PR 1301260876 JA_REDACTED.pdf

NAVAL MEDICAL RESEARCH UNIT SAN ANTONIO

JUSTIFICATION & APPROVAL FOR USE OF OTHER THAN FULL & OPEN COMPETITION

FY ‘25 Page1

1. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING ACTIVITY:

This Justification and Approval (J&A) is executed by the Naval Medical Research Command

(NMRC), 503 Robert Grant Avenue, Silver Spring, MD 20910, on behalf of the requesting agency, Naval Medical Research Unit San Antonio (NAMRU-SA), 3650 Chambers Pass, Building 3610, JBSA Fort Sam Houston, TX 78234.

2. NATURE/DESCRIPTION OF CONTRACT ACTION:

Approval is requested to award a contract to Haemonetics Corporation for a service agreement on three

TEG®5000 devices (SN S012007433/ECN 106850, SN S012007435/ECN 106581, and SN

S091907315/ECN 106849).

3. DESCRIPTION OF REQUIRED SUPPLIES/SERVICES:

The requirement is for a contract to provide an annual service agreement for the maintenance of three

TEG®5000 devices (SN S012007433/ECN 106850, SN S012007435/ECN 106581, and SN

S091907315/ECN 106849). The annual service agreement includes performing two on-site preventative maintenance inspections per year with parts, labor and travel expenses covered. Inspections will be scheduled and performed with customer site as required. Unlimited technical and application telephone assistance will be available 24 hours, 7 days a week to answer technical instrument, software, and reagent application questions. Unlimited on-site emergency call service with parts, labor and travel expenses covered during normal business hours (Monday thru Friday, 8:30am-5:30pm local time, excluding weekends and holidays). Contract excludes peripherals such as computer, printers, pipettes, software, etc.

Prior to entering agreement any equipment not presently under warrant or service agreement is subject to a pre-contract inspection. The period of performance for this contract is anticipated to be a base period of

12-months followed by four 12-month option periods for a total of 60 months.

4. IDENTIFICATION OF THE JUSTIFICATION RATIONALE AND/OR DEMONSTRATION

OF CONTRACTOR’S UNIQUE QUALIFICATIONS:

10 U.S.C. 2304c (1), as implemented by FAR 6.302-1; only one responsible source and no other supplies or services will satisfy agency requirements.

The reason for justification of use of the cited statutory authority is due to previous maintenance contract

(N32398-22-P-0711) meeting expectations for the TEG®5000 analyzer maintenance, the requirements for consistency in data obtained from the TEG®5000 analyzers, as well as the research capability provided by the analyzers. The TEG®5000 Thromboelastograph Hemostasis Analyzer System is technology that assesses and monitors bleeding and thrombosis in real-time blood samples. The

TEG®5000 devices located at NAMRU-SA are necessary to conduct hematological analysis of fibrinogen levels, platelet functionality, and rapid detection of clot strength impairment. Due to the demand of numerous protocols and to maintain testing ability in-house, on-site service is required for the machine to reduce interruption in experimental projects. The TEG®5000 Thromboelastograph

Hemostasis Analyzers are manufactured by Haemonetics Corporation and have been covered under a maintenance warranty since the original purchase date and NAMRU-SA wants to prevent lapse in coverage. Haemonetics Corporation is the only company that can provide the preventative maintenance due to proprietary equipment, technology, and software. Haemonetics Corporation states that third-party vendors are not authorized to perform any services and service provided by any other outside sources would void the warranty for the device.

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5. MARKET SURVEY/RESEARCH CONDUCTED:

Market research was performed by CDR Brendan O’Brien. Haemonetics Corporation is the current manufacturer of the TEG®5000 analyzer and was contacted to provide a quote to meet all requirements for on-site preventative maintenance and repair service agreement. During communication with

Haemonetics Corporation it was determined that the analyzer is proprietary property (e.g. technology, software, equipment) of Haemonetics Corporation, which means they are the only vendor capable of performing preventative maintenance for the machine. The devices have been under warranty since original purchased date and in accordance with service agreement having an outside third-party vendor perform maintenance would void an existing warranty. Therefore, Haemonetics Corporation is the sole vendor capable of fulfilling the Government’s requirement.

6. REMOVE OR OVERCOME BARRIERS TO COMPETITION:

If future requirements exist that do not require the same or similar end results, the government will solicit through full and open competition to remove barriers.

See Approvals on Next Page

FY ‘25 Page3

TECHNICAL/REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this justification and its supporting acquisition planning documents, except as noted herein are complete and accurate to the best of my knowledge and belief.

Technical Cognizance:

BIBERSTON.JEFFREY.DAVID Digitally signed by

BIBERSTON.JEFFREY.DAVID.1243008103

Date: 2025.05.14 07:52:29 -05'00'

Jeff Biberston, LCDR Date

Dept. Head, Expeditionary & Trauma Medicine

Naval Medical Research Unit San Antonio

Requirements Cognizance:

6/6/25

Nicholas J. Hamlin, CDR Date Acting Commanding Officer

Naval Medical Research Unit San Antonio

CONTRACTING OFFICER APPROVAL

6/18/2025

Contracting Officer Date

Naval Medical Research Command

HAMLIN.NICHOLAS.JAM Digitally signed by

ES.1283653362

HAMLIN.NICHOLAS.JAMES.1283653362

Date: 2025.06.06 14:28:01 -05'00'

CARTER.SHAMAI.M.162 Digitally signed by

4726649

CARTER.SHAMAI.M.1624726649

Date: 2025.06.18 11:31:43 -04'00'

.1243008103