BRAND NAME JUSTIFICATION AND APPROVAL.pdf

BRAND NAME JUSTIFICATION AND APPROVAL

(Simplified Acquisition Procedures less than the SAT)

Purchase Request Number: N6809620SBC101

1. Requesting Department:

USNH Laboratory

2. Description of Action being Approved:

Brand Name procurement for BIOFIRE Panels and Maine Mollecular QC Materials

3. Description of Product, Supplies or Services required to meet the Department's needs:

BioFire RP2.1 Panel (30 Tests), Product Code: 423738; BioFire Blood Culture Identification 2

(BCID2) Panel (30 Tests), Product Code: RFIT-ASY-0147; FilmArray BCID2 Control Panel 6P/6N, Product Code M416. RP2.1/RP2.1 Plus Control Panel Prodict Code M441

Estimated Cost $270,862.55

4. Identity the authority permitting other than full and open competition. (Requesting Office completes with assistance or Contract Specialist).

FAR 13.106-1(b)(1)(i) states for purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization).

5. Justification Rational:

The Biofire Film Array Torch is proprietary property of the Biofire Co. and the materials used to run testing must be CLIA approved – CLIA regulations require a laboratory to have quality control (QC) procedures to monitor the accuracy and precision of the complete testing process. The QC Materials must be compatible to BioFires indicated panels. Maine Moleculars FilmArray BCID2 Control panels are the only QC materials compatible to The Biofire BCID2 Panels. Essentially, the BioFire

RP2.1/RP2.1 plus control panels are the only materials compatible to BioFire RP2.1.

Based on the information provided above, BioFire’s Filmarray panels must be quality controlled by

Maine Mollecular’s QC items in order to complete the testing process. There are no other QC items available in the market (CLIA approved) that are compatible. See Technical note attached from BioFire

Diagnostics LLC.

The Lab is in need of Both BioFire and Maine Molecullar brands as they work hand in hand. The tests will not be validated without the other.

Best Value Determination

An order or contract issued under this brand name justification represents the best value as the agreed to prices will be based upon either (I) competitive quotations or offers from authorized suppliers of the brand name product in a competitive environment, (2) a comparison of the prices received with past prices. Or (3) the results of the market research. Therefore, the price paid, in conjunction with the solicitation’s non-price evaluation factors and significant sub-factors that establish the requirements of acceptability for the product will represent the most advantageous offer and provide the greatest overall benefit in response to the requirement.

6. Market Research Conducted:

Conducted an extensive search on the web and determined that there is no other brand that is compatible to the existing machines used for testing. The requested test kits are exclusive and hold proprietary data.

The technical note provided by BioFire states the type of quality control material needed for the type of testing. Although this is a brand name procurement there are limited sources that are able to provide the Brand name items.

7. Statement of actions, if any to remove barriers to competition in the future. How will you ensure these requirement will be open to other potential sources in the future?

For future requirements of this type, we will once again conduct extensive market research to try to locate competition on our requirement / or post a sources sought notice.

I have determined, in accordance with FAR 13.106-1(b)(1), that the circumstances of this contract action deem only a brand name is reasonably available.

As the technical or requirement personnel, I certify that the evidence of the supporting data that forms the basis of this justification is complete and accurate.

Technical/Requirements Personnel Printed Name Date

Contracting Officer Date