2020-36 Sole Source Justification - XTAG CF KITS - Post.pdf

Single Source Justification (Simplified Acquisition)

FOR OFFICIAL USE ONLY

November 2018 FOR OFFICIAL USE ONLY Page 1 of 2

Section A: General Contract Information

Is this a Bridge Action as defined in the AF Bridge Action Reduction Plan? Yes No

Contracting Activity: 81 CONS

Project/Program Name: XTAG CF Kits

Purchase Request / Local ID Number: FM301093310369

Estimated Contract Cost (including Options): $59,472.00

Section B: Description of the Supplies/Services Required

81st Medical Diagnostic and Therapeutic Squadron/Genetics Flight (81MDTS/SGQG) requests the sole source procurement of 30 xTAG® Cystic Fibrosis CF39v2 (Item #I027C0231) Kits. Theses reagent kits shall offer the ability to test CFTR mutations and be compatible with already owned analyzers.

Section C: Justification for Soliciting from a Single Source or Brand Name xTAG® Cystic Fibrosis In-Vitro Diagnostic (IVD) assays are designed to detect and identify the most common cystic fibrosis transmembrane conductance regulator (CFTR) mutations and variants. They offer the ability to test for the 39 CFTR mutations recommended by the American College of Medical Genetics/American College of Obstetricians and Gynecologists (ACMG/ACOG), as well as the flexibility to use an expanded panel of CF mutations to obtain broad ethnic coverage across populations. xTAG® Technology uses a proprietary universal tag system that allows easy development and optimization of nucleic acid assays. The kits are designed for use with the three existing Luminex analyzers in the lab.

Section D: Efforts to Obtain Competition

A Sources Sought was posted on 9 December 2019 and closed 16 December 2019 on beta.SAM and GSA EBuy, no responses were received on either platform. Luminex Corporation, the suggested sole source vendor, was contacted to verify if they would provide a quote in the subsequent solicitation; they have confirmed that they will. Companies including Thermo Fisher, Kerafast, and Fisher Scientific were contacted about their reagent kits;however, none were able to meet the requirement as they do not specifically analyze CFTR mutations and rather specialize in different areas as confirmed by their Government Sales Representatives.

There is no reasonable expectation that there will be two or more responsible offerors.

Section E: Steps to Preclude Future Single Source or Brand Name Awards

81 MDTS and 81 CONS will continue to review and monitor the commercial market to identify other suitable products in the event they become available.

Single Source Justification (Simplified Acquisition)

FOR OFFICIAL USE ONLY

November 2018 FOR OFFICIAL USE ONLY Page 2 of 2

Section F: Contracting Officer's Determination

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

Date Typed Name and Rank/Grade of Contracting Officer

TENISHA E. AUSTIN, 2d Lt, USAF

Signature of Contracting Officer 18 Dec 19