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An on-site audit aims to review operational policies, procedures and practices in place. The audit involves a visual inspection of the premises, a review of documentation and discussions with a range of staff involved in licensable activities.
A number of considerations are made when deciding which establishments are prioritised for audit; these include, for example, the results of compliance updates.
A comprehensive suite of National Operating Procedures (NOPs) are available on the NHSBT microsite. There are NOPs covering:
Yes. There must be consent for research in place from the donor or a person in a qualifying relationship to the donor immediately before their death.
A serious adverse event (SAE) is defined in the Regulations as ‘any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating...
It is a statutory condition of an ODT licence to report SAEARs to NHSBT within 24 hours of discovery of the incident by the licence holder.
In the context of testing, examples of SAEs may be related to mislabelling, transcription errors, loss of traceability of samples, failure in testing protocols etc. All incidents should be reported to NHSBT. NHSBT will then report incidents falling into the category of SAEARs to the HTA.
The HTA directs that, for living donation, only UKAS accredited laboratories should be used, unless by doing so there is a risk to the donor or recipient which would outweigh the risk of using a non-accredited laboratory or one with an unknown status, e.g. due to time constraints in an emergency...
Although NHSBT keeps a register of all living donors for follow-up, all transplant centres are required to keep this information on site. Local practice will vary depending on how follow-up clinical visits, or visits to local GPs or hospitals are managed.