Guidance

Chapter 5: donor assessment

Updated 21 May 2024

Requirements for donor assessments are contained in the Human Tissue Authority’s (HTA) Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment and EU organ donation directives.

Once a donor has been identified there are 3 principal components to assessing suitability as a source of human materials for clinical use.

1. Clinical risk assessment

The first component comprises a clinical risk assessment based upon an interview, which addresses the likelihood of a donor having been exposed to a variety of infection risks. This interview is an opportunity to explain the consequences of making a donation, including testing, possible results and the impact of positive results on the contacts of the donor. In the case of deceased donors, the most relevant life partner or close relative should be interviewed to ascertain the required medical, behavioural and travel history. Additional information may be available from the referring clinician, the primary healthcare practitioner, the donor’s GP, post-mortem examination and/or examination at the time of tissue procurement or organ retrieval. The information needed for assessing the infection risk from donors is also set out in the NHS Blood and Transplant Patient Assessment Form (PA1), or equivalent. This information does not necessarily exclude donation but is required to inform the final risk and benefit analysis prior to transplantation. Guidance on the assessment of donors of gametes and embryos is outlined in Guidance note 11 (Donor recruitment, assessment and screening) of the Human Fertilisation and Embryology Authority (HFEA) code of practice. Donors of gametes must be selected for testing on the basis of a questionnaire and through a personal interview performed by a qualified and trained healthcare professional.

Detailed information is needed on the following:

• treatment received in the illness before donation (including duration and dose of antimicrobial and other drug therapy)
• vaccination history and immunisation status
• history of receipt of blood, blood components, blood products, tissue or organ graft
• if large volume intravenous fluid administration has occurred, then consideration needs to be given to the effects of haemodilution when interpreting test results
• previous or current immunosuppression (by disease or drugs) as this may affect the interpretation of test results or the donor’s suitability
• travel history or domicile outside of the UK. Infections may be acquired during travel outside the UK that have the potential for transmission through transplantation. These infections include malaria, West Nile virus and rabies. In addition to the well-documented infectious risks, there must be ongoing vigilance for the possibility of infection with a pathogen demonstrating geographic epidemiology or an emerging infection. Information regarding infectious risks associated with travel or domicile outside the UK may be sought from:
  • the Joint United Kingdom Transfusion and Tissue Transplantation Professional Advisory Committee Geographical Disease Risk Index
  • the US National Travel Health Network and Centre website
  • Public Health Scotland Fit for Travel
  • the European Centre for Disease Control
• history of contact with animals and other vectors - transplantation may transmit zoonotic infections
• history that may have put the donor at increased risk of transmissible spongiform encephalopathies (TSEs) - see Chapter 12
• history of malignancy, recent infectious disease or exposure to an infectious disease
• behavioural history that could have put the donor at risk of transmissible pathogens - this will include questions about risk behaviours such as:
  • recreational drug use
  • men who have sex with men (MSM)
  • sex with commercial sex workers
  • sex with a partner known to have a sexually transmissible disease
  • acupuncture
  • tattooing
  • body piercing
• results of any recent microbiological tests should be reviewed

2. Physical examination of potential donor

The second component is a physical examination of the potential donor that should be undertaken at the time of organ donation or tissue retrieval. This may indicate extra risks of infection and should be taken into account when assessing the donor suitability. For example, needle marks on the potential donor could indicate possible injecting drug use risk behaviour. In the case of potential deceased organ or tissue donation, a physical assessment body map is completed by the specialist nurse organ donation (SNOD) or the tissue establishment retrieval team.

3. Microbiological testing

The third component comprises microbiological testing. While medical and behavioural assessment will be similar for all donors, the actual microbiological assessment will vary for different types of donors but must include those that are mandatory under current regulations. The results of the donor-suitability assessment will inform the balance of risk and benefit in deciding whether a donor is suitable in particular transplant situations.

See a list of all chapters in this guidance