The service provider shall provide comprehensive stem cell storage and processing for the purchaser, Barts Health NHS Trust.

All activities must comply with direction given under the Human Tissue Acts 2004 (HTA) and any subsequent Direction given by the HTA and JACIE Accreditation and European Union Directive (EUD) 2004/23EC, ‘Setting standards on quality and safety for the donation, procurement, testing processing, preservation, storage and distribution of tissue and cells’ and the implementing EUD 2006/17EC and EUD2006/86EC.

The service provider stem cell laboratory will provide all necessary resources in line with health and safety, COSHH and Hospital policies inclusive of support staff, equipment or plant, consumables and other facilities, which are necessary for the efficient and effective operation of the agreement on the service’s sites.

All activities must comply with Direction given under the Human Tissue Acts 2004 (HTA) and any subsequent direction given by the HTA and JACIE Accreditation and European Union Directive (EUD) 2004/23EC, ‘Setting standards on quality and safety for the donation, procurement, testing processing, preservation, storage and distribution of tissue and cells’ and the implementing EUD 2006/17EC and EUD2006/86EC.

To ensure the continued access for patients to clinical trials providing them with access to novel therapies (e.g. ATIMP/GTC) the provider must have experience of working to MHRA standards in cell therapies.

The harvesting of cells from patients or donors will take place at Barts Hospital. The cells will then be transported to the service provider’s stem cell laboratory, where processing including positive or negative selection, freezing and storage, if necessary are undertaken. The service provider is required to receive and process and return non-frozen and/or cry preserved haematopoietic stem cells/bone marrow for patients requiring transplant at Barts.

The service provider stem cell laboratory will provide all necessary resources in line with health and safety, COSHH and hospital policies inclusive of support staff, equipment or plant, consumables and other facilities, which are necessary for the efficient and effective operation of the agreement on the service’s sites.

Both parties (purchaser and provider) must ensure that the premises, facilities, equipment and materials used by them are fit for purpose and that they are selected, maintained and used in accordance with sections equipment and material, facilities and premises of the guide to quality and safety assurance for human tissue and cells for Patient Treatment Nov 2010 implementing Direction 003/2010 and paragraph 33 of Direction 002/2007 and with paragraphs 36-44 Directions 002/2007 (this is for activities performed on behalf of the Licence Holder).