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Audit of operative consentingAudit of operative consenting
Risk Management MeetingRisk Management Meeting
RCOG, May 2008RCOG, May 2008
Dr Dana TouqmatchiDr Dana Touqmatchi
Dr James D M NicopoullosDr James D M Nicopoullos
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RCOG, Clinical Governance Advice, 2003
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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
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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
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Audit Topic
• Quality of Surgical Consent– Focused area– High volume area– Associated with potential for high morbidity– Good evidence to inform practice
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Importance of consent
• CNST (April 1995 – March 2007)– 40,165 total claims– 8,532 O&G claims
• 21% of all claims
• 2nd highest specialty
– O&G claims incur highest cost• £2,475 million
• More than next five most costly combined (£2423million)
NHSLA Factsheet 3, 2007
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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)
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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
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Audit Standard
“Aim is to ensure that all patients are given consistent and adequate information for consent”
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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)
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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
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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
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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
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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
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Consent Advice 1 – Diagnostic Hysteroscopy
Serious
Perforation (0.76%)(0.76%) 70% (14/20)
Infection 70% (14/20)
Failed visualisation 0% (0/20)
Frequent
Vaginal Bleeding 70% (14/20)
Pelvic / Shoulder Pain 0% (0/20)
Additional Procedures
Laparoscopy 55% (11/20)
Transfusion 50% (10/20)
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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
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Consent Advice 2 – Diagnostic Laparoscopy
Serious
Visceral Damage 100% (20/20)
Failure gain entry 5% (1/20)
UterinePerforation 50% (10/20)
Overall Complication (2/1000)(2/1000) 5% (1/20)
Death (3-8/100,000)(3-8/100,000) 0% (0/20)
Frequent
Failure identify disease 10% (2/20)
Bruising 5% (1/20)
Shoulder-tip Pain 5% (1/20)
Additional Procedures
Laparotomy 70% (14/20)
Repair 30% (6/20)
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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??
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Consent Advice 4 – TAH (Benign)
Serious
Bladder damage (0.7%)(0.7%) 70% (14/20)
Bowel damage (0.04%)(0.04%) 80% (16/20)
Haemorrhage (1.5%)(1.5%) 95% (19/20)
Return to theatre 45% (9/20)
Abscess / infection (0.2%)(0.2%) 90% (18/20)
VTE (0.4%)(0.4%) 80% (16/20)
Death 0% (0/20)
Frequent
Wound infection 0% (2/20)
Frequency 5% (1/20)
Delayed healing 0% (0/20)
Keloid 0% (0/20)
Additional Procedures
Transfusion 70% (14/20)
Repair 50% (10/20)
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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
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Consent Advice 5 – Vaginal Repair/VH
Serious
Damage bladder 75% (15/20)
Damage Bowel 80% (16/20)
Haemorrhage 100% (20/20)
Bladder disturbance 30% (6/20)
Pelvic Abscess/infection 95% (19/20)
VTE 60% (14/20)
Dyspareunia 10% (2/20)
Failure/recurrence prolapse 25% (5/20)
Frequent
Urinary retention 15% (3/20)
Vaginal Bleeding 95% (19/20)
Frequency 15% (3/20)
Pain 0% (0/20)
Additional Procedures
Transfusion 40% (8/20)
Laparotomy / Repair 40% (8/20)
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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
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Consent Advice 7 – LSCS
Serious
Hysterectomy (0.7%)(0.7%) 15% (6/40)
Further surgery (0.5%)(0.5%) 68% (27/40)
ITU (0.9%)(0.9%) 5% (2/40)
Bladder damage (0.1%)(0.1%) 93% (37/40)
Ureteric damage (0.03%)(0.03%) 50% (20/40)
Death 0% (0/40)
Fetal Laceration (<2%)(<2%) 50% (20/40)
Future Pregnancy Risk
Uterine rupture (<0.4%)(<0.4%) 0% (0/40)
Placenta Praevia / Accreta (0.4-0.8%)(0.4-0.8%) 0% (0/40)
IUD risk (0.4%)(0.4%)
Frequent
Wound / Abdo Pain 8% (3/40)
Repeat LSCS risk 0% (0/40)
Additional Procedures
Transfusion 93% (37/20)
Repair 60% (24/20)
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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
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Consent – By risk category
Serious Frequent Extra
Hysteroscopy 47% 35% 53%
Laparoscopy 32% 7% 50%
TAH 66% 4% 60%
VH / Repair 48% 31% 40%
LSCS 31% 4% 76%
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Consent – Who is consenting?
SHO SpR Consultant
Hysteroscopy 16% 47% 37%
Laparoscopy 25% 55% 20%
TAH 15% 50% 35%
VH / Repair 10% 47% 43%
LSCS 3% 92% 5%
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Consent – By Grade overall
SHO SpR Con
Serious 52% 46% 37%
Frequent 16% 12% 14%
Extra 47% 74% 12%
10
20
30
40
50
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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
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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
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Implementation of change
• Increased accessibility of Guidelines
– Elizabeth Ward
– Day Surgery Unit – all sites
– Gynae Emergency Treatment Room
– Pre-clerking clinics – Antenatal / Gynae
– GOPD
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Elective LSCS Proforma
• Checklist for use at:– Counselling at LSCS clinic– LSCS consent clinic– Particularly for VBAC/Maternal choice
counselling
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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
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The way forward
Implementation of Recommendations
??Re-education??
Printed Guidelines in accessible/visible locations
Re – audit after suitable time period
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Conclusion
• Audit of 120 case-note consent forms
• Against recognised RCOG guidelines as standard
• Significant deficiencies identified
• Action plan suggested
• Re-audit