In this tender, Region Zealand wishes to enter into a contract for the acquisition of a Solution that generally includes functionality for displaying WSIs and macro images and associated data life cycle management software for Digital Pathology, including services for implementation, maintenance and further development thereof. The expected acquisition includes a Solution to replace the microscope with the functionalities that a pathologist needs to describe and assess the digitized preparation section as well as to support the conduct of multidisciplinary conferences, consultations, research and teaching.
1) Background to the tender
With Digital Pathology, Region Zealand wants to introduce digitized workflows for microscopy of tissue samples in the field of pathology. The tender concerns a standard solution for displaying WSIs as a result of scanned slides, so that the digital images (WSIs and macro images) of tissue samples are assessed on a PC screen in relation to diagnosis, research and teaching. Furthermore, with the Solution, users must be able to share WSIs with a colleague within their own region or outside the region in case of, among other things, the need for conference, consultation, research and teaching. The solution must also be able to include functionality to support data life cycle management (DLM) as well as include a local repository in the Solution in conjunction with the Customer's VNA in relation to storing WSIs and macro images. It is important for the future workflow for Digital Pathology that the Customer's LIMS/Pathology System is central to the pathology's work flow, so that the Solution is integrated into the Customer's LIMS for use in retrieving WSIs and macro images. DLM must be able to handle conditions and actions that trigger changes in the storage of WSIs and macro images. The solution must also be able to compress WSIs and convert Macro images to DICOM. The customer wants the solution to be able to integrate to other components of the system landscape relevant to digital pathology. The solution will also support the Customer's DICOM strategy and requirements for compliance with data standards in connection with the storage of WSIs, macro images and associated metadata. The solution must include integration between the Solution and the Customer's VNA, the Customer's Pathology System, the Customer's user management (e.g. AD and IdM), the Customer's DICOM conversion engine, the Customer's solution for macro images, the Customer's CPR service and the Customer's existing third-party image analysis software Oncotopix from Visiopharm. The solution should, as far as possible, make it possible to integrate with future professional third-party tools for performing digital image analysis, e.g. for diagnosis-supporting image analysis through artificial intelligence (AI). The solution must be delivered as an on-premise solution. The solution does NOT include glass scanners, VNA, image analysis software (based on e.g. AI), hosting, storage and operation of the infrastructure. Significant technologies underlying the contract, e.g. in relation to integrations, are: DICOM, DICOM Web, HL7, IHE XDS, IHE XCA, NDPI, Leica SCN, JPEG, TIFF, XML, URI calls and non-proprietary interfaces.
Region Zealand is one of the 5 regions in Denmark that, among other things, handles the operation and development of hospitals in Denmark. There are approximately 835,000 citizens living in Region Zealand. In 2020-2022, an average of approximately 80,000 requisitions in the histology area have been processed per year in Region Zealand. Region Zealand's pathology is gathered in one department spread over 2 geographical locations (Næstved and Roskilde). From 2023/24, the entire Department of Pathology will be gathered in Køge. Today, Region Zealand has approx. 200 users across pathologists, bioanalysts and secretaries, who will need access to the future Solution. In addition, the solution must be accessible by external users outside the pathology department and outside the region in relation to the organization of conferences and consultations.
2. Hovedydelser
The contract includes the following main benefits:
A: Implementation (including any necessary adjustments and configurations of the Solution as well as project management, testing, documentation and installation, etc.)
B: Maintenance of the Solution and 2nd line support
C: Training of users
D: Consultancy services, e.g. further development services
If all or part of the Solution falls within the definition of medical device, cf. MDR (Regulation (EU) 2017/745 of the European Parliament and of the Council) or IVDR (Regulation (EU) 2017/746 of the European Parliament and of the Council), the Supplier must comply with requirements for CE marking in accordance with the MDR or IVDR.