Sebia reagents and services

The Florida Department of Health, Bureau of Public Health Laboratories, Newborn Screening Unit is procuring reagents, controls, calibrators, consumables, and related services exclusively from Sebia, Inc. for the FDA-approved CAPILLARS 3 DBS automated analyzer, a system critical to the qualitative screening of newborn blood samples for normal and abnormal hemoglobin variants. This single-source acquisition, authorized under Chapter 60A-1.045, F.A.C., and supported by Sections 120.57(3) and 287.057(3), F.S., is justified due to the proprietary nature of Sebia’s technology, which is the only solution compatible with the CAPILLARS 3 DBS system and meets the regulatory and technical requirements for reliable, high-throughput newborn screening. The three-year contract, valued at $2,695,571.00, ensures continuous operation of vital diagnostic services that enable early detection of genetic and inheritable disorders, facilitating prompt clinical intervention. Delivery and performance are specified to occur at the Bureau of Public Health Laboratories in Tallahassee, Florida, with the full scope focused on maintaining the accuracy, speed, and reliability of screening processes. No competitive evaluation factors or FAR clauses apply to this procurement, as the acquisition is non-competitive by design and governed entirely by state administrative and statutory authority. Sebia, Inc. is recognized as the sole manufacturer and distributor of the required components, with no alternative vendors capable of providing interchangeable or approved substitutes. Submission of proposals is restricted to hard copy format via U.S. mail or hand delivery to the Florida Department of Health in Tallahassee, with electronic submissions explicitly prohibited. The point of contact for the solicitation is Yasemin Sulker, and purchasing authority rests with Sonja German, though formal designations for Contracting Officer or Contracting Officer’s Technical Representative are not explicitly provided. Packaging, preservation, labeling, and inspection standards are not detailed in the document but are implicitly required to meet FDA and CLIA compliance, with acceptance of goods expected at the BPHL facility. No invoice processing system, accounting codes, or FOB terms are specified, and no attachments or additional clauses beyond the state procurement justification are included, reflecting a streamlined, single-source alignment with clinical and regulatory necessities.