FY26.Justification FAR Part 13 Bloodbank All signed_Redacted 1_Redacted 2_Redacted3_Redacted4.pdf

Control Number: 25-MRCO-WEST-262

JUNE 2025

JUSTIFICATION REVIEW DOCUMENT

FAR Part 13 Justification and Approval

Simplified Procedures for Certain Commercial Items

Program/Equipment: Lease automated Blood Bank Systems that includes equipment, service, maintenance, consumables, disposables, and reagents necessary for automated blood bank analyzers and blood bank testing for Martin Army Community Hospital (MACH), Fort Benning, Georgia, 31905.

Authority: Title 41 United States Code (U.S.C.) §1901(e)(2) as implemented in Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

Amount: The total estimated value of this effort including all options and extensions in accordance with FAR 52.217-8.

Prepared by:

Contracting Officer:

l

Technical:

Requirements:

JUNE 2025

Capture-R (CAP) Ready technology for automated blood bank testing. This equipment is needed to ensure that the laboratory continues to process samples of new recruits in-processing at the 30th Adjutant General (AG) Replacement Battalion (BN). Soldiers have to have their blood type determined. This analyzer allows the laboratory to test hundreds of samples daily because it has a throughput of over 200 results per hour.

The results can be released to healthcare providers in the allotted 72-hour time period so that trainees can have their identification tags made and issued before starting basic training.

b. Alternatives: Werfen USA (recently acquired Immucor and provide their products) offers the Neo Iris Systems and is the only responsible source capable of meeting the service and supply needs with their Immuno-Hematology automated Blood Bank Analyzer and Reagents. There are no known alternatives that can meet all the government’s minimum requirements.

c. Impact if not approved: These tests are crucial to mission as they provide for rapid turnaround time of blood types to 30th AG BN so that basic trainees can receive identification tags timely and patients can receive blood products or transfusion if required to prevent bleeding to death.

7. Efforts to Obtain Competition: A source sought notice for Immuno-Hematology blood bank analyzer was posted with the minimum reagent requirements to https://SAM.gov from 23 July 2025 through 28 July 2025. There were four (4) responses to the sources sought. All notices required by FAR 5.201 shall be or have been published, and any bids or proposals received shall be considered.

a. Effective competition: Werfen systems (currently in place at Martin Army Community Hospital) utilize the proprietary CAP Ready technology for automated blood bank testing, and therefore no competition is expected.

b. Subcontracting competition: There are no current subcontracting opportunities available.

8. Actions to Increase Competition: Based on current market research, and the results of the Sources Sought Notice, competition is not anticipated for this requirement because there is currently only one vendor that can meet the requirement for the required base minimum of 100-120 tests per hour, to ensure timely processing. The Medical Readiness Contracting Office-West will continue to evaluate the capabilities of other vendor’s products and re-procure the products that provides the best value to the Government.

9. Market Research: Market Research was conducted in accordance with Federal Acquisition Regulation (FAR) Part 10 to identify all qualified sources. Market research was conducted by the contracting office on 20 - 31 July 2025. Internet research and technical evaluation of capabilities statements from the source sought responses found companies, Werfen USA, and that offer an

JUNE 2025

Immuno-Hematology blood bank analyzer. However, only the Werfen USA analyzer can meet the needs of the government. Martin Army Community Hospital, Fort Benning, currently has limited personnel therefore the analyzer with the greatest throughput for samples is needed to meet the clinic’s mission with the best efficiency. Due to the increased basic training population the productivity of the requested analyzer is of importance in order that there is no backlog with the testing. Electronic Catalogue (ECAT) does not offer retail, leasing, or provisioning of equipment. This requirement is being procured externally because the awarded contractor’s equipment will be provided as part of the contract. The ‘all or none’ supplies, analyzer, and analyzer servicing are not available from wholesale supply sources (e.g. Defense Logistics Agency (DLA), Department of Veterans Affairs, General Services Administration (GSA), and military control points.) The contract specialist reviewed the DLA and Medical Master Catalog platforms, and the supplies and leased analyzer are not available.

A Small Business Administration (SBA) Dynamic small business search and Quick Market search was conducted using key words “325413”, Blood Bank Analyzer and Blood Bank Analyzer Reagents with no small businesses that are currently listed.

10. Interested Sources: A Source Sought Notice was posted on SAM.gov from 23 July 2025 through 28 July 2025 and accumulated four (4) responses from interested vendors. The vendors capability statement was evaluated by the Requiring Activity. In total, vendors were assessed to identify which source was capable of meeting all of the requirement, and whether it can be competitively solicited.

1. Werfen USA, LLC: Werfen USA submitted a response to the sources sought.

Werfen USA can provide all elements of the requested requirement. The Werfen USA NEO Iris analyzer offers the government the analyzer that offer the highest throughput per hour, at a base minimum throughput of 100 -120 tests per hour, to ensure timely processing and that will provide for the MACH laboratory to meet their mission with no backlog of testing the samples.

2. submitted a response to the sources sought. Analyzers offers throughput does not meet the government’s high volumes requirement for the laboratory testing. Therefore, proposed IH Analyzers from would not meet the government’s mission.

3. Submitted a response to the source sought. Gel method Analyzers offers cannot meet throughput volumes of the government’s high volumes requirement for the laboratory testing. Therefore, proposed Gel Analyzers from would not meet the government’s mission.

4. responded to the source of sought that they are interest and provided a capability statement. has a with

. The vendor is stating that they will receive our samples,