Clinical Safety¶
This section documents the clinical safety framework for Quill Medical, covering regulatory compliance, risk management processes, and hazard identification.
Quill Medical is a Health IT System as defined by DCB 0129 and DCB 0160. Compliance with both standards is mandatory under Section 250 of the Health and Social Care Act 2012.
Contents¶
- Regulatory Framework — DCB 0129, DCB 0160, DTAC, and related standards
- Clinical Safety Officer — The CSO role, qualifications, responsibilities, and training
- Risk Management System — The Clinical Risk Management System and its core deliverables
- Hazard Log Guide — Hazard identification, the risk matrix, and assessment process
- EPR-Specific Hazards — Hazard categories specific to an Electronic Patient Record
- Development Integration — Embedding clinical safety in the development lifecycle
- Resources — Key links, training, templates, and consultancies
Key Documents (Produced Under This Framework)¶
The following documents are produced and maintained as part of the Clinical Risk Management System. They are stored separately from this reference documentation:
| Document | Description | Approver |
|---|---|---|
| Clinical Risk Management Plan (CRMP) | Defines scope, methods, roles, and risk acceptability criteria | CSO |
| Hazard Log (CSHL) | Living register of all identified hazards, mitigations, and residual risk | CSO |
| Clinical Safety Case Report (CSCR) | Structured safety argument with supporting evidence for each release | CSO |
| Clinical Risk Management File | Master folder containing all clinical safety documentation and evidence | CSO |