevailing concerns in the organisation • Time consuming and labour intensive • Qualitative rather than quantitative Dr Lee Gruner 2004

41. Use of RCA • Needs to be regular enough for staff to develop skills • Decision to conduct an RCA depends on organisational leadership • Needs to be conducted for all DHS reportable sentinel events • Only one detailed study of regular use of RCA and its outcomes • RCA and follow up of serious drug events over 12 month period led to a 45% decline in ADEs attributed to blame free RCA and changes in policy and process Dr Lee Gruner 2004