Single Source Justification MPT to SAT.doc

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

Attachment 1: Single Source Justification for SAP under the SAT

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: 36C250-25-AP-3539

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10 located at 260 E University Avenue, Cincinnati, OH 45219-2356, in support of VISN 10, Richard L. Roudebush (RLR) VA Medical Center (VAMC), 1481 West 10th Street, Indianapolis, IN 46202-2803. 2237 #: 583-25-3-997-0167

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The RLR VAMC Dialysis Unit currently has three (3) out of five (5) portable Reverse Osmosis (RO) Systems that have failed, significantly impacting their ability to maintain adequate dialysis treatment capacity. This new one-time request for a firm fixed price contract is to procure three (3) brand name Aqua C Uno H RO systems to replace the failed RO portable systems. Procurement of the requested equipment/services will ensure continuity of life sustaining dialysis treatments for our Veteran patients, prevent potential noncompliance with regulatory standards and procedures for water purification as mandated by the Association for the Advancement of Medical Instrumentation (AAMI), Centers for Medicare & Medicaid Services (CMS) and VA Directives. The products/services required follows.

· 24-10VA-1 - AquaC 15 Amp – Quantity of 3 Units Each

· 24-AAMI-1 - Microbiological Profile Kit(CFU and LAL) - Quantity of 3 Units Each

· 24-ACCK-0 - AquaCaddy V2 Bolt On HD Conn.Kit(Option) - Quantity of 3 Units Each

· 24-ACMF-1 - 9.75” 1 Micron Filter - Quantity of 3 Units Each

· 24-ACMF-5 - 9.75” 5 Micron Filter - Quantity of 3 Units Each

· 24-CBFC-0 - Carbon Block Filter Cartridge - Quantity of 3 Units Each

· 24-CWST-0 - City Water Sample Test NTL Equivalent - Quantity of 1 Unit Each

· 24-AC02-0 - Aqua Caddy - Dual Carbon Block - Quantity of 3 Units Each

· 24-AAMI-0 - AAMI Water Profile Kit - Quantity of 1 Unit Each

· 24-WTTS-0 - Water Treatment Test Strip Kit - Quantity of 1 Unit Each

· 24-020P-1 - CA-20P, 50% Citric Acid Rinse Solution - Quantity of 1 Unit Each

· M565911 - Extended Ring Main 2x5m - Quantity of 1 Unit Each

· 111147 - Aqua C Uno RO Install with Isopure Cart - Quantity of 3 Units Each

· Training – Initial training consisting of a minimum of twenty-four (24) hours to a maximum on forty (40) hours and one (1) follow-up training for five (5) - healthcare professionals. If additional clinical support training is needed beyond the initial training and one (1) follow-up training, then additional fees will apply. – Quantity of 1 Unit Each

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The existing water treatment setup requires augmentation with a portable RO system to support flexible, mobile dialysis operations within the RLR VAMC Dialysis Unit. The brand name Aqua C Uno H RO system, manufactured by Fresenius USA, Inc. d/b/a Fresenius Medical Care, has been evaluated and selected as the best option to meet the facility’s needs due to its reliability, portability, and compatibility with the existing unit infrastructure.

The system provides a flow rate of 120-180 L/hr, recovery of 60-75% and meets AAMI water purity standards. Each unit is portable and built on stainless steel frames with optional AquaCaddy support. The units are specifically designed for hemodialysis applications and meet the stringent water quality requirements mandated by AMMI and Centers for Medicare & Medicaid Services (CMS) standards. The Aqua C Uno System offers several critical advantages such as, portability which allows flexibility in patient care locations within the unit, high reliability and proven performance which reduces the risk of further system failures, and system compatibility with the existing dialysis infrastructure, minimizes training requirements and time required for integration. The system was found to be quieter (disturbed patients less) than the other system tested. It provided a specific disinfection protocol that supports the clinical needs. The immediate availability of the system will permit rapid replacement of the three (3) failed units and prevents interruption in patient care.

In accordance with (IAW) FAR 13.106-1(b)8.405-6, Fresenius USA, Inc. d/b/a Fresenius Medical Care is the original equipment manufacturer (OEM) and provided an email dated 06/03/2025 to confirm there are no authorized resellers for this brand name system. The OEM is the sole source provider. The VA and SBA Rules of Two cannot be obtained.

4. Description of market research conducted and results or statement why it was not conducted: Market research was initiated by the RLR VAMC Dialysis Unit Managers, inpatient nurses and Biomedical (BioMed) staff. The Unit Managers surveyed industry for market availability. Face-to-face demonstrations of the equipment were provided for clinic stakeholders by two (2) vendors ((1) Small and (1) Large Business). The demonstrations were followed by approximately an hour of questions and answers. The equipment remained at the facility to allow staff a day or two to examine the units and was then retrieved by the respective companies. The clinicians determined that the brand name Aqua C Uno H RO system provides the best options capable of meeting the facility’s needs.

Additional market research queries were conducted by the Contracting Specialist using product North American Industry Classification System (NAICS) product code 334513, keywords “reverse osmosis system”, and OEM item part numbers/descriptions to search Veteran Small Business Certification (VetCert), Small Business Administration (SBA) Dynamic Small Business Search (DSBS), Veteran Affairs (VA) National Acquisition Center (NAC) MedSurg Catalog, General Services Administration (GSA) Advantage, GSA eLibrary, Federal Procurement Data System-Next Generation (FPDS-NG) databases, and other sources.

The market research findings revealed that there are multiple business concerns, including service disabled veteran owned small businesses (SDVOSBs), veteran owned small businesses (VOSBs) and large businesses (LBs) within those search parameters; however, none were found to offer the specific brand name equipment/services required for this request. The product NAICS code is not included in the Non-Manufacturer Rule (NMR) Class Waiver.

The OEM is a large business and sole source provider of the brand name Aqua C Uno H RO System, including installation and training services. There is no reasonable expectation of receiving offers from two (2) or more responsible small businesses that are competitive in terms of fair market prices, quality and delivery. The VA and SBA Rules of Two cannot be obtained.

It is determined that a sole source open market award to the OEM will provide the best value to the Government.

Revision: 01

Effective Date: 11/15/2024 Acquisition ID #: 583-25-3-997-0167