Children’s Health Ireland at Temple Street would like to invite suitably qualified suppliers to tender for the design and supply of a Newborn Screening Card for the collect of blood sample

Tender description

Children’s Health Ireland at Temple Street (CHI at Temple Street) would like to invite suitably qualified suppliers to tender for the design and supply of a Newborn Screening Card for the collection of blood sample from infants by heel prick on appropriate filter paper for the National Newborn Screening Programme. Provision must be made for the collection of blood for the metabolites currently analysed and for any future additions. Provision must also be made for full infant demographics and other details as required by the programme. Vendors must have previous experience of designing manufacturing and supply of bloodspot screening cards and be fully accredited to international manufacturing quality and supply standards and the screening card must comply with appropriate international legislation and regulation. This User Requirement Specification (URS) defines the Department of Paediatric Laboratory Medicine’s requirements with respect to dried blood spot (DBS) CE, IVD marked sample collection device for in-vitro diagnostics of newborn screening disorders using, newborn sample blood (dried blood spot sample). The device must fulfil the requirements of the standard CLSI NBS01-A6 Blood Collection on Filter Paper for Newborn Screening Programmes: Approved Standard – Sixth Edition, be approved by the Food and Drug Administration (FDA), Newborn Screening Quality Assurance Program (NSQAP) and also the Centers for Disease Control and Prevention (CDC) and fulfil bloodspot portion of card requirements as per our specifications (see below). It must be fully compatible with the procedures and processes in the National Newborn Bloodspot Screening Laboratory in CHI, Temple Street and cannot contribute to result variability compared with the existing cards. All product offered as part of this tender must be CE marked and in particular comply with ISO 13485 Medical Device Directive and Directive 98/79/EC In-Vitro Diagnostic Device. ~100,000 Cards per annum