Microbiology Serology & Ancillary Services

NHSBT requires a direct contractual relationship with either a manufacturer or any other economic operator for a complete end-to-end integrated solution for the Microbiology Serological and Ancillary Testing of blood and non-blood donations, which must include all the necessary equipment, assays, reagents, installation, maintenance (planned and un-planned), consumables, software including an inter-operability provision with NHSBT’s existing IT infrastructure and overall on-going support mechanism that may be required to carry out the necessary testing as stated below for the duration of the Framework Agreement. 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 solution 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). <br/><br/>The current contract held with NHSBT for the Microbiology Serology Service includes the supply of the mandatory and selective serology assays, consumables, instrumentation, uninterruptable power supply and software required for result management and interface(s) with host systems; including servers to support the IT infrastructure.<br/>Mandatory testing is undertaken on all blood and non-blood donations. The assays currently required include: Hepatitis B (HBsAg), Human immunodeficiency virus (HIV 1&2 Ab/Ag), Hepatitis C (anti-HCV), syphilis antibodies, and anti-HBc for non-blood donations. These tests are undertaken on high throughput automated equipment. Additional discretionary testing is also undertaken on select donations. These include testing for human T- lymphotropic virus (anti-HTLV), cytomegalovirus (anti-CMV), malarial antibody (anti-malaria), Hepatitis B antibodies (anti-HBc & anti-HBs) and Trypanosome cruzi (anti-T. cruzi). Deceased (non-heart beating) donor screening is performed at Microbiology Services Laboratory (MSL), Colindale and the assays used in MSL Colindale must be suitable for deceased donor screening. This Framework Agreement will also cover any further, replacement or future Microbiology Serology and Ancillary Testing Service requirements for the duration of the Framework, including without limitation, Goods, Equipment and Software. <br/>The Successful Tenderer must be prepared to undertake a KEG Assessment (Kit Evaluation Group) of the assays prior to the award of the Framework Agreement and Contract.. <br/>There is a requirement for automated instrumentation to enable high throughput testing of mandatory and discretionary testing for blood and non-blood donors, archiving and long-term storage of plasma samples as part of this Framework Agreement. Instrumentation for sample sorting is also for consideration.<br/>All Microbiology Serology testing requirements must be in accordance with the Guidelines for the Blood Transfusion service in the United Kingdom (www.transfusionguidelines.org/red-book ↗) and rules and guidance for pharmaceutical manufacturers and distributors from time to time in force.<br/>NHSBT currently undertakes Microbiology Serology testing on approximately 1,500,000 donations per annum. The testing capacity is expected to grow over the course of the contractual term.<br/>The Tenderer must be able to facilitate tests for other ancillary services that may be determined as Microbiology Serology from time to time. 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.