Sole Source Justification_signed.pdf

Single Source/Brand Name Justification United States Department of Agriculture

FAR 13.106-1(b)(1) – Simplified Acquisitions

1. Identification of the agency and the contracting office.

USDA APHIS

Animal and Plant Inspection Service 250 Marquette Ave., Suite 410 Minneapolis, Minnesota 55401

2. Description of supply or service required to meet the agency’s needs.

USDA proposes to enter into a firm-fixed-price contract with Scinomix Inc. using FAR Part 13 simplified acquisition procedures.

Product No. Description Unit Quantity 2000-0749 Sci-Print VXL EA 1 1061-913-000 VXL Barcode Reader Assembly EA 1 2000-616 VXi-Compatible with VXL EA 1 2000-0750 Scinomix Peri Pump EA 1 1044-500-017 Rack for 2ml cryovial (Nunc/Corning Internal Thread) EA 12 2000-181 Tubing Kit, Peristatic Pump

* This kit is compatible with the 1044-692-000 fill arm and contains all of the following:

EA 1

2000-179 - Silicone tubing, to run from source to pump AND from pump to fill arm, Qty: 1 EA

2000-206 - Plastic quick turn coupling, Qty: 1 EA 2000-207 - 18 gauge stainless steel needle with luer lock, Qty: 1 EA 2000-208 - 14 gauge stainless steel needle with luer lock, Qty: 1 EA 2000-213 - Polyproplene barbed fitting, Qty: 2 EA 2000-292 - 7 in. silicone tubing, used for transfer around pump head, Qty: 1

EA

SP-1007-S Label Kit Squix – 0.5”x1.2” Includes tube label + rubbon kits, 5,000 labels + ribbon White label with transparent patch on clear backing, no perforation 2 rolls of labels: 0.5” x 1.2”, 1.55” gap, 3” core, 2,500 L/r (2000- 1077)

Ribbon: Premium resin ribbon, 40mm x 450m, 1” ID (2000-464)

EA 1

Installation and Training (5 people will attend training) EA 1

The fully automated vial handler system is to be used for automated vial labeling, organization, and preparation for large studies to be conducted in the National Bio and Agro-defense Facility’s (NBAF) maximum containment, Biosafety Level-4 (BSL4) laboratory. This instrument will not only greatly improve efficiency with “walk-away” automation, the system will also reduce the occurrence of mislabeling and disorganization of vials which is critical to proper inventory of high-consequence pathogen samples that are covered under the Federal Select Agent Program (FSAP).

The machine will be required to provide all of the following (salient characteristics):

High throughput processing of tubes (at least 400 tubes / hour)

At least a twelve-position deck capable of accommodating up to 1200 tubes total Thermal transfer-based printing capabilities Compatibility with a variety of vial styles and manufacturers, including Matrix and Micronic 2D Capable of labeling tubes and vials ranging from 0.5 ml to 50 ml Allows for the filling of aqueous solutions and uncapping and recapping of screw top vials Utilizes a barcode scanner to read and validate work Capable of reorganization of previously labelled vials

As described above, the utility of this instrument is to minimize the hands-on time and reduce the possible of mislabeling vials to be used for studies conducted in the BSL4 laboratory, therefore the functions listed above must be fully automated and the system must be capable of validating its performance.

Due to various circumstances and capabilities of the automated tube labeling and organizing instrument (see below), the Scinomix Sci-Print VXL system with the VXi bulk tube feeder with the accessory peristaltic pump is the only instrumentation capable of fully meeting all the above needs.

3. The rationale or circumstances for limiting competition.

The Sci-Print VXL system with the VXi bulk tube feeder and accessory peristaltic pump from Scinomix is able to fulfill the functions listed above and is compatible with the National Bio and Agro-defense Facility’s (NBAF) current workflow and established infrastructure. No other known products can meet the Agency’s requirement. One of the goals of incorporation of this equipment is to reduce the possibility of mislabeling vials and tubes used in the inventory of pathogens covered under the Federal Select Agent Program (FSAP) regulations. As viruses that will be used in the BSL4 laboratory are considered threats to animal agriculture and human public health, as well as the national agriculture economy, proper maintenance of this inventory is critical. This is also a function of maintaining our registration in FSAP.

The Sci-Print VXL system with the VXi bulk tube feeder is manufactured and sold exclusively by Scinomix Inc (UEI KMW5L9T9S2N1).

4. A description of the market research conducted and the results or a statement of the reason market research was not conducted.

Market research was conducted in accordance with FAR Part 10, details of which are in the market research document in the contract file. This effort did not yield any additional sources that can meet the Government’s requirement. Other products could not utilize the required labels and did not have the required throughput and/or could not account for the variety of tube types and sizes, nor the labeling or throughput requirements.

Please refer to the above explanation. Briefly, companies offering a variety of laboratory tube handling options were evaluated for their currently available technology and their instrument capabilities for performing the aforementioned operations. The Scinomix was the only company offering instrumentation that fulfilled all requirements, therefore the Sci-Print VXL with VXi bulk feeder and accessory peristaltic pump was selected for its utility in the project.

5. Estimated price, including all options, if applicable.

The estimated total cost is below the simplified acquisition threshold.

6. Recommended source(s).

Scinomix Inc.

Certifications

Supporting data that is the responsibility of technical or requirements personnel and which form the basis for this justification are accurate and complete to the best of my knowledge.

Charles E. Lewis

The information contained in this justification is accurate and complete to the best of my knowledge and belief and in accordance with Federal Acquisition Regulation 13.106-1(b)(1), I hereby determine the circumstances described above deem only one source, or limited sources, reasonably available and competition is precluded for the reasons indicated in this document.

Lisa Draves Contracting Officer