SAM #36C10B27Q0056

VA VBECS Blood Banking Software Sustainment and Operations Support

The Department of Veterans Affairs is seeking vendors to sustain its existing VBECS blood banking software and supporting environment. - Government buyer: Department of Veterans Affairs (VA), including the Veterans Health Administration; Office of Information & Technology, Product Delivery Service; Office of Procurement Operations, Technology Acquisition Center. - OEMs and vendors: Microsoft is named for Azure Government and Azure DevOps technologies. No prime contractor or VBECS software vendor is identified. - What is requested: Operations, maintenance, and full-lifecycle sustainment for VBECS version 2.4.1.1A-00-02, an FDA-regulated Class II medical-device system used for blood banking and transfusion services. No product quantities or part numbers are specified. - Core support: Bug fixes and Tier 3 defect resolution; software, database, network, and system administration; configuration and patch management; testing, deployment, documentation, monitoring, incident response, project management, and reporting. The environment includes approximately 460 virtual servers; historically, 5–10 tickets are referred monthly. - Quality and security: Maintain audit-ready quality records and system documentation; support FDA 510(k) activities, 21 CFR Part 820, ISO 13485:2016, medical-device reporting, corrective and preventive actions, validation, and audits. Support VA cybersecurity, privacy, Authority to Operate (ATO), and Continuous Authorization and Monitoring documentation in the SNOW environment. - Optional work: Prepare VBECS blood-bank data extracts for electronic health record modernization deployments (historically five extracts per site; optional task may be exercised once in each of five performance periods), and assess and implement a solution to consolidate VBECS and reduce its Azure footprint while maintaining secure, reliable, uninterrupted operations. - Other recurring deliverables: Monthly wastage and annual blood-usage reports, ad hoc reports, monthly progress and status reporting, and quarterly VA Technical Reference Model compliance reviews.

Description

VA is seeking sources that are able to provide full lifecycle sustainment and operational support, and any associated bug/fix development, and regulatory compliance services for the VA s existing Veterans Health Administration s VBECS, an FDA regulated Class II Medical Device Software product. The Contractor will be required to plan, manage, develop bug/fixes, test, deploy, maintain, document, and continuously monitor the VBECS system throughout the DevOps lifecycle. The Contractor will be required to maintain all system related documentation, ensuring accuracy, traceability, and compliance with FDA Quality System Regulations (21 CFR 820), ISO 13485:2016, and VA cybersecurity and privacy requirements. The Contractor will be required to support all activities required to maintain the VBECS s existing Authority to Operate, including preparation, validation, and submission of documentation within the SNOW Continuous Authorization and Monitoring environment, and continuous support for audits, assessments, and security reviews.

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