PME for Tissue and Cell Management System

“King's College Hospital NHS Foundation Trust ("the Trust") is carrying out preliminary market engagement under the Procurement Act 2023 to understand the solutions available for a tissue and cell management system supporting its stem cell transplantation and cellular therapy laboratory services. The Trust currently uses a commercial off-the-shelf tissue and cell management system, in live use since 2023. The infrastructure on which it runs reaches end of support in January 2027, and the Trust is assessing its options for continuity of service from 2027. These include upgrading or migrating the existing solution and adopting an alternative solution. The purpose of this engagement is to establish which providers of this type of system exist in the market, and their level of interest, to help the Trust decide on the most appropriate route to market and timescales. The outcome will inform the Trust's requirements, options appraisal and business case, and the Trust anticipates that it will be followed by a formal procurement. The Trust is seeking solutions that provide end-to-end management and traceability of cellular therapy products, from donor and patient registration through collection, processing, cryopreservation, storage, issue and administration. The solution will need to support:

• labelling and traceability in line with ICCBBA ISBT 128 standards;

• a complete and secure audit trail;

• quality management, including deviations and non-conformances;

• inventory and storage location management; and

• reporting. The solution will need to enable the service to meet Human Tissue Authority (HTA) licensing requirements and FACT-JACIE accreditation standards. It should also meet electronic record and traceability requirements under GAMP 5, GMP Annex 11 (Computerised Systems) and 21 CFR Part 11, and comply with MHRA data integrity expectations. Supplier support for installation, operational and performance qualification (IQ/OQ/PQ) will be required before go-live, together with an approach to upgrades after go-live that controls system changes and minimises the revalidation burden. The Trust is particularly interested in understanding the following:

• which suppliers offer a solution that can meet these requirements, and any areas that would not be met;

• deployment models (on-premise, supplier-hosted or cloud/SaaS), including whether solutions can be delivered on Microsoft-based infrastructure (Windows Server and Microsoft SQL Server) or as a fully hosted service;

• whether suppliers have live interfaces with Epic or other electronic patient record systems in the UK;

• typical implementation timescales, including validation and data migration;

• indicative costs, to help inform the Trust's Outline Business Case;

• whether the solution is available through an NHS England-approved framework agreement or dynamic market; and”