Welsh Bone Marrow Donor Registry Stem Cell Collection Facility

Tender description

The collection, testing and distribution of Blood Stem Cell products used of human application. The WBMDR requires engagement of supplier(s) for the provision of facilities and resources to collect Bone Marrow (BM) and Peripheral Blood Stem cells (PBSC) This service is business critical to the WBMDR and as such every aspect of the service must be of the appropriate specification, however it is expected that this will be a collaborative partnership, and as such the supplier should indicate which aspects they expect to be provided by WBMDR where an option of provision is shown. All services must meet Human Tissue Authority Quality and Safety Regulations and FACT-JACIE standards. Blood stem cells are collected by two primary methods bone marrow aspiration and via apheresis following G-CSF mobilisation. A Bone Marrow Collection Centre (BMC) is a medical facility at which bone marrow collection from selected WBMDR donors takes place. The Apheresis Collection Centre (ACC) is the facility at which blood mononuclear cells (e.g. G-CSF stimulated blood stem cells or unstimulated peripheral blood lymphocytes) from selected WBMDR donors are collected by automated apheresis this procedure can take up to 7 hours. The WBMDR is looking to secure services within a 45 minute drive of its Talbot Green Headquarters located near Cardiff. The collection team must have a designated, responsible person (usually a Consultant) with at least two years experience in cellular therapy product collection procedures This responsible person must agree that the donor is acceptable for the procedure, taking account of the Donor Medical Assessment provided by the WBMDR and the donor’s “on the day” fitness. The collection facility must be within 45 minute car journey of WBMDR office in Talbot Green Provide adequate facilities for the collection, processing and temporary storage of cellular therapy products to include but not limited to: Environmental controls for areas where product is exposed to the environment. Appropriate laboratory space for processing, labelling and packaging of products. Provide appropriate equipment for the processing of products (optional) Have access to Pharmacy for prescription of required drugs Provide on-site clinical cover for donor care issues from admission through to discharge of the donor including intervention and referral where required. Lot 1: Lot 1: Bone Marrow Collection facility and resources The service must have previous experience of bone marrow collection (at least 3 bone marrow collections during the last 3 years) and provide facilities and resources for bone marrow collection under general anaesthetic including but not limited to: surgical operating room and access to emergency and intensive care services Provide the collection team which must have a designated, responsible person (usually a Consultant) with at least two years experience in cellular therapy product collection procedures Ensure the anaesthetic, whether general or regional, is administered by an appropriately qualified/experienced Anaesthetist Provide adequate facilities for the collection and minimal processing of Bone Marrow collections including: Environmental controls for areas where bone marrow product is exposed to the environment. Provide appropriate onsite laboratory facilities for: rapid TNC enumeration of bone marrow products FBC of donors pre and post procedure Labelling and preparation of products in readiness for transportation. Lot 2: Lot 2 Peripheral Blood stem Cell Apheresis facility and resource The supplier must provide a suitable designated collection area that considers donor well-being and optimal collection success; This area must not be a communal ward. The area should be private and consideration given to toileting, donor rest, privacy and anonymity. The area should be away from a main thoroughfare and quiet The area must be suitably spaced to allow a single companion in addition to space required for nursing staff. The supplier must provide an adjustable hospital ‘type’ bed for the donor to lie on throughout the collection The area should have power outlet in vicinity of the bed for small electrical items such as tablets or mobile phones in addition to that required for the apheresis machine. The area must be temperature monitored and adjustable air conditioning present to prevent over heating of anticoagulant. The supplier must have access to a pharmacy for procurement and issue of drugs utilised during the collection including procurement and storage of a small stock of G-CSF as directed by the manufacturer. The supplier should provide a collection team to include medical and nursing staff experienced in apheresis collection (optional). The supplier should provide all equipment for the collection of blood stem cells (optional) The system must be supported by a detailed contract with the supplier.