Statement of Work.docx

STATEMENT OF WORK (SOW)

InVita RFID Cabinet

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), requires the acquisition of a Radio Frequency Identification (RFID) storage cabinet integrated with Unique Device Identifier (UDI)-compliant tissue and implant tracking software to support patient safety, regulatory compliance, and efficient inventory management.

Tracking tissues, biologics, and implantable medical devices is a federal regulatory requirement under FDA 21 CFR Part 830 (UDI) and is critical to patient safety. VA healthcare facilities face ongoing resource challenges including staff shortages and budget constraints, making it essential to minimize staff time consumed by manual data entry and to maintain precise control over high-value inventory. This acquisition will provide an automated, real-time RFID-based inventory management solution for use in the operating room (OR), Catheterization (Cath) lab, ambulatory surgery center, or any facility location that stores high-value implantable inventory.

Description The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), requires one (1) InVita UDTracker® RFID Cabinet — consisting of Terso Solutions RFID cabinet hardware integrated with InVita's UDTracker® tissue and implant tracking software — to support real-time, automated inventory management of tissues, biologics, and implantable medical devices at Salt Lake City VA Medical Center. Together, the hardware and software shall deliver complete inventory visibility, reduce implant retrieval time from storage to the operating room, improve reconciliation efficiency, minimize human error, and reduce product loss, expired waste, and stockouts. The system is intended for use in operating rooms, cardiac catheterization (Cath) laboratories, ambulatory surgery centers, or other locations where high-value medical inventory is stored.

Compliance The contractor shall ensure the system meets all applicable federal, VA, and industry standards, including:

· FDA 21 CFR Part 830 – Unique Device Identification (UDI) requirements for medical device tracking

· FDA 21 CFR Part 820 – Quality System Regulation for medical device manufacturers

· The Joint Commission – Implant and tissue tracking standards (RC.02.01.01 and related)

· American Association of Tissue Banks (AATB) – Tissue traceability standards

· HIPAA – Privacy and Security Rules (45 CFR Part 164) for any patient-linked inventory data

· VA Handbook 6500.6 – VA Contract Security requirements for software interfacing with VA networks

· ISO 9001 – Quality Management Systems

· FAR Part 12 – Acquisition of Commercial Items IT Security Note: Because the UDTracker® software interfaces with VA network infrastructure, this acquisition requires CIO/Designee review and Information Security Officer (ISO) coordination prior to award and system deployment, per FAR 7.105(b)(18) and VA Handbook 6500.6.

Scope The contractor shall:

a. Deliver and install one (1) RFID-enabled storage cabinet (Terso Solutions hardware) at the VA facility location designated by the Contracting Officer's Representative (COR).

b. Configure and integrate the InVita UDTracker® software with the RFID cabinet hardware to enable real-time, automated inventory transaction capture.

c. Conduct acceptance testing in the presence of the VA OR Manager to confirm full system functionality prior to Government acceptance.

d. Provide on-site training for designated VA clinical and supply chain staff on system operation, inventory management functions, reporting, and basic troubleshooting.

e. Deliver all user manuals and training materials in electronic format to the COR.

f. Provide a minimum one (1) year manufacturer's warranty on hardware from the date of Government acceptance, and software support including updates and help desk access during the warranty period.

Items to be purchased.

END OF STATEMENT OF WORK

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