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

RCOG, Clinical Governance Advice, 2003

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

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

Audit Topic

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

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

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)

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

Audit Standard

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

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)

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

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

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

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

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)

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

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)

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??

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)

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

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)

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

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)

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

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%

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%

Consent – By Grade overall

SHO SpR Con

Serious 52% 46% 37%

Frequent 16% 12% 14%

Extra 47% 74% 12%

10

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30

40

50

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

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

Implementation of change

• Increased accessibility of Guidelines

– Elizabeth Ward

– Day Surgery Unit – all sites

– Gynae Emergency Treatment Room

– Pre-clerking clinics – Antenatal / Gynae

– GOPD

Elective LSCS Proforma

• Checklist for use at:– Counselling at LSCS clinic– LSCS consent clinic– Particularly for VBAC/Maternal choice

counselling

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

The way forward

Implementation of Recommendations

??Re-education??

Printed Guidelines in accessible/visible locations

Re – audit after suitable time period

Conclusion

• Audit of 120 case-note consent forms

• Against recognised RCOG guidelines as standard

• Significant deficiencies identified

• Action plan suggested

• Re-audit