The general principles of microbiological testing and the specific testing requirements for tissue donors are covered in Chapter 9. Testing must be completed in a licensed Tissue Establishment or under a third party agreement between the testing laboratory and the licensed Tissue Establishment. If a third party laboratory is used to perform any aspect of donor testing, the specific requirements and responsibilities of both parties in achieving them must be defined in a written agreement. Such testing should, as a minimum, be performed in accordance with the guidance in this document. There should be protocols for assuring the veracity and security of the sample, labelling, and supporting documentation. The time from sample acquisition to testing or freezing of the sample should be minimised and must be consistent with test kit manufacturers’ recommendations or validated for the purpose. Due consideration should be given to dilution of the sample (see section 20.7).
Additional discretionary testing may be required (e.g. for malaria, Chaga’s disease or West Nile Virus), dependent on the donor’s travel history. RhD testing may be required on donors if the retrieved tissues will contain residual red cells or red cell membranes at the time of implantation.
The tissue bank should have a documented policy to follow in the case of donors with reactive screening tests. There should be protocols for alternative or confirmatory testing and acceptance or rejection of donations.
A positive result should be notified urgently to the source bank, Specialist Nurse Organ Donation or supplier of the tissue or cells so that clinicians in all centres that have received material from the same donor can be informed and take appropriate action. Where tissue or cells from a donor have been sent to other banks or centres, these banks or centres must be told about the positive result. Reports of positive tests should be included in the routine donor surveillance programmes and notified to the HTA (see section 21.8).