Primary Blood Grouping MSC

NHSBT requires a direct contractual relationship with either the manufacturer or any other economic operator for a complete end-to-end integrated Service, which must include all the necessary Equipment, Goods, Installation, maintenance, Consumables, Reagents, Software, including an inter-operability provision with NHSBT's existing IT infrastructure, and an overall on-going support mechanism that may be required to carry out the necessary testing as stated below.

All invitro diagnostic medical devices, for example, Instruments, Consumables and Reagents must be CE/UKCA marked. GB will continue to recognise CE marking under the IVDD or IVDR until 30 June 2023 and from 1 July 2023 devices placed on the GB market must be UKCA marked under the UK MDR 2002 as amended.

The end-to-end Service must be capable of producing test results in a format that can be utilised by NHSBT's host IT system (PULSE) (or any replacement system) without the need for changes to PULSE (or any replacement system).

The Equipment should also be compatible with NHSBT's manufactured reagents and where possible, with those from third party reagent suppliers. NHSBT requires a high throughput blood and non-blood donation screening for primary blood grouping testing system(s), for ABO and Rh D typing (as a minimum DIV, DV and DVI), antibody screening and red cell phenotyping including Rh for donor blood samples. As a minimum, the Service provided must be capable of undertaking the testing of blood and non-blood donor samples and providing accurate results for the following:• ABO group• Rh phenotype D, C, c, E, e • Kell • Atypical antibody screen• High titre anti-A and anti-B screening• Red cell phenotypes S, s, Jka, Jkb (test system should include an option of Cw and M).

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 rules and guidance for pharmaceutical manufacturers and distributors. The annual estimated throughput of the NHSBT primary automated blood sample testing equipment tests approximately 1,500,000 to 1,700,000 donations (of which ca. 1500 - 2100 are non-blood donors) are tested per annum across two NHSBT testing sites, namely Manchester and Filton.

The Tenderer must also be able to accommodate technological and digital changes in the current and future such that NHSBT is able to access the state-of-the art digital developments and IT solutions in the diagnostics market.