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Standards › Standard 43 › Standard operating procedures (SOPs)

Standard operating procedure (SOP) · TXP-SOP-001 · Version 1.0 · Approved by the ASF Expert Committee

Supports: 43.4

At a glance

  • Each recipient is evaluated against the documented clinical eligibility criteria (TXP-FRM-002).
  • Consent covers realistic outcomes, risks and alternatives.
  • The recipient is given time to consider before signing.
  • The evaluation and consent are reviewed by a second clinician.
  • Stop and get help straight away if: a recipient is listed for transplant with no documented evaluation or consent.

1. Purpose

To make sure recipients are selected on clinical grounds and choose transplant with full information (43.4).

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

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.

5. Responsibilities

Role Responsibility Competence
Transplant clinician Evaluates the recipient and leads the consent discussion Transplant programme director
Second clinician Reviews the evaluation and consent Transplant clinician

6. Materials and equipment

Item Requirement Condition
Records and forms named in this document Current version Checked before use

7. Safety

8. Before you start

9. Procedure

Step 1. Evaluate.

  • Evaluate the recipient against the eligibility criteria and record it (TXP-FRM-002).

Key point: Evaluated.

Step 2. Discuss.

  • Discuss realistic outcomes, risks and alternatives, and allow time to consider.

Key point: Discussed.

Step 3. Consent and review.

  • Record consent and have a second clinician review the file.

Key point: Reviewed.

10. Decision points

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

13. Monitoring

Measure Target Frequency Owner If not met
Recipients with evaluation and consent recorded 100% Quarterly Transplant programme director Escalate to the clinical director

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

16. Related documents

ID Title Use
TXP-FRM-002 Recipient evaluation and consent record Record
CON-FRM-001 Consent record (existing) Record

17. Evidence

Reference Note
E-009 Based on the WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation (2010), including the principles on donation without commercial gain, and the ASF Hospital standard for consent.
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

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References

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