Brand Name Justification Redacted.pdf

MEMORANDUM TO THE FILE

Subj: BRAND NAME JUSTIFICATION

I. BACKGROUND:

In accordance with the Revolutionary FAR Overhaul (RFO) 12.102(a), this memorandum documents the decision and the basis for the decision to restrict competition for acquisitions valued at or below the Simplified Acquisition Threshold (SAT) through the use of brand-name descriptions without allowing for "equal" products.

II. DESCRIPTION OF ITEM OR SERVICE:

This requirement is for the procurement of a brand-name QuantStudio 5 Real-Time PCR System (96-Well 0.2 mL Block) and associated sustainment consumables to support the forward-deployed bio-surveillance mission at Naval Medical Research Unit EURAFCENT (NAMRU-EAC).

The items must be delivered to NAS II Sigonella, Italy, and include a standard 12-month manufacturer’s warranty, to include onsite support at the final delivery destination.

The total estimated value of this supply contract is .

III. BASIS FOR DECISION:

In accordance with RFO 12.102(a), the Contracting Officer has determined that a brand-name restriction to Thermo Fisher Scientific is necessary to meet the Government’s minimum mission requirements based on the following:

• This brand-name restriction is essential as it is the only method that ensures the Government receives a genuine, factory-calibrated product that meets NAMRU-EAC's stringent quality, biological safety, and performance specifications. The QuantStudio brand is uniquely required to maintain technical compatibility with existing command assets and is directly standardized with the Navy Research Lab’s (NRL) established bio-surveillance assays. The required TaqMan assays, calibration kits, and master mixes are manufactured exclusively by Thermo Fisher Scientific, creating a closed-loop system of proprietary physical dimensions and software parameters. Competing systems lack the proprietary optical sensors and calibration compatibility required to run these specific molecular assays.

• Why a “brand name or equal” purchase description cannot be used:

A "brand name or equal" description cannot be used because a different manufacturer's system would be completely incompatible with established Navy and NRL testing protocols. Introducing an alternate brand would require significant additional time and administrative delay. NAMRU-EAC would be forced to halt active bio-surveillance operations to have the competitor device approved, develop entirely new Standard Operating Procedures (SOPs), execute extensive result deviation reporting, and conduct mandatory manufacturer-specific maintenance training for laboratory personnel. This operational and validation gap would severely degrade NAMRU EURAFCENT’s mission capability at the forward-deployed lab to rapidly respond to evolving viruses that impact warfighters in Eastern Africa.

• How market research indicates other companies’ similar products cannot be modified:

Market research confirms that while other commercial manufacturers produce real-time PCR diagnostic systems, their base products lack the proprietary optical sensors required to natively read the Government's required TaqMan reagent plates. These competing systems cannot be modified or re-engineered to meet the agency’s needs without causing severe calibration errors, risking critical data corruption, and voiding the manufacturer's warranty. Therefore, only the Thermo Fisher Scientific brand can fulfill the Government's minimum mandatory requirements.

IV. COMPETITION STRATEGY:

The RFQ will be posted publicly on SAM.gov to allow any authorized distributor of Thermo Fisher Scientific products to submit a quote.

Requiring Activity

Contracting Officer

Contract Specialist