Accréditation Sans Frontières · ASF Health Standards 9.0
Standard 10 · Organ & Tissue Transplant
6 criteria · base standard
Base standard. 6 criteria, of which 3 non-negotiable. Each criterion is numbered 10.Y, with its classification and verification questions.
Criteria
- 10.1 Donor Consent Obtained Through a Process Independent of the Transplant Team (NON-NEGOTIABLE)
- 10.2 Organ Allocation Follows a Transparent, Documented Protocol (NON-NEGOTIABLE)
- 10.3 No Financial Incentive to Donor or Family (NON-NEGOTIABLE)
- 10.4 Recipient Evaluation and Informed Consent Process (CORE)
- 10.5 Organ and Tissue Traceability, End to End (CORE)
- 10.6 Post-Transplant Follow-Up and Outcome Tracking (STANDARD)
10.1 Donor Consent Obtained Through a Process Independent of the Transplant Team
NON-NEGOTIABLE
Donor or donor-family consent for organ or tissue donation is obtained through a process independent of the transplant team requesting the organ, with the independence structurally built in — not a theoretical separation undermined by the same staff being involved in both roles.
VERIFICATION QUESTIONS
- Is the person obtaining consent organisationally separate from the transplant team, not just nominally distinct while reporting to the same leadership?
A structural, not just a titular, separation is what protects against conflict of interest. - Is there a documented process ensuring the family or donor is never approached by someone with a direct stake in the transplant outcome?
The specific person requesting consent should have no personal or professional interest in a "yes" answer. - Can staff describe this separation clearly and confidently when asked?
If staff cannot articulate how the separation works, it may not be built into practice.
10.2 Organ Allocation Follows a Transparent, Documented Protocol
NON-NEGOTIABLE
Organ allocation decisions follow a written, transparent protocol based on clinical criteria, applied consistently, with any deviation from the standard protocol specifically documented and justified — not informal decisions vulnerable to undue influence.
VERIFICATION QUESTIONS
- Does a written protocol govern allocation decisions, not informal judgement applied case by case?
A written, consistent protocol is a specific, checkable safeguard against undue influence. - Is any deviation from the standard protocol specifically documented with a clear clinical justification?
An undocumented deviation is a specific, checkable gap that undermines the protocol's purpose. - Is the allocation protocol and decision record available for independent review?
Transparency means a decision can be reviewed, not just exist on paper.
10.3 No Financial Incentive to Donor or Family
NON-NEGOTIABLE
No financial payment or material incentive, beyond legitimate reimbursement of documented direct costs, is offered to a donor or donor family in connection with organ or tissue donation, with staff trained to recognise and refuse any such arrangement.
VERIFICATION QUESTIONS
- Is there a clear, written policy explicitly prohibiting financial incentive beyond legitimate documented cost reimbursement?
A specific, written prohibition, not an assumed understanding. - Are staff trained to recognise what counts as a legitimate reimbursement versus a prohibited incentive?
The distinction needs to be concrete and understood, not left to individual judgement in the moment. - Is there a documented process for reporting any suspected violation of this policy?
An actionable reporting pathway, not just a policy statement with no mechanism behind it.
10.4 Recipient Evaluation and Informed Consent Process
CORE
Transplant recipients undergo a documented evaluation against clinical eligibility criteria, with informed consent covering realistic outcomes, risks, and the source of the organ or tissue where legally and clinically relevant — not a general surgical consent treated as sufficient.
VERIFICATION QUESTIONS
- Is recipient evaluation against clinical eligibility criteria documented, not assumed from referral alone?
A referral for transplant evaluation is not the same as a documented eligibility determination. - Does informed consent cover realistic outcomes and risks specific to transplant, not a generic surgical consent form?
Transplant carries specific risks and realistic outcome ranges that a generic surgical consent does not address. - Is the recipient's understanding verified, not just a signature obtained?
A signature confirms a form was signed, not that the content was understood.
10.5 Organ and Tissue Traceability, End to End
CORE
Every organ or tissue is traceable through a documented chain of custody from donor to recipient, including handling, testing, and transport, with no gap in the record at any point in that chain.
VERIFICATION QUESTIONS
- Is there an actual, continuous chain of custody record, with no gap at any handling point?
A single gap in the chain undermines the entire traceability purpose. - Does the record include testing and screening results specific to that organ or tissue, not just a general log entry?
Specific, retrievable results, not a generic pass/fail note. - Can the full chain be reconstructed on request for a specific organ or tissue?
Retrievable on demand, not theoretically traceable but practically difficult to reconstruct.
10.6 Post-Transplant Follow-Up and Outcome Tracking
STANDARD
Transplant recipients are followed systematically after the procedure, with graft and patient outcomes tracked and reported, not lost to follow-up once the recipient is discharged from the immediate post-operative period.
VERIFICATION QUESTIONS
- Is there a documented, systematic follow-up schedule, not informal contact depending on the recipient's own initiative?
A proactive schedule, not reliance on the recipient to seek follow-up themselves. - Are graft and patient outcomes tracked and aggregated, not scattered across individual, unconnected patient files?
Aggregated tracking enables the programme to monitor its own outcomes over time. - Is there a documented process for what happens when a recipient is lost to follow-up?
A specific, active process for re-engagement, not simply accepting the loss. ————————————————————