P03_RFO 12_JA OVER SAT_SAP Restricting Comp SP mjc_BC signed.pdf

Acquisition Plan # 36C241-27-AP-0418

DEPARTMENT OF VETERANS AFFAIRS

RESTRICTING COMPETITION USING SIMPLIFIED PROCEDURES

FOR COMMERCIAL ITEMS IN ACCORDANCE WITH RFO 12.102

Acquisition Plan Action ID: 36C241-27-AP-0418

1. Contracting Activity: Department of Veterans Affairs, VISN 01, NCO 1 on behalf of Boston

Healthcare Medical Center to include West Roxbury, 1400 VFW Parkway, West Roxbury, MA, and Jamaica Plain, 150 South Huntington Avenue, Boston, MA.

2237: 523-27-1-7441-0004

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

This procurement is for a new contract consisting of a base year and four option years to provide preventive maintenance, parts replacement, and water quality testing for the reverse osmosis (RO) water purification systems installed at VA Jamaica Plain and VA West Roxbury. The action establishes a long-term service agreement to ensure these FDA-cleared medical water systems remain fully operational, compliant with required dialysis water quality standards, and supported by OEM-certified technicians. The contract will furnish all necessary labor, materials, replacement components, and technical services needed to sustain uninterrupted operation of the RO systems throughout the period of performance.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The Department of Veterans Affairs requires comprehensive preventative maintenance, water testing, replacement parts, and ongoing technical support for the reverse osmosis (RO) water purification systems located at VA Jamaica Plain and VA West Roxbury. To ensure compliance with all applicable federal regulations governing dialysis water quality, the Contractor shall provide certified Field Service Agents, labor, tools, materials, OEM-approved parts, and monthly service visits needed to maintain continuous, safe operation of both the CWP 102H Central Heat Disinfect RO system at Jamaica Plain and multiple MHX Portable Heat Disinfect RO units at West Roxbury.

Services include monthly and quarterly inspection and cleaning of RO membranes, chemical disinfection, feed water chemistry testing, carbon block filter replacement, pretreatment system inspections, performance reviews, and documentation of all maintenance and system readings.

Preventive maintenance kits, test strips, cleaning agents, emergency service support, equipment calibration, system troubleshooting, and required reporting are also included. These supplies and services are essential to ensure uninterrupted delivery of AAMI-compliant water for patient dialysis operations and to mitigate risk associated with equipment failure, water contamination, or lack of regulatory compliance.

Estimated Value: $805,977.44

4. Statutory Authority Permitting Restricted Competition:

RFO 12.102 Restricting Competition. The statutory authority for applying the Simplified Acquisition Procedures is 41 U.S.C. § 1901 and is implemented by RFO 12.102(b) for Restricting Competition using Simplified Acquisition Procedures for Commercial Products and Services. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency

Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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

Evoqua Water Technologies, LLC is the original equipment manufacturer (OEM) and sole source provider of the CWP-100H/S reverse osmosis (RO) medical water purification system used within VA dialysis operations. The CWP-100H/S is an FDA-cleared medical device under 510(k) requirements and is engineered specifically to produce hemodialysis-grade water compliant with ANSI/AAMI standards. As the OEM, Evoqua is the only entity authorized and certified to perform required preventative maintenance, chemical disinfection, system cleaning, calibration, emergency support, and technical troubleshooting for this equipment. No third-party vendors are trained, certified, or permitted to service this device, nor can they provide the proprietary parts, consumables, software, or documentation necessary to maintain regulatory compliance.

Use of non-OEM parts, filters, chemicals, or service providers would compromise FDA medical device clearance, invalidate warranties, and create unacceptable risk to patient safety due to potential water quality failure or inability to meet ANSI/AAMI dialysis standards. Additionally, Evoqua retains exclusive control of all maintenance protocols, replacement components, technical specifications, and diagnostic procedures for the CWP-100H/S system. Because these items are not distributed to any other vendor or reseller, only Evoqua can provide the full scope of support required to ensure safe, reliable, and compliant operation of the RO systems installed at VA facilities.

Given these unique OEM qualifications, technical requirements, and regulatory constraints, only Evoqua Water Technologies can meet the Government’s minimum needs. Therefore, use of the cited sole-source authority is fully justified and essential to protect patient safety and maintain compliance with federal medical device standards. A sole source letter was provided and on file.

