Risk Assessment

1. Risk Assessment Dr Mike Rejman Risk Assessment Adviser

2. Why do Accidents Happen?

3. Why do Accidents Happen?

4. How do Accidents Happen? Organisation and processes - Deficiencies Prior conditions - basic causes & contributory factors “Unsafe” acts - active failures (SRK errors) Multiple Defences Patient Safety Incident

5. Understanding the Problem • ~ 80% of accidents are attributable to human factors, at the individual level, the organisational level, or more commonly both • This is a conservative figure and is irrespective of domain • To manage this we need to identify and understand the risks (causes and contributory factors) • Without this we can’t put appropriate remedial action in place

6. Seven Steps to Patient Safety • Build a safety culture • 2. Lead and support your staff • 3. Integrate your risk management activity • 4. Promote reporting • 5. Involve patients and the public • 6. Learn and share safety lessons • Implement solutions to prevent harm

7. Step 3 - Integrated Risk Management All risk management functions and information: patient safety, health and safety, complaints, clinical litigation, employment litigation, financial and environmental risk Training, management, analysis, assessment and investigations Processes and decisions about risks into business and strategic plans

8. Risky Jobs

9. Risky Jobs

10. Risk Assessment by Donald Rumsfeld As we know, There are known knowns. There are things we know we know. We also know there are known unknowns. That is to say We know there are some things we know we do not know. But there are also unknown unknowns - The ones we don’t know we don’t know.

11. 1 10 30 600 The Accident Iceberg accidents serious incidents incidents near misses & hazards

12. Prior Indicators of Risk • Challenger Space Shuttle • evidence of seals shrinking in cold temperatures, but political pressure to launch • Columbia Space Shuttle • long-standing problem with foam falling off (for 9 years) • even after Columbia disaster, a minority report noted at least 3 crucial issues not actioned • this endangered Discovery

13. Poor Design and Labelling

14. Poor Design and Labelling

15. Identifying Areas of Risk • Retrospective – learn lessons • Accidents and incidents, • Root Cause Analysis • Prospective – anticipate issues • Reporting systems, near misses, reported hazards • Prospective Risk Assessments, (proactive hazard assessment)

16. (H)FMEA (Healthcare) Failure Modes and Effects Analysis HACCP Hazard and Critical Control Points HAZOPS Hazard and Operability Studies PRA Probabilistic Risk Assessment SWIFT Structured ‘What If’ Technique HRA Techniques HEART Human Error Analysis and Reduction Technique THERP Technique for Human Error Prediction SHERPA Systematic Human Error Reduction and Prediction Approach GEMS Generic Error Modelling System IDEAS Influence Diagram Error Analysis System Some Risk Assessment Methods

17. There are a great many methods Most were developed in safety-critical industries other than healthcare, only a few have been adapted to healthcare, with mixed success Problems over some quantitative, some qualitative whether they can combine factors or only treat them independently, issues over ‘number’ generation few experimental comparisons, validation, or guidance some very resource intensive Which one to use? Risk Assessment Methods

18. NPSA is developing two approaches to the issue – (i) Patient Safety Research Fund – longer term research to identify the best methods for healthcare and adapt methods if necessary. Will take 2+ years to produce a toolbox (ii) ‘Fast track’ pragmatic approach to produce guidance in the short-term Risk Assessment Methods

19. How bad could this be ? Is there a need for action, if so what? What could go wrong? How often? Risk Assessment’s Four Basics Questions

20. Lead to Four Management Options • Terminate • Treat • Tolerate • Transfer

21. SWIFT • Structured ‘What IF’ checklisT • Good technique for considering both human and organisational factors, as well as equipment factors, that may affect safety • Structure • Identification driven by: • Question driven • What-if ………? • Checklist • Best done using a multi-professional group

22. Establish the Context Identify Risks Analyse Risks Likelihood Consequences Risk Assessment Level of Risk Monitor and Review Communicate and Consult Evaluate Risks yes Accept Risks? no Treat Risks Risk Assessment Flow DiagramAustralian/New Zealand model • Risk assessment is a “PROCESS” • Helps to determine if systems, facilities or activities are acceptable • Aid to decision making

23. Record Sheet

24. Risk Matrices • Used for: • Qualitative assessment of the level of risk from an event • Commonly used in risk assessments • Found in many forms

25. Risk Matrix • Two dimensions • Consequence • (Also commonly called impact or severity) • Likelihood • (Also commonly called frequency or probability) • How to use • Define for a risk: • Its consequence • Its likelihood • Read off the risk level Risk Frequency/Likelihood/Probability Consequence / Severity / Impact

26. How to Use a Risk Matrix • Identification of hazardous event/scenario • Determining the risk using a risk matrix • Assessment of the event’s/scenario’s consequence • Assessment of the event’s/scenario’s likelihood of occurrence • Determination of risk, (plotting scenarios on the risk matrix) • Risk evaluation and decision making

27. How to Use a Risk Matrix • Assessment of the event’s/scenario’s consequence • May be a range of possible outcomes • If possible chose outcome which is of regular concern • (Otherwise assess risk for different outcomes)

28. How to Use a Risk Matrix • Assessment of the event’s/scenario’s likelihood • Note that the likelihood is for the outcome being considered • Common error is to match event likelihood with worst case outcome which only happen in a minority of the event outcomes

29. How to Use a Risk Matrix • Determination of risk • Plot scenario on the risk matrix

30. Risk Evaluation and Decision Making • The risk classes help drive risk mitigation decision making • Common approach: • Where the risk is assessed as: • “Low” • Evaluate as tolerable • No risk mitigation recommendations needed • “High” • Evaluate as intolerable • Risk reduction is required - aim to reduce medium or low • “Medium” • Evaluate as tolerable if ALARP demonstrated • Practical and cost effective recommendations to reduce risk needed

31. For Example - IT Systems • Introducing IT systems can greatly increase capacity AND help eradicate certain errors BUT • Unless systems are carefully designed to take account of human factors, they can actually increase errors and even introduce new ones, with catastrophic consequences

32. New Technology in Airbus 320 • ‘Glass cockpit’ and ‘fly by wire’ state of the art technology • Multifunction displays with many ‘pages’ some of which are remarkably similar • Operator awareness issues - leading to the introduction of a new error - ‘mode error’ • 87 people died in a crash at Strasbourg

33. ‘New’ Error

34. Results from NPSA Funded Study on GP IT Systems (University of Nottingham) • Allergy alert may not be generated • Hazard alert generated every third prescription • Single keystroke to over-ride alert • No audit trail • Not all safety functionality activated (e.g. contra-indications) • Hazards generated by drop-down menus (wrong selection made – awareness) • GPs unsure of safety functionality on systems • Some think functionality is present when it isn’t (e.g. contra-indications)

35. Risk Assessment To ensure safe operation … Systems and Processes need: • To be well designed (human factors) and thoroughly risk assessed • To be more intuitive • To make wrong actions more difficult • To make correct actions easier (telling people to be more careful doesn’t work) • And it should be easier to discover error

36. Hospital at Night (HaN) Risk Assessment Guide • Presents an approach to risk assessing Hospital at Night solutions • Available on the NPSA web site