Microbiology Serology Testing

Description

This Prior Information Notice (PIN) follows KEG PIN released on 7th October 2020 reference 2020/S 198-481270 and a further PIN for Microbiology Serology Managed Service Contract released on 28th January 2021 reference 2021/S 000-001795 and all information herein supersedes this.<br/><br/>This Prior Information Notice (PIN) is separate to any tender opportunity and not related in any form whatsoever to any subsequent activity that NHSBT may wish to pursue. The purpose of this PIN is to inform the market of NHSBT’s intention to tender, to improve NHSBT’s knowledge on the status of manufacturer(s) or economic operator(s) that can supply a commercially available Microbiology Serology Provision and to gauge market interest in the new provision of this service. It is the intention of NHSBT to further engage with only those manufacturer(s) and economic operator(s) who meet the outline requirements. Lot 1: 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 screening/testing of blood and non-blood donations , which must include all the necessary equipment, installation, maintenance, consumables, reagents, software including an inter-operability provision with NHSBTs existing IT infrastructure and overall ongoing 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 solution must be capable of producing test results in a format that can be utilised by NHSBT’s host IT system (PULSE) without the need for changes to PULSE. <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/><br/>Mandatory testing is undertaken on all blood and non-blood donations. The assays 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. <br/><br/><br/>Kit Evaluation Group (KEG) approval of the assays must be obtained prior to the award of the contract. <br/><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 contract. Instrumentation for sample sorting is also for consideration.<br/><br/>All Microbiology Serology testing requirements 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.<br/><br/>NHSBT undertakes Microbiology Serology testing on approximately 1,700,000 donations per annum across two prinicipal testing sites, namely Manchester and Filton, and also at the Microbiology Services Laboratory at Colindale.<br/><br/>It is NHSBT's intention to engage with the market to understand the market capabilities and interest in tendering for this service. The format for further activities associated with this service will be communicated to those that respond to this PIN.<br/><br/>Expressions of interest should be e-mailed to claire.barnes@nhsbt.nhs.uk by no later than 1600 hours on Monday 10th January 2022. Interested manufacturers and economic operators are requested to provide the following information: <br/><br/>• Company name <br/><br/>• Address<br/><br/>• Contact details<br/><br/>• A brief paragraph to i) summarise your company’s information outlining the principal line of business; ii) an explanation of your suitability to provide this service to NHSBT; and iii) confirmation of your interest in participating in the tender.