1. Patient Safety in Women’s health: View from the National Observatory Prof James Walker Clinical Associate National Patient Safety Agency

2. Background The NPSA: was established July 2001 is a Special Health Authority has been created to co-ordinate efforts to identify and learn from patient safety incidents

3. Clinical Governance Governance Developed: An organisation with a memory, which looked at learning from adverse incidents in the NHS; and Building A Safer NHS for Patients, which set out the government’s plans to address OWAM’s recommendations.

4. Why is patient safety important?

5. Medicine in the old days was simple, safe and ineffective. Now it is complex, very effective but potentially dangerous Sir Cyril Chantler, Chairman of the King's Fund Chairman of Board GOSH

6. 0 50 100 150 200 250 300 350 400 450 193519401945195019551960196519701975 Source: General Register Office and OPCS, Reproduced in Birth counts, Table A10.1.3. Graph by Alison Macfarlane Deaths per 100,000 total births Abortion and miscarriage Prolonged labour, trauma and other causes Toxaemia Haemorrhage Puerperal sepsis Puerperal phlebitis, thrombosis and embolism Maternal mortality by cause (E&W) 1935-78

7. Maternal Mortality in Iraq

8. Massive Obstetric Haemorrhage28% Post Abortion19% Eclampsia17% Infection15% Post Anaesthetic and Other14% Obstructed Labour/Ruptured Uterus 7%

9. Obstetric Claims Obstetric claims account for over 70% of all NHS litigation expenses with an average cost of cerebral palsy cases of £1.5m. Current estimate that obstetric claims amount to £400m of total £600m projected NHS costs. Source: Learning from litigation: an analysis of claims for clinical negligence Vincent, Davy, Esmail, Neale, Elstein, Cozens, Walshe August 2004

10. A problem in maternity services? Findings from root cause analyses of 37 adverse events/near misses in obstetrics (Ashcroft, 2002) –in 92% cases there no guidelines or protocols to advice on clinical practice or organisational issues –49% members of staff were unfamiliar with labour ward protocols and failed to follow them CEMD report ‘Why mothers die 1997-1999’ highlighted need for guidelines to be used –“women are still dying of potentially treatable conditions where the use of simple diagnostic guidelines may help”

11. Fire risk

12. "First, Do No Harm" Most practitioners are caring individuals –Highly skilled –Highly trained But we still make mistakes Usually in repetitive (normal) tasks –Omission It is not usually the emergency

14. Problems for the Beaver Learn task but watching and doing –Trial and Error Learning ends with the accident –No audit trail of problems –No “system” memory No guideline development Continued accidents The system is inherently dangerous

15. Safety First Simplifying and encouraging reporting of safety incidents More rapid reporting and notification of serious incidents to the NPSA within 36 hours leading to more rapid learning Capturing risky situations Using patient safety data to inform learning and action locally – analysis, learning and feedback. Safety First highlights key areas for improvement in current safety reporting systems in the NHS. These include:

16. Event Reporting Mainstay of risk management Part of every-day practice Within the airline industry –routine error (near miss) reporting followed by root-cause analysis and risk management, has led to a 4 fold reduction in major airline incidents

17. Error Analysis The traditional way –person approach –individual involved is questioned –the problem tackled at that level Tackling the individual –does not remove the pre-existing risk of error –the error trap

18. Person Approach "If a surgeon has made a deep incision in the body of a man with a lancet of bronze and saves the man's life, or has opened an abscess in the eye of a man and has saved his eye, he shall take 10 shekels of silver. If a surgeon has made a deep incision in the body of a man with his lancet of bronze and so destroys the man's eye, they shall cut off his hand” –Laws of Hammurabi, Babylon, BC 1792

19. Root-cause analysis of major airline events Failure to follow accepted procedures Misinterpretation of instruments Incorrect decisions Ignoring advice from colleagues Failure of team working Equipment failure Pilot error

20. Themes from systematic review of the data High proportion of incidents reported relate to Trust maternity ‘trigger list’ categories Following these the top five themes are: –Communication –Staffing levels –Medication –Equipment –Patient ID

