PR 1301260872_JNA_REDACTED.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 Command (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 an annual service agreement for the maintenance of two Chronolog

Model 700-4 Lumi-Aggregometers (SN 2210032/ECN 108341 and SN 2210032-1/ECN

108342). The Government intends on awarding a Firm Fixed Price contract. The proposed source is Chrono-Log Corporation, 2 West Park Road, Havertown PA 19083.

3. Description of Supplies or Services:

The Naval Medical Research Unit San Antonio (NAMRU-SA) is conducting hemorrhage resuscitation research that requires the ability to measure platelet functionality and ATP secretion in blood samples. The requirement is for two four-channel lumi-aggregometers capable of measuring the following test applications: impedance, turbidometric, luminescence, and optical/light transmission (LTA) aggregometry. The aggregometers will have a LCD display with 24 character capability, electronically controlled heater block (37o ± 0.2oC), a nine speed stirrer (400-1200 RPMs), two dual channel modules, and has the ability to analyze up to four (4) blood specimens (whole blood, washed platelets, and platelet rich plasma). Included software program will provide real time display of the channels simultaneously with a display of up to eight (8) measurement graphs and result reporting analysis includes: maximum amplitude, slope, lag time, or area under the curve. Additionally, the equipment will include an on-site service contract to cover the warranty year plus two additional years. Service and repairs will be conducted on-site with an annual preventive maintenance and recalibration. A dual channel service loaner will be available, as well as software upgrades will be provided at no additional cost. Navy Research Fiscal Year 2025 funds in the amount of $26,450.00 will be used to procure this requirement.

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 Chrono-log Model 700 has several testing applications that are required for the laboratory to include: whole blood impedance aggregometry and luminescence, plasma optical/turbidometric/LTA aggregometry and luminescence, and washed platelet optical/turbidometric/LTA aggregometry and luminescence. Additionally, the Model 700-4 is the only four channel Lumi-Aggregometer available on the market that can simultaneously measure platelet aggregation and ATP release in up to four blood samples.

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 SAM.gov 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 the Chrono-Log Corporation’s 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 within the October – December 2024 timeframe. This research consisted of reviews of previous procurements for platelet aggregometers 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: platelet aggregometer. Consequently, the Government’s technical experts determined that Chrono-Log Corporation 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 requirement for a platelet aggregometer system that is capable of measurements with multiple methodologies (e.g. impedance, turbidometer, optical, and light transmittance) is necessary to provide a complete coagulation profile. A variety of platelet agonists (ADP, collagen, ristocetin) and antagonists (arachidonic acid) are available to utilize on this platform.

The instrument software allows users to create assay protocols configured to their unique application. Additionally, the system uses micro-samples of whole blood, which is necessary with research in smaller laboratory animals, as well as limited volumes from larger animal studies. Chronolog instruments are specific to very particular software upgrades and various parts can only be manufactured by Chronolog Corporation.

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

Jeffrey Biberston, LCDR

Dept. Head, Expeditionary & Trauma Medicine

Naval Medical Research Unit San Antonio

Phone Date

Requirements Cognizance

Nicholas J. Hamlin, CDR

Acting Commanding Officer

Naval Medical Research Unit San Antonio

Phone

210-539-5334

Date

6/6/25

CONTRACTING OFFICER CERTIFICATION

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

Phone: (301) 319-9955 Date: 6/18/2025 Contracting Officer Naval Medical Research Command

BIBERSTON.JEFFREY.DA

VID.1243008103

Digitally signed by

BIBERSTON.JEFFREY.DAVID.1243008103

Date: 2025.05.19 13:31:36 -05'00'

HAMLIN.NICHOLAS.JAM Digitally signed by

ES.1283653362

HAMLIN.NICHOLAS.JAMES.1283653362

Date: 2025.06.06 14:23:22 -05'00'