J_A_Redacted.pdf

CUI//SP-PROCURE//FEDCON

JUNE 2025

CUI//PROCURE

CUI//PROCURE

JUSTIFICATION REVIEW DOCUMENT

FAR Part 12 Justification and Approval for Other than Full and Open Competition

Program/Equipment: Automated Apheresis Equipment for Robertson Blood Center at the Carl R. Darnall Army Medical Center (CRDAMC), Fort Hood, Texas.

Authority: Title 41 United States Code (U.S.C.) §1901 as implemented in Revolutionary FAR Overhaul (RFO) Federal Acquisition Regulation (FAR) 12.102(b), restricting competition for acquisitions valued over the simplified acquisition threshold.

JUNE 2025

CUI//PROCURE

CUI//PROCURE

FAR Part 12 Justification and Approval for Other than Full and Open Competition

1. Requiring Activity: Robertson Blood Center (RBC) at Carl R. Darnall Army Medical Center (CRDAMC), Fort Hood, Texas.

2. Contracting Activity: Fort Hood Health Contracting Branch, Medical Readiness Contracting Office-West (MRCO-W), United States Army Health Contracting Activity

(USAHCA)

3. Description of Action: Request approval to award a new one time buy for Automated Apheresis Equipment for RBC CRDAMC, Fort Hood, Texas. It is anticipated for a Firm-Fixed-Price (FFP) sole-source contract to Terumo Blood and Cell Technologies (BCT), CAGE: 1VBG2, 10811 W. Collins Ave, Lakewood, Colorado, 80215-4440. The contract is funded with FY26 Defense Health Program (DHP) funds.

4. Description of Supplies/Services: The RBC operates under the regulatory authority of the Food and Drug Administration (FDA) and the Association for the Advancement of Blood & Biotherapies (AABB) to provide life-saving blood products for the Armed Services Blood Program (ASBP). The center's mission requires flexibility to collect specific blood components based on rapidly changing inventory needs. The Trima Accel® system is the only available technology that can concurrently collect any combination of platelets, plasma, and red blood cells from a single donor in one appointment. This unique capability is critical to maximizing the impact of each donation and ensuring the right blood products are available for service members. Competing systems, such as the Haemonetics NexSys PCS® and the Fresenius Kabi Aurora Xi™, are highly specialized plasmapheresis devices designed for plasma-only collection and cannot collect platelets or red blood cells. The Trima Accel® also offers significant operational advantages, including procedure times up to 40% shorter than comparable devices, which enhances donor satisfaction and center throughput. Furthermore, acquiring the Trima Accel® system ensures standardization and interoperability with other blood donor centers across the ASBP, which also utilize the Trima® platform. This parity streamlines training, maintenance, and operational protocols, which is a critical factor for mission readiness

JUNE 2025

CUI//PROCURE

CUI//PROCURE

5. Authority Cited: Title 41 United States Code (U.S.C.) §1901 as implemented by RFO FAR 12.102(b), restricting competition for acquisitions valued over the simplified acquisition threshold.

6. Reason for Authority Cited:

a. Background: The Robertson Blood Donor Center is a critical asset within the ASBP, tasked with supplying life-saving blood products to support global Department of War operations. Operating under the strict regulatory compliance of the FDA and the AABB, the center must maintain high operation readiness. To fulfill its mandate, the center requires, agile, state-of-the-art collection capabilities to immediately respond to the fluctuation and critical blood inventory requirements of the Armed Services.

b. Alternatives: An assessment of alternative solutions was conducted, evaluating competing automated apheresis technologies such as the Haemonetics NexSys PCS® and the Fresenius Kabi Aurora Xi™. These alternatives were deemed unacceptable as they are engineered strictly for plasma collection and lack the concurrent multi-component (platelet, plasma, and red blood cell) capabilities required by the RBC. Additionally, the alternative of utilizing multiple single-component devices or reverting to manual whole blood collection was evaluated;

however, these approaches would drastically increase procedure times, require significantly more floor space, and reduce overall donor throughput, ultimately failing to meet the rapid operational readiness and efficiency requirements of the

