In preparation for ODT establishments considering or planning, for transplantation services to resume, we have created this guidance. This is aimed at transplant centres considering using “clean sites” or alternative hospital premises to their base location in order to resume their transplant programmes.
You will need to inform the HTA of your plans using the contact details at the bottom of the page.
Please note, licences granted under the ODT Regulations apply to persons (corporate bodies or individual people), rather than premises. In practice, this means that the staff employed by licensed corporate bodies (such as NHS Trusts, or NHS Blood and Transplant) or licensed individuals can conduct a licensable activity in a range of locations that are authorised by their employer.
In summary, licensable activities can be carried out on alternative hospital premises with no changes needed to the licence.
However, establishments will need to consider other issues as part of their planning, in particular:
If equipment from the new remote hospital site is used during transplant related activity, the establishment will need to assure themselves that the material and equipment used meets the requirements of The Medical Devices Regulations 2002 (SI 2002/618). Each establishment should consider obtaining and holding a copy of the relevant documentation demonstrating that equipment meets these requirements where relevant.
Each establishment will need to assure themselves of the procedures for sterilisation that will be used for any materials and equipment taken to another hospital that will be sterilised at the remote site.
Each establishment should consider:
- Obtaining and holding a copy of the certificate of accreditation for the department or establishment carrying out sterilisation of equipment; or
- any trust-wide policies on sterilisation of equipment of the hospital where the transplant activity will be undertaken. This is not relevant if equipment will be returned and sterilised at the establishment’s original base hospital site.
Each establishment will need to assure themselves that any perfusion fluids being stored at the new remote site are being stored in suitable, temperature monitored environments and in line with the manufacturer’s instructions.
If staff from the new remote hospital site will be present in the operating theatre where transplant related activity takes place, they may be less familiar with transplantation processes and should be thoroughly briefed to ensure the following GN assessment criteria are met:
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GN1: Healthcare personnel directly involved in the chain from donation to the transplantation or disposal of an organ are competent and suitably qualified or trained to perform their tasks.
- GN2: Healthcare personnel directly involved in the chain from donation to the transplantation or disposal of an organ are provided with the training necessary to perform their tasks.
- GN3: Medical activities are performed under the advice and guidance of a registered medical practitioner, and there are operating procedures in place to demonstrate this.
In reviewing GN3, establishments must consider under what governance system they will be undertaking the licensable activities. Consideration should be given to reporting of Serious Adverse Events and Reactions, for example.
Establishments that plan to undertake transplant related activity at new remote premises must contact NHSBT Hub Operations so that location, address and delivery details of the new premises are recorded against the transplanting establishment’s record. Establishments must also consider their obligations with regards to organ traceability. If transplant related activity does commence at new remote hospital premises, then new systems regarding recording delivery dates and times may need to be put in place. As mentioned above, staff from the remote hospital site or existing establishment staff should be trained in these new procedures.
Establishments must also consider the route of transport for tissue typing materials and ensure laboratories have the correct address and contact details of the new remote hospital premises. If a different tissue typing laboratory is used instead of the usual laboratory, the establishment should endeavour to use only laboratories accredited by UKAS (deceased donation). 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.
We recommend that establishments record their decisions on the points above and keep a record of any agreements made between the base hospital site and the remote hospital site.
Further information on licensing requirements can be found in the HTA ODT documentary framework. Please also refer to NHSBT guidance on reopening transplant centres.
You must inform the HTA prior to any changes being implemented. Please email transplants@hta.gov.uk or call 020 7269 1900 and ask to speak with Adam.