NMRC JA. ABL90 Flex Plus_ACO_signed rev.1.pdf

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Center (NMRC), Silver Spring, MD, on behalf of the Navy to meet Navy Expeditionary Medical Research requirements.

2. Nature and/or description of the action.

The proposed action is for the procurement of a the ABL90 Flex Plus blood gas analyzer. The Government intends on awarding a Firm Fixed Price Contract. The proposed source is Radiometer America, Inc., 250 S. Kraemer Blvd. Mail Stop B1. SW.11, Brea CA 92821.

3. Description of Supplies or Services:

The Navy Medical Research Unit-San Antonio (NAMRU-SA) is currently conducting research in trauma and controlled-hemorrhagic shock while utilizing model development animals.

Following trauma, arterial blood gas (ABG) readings are helpful in determining the severity of damage to the patient as well as provide guidance in treatment. Procurement of this instrument will allow NAMRU-SA to take serial ABG measurements during protocols to better assess effective fluid resuscitation as well as determine whether further intervention is needed. The ABL Flex Plus analyzer delivers test results in just 35 seconds on up to 17 vital parameters (blood gases, electrolytes, metabolites, and co-oximetry) while using as little as 65ul of blood sample. Additionally, the equipment will include an on-site service contract to cover the warranty while service and repairs will be conducted on-site with an annual preventive maintenance and recalibration. The equipment will include a base year of one-year on-site service contract to cover the warranty while service and repairs will be conducted on-site with an annual preventive maintenance and recalibration. Navy Operation and Maintenance Fiscal Year 2025 funds will be used for coverage during the base period.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1) and FAR 13.106-1(b)(1) soliciting from a single source.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The reason for justification of use of cited statutory authority is that Radiometer America, Inc is the sole manufacturer for the ABL Flex Plus Blood Gas Analyzer as well as the only source of its highly specific cartridges required to productively provide the accurate readings needed to produce the results required to collectively assess the patient’s needs. Furthermore, this instrument comes highly recommended by various project sponsors and will be used by NAMRU-SA to perform blood gas analysis during surgical research projects.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to NECO and/or FedBizOpps in accordance with FAR 5.202.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from Radiometer America, Inc.

commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

Market research was conducted in the October through December 2024 timeframe. This research consisted of reviews of previous procurements for several blood gas analyzers and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, GSA Advantage, and FPDS-NG using the following search words: arterial blood gas analyzers, blood gas analyzers and ABL 90 analyzers.

Consequently, the Government’s technical experts determined that Radiometer America, Inc. is the only source that can meet the Government’s requirements. The results of the market research are attached.

9. Other facts supporting the use of other than full and open competition.

The ABL90 Flex Plus analyzer will provide useful readings under one minute that are helpful in determining the severity of damage to patients as well as provide guidance in treatment. The equipment will operate within factory specifications to maintain consistency in research data and the vendor will supply a service report detailing each preventive maintenance procedure performed, as well as service reports related to on-site service calls, as needed, upon completion of work.

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

For the reasons set forth in Paragraph 5, NMRC has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, NMRC will assess whether competition for future requirements is feasible.

The Government (or Program Office) expects to obtain a technical data package that will support competition for future acquisitions of the same or similar items.)

12. Point of Contact.

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification are the Contracting Officers in the Material Management Department (MMD) and can be reached by emailing usn.detrick.nmrc.mbx.mmd-contracts@health.mil.

mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

LCDR Jeffrey Biberston Phone Date Dept. Head, Expeditionary & Trauma Medicine

NAMRU-SA

Requirements Cognizance

HAMLIN.NICHOLAS.

JAMES.1283653362

Digitally signed by

HAMLIN.NICHOLAS.JAMES.1283653362

Date: 2025.06.06 14:19:14 -05'00' 210-539-5334 6/6/25

Nicholas J. Hamlin, CDR Phone Date Acting Commanding Officer

NAMRU-SA

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer Phone Date Naval Medical Research Command

AVID.1243008103 Date: 2025.05.19 16:28:22 -05'00'

SHARPE.DEBORA Digitally signed by

SHARPE.DEBORAH.M.123212742

H.M.1232127429 9 Date: 2025.07.14 09:01:38 -04'00'