The Relationship between Clinical Governance, Risk Management and Patient Safety

1. The Relationship between Clinical Governance,Risk Management andPatient Safety Mike Toner Associate Director – Governance & Risk Management West Middlesex University Hospital – NHS Trust

4. ‘UK: blunders by doctors kill 40,000 a year’Sunday Times, 19 Dec 1999 “Medical error is the third most frequent cause of death in Britain after cancer and heart disease…….kills four times more people than die from all other types of accidents.” NB – USA approx. 98,000/year; Australia approx. 10,000/year

6. Airline pilots are required to have time off to sleep, do everything in duplicate and follow protocols. Why do doctors kill more people than airline pilots? Dr Tom Chalmers BMJ 1998; 317

7. WORKING TOGETHER • How do we keep this in the air?

8. The Plane Truth

9. CREW RESOURCEMANAGEMENT • Human Behaviour (major cause in 73% of Accidents) • If you are good – you should not make mistakes • Experience avoids errors • Working in Teams and with modern equipment should happen naturally Starting point is that human beings make mistakes

11. Human beings make mistakes because the systems, tasks and processes they work in are poorly designed.Dr Lucian Leapetestifying to the President’s Commission on Consumer Protection and Quality in Health Care

12. Characteristics of a culture of safety • Acknowledgement of risk and responsibility for risk reduction • Errors recognised and valued as opportunities for improvement • Non-punitive and safe environment; freedom from fear Enhancing Patient Safety and Reducing Errors in Health Care, 1998

13. Characteristics of a culture of safety • Honest and open communication with confidentiality of information • Mechanisms for reporting and learning • Organisational commitment, structure and accountability Enhancing Patient Safety and Reducing Errors in Health Care, 1998

14. Blueprint for the new national system for learningfrom adverse patient Incidents www.doh.gov.uk/buildsafenhs Building a safer NHS for patients IMPLEMENTING AN ORGANISATION WITH A MEMORY

15. Feedback NHS Trusts/ PCGs/PCTs/ etc. International collaboration e.g. Australia, USA, Hong Kong, etc. NPSA Central repository Standardised information NHSLA Staff Conf. Inquiries MDA Supplementary info MCA PHLS Ombudsman Patients/ Carers CHI NHS complaints Etc. “….implement, operate and oversee all aspects of the new national system for learning…..to improve patient safety by reducing the risk of harm…..”

16. Feedback International collaboration e.g. Australia, USA, Hong Kong, etc. NHSLA Staff Conf. Inquiries MDA Supplementary info MCA PHLS Ombudsman CHI Patients/ Carers NHS complaints Etc. NHS Trusts/ PCGs/PCTs/ etc. NPSA Central repository Standardised information

17. HOW DO WE MANAGE RISK IN HEALTHCARE

18. Riskis the chance of something happening that will have an impact upon objectives What is Risk? Riskis calculated by multiplying the likelihood of an event occurring against the potential or actual consequences Likelihood X Consequences = Risk

21. Principles of Risk Management • A culture where Risk Management is considered an essential and positive element in the provision of healthcare. • Risk reduction and quality improvement should be seen as activities worthy of being pursued. • Risk management often works within a statutory framework which cannot be ignored. • A risk management approach should provide a supportive structure for those involved in adverse incidents or errors by enabling a no blame culture.

22. Processes should be strengthened and developed to allow for better identification of risk. • Managing risk is both a collective and an individual responsibility. • Recognise that resources may sometimes be required to address risk. • Every organisation should strive to understand the causes of risk, its link with quality and the importance of addressing issues.

23. Risk and Quality Management Risk ManagementProcessQuality Management Process Plan Establish Context COMMUNICATE MONITOR Do Identify Risks Analyse Risks Study/Check Evaluate Risks Treat Risks Act

24. ESTABLISH CONTEXT Clinical Governance Framework Risk Management Plan DEPARTMENTS RISK IDENTIFICATION Reports, claims or complaints TRUST WIDE Identify extreme/high risks Analyse latent conditions RISK ANALYSIS Risk ranking Root cause analysis TRUST WIDE Develop risk treatments Communicate learnings RISK EVALUATION Risk register and cost benefit Performance standards YES Accept risk NO RISK TREATMENT Eliminate, Minimise, Transfer

25. Risk Assessment MatrixCost Benefit Analysis MatrixRoot Cause AnalysisRisk Registers/Action Plans Risk Management Tools

26. Root Cause Analysis A systematic process that uses information gathered during an investigation of undesirable event to determine the underlying reasons for deficiencies or failures.

