1. RISK MANAGEMENT IN OBSTETRICS S Arulkumaran Professor & Head Division of Obstetrics & Gynaecology St.George’s Hospital Medical School University of London

2. Some Definitions Risk: The potential for unwanted outcome (Wilson) Chance or possibility of loss or bad consequence (Oxford dictionary) Clinical Risk Incident: Injury or harm to a patient as a result of care or treatment Near Miss: An incident where there is a potential for harm or injury to a patient

3. Serious Clinical Incident a situation in which one or more patients are involved in an incident which is likely to have: 1. An adverse effect on patients 2. Cause a major disruption to service 3. Attract press/media attention 4. Lead to a legal claim

4. Whose fault is it? Speed limit Failure of brakes Untrained driver Driver slept New territory Faulty/new tracks Faulty/new signals No speed check

5. Contingent Liability by Speciality (CNST, 1997) Speciality Accident & Emergency Anaesthetics General Surgery Gynaecology General Medicine Paediatrics Obstetrics Orthopaedics Cardiac Surgery Others TOTAL Value £million 2.3 2.9 2.1 1.2 1.6 2.9 59.1 1.6 1.5 6.0 81.2

6. Medical Negligence in the UK Potential claims £2.8bn in 1998 Obstetrics - largest claims - £1.4bn Handicapped child - sadness for life 38% of claims handled by defence unions

7. Potential Problem Areas : Obstetrics (1) Antenatal Pre-natal diagnosis Labour/Delivery Meconium stained liquor CTG interpretation/fetal blood sampling Decisions to “wait and see” Use of oxytocic drugs Management of previous LSCS Inappropriate use of forceps Shoulder dystocia Analgesia

8. Potential Problem Area : Obstetrics (2) Postnatal Rubella immunisation Anti-D immunoglobulin Guthrie result Contraceptive advice

9. Potential Problem Areas : Gynaecology Complications of surgery Failed sterilisation Delay in diagnosis “Lost” IUCD Retained foreign bodies

10. Why Do Risks Occur? System failures Short cuts Communication breakdowns Ill-defined responsibilities Inadequately trained staff Inadequate policies/procedures/guidelines Poor interagency/interdepartmental working Dishonesty

11. Harvard Study : Hospital Adverse Events Study of >30,000 hospital records Acute care setting - New York hospitals 51 hospitals randomly selected Adverse events identified in the treatment of 3.7% Approximately 28% of these considered to have resulted from negligent care or treatment

12. NHS ERRORS: FACTS AND FIGURES An estimated 850,000 adverse incidents and errors occur every year in the NHS, affecting one in ten admissions A third of adverse incidents lead to patient disability or death Adverse events cost approximately £2bn a year in hospital stays alone Clinical negligence cost the health service more than £400m a year bma news 1.3.03.

13. Error Producing Conditions (William, 1988) Condition Unfamiliarity with task Time shortage Information overload Misperception of risk Poor feedback from system Inexperience Poor instructions Inadequate checking Disturbed sleep patterns Hostile environment Risk Factor x17 x11 x6 x4 x3 x1.6 x1.2

14. National Patient Safety Agency-NPSA NPSA targets – end of 2005 Cut the number of incidents in obstetrics and gynaecology that result in litigation by 25 % Cut the number of serious prescribed drug errors by 40 % Eliminate suicides by hanging from shower and curtain rails among mental health patients www.npsa.org.ukwww.npsa.org.uk www.doh.gov.uk/buildsafenhs

15. Clinical Risk Management : Aims (1) To reduce/eliminate harm to patients Improve quality of care Deal effectively with the injured patient: explanations/apology provide continuity of care swift compensation

16. Clinical Risk Management : Aims (2) To protect the Trust: staff morale/supporting staff reputation financial resources To meet clinical governance initiatives To achieve CNST standards

17. Risk Management Process (1) Identification of Risk Analysis of Risk Control of Risk Funding of Risk

18. Risk Management Process (2) Organisation of service Professional competence Equipment Record keeping Communication

19. Risk Management Group Lawyer with medical litigation experience - Chair Senior Midwife - collected adverse events/ statements - Co-ordinator Clinical Director of Obstetrics and Gynaecology Director of Midwifery Consultant Anaesthetist and Paediatrician Consultant Obstetrician and Senior Registrar Hospital Legal Officer

20. Tasks of Risk Management Group Review based on list of adverse events - cases of possible litigation Advice on general management policies Support for staff and patients Staff give a report when events are fresh Not called to give evidence - supportive and not inquisitorial Identifies unsatisfactory practices

21. Identification of Risk Encourage incident reporting Should have an open organisational (proportionate blame) culture Research and sharing of evidence based practice Incident may be trivial - recurrences need remedial action Open discussions of “near miss incidents”

