6515--Richmond Viscoelastic Testing Instrumentation FY25
ID: 36C24625Q0061Type: Solicitation
Overview

Buyer

VETERANS AFFAIRS, DEPARTMENT OFVETERANS AFFAIRS, DEPARTMENT OF246-NETWORK CONTRACTING OFFICE 6 (36C246)HAMPTON, VA, 23667, USA

NAICS

Surgical and Medical Instrument Manufacturing (339112)

PSC

MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES (6515)

Original Source

https://sam.gov/opp/d47e53a05da14b8c83f352ddac77097f/view
Timeline
    Description

    The Department of Veterans Affairs is seeking proposals for a Viscoelastic Testing Instrumentation System and associated supplies for the Richmond Veterans Affairs Medical Center. The procurement aims to establish a firm-fixed-price contract for a system capable of real-time hemostatic analysis, including the lease of necessary instrumentation and consumables over a five-year term, which consists of a base year and four optional years. This equipment is crucial for enhancing laboratory capabilities and ensuring high-quality medical services for veterans, with specific requirements for FDA clearance, maintenance, and operational support outlined in the solicitation. Interested vendors should contact Jo A Harris at Jo.Harris@va.gov for further details regarding the proposal submission process.

    Point(s) of Contact
    Jo A HarrisContract Specialist
    Jo.Harris@va.gov
    Files
    Title
    Posted
    36C24625Q0061_1.docx
    The Richmond Veterans Affairs Medical Center aims to solicit proposals for a Viscoelastic Testing Instrumentation System and associated supplies through a firm-fixed-price contract. This solicitation outlines a procurement process for a system capable of real-time hemostatic analysis with integrated information management and the lease of the required instrumentation and consumables over a five-year term, which includes a base year and four optional years. The proposal must meet specific technical requirements, comply with federal regulations, and ensure eligibility for small business participation. Key aspects highlighted include detailed specifications for equipment performance, maintenance and operational requirements, quality control measures, and training provisions for VA personnel. The contractor must demonstrate proven FDA clearance and experience, provide consistency in reagent and calibration materials, and facilitate seamless operation within the existing VA laboratory systems. The document emphasizes adherence to procurement protocols, contractor obligations for service and support, and the Government's expectations of timely implementation and compliance with quality standards. Comprehensive reporting of testing results and responsiveness to equipment maintenance are critical components expected from the awarded contractor, reflecting the government’s commitment to providing high-quality medical services through empowered laboratory capabilities.
    36C24625Q0061.docx
    The Department of Veterans Affairs (VA) is issuing a presolicitation notice for the procurement of Viscoelastic Testing Instrumentation for the Richmond Veterans Affairs Medical Center (VAMC). The goal is to lease new viscoelastic testing systems for Point of Care utilization, which must integrate with current VA laboratory middleware systems like GEMWeb plus or Unipoc. The solicitation will be open for responses starting around October 3 or 4, 2024, with a five-day submission window for quotes. Interested contractors must be registered in the System for Award Management (SAM) and comply with certain requirements for service-disabled and veteran-owned businesses. Suppliers should provide comprehensive documentation, including company details, SAM Unique Entity Identification (UEI), and proof of authorization to distribute the products. The VA anticipates one contract award for the required instrumentation, emphasizing the need for accurate clinical parameter reporting on various blood specimens. This procurement illustrates the VA's ongoing efforts to enhance medical instrumentation and services for veterans.
    6550.pdf
    VA Directive 6550 Appendix A provides a systematic framework for the procurement of both network-connected and non-network-connected medical devices that store sensitive information within the Department of Veterans Affairs (VA). It outlines detailed requirements concerning equipment details, manufacturer information, and technical specifications necessary for compliance and security measures. The document necessitates the completion of various fields, such as the device category, manufacturer contacts, and pertinent operational details, including the device's network connectivity, operating system, and security protocols like two-factor authentication and antivirus support. Additionally, it raises critical considerations regarding the device's compatibility with VA's existing systems and security policies. Moreover, existing Enterprise Risk Analysis (ERA) documentation must be verified, and new ERAs are mandated for significant software updates. The process includes approval by Biomedical Engineering and the Information Systems Security Officer, ensuring devices are compliant with VA standards to mitigate risks associated with data storage and network vulnerabilities. Overall, this directive emphasizes the importance of cybersecurity in the procurement of medical devices to safeguard sensitive patient information while adhering to federal regulations.
    VHA Local BAA Template Aug2023.rtf
    The Business Associate Agreement between the Department of Veterans Affairs (VA) and <Company/Organization> outlines the responsibilities and obligations concerning the use and disclosure of Protected Health Information (PHI) in compliance with HIPAA and HITECH regulations. It establishes that the VA, as a Covered Entity, retains ownership of PHI while requiring <Company/Organization>, as a Business Associate, to implement safeguards to protect this information. Key provisions include restrictions on PHI use, notification obligations for breaches or incidents, the requirement for written assurances and prompt reporting of any PHI-related incidents, and the need for subcontractors to adhere to similar standards. The Agreement also stipulates that PHI must be returned or destroyed upon termination of the contract, and emphasizes the liability of the Business Associate for violations of HIPAA rules due to their actions. This document reinforces the commitment to safeguarding sensitive veteran health information while ensuring compliance with federal regulations, reflecting the VA's diligent approach to managing health data in its operations.
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