Patient Safety
KEIT DAY HOSPITAL
Quality, incident reporting and clinical audit protocol
Official Manual of Clinical, Care and Organizational Protocols
| Document Code | KEIT-SOP-28 | Version | 2.0 |
|---|---|---|---|
| Revision | 02 | Status | Official |
| Issue Date | 28/03/2026 | Next Review | 28/03/2027 |
| Prepared by | Medical Directorate / Quality | Approved by | |
| Signature and Date | Distribution | Controlled - Internal Use |
Purpose of the document. To officially define the scope, responsibilities, operating procedure, KEIT standards, records and protocol review criteria.
1. Document Control Information
| Application | All clinical, nursing, technical and organizational personnel involved in the described process. |
|---|---|
| Archiving | KEIT internal document management system and a controlled copy in the relevant areas. |
| Review | At least annually or earlier in the event of regulatory, organizational or technological updates. |
2. Scope of Application
Applicable throughout the entire facility and across all clinical, technical, organizational and care services.
3. Responsibilities
- Medical Directorate and Clinical Directorate: promotion of the quality management system and periodic review activities.
- All personnel: reporting of incidents, near misses, non-conformities and process-related issues.
- Department managers: analysis of root causes and implementation of corrective actions.
4. Operating Procedure
- Enable and encourage prompt internal reporting of adverse events, near misses and non-conformities.
- Collect data in a structured manner while ensuring full traceability.
- Analyze events using a systems-based, non-punitive approach, identifying both immediate and root causes.
- Define corrective and preventive actions, assign responsibilities and establish implementation timelines.
- Schedule regular clinical and organizational audits covering safety indicators, infections, thromboprophylaxis, checklists, medications, medical devices and patient satisfaction.
- Monitor the effectiveness of implemented actions over time.
5. KEIT Operational Standards
- KEIT considers near misses and internal reporting as tools for continuous improvement rather than merely administrative requirements.
- Multidisciplinary audits enable practical review and continuous improvement of clinical processes and protocols.
6. Records and Documentation
- Incident reporting forms.
- Clinical audit reports.
- Corrective action plans and follow-up documentation.
7. Review and Updates
Quarterly review of key performance indicators and annual update of the quality management system.
Implementation Note
This document is an internal operational draft. Before final adoption, review by the Medical Directorate, Clinical Directorate, Legal Advisor and the relevant department managers is recommended.
This document is an internal operational draft. Before final adoption, review by the Medical Directorate, Clinical Directorate, Legal Advisor and the relevant department managers is recommended.
8. Related Attachments and Forms
- Operational checklists, recording forms, audit sheets and maintenance registers applicable to this protocol.
- Any department-specific or equipment-specific technical attachments are referenced in the relevant local operating instructions.
9. Final Approval
| Position | Name and Signature | Date |
|---|---|---|
| Medical Directorate |
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