A.02. DHA JA FAR Part 13.5- RFO reference changes 7.30 - redacted HT942626PE042.pdf

CUI//PROCURE

Control Number: FY26-0564

Justification and Approval (J&A) for Other than Full and Open Competition Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) Parts 6 and 12 Implemented by Class Deviation 2026-O0017, Revision 1

1. Identification of the Agency and Contracting Activity: Defense Health Agency (DHA) Contracting Activity (DHACA), Research and Development , Contracting Division 1, Contracting Branch 1, 808 Schreider Street, Fort Detrick, MD 21702-5014.

2. Nature and/or Description of Action being Approved: This is a follow-on materiel requirement, standalone, firm fixed price (FFP), best value/sole source contract.

3. Description of Supplies/Services: The contractor shall provide all Sentosa sequencer kits, consumables, supplies, sequencing systems and sub-components, and maintenance and repair as specified in the Minimum Essential Characteristics (MECs). The human immunodeficiency virus (HIV) Diagnostics and Reference Lab (HDRL), Diagnostics and Countermeasures Branch (DCB) at the Walter Reed Army Institute of Research (WRAIR) currently utilizes the Sentosa SQ Next Generation Sequencing (NGS) system in order to perform HIV genotype testing which is critical for the monitoring of drug resistance mutations in HIV-1 infected soldiers and their beneficiaries. The Sentosa NGS system includes instrumentation and reagents required to perform the Vela Sentosa SQ HIV-1 Genotype test in a College of American Pathologist (CAP) accredited laboratory. As the system and assay is Food and Drug Administration (FDA) approved, clinical testing laboratories are required to use the instruments and reagents approved by the FDA in the execution of the test. This requirement is to establish a follow-on contract to purchase Sentosa brand sequencer kits and consumables. With the purchases of the consumables, the vendor shall provide DCB with use of Sentosa NGS systems and sub-components. In addition, the vendor shall maintain the systems to ensure instruments meet and maintain CAP standards for clinical testing operations.

Period Period of Performance Estimated Value Type of Funding Base September 30, 2026 – September 29, 2027 $383,378.38 O&M 1-year Option Period One September 30, 2027 – September 29, 2028 $394,879.73 TBD Option Period Two September 30, 2028 – September 29, 2029 $406,726.12 TBD Option Period Three September 30, 2029 – September 29, 2030 $418,927.91 TBD Option Period Four September 30, 2030 – September 29, 2031 $431,495.74 TBD Total $2,035,407.89

Source Selection Information - See FAR 2.101 and 3.104-4

1 NOV 2024

Controlled by: Defense Health Agency (DHA) Controlled by: Contracts Division 1 CUI Category(ies): Source Selection Limited Dissemination Control: FEDCON POC: Lance L. Nowell

4. Statutory Authority Permitting Other Than Full and Open Competition: The statutory authority permitting the sole source acquisition is 41 United States Code 1901 as implemented in RFO FAR 12.102(b) which states, “For acquisitions valued over the simplified acquisition threshold, prepare a written justification and obtain approval of the justification as described in 6.104.” and RFO FAR 12.201-1, “Simplified procedures” as identified in Table 12-1 in RFO FAR 12.102(b).

5. Rationale Justifying Use of Authority Cited: In accordance with RFO 6.103-1, Only one responsible source can supply the required products, and no other type of supplies or services will satisfy requirements. Vela Diagnostics is the only manufacturer of the Vela SQ Sentosa NGS system that is currently used by DCB. The manufacturer does not authorize third party vendors to retail or support their products. Further, only Sentosa brand name consumables are compatible with the Senta NGS system and are only available for procurement through the manufacturer. Searches on the FDA site show that the Vela SQ Sentosa NGS system is currently the only FDA approved vendor for HIV-1 genotype assay that is commercially available. The two other sequencing platforms listed on the FDA site have been withdrawn from the marketplace and are no longer commercially available. Other platforms are available in the marketplace; however, they are Research Use Only (RUO) products for HIV resistance research applications. RUO platforms/products cannot be used to generate clinical test results for Physicians to inform patient management. HIV-1 Genotype testing is one of several essential assays that fall under HDRL clinical diagnostic operations which are CAP accredited and require FDA approved tests for report of diagnostic test results to Physicians. The DCB currently uses Vela Sentosa products and equipment with positive experience and workflow. Therefore, Vela Diagnostics is the only responsible source that can meet this requirement.

