P03 Part 806.3 Atch7 FAR6 JA OVER SAT signed all.pdf

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Attached to
J046--P/M Service for Dialysis Reverse Osmosis System Federal contract opportunity
Solicitation number
36C24122Q1209
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 1

About this file

This document contains a justification and approval for other than full and open competition for a federal contract. The Department of Veterans Affairs intends to award a sole source contract to Evoqua Water Technologies LLC to provide preventative maintenance and service calls for a reverse osmosis water treatment system located at the Connecticut Healthcare System West Haven Veterans Medical Center. Evoqua is the original equipment manufacturer and sole authorized provider for parts, service, and maintenance of the proprietary reverse osmosis machine, which is a medical device that has received FDA clearance. The base period of performance is one year with potential option years to be exercised at the government's discretion.

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36C24122P1403_1.docx DOCX document
Letter Sole Source_CWP_3Jan22.pdf PDF

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Part 806.3 Other Than Full and Open Competition (OFOC) Attachment 7: Request for Sole Source Justification Format >SAT

Rev: 13 Effective Date: 02/01/22 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C241-22-AP-3212

1. Contracting Activity:

Department of Veterans Affairs, VISN 01, VA Connecticut Medical System Facilities Management Service. The Dialysis reverse osmosis equipment requires preventative maintenance service for the

CT HCS.

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

VA Connecticut is seeking to acquire preventative maintenance service for very critical reverse osmosis water treatment equipment. Evoqua Water Technologies, LLC having acquired the Mar Cor Purification, Inc. business on January 2, 2022, is a medical device manufacturer and the sole source provider of the CWP 100 H/S unit and its replacement components for the United States of America.

The CWP 100 H/S unit is a Reverse Osmosis (RO) machine identified as a medical device and has an FDA 510(k) clearance. It is exclusively designed to make hemodialysis water quality that meets ANSI/AAMI standards.

3. Description of Supplies/Services :

The purpose of this contract is to provide preventative maintenance and service calls for the reverse osmosis system located within Dialysis. The contract shall be awarded for a base year (12 months) and a potential of four (4) annual option years to be exercised at the discretion of the Government.

4. Statutory Authority Permitting Other than Full and Open Competition:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

Rev: 13 Effective Date: 02/01/22 Page 2 of 3

5. Demonstration that the C Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Evoqua is the only company authorized to perform the work needed on this specific brand of equipment. No other company or business has been given the authority or position to perform and provide technical support both in the field and/or through telecommunications. Evoqua is the only authorized/certified provider for disinfection and preventative maintenance services on this equipment. If CWP 100 H/S unit parts and consumables are not purchased through a sole source, it would adulterate the medical device clearance, make null and void all applicable warranties, and place unnecessary risk by using non-conforming components. Procuring CWP 100 H/S devices, parts, consumables, and services from Evoqua Water Technologies saves you time and money by offering reliable, safe, and effective equipment and by providing single-source management and delivery, all while insuring you maintain compliance.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

The Contracting Officer verified several sites to see if other vendors could provide this service, among those were GSA, Vet Biz, SBA, and Sam.gov. A Sources Sought was released in which no vendors illustrated they could provide this service. To ensure this was fact, the CO requested and received a sole source letter from Evoqua (attached in the 2268 package).

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

Reasonable:

In this sole source environment, there were several alterations made to the performance work statement that ultimately saved the Government significant amounts of money while simultaneously providing us with the essential services required for this system. These updates reduced the overall contract value substantially, resulting in an overall total contract value of $483,669.43, while the Government IGCE was established at $1,824,769.60.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Substantial market research was completed for this acquisition. Market research was conducted in VetBiz for any Veteran Owned business with the capability of performing the requested services.

Using NAICS code 811219 with keywords Reverse osmosis equipment maintenance service, no potential vendors were located. DSBS searches using NAICS 811219 returned no vendors. A GSA Search illustrated no results.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

See Above

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

EVOQUA WATER TECHNOLOGIES LLC

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 Contracting Officer will continue to perform annual market research to ensure the price continues to be fair and reasonable, to see if any apples-to-apples comparisons can be made, and to determine if there are in fact other vendors who could potentially provide this service for future

Rev: 13 Effective Date: 02/01/22 Page 3 of 3 contracts. Given the fact that this service is considered proprietary in nature, it is highly unlikely at this point.

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.

Name Kyrston Brooks Date Title Engineer Facility CT HCS West Haven VAMC

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

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

Name Craig Harris Date Title Contracting Officer, Commercial Team 2 Facility NCO 1

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

Name Joshua Davis Date NCO 1 Duty Title Supervisory Contracting Officer

Facility NCO 1

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