27. ADVERSE EVENT (Serious Untoward Incident) Immediate & Underlying Causes Patient/ Individual (staff)/Team & Task/Environment Factors Immediate Cause(s) Underlying Cause(s) Contributory factors Management/ Organisational & Institutional Context Factors Root Cause(s) Doing Less Harm Based on Charles Vincent

28. 1. Identify incidents/ issues and investigation/ analysis level 10. Evaluate effectiveness of actions 2. Select investigation and analysis team 9. Implement action plan 3. Plan and conduct investigation RCA Process LEARN & IMPROVE 8. Report and action plan 4. Determine sequence of events 7. Develop risk reduction/ quality improvement strategies 5. Identify contributing factors 6. Determine root causes

29. Factors contributing to adverse incidents1 1. Based on Adams & Vincent, The London Protocol, 2004 www.ihi.org

30. Bristol Royal Infirmary • In the period from 1991 to 1995 between 30 and 35 more children under 1 died after open-heart surgery in the Bristol unit than might be expected had the unit been typical of other PCS units in England at the time.

31. www.jcaho.org

34. Standards for Better Health • Safety • Clinical and Cost Effectiveness • Governance • Patient Focus • Accessible and Responsive Care • Care Environment and Amenities • Public Health

35. Assurance: The Board Agenda • What assurance means in the NHS • Building an assurance framework • What sources of possible assurance are available to a Board and how those assurances can be co-ordinated • Building the Assurance Framework: A Practical Guide for NHS Boards – March 2003 www.controls assurance.gov.uk

36. What Boards must do (1) • Establish principal objectives (strategic & directorate) • Identify the principal risks that may threaten the achievement of these objectives – typically in the range of 75-200 depending on the complexity of the organisation • Identify and evaluate the design of key controls intended to manage these principal risks, underpinned by core controls assurance standards • Set out the arrangements for obtaining assurance on the effectiveness of key controls across all areas of principal risk

37. What Boards must do (2) • Evaluate the assurance across all areas of principal risk • Identify positive assurances and areas where there are gaps in controls and/or assurances • Put in place plans to take corrective action where gaps have been identified in relation to principal risks • Maintain dynamic risk management arrangements including, crucially, a well founded risk register

38. Assurance Framework SIC CEO BOARD 6-12 current issues Priority Setting & Assurance (Clinical/Management) Independent Assurance ‘Top-down’ population External Audit Audit Committee Governance / Risk Committees 75-200 principal risks Internal Audit RISK REGISTER ‘Bottom-up’ population

39. [Board] Assurance Frameworks are designed to help manage the risks that exist within organisations. Their particular focus is to manage high-level risk based on a top-down approach. These high-level risks can be defined as those that could threaten the achievement of an organisation’s principal objectives.

40. Assurance: The NHS Perspective “How do you equate the total accountability of the board with the physical impossibility of knowing everything that is being done in the board’s name.”Sir Stuart Burgess, 1995

41. The Current Position • Most preventable adverse events are occurring and recurring without modification to management systems • Conditions that predispose to adverse events are rarely identified or analysed in depth to provide organisational learning

42. The Current Position • Financial indicators are the primary measure for healthcare performance • Providers are rewarded for error when paid for to rectify poor patient outcomes • Health services could be financially penalised if initiatives reduce activity

43. The Current Position • Most healthcare providers are neither directed towards, nor accountable for, improving patient safety • Safety is not listed as a primary objective within most strategic or business plans

45. Effecting System Wide Changes When organisational management systems only focus on financial performance, the ethical requirement to improve safety is often left to individual clinicians. However, individual clinicians are rarely empowered to effect system wide improvements.

46. “Clinical Governance development programes and annual reports, together with sound Governance systems and processes within the Trust will be key to Boards reaching an opinion on the systems of internal control operating in clinical areas.”

47. The common sources of information that are used by NHS Trusts to populate their Risk Registers Reactive Proactive Organisation Objectives Risk Assessments Incidents Complaints Claims Internal Inspections Audits Consultation -Staff & Patients Internal Internal Risk Register External External Benchmarking National Initiatives Consultation External Stakeholder CHI, RPST, CNST, HSE Reports Mandatory / Statutory Targets MDA, MCA Notices; NPSA safety alerts, etc. National Enquiry Reports Reactive Proactive

48. Assurance Framework Board Objectives (Business Plan) Principal Risks cascade Principal Directorate risks Directorate/Service Objectives Risk Register Quantified evidence of costs of failure informs learning Incidents – Clinical & non-clinical

49. Risk Management Assurance Framework Risks Other Risks –Assessments Controls Assurance Risks Risk Register Monitoring & Review Panel (sub-group) Governance / Board Report

50. Assurance Framework Process: 3 Review Strategic & Operational Plan Agree Principal Objectives Assess Risks & Controls – score & Action plan Process to analyse & link risks Risk Input Agree actions to get needed Assurances Board to approve AF, Assurances, Gaps & Remedy Risk Register Governance / Board Report