Digital Pathology Solution: Digital Scanning, Image Management, AI Quality Control, AI Diagnostic Integration Framework, Storage and Teleconsultation

Cambridge University Hospitals NHS Foundation Trust (CUH) seeks to engage with potential suppliers via this Preliminary Market Engagement (PME) exercise to seek feedback and information to inform the forthcoming procurement of a comprehensive Digital Pathology Solution for the Department of Histopathology and Diagnostic Cytology and Haemato-oncology departments at Addenbrooke's Hospital, Cambridge Biomedical Campus. CUH is part of the Mid-East-5 Pathology Network, which also includes North West Anglia NHS Foundation Trust and Bedfordshire NHS Foundation Trust. The network is interested in how closer collaboration over Histopathology can be achieved and are considering potential for jointly approaching this procurement to enable a closer working model to be achieved through common digital technology and interoperability.

CUH is a Comprehensive Cancer Centre (CCC) and one of the largest NHS teaching hospital trusts in England. The Department processes approximately over 2000 slides per working day, including H&E, immunohistochemistry (IHC), in-situ hybridisation (ISH), special stains and an 8% annual growth rate projected. The laboratory is working towards running a fully automated pre-analytical and microtomy workflow including the Inpeco Flexpath system; Dainippon Seiki AT-192 trimmer and AS-410M sectioner distributed by Axlab UK, IHC platforms (Leica BOND-III,Leica BOND-PRIME and Ventana BenchMark Ultra Plus), HE staining equipment (Leica Spectra ST and CV), and Epic Beaker as its LIMS.

The current digital pathology system includes the Philips SG300, Objective imaging Glissando and the Philips Image management System.

The anticipated requirements include:

• Whole Slide Imaging (WSI) scanner fleet achieving a minimum aggregate throughput of 400 slides per hour at 40x equivalent resolution or better (0.25 um/pixel minimum) for CE/UKCA-cleared primary diagnostic use, compatible with H&E, IHC, ISH, special stains and cytological preparations
• Image Management System (IMS) providing primary diagnostic reporting, zero-footprint web viewer, bidirectional Epic Beaker integration, and an open AI integration framework for future CE/UKCA-cleared third-party AI algorithm integration without proprietary marketplace lock-in. IMS allowing integration of Macro/Block photography and associated to the Epic Beaker accession number for specimen/block/ slide comparison
• AI-enabled Quality Control (QC) module operating pre-release to the reporting worklist, covering H&E, IHC, and special stains with stain-specific configurable thresholds, integrated rescan workflow and CE/UKCA IVD-MD SaMD regulatory clearance
• Scalable petabyte-class whole slide image storage with UK data residency throughout the contract term, Minimum 1.2 PB usable capacity at contract start, scalable to 7 PB by Year 7. Suppliers may propose on-premise, cloud (UK data centres only), hybrid or nationally managed storage solutions. Solutions that provide or connect to national NHS digital pathology storage programmes are encouraged to describe this capability and the terms of access
• Secure, standards-based whole slide image sharing to support:

(a) intra-NHS sharing across pathology services enabling rapid second opinion and regional MDT collaboration, without requiring bilateral configuration with each receiving organisation;

(b) external sharing to national and international second-opinion centres, academic institutions and clinical trial sponsors via DICOM or encrypted time-limited links without VPN access;

(c) receipt and viewing of inbound images from external senders. All transfers must be encrypted with access audit logging and link expiry controls. Suppliers providing or connecting to national NHS digital pathology image exchange programmes are encouraged to describe this capability and the interoperability standards supported;

(d) de-identified image sharing with annotation for research purposes;

(e) Ability to audit access of shared images/ cases

• Workload management and analytics dashboard: scanner throughput monitoring against a fleet target of >=400 slides/hr, pathologist workload allocation, TAT analytics, error logs and SLA management
• AI Diagnostic Integration Framework: open vendor-neutral API enabling future procurement and integration of CE/UKCA-cleared diagnostic AI algorithms without full platform replacement. Note: diagnostic AI algorithms are not being procured under this notice

The Authority welcomes responses from all supplier types including individual vendors and consortia, established major providers of digital technology solutions, Small and Medium-sized Enterprises (SMEs) and niche innovators. Suppliers may respond to the full scope or to individual component areas. The Authority does not pre-determine the delivery model and is open to end-to-end solutions, modular proposals, and solutions that leverage established national NHS infrastructure, provided all requirements set out in this notice are demonstrably met.

The Authority wishes to engage the market on the following specific points:

• Market capability for high-throughput WSI scanning at >=400 slides/hour at 40x for CE/UKCA primary diagnosis, including emerging entrants
• Market capability for specialist scanner with the capability for minimum 60x scanning, polarisation and full z-stack scanning
• CE/UKCA IVD-MD primary diagnosis regulatory status of IMS platforms in the UK and timeline for platforms where clearance is in progress
• Capability to integrate with national NHS digital pathology storage and image exchange programmes via DICOM standards including whether proposed IMS and storage solutions support interoperability with established national NHS infrastructure without mandating a specific viewer or IMS platform at the receiving end
• Open AI framework maturity: vendor-neutral for CE/UKCA third-party diagnostic AI integration; confirmed partner integrations with Paige, Ibex, Visiopharm, PathAI or equivalent; multi-algorithm-per-slide support
• Epic Beaker integration maturity: confirmed bidirectional HL7/FHIR at scale; existing Epic Beaker reference sites
• UK field service and support infrastructure for 7-year contract: engineer response times; parts availability guarantee; preventive maintenance programme
• Available commercial models: capital purchase, managed service, pay-per-scan, reagent-rental equivalent; indicative pricing for 7-year contract at stated volumes
• Social value commitments and NHS Net Zero aligned carbon reduction pathways