Netherlands – Blood-testing reagents – Levering en implementatie van en onderhoud aan een gevalideerde Totaaloplossing voor de SCID- en SMA-screening ten behoeve van meerdere laboratoria

Neonatal heel prick screening (NHS) is a national screening programme carried out on newborns in the first week after birth. In the Netherlands (European and Caribbean Netherlands), approximately 170,000 newborns receive the heel prick each year. The heel prick screening is the longest-running national screening programme in public health care. The analysis of the heel prick blood currently provides important information on twenty-seven rare, often hereditary, serious conditions. The blood test will be conducted by three screening laboratories from 2026, with the RIVM-GZB screening laboratory serving as the reference laboratory. The screening laboratories are responsible for the analysis of the heel prick blood sample and timely reporting of the result. All screening laboratories have been using, among other things, a Total Solution for SCID screening since January 2021. From 1 June 2022, SMA has also been added to the programme, and the laboratories screen with a multiplex Total Solution that can screen for both SCID and SMA. Additionally, there is the possibility that a decision will be made in the coming years to start screening for X-linked Agammaglobulinemia (XLA). To ensure uniformity, the RIVM has decided to purchase and make available to the screening laboratories the equipment (hardware), software, reagents, and related maintenance (preventive, corrective, adaptive), also known as the Total Solution. This Tender Procedure concerns an order for the delivery, implementation, and maintenance of a validated Total Solution for SCID and SMA screening for the screening laboratories. The aim of this European tender is to conclude an Agreement with one Contractor, according to the principle of reagent rental, whereby the supplier remains the owner of the equipment. The Contractor will be fully responsible for delivering, implementing, and continuously making the Total Solution available, and for performing related services in accordance with the specifications set out in the Tender Documents.