Offsite Storage of Liquid Nitrogen Vessels

Description

NHS Blood and Transplant (NHSBT) is a Special Health Authority in England, with responsibilities across the United Kingdom for organ donation and transplantation. Our core purpose is to ‘save and improve lives’ through the provision of a safe and reliable supply of blood components, solid organs, stem cells, tissues and related services to the NHS, and to the other UK Health Services where directed. <br/><br/>NHSBT is required to store human tissue and cells for human application, research and IVD products in vapour phase liquid nitrogen vessels. Where facilities are available, storage is carried out at NHSBT sites. In some cases, there is insufficient storage space so NHSBT has a requirement to store some cryostorage vessels permanently off site. There is also a requirement to have in place a contingency plan to transfer cryostorage vessels off site for temporary storage in emergency situations.<br/><br/>NHSBT is looking to award a Framework Agreement for the Provision of external storage of liquid nitrogen vessels containing human tissue and cells for human application.<br/>Liquid nitrogen vessels will need to be collected from their existing storage sites located across England and transported to the service providers premises which must be HTA licensed to store and distribute human tissues and cells for human application under the Human Tissue (Quality and Safety for Human Application) Regulations 2007.<br/>The temperature of liquid nitrogen vessels must be continually monitored, with records provided to demonstrate that products they contain remain below -150C at all times.<br/>The service provider will also be required to locate cryopreserved products from the cryostorage vessels and deliver to NHSBT sites in a dry shipper, upon request. Lot 1: • HTA licensed to store and distribute human tissues and cells for human application under the Human Tissue (Quality and Safety for Human Application) Regulations 2007.<br/><br/>• All ventilation systems in the liquid nitrogen store must comply with British Compressed Gases Association (BCGA) code of practice Guidance Note G11 and HSE guidance.<br/><br/>• Immediately accommodate 80 liquid nitrogen vessels measuring up to 1.2m in diameter, including providing transportation from their existing location in Nottingham .<br/><br/>• Transport and accommodate up to 35 cryostorage vessels, with up to 72 hours’ notice, during times of emergency.<br/><br/>• Collect and transport cryostorage vessels to and from NHSBT sites, including providing evidence of cold chain.<br/><br/>• Locate and deliver cryopreserved products from the liquid nitrogen vessels to NHSBT sites upon request using a dry shipper. This would normally be with a minimum of 3 days’ notice, although products may be required within 24 hours in times of emergency. <br/><br/>• Products must be maintained below -150C at all times. The service provider must provide temperature records to NHSBT to demonstrate cold chain during transit.<br/><br/>• Liquid nitrogen must be fitted with temperature sensors, with staff available to attend alarms 24 hours / day. <br/><br/>• Provision of sufficient storage space to enable NHSBT future cryostorage expansion, estimated to be an additional 20-30 cryovats during the term of the Framework Agreement.