7A21--FCS Express Clinical Edition

SPECIAL NOTICE
INTENT TO AWARD ON A SOLE SOURCE BASIS
Department of Veterans Affairs Network Contracting Office (NCO) 08
This is a Special Notice of intent to award on a sole source basis. This is not a solicitation. The Department of Veterans Affairs, NCO 08, intends to negotiate and award a requirement for FCS Express Clinical Edition flow cytometry analysis software to De Novo Software, the exclusive developer and distributor of the product. The applicable NAICS code is 513210 (Software Publishers). The PSC/FSC is 7A21 (IT and Telecom Business Application Software). The authority for this action is FAR 13.106 1(b): Soliciting from a single source, and this notice fulfills FAR 5.101(a) posting requirements.
The VA requires a fully integrated, FDA listed, 21 CFR Part 11 compliant flow cytometry analysis system with multi user access; automated real time reporting; integrated spreadsheets, gating, and transformation algorithms; comprehensive audit trails; permission controlled workflows; embedded QC features; LDAP/AD Single Sign On; HIPAA compliant logging; and seamless interoperability with VA laboratory systems (VistA/Data Innovations). Market research concludes that only De Novo Software can provide all required capabilities, security features, validation packages (IQ/OQ), and proprietary integrations necessary for VA clinical operations. FCS Express Clinical Edition is not sold through distributors or resellers; it is exclusively available from the OEM. Therefore, De Novo Software is the only responsible source capable of meeting the Government s minimum needs.
Interested persons may contact the Contract Specialist via email at [Insert Contract Specialist Email] regarding this procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer.