SSJ ATTACHMENT_Redacted.pdf

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

VHAPM Part 813.106 Page 1 of 4 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

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: 36C250 23 AP 5586

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 10, Dayton VA Medical Center (CLE VAMC) Network Contracting Office

(NCO) 10.

Transaction: 552 24 2 772 0002

Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Network Contracting Office (NCO) 10 intends to award a new, firm fixed price, purchase order to Radformation, Inc., a large business, via Open Market. This request is for Radformation Software Subscription.

ESTIMATED DOLLAR VALUE:

REQUIRED DELIVERY DATE: 120 Days ARO

2. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Per FAR 11.105 Items peculiar to one manufacturer and

12.4 Unique Requirements Regarding Terms and Conditions for Commercial Items, Radformation, Inc., is uniquely qualified to provide a Radformation Software Subscription based on the following unique characteristics:

AI auto contouring including both CT and MR models;

Option for direct integration to the Eclipse Treatment Planning System through API for simple import of structures;

Ability to generate planning structures including multi step Boolean operations that can be defined within templates;

Mechanism to efficiently review generated contours that automatically scrolls through structures and sets appropriate window/leveling;

Unique contour editing tools including ability to interpolate recent edits;

History tracking of contour modifications for additional safety;

Models include a variety of nodal structures and the capability to build nodal chains/leveling within the interface on the fly; and Option for direct integration with Clear Check software.

VHAPM Part 813.106 Page 2 of 4 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

3. Description of market research conducted and results or statement why it was not conducted: Market research was conducted by the Contracting Officer and the service to identify available sources to meet the requirements as follows:

While the VetCert query indicated 630 businesses, it was determined by contacting the OEM, that they do not have any authorized distributers. Additionally, the query of the various contract databases listed above in #3, and detailed below, did not indicate there are any existing contract vehicles available to procure Radformation, Inc. products which it has been determined is what is needed to meet the requirement.

In accordance with January 9, 2023, requirement for VetCert usage, VetCert was queried, as required, using NAICS 513210. The search provided 630 results. Veteran Small Business Certification (sba.gov)

A Sources Sought, under RFI 36C25024Q1209, using NAICS 513210, was posted on SAM.gov, Contract Opportunities on September 21, 2023, with a response date of September 25, 2023. No responses were received.

The OEM, Radformation, Inc., was contacted to receive a list of authorized distributors, with a concentration on SDVOSB and VOSB authorized distributors and to determine in what country(ies) the Radformation Software Subscription is manufactured. The Radformation Software Subscription are manufactured in America. The OEM contact, Wendy Lang, stated that Radformation, Inc. is the manufacturer of the Radformation Software Subscription, and does not utilize any authorized distributors at this time.

Medical Surgical Prime Vendor (MSPV) Contracts: MSPV Generation Z v1:

https://www.va.gov/opal/sac/mspvNG.asp. The MSPV product list was reviewed to determine if these items are available through the transition distribution contracts. The equipment required by this procurement is not included in the MSPV transition distribution contracts product list. Medical/Surgical Prime Vendor (MSPV) Program Office of Procurement, Acquisition and Logistics (OPAL) (va.gov)

Small Business Administration (SBA) Dynamic Small Business Search (DSBS): A search was conducted on the SBA’s DSBS at https://web.sba.gov/pro net/search/dsp_search help.cfm?goto=Keywords in an attempt to find small business manufacturers of Radformation Software Subscription by selecting “manufacturing” in General Nature of Business and using keywords “Radformation Software Subscription” and NAICS code 513210. Two vendors: Windham Maier Operating, LTD, and Numia Medical Technology LLC for a were displayed using this search. SBA SBA Search Results These vendors did not respond to the Sources Sought posted to state if the were compatible with Alaris.

National Contracts, BPAs, and BOAs: A search the National Strategic Source Listing found at https://www.va.gov/opal/sac/index.asp. No national contracts are available for use

VHAPM Part 813.106 Page 3 of 4 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020 for this requirement. Medical/Surgical Prime Vendor (MSPV) Program Office of Procurement, Acquisition and Logistics (OPAL) (va.gov)

Interagency Contract Directory: A search of the Interagency Contract Directory tool at https://www.contractdirectory.gov/contractdirectory/ for Radformation Software Subscription resulted in no contract vehicles available that offer the required equipment. Interagency Contract Directory Portal

GSA eLibrary: https://www.gsaelibrary.gsa.gov/ElibMain/home.do: Various GSA searches did not locate a GSA Federal Supply Schedule (FSS) contract that includes the items required; therefore, GSA is not a source for this requirement. Search Results (gsaadvantage.gov)

Electronic Catalog (ECAT): https://www.medical.dla.mil/WAM/Home/consent;. A search on ECAT did not locate an ECAT contract that includes the items required;

therefore, ECAT is not a source for this requirement. DMMonline (dla.mil)

An additional search of the Category Management (CM) Quick Decisions Dashboard https://d2d.gsa.gov/report/metrics cm quick decisions dashboard was conducted using the product search tool for “Radformation Software Subscription.” There were zero “0” results. As such, there are no available category management solutions for the required equipment. Equipment Home (dla.mil)

Federal Procurement Data System (FPDS): https://www.fpds.gov. A search on FPDS, with “Radformation Software Subscription” in the search tool, located the following:

FPDS NG ezSearch – there were several results, all from Radformation, Inc.

IAWMB MemorandumM 19 13 Category Management: Making Smarter Use of Common Contract Solutions and Practices, this requirement cannot be satisfied through Best in Class contracting (BIC).

The U.S. Food & Drug Administration (FDA) tool at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151706, is not applicable to this procurement: 510(k) Premarket Notification (fda.gov)

The BAA applies to this procurement. There are no Buy American Act (BAA) issues to be concerned with, the OEM was contacted to verify if this was a domestic end product and it was confirmed that the products are, however, are also an exception being IT;

therefore, the BAA will be satisfied. There are no Trade Agreement Act (TAA) to be concerned with.

FITARA is not required.

VHAPM Part 813.106 Page 4 of 4 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

Based on the results of market research, the Government determined that this will be solicited via open Market. Additionally, based on the market research and due to the OEM not having any authorized distributors, the VA Rule of Two and SBA Rule of Two cannot be met.

4. 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.

Rachelle J. Hamer Date Contracting Officer

RACHELLE HAMER Digitally signed by RACHELLE HAMER Date: 2023.10.05 14:24:25 -04'00'