6. Efforts to Obtain Competition: Efforts to obtain competition were not feasible, as market research revealed that only the manufacturer, Vela Diagnostics, can provide the required products that are FDA approved for clinical HIV drug resistance mutation screening. The manufacturer does authorize third party vendors to retail certain products; however, this requirement is considered a reagent rental agreement and can only be fulfilled by the manufacturer, Vela Diagnostics. A letter from Vela Diagnostics’s Associate Director of Government Sales, Ms. Keisha Shaut dated 27 July 2026 confirms this information (See Enclosure 1).

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition: The nature of this requirement is not conducive to competition due to compatibility of brand name requirement. These products are proprietary to the manufacturer’s equipment. Competition will only increase as more manufacturers and sequencing platforms become FDA approved for HIV drug resistance mutation screening.

8. Market Research: Market research was conducted January 2026. Market research indicates that HIV-1 sequencer system test kits, reagents, and consumable products are commercially available. No small business concerns were able to be located. These products are brand name specific and can only be procured through the manufacturer as they are the only manufacturer with the required FDA approval for use in clinical diagnostic laboratories. Therefore, it is recommended to procure this requirement sole source through the manufacturer Vela Diagnostics, FFP, base plus four option year contract.

2 NOV 2024

9. Other Facts:

A. Procurement History:

Contract number: W81XWH21P0202 Vendor: Vela Diagnostics USA Inc.

Contract value: $1,439,264.40 Period of Performance: 30SEP2021 – 29SEP2026 Acquisition: Sole source Scope: The Contractor shall provide Sentosa SQ Next Generation Sequencing (NGS) system, instruments, software, server, test kits, reagents, and consumables used to generate HIV-1 sequences to the protease / reverse transcriptase and integrase genes from patient specimens.

B. Is this a new requirement? No.

(1) If 9. B. is No, was the action just prior to this one competed? No.

(2) If 9. B. is Yes, what has changed where this action cannot be competed? Not applicable.

C. Additional Information: None.

10. Interested Sources: To date, only one (1) source has written to express an interest in fulfilling this requirement. Dr. Kristina K. Peachman conducted a technical evaluation of the vendor’s capabilities statement and determined that the small business was not capable of fulfilling this requirement. The results of this technical evaluation can be found in the Market Research document (See Enclosure 2)

11. 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.

Dr. Kristina K. Peachman Microbiologist, COR

DCB, WRAIR

3 NOV 2024

12. 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.

Dr. Kristina K. Peachman Microbiologist, COR

DCB, WRAIR

4 NOV 2024

13. Fair and Reasonable Cost Determination:

I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for Determination:

Lance Nowell Contracting Officer

DHACA

14. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

Digitally signed by

BENJAMIN.MICHAEL.J.10199837

EL.J.1019983737

Michael Benjamin Office of General Counsel

DHACA

Date: 2026.08.11 15:11:43 -04'00'

15. Contracting Officer Certification:

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

5 NOV 2024

BENJAMIN.MICHA

-04'00'

Review

I have reviewed this justification and find it adequate to support the sole source acquisition.

HARRIS.PATRIC Digitally signed by

HARRIS.PATRICK.K.1395451320

K.K.1395451320 Date: 2026.08.03 15:56:57

Patrick Harris Branch Chief

DHACA R&D CD1 CB1

I have reviewed this justification and find it adequate to support the sole source acquisition.

Digitally signed by

BENJAMIN.MICHAEL.J.101998373

EL.J.1019983737

Michael Benjamin Office of General Counsel

DHACA

Date: 2026.08.11 15:12:21 -04'00'

BENJAMIN.MICHA

6 NOV 2024

Approval Based on the foregoing justification, I hereby approve the procurement of Sentosa sequencer kits, consumables, supplies, sequencing systems and sub-components, and maintenance and repair on an other than full and open competition basis pursuant to the authority of RFO 12.201- 1, Simplified procedures, for acquisition described at 12.001(c), subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.

Encls

Enclosure Number Title Date

(MM/DD/YY)

Number of Pages

ENCL 1 Vela Diagnostics Third Party Vendor Letter ENCL 2 Market Research Document

7 NOV 2024

NOWELL.LANCE.L NOWELL.LANCE.LINN.10408361

Digitally signed by

INN.1040836183

-04'00'