REDACTED A02-JA-Magpix.pdf

CUI

Control Number: JA26-0527

Source Selection Information - See FAR 2.101 and 3.104-4

1 OCT 2024

Justification and Approval (J&A) for Other than Full and Open Competition

Federal Acquisition Regulation (FAR) Part 6

1. Identification of the Agency and Contracting Activity: Defense Health Agency, Defense Centers for Public Health - Aberdeen Toxicology Directorate, DHA Contracting Activity

(DHACA).

2. Nature and/or Description of Action being Approved: The purpose of this requirement is for a new Firm Fixed Price contract for preventative maintenance and service with Luminex

3. Description of Supplies/Services and Estimated Value: This sole source service contract with Luminex for the preventive maintenance and service of two (2) MAGPIX RUO instruments.

Period Period of Performance or Required Delivery Date Estimated Value

Base Period 09/22/2026-09/21/2027 $13,056.00

Option Period 1 09/22/2027-09/27/2028 $13,448.00

Option Period 2 09/22/2028-09/21/2029 $13,852.00

Total $40,356.00

4. Statutory Authority Permitting Other Than Full and Open Competition: 10 United States Code (U.S.C.) 3204(a)(1) as implemented in FAR 6.103-1(b), One responsible source.

5. Demonstration that the Proposed Contractor’s Unique Qualifications or the Nature of the Acquisition Requires Using the Authority Cited: Preventive maintenance and service of two (2) MAGPIX RUO instruments is mission critical because they are used to support in vitro studies carried out by the Defense Centers for Public Health - Aberdeen Toxicology Directorate (DCPH- ATS-TOX) in support of warfighter safety and health. The MAGPIX RUO instruments are used to perform up to 50 different tests in a single reaction volume and has the ability to read a 96-well plate in 60 minutes. These instruments also allow DCPH-ATS-TOX scientists to test for 50 different analytes using smaller sample sizes. The MAGPIX instruments save significant time and labor; greatly enhancing the efficiency of the in vitro assay process, requiring smaller sample volume, testing for multiple analytes simultaneously, and providing fast and accurate results. The proper operation of these instruments is essential to provide time-sensitive data in support of studies costing tens of thousands of dollars each. Failure to maintain these instruments in correct operating condition will result in the loss of critical data, leading to mission-failure for the DCPH-A Toxicology Directorate. This contract will provide essential preventive and emergency

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maintenance service for these instruments, software updates and modifications, and telephonic and email remote support. Luminex is the sole manufacturer of xMAP instruments, including the MAGPIX RUO. As such, Luminex is the sole provider/designee for direct service on these instruments. No other organization is authorized or qualified to sell or provide direct services.

6. Efforts to Obtain Competition: A Notice of Intent to sole source was posted to SAM.gov for 15 days. No responses were received.

7. Contracting officer determination that the anticipated cost to the Government will be fair and reasonable. I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable in accordance with the Federal Acquisition Regulation (FAR) 15.404, Proposal Analysis. Techniques to be used will be comparison with the Independent Government Estimate and historical pricing on previous purchases. As part of this basis, Certified Cost and Pricing Data IS NOT required in accordance with FAR 15.403-1(b)(3).

8. Market Research: Dr. Meredith E. Bohannon, Biologist, DCPH-ATS-TOX, has been responsible for maintaining the MAGPIX RUO instruments since 2020 and is highly familiar with preventive maintenance and service requirements. Market research consisted of Dr.

Bohannon contacting Luminex representatives, who advised the Luminex Corporation is the sole manufacturer of the MAGPIX RUOs and is therefore the sole source for preventive and emergency maintenance services. This is documented in writing via the Sole Source letter from Jen Tewani, Senior Product Manager, Service, on 15 December 2025. For this reason, it is not possible to compete the current acquisition.

9. Other Facts Supporting the Use of Other than Full and Open Competition: Disapproval of this J&A will result in failure to maintain these instruments in correct operating condition. This will lead to the loss of critical data, and inability to fulfill commitments to external customers who regularly provide significant funding to the Defense Health Agency for toxicological studies, the results of which significantly contribute to the body of knowledge regarding health and readiness issues of critical import to the Department of Defense. This would cause irreparable damage to customer relationships and, consequently, mission-failure for DCPH-ATS-TOX.

10. Interested Sources: Luminex is the sole manufacturer of xMAP instruments, to include the MAGPIX RUO. As such, Luminex is the sole provider/designee for direct service on these instruments.

No other organization is authorized or qualified to sell or provide direct services.

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

FEB 2026

12. Technical Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Signature: ________________________________

Typed Name: Dr. Meredith E. Bohannon Title: Biologist

13. Requirements Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Typed Name: Dr. Michael J. Quinn Title: Director

15. Contracting Officer Certification: I certify this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Courtney A. Piar Title: Contracting Officer