1. Audit of operative consenting Risk Management Meeting RCOG, May 2008 Dr Dana Touqmatchi Dr James D M Nicopoullos

2. RCOG, Clinical Governance Advice, 2003

3. Audit Cycle Selection of a topic Identification of an appropriate standard Data collection to assess performance Implementation of change to improve care Data collection to determine improvement in care RCOG, Clinical Governance Advice, 2003

4. Audit Cycle Selection of a topic Identification of an appropriate standard Data collection to assess performance Implementation of change to improve care Data collection to determine improvement in care RCOG, Clinical Governance Advice, 2003

5. Audit Topic Quality of Surgical Consent –Focused area –High volume area –Associated with potential for high morbidity –Good evidence to inform practice

6. Importance of consent CNST (April 1995 – March 2007) –40,165 total claims –8,532 O&G claims 21% of all claims 2 nd highest specialty –O&G claims incur highest cost £2,475 million More than next five most costly combined (£2423million) NHSLA Factsheet 3, 2007

7. Importance of consent “Obtaining Valid Consent” (RCOG, Clinical Governance Advice, 2004) “Good practice in consent: achieving the NHS Plan commitment to patient-centred consent practice” ( Department of Health, 2003) “Seeking patients' consent: The ethical considerations” (General Medical Council, 1998) “Consent Toolkit” (British Medical Association, 2003)

8. Audit Cycle Selection of a topic Identification of an appropriate standard Data collection to assess performance Implementation of change to improve care Data collection to determine improvement in care RCOG, Clinical Governance Advice, 2003

9. Audit Standard “Aim is to ensure that all patients are given consistent and adequate information for consent”

10. Audit Standard Consent Advice 1 - Diagnostic Hysteroscopy Consent Advice 2 - Diagnostic Laparoscopy Consent Advice 4 - TAH Consent Advice 5 - Vaginal Repair / VH (October 2004, RCOG) Consent Advice 7 – LSCS (May 2006, RCOG)

11. Audit Standard Common Themes –Follow structure of DOH Consent Form –Intended Benefit –“Recommended that clinicians make every effort to separate serious from frequently occurring risks” –Documents “Serious” risks –Documents “Frequent” risks

12. Audit Standard Common Themes –“Women who are obese, have had previous surgery or who have pre-existing medical conditions must understand that the quoted risks for serious or frequent complications will be increased” –Additional Procedures –Information Leaflet given in clinic –Awareness of type of anaesthesia

13. Audit Cycle Selection of a topic Identification of an appropriate standard Data collection to assess performance Implementation of change to improve care Data collection to determine improvement in care RCOG, Clinical Governance Advice, 2003

14. Data Collection 3 month audit period (Sept-Nov 07) –First 20 notes for Consents 1,2,4,5 –First 40 notes for Consent 7 (LSCS) Watford General site only Data collected by 1 clinician (DT) Data input directly onto Excel proforma based on RCOG standards

15. Consent Advice 1 – Diagnostic Hysteroscopy Serious (0.76%) Perforation (0.76%)70%(14/20) Infection70%(14/20) Failed visualisation0%(0/20) Frequent Vaginal Bleeding70%(14/20) Pelvic / Shoulder Pain0%(0/20) Additional Procedures Laparoscopy55%(11/20) Transfusion50%(10/20)

16. Consent Advice 1 – Diagnostic Hysteroscopy 1/20 documented information leaflet given 6 consent forms failed to mention any side – effects / extra procedures –5 consultant –1 SHO

17. Consent Advice 2 – Diagnostic Laparoscopy Serious Visceral Damage100%(20/20) Failure gain entry5%(1/20) UterinePerforation50%(10/20) (2/1000) Overall Complication (2/1000)5%(1/20) (3-8/100,000) Death (3-8/100,000)0%(0/20) Frequent Failure identify disease10%(2/20) Bruising5%(1/20) Shoulder-tip Pain5%(1/20) Additional Procedures Laparotomy70%(14/20) Repair30%(6/20)

18. Consent Advice 2 – Diagnostic Laparoscopy 1/20 documented information leaflet given 4 consultant consents with 0/4 mentioning risk of perforation or requiring open intervention/repair Need to mention risk of death??

