These duties apply to providers registered with the Care Quality Commission (CQC) in England. Clinical governance is the framework through which you are accountable for continuously improving the quality of your services and safeguarding high standards of care. CQC assesses it mainly under the well-led key question, alongside the other four: safe, effective, caring and responsive.
Meet the fundamental standards
Every registered provider must meet the fundamental standards, the minimum below which care must never fall. Regulation 17, good governance, is the one that makes clinical governance a legal requirement.
Set up systems that monitor and improve quality
Regulation 17 requires you to establish and operate systems that let you:
- assess, monitor and improve the quality and safety of your services, including the experience of the people using them;
- assess, monitor and mitigate risks to the health, safety and welfare of service users and others;
- keep an accurate, complete and contemporaneous record of each service user's care and treatment, and the decisions taken;
- keep the records needed for staff and for managing the service;
- seek and act on feedback from patients and others.
CQC can ask you for a written report within 28 days on how far these systems are working, and for your plans to improve.
Record incidents and learn from them
Your risk systems need a way for staff to report incidents and near misses, a proportionate review of what went wrong, and a route from the findings to changed practice. Report to the board or governance meeting regularly so that themes are seen across incidents, complaints and audits, not one at a time.
Be open with patients when something goes wrong
You have a defence only if you took all reasonable steps and exercised all due diligence.
Audit and improve
Clinical audit measures your practice against a standard, such as a NICE guideline, then changes what falls short and measures again to confirm the change worked. A completed cycle gives you the evidence Regulation 17 asks for.
Quality improvement methods such as Plan-Do-Study-Act cycles and the Model for Improvement give small changes a structure. CQC does not prescribe a method; it looks for improvement work that is part of how you are governed rather than isolated projects.
Handle complaints as a governance tool
Keep a complaints log, report themes to the board, and use them to change how you work. Where a complaint also involves a notifiable safety incident, the duty of candour runs alongside the complaints process.
Legal basis
Primary legislation and key regulations
Official guidance
CQC - Regulation 20, duty of candour (opens in a new tab)
www.cqc.org.uk · England
GP mythbuster 65: Effective clinical governance arrangements in GP practices - Care Quality Commission (opens in a new tab)
CQC · England
GP mythbuster 26: General practice nurses - Care Quality Commission (opens in a new tab)
CQC · England
Dental mythbuster 2: Keeping up to date for the dental practice team - Care Quality Commission (opens in a new tab)
CQC · England
Services repeatedly rated requires improvement - Care Quality Commission (opens in a new tab)
CQC · England
Reporting medicine related incidents - Care Quality Commission (opens in a new tab)
CQC · England
Good governance of medicines - Care Quality Commission (opens in a new tab)
CQC · England
NHS Resolution - Saying Sorry (opens in a new tab)
resolution.nhs.uk
Healthcare Quality Improvement Partnership (HQIP) (opens in a new tab)
www.hqip.org.uk
NHS England Freedom to Speak Up (opens in a new tab)
www.england.nhs.uk · England
NHS England Patient Safety (opens in a new tab)
www.england.nhs.uk · England
CQC assessment framework - Well-led (opens in a new tab)
www.cqc.org.uk · England