Root Cause Analysis Theory and Practical Application of adverse event investigations

1. Root Cause Analysis Theory and Practical Application of adverse event investigations MG Schoon

2. Definition • Any event in the chain of causes that, when acted upon by a solution, prevents the problem from recurring. Purpose • Identify causative factors and develop corrective strategies • To prevent adverse events/outcomes • Prevent harm • Improve quality care and patient safety

4. Near miss • A patient safety incident that did not cause harm • Near miss in pregnancy Adverse outcome that did not result in death

5. PATIENT SAFETY PREVENTION/ IMPROVEMENT TOOLS Patient satisfaction survey Patient complaints Adverse events assessments Dashboards/ trend analysis (trigger tools) Clinical audits Clinical case reviews Clinical guidelines & protocols Checklists Fire drills/ simulation exercises

6. Patient safety culture Patient safety is everybody’s business 

8. ROOT CAUSE ANALYSIS An effective tool for systematically identifying problems and analysing critical incidents to generate systems improvements

9. ROOT CAUSE ANALYSIS Find out: • What happened • Why did it happen • What can be done to reduce the likelihood of a recurrence

10. Cases that should not be subjected to RCA Events thought to be the result of a criminal act Purposefully unsafe acts (intended to cause harm) Acts related to substance abuse Events involving suspected patient abuse of any kind

11. Strong support from upper management It must be accepted that results of any given root cause analysis will be for improving situations, not for assigning blame Berry & Krizek

12. RCA 1. is inter-disciplinary, involving experts from the frontline services; 2. involves those who are the most familiar with the situation; 3. continually digs deeper by asking why, why, why at each level of cause and effect; 4. identifies changes that need to be made to systems; and 5. is as impartial as possible in order to make clear the need to be aware of and sensitive to potential conflicts of interest

13. Success depends on involvement of the attending physician, consulting specialist and other providers

14. Check for eligibility for RCA • Deliberate harm test • whether the actionswere as intended, not whether the outcomewas as intended • Incapacity test • Was a staff member ill or intoxicated • Foresight test • Did the individual depart from agreed protocols or safe procedures? • Substitution test • Would another individual coming from the same professional group, possessing comparable qualifications and experience, behave in the same way in similar circumstances?

15. RCA Steps Collect information Causal factor charting Root cause identification Recommendations

16. Overview of RCA Process AE occurs Evaluate Implement corrective action plan Patient safety reporting system ie Aims call centre 6262/6464 Initiate and complete RCA RCA required ? SAC rating YES NO No further action required

17. Collect information • Gather information already documented • Review health records • Flow chart/ timeline • Get additional information • Site visit • Interviews

18. Map timeline-chain of events Kitchen burn Mary fry chicken in pan Fire spread Mary leave pan unattended Throw water in pan Fire start on stove Mary come back – get fire extinguisher Fire extinguisher does not work

19. Causal factor charting Kitchen burn Mary fry chicken in pan Fire spread Mary leave pan unattended Throw water in pan Fire start on stove Mary come back – get fire extinguisher Electric burner short Melt hole in pan Oil leak and ignite Fire extinguisher does not work

20. Causal factor charting Kitchen burn Mary fry chicken in pan Fire spread Mary leave pan unattended Throw water in pan CF CF Fire start on stove Mary come back – get fire extinguisher Electric burner short Melt hole in pan Oil leak and ignite Fire extinguisher does not work CF CF

21. Knowing what adverse events occur is only the first step. Most adverse events result from a complex series of behaviours and failures in systems of care. Investigation of the patterns of adverse events requires unearthing the latent conditions and systemic flaws as well as the specific actions that contributed to these outcomes. Dr. G. Ross Baker & Dr. Peter Norton

22. Swiss cheese model most accidents can be traced to one or more of four levels of failure • Organizational influences, • unsafe supervision, • preconditions for unsafe acts, and • the unsafe acts themselves.

