Standard 43: Organ and Tissue Transplant

Why it matters. Donation must be a free choice, made by the donor or their family, and not pressured by the team that will use the organ. A consent process separate from the treatment team protects that choice.

Sample. Review donor consent records for all donations in the last 12 months.

1. Donor or family consent is obtained by a process independent of the transplant team.

Method. Check each consent for the person who took it and their role in the transplant team.

Evidence to show. Donor consent independent of the transplant team (TXP-POL-001).

Pass when. No consent was taken by a member of the requesting transplant team.

2. Consent is recorded with the donor’s known wishes or the family’s decision.

Method. Check each consent record for the wishes or decision recorded.

Evidence to show. Donor consent record (TXP-FRM-001).

Pass when. Every consent records the wishes or decision.

3. The consent process is documented in the same form for each case.

Method. Check the consent records for the steps completed.

Evidence to show. Informed consent before significant care (CON-SOP-001, existing, reused).

Pass when. Every consent follows the documented steps.

Immediate fail (any one means the criterion is not met)

• The transplant surgeon who needs the organ asks the family for consent.

Why it matters. Organs are scarce. Allocating them by a written, transparent rule, based on clinical need, is the only fair way to decide who receives one.

Sample. Review organ allocation decisions for the last 12 months, including any decision that departed from the protocol.

1. Allocation follows the written protocol and its clinical criteria.

Method. Check each allocation against the protocol criteria.

Evidence to show. Organ allocation protocol (TXP-POL-002).

Pass when. Every allocation follows the protocol criteria.

2. Each allocation is recorded with the criteria used.

Method. Check each allocation record for the criteria and the date.

Evidence to show. Allocation decision register (TXP-REG-001).

Pass when. Every allocation records the criteria used.

3. Any departure from the protocol is recorded with the reason and reviewed.

Method. Check each departure for the reason and the review.

Evidence to show. Allocation decision register (TXP-REG-001).

Pass when. Every departure has a reason and a review.

Immediate fail (any one means the criterion is not met)

• A kidney allocated to a friend of a senior clinician with no criteria recorded.

Why it matters. Paying a donor or their family for an organ is exploitation and is banned in most places. Only legitimate costs, such as travel, may be covered, and only with a record.

Sample. Review all payments and reimbursements linked to donation for the last 12 months.

1. No payment or incentive is offered to a donor or donor family.

Method. Check the payment log for any payment to a donor or family.

Evidence to show. No financial incentive (TXP-POL-003).

Pass when. No sampled payment is an incentive.

2. Each reimbursement is for a documented direct cost.

Method. Check each reimbursement for the receipt and the cost category.

Evidence to show. Payments and reimbursement register (TXP-REG-002).

Pass when. Every reimbursement has a receipt and a documented direct cost.

3. Each reimbursement is approved before payment.

Method. Check each reimbursement for the approval before the payment date.

Evidence to show. Payments and reimbursement register (TXP-REG-002).

Pass when. Every reimbursement was approved before payment.

Immediate fail (any one means the criterion is not met)

• A family paid for the donor’s funeral costs as a reward for donation, with no receipt.

Why it matters. A transplant recipient must be fit for the procedure and understand its risks. A documented evaluation and informed consent make sure the decision is sound.

Sample. Review evaluation and consent records for 15 transplant recipients.

1. Each recipient is evaluated against documented clinical eligibility criteria.

Method. Check each evaluation for the criteria checked and the outcome.

Evidence to show. Recipient evaluation and consent (TXP-SOP-001).

Pass when. Every recipient has a documented evaluation.

2. Consent covers realistic outcomes, risks and alternatives.

Method. Check each consent for the three elements.

Evidence to show. Recipient evaluation and consent record (TXP-FRM-002).

Pass when. Every consent covers all three elements.

3. The recipient is given time to consider before consent is signed.

Method. Check the time between the discussion and the signed consent.

Evidence to show. Informed consent before significant care (CON-FRM-001, existing, reused).

Pass when. Every recipient has time recorded before consent.

Immediate fail (any one means the criterion is not met)

• A recipient listed for transplant with no documented evaluation and no consent discussion of risks.

Why it matters. 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.

Sample. Review chain of custody records for 15 organ or tissue donations from donor to recipient.

1. Every organ or tissue has a documented chain of custody from donor to recipient.

Method. Check each donation for a custody record at each handover.

Evidence to show. Chain of custody for tissues and organs (FRT-SOP-007, existing, reused).

Pass when. Every donation has a complete custody record.

2. Handling, testing and transport are recorded at each step.

Method. Check each record for the handling, testing and transport entries.

Evidence to show. Organ handling and transport record (TXP-FRM-003).

Pass when. Every step is recorded with time and person.

3. Each unit is traceable from donor to recipient.

Method. Trace a sample of units through the traceability register.

Evidence to show. Donation traceability register (BLD-REG-002, existing, reused).

Pass when. Every sampled unit can be traced end to end.

Immediate fail (any one means the criterion is not met)

• A donor organ arrives with no label and no record of transport temperature.

Why it matters. After a transplant, the graft and the patient must be followed for years. Tracking outcomes shows whether the service is succeeding, and catches problems early.

Sample. Review follow-up records for all recipients transplanted in the last 2 years.

1. Each recipient is followed up at the defined schedule.

Method. Check each recipient record for the follow-up visits against the schedule.

Evidence to show. Post-transplant follow-up and outcome tracking (TXP-SOP-003).

Pass when. Every recipient is followed up on schedule.

2. Graft and patient outcomes are recorded and reported.

Method. Check the outcome register for each recipient and the report.

Evidence to show. Graft and patient outcome register (TXP-REG-004).

Pass when. Every recipient has outcomes recorded and reported.

3. Recipients lost to follow-up are traced.

Method. Check each recipient lost to follow-up for the tracing attempts.

Evidence to show. Post-transplant follow-up and outcome tracking (TXP-SOP-003).

Pass when. Every recipient lost to follow-up has tracing attempts recorded.

Immediate fail (any one means the criterion is not met)

• A recipient discharged after transplant and lost to follow-up within six months.