Standards › Standard 8 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · FRT-SOP-007 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 8.11
At a glance
- Every tissue or organ has a documented chain of custody from donor to recipient.
- Each handling, test and transport step is signed.
- There is no gap in the record at any point.
- A gap stops use until it is resolved.
- Stop and get help straight away if: a tissue or organ is used or moved with a gap in its chain of custody.
1. Purpose
To trace every tissue or organ from donor to recipient with no gap (8.11).
2. Scope
| Applies to | Clinical and support staff in the hospital |
| Locations | All wards, clinics and departments of the facility |
| When | Whenever the activity described is carried out |
| Does not apply to | Activities covered by another document listed in section 15 |
3. Definitions
| Term | Meaning |
|---|---|
| Clinical lead | The doctor or nurse in charge of the area at the time |
4. Background
An organ or tissue must be traceable from donor to recipient, through every step of handling, testing and transport. Without a chain of custody, an unsafe donation cannot be found or stopped.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Clinical director | Owns the chain of custody | Clinician |
| Coordinator | Keeps the record at each step | Coordinator |
6. Materials and equipment
| Item | Requirement | Condition |
|---|---|---|
| Records and forms named in this document | Current version | Checked before use |
7. Safety
- Stop and call for help if a patient is at immediate risk. Do not delay urgent care to complete paperwork.
8. Before you start
- Confirm the forms and equipment named in this document are available and current.
9. Procedure
Step 1. Start the chain.
- Record the donor and the tissue or organ identity at collection (FRT-FRM-005).
Key point: The chain starts at donation.
Step 2. Sign each step.
- Sign each handling, test and transport step with the time and the condition.
Key point: No step without a signature.
Step 3. Close.
- Close the chain at the recipient, and check there is no gap.
Key point: No gap at the end.
10. Decision points
- No decision points in this procedure.
11. Special situations
| Situation | Action |
|---|---|
| Out of hours | Follow the same steps. Use the on-call contact on the wall of the area. |
12. Escalation
- Any serious problem goes to the duty clinical lead at once and to the clinical director the same day.
13. Monitoring
| Measure | Target | Frequency | Owner | If not met |
|---|---|---|---|---|
| Chains with no gap | 100% | Quarterly | Clinical director | Escalate to chief executive |
14. Records
| Record | Kept in | Retention |
|---|---|---|
| Record named in this document | Patient record or the area file | the period set by the facility’s records policy years |
15. Training
- Staff are trained in this document at induction and refreshed each year, with a recorded competency check.
16. Related documents
| ID | Title | Use |
|---|---|---|
| FRT-FRM-005 | Chain of custody record | Record |
17. Evidence
| Reference | Note |
|---|---|
| E-009 | Based on the WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation (2010). |
| E-006 | ASF Policy Framework v1.2. Adapted. |
| E-009 | ASF Expert Committee consensus. |
18. Change history
| Version | Date | What changed | Approval |
|---|---|---|---|
| 1.0 | the date of approval | First version | set Expert Committee approval |
E-learning for this document
- Supplier Evaluation and Purchasing (T-13)
- Equipment, Reagents & Traceability (LAB-04)
References
- Accréditation Sans Frontières (2026). ASF Policy Framework v1.2. (E-006)
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)