1. Learning about Safe Systems Dr. Maureen Baker CBE DM FRCGP Clinical Director for Patient Safety NHS Connecting for Health

2. Overview The NPfIT Development of patient safety movement Safe systems in a safety critical industry Safety management systems NHS CFH Clinical Safety Management System The Clinician/System Interface

3. The National Programme for IT in the NHS in England Established 2002 Has a number of central features and programmes (National Spine; Choose and Book; GP2GP; National Care Record Service; Picture Archive and Communications Service; Electronic Transfer of Prescriptions) Local Service Providers Estimated cost £12.4 Billion over 10 years (contracts, training and implementation) Being delivered by NHS Connecting for Health

4. What for? NHS Modernisation? OR To support better safer care?

5. Healthcare – a Safety Critical Industry Studies based on retrospective analysis of medical records Harvard study 1991 (Lucien Leape) – adverse event rate in ‘hospitalisations’ of 3.7% of which two thirds were ‘errors’ Australian study 1995 (Ross Wilson) – adverse event rate 16.6% British study 2001 (Charles Vincent) – adverse event rate of 10.8%

6. To Err is Human (Institute of Medicine 1999) As many as 98,000 people die each year in USA from medical errors that occur in hospitals. That is more than die in RTAs or from breast cancer or AIDS. Medical error is fifth leading cause of death in USA

7. An Organisation with a Memory (CMO, 2000) The NHS is doomed to make the same mistakes over and over again as we have no way of learning from when things go wrong

8. Human Error (Reason, 1990) Humans are fallible and errors are inevitable Systems approach takes holistic view of causes of failure Cannot change the human condition but can change conditions in which people work and minimise opportunities for error

9. Learning from when disasters happen in safety critical industries Complex set of interactions No single causal factor Combination of local conditions, human behaviours, social factors, organisational weaknesses

10. When things go wrong in healthcare Complex set of interactions No single causal factor Combination of local conditions, human behaviours, social factors, organisational weaknesses

11. The Contribution of Health IT Positive Supporting clinicians in delivering better safer care Negative BUT CAN INTRODUCE NEW HAZARDS THAT WEREN’T THERE BEFORE !

12. Safer Care, i.e.: x > y = a+b What we are trying to achieve? Risk Baker, M et al, Safer IT in a Safer NHS: Account of a Partnership, The British Healthcare Computing & Information Management, Vol. 23 No. 7 Sept 2006

13. Learning from failure “The NHS is not unique: other sectors have experience of learning from failures which is of relevance to the NHS” Sir Liam Donaldson in ‘Organisation with a Memory’

14. Safety Critical Industries with Safety Approach Aviation Railways Oil and Gas Construction Nuclear Military

15. NHS CFH Clinical Safety Management System Based on principles of IEC 61508 Light touch, yet robust Three key pieces of documentation Practical and pragmatic – in place for over 4 years Supplemented by established Safety Incident Management Process

16. NHS CFH CSMS Deliverables Hazard assessment Safety case Safety closure report Clinical Authority to Release (CATR) (Includes ‘caveats’)

17. Safety Incident Management System Incidents related to Health IT reported and logged Assessed and managed by Clinical Safety Group (clinicians and safety engineers) Aim to ‘make safe’ (remove potential for harm) with 24 hours Around 430 incidents reported since 2005 97% made safe within 24 hours

18. NHS IT – What can go wrong? Patient identification (wrong notes, wrong results, wrong procedure) Data migration (re-start discontinued drugs, incorrect preservation of meaning) Data mapping (mapped to non-identical preparation, eg long-acting or slow release) Data corruption (over-writing of info on NHS Spine)

19. The Role of Clinicians in Safety Management Awareness – not just IT, not just records, but systems that can have positive or negative impact on patient care Risk management and safe implementation – engage in assessing what could go wrong and what can be done to prevent things going wrong Data quality is a patient safety issue Remain ‘thinking clinicians’ – IT is a tool, YOU are the clinician

20. Passing the Safety Baton NHS CFH (and Software Providers) Support from: Clinical Safety Group Clinical Authority to Release Implementing organisation (Hospitals Pharmacists, GPs etc.) Support from: Internal Risk Team Safer Design and Development Safer Implementation Passing the Baton – Ownership passed from NHS CFH to NHS

21. National Programme for IT in NHS “ The National Programme is not just an IT programme, but a patient safety and clinical governance programme” Gordon Hextall, Chief Operating Officer NHS CFH

22. Conclusion Healthcare is a safety critical industry IT systems don’t deliver care, but are used by clinicians in the delivery of care Good safety practice requires proactive work – systems as safe as design and forethought will allow Understanding of benefit and risks of IT by clinicians is essential for safe care