Safety alerts, significant events and duty of candour: the primary care evidence trail

Why these three matter so much

When CQC finds a breach in a GP practice or independent clinic it is very often one of three things: a safety alert that was not actioned, a significant event that was recorded but not learned from, or an incident where duty of candour was not applied. All three sit under Regulations 12, 17 and 20 and all three are easy to evidence if you build the habit.

Safety alerts (CAS / MHRA)

1. Nominate an alerts lead and a deputy; alerts arrive through the Central Alerting System and MHRA drug safety updates.
2. Log every alert in an alerts register: date received, relevance (yes/no and why), action required, clinical searches run, patients contacted, date closed.
3. Run the search on your clinical system for affected patients and record the outcome for each.
4. Review the register at your clinical governance meeting and re-check historic alerts annually — CQC's clinical searches specifically look for patients still affected by older alerts (for example valproate, or medicines with interaction warnings).

Significant event analysis (SEA)

A good SEA answers five questions: what happened, why, what was the impact, what have we changed, and how do we know the change worked? Involve the whole team, record it on a standard template, and discuss it at a team meeting so learning is shared. Group events by theme over the year — trends are stronger evidence than single reports.

Duty of candour (Regulation 20)

When an incident meets the threshold of a notifiable safety incident (moderate harm, severe harm, prolonged psychological harm or death), you must:

• tell the patient or their representative in person as soon as reasonably practicable;
• apologise, explain what is known and what will be done;
• follow up in writing with the findings and next steps;
• keep a record of the whole process.

Say sorry — an apology is not an admission of liability. Train reception and clinical staff to recognise the threshold and record candour steps within the SEA itself.

Joining the threads together

Inspectors want to see the loop close: alert or incident → analysis → candour → action → audit. Keep the alerts register, the SEA log, the complaints log and the audit programme in one governance folder and review it monthly. The weekly readiness checklist in your dashboard prompts the alerts, significant-event and safeguarding checks each week, and the GP & Independent Hospital Starter Policy Pack includes the Significant Events, Duty of Candour and Safety Alerts policies and templates. If an incident is complex, ask the AI Compliance Assistant and it will connect you to a specialist.