Attachment 1 Single Source Justification MPT to SAT_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

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

Acquisition Plan Action ID: 36C244-23-AP-1366

1. Contracting Activity: Department of Veterans Affairs, VISN 4, Wilmington VA Medical Center 1601 Kirkwood Hwy. Wilmington, DE 19805. PR: 460-23-1-3384-0058

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Wilmington VAMC has a new brand name request for the P/N 10135-000 Erbe Argon Plasma Coagulation Unit APC 3. APC is a monopolar electrosurgical procedure in which electrical energy is transferred to the target tissue using ionized and, thus, conductive argon gas (argon plasma), without the electrode coming into direct contact with the tissue. In contrast to laser technology procedures, the transfer of energy between the electrode and the tissue occurs in accordance with electrophysical laws (electrical field), and not the laws of optics. The argon plasma follows the path of least electrical resistance, regardless of whether the tissue lies directly in front of the electrode or lateral to it, and regardless of the direction of the argon gas flow. For the transfer of energy, it is important to ensure the greatest possible concentration of gas between the tip of the probe and the target tissue.

Item No. Part No. Description Qty

0001 10135-000 ERBE ARGON PLASMA COAGULATION UNIT APC 3 2

0002 20134-006 APC 2 PRESSURE REDUCER WITH SENSOR 2

0003 10160-000 ERBE VIO 3 ELECTROSURGICAL UNIT 2

0004 20180-000 VIO CART W/FOOTSWITCH HOLDER, CABLE WRAP AND 1 TANK FIXATION KIT 2

0005 20180-010 VIO CART WIRE BASKET 2

0006 20180-141 APC3 TO VIO CART FASTENING SET 2

0007 20189-353 TWO-PEDAL FOOT SWITCH; VIO 3; REMODE; BRACKET; MIDDLE PIECE 2

0008 20192-135 MONOPOLAR CABLE MO 3 PIN; OD 3MM SOCKET; L 4.5M 4

0009 20192-133 MONOPOLAR CABLE MO 3 PIN; MIS OD 4 MM; L 4.5 M 4

The estimated value of the proposed action is $

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Brand Name Erbe Argon Plasma Coagulation Unit APC 3 has improved efficiency due to the technology of the VIO Systems, the Tissue effect around 50% higher than ICC System technology when using the same output settings. High-frequency voltage increases when the output setting (i.e., wattage) is increased. High-frequency output can be adjusted to a maximum of 120 watts. Consistent firing at 30 watts or above with an application distance of up to 5 mm, the continuous application of energy. Plasma initiation and support during activation are accomplished

Last Updated: 02/01/22 Page 2 of 3 via proprietary algorithms. The application of energy with the PULSED APC Effect 1 and Effect 2 is discontinuous (i.e., pulsed) using two (2) different frequencies. The average energy output over time is the same for both modes. PULSED APC Effect 1 has a higher energy output per pulse with a longer interval between pulses (approx. 1 pulse/second). PULSED APC Effect 2 has a greater number of pulses (16 pulses/ second) with a lower energy output per pulse. Compared to FORCED APC, it has a constant high-frequency voltage over the whole setting range and consistent firing from 10 watts with application distances of up to 7 mm (distance between the probe and the tissue). This is limited due to hollow organ intervention.

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

NCO4 conducted the following market research for this acquisition:

NCO4 correspondence with the Original Equipment Manufacturer. NCO4 contacted the OEM ( ) for authorized distributors (01-24-2023). Vendor representative responded by identifying one (1) vendor: Proaim Americas, LLC (Small Business).

Previous NCO4 Market Research (Purchase Order 36C24423P0146, 12-16-2022) confirms an OEM practice of procuring Federal Government requirements through the small business vendor, -17-2022).

NCO4 acknowledges Erbe USA, Incorporated, business practice of using the small business vendor, Proaim as their sole source distributor.

System for Award Management (SAM) Contract Opportunities (CO). A Sources Sought Synopsis (36C24423Q0335) was posted from 01-17-2023 to 01-24-2023. This effort produced one (1) response: ProAim Americas, LLC (Small Business).

U.S. General Services Administration (GSA) Databases. Seeking Sources RFQ ID: RFQ1609393 was posted on GSA eBuy from 02-16-2023 to 02-21-2023. This effort produced one (1) response:

Veterans Healthcare Supply Solutions (SDVOSB) validated that they do not carry this part or service.

A keyword search of Part Number -000" in the GSA Advantage and GSA eLibrary found zero

(0) vendors.

Interagency Contract Directory Portal (ICDP); VA National Acquisition Center (NAC) Contract Catalog Search Tool (CCST); VA Supply Chain Master Catalog (SCMC). A keyword search of Part Number -000" in the ICDP, VA NAC CCST, and VA SCMC found zero (0) vendors.

(03-14-2023).

DLA Troop Support Medical Electronic Catalog (ECAT). A keyword search of Part Number - 000" in the ECAT found one (1) vendor: ProAim Americas, LLC (Small Business).

Federal Procurement Data System-Next Generation. A keyword search of the Item Description -NG found one (1) vendor: ProAim Americas, LLC (Small Business).

Last Updated: 02/01/22 Page 3 of 3

SBA Non-Manufacturer Rule (NMR) class waiver list. A keyword search of the SBA NMR class waiver list found one (1) waiver. The NMR applies as there is an existing SBA Class Waiver and the CO has no reasonable rationale to submit an individual class waiver as the VA Rule of Two has not been met.

Veterans Health Administration (VHA) Procurement Guide (PG) Nonmanufacturer Rule (NMR) Decision Tree. NCO4 used the VHAPG NMR Decision Tree and determined that the current NAICS Code with the class waiver would allow for SDVOSB/VOSB Set-Aside if and only if two SD/VOSB vendors were capable. This condition does not exist at present in the current market place.

Market Research indicates one (1) vendor: ProAim Americas, LLC (Small Business) is the only entity able to satisfy all requirements. While there is an SBA NMR class waiver, the Rule of Two has not been met. Based on the above Market Research, NCO4 recommends issuing a single source acquisition to ProAim Americas, LLC (Small Business) in accordance with FAR 13.106-1(b). This procurement is Brand Name Only and the market research is less than 12 months old.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.