S03 Brand Name Justification NuTrace Fiber Laser_Redacted.pdf

Last Updated: 02/01/22 Page 1 of 2

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C244-22-AP-6211

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 4, Commodities 1, 1601 Kirkwood Hwy, Wilmington, DE 19805 PR # 646-22-3-233-0435.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The VA Pittsburgh Healthcare System (VAPHS) Sterile Processing Service has a brand name requirement to purchase a NuTrace Model 1064nm 20W - NUX20 NG Fiber Laser; a model with customizable features needed to uniquely mark instrumentation used in various clinical areas at our facility.

VAPHS Sterile Processing Services currently does not have the ability to laser etch instruments with CensiTrac barcodes. Without the laser etching capabilities in place, Sterile Processing Service at VA Pittsburgh does not have the ability to add laser etching barcodes to instruments for tracking. This decreases visibility and traceability of instruments in surgical trays; and can cause surgical delays and lead to instrument trays not being available for surgery. In addition, having access to laser etching capabilities at VA Pittsburgh Healthcare System will place Sterile Process Service on a path of 100% instrument traceability and accountability to support the VA mission of providing quality care to our Veterans. This is a new requirement for a NuTrace Fiber Laser as follows: 1.) NuTrace Fiber Laser 1064nm 20W NUX20 NG (Qty. 1); 2.) NuTrace 2 Tier Services (Qty. 3); 3.) FREIGHT for Materials (QTY. 1) The estimated total cost of this requirement is $ .

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: NuTrace Fiber Laser 1064nm 20W - NUX20 NG. This specific Model 1064nm 20W - NUX20 NG Fiber Laser is unique because it has customizable features needed to uniquely mark instrumentation used in various clinical areas at our facility.

1. The brand model must have the capacity of being able to laser etch titanium, stainless steel, bronze, aluminum, anodized aluminum, anodized titanium, hard plastics, glass and more The Model 1064nm 20W - NUX20 NG Fiber Laser workstation must be compact in design for bench-top operation minimal workspace needed.

2. Fast and precise electric Z-axis for easy focusing.

3. Fume extraction port and laser protection class must be CDRH class 1 per the VAPHS Laser

Committee for safe operation. O.D 5+ protection glass. This device has already been approved for use by the laser committee.

4. Configuration must comply with the 21CFR1040.10 -1040.11.

5. This brand model has approval from the VAPHS Laser Safety Officer.

4. Description of market research conducted and results or statement why it was not conducted:

Market research was conducted by searching GSA Advantage, SAC contracts, SCMC, MEDPDB, and ECAT as well as FPDS and SAM. The Contract Specialist contacted the Original Equipment Manufacturer (OEM) and found the following sources/authorized distributors: Promedical Inc DBA NuTrace (OEM; Small Business), Martin AIJS, LLC (SDVOSB), and National Advanced Endoscopy Devices, Inc. (WOSB).