TRANSMEDICS LONGTERM SSJ_Redacted.pdf

36C244-26-AP-1685| TransMedics Donor Organ Recovery, Perfusion, and Transportation

DEPARTMENT OF VETERANS AFFAIRS

RESTRICTING COMPETITION USING SIMPLIFIED PROCEDURES

FOR COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 12.102

This justification aligns with the deviation outlined in the Revolutionary FAR Overhaul (RFO) for FAR 12.201-1 Simplified Acquisition Procedures, as required by Executive Order (E.O.) 14275, Restoring Common Sense to Federal Procurement, signed April 15, 2025. Deviation effective date: October 14, 2025.

Acquisition Plan Action ID: 36C244-26-AP-1685

1. Contracting Activity:

Department of Veterans Affairs (VA), Veterans Integrated Service Network 04 (VISN04), VA Pittsburgh Healthcare System (VAPHS), Network Contracting Office 4 (NCO4).

2. Nature and Description of the Action Being Processed:

This single source award justification supports procurement of TransMedics, Inc. contractor services to provide deceased donor organ recovery, perfusion, and transportation from organ recovery hospitals within the TransMedics Great Lakes, Mid-Atlantic, Southeast, Northeast, South, Prairies, Midwest, or Texas regions to the VAPHS transplant center in Pittsburgh, PA. The Government anticipates award of a firm fixed price Indefinite Delivery Indefinite Quantity (IDIQ) contract with a performance period of one year from date of award. The total estimated contract value is

3. Description of Services Required to Meet the Agency’s Needs:

VAPHS maintains one of three independent VA liver transplant programs in the U.S., with the potential to serve Veterans Health Administration (VHA) patients residing in the eastern half of the country. Liver transplants may use organs from living or deceased donors. In cases involving deceased donor organs, the federally-designated regional Organ Procurement Organization (OPO) servicing the deceased donor’s location will populate available liver donor information into the United Network for Organ Sharing (UNOS) national database, which uses criteria such as blood type, tissue type, organ size, patient urgency, and waiting time to create a list of potential recipients.

Upon identifying a priority recipient, the organ offer is sent to the recipient’s transplant center, where the transplant team evaluates its suitability based on medical compatibility, patient condition, and readiness. Once accepted, the organ is transported to the transplant center, and the recipient undergoes transplant surgery.

VAPHS requires the proprietary perfusion technology and service support of TransMedics Organ Care Service (OCS) to significantly expand the potential pool of donor organs for VA patients. By enhancing the viability of donor livers, TransMedics OCS enables the VAPHS transplant team to consider organs from high risk or medically complex donors, advanced age donors, Donation after Cardiac Death (DCD) donors over age 45, and regionally imported DCD donors that require prolonged transportation time. In the absence of TransMedics OCS technology, the VAPHS transplant team would not consider donor organs from these groups, resulting in missed opportunities for life-saving transplants.

TransMedics OCS would significantly increase the likelihood that these donor offers would be accepted for VA patients.

VAPHS has repeatedly procured TransMedics OCS through a series of emergency contracts since September 2025 with successful outcomes, and requires a long-term contract vehicle to accommodate the program’s demonstrated need, and alleviate the administrative burden of repetitive emergency procurements. A long-term indefinite delivery vehicle will also enable the VAPHS transplant team to coordinate delivery of services with the contractor without NCO4 contracting support when transplant cases arise outside of normal business hours.

4. Statutory Authority Permitting Other than Full and Open Competition:

FAR 12.102 Restricting Competition. The statutory authority for restricting competition on this procurement is 41 U.S.C. § 1901 and is implemented by FAR 12.102(b) for restricting competition using Simplified Acquisition Procedures for commercial items. Competition is restricted on this procurement for the reason below:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

TransMedics’ capability is distinguished by a unique combination of proprietary perfusion technology and service support that satisfies VAPHS’s integrated need for deceased donor organ recovery, organ perfusion and monitoring, and transportation from a wide range of donor locations.

Market research has not identified other sources with the capability to provide normothermic (normal body temperature) ex-vivo perfusion technology in conjunction with trained staff to monitor the equipment and organ in transport from a comparable range of donor organ recovery locations.