19. Consent Advice 4 – TAH (Benign) Serious (0.7%) Bladder damage (0.7%)70%(14/20) (0.04%) Bowel damage (0.04%)80%(16/20) (1.5%) Haemorrhage (1.5%)95%(19/20) Return to theatre45%(9/20) (0.2%) Abscess / infection (0.2%)90%(18/20) (0.4%) VTE (0.4%)80%(16/20) Death0%(0/20) Frequent Wound infection0%(2/20) Frequency5%(1/20) Delayed healing0%(0/20) Keloid0%(0/20) Additional Procedures Transfusion70%(14/20) Repair50%(10/20)

20. Consent Advice 4 – TAH Information leaflet given – 10% (2/20) 2 consent forms had no hospital numbers 14 failures to mention either –bladder damage –bowel damage –VTE –12 of 14 consultant consents 1 consent form mentioned only bladder damage

21. Consent Advice 5 – Vaginal Repair/VH Serious Damage bladder75%(15/20) Damage Bowel80%(16/20) Haemorrhage100%(20/20) Bladder disturbance30%(6/20) Pelvic Abscess/infection95%(19/20) VTE60%(14/20) Dyspareunia10%(2/20) Failure/recurrence prolapse25%(5/20) Frequent Urinary retention15%(3/20) Vaginal Bleeding95%(19/20) Frequency15%(3/20) Pain0%(0/20) Additional Procedures Transfusion40%(8/20) Laparotomy / Repair40%(8/20)

22. Consent Advice 5 - Vaginal Repair / VH Information leaflet given – 5% (1/20) 5 failures to mention Bladder damage –3 Consultant / 2 SpR 4 failures to mention Bowel damage –3 Consultant / 1 SpR Dyspareunia/QOL mentioned in 2 forms –Both by same consultant –GMC implications Recurrence mentioned in 5 forms –4 completed by same SpR No consultant mention of any additional procedures

23. Consent Advice 7 – LSCS Serious (0.7%) Hysterectomy (0.7%)15%(6/40) (0.5%) Further surgery (0.5%)68%(27/40) (0.9%) ITU (0.9%)5%(2/40) (0.1%) Bladder damage (0.1%)93%(37/40) (0.03%) Ureteric damage (0.03%)50%(20/40) Death0%(0/40) (<2%) Fetal Laceration (<2%)50%(20/40) Future Pregnancy Risk (<0.4%) Uterine rupture (<0.4%)0%(0/40) (0.4-0.8%) Placenta Praevia / Accreta (0.4-0.8%)0%(0/40) (0.4%) IUD risk (0.4%) Frequent Wound / Abdo Pain8%(3/40) Repeat LSCS risk0%(0/40) Additional Procedures Transfusion93%(37/20) Repair60%(24/20)

24. Consent Advice 7 - LSCS 1 consent form not completed at all – ? Grade 1 Consent outcome biased by type of LSCS Taking Elective alone –No consents mentioned Effect on repeat LSCS Risk of IUD Risk of Placentation problems 7 failures to mention visceral damage/infection/VTE

25. Consent – By risk category SeriousFrequentExtra Hysteroscopy47%35%53% Laparoscopy32%7%50% TAH66%4%60% VH / Repair48%31%40% LSCS31%4%76%

26. Consent – Who is consenting? SHOSpRConsultant Hysteroscopy16%47%37% Laparoscopy25%55%20% TAH15%50%35% VH / Repair10%47%43% LSCS3%92%5%

27. Consent – By Grade overall SHOSpRCon Serious52%46%37% Frequent16%12%14% Extra47%74%12%

28. Audit Cycle Selection of a topic Identification of an appropriate standard Data collection to assess performance Implementation of change to improve care Data collection to determine improvement in care RCOG, Clinical Governance Advice, 2003

29. Implementation of change Consultant agreement on standards Options considered to improve documentation: –Improved awareness of RCOG guidelines Dedicated teaching session Dedicated induction session –Pre-printed Consent Forms Time Cost –Consultants to “delegate” junior staff to consent routine cases

31. Implementation of change Increased accessibility of Guidelines –Elizabeth Ward –Day Surgery Unit – all sites –Gynae Emergency Treatment Room –Pre-clerking clinics – Antenatal / Gynae –GOPD

34. Elective LSCS Proforma Checklist for use at: –Counselling at LSCS clinic –LSCS consent clinic –Particularly for VBAC/Maternal choice counselling

36. Audit Cycle Selection of a topic Identification of an appropriate standard Data collection to assess performance Implementation of change to improve care Data collection to determine improvement in care RCOG, Clinical Governance Advice, 2003

37. The way forward Implementation of Recommendations ??Re-education?? Printed Guidelines in accessible/visible locations Re – audit after suitable time period

38. Conclusion Audit of 120 case-note consent forms Against recognised RCOG guidelines as standard Significant deficiencies identified Action plan suggested Re-audit