Managed Service Contract for the Bacterial Screening of Platelets

A direct contractual relationship with either the manufacturer or any other economic operator for a complete end-to-end integrated solution, which includes all the necessary equipment, 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 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/>A fully integrated, high throughput, automated bacterial screening system which can detect bacterial contamination in platelet components. The system will be used in Filton (Bristol), Manchester and Colindale (London) where approximately 270,000 adult therapeutic doses of platelets are manufactured each year. The system must be CE/UKCA marked. Additional requirements to be included with the managed service contract include:<br/>- continuous calibrated temperature monitoring<br/>- ability to integrate with NHSBT information management system<br/>- alerting software (for positive results, hardware errors, temperature excursions)<br/>- consumables (including, but not limited to, sterile sampling connecting devices)<br/><br/>All test protocols must be in accordance with the Guidelines for the Blood Transfusion service in the United Kingdom (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.