TransMedics’ proprietary OCS device is a fully-portable, FDA-approved perfusion technology for Donation after Brain Death (DBD) and DCD liver transplant indications. Deceased donor organ transportation typically occurs in cold static storage (in a cooler on ice, for example) that cools the organ to approximately 4 degrees Celsius to decrease metabolic demand, but this method ultimately generates cold ischemic injury to the organ.

Additionally, TransMedics can provide a physician to surgically recover the organ from a potential donor at the organ recovery location, and provide trained Intensive Care Unit/Critical Care Monitoring (ICU/CCM) registered nurses to maintain the perfusion equipment and monitor organ viability during transportation to the VAPHS transplant center. The TransMedics’ logistics network encompasses recovery and transportation of donor organs from anywhere in the continental U.S. to the VAPHS transplant center; however, the Government anticipates limiting regional coverage under this proposed contract to the TransMedics Great Lakes, Mid-Atlantic, Southeast, Northeast, South, Prairies, Midwest, and Texas regions.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

The Agency has performed market research as detailed in Section 8 below to identify potential sources for these services. However, market research indicates that TransMedics is the only source with capability to satisfy the Agency’s requirement. The Agency has posted a Sources Sought Notice to System for Award Management (SAM) Contract Opportunities (eCMS PIID 36C24426Q0067 posted 10/31/2025-11/14/2025) to identify interested and capable sources. The CO intends to post a Notice of Intent to Sole Source to SAM upon approval of the justification.

7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable:

TransMedics OCS technology is widely used in the private market, yet the VAPHS transplant program is the first to incorporate these services in the federal healthcare sector. As such, there are no historical or existing federal contracts for these services beyond emergency NCO4 contracts to use for comparative price analysis.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

The market for organ preservation technology is rapidly evolving as companies innovate new solutions. The transplant team’s clinical SME worked with the contract specialist (CS) to identify comparable technologies and other potential sources for these services. This internal market research relied on the clinical SME’s personal knowledge, review of professional literature, and internet searches. These market research efforts indicated that TransMedics is the only source with capability to satisfy the total integrated need of the VAPHS transplant program, as detailed in Section 5 above. Additionally, the contract specialist posted a Sources Sought Notice to System for Award Management (SAM) Contract Opportunities (eCMS PIID 36C24426Q0067 posted 10/31/2025- 11/14/2025), to identify companies that may have been overlooked in the internal market research process. The CS received no responses from vendors that indicated potential capability to satisfy the Agency’s requirement.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

NCO4 awarded at least eight previous sole source awards for these services to TransMedics on the basis of unusual and compelling urgency since September 2025. The CO posted award notices to SAM Contract Opportunities to publicize the contract awards and received no responses from vendors indicating capability to provide similar services.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

TransMedics, Inc. has indicated interest in the acquisition and demonstrated capability to satisfy the requirement through performance on several emergency NCO4 contracts for these services since September 2025.

The two sources listed below expressed interest in timely response to Sources Sought Notice 36C24426Q0067. However, neither source indicated capability to satisfy the requirement or described the services their companies typically offer, as requested in the notice.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required:

The Agency’s market research has not identified other sources with the capability to satisfy the requirement and participate in a competitive procurement. The requirement cannot be relaxed without limiting the patient care objectives of this procurement. The market for these services is rapidly evolving, however, and the Agency will continue to conduct market research to identify the potential for competitive re-procurement to follow this proposed one year contract.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona

Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Date

Transplant Administrator VA Pittsburgh Healthcare System

13. Approvals in accordance with VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Heather Krah Date Contracting Officer, Services Team 1, NCO 4

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Erik Whitaker Date Branch Chief, Services Team 1, NCO 4

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $90 million) or approve ($900k to $90 million) for other than full and open competition.

Gerald F. Jacobs Date VHA Head of Contracting Activity Advocate for Competition Executive Director, RPO-East

HEATHER

KRAH

Digitally signed by

HEATHER KRAH

Date: 2026.03.19 08:47:10 -04'00'

ERIK

WHITAKER

Digitally signed by

ERIK WHITAKER

Date: 2026.03.19 09:01:41 -04'00'

GERALD

JACOBS

Digitally signed by

GERALD JACOBS

Date: 2026.03.20 09:35:31 -04'00'

3/18/26

3/20/26

3/19/26