4-SOW-overview.doc

This is a Scope of Work overview document for Contract #226354 administered by the Utah Department of Health and Human Services (DHHS) for the procurement of GAA-IDUA Assay Substrates, GAA-IDUA Assay Internal Standards, and 2-plex assay buffer reagents. The contractor supplies these specialized reagents to the Newborn Screening Lab at the Utah Public Health Laboratory for use in screening for Mucopolysaccharidosis Type I (MPS-I) and Pompe disease. Historically, the contract includes approximately 600 vials annually of each component: 2-plex assay buffer at pH 4.7 (3 mL/vial), lyophilized GAA and IDUA substrate, and lyophilized GAA and IDUA internal standard. One vial of each component is sufficient for 100 screening assays. Shipments are delivered quarterly or as requested, with invoices due within 30 days of delivery. The contractor must notify DHHS at least 48 hours prior to any inability to meet expected shipment dates.

The pricing structure specifies a cost of $166.667 per unit for each combined Substrate Mix vial, Internal Standard Mix vial, and Buffer vial. Required documentation includes purity analysis and absolute amounts or concentrations performed by quantitative NMR (qNMR). This contract award is being made without engaging in a standard competitive procurement process under the Utah Procurement Code, citing justification that there is only one source for the procurement item or that transitional costs and other circumstances make standard procurement processes impractical and not in the best interest of the DHHS. The notice indicates this is a funds increase for the existing Contract #226354 designated as JM27-116.