JA Sole Source FAR Part 13 Redacted.pdf

CUI//SP-SSEL

Immuno-Hematology Blood Bank Analyzer and Reagents

Control Number: 25-MRCO-WEST-170

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

SEP 2021

d. RAHC perform approximately 18,000 ABO/Rh tests per year.

e. Sample types are submitted using the pink top tubes but must be able to use purple top EDTA tubes as a backup.

f. The power outlet currently being used is a 110 V dedicated outlet.

g. The immunohematology instrument must be automated and perform all routine immunohematology testing procedures, primarily blood grouping. The instrument should also have the capability to perform antibody screening and identification should RAHC resume these tests in the future.

h. Due to the high-volume workload at RAHC, the analyzer must have continuous loading access.

i. The instrument must have on-board reagent storage capable of processing over 200 samples without reloading.

j. A reasonable return policy must include time for reagent orders to be verified before being accepted. Should the government find a discrepancy and/or reject, the vendor will accept the reagent and no charge to the government.

k. Due to limited blood bank staffing and a high workload during peak months (January to October), the selected analyzer must offer the highest throughput per hour, at a base minimum of 100-120 tests per hour, to ensure timely processing.

l. Must not require any added expense for plumbing, drainage, or water systems. Self-contained, on-board water management eliminates special requirements for off-board plumbing.

m. The analyzers must interface with the government's system (CERNER, MHS Genesis), recognize MHS-Genesis-generated barcode labels on primary sample tubes, and support automated/semi-automated pre- and/or post-analytical specimen processing. These systems should be platform-based and offer full, walk-away automation (i.e., an automation/robotic line) depending on laboratory space constraints.

n. The system must function without requiring remote communication to outside sources.

o. The Immunohematology analyzers must have an approved Authorization to Operate (ATO) on the government network.

Therefore, Werfen USA is the only responsible source capable of meeting the government’s minimum requirements.

Immuno-HematologyBlood Bank Analyzer and Reagents

Control Number: 25-MRCO-WEST-170

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

SEP 2021

6. Efforts to Obtain Competition: A sources sought notice for Immuno-Hematology blood bank analyzer was posted with the minimum reagent requirements to https://SAM.gov from 6 May 2025 through 12 May 2025. There were three 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. Based on market research that was conducted and the results of the Sources Sought Notice, competition is not anticipated for this requirement. The Government will continue to assess the market for new entrants. It is anticipated that only one vendor can meet this requirement for the Immuno-Hematology blood bank analyzer.

b. Subcontracting competition. As per FAR 19.705-2, if a subcontracting possibility exists, the contractor will be required to submit a subcontracting plan.

Therefore, at this time only Werfen USA can provide for the Immuno-Hematology blood bank analyzer that meets the government’s needs.

7. 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.

8. Market Research:

Reynolds Army Health Clinic 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.

Federal Supply Schedules, Government wide acquisition contracts, multi-agency contracts, and any other procurement instruments intended for use by multiple agencies, including blanket purchase agreements (BPAs) under Federal Supply Schedule contracts (e.g., Federal Strategic Sourcing Initiative (FSSI) agreements accessible at http://www.gsa.gov/fssi was researched 1 May 2025 by the contract specialist. Werfen USA has a current federal supply schedule however the requested items are currently unavailable. Ortho Clinical and Government Scientific Source also have current FSS schedules however they cannot provide for the Immuno-Hematology blood bank analyzer that meets the government’s needs.

Immuno-HematologyBlood Bank Analyzer and Reagents

Control Number: 25-MRCO-WEST-170

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

SEP 2021

Werfen USA: Werfen USA submitted a response to the sources sought. Werfen USA can provide all elements of the requested requirement. The Werfen USA Immucor 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 RACH laboratory to meet their mission with no backlog of testing the samples.

Ortho-Clinical Diagnostics, Inc.: Ortho-Clinical Diagnostics, Inc. submitted a response to the sources sought. Ortho-Clinical Diagnostics, Inc. Vision Analyzer offers throughput of 48 tests per hour, which does not meet the government’s minimum requirement for the laboratory testing. Therefore, proposed Vision Analyzer from Ortho Clinical Vision Analyzer would not meet the government’s mission.

Government Scientific Source: Government Scientific Source submitted a response to the sources sought. Government Scientific Source analyzer the BioRad IH-500 offers throughput of 50 tests per hour, which does not meet the government’s minimum requirement for the laboratory testing. Therefore, proposed BioRad IH-500 from Government Scientific would not meet the government’s mission.

An 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.

DLA ECAT and Medical Master Catalog were researched and the DLA and ECAT platforms with the requested Immuno-Hematology blood bank analyzer and requested comprehensive list of reagent supplies are currently not available.

Internet Research found three companies, Werfen USA, Ortho Clinical and Government Scientific that offer an Immuno-Hematology blood bank analyzer. However, only the Werfen USA analyzer can meet the needs of the government.

9. Interested Sources per the sources sought:

Werfen USA Ortho-Clinical Diagnostics, Inc Government Scientific Source

10. Other Facts:

a. Procurement history.

Contract number: W81K0023P0189 Government Scientific Source.

Description of requirement: Immuno-Hematology blood bank analyzer Competitive status: Sole Source Contract type: Firm Fixed Price Total awarded amount: $241,159.10

Immuno-Hematology Blood Bank Analyzer and Reagents

Control Number: 25-MRCO-WEST-170

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

SEP 2021

Number of option periods: 01 October 2023 to 30 September 2025 Number of Offerors: One Source Selection Method: Sole Source to retain continuity and ability to fulfill the Government’s requirement.

Authority cited: FAR 10 United States Code 3204(a)(1) as implemented in Federal Acquisition Regulation 6.302-1(a)(2)(ii)(A), Substantial duplication of cost to the Government that is not expected to be recovered through competition; and (B), Unacceptable delays in fulfilling the agency’s requirements.

Basis for fair and reasonable pricing: Sole Source Only one offer was received that complies with the terms of the request.

A summary of the contents of paragraph 7 of the justification: Until it is determined that the current Government Scientific Source, Inc. no longer meets the Reynolds Army Health Clinic (RACH) requirements due to the CERNET IT Network backlog problem, it must continue to be procured from the only responsible source with the analyzers connected to the DHA network. The RACH requesting agency continues to evaluate the medical equipment capabilities of other vendors through market research and meeting with other vendors and the demonstrations of their products.

If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes: No changes.

Contract number: W81K0018P0498 Government Scientific Source.

Description of requirement: Immuno-Hematology blood bank analyzer Competitive status: Full and Open Competition Contract type: Firm Fixed Price Total awarded amount: $626,205.75 Number of option periods: 1 October 2018-30 September 2023, Base + 4 Options Number of Offerors: Two Source Selection Method: Lowest Price Technically Acceptable. Price and ability to fulfill the Government’s requirement.

Basis for fair and reasonable pricing: After technical evaluation the end user chose Government Scientific Source to be the most technically acceptable If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources: Werfen USA is now the only known source who can meet the Government’s minimum requirements.

b. other facts. N/A

11. Technical/Requirements Certification:

I certify 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.