Single_Source_Justification_-_Luminex.pdf

Single Source Justification (Simplified Acquisition)

Page 1 of 1Updated: 9 Jun 16

Section A: General Contract Information

Contracting Activity: 81 CONS/LGCB

Project/Program Name: xTAG CF Kits

Purchase Request/Identification Number: FM301090920060

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

Section B: Description of the Supplies/Services Required

81st Medical Operations Squadron/Genetics Flight (91 MDOS/SGOU) request a sole source purchase of Cystic Fibrosis (CF) Reagents (I027C0231), 30 each at $1,982.40 per kit through Luminex Corporation. These reagents come in one kit - xTAG CF 39 Kit v2 96/PK.

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 23 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 optimizations of nucleic acid assays. The kits are designed for use with the three existing Luminex analyzers in the lab. There is no other company that produces an xTAG CF Kit for use with the Luminex, nor can any other company make a CF Kit that is compatible with the pre-existing analyzer that MDOS is already using. Converting to another analyzer and using other products will cost approximately $150,000.00. If this item is not obtained, 77% of the laboratory workload will be halted, thousands of patient samples will not be tested, and outsourcing to a civilian facility would cost $3M.

Section D: Efforts to Obtain Competition

A search on Google was conducted for “Cystic Fibrosis Kits” and 4 possible vendors were found to be able to provide this item (e.g.

Luminex, Illumina, Bioo Scientific, and Hologic). However, Luminex is the only vendor that can provide the xTAG CF Kit, which is already compatible with the pre-existing analyzer that 81 MDOS already uses. It would cost approximately $150,000.00 if the lab were to use other products that would necessitate the procurement of a different gene analyzer. According to the market research, Luminex will be the only vendor that will be able to fulfill this requirement. A sole source acquisition from Luminex will be fulfilled through a firm-fixed-price purchase order.

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

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

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

05-Apr-2019

Typed Name and Rank/Grade of Contracting Officer

TIMOTHY M. THULIN, MSgt, USAF

Signature of Contracting Officer

Single Source Justification (Simplified Acquisition) Page of Updated: 9 Jun 16 Section A: General Contract Information Section B: Description of the Supplies/Services Required Section C: Justification for Soliciting from a Single Source or Brand Name Section D: Efforts to Obtain Competition Section E: Steps to Preclude Future Single Source or Brand Name Awards 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.

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