6515--Intent to Sole Source: Portable Reverse Osmosis Water Purification System for the James J. Peters VAMC.

Notice of intent to award a sole source contract to Fresenius USA Marketing, Inc. via SAC mandatory national contract no. 36C10G22D0012.

SOL: 36C24226Q0751

DUE: 07/03/2026

SET ASIDE: N/A

NAICS: 334516

POP STATE: 30 Days ARO

AGENCY: Department of Veterans Affairs; VA Healthcare System, 130 West Kingsbridge Road, Bronx, NY 10468.

Email: Jonatan.rondon@va.gov

The Department of Veterans Affairs, Margaret Cochran Corbin VA Campus, intends to award a one-time firm fixed-price, sole source contract to Fresenius USA Marketing, Inc. the authority of Federal Acquisition Regulation (FAR) 13.106-1(b) (1)(ii) to Fresenius USA Marketing, Inc. located at 920 Winter Street

Waltham, MA 02451 for their Portable Reverse Osmosis Water Purification System.

Background

This Statement of Work (SOW) establishes the requirements for the one-time procurement of four (4) brand name only AquaC 20 Amp portable reverse osmosis (RO) water purification systems with AAMI Water Profile Kit. The systems are required to support hemodialysis operations and to ensure a safe, AAMI-compliant water supply for patient care. The current portables require immediate replacement due to frequent, high-level bacterial contamination. Despite rigorous, in-depth disinfection and ongoing maintenance, the units advanced age and deterioration prevent effective sanitization.

Scope

Purchase of AquaC UNO RO 20 amp water purification system which includes equipment installation and training

Specific Tasks

The contractor shall furnish and deliver the following equipment:

Four (4) AquaC 20 Amp Portable Reverse Osmosis Systems (Product No. 24-0970-1)

Four (4) AAMI Water Profile Kits (Product No. 24-AAMI-0)

The contractor shall provide complete installation of all four (4) AquaC RO units, including mounting on existing Marcor carts, plumbing connections, and system commissioning.

The contractor shall provide on-site or training-center technical training for Medical Center clinical staff in accordance with the following parameters:

Service: AquaC System Tech Training at Training Center (Product No. 111122)

Initial training shall consist of a minimum of twenty-four (24) hours, not to exceed forty (40) hours, for up to five (5) healthcare professionals.

One (1) follow-up training session is included within the contract price.

Training must be initiated within thirty (30) calendar days after system installation; the follow-up training must be initiated within ninety (90) calendar days after installation. Failure to initiate within these windows shall result in expiration of included training, and additional fees will apply.

Additional attendees beyond five (5) and any additional training beyond initial plus one follow-up session are not included in this SOW and will incur additional charges.

AquaC Salient Characteristics:

System Type

Portable, single-patient reverse osmosis (RