SAM #36C24826Q1122

Sole Source Procurement of FCS Express Clinical Edition Software for VA NCO 8

This opportunity is a sole source procurement by the Department of Veterans Affairs, Network Contracting Office 8 (NCO 8), for specialized clinical software. - Sole source contract for FCS Express Clinical Edition flow cytometry analysis software - OEM and exclusive vendor: De Novo Software - Software must be FDA-listed and 21 CFR Part 11 compliant - Features required: 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 - Must integrate seamlessly with VA laboratory systems (VistA/Data Innovations) - Includes validation packages (IQ/OQ) and proprietary integrations - De Novo Software is the only source; product not available through resellers or distributors - No competing vendors or products identified due to proprietary requirements - Estimated contract value likely in the $20,000 - $50,000 range for specialized clinical software - Period of performance not specified; likely annual or multi-year software license

Description

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.

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