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

Description

Prior to commencing a formal procurement process and to help inform our strategy/ requirements, NHSBT is seeking to engage with suppliers 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. <br/> <br/>NHSBT would like to consult the market to improve our knowledge of all current systems available in the marketplace, identify further opportunities and, potential issues, and gauge market interest in the proposed service. The equipment will be high throughput with walk away operation and the technology will meet the current and future needs of the service, in a cost-effective manner. 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. <br/><br/>At this stage, it is envisaged that an Open procedure will be undertaken as NHSBT’s requirements can be clearly articulated. <br/><br/>It is NHSBT's intention to engage with the market to gather detailed information about the marketplace's capabilities. The format for this will be communicated to those that respond to this PIN. If a supplier engagement day is deemed necessary, this will be held in November 2023. If you are interested in this requirement, please email jo.murphy@nhsbt.nhs.uk. Please include an overview of your solution to meet the requirements in this PIN.