Managed Service Contract for the Provision of Secondary Blood Grouping & Sickle Cell Testing

Description

NHSBT is looking to award a Managed Service Contract for the supply of commercially available automated blood group testing equipment for use as a secondary testing technology for ABO and Rh D typing, antibody screening and identification, extended red cell phenotyping and HbAS (heterozygous sickle cell trait) screening for donor blood, tissues and stem cell (haemopoietic progenitor cells and therapeutic cells) samples. Lot 1: NHSBT requires a direct contractual relationship with either the manufacturer or any other economic operator for a complete end-to-end integrated solution, which must include all the necessary equipment, installation, maintenance, consumables, reagents, and IT provision of hardware, middleware and software, allowing interoperability over a private VPN between the supplier and NHSBT and connectivity to the NHSBT LIMS systems, and an overall on-going support mechanism that will be required to carry out the necessary testing as stated below.<br/><br/>A complete solution (test system) includes all necessary maintenance, consumables, software and overall support required to carry out the testing. All invitro diagnostic medical devices, for example, instruments, consumables, and reagents must be CE/UKCA marked. GB will continue to recognise CE marking until the UK requirements fully apply (subject to transitional arrangements set out for CE marked devices), in compliance with the UK Medical Devices Regulations 2002, as amended.<br/><br/>https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations<br/><br/>The system will be used in Filton (Bristol) and Manchester donor testing sites and the following is required for: (annual volume estimation in brackets):<br/><br/>- ABO (repeat tests from primary test systems and confirmatory testing (6,200 to 10,000).<br/>- RhD (repeat tests from primary test system and confirmatory testing) (8,000 to 10,000)<br/>- Antibody neat screen to detect clinically significant antibodies in plasma using a minimum of 3 screening cells (113,000)<br/>- Antibody titre testing (1:10 and 1:50) to detect clinically significant antibodies in plasma at those dilutions using a minimum of 3 screening cells (6,800)<br/>- Paediatric antibody neat screen to detect clinically significant antibodies in plasma using a minimum of 3 screening cells (135,000)<br/>- Fya (60,000 to 73,000)<br/>- Fyb (60,000 to 72,000)<br/>- k (10,000 to 12,000)<br/>- Lua (10,000)<br/>- Kpa (10,000)<br/>- Haemoglobin S screen suitable to test for HbAS (heterozygous sickle cell trait) for blood donation (70,000 to 84,000)<br/><br/>All test protocols must be in accordance with the Guidelines for the Blood Transfusion service in the United Kingdom (https://www.transfusionguidelines.org/red-book) and the Good Practice Guidelines for Blood Establishments that are required to comply with Directive 2005/62/EC. These are published in the 20th edition of the Guide to the preparation, use and quality assurance of blood components.