Norway – Medical equipments, pharmaceuticals and personal care products – 77424 UL KLM MBK Hematology instrument (3) - Intention notice.

Notice of Intent At the Hematology Unit of the Department of Medical Biochemistry at Ullevål Hospital, an automated hematology line from Sysmex is used, integrated into a cobas 8100 automation system from Roche. The system handles hematology analyses for the entire Ullevål Hospital, including outpatient clinics, the emergency department, the pediatric emergency department, and intensive care units, where rapid and reliable results are critical. The hematology line from Sysmex was procured in 2014/2016 (4 hematology instruments (XN-10/XN-20)). In 2023, the hematology line was expanded with an SP50, 2 × G11, and Interrliner and integrated into large-scale automation with the cobas 8100 automation system. Due to increased maintenance needs and operational interruptions resulting from age, modules in the hematology line must be replaced. To our knowledge, Sysmex is the only supplier that has hematology instruments approved and technically integrable with the cobas 8100 automation system and the Sysmex analytical line. Laboratory operations are based on an established automation line with associated middleware and integrated control systems. Introducing a different hematology system would require parallel operation, full revalidation, manual sample handling, and the absence of necessary system monitoring. This entails increased risk of errors and delayed turnaround times. Switching to another supplier would also require replacing the entire automation platform for hematology, which would represent a disproportionate intervention in the existing infrastructure. Sysmex Norway NUF is therefore the only supplier that can technically provide equipment compatible with the current solution. The following modules are to be replaced: 4 hematology instruments (2 × XR-20, 2 × XR-10), 1 barcode reader (BT40), 1 start module (ST-40), 1 controller (CT-90), 3 conveyor units (CV-50), and 1 reagent unit (RU-2). Conclusion OUS considers that the conditions for a direct procurement pursuant to FOA § 13-4 (2) are met. Sysmex Norway NUF is the only supplier capable of delivering equipment that is technically compatible with the existing automation and associated control system, and thus able to maintain necessary operations without increased risk to patient safety. Any objections must be submitted to the project manager within 10 days after the publication of this notice.