23. In many traditional analyses, the most visible causal factor is given all the attention

24. Root cause identification Do Root cause mapping of causal factors

25. Ishikawa diagrams Personnel Measurements Materials Environment Methods Equipment

26. Ishikawa diagrams Personnel Measurements Materials Shifts Alloys Callibration Training Lubricants Microscopes Suppliers Operators Inspections Angle Wear Humidity Callibration Speed Temperature Callibration Callibration Environment Methods Equipment

27. Causal factor charting Was that policy in use/known to mary? Kitchen burn Was there a policy regarding phone use in the kichen? Mary fry chicken in pan Fire spread Why did she answer the phone Mary leave pan unattended Why did mary leave the pan unattended? Throw water in pan CF CF Fire start on stove Mary come back – get fire extinguisher Electric burner short Melt hole in pan Oil leak and ignite Fire extinguisher does not work CF CF

28. Causal factor charting Kitchen burn Was the policy adhered to? Mary fry chicken in pan Is there a replacement policy? Fire spread Was the burner checked/ serviced? Mary leave pan unattended Throw water in pan Why did the electric burner short? CF CF Fire start on stove Mary come back – get fire extinguisher Electric burner short Melt hole in pan Oil leak and ignite Fire extinguisher does not work CF CF

29. Causal factor charting Kitchen burn Is fire drills done to practice fire emergency procedures? Mary fry chicken in pan Was Mary trained on the use of Fire extinguisher? Fire spread Was the fire extinguisher checked/ serviced? Mary leave pan unattended Throw water in pan Why did the fire extinguisher not work? CF CF Fire start on stove Mary come back – get fire extinguisher Electric burner short Melt hole in pan Oil leak and ignite Fire extinguisher does not work CF CF

30. Causal factor charting Kitchen burn Mary fry chicken in pan Fire spread Was the fire brigade called? Did whe call for help? Why Not? Mary leave pan unattended Throw water in pan Did Mary know how to extinguish an oil fire? CF CF Fire start on stove Mary come back – get fire extinguisher Electric burner short Melt hole in pan Oil leak and ignite Fire extinguisher does not work CF CF

31. Root cause summary

32. Root cause summary

33. Recommendations List the recommendations Write a report regarding the findings Suggest some implementation strategies

34. RCA Thoroughness 1. an understanding of how humans interact with their environment; 2. identification of potential problems related to processes and systems; 3. analysis of underlying cause and effect systems through a series of why questions; 4. identification of risks and their potential contributions to the event; 5. development of actions aimed at improving processes and systems; 6. measurement and evaluation of implementation of these actions; and 7. documentation of all steps (from the point of identification to the process of evaluation).

35. RCA credibility 1. include participation by the leadership of the organization and those most closely involved in the processes and systems; 2. be applied consistently according to organizational policy/procedure; and 3. include consideration of relevant literature.

36. Root cause analysis techniques Re-enactment ( computer or a simulator) Comparative re-enactment Re-construction-reassembling Barrier analysis Bayesian inference Change analysis - comparing the way an episode did happen with the way it was intended to happen. Current Reality Tree  Failure mode and effects analysis Fault tree analysis Five whys  Ishikawa diagrams  Why-Because analysis  Pareto analysis "80/20 rule" RPR Problem Diagnosis - Kepner-Tregoe Approach PROACT Approach  Project Management Approaches.

37. USE of training to reduce errors Training Too Little inaccuracy Training Optimal prevent errors Training Too much Inefficiency

38. The Institute of Medicine’s Six Elements of Quality 1. Patient safety. Are the risks of injury minimal for patients in the health system? 2. Effectiveness. Is the care provided scientifically sound and neither underused nor overused? 3. Patient centeredness. Is patient care being provided in a way that is respectful and responsive to a patient’s preferences, needs, and values? Are patient values guiding clinical decisions? 4. Timeliness. Are delays and waiting times minimized? 5. Efficiency. Is waste of equipment, supplies, ideas, and energy minimized? 6. Equity. Is care consistent across gender, ethnic, geographic, and socioeconomic lines? Source: Institute of Medicine 2001.

39. SUMMARY Investigation: The investigation takes place where the event took place. Get sufficient information by: Studying all relevant documents Obtaining reports and/or sworn statements Conducting interviews with complainant/patient/family and staff, as well as supervisors/management Doing observations Brainstorming sessions Determine cause of adverse event Determine whether precautionary and corrective measures are in place Write full report with recommendations to Management and DAEC/PAEC

40. Disclosure & Rationalisation Disclosure to non-physicians Disclosure to physicians Disclosure to patients Disclosure to facility Rationalisation to cover-up