SAM #36C10B27Q0056

VA VBECS software operations, maintenance, and lifecycle sustainment

The Department of Veterans Affairs is seeking vendors to sustain and operate its VBECS blood-banking software and supporting environment. - Government buyer - Department of Veterans Affairs (VA), Veterans Health Administration (VHA) - Office of Information & Technology (OIT), Product Delivery Service; procurement through the Office of Procurement Operations, Technology Acquisition Center (TAC) - Requested support - Full-lifecycle operations and maintenance for VISTA Blood Establishment Computer Software (VBECS), an FDA-regulated Class II medical-device system used for blood banking and transfusion services. The identified system version is 2.4.1.1A-00-02. - Software maintenance, bug fixes, Tier 3 defect analysis, testing, deployment, configuration management, database and interface support, incident resolution, and system administration. - Secure operations in Microsoft Azure Government, including Azure DevOps continuous integration/continuous delivery, Infrastructure as Code, Desired State Configuration, patching, and environment validation. The environment includes approximately 460 virtual servers. - Quality-system and regulatory support, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485, 510(k) support, Medical Device Reporting, corrective and preventive actions, validation, hazard analysis, traceability, document control, and audit readiness. - VA cybersecurity, privacy, Authority to Operate (ATO), and Continuous Authorization and Monitoring support, including security documentation, remediation tracking, audits, assessments, and reviews. - Project management, status reporting, VBECS reports, and maintenance of system documentation and quality records. - Optional work - EHR modernization blood-bank data extracts: historically five extracts per deployment site; may be exercised once in each of the five contract periods. - VBECS Azure consolidation: assess, design, and implement a solution to reduce the Azure footprint while maintaining security, compliance, reliability, scalability, and uninterrupted operations. This task has a six-month performance period and may be exercised once. - OEMs and vendors - Microsoft is named in connection with Azure Government; ServiceNow is referenced for CAM artifacts. Neither is identified as the VBECS software OEM. No VBECS manufacturer, reseller, or other contractor is named. - Quantities and part numbers - No products are listed for purchase, and no product part numbers or firm service quantities are provided. The VBECS version is 2.4.1.1A-00-02. - Notable requirements - Support must preserve patient safety and regulated-system audit readiness while meeting VA security and privacy requirements. - Tier 3 support historically receives 5–10 referred tickets per month; service hours are weekdays during extended business hours, excluding government holidays. - Reporting includes monthly wastage, annual blood usage, and directed ad hoc reports; ad hoc requests historically average about one per month.

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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