P03 JA_Trackcore_8.27.26_Redacted_Final.pdf

TrackCore Implant Tracking Solution VA-26-00051240

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity: Department of Veterans Affairs (VA)

Office of Procurement Operations Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

2. Description of Action: The proposed action is for the establishment of an Indefinite Delivery/Indefinite Quantity (IDIQ) contract for brand name TrackCore Implant Tracking Solution including all related supplies and services. The proposed solicitation shall be issued on a sole source basis directly to PAR Excellence Systems, Inc (PAR), 11500 Northlake Drive Suite 135, Cincinnati, Ohio, 45249.

Orders under the IDIQ will be issued on a firm-fixed price basis.

3. Description of Supplies or Services: VA is seeking a solution to efficiently and accurately track all biological and non-biological implantable items. This solution shall include radio frequency identification enabled medical storage units and peripheral scanning/printing devices hardware, supplies, perpetual software licenses, project/account management, maintenance and warranty support, and support services such as design, implementation and configuration, training, materials, equipment, and transportation/delivery in compliance with federal, state, and local regulations. This solution shall interface with the Federal Electronic Health Record (FEHR) system to be able to auto-populate the patient record in the electronic health record to include the implant specifics for compliance and tracing.

The FEHR runs on the Cerner/Oracle Health platform; accordingly, VA requires an implant tracking solution that inherently interoperates with, and is supported by, the Cerner/Oracle Health platform. This is needed to comply with the Veterans Health Administration (VHA) policy as well as VHA Directive 1081.02 which requires all biological and non-biological implants in a hospital to be tracked from manufacture to end user and be entered into the electronic health record for the patient. The solution shall meet all Food and Drug Administration guidelines, regulations, and laws. The scope of this requirement includes all VA medical centers (VAMCs), as well as any respective Community Based Outpatient Centers associated with the main medical centers, specifically the renewal of existing software and maintenance at 89 VAMCs, and expansion to an additional 57 VAMCs.

The IDIQ shall consist of 1, 12-month ordering period from the date of award with 4, 12-month option periods for a total ordering period of 5 years from the date of award.

The period of performance will be established on each IDIQ order. The total estimated ceiling price of the proposed IDIQ action is

4. Statutory Authority: The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(1) as implemented by the Revolutionary FAR Overhaul (RFO) 6.103-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

operational replacement system for at least five years.

Second, there is a compliance gap risk. During the entire transition period, VHA Directive 1081.02 compliance is at risk at all 89 currently active sites. There is no mechanism to maintain compliant implant tracking in the FEHR during a platform migration. The regulatory and patient safety exposure during a four to six year transition is unquantified but material and has no dollar equivalent in the cost model.

These estimated duplicative costs would not be recovered through competition.

These estimates are based on previous acquisition history. In addition, the existing TrackCore software and support would need to be maintained until the new software solution is integrated and available.

Without acquiring the TrackCore software solution, hardware, and support, VAMCs will be unable to provide the most efficient and high-quality patient care which would hamper VA’s ability to monitor and track and ultimately 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. There is no competition anticipated for this acquisition. In accordance with RFO 6.301(b)(2) and 5.201(c)(3), this justification shall be posted with the solicitation. Furthermore, the proposed action will be synopsized on the Contracting Opportunities Page in accordance with RFO

5.301. Any proposals that are received shall be evaluated.

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: VA’s technical experts conducted market research to determine whether any other source could provide the required services. Specfically, in April 2026, VA technical experts performed web-based market research by reviewing similar brand-name solutions such as UDITracker, WaveMark, and QSight. Based on their review, the VA technical experts determined that none of these products could meet the interoperability and compatibility requirements necessary to function with the FEHR system. The critical distinction is interoperability with the FEHR. The FEHR runs on the Cerner/Oracle Health platform, and TrackCore is the only implant tracking system that can inherently interoperate with it and be supported by it. The other systems cannot natively integrate with Cerner/Oracle Health and could only be made to do so if VA procured custom development work to build that integration.

Other companies provide software maintenance and technical support solely for their own proprietary products, which would require VA sites to procure entirely new equipment, transition to a different software platform, fund new integration development, and train staff on a new system. Although these developers offer products with similar functionality, VA sites already own TrackCore software and associated equipment. Since TrackCore is compatible with Cerner, it will ensure that sites will not have to transition systems again during the FEHR implementation.

Based on all market research efforts, the Government’s technical experts concluded that only TrackCore can meet all of VA’s requirements.

In May 2026, additional market research was conducted using the National Aeronautics and Space Administration Solutions for Enterprise-Wide Procurement V Government Wide Acquisition Contract Provider Lookup Tool. The Provider Lookup Tool identified two contract holders that are resellers of TrackCore brand-name products and services. Both were eligible and certified Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns: Four Points Technology, LLC (Four Points) and Veteran Information Technologies, LLC. The Contracting Officer contacted PAR directly to 1) verify its authorized resellers, and 2) confirm if its resellers can comply with limitations on subcontracting requirements applicable to an SDVOSB/ Veteran-Owned Small Business (VOSB) set-aside or sole-source action under VA Acquisition Regulation (VAAR) clauses 852.219-73, 852.219-74, 852.219-75, and 852.219-76. In response, PAR stated that it has one reseller, Four Points, however it also indicated that its reseller cannot meet the limitations on subcontracting requirements. These clauses require that an SDVOSB/VOSB contractor not pay more than 50% of the amount paid by the Government to firms that are not SBA Veteran Small Business Certification certified SDVOSBs/VOSBs.

Certification of VAAR 852.219-75 and/or 852.219-76 is mandatory under an SDVOSB/VOSB set-aside acquisition strategy. On June 11, 2026, PAR further explained that, due to its role in supporting the FEHR effort, licensing and implementation services for VA sites adopting FEHR are more appropriately provided directly by PAR rather than through a reseller. Accordingly, PAR anticipates discontinuing the use of a reseller for these requirements. Since no small business concerns of any socio-economic category are capable of meeting the requirement, there is no opportunity for any type of small business set-aside or small business sole-source acquisition strategy. Therefore, as PAR is the only contractor able to fully support the requirement, a solicitation will be issued directly to PAR on a sole-source basis.

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 price analysis to be conducted in accordance with

RFO 15.404-1.

12. Contracting Officer Certification/Approval

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

HCA Concurrence

In my role as Head of the Contracting Activity, based on the foregoing justification, I hereby concur with the acquisition of the TrackCore Implant Tracking Solution including all related supplies and services, 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.

Senior Procurement Executive Approval

In my role as Agency Senior Procurement Executive, based on the foregoing justification, I hereby approve the acquisition of the TrackCore Implant Tracking Solution on an other than full and open competition 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.