SOLE SOURCE JUSTIFICATION.pdf

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J065--Tablo New Service Contract (VA-22-00003265) NY Harbor
Solicitation number
36C24222Q0040
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This document is a sole source justification for a service maintenance contract for Tablo Hemodialysis Systems across multiple VA medical centers in New York and New Jersey. The contract was awarded non-competitively to SDV Office Systems, LLC as the sole authorized distributor and service provider for Outset Medical, the original equipment manufacturer. The base period is effective from December 2021 through November 2022 with an estimated value of $134,167. The total estimated contract value including all option years is $694,167. The justification cites authority under the VAAR to make noncompetitive awards to verified service-disabled veteran-owned small businesses. Market research found no other qualified providers. The related federal contract opportunity notice shows contract 36C24222P0225 was awarded to SDV Office Systems, LLC on December 9, 2021 for the base year amount.

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Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format >SAT

VHAPM Part 819.7007/7008 Page 1 of 3 Original Date: 08/30/2017 Revision 03 Eff Date: 04/03/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-21-AP-2383

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Network

Contracting Office 02. This procurement supports the following VA VISN 02 facilities:

VAMC Syracuse 800 Irving Ave Syracuse, NY 13210 528-22-1-7803-0017

VAMC Albany 113 Holland Ave Albany, NY 12208 528-22-1-8803-0021

VAMC Brooklyn 800 Poly Pl.

Brooklyn, NY 11209 630-22-1-4454-0001

VAMC Manhattan 423 E 23rd St.

New York, NY 10010 630-22-1-4454-0001

VAMC New Jersey 385 Tremont Ave.

East Orange, NJ 07018 561-22-1-668-0014

VAMC Northport 79 Middleville Road Northport, NY 11768

2. Nature and/or Description of the Action Being Processed:

VHA Network Contract Office 02 intends to award a multi-site contract to SDV Office Systems, LLC, who is the sole authorized distributor for Outset Medical and sole manufacturer of Tablo Dialysis systems.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The included sites require a service maintenance contract to provide repairs, tools, and preventative maintenance for Outset

VHAPM Part 819.7007/7008 Page 2 of 3

Revision 03 Eff Date: 04/03/2020

Tablo Hemodialysis Systems with an anticipated period of performance of a one-year base period and four option years. The base period will be effective from 12/01/2021 to 11/01/2022.

The estimated value of the base year is $134,167. The total estimated value of the base and all options is $694,167.00.

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S.

Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7007 or 819.7008 up to $5,000,000. Check the specific VAAR clause used below:

(X ) 819.7007 Sole source awards to a verified service-disabled veteran-owned small business; or ( ) 819.7008 Sole source awards to a verified veteran-owned small business

5. Demonstration that the Contractor’s Unique Qualifications and/or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The original equipment manufacturer, Outset Medical, provided documentation indicating that SDV Office Systems, LLC (DBA SDV Medical) is the only source authorized to provide repairs on their devices. Being the sole authorized source, SDV Medical is the only vendor that can meet the needs of this requirement.

The authority at VAAR 819.7007 allows sole source awards to SDVOSB based on 38 U.S.C. 8127(c) and this SDVOSB concern has been determined to be a responsible source with respect to performance.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by subpart

5.2 and, if not, which exception under 5.202 applies:

A public notice of the VA’s intent to negotiate with a sole source was posted to SAM from October 8, 2021 until October 20, 2021. No additional sources responded to this notice.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

The Contracting Officer has determined that this Sole Source, Firm-Fixed-Price Purchase Order is fair and reasonable based on both the validity of the comparison and the price reasonableness of previous award prices, market research, and the Independent Government Cost Estimate as documented in the contract file.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Searches conducted using VIP and SBA’s DSBS using keyword “tablo” and NAICS 811219 returned no results. GSA eLibrary showed one vendor, Divine Imaging Inc., who offer products and services related to Tablo HDTV DVR devices rather than the Tablo Hemodialysis System. They cannot perform the required services.

https://www.acquisition.gov/content/part-5-publicizing-contract-actions

VHAPM Part 819.7007/7008 Page 3 of 3

Revision 03 Eff Date: 04/03/2020

The Contracting Officer met with the OEM, Outset Medical, who indicated that service agreements are to be handled by their authorized distributor. SDV Office Systems, LLC is the only vendor uncovered during market research that can provide the needed service.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: SDV Office Systems, LLC DBA SDV Medical Services, 26 Macallan Ln, Asheville, NC 28805

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

The VA will continue to conduct robust market research to ensure similar actions are awarded competitively whenever possible.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Troy Kozlowski Date Biomedical Engineer

COR

NYHHCS

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Joseph Cellino Date Contracting Officer

NCO 02

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Rachel Beason Branch Chief Date NCO 02 Services II https://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx

2021-11-30T17:00:41-0500
TROY KOZLOWSKI 3487739
2021-12-03T15:24:21-0500
Joseph R. Cellino 391287
2021-12-03T15:37:25-0500
Rachel A. Beason 966443

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