One Lambda Justification and Approval_signed rev..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.

The C.W. Bill Young Marrow Donor Recruitment and Research Program is managed by the BMRD and this Navy program is responsible for recruitment, HLA+ABO typing for registration of volunteer marrow donors across the Department of Defense. Approximately 20,000 DOD potential marrow donors volunteer and register with this DoD program each year across U.S.

military installations and ships worldwide.

This Navy program has developed and supported development of much of the science and technology responsible for accurate identification of HLA genes required for transplant matching between donors and patients. This has resulted in extraordinary expansion and improvement of the science and technology of this critical set of human genes and led directly to extraordinary improvement in clinical hematopoietic transplant outcomes.

2. Nature and/or description of the action.

The proposed action is for reagents from One Lambda Inc. a part of Thermofisher Scientifc.

NMRC intends on awarding a Firm Fixed Price contract. The proposed source is One Lambda, Inc. a part of Thermofisher Scientific, 22801 Roscoe Blvd., West Hills, CA 91304-3200, USA

3. Description of Supplies or Services:

The Bone Marrow Program Directorate would like to procure reagents from One Lambda Inc., a part of Thermofisher Scientific. RSSOX2B1-LABType™ XR Class II DRB1 Locus Typing Test, RSSOX1A-LABType™ XR Class I A Locus Typing Test, and RSSOX1B-LABType™ XR Class I B Locus Typing Test.

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 6.302-1 sole source (including brand name) acquisitions or FAR 13.106-1(b)(1) soliciting from a single source.

10 U.S.C. 2304(c)(1), Only one responsible source.

FAR 13.106-1(b)(1) <$250K

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

One Lambda Inc., a part of Thermofisher Scientific is the only manufacturer of these custom kits that have been validated and utilized in the lab for HLA typing for many years.

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

This requirement will be posted to the government point of entry 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 One Lambda Inc., a part of Thermofisher Scientific 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 survey was conducted as One Lambda Inc., a part of Thermofisher Scientific is the only know vendor that makes these typing test kits.

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

This Navy program has developed and supported development of much of the science and technology responsible for accurate identification of HLA genes required for transplant matching between donors and patients through the use of these reagents from One Lambda Inc., a part of Thermofisher Scientific.

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 are feasible.

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.

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

GROGL.MAX.

1052856031

Digitally signed by

GROGL.MAX.1052856031

Date: 2024.03.21 11:45:49 -04'00'

Dr. Max Grogl Phone Date Director, Bone Marrow Program Department/Command

Requirements Cognizance

Name Phone Date Title Department/Command

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer Phone Date

SHARPE.DEBORAH.M.1232127429 Digitally signed by SHARPE.DEBORAH.M.1232127429 Date: 2024.06.07 12:02:58 -04'00' mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil