BNJ - Quantra QPlus___Redacted.pdf

Single Source Justification (Simplified Acquisition)

FOR OFFICIAL USE ONLY

March 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: 1st Special Operations Contracting Squadron/PKC

Project/Program Name: Quantra QPlus - System for the evaluation of blood coagulation

Purchase Request/Identification Number: F2FF110027AW01

Estimated Contract Cost (including Options)

Section B: Description of the Supplies/Services Required

HQ AFSOC/SGR requires a fully automated hemeostasis system for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in cardiovascular and major orthopedic surgeries before, during, and following the procedure. Design must operate at the point-of-care and in critical care environments by non-laboratory personnel.

- Sample processing time of less than one (1) minute

- Viscoelastic results achieved in less than 15 minutes

- Room Temperature Cartridges

- Point-of-care to evaluate the viscoelastic properties of whole blood by means of the following functional parameters: Clot Time

(CT), Clot Time with Heparinase (CTH), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS), and Clot Time Ratio (CTR).

- Ultrasound technology that does not require moving mechanical parts or direct contact with the sample.

The following equipment is required to meet the HQ AFSOC/SGR needs: Quantra QPlus CLIN 0001 - Quantra QPlus (QTY - 1 Each)

The estimated delivery is 60 days after receipt of contract award.

Section C: Justification for Soliciting from a Single Source or Brand Name

The supplies required by HQ AFSOC/SGR demonstrates a unique and innovative concept not yet available from multiple manufacturers. The Quantra QPlus is the only Viscoelastic test on the market that has been FDA reviewed for use at point of care.

Furthermore, the Quantra QPlus was awarded a de novo classification.

The Quantra QPlus System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, and Quantra Quality Controls Level 1 and 2. The Quantra QPlus System is intended for in vitro diagnostic use. The Analyzer evaluates the hemostatic state of a blood sample. The Analyzer uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry to measure the shear modulus of whole blood during coagulation. The Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation state of a 3.2% citrated venous whole blood sample. The QPlus Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes tests with a heparin neutralizer.

The Quantra QPlus System is an in vitro diagnostic device designed to assess a patient's coagulation status by measuring the shear modulus of a blood sample during clot formation in perioperative settings in the point of care (POC) or clinical laboratory settings.

System directly measures the shear modulus and the elasti properties of the clot and therefore can correctly quantify the contribution platelets to clot stiffness. The Quantra Hemostasis Analyzer is the only fully integrated and automated in vitro diagnostic device designed to assess a patient's coagulation status by measuring the viscoelastic properties of a blood sample during clot formation. The analyzer consists of a base instrument with a software component. The instrument and the software are a closed system, using only Quantra assay cartridges.

The QPlus Cartridge is a single-use four-channel plastic cartridge which has a sample port on one end to draw the blood sample into the cartridge without requiring any sample pipetting. Lyophilized reagents are embedded into the four channels within the cartridge. The four channels enable four independent reactions/tests to be run simultaneously.

Single Source Justification (Simplified Acquisition)

FOR OFFICIAL USE ONLY

March 2018 FOR OFFICIAL USE ONLY Page 2 of 2

The analyzer displays the test results in three different views: dial display screen, stiffness curves, and trend data. The dial display screen is the primary viewing screen and has a dial for each of the six output parameters (Clot Time, Clot Time with Heparinase, Clot Stiffness, Fibrinogen Contribution to Clot Stiffness, Clot Time Ratio, and Platelet Contribution to Clot Stiffness). Each dial shows the reference range, assay measurement range, parameter abbreviation, and the numerical result for the corresponding parameter.

Section D: Efforts to Obtain Competition

A sources sought notice was published on 3 February 2020 through 12 February 2020 for market research purposes. A total of three (3) responses/capability statements were received from No pre-existing Federal Government contract vehicles are available to support this effort. The following companies' websites were used to conduct market research: All of the aforementioned companies mentioned provide hemostasis analyzer systems. However, only one company can provide a system that meets AFSOC/SGR's minimum needs. Furthermore, the required brand name system received a de novo classification and has been FDA reviewed for use at point-of-care.

The brand name items requested are manufactured by a small business. Market research shows there are at least three (3) authorized small business distributors/resellers of the requested items. There is a reasonable expectation of receiving competitive offers from two (2) or more small businesses in terms of fair market price, quality, and delivery. This acquisition shall be solicited as a 100% small business set-aside.

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

Through multiple means, HQ AFSOC/SGR will continue to monitor market information/sources and technical publications to determine whether other sources can meet their requirements. Currently, the Quantra QPlus System (Quantra Hemostasis Analyzer, QPlus Cartridge, and Quantra Quality Controls Level 1 and 2) has been cleared through the FDA de novo process and for use at point-of-care.

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.