21. Reason’s ‘Swiss cheese’ model some holes due to active failures other holes due to latent conditions hazards losses defences. barriers and safeguards James Reason 1997

22. System Approach Wider in its remit –more open –based on concept of system failures –Different outcome for the individual –more likely to produce solutions reduce the chance of recurrence. requires trusting environment –a ‘no blame’ approach

23. Systems Approach More comprehensive covering –The person –Team –Procedure –Environment –Organisation

24. Systems Approach Not –‘who made a mistake’ but –‘how and why have the defences failed’

25. “We can’t change the human condition, but we can change the conditions under which humans work” James Reasons Solution

26. Defences, barriers, and safeguards Technical –alarms, physical barriers, automatic shutdowns Human –doctors, midwives, administrators Documentation –guidelines, standard operating procedures Act to –prevent error –protect the patient Defences are mostly successful –but not infallible.

27. Safety Driving is safer –Design Speed limits ABS –Safety Car design Seat belts Airbags We are not better drivers

28. Increasing the number of Barriers to prevent Patient Safety Incidents Swiss Cheese Cheddar Cheese

29. Guidelines Keep them simple For routine things Use checklists Use audit of practice

30. Are they effective? “The distribution of methodologically sound clinical guidance does not, however, ensure implementation” The Obstetrician & Gynaecologist, 2001, p93

31. Guidelines Too many Too complicated End unto themselves Job is done Not proven or validated

32. Yorkshire Guidelines Consensus guidelines –Obstetricians and Anaesthetists –All units in Yorkshire Commenced May 1997 By 1999, all units using Regional audit of cases –Each hospital auditing own cases –Regional co-ordination –Collection of data

33. ICU admissions in Yorkshire

34. Airline industry similar to medicine requires concentration –long periods of little activity –sudden emergencies –instant decision making team working which is interdependent

35. In Medicine Experts often not present at time of crisis (a latent failure) –be aware of the possibility of failure –be prepared to recognise and recover Assess possible risks –risk assessment Rehearsing familiar scenarios –Drills Common sense training

36. Drills and Skills Teach basic skills –For all Multidisciplinary –Team working Update

37. Airline industry Guidelines for the routine Check lists Drills for emergencies Experience for the unusual If they make a mistake - they die too

38. Designing out faults Copied from industry Assess the environment leading to the event Design solutions –Training/supervision –Design equipment/Hospital –Encourage change in behavior (Guidelines)

39. a) periodically plot spillage area on an X-bar chart, look for special causes (audit) b) double the size of the fixtures (prevent) c) hire an attendant to monitor and reprimand “less hygienic” users (supervise) d) Hand out guidelines on entry to toilet what would you do? Source: Wall Street Journal, used by John Grout, NPSA Seminar, 17 January 2003 JFK International terminal men’s restrooms

40. e) etch the image of a fly on the porcelain - (Focus) Source: Wall Street Journal, used by John Grout, NPSA Seminar, 17 January 2003 JFK International terminal men’s restrooms

41. Drug Administration

42. Fully assess risk Past history Woman’s understanding of the risk Flagging of the problem Notifying –(warning/planning) Guidelines

43. What about Obesity? Increasing problem Not allowed to talk about it We do not weigh people any more Ignore the problem Wait for the disaster

44. Approach to Risk You need to know: Min age is 12. Max weight is 16st. Min height is 4'11''. Unsuitable for pregnant women or anyone unable to climb up into the cockpit or fit in a standard car seat. You need to know: Full manual driving licence required. As a guide max weight is 16st to 18st and you should be between 5'1'' and 6'4''.

45. Solution Development Processes Understanding the what, how and why Identify potential solutions Risk assess solutions Pilot and learn Implementation Evaluation and impact assessment

46. Where are we now? Guidelines to inform –Routine Checklists to focus –Prompts –Memory aids –Care Bundles Drills for skills –Regular –For all Audit trail –Prove what you do

47. We need to share the learning from our mistakes to try and stop them happening again …..