A02 JA for Other than Full and Open Competition_Redacted.pdf

CUI

Control Number:

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), DHA Contracting Activity (DHACA), Research and Development-Contracts Group 2 in support of the Defense Centers for Public Health – Aberdeen, Laboratory Science, Emerging Biological Threats Branch.

2. Nature and/or Description of Action being Approved: This will be a Firm Fixed Price contract.

3. Description of Supplies/Services and Estimated Value: Defense Centers for Public Health – Aberdeen (DCPH-A) Emerging Biological Threats and Microbiological Analysis laboratory requires the purchase, delivery, installation, method programming, operator training and twelve

(12) month warranty of one (1) Hamilton NGS STAR automated liquid handling workstation per the Minimum Essential Characteristics (MECs), for the testing of rainwater samples which will be reported out to multiple entities in support of mission critical population-level biothreat surveillance, including FHP assets at the installation and GCC levels as well as enterprise-level programs such as the DoW Biosurveillance Program and Navy Bureau of Medicine and Surgery (BUMED). The samples are complex and require specific library kits with compatibility only to the NGS STAR. There are currently validated results that need to be run with the same piece of equipment in order to not void ongoing protocols and be able to meet mission requirements.

DELIVERY DATE ESTIMATED VALUE TYPE OF FUNDING

30 NOV 2026

4. Statutory Authority Permitting Other Than Full and Open Competition: Revolutionary FAR Overhaul (RFO) 12.102(a), For acquisitions valued at or below the simplified acquisition threshold (SAT), document the decision that only one source is available and the basis for the decision.

5. Rationale Justifying Use of Authority Cited: Based on comparative assessment of technical specifications, product sheets, and community feedback a comparison to other liquid handling instruments, particularly the Tecan Fluent 780/1080 and Beckman Coulter Biomek i7 Hybrid was done. The following summary of these findings are:

A. Proprietary Hardware: The hardware on the Hamilton NGS STAR has been designed and optimized for highly sensitive NGS library prep.

B. Proprietary Validated Protocols: The manufacturer will design and validate protocols on the NGS STAR for the Illumina Viral Surveillance Panel v2 and the QIAGEN QIAseq xHYB Viral and Bacterial Library Kit which are currently being used in our labs.

Vendor-Validated Methods

The NGS STAR comes with methods validated for the Illumina Viral Surveillance Panel v2 and the QIAGEN QIAseq xHYB Viral and Bacterial Library Kit.

Interagency Standardization

JPC, USUHS, USDA, NIH, and AFMES/AFDIL already utilize Hamilton workstations, allowing for protocol sharing and inter-agency continuity.

A. Hamilton NGS STAR Workstation:

i. Deck Specifications: Features up to 54 grid positions (deck capacity varies by configuration) that can be optimized for automated NGS layouts.

ii. Contamination Control: Utilizes proprietary CO-RE (Compressed O-Ring Expansion) technology for aerosol-free tip pickup and ejection, which is a critical safety control when handling high-consequence environmental and clinical pathogens.

iii. Software & OS: Runs on VENUS 6 software on a DoD-compliant Windows 11 operating system.

iv. Pre-validated Workflows: Fully pre-validated and vendor-supported for the key molecular chemistry currently used at DCPH-A (such as the Illumina Viral Surveillance Panel and QIAGEN QIAseq kits)

v. Dimensions: 76.0 inches (Length) x 39.8 inches (Width/Depth) x 35.6 inches (Height).

B. Tecan Fluent 1080 Workstation:

i. Deck Specifications: Features 72 deck grids accommodating up to 72 microplates

ii. Software & OS: Utilizes Fluent Control software running on Windows 11 Enterprise LTSC (which is DoD-compliant).

iii. Why the Tecan Fluent 1080 will NOT meet DCPH-A Emerging Biological Threats Branch needs:

1. Lack of VENUS Software Compatibility: Does not run VENUS software. This prevents the direct import of established, pre-coded NGS methods.

2. Extensive Protocol Re-Development Required: Transitioning to Tecan's Fluent Control software would require extensive time, labor, and budget (estimated at 12–18 months and over $250,000) to independently code, optimize, and validate all genomic library preparation protocols from scratch.

3. Incompatible Contamination Control Mechanism: The Fluent 1080 utilizes standard friction-based or liquid-system tip ejection. It lacks Hamilton's proprietary CO-RE technology, introducing an unacceptable risk of micro-aerosol generation and cross-contamination during high-throughput biological threat runs.

C. Beckman Coulter Biomek i7 Hybrid Workstation:

i. Deck Specifications: Features up to 45 deck positions in an enclosed workspace.

ii. Software & OS: Powered by icon-based Biomek software running on a Windows 10 operating system.

iii. Why the Biomek i7 Hybrid will NOT meet DCPH-A Emerging Biological Threats Branch needs:

1. Operating System is NOT DoD Compliant: The Biomek software natively relies on standard commercial Windows 10 configurations. Without an LTSC or Windows 11 platform, it fails to meet the strict DoD Risk Management Framework (RMF) STIG requirements, meaning it would be denied an Authority to Operate (ATO) on the military network.

2. Substantially Smaller Footprint: With only 45 deck positions (compared to the high-capacity, multi-tier layout options on the Hamilton platforms), it limits the integration of required on-deck accessories (such as shakers, magnetic ALPs, and thermocyclers) needed to achieve a fully automated, hands-off workflow.

3. Incompatible Software Environment: Does not support VENUS software, eliminating any ability to leverage validated, pre-programmed methods or share protocols seamlessly with other military public health labs.

D. Illumina Protein Prep Automation System (IPPAS):

i. Deck Specifications: This system is a specialized, OEM-customized version of the Tecan Fluent 780 system, custom-configured exclusively for proteomic and protein-based assays.

ii. Software & OS: Operated via the Illumina Lab Automation Software Solution

(ILASS).

iii. Why the Illumina Protein Prep Automation System will NOT meet DCPH-A Emerging Biological Threats Branch needs:

1. Incompatible Mission Chemistry: This system is specifically designed, branded, and optimized to run protein preparation assays (such as the Illumina Protein Prep/SomaSeq proteomic discovery panels). It is not configured or validated to run the multiplexed DNA/RNA library preparations required for environmental wastewater and clinical pathogen Biosurveillance.

2. Lack of General NGS Protocol Flexibility: The software (ILASS) and deck layouts are highly restricted and locked down for targeted proteomic workflows, meaning it