Patient Safety
KEIT DAY HOSPITAL
Informed consent, transparency and patient communication protocol
Official Manual of Clinical, Care and Organizational Protocols
| Document Code | KEIT-SOP-25 | 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 controlled copies in the relevant departments. |
| Review | At least annually or earlier in the event of regulatory, organizational or technological updates. |
2. Scope of Application
Applicable to all clinical and administrative pathways within the facility involving assessment, quotation, contract, informed consent and follow-up.
3. Responsibilities
- Surgeon: medical and clinical explanation of indications, limitations, risks and potential complications.
- Patient Coordination Team: delivery of documentation, organizational guidance and informational support.
- Clinical Directorate: supervision of document content and documentation traceability.
4. Operating Procedure
- Provide the patient, sufficiently in advance of the procedure, with a detailed quotation, contract, warranty certificate and informational documentation.
- Explain, in a clear and understandable manner, the realistic objectives, limitations, expected recovery, risks and possible complications of the procedure.
- Send the informed consent document to the patient by email before the procedure to allow careful review and informed questions.
- Verify that the patient has understood the documentation and has had sufficient opportunity to request clarification.
- Obtain all required signatures and archive the complete documentation.
- Ensure traceability of all significant communications before and after the procedure.
5. KEIT Operational Standards
- KEIT prioritizes financial and clinical transparency: no unexpected costs, a detailed contract and a warranty certificate.
- Informed consent is carefully explained and is never treated as a mere administrative formality.
- Key communications are also summarized and documented in writing.
6. Records and Documentation
- Quotation and contract.
- Informed consent.
- Document delivery emails.
- Register of significant communications.
7. Review and Updates
Periodic review of forms and the language used when communicating with patients.
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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