22. Events That Need Reporting Admission to NNICU for severe birth asphyxia Neonatal convulsions Shoulder dystocia Intrapartum stillbirth Birth trauma Undiagnosed congenital malformation

23. Investigation of Adverse Events – (RCA) Poor outcome Near miss events 1. Identify incident 2. Interview participants : ensure confidentiality all involved : may include non-clinical staff, parents explain purpose of interview ask to provide a detailed description of sequence of events special reference to own role and anyone they came into contact with

24. Investigation of Adverse Events (2) Use open questions establish reasons why action taken/not taken anything different with benefit of hindsight? Any suggestions for improvements follow up references to changes in pace, emotions clarify any contradictions notes may act as a distraction at early stage - can prevent description of thinking behind action follow up interview with access to casenotes for accuracy

25. THE RISK MANAGEMENT PROCESS Identify healthcare risk Review current practices (AUDIT) Establish goals that will eliminate/reduce risk Develop action plan to meet goals Educate/train staff on desired changes Monitor changes (AUDIT) Have changes reduced risk frequency/severity? NO : re-establish goals YES : continue to monitor

26. Review of Records Compliance with agreed guidelines/protocols;  Administration of steroids if delivery <34 wks  Consultant presence - in potentially complicated CS, placenta previa, abruptio placenta, preterm <32 wks, multiple previous CS  Prophylactic antibiotics and thromboprophylaxis for CS  Decision to delivery interval 10mins

27. Risk Management Audit Cyclical Rectify shortcomings Show improvement in next audit cycle

28. Surgical Morbidity Cystotomy Ureter injury Vesico-vaginal fistula Bowel injury (full thickness) Haemorrhage-return to OR -transfusion -haematoma Reoperation (includes such things as drainage of abscess, reimplantation of ureter etc.)

29. Associated Morbidity Infection- requiring antibiotics, but excluding UTI (Pyelonephitis included) Bowel : Ileus/Obstruction Thromboembolism Readmission - within 6/52 or related to the original surgery ICU

30. Risk Analysis Analysis of reported incidents and outcome of audits - determines:- Severity of risk Likelihood of recurrence Cost benefit analysis Prioritisation Additional funding to contain risk

31. Risk Control (1) General and specific action plans Multidisciplinary and known to all staff Include in staff induction programmes Protocols and guidelines accessible to staff and in different work areas

32. Risk Control (2) Difficulty in adhering to protocols - remedial action to be taken Good and competent clinical practice Good communication Good record keeping

33. Organisation of Service (1) Adequate staffing level 1.5 midwives to 1 woman in labour if not all the time - majority of time Experienced obstetrician, paediatrician and anaesthetist available within delivery unit or at short notice

34. Organisation of Service (2) Designated consultant to delivery unit. Overall responsibility for guidelines/ protocol development, standard setting and audit Multidisciplinary team to resolve major clinical problems Clear professional responsibilities in intrapartum care

35. Medical Equipment Adequate to provide care (eg ventilators) Checked and maintained regularly Staff know how to use them and resolve problems Equipment updated especially with increased services Additional equipment

36. Professional Competence Induction programme is mandatory Supervised clinical care for period of time Skill in adult and neonatal resuscitation Training in interpretation of CTG Emergency drill for PPH, shoulder dystocia Review of statistics/case discussions/ educational activities

37. Communication (1) Verbal if not adequate - written information Different languages - interpreters Definitive explanation and consent (written if risks +) e.g. screening and diagnostic tests, operative deliveries

38. Communication (2) Honest explanation by involved Senior Clinician when things go wrong Communication with on-call staff - streamlined High risk areas - personnel handover at the senior level Lines of communication and command should be clear

39. Record Keeping Legible, accurate annotated date/time, signature Complete and contemporaneous Mother and baby notes stored for 25 years CTG - electronic archival - fades and gets misplaced Photocopies of notes and CTGs - certified and kept Policy decisions regarding place and format of storage - obstetricians should be involved

40. Success of Clinical Risk Management No immediate dividends Difficult to quantify Avoidance of adverse outcome and medico legal claims Prime motive of risk management - improvement of quality of care Culture of openness, clinical competence, professional development, good practice and communication

41. “Risk Management should be a mandatory agenda to improve quality of service”

42. Clinical Governance Accreditation of Professional Services revalidation Guidelines Education & Training Audit Risk management Patients’ complaints

43. CLINICAL PRACTICE Research & Audit Cost effective Health care Consultation – not confrontation Evidence based medicine Patient’s wishes/ request Facilities Available/ Knowledge experience

44. Whose fault is it? Speed limit Failure of brakes Untrained driver Driver slept New territory Faulty/new tracks Faulty/new signals No speed check Mostly it is a System Failure

45. THANK YOU