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

In accordance with VA market research requirements and established NCO 1 procurement practices, the Contracting Office undertook all reasonable steps to identify potential sources prior to confirming the proprietary nature of this acquisition. As part of these efforts, the Contracting Officer reviewed prior procurement history for the CWP 100H/S medical water purification system and verified that Evoqua Water Technologies is the sole OEM-authorized provider of all required parts, consumables, and maintenance services.

Additionally, NCO 1 reviewed available government databases consistent with typical VA market research practice—such as VetCert, DSBS, FPDS, GSA eLibrary, NAC, and HTME—to determine whether any alternative vendors were capable of providing OEM-certified services. Similar to prior sole-source reviews documented within the organization, these searches confirmed that no other vendors are approved, trained, or permitted to service Evoqua’s FDA-cleared RO medical devices or supply compliant replacement components.

Furthermore, an intent to sole source was posted to Sam.gov to confirm market research and no responsible offers were submitted for consideration to date.

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

The Contracting Officer has determined that the anticipated cost to the Government is fair and reasonable based on a comparison of the contractor’s proposed pricing to prices previously paid for similar preventative maintenance and service agreements for Evoqua water purification systems at VA facilities. Historical pricing reflects consistent cost patterns for equivalent equipment, scope, service frequency, and OEM-required tasks, and the current proposal aligns with these established amounts aside from routine increases associated with labor, materials, and inflation. Because Evoqua is the sole OEM-authorized provider of certified maintenance, disinfection, replacement components, and technical support for the CWP 100H/S system, no competitive market exists for alternative price comparison. As a result, evaluation against previously awarded purchase orders and prior year service proposals is the most reliable method for assessing price reasonableness.

Based on this comparison, the proposed pricing is considered fair, reasonable, and in line with historical OEM costs.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: A search on SBA with NAICS 811210 and keywords “Mar Cor” and “Evoqua” had 0 results. A search on GSA Advantage with keywords “reverse osmosis service,” “Evoqua Water Technologies,” and “Mar Cor,” did not yield any relevant results. AddsUp was then searched with keywords “reverse osmosis service,” and another previous procurement was identified with the OEM Evoqua Water Technologies on a sole source basis; 36C24122P1403 awarded as a base plus four (4) year option contract on 9/27/22. Also, an intent to sole source was posted to Sam.gov, 36C24126Q0856. No offers were submitted for consideration confirming market research conducted.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Evoqua Water Technologies technicians hold active government contractor PIV credentials, allowing them to perform after-hours service without being escorted. This is essential, as most maintenance occurs outside of normal business hours.

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: At this time, no actions are planned to remove or overcome any barriers to competition as this equipment may only be serviced by the OEM throughout the equipment’s lifecycle which is expected to continue for the next five years. The CO 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. 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.

Siva Prakash Date Supervisor HTM VAMC Boston

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.

Date

Contracting Officer VHA NCO 1 RPO East

b. One Level Above the Contracting Officer (Required over $350K but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Sheryl Anthony Date Brand Chief VHA NCO 1 RPO East

SIVA

PRAKASH

Digitally signed by

SIVA PRAKASH

Date: 2026.09.28 14:36:45 -04'00'

MANASES CABRERA

Digitally signed by MANASES

CABRERA

Date: 2026.09.28 14:50:05 -04'00'

SHERYL ANTHONY

Digitally signed by SHERYL

ANTHONY

Date: 2026.09.28 15:11:58 -04'00'

14550 28th Ave North Plymouth, MN 55447 USA

Tel: (800) 633-3080 Fax: (763) 210-3868

January 8, 2026

Re: Sole Source Justification for the CWP 100 H/S Central Water Plant

To Whom It May Concern, Evoqua Water Technologies, LLC having acquired the Mar Cor Purification, Inc. business, 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.

The CWP 100 H/S is not marketed through distribution channels or through OEMs, but sold directly to dialysis providers within hospitals, free-standing clinics, at-home providers, and other institutions that deliver hemodialysis therapies. These units are completely assembled and thoroughly tested in our ISO 13485 compliant, and FDA registered medical device manufacturing facility in Plymouth, Minnesota.

Our company provides installation, onsite product orientation, documented protocols, regional field service technicians, preventative maintenance programs, on-call technical support, user training programs, and a complete line of consumables and spare parts. 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.

If you have any other questions, please contact us at 800-633-3080.

Sincerely, Michael Verguldi Sr. Product Manager