Chapter 4: referral for donation
Updated 21 May 2024
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This publication is available at https://www.gov.uk/government/publications/guidance-on-the-microbiological-safety-of-human-organs-tissues-and-cells-used-in-transplantation/chapter-4-referral-for-donation
Deceased donors
The donor’s family and/or the most relevant life partner should be interviewed, and supporting information obtained from relevant health professionals such as the donor’s GP. Standard questionnaires are used to seek relevant information and should be kept as part of the donor record. Wherever possible any post-mortem findings will need to be available to ensure that an appropriate risk assessment is complete and that all information pertaining to the cause of death is taken into account.
Current microbiological results on the donor should be available from the donor’s clinician and must be included in the comprehensive patient assessment process conducted by the trained healthcare professional. Where circumstances dictate, the risk arising from the use of materials from potentially infected, or known to be infected, donors should be discussed with a consultant or specialist with relevant knowledge regarding and expertise regarding that infectious risk. Advice from a specialist centre may be required for defining the balance between risk and benefit. Such discussion is normally between medical staff in the transplant unit receiving the organ and the relevant local transplant unit consultant microbiologist or virologist.
The information gathered by the trained healthcare professional must include the relevant microbiological findings.
Assessment of donor risk does not end at the time of retrieval of tissues and organs. Important information relating to the risk of transmission of infection may become available after transplantation. This information must be made available by the organ donation team or tissue establishment to the recipient centres for appropriate management of the recipient.
Living donors
Some people wish to donate an organ to a relative, to another person they are close to or to an individual they do not know. The latter situation may occur in the setting of paired donation, pooled donation and non-directed altruistic donation. Others may agree to donate surplus tissue, such as heart valves from the replaced heart after heart transplantation, bone following hip-replacement surgery, or umbilical cells to a cord blood bank. The information needed to assess any risk should be gathered from the potential donor or, in the case of child donors too young to understand the issues, from the adult with parental responsibility for that child as specified by the Human Tissue Act 2004[footnote 1] and the current Human Tissue Authority (HTA) code of practice on consent.
Autologous tissue donation is a special example of living donation where tissue or cells previously taken from an individual is transplanted to meet that same individual’s clinical needs. Where tissues and cells for autologous donation are removed and are to be stored and/or cultured, then microbiological screening of the donor prior to the procedure is a requirement of the Human Tissue (Quality and Safety for Human Application) Regulations 2007. HTA has a statutory requirement that while awaiting microbiological testing results, tissues and cells are quarantined regardless of ultimate destination. An autologous donation from an infected donor must be stored securely in a way that does not pose an infection risk to other donations stored in the same facility.
Donors of gametes (spermatozoa or eggs) and embryos
The various uses of gametes and embryos for reproductive purposes have additional considerations to organ or tissue transplantation. Their use in the human body carries a small risk of infection transmission not only to recipients, but also to any child that might result from fertility procedures.
Partner donation is defined as a procedure that intends to produce a pregnancy in a woman who is in an intimate relationship with a man who is providing the spermatozoa. In relation to infection risk, it may be considered to be similar to autologous donation.
Donation of gametes or embryos to a non-partner recipient requires further assessments and testing. The definition of such donors is given in the Human Fertilisation and Embryology Authority (HFEA) code of practice. Where cryopreserved embryos are donated to a third party, there may be a period of several years between the embryo creation and donation.
Embryonic stem cell (ESC) lines for therapeutic use may be derived from embryos created for treatment of infertility that are surplus to clinical requirements. Similar criteria apply as for other stem cell lines taking account of the potential time interval between embryo creation and donation. If the embryos are created for the purpose of creation of ESCs rather than fertility, the same criteria will apply as for tissue and cell donation. Further guidance relating to the regulatory requirements for conducting human stem cell research is available on the EuroStemCell website.
SaBTO has previously published a review considering risks of infection from cell based advanced therapies: Donation of starting material for cell-based advanced therapies: a SaBTO review.
Table 1 gives examples of donations relevant to these guidelines.
Table 1: examples of donors and circumstances of donation
| Type of donor | Circumstances surrounding the donation | Example |
|---|---|---|
| Deceased - DBD (donation after brain stem death) | Retrieval from donor certified as dead by neurological criteria while on respiratory and circulatory support | All organs and tissues |
| Deceased - DCD (donation after circulatory death) | Retrieval of organs usually within one hour of circulatory arrest | - Kidney - Liver - Lung - Pancreas and islet cells - Heart |
| Deceased - DCD (donation after circulatory death) | Donations of tissues up to 48 hours after death | - Eye or cornea [note 1] - Heart valves - Bone - Tendons - Skin - Cartilage |
| Living allogeneic - directed | A donation from a living relative or someone emotionally related Related haematopoietic stem and progenitor cells (HSPC) donors - for example, a sibling or parent |
- Kidney - Liver - Lung - Pancreas - Small bowel - Limbal stem cells - HSPC-marrow - HSPC-apheresis - HSPC-cord blood |
| Living allogeneic - voluntary unrelated donation of organ or tissues to an unknown individual | Altruistic donation of organs and tissues Large registries are now available nationally and internationally in order to select volunteer unrelated HSPC for transplantation |
- Kidney - Liver - Bone - Reproductive cells - Amniotic membrane - HSPC-marrow - HSPC-apheresis - HSPC-cord blood - Human ESCs - Induced pluripotent stem (iPS) cells |
| Autologous - tissues and cells | Procedures involving retrieval of tissues and cells for use in the donor | - Skin - Bone - Keratinocytes - Limbal stem cells - HSPC-marrow - HSPC-apheresis - HSPC-cord blood - Cartilage - Reproductive cells |
Note 1: donation for corneas should take place within 24 hours of death.
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Donation in Scotland is undertaken according to the Human Tissue (Scotland) Act 2006. ↩