Draft for review by a Clinical Safety Officer. Adapt it to your practice before use.
Clinical Risk Management System (DCB0160) · Prepare stage
Clinical risk management system
Oakfield Surgery (a made-up practice)
| Practice | Oakfield Surgery |
|---|---|
| Version | 1.0 |
| Approved by | The partners, at the practice meeting on 12/01/2026 |
| Next review | January 2027 |
1. Purpose
This document sets out how the practice manages clinical risk when it introduces, changes, uses and switches off digital tools (health IT systems), in line with the NHS standard DCB0160. It applies to every tool that could affect patient care, whoever bought it.
2. Who does what
| Role | Responsibility | Name |
|---|---|---|
| Partners | Accountable for clinical safety in the practice. Accept the remaining risk before a tool goes live. | All partners |
| Clinical Safety Officer (CSO) | A registered clinician trained in clinical risk management. Leads the assessment and signs the safety case report. | Dr Helen Marsh, GP partner |
| Practice manager | Keeps the technology register and the safety documents. Organises workshops, training and reviews. | Jo Reid |
| All staff | Use tools as trained, follow the controls, and report problems and near misses. | Everyone |
If your CSO is external or shared across your PCN, say so here and how to contact them.
3. Our process
For each tool, we follow five stages. The paperwork matches the risk: a minor change may need one line in the hazard log, a new clinical tool needs the full set.
- Prepare: add the tool to the technology register, get the supplier's safety documents, agree the plan.
- Assess: hold a hazard workshop and write the hazard log.
- Approve: the CSO writes and signs the safety case report; the partners accept the remaining risk.
- Go live: train staff, put the controls in place, tell patients.
- Monitor and review: record incidents, check the controls work, and review the hazard log.
4. How we score risk
Each hazard is scored for likelihood and severity using the grid below, before and after controls.
| Likelihood ↓ / Severity → | Minor | Significant | Considerable | Major | Catastrophic |
|---|---|---|---|---|---|
| Very high | 3 | 4 | 4 | 5 | 5 |
| High | 2 | 3 | 3 | 4 | 5 |
| Medium | 2 | 2 | 3 | 3 | 4 |
| Low | 1 | 2 | 2 | 3 | 4 |
| Very low | 1 | 1 | 2 | 2 | 3 |
| Score | What it means |
|---|---|
| 1 to 2 | Acceptable. Record it and keep it under review. |
| 3 | Reduce it if you reasonably can. The CSO records why the remaining risk is acceptable. |
| 4 | Must be reduced before go-live. |
| 5 | Unacceptable. The tool can't be used as planned. |
5. The documents we keep
For each tool we keep a clinical risk management file containing: the plan, the supplier's safety documents, our hazard log, our safety case report, training records and the incident log. Files are kept in:
Where the files are kept
Shared drive > Governance > Clinical safety > [tool name]. The practice manager controls access.
6. Incidents
Problems with digital tools, including near misses, go into the incident log and through our usual significant event process. The CSO reviews each one and updates the hazard log. We report to the supplier and, where relevant, to the Learn from Patient Safety Events (LFPSE) service and the MHRA Yellow Card scheme.
7. Training
The CSO completes recognised clinical safety training and keeps it up to date. Staff are trained before using a new tool, and attendance is recorded.
CSO training and date
NHS England clinical safety practitioner training, completed 2025.
8. Review
This document is reviewed every year, or sooner if national guidance or our arrangements change.
| Role | Name | Signature | Date |
|---|---|---|---|
| Clinical Safety Officer | |||
| On behalf of the partners |