ASBP.

c. Impact if not approved: Failure to approve the acquisition of the Trima Accel® Automated Blood Collection Systems will directly degrade the RBC capability to meet the requirements of the ASBP. Without this technology, the RBC will lack the essential multi-component collection flexibility required to respond to rapidly shifting theater inventory needs for platelets and red blood cells. Relying on inferior alternatives would result in an estimated 40% increase in procedure times, significantly reducing donor throughput and overall mission efficiency.

Furthermore, a lack of standardization with the existing ASBP fleet would create interoperability gaps in training and maintenance protocols, increasing the risk of operational downtime. Most critically, the inability to maximize the yield of each donation poses a direct risk to the timely availability of life-saving blood products for service members in support of global contingency operations.

7. Efforts to Obtain Competition: A sources sought notice was posted to SAM.gov for seven (7) days. One interested vendor responded; however, a technical review determined the vendor's alternative equipment was incapable of meeting the concurrent multi-component requirement. The Contracting Officer will publish the required synopsis notices IAW FAR 5.201, and any subsequent bids or proposals received shall be evaluated.

JUNE 2025

CUI//PROCURE

CUI//PROCURE

a. Effective competition: Terumo BCT is the sole manufacturer. The reference letter was received on 20 May 2026 and has been uploaded to PCF. Competition is not anticipated due to the proprietary and patented nature of the concurrent multi-component apheresis technology manufactured by Terumo BCT.

b. Subcontracting competition: N/A IAW FAR 19.705.2(c)

8. Actions to Increase Competition: The Government will continue to monitor the medical device market for new technological entrants. If other compatible, multi-component products become FDA-approved and available in the future, extensive market research will be performed to consider other sources that meet or exceed the mission requirement. An evaluation of the market will be conducted prior to any future tech-refresh or renewal related to this requirement, focusing on pricing, availability, and alternative capabilities.

9. Market Research: In accordance with FAR Part 10 and DFARS 210.001, market research was conducted on 20 January 2026. Market research, as detailed in Part 2 of the Market Research Report, involved a thorough analysis of the apheresis system. The automated blood collection (apheresis) market is highly consolidated, with a few major manufacturers providing specialized equipment. Market research indicates that Terumo BCT’s Trima Accel® holds a unique position as the premier concurrent multi-component collection system. While competitors offer automated apheresis devices, their capabilities are generally restricted to single-component or specialized collection, making them unsuitable for dynamic, high-yield military blood center operations.

The following market research techniques were used for this requirement:

Review of Mandatory Sources: A review as required by FAR Part 8 confirmed the required items are not available through the Federal Supply Schedule (FSS), GSA Advantage!, or other government-wide acquisition contracts.

Database Searches: The Federal Procurement Data System (FPDS) was queried to identify historical contract actions for similar requirements.

Industry Queries: Known industry leaders, including Haemontics and Fresenius;

their products do not meet the multi-component collections required by the Government.

Internet Research: Confirmed the market is dominated by three large manufacturers, with Terumo being the only source for this specific capability.

This research concludes that no other source, including small businesses, can provide apheresis machines meeting the Government's concurrent collection requirements.

This market research concluded that no other source, including any small business, could provide the apheresis machines. The market research has determined that due to the proprietary nature of the existing equipment, only one vendor, Terumo BTC can meet the government's needs within the timeframe required.

JUNE 2025

CUI//PROCURE

CUI//PROCURE

10. Interested Sources: One other source expressed interest during the sources sought phase; however, a technical review found them incapable of meeting the specific, multi-component technical requirements of this solicitation.

11. Other Facts:

a. Procurement history. N/A

1) This is a new one-time buy.

b. Other facts. None.