USP 797/800 Compliance Monitoring Subscription
ID: 36C26325Q0514Type: Solicitation
Overview

Buyer

VETERANS AFFAIRS, DEPARTMENT OFVETERANS AFFAIRS, DEPARTMENT OFNETWORK CONTRACT OFFICE 23 (36C263)Saint Paul, MN, 55101, USA

NAICS

Software Publishers (513210)

PSC

IT AND TELECOM - BUSINESS APPLICATION/APPLICATION DEVELOPMENT SOFTWARE AS A SERVICE (DA10)

Original Source

https://sam.gov/opp/fae863e4a3bc4311949f9689df96a180/view
Timeline
    Description

    The Department of Veterans Affairs is soliciting proposals for a USP 797/800 Compliance Monitoring Subscription to support the Veterans Integrated Service Network 23 (VISN 23). This procurement aims to acquire a web-based software system that ensures compliance with USP 797/800 standards for sterile compounding, providing functionalities such as customizable documentation, monitoring capabilities, training resources, and personnel certification tracking. The contract, valued at $47 million, is expected to commence on June 1, 2025, with options for up to four additional years, and interested contractors must submit their quotes by 13:00 CST on May 6, 2025, to Emanuel Nevarez at emanuel.nevarez@va.gov.

    Point(s) of Contact
    Emanuel Nevarez
    (320) 255-6354
    emanuel.nevarez@va.gov
    Files
    Title
    Posted
    36C26325Q0514.docx
    This Special Notice from the Department of Veterans Affairs outlines the intention to award a sole source contract for USP 797/800 Compounding Sterile Products Documentation Software to Pharmacy OneSource, INC. The contract will support the Veteran Integrated Service Network 23 (VISN23) and is justified under the authority of 41 U.S.C. 3304(a)(1) and FAR regulations. The contracting office is located in St. Cloud, MN, with a response deadline of March 12, 2025. The notice indicates that market research confirms that Pharmacy OneSource has an existing federal contract capable of fulfilling the required compliance monitoring subscriptions. Although this is not a solicitation for competitive quotes, responsible vendors are encouraged to express their interest in providing related services, accompanied by documentation of their capabilities and relevant FSS contract numbers, via email to the Contracting Specialist, Emanuel Nevarez. This summary serves as a preemptive notice regarding potential procurement actions concerning essential software services for the VA's pharmacy operations, emphasizing the government's priority to utilize existing sources while maintaining compliance with applicable regulations.
    P09 V23 USP 797 800 SOW Draft 1.docx
    The VISN 23 Pharmacy Services seeks a contractor to provide a web-based software solution for documenting compliance with USP Chapters 797 and 800, which govern sterile compounding practices. The software must support all users, including pharmacists and pharmacy technicians, by offering features such as customizable task templates, training modules, alert notifications for overdue tasks, and comprehensive reporting capabilities. The system should enable real-time monitoring of quality assurance data and be compatible with federal security requirements, ensuring no Protected Health Information is recorded. Required training for pharmacy staff will focus on system functionality and quality assurance practices. The contract, structured as a firm-fixed-price agreement, will commence in June 2025 for a base year, with options for four additional years. The proposal emphasizes the importance of implementing a user-friendly and compliant software program to enhance the safety and efficiency of sterile compounding processes within VISN 23 facilities.
    S02 36C26325Q0514 USP797 800 VISN 23.pdf
    The document outlines a Request for Proposal (RFP) from the Department of Veterans Affairs (VA) for a web-based software system to ensure compliance with USP 797/800 standards regarding sterile compounding in its Pharmacy Services across various locations within VISN 23. The system aims to support multiple user roles, including pharmacists and technicians, by allowing access to compliance documentation, training, and quality assurance metrics. Key features include customizable documentation, monitoring capabilities, training resources, alerts for overdue tasks, and the ability to track personnel certification statuses. The RFP specifies a total award amount of $47 million and emphasizes contractor responsibilities for support and system maintenance while adhering to federal regulations. Contract performance is scheduled to begin on June 1, 2025, with options for up to four additional years based on need. It underscores the VA's commitment to enhancing medication compounding safety through technology.
    V23 USP 797 800 SOW.docx
    The document outlines a Request for Proposal (RFP) for a web-based software system to assist VISN 23 Pharmacy Services in adhering to USP 797/800 standards for compounding sterile products. The software will be crucial for documentation, tracking certifications, training, risk management, and quality assurance in sterile compounding environments. Key features include user access for pharmacists and technicians, customizable reporting capabilities, pre-built tasks, and alerts for overdue activities. The contractor must ensure compliance with security regulations and provide adequate training for users through virtual sessions. The contract is structured as a firm-fixed-price agreement with an initial performance period from June 1, 2025, to May 31, 2026, with options for four additional years. The system must be user-friendly, maintained in real-time, and capable of generating meaningful compliance reports while respecting data privacy and security requirements. The successful implementation of this solution is pivotal for enhancing the safety and efficiency of compounding practices within the facilities.
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