JA FAR 16.5_UDITracker_FINAL_Redacted.pdf

VISN 8 UDITracker VA-25-00064680

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition, and Logistics Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

2. Description of Action: The proposed action is for a firm-fixed price task order to be issued under the National Aeronautics and Space Administration (NASA) Solutions for Enterprise Wide Procurement (SEWP) V Government-wide Acquisition Contract (GWAC) for Unique Device Identification Tracker (UDITracker) hardware and software for Veterans Integrated Service Network (VISN) 8 sites.

3. Description of the Supplies or Services: VA, Veterans Health Administration (VHA) VISN 8, Sunshine Health Care System has a brand name requirement for Champion Medical Technologies, doing business as InVita Healthcare Technologies (InVita) UDITracker for seven (7) VISN 8 facilities to include Bay Pines VA Healthcare System, West Palm Beach VA Medical Center, James A. Haley Veteran�s Hospital, Miami VA Healthcare System, North Florida/South Georgia Veterans Health System, Orlando VA Healthcare System, and VA Caribbean Healthcare System. The contractor shall provide the UDITracker/Implant 360 implementation including, the Veterans Health Information Systems and Technology Architecture (VistA) interface implementation, the Single Sign- On (SSO) Integration implementation, Radio-Frequency Identification (RFID) cabinet storage, training, and the installation of all associated software and cabinet hardware.

The assigned North American Industry Classification System (NAICS) code 541519, Information Technology Value Added Resellers, with a size standard of 150 employees is appropriate for this action.

VA requires a solution that meets the current requirements of the Joint Commission to have a system in place for the tracking of all implants with software and cabinet storage, which provides bidirectional traceability of implants at the point of use. Specifically, VA requires a solution that interfaces with the Veterans Health Information Systems and Technology Architecture (VistA) and the Single Sign-On (SSO) solution. The system must also integrate with Computerized Patient Record System (CPRS), Medicaid Management Information System, and EMR systems to provide automated tracking.

The system shall have the ability to have bi-directional integration between the software and the VA Electronic Health Record (EHR) and VistA. VA requires a solution that manages and tracks inventory of all implants including tissue, orthopedic, cardiovascular and implantable devices throughout the device life cycle from receipt of device through recall management. VA requires software that functions with devices to scan two-dimensional (2D) and three-dimensional (3D) barcodes for inventory management. The required technology shall capture GS1 Standards, Health Industry Business Communications Council (HIBCC) and International Standard for Blood and Transplant (ISBT) barcodes. VA also requires a solution that meets the Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. The FDA published a final rule on Feb. 14, 2014, requiring manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive.

The period of performance consists of a 12-month Base Period, with two (2) 12-month Option Periods. The total estimated value of the proposed action is including all options.

4. Statutory Authority: Pursuant to Federal Acquisition Regulation (FAR) 16.505(a)(4), the following brand name requirement is being justified and approved as an exception to fair opportunity under the statutory authority of Section 41 U.S.C. 4106(c)(2) as implemented by FAR 16.505(b)(2)(i)(B), entitled �Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized�.

5. Rationale Supporting Use of Authority Cited Above: Based on market research, as described in Section 8 of this justification, it was determined that only InVita brand name UDITracker has the required capability to satisfy this requirement and limited competition is viable among resellers for the brand name InVita UDITracker. InVita meets the current requirements of the Joint Commission to have a system in place for the tracking of all implants with software and cabinet storage, which provides bidirectional traceability of implants at the point of use. Specifically, InVita�s UDITracker interfaces with the Veterans Health Information Systems and Technology Architecture (VistA) and the Single Sign-On (SSO) solution. The system also integrates with Computerized Patient Record System (CPRS), Medicaid Management Information System, and EMR systems to provide automated tracking. The system has the ability to have bi-directional integration between the software and the VA Electronic Health Record (EHR) and VistA. InVita�s software manages and tracks inventory of all implants including tissue, orthopedic, cardiovascular and implantable devices throughout the device life cycle from receipt of device through recall management. InVita�s software functions with devices to scan two-dimensional (2D) and three-dimensional (3D) barcodes for inventory management. Invita�s technology captures GS1 Standards, Health Industry Business Communications Council (HIBCC) and International Standard for Blood and Transplant (ISBT) barcodes. InVita�s solution automates the chain of custody from receipt of items to tracking inventory through use, documenting key information, and managing critical recalls. InVita�s solution manages inventory to reduce waste, optimize efficiency and ensure patient safety and delivery of high-quality care.

Additionally, RFID Storage is required to automate the chain of custody for tissue and implants and automatically tracking inventory at the point of use. The required platform shall provide additional analytics and reports through an integrated dashboard, enabling users to identify meaningful usage patterns by a variety of variables and use the insights to inform better business decisions. VA requires a solution that streamlines and automates tissue and implant management to help ensure compliance and reduce costs while increasing patient safety. Deep integration with vendors and the Food and Drug

Administration (FDA) and scanning of existing manufacturers codes reduces double data entry and the potential for error.

Based on VA technical reviews, InVita meets all VA requirements. InVita�s UDI software system has the sole ability to synchronize data across VA EHR platforms, VistA and CPRS through Document Storage Systems. This capability to interface with these platforms ensures real-time data synchronization and reduces the likelihood of errors associated with multiple data entry. By connecting to existing VA systems, InVita automates workflows and facilitates a more efficient process for tracking implants from procurement to patient implantation and follow-up. Providing end-to-end tracking of implants is in compliance of an FDA mandate and ensures that all necessary data is captured and easily accessible for audits and reporting. The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. The FDA published a final rule on Feb. 14, 2014, requiring manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive. The use of any other software would require VA to build customized tools, scripts, and processes. The development and integration of any other software solution would also require replacement of existing hardware, resulting in an estimated duplicative cost of approximately $2,100,000.00. Additionally, it would take a minimum of 18 months to obtain approval, funding, and design the interfaces. These estimates are based upon previous development and configuration efforts of similar size and scope. The estimated duplicative costs would not be recovered through competition.

Finally, the brand name InVita UDITracker solution is a proprietary hardware/software solution; therefore, only InVita or its authorized resellers can provide maintenance on its hardware/software products. The proprietary data and source code is required to ensure all updates and patches are properly pushed through to the fielded solution and to ensure the solution is properly configured. Access to this code is also required to ensure all services provided on the solution are properly configured. No source other than InVita or its authorized resellers have access to the proprietary data and source code necessary to provide the required patching and version upgrades/enhancements and security updates for the UDITracker solution. Without acquiring the InVita UDITracker solution, the VISN 8 locations will be unable monitor and track implants and provide timely care to Veterans.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in Section 8 of this justification. This effort did not yield any additional sources that can meet the Government�s requirements. However, the undersigned VA technical representative determined that limited competition is available among authorized resellers for brand name InVita UDITracker. In accordance with FAR 16.505(a)(4)(iii)(A)(1), this justification will be provided with the solicitation to all appropriate NASA SEWP V GWAC holders. Furthermore, in accordance with FAR 5.301, 16.505(b)(2)(ii)(D), and 16.505(a)(4)(iii), the award notice for this action will be synopsized on the Contract Opportunities website and this justification will be made publicly available within 14 days of award.

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

8. Market Research: During June 2025, VA technical experts completed market research by reviewing similar implant tracking products. The other similar implant tracking products reviewed were from TrackCore and BD Pyxis. Based on reviews of these products, the Government�s technical experts determined that neither TrackCore nor BD Pyxis can meet the Government�s interoperability and compatibility requirements previously discussed in Section 5. Specifically, TrackCore and BD Pyxis products do not have the ability to interface with VA platforms VistA and CPRS.

VA conducted additional market research through a manufacturer provider lookup utilizing NASA SEWP V GWAC to identify potential resellers for brand name InVita UDITracker. A manufacturer provider lookup for InVita returned one (1) Service- Disabled Veteran-Owned Small Business (SDVOSB), FedStore Corporation, under groups B and C. Additionally, the Contract Specialist contacted InVita to request a list of authorized resellers in June 2025. InVita confirmed that ThunderCat Technology (ThunderCat) is also an authorized SDVOSB reseller under NASA SEWP groups B and C. Further, InVita confirmed they are willing to authorize additional SDVOSB resellers on NASA SEWP if approached. A copy of the email has been uploaded to the contract file. As a result, there is a reasonable expectation for competition on the NASA SEWP V GWAC amongst SDVOSBs.

9. Other Facts: None.

10. Technical/Requirements Certification I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

11. Fair and Reasonable Cost Determination I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable based on competition. Additionally, NASA SEWP V has already determined the prices on contract to be fair and reasonable. Finally, the successful quote will be compared with the Independent Government Cost Estimate.

12. Contracting Officer Certification I certify that this justification is accurate and complete to the best of my knowledge and belief.

13.Office of General Counsel (OGC) Review I have reviewed this document and find it legally sufficient, based on the representations set forth in the documents and, if any, attachments. The Advocate for Competition�s approval is an independently supported decision not wholly reliant on the legal sufficiency determination.

Advocate for Competition Approval In my role as procuring activity Advocate for Competition, based on the foregoing justification, I hereby approve the acquisition of brand name InVita UDITracker hardware and software on an other than fair opportunity basis pursuant to the authority cited in Section 4 above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition.