Clinical Governance and Patient Safety

Clinical Governance Framework

Clinical governance is the system through which NHS organisations are accountable for continuously improving the quality and safety of their services. It has seven key components:

1. Clinical effectiveness: evidence-based practice, NICE guidelines, clinical pathways
2. Risk management: identifying, assessing, and mitigating clinical risks; risk registers
3. Patient experience: patient surveys, complaints management, patient involvement
4. Communication: effective handover, team communication, documentation
5. Resource management: staffing, equipment, training
6. Strategic capacity: leadership, organisational learning, culture of safety
7. Learning: continuous professional development, education, training, appraisal

Clinical Audit

The Audit Cycle

1. Select topic and define standard (based on guidelines/evidence)
2. Measure current practice (data collection)
3. Compare against standard (identify gaps)
4. Implement changes (action plan to close gaps)
5. Re-audit (complete the cycle — assess improvement)

• Audit is NOT research — it measures current practice against known standards
• PDSA cycle (Plan, Do, Study, Act) is an alternative framework for quality improvement
• Results should be shared with the team and used to drive improvement
• Departmental audit meetings: regular forum for presenting audit findings

Serious Incident Investigation

Root Cause Analysis (RCA)

• Systematic process to identify underlying causes (not just proximate causes)
• Timeline of events: what happened, when, who was involved
• Contributing factors: human, organisational, environmental, patient factors
• Root causes: the fundamental systemic issues that allowed the incident to occur
• Recommendations: specific, measurable, achievable, relevant, time-bound (SMART)
• Focus on systems, not individuals (just culture approach)

Duty of Candour

• Statutory duty (Health and Social Care Act 2008, Regulation 20): organisations must be open with patients when a notifiable safety incident occurs
• Inform the patient/family as soon as reasonably practicable
• Provide a truthful account of what happened
• Offer an apology (apology ≠ admission of liability)
• Provide written notification and follow-up
• Offer support (including independent advice if requested)

Incident Reporting

• Datix (or equivalent): electronic incident reporting system used across NHS
• All incidents should be reported, including near-misses
• Reporting is non-punitive (supports learning, not blame)
• Grading: near-miss, no harm, low harm, moderate harm, severe harm, death
• Serious incidents: investigated with RCA; reported to commissioners and CQC
• Never Events: incidents that should never occur if preventive measures are in place (e.g. wrong-site surgery, retained foreign object)

Key National Programmes

MBRRACE-UK (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries)

• National programme for maternal and perinatal death surveillance
• Publishes triennial reports on maternal deaths — key learning points for all obstetricians
• Recent themes: sepsis, haemorrhage, VTE, cardiovascular disease, mental health as leading causes
• Inequalities: Black women 4x more likely, Asian women 2x more likely to die in pregnancy than White women

Each Baby Counts (RCOG)

• National quality improvement programme
• Reviews term intrapartum stillbirths, neonatal deaths, and brain injuries
• Aims to reduce these by 50%
• Key findings: failures in CTG interpretation, escalation, and communication are recurring themes

Saving Babies' Lives Care Bundle (NHS England)

• Evidence-based care bundle to reduce stillbirth
• Elements: reducing smoking, risk assessment for fetal growth restriction, raising awareness of reduced fetal movements, effective fetal monitoring in labour

Complaints Handling

1. Acknowledge the complaint promptly (3 working days)
2. Investigate thoroughly and fairly
3. Respond within agreed timeframe (usually 25-60 working days)
4. Offer a meeting to discuss if appropriate
5. Learn from the complaint and implement changes
6. If not satisfied: refer to Parliamentary and Health Service Ombudsman (PHSO)
7. Document all steps

GMC Referral

• Concerns about a colleague's fitness to practise should be raised through appropriate channels
• First: raise locally (clinical lead, medical director)
• If local resolution fails or concern is serious: refer to GMC
• GMC investigates: health, conduct, performance concerns
• Duty to report: if a colleague poses a risk to patients, there is a professional obligation to act
• Protecting patients takes priority over loyalty to colleagues

Key Points Examiners Mark

• Understands the audit cycle and can describe it clearly
• Knows the difference between audit and research
• Demonstrates understanding of RCA process (systems focus, not blame)
• Aware of duty of candour (both professional and statutory)
• Knows about MBRRACE-UK findings and their implications
• Can discuss incident reporting in a constructive, non-punitive framework
• Shows awareness of health inequalities in maternal care
• Practical suggestions for quality improvement

Common Pitfalls

• Confusing audit with research
• Focusing on blame rather than system improvements in incident analysis
• Not knowing MBRRACE-UK key findings (inequalities, leading causes of death)
• Forgetting duty of candour when discussing incident management
• Not completing the audit cycle (many candidates describe data collection but not re-audit)
• Being vague about "lessons learned" — examiners want specific, actionable recommendations

Clinically reviewed by NHS obstetricians and gynaecologists

MRCOG AI is an independent educational tool. It is not affiliated with, endorsed by, or connected to the Royal College of Obstetricians and Gynaecologists (RCOG).