JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

22.6: Donor selection, consent and testing

22.6.1: Allogeneic HPC-M donors

22.6.1.1: General principles

  • Registries must have detailed policies and procedures for the testing and assessment of donors of HPC and TC. These must be in accordance with the requirements of the EU Directives on Tissues and Cells, FACT-JACIE Standards and the WMDA.
     
  • Counselling: Relevant information must be given to potential donors at appropriate times. This shall include an explanation of the risks of the procedure; benefits for the intended recipient; tests to be performed to protect the health of the donor and recipient; the policy of informing donors of significant abnormal results; the possible need for second donations of HPC or TC; the right to withdraw from the donation; the risk of death for the recipient if the donor withdraws after the recipient’s conditioning therapy has started; anonymity policy; insurance arrangements; reimbursement of expenses.
     
  • Consent: The donor must be competent to give and have given valid consent before conditioning therapy is initiated in the recipient. Consent must be obtained in accordance with the requirements of the Human Tissue Act and the HTA’s Codes of Practice on consent, and donation of allogeneic bone marrow and peripheral blood stem cells for transplantation.

22.6.1.2: Medical history, physical examination and testing

  • The donor medical assessment must be performed according to the requirements of the EU Directives on Tissues and Cells, FACT-JACIE Standards and the WMDA.
     
  • Anonymity must be maintained between donors and recipients in accordance with the requirements of EU Directive 2004/23/EC. The British Bone Marrow Registry (BBMR) and the Welsh Bone Marrow Donor Registry (WBMDR) must have robust policies for donor anonymity and follow-up in accordance with the requirements of the WMDA, FACT-JACIE and NetCord-FACT Standards and the relevant EU Directives.

22.6.2: Allogeneic HPC-A donors

HPC-A may be collected after mobilisation with a licensed G-CSF preparation.

The requirements of section 22.6.1 also apply. A donor of HPC-A must be found fit for both apheresis and G-CSF administration and may also be assessed for fitness to undergo bone marrow harvest in the event of failure to mobilise stem cells.

22.6.3: Autologous HPC-M and HPC-A donors

The assessment and counselling of patients is not within the scope of these guidelines. However, consent must be obtained in accordance with the requirements of the HTA. The requirements for processing, preservation, storage and testing of autologous donations are described in sections 22.9, 22.10 and 22.11.

22.6.4: Repeat donations of allogeneic HPC-A, HPC-M or first or repeat donations of TC

These are requests either for further donations of HPC, for the same or a different patient, from donors who have in the past given an HPC donation, or for a TC donation for the same patient where an HPC donation has already been given. Individual assessment of each request is required. This must include further medical assessment with appropriate testing, counselling and consent.

22.6.5: Allogeneic HPC-C donors

  • HPC facilities/cord blood banks must have detailed policies and procedures for the assessment and testing of donor mothers and infant donors of HPC-C. These must be in accordance with the requirements of the EU Directives on Tissues and Cells, NetCord-FACT Standards and the WMDA.
     
  • Maternal assessment must be performed by appropriately trained staff, according to the requirements of the EU Directives on Tissues and Cells, NetCord-FACT Standards and the WMDA.
     
  • Infant assessment must be performed by appropriately trained staff, according to the requirements of the EU Directives on Tissues and Cells, NetCord-FACT Standards, SaBTO and the WMDA.
     
  • Testing requirements, see section 22.11 Maternal samples taken at time of collection of the HPC-C (Day 0 to +7) shall be tested in accordance with the requirements of the EU Directives on Tissues and Cells, NetCord-FACT Standards and the WMDA.
     
  • Consent. Detailed information must be provided to potential donor mothers prior to requesting consent, in terms and translations relevant to the mother. Consent for collection must be obtained prior to harvest of the cord blood. Consent must be obtained in accordance with the requirements of the Human Tissue Act, the HTA’s Codes of Practice for consent and donation of organs, tissue and cells for transplantation, the EU Directives on Tissues and Cells and NetCord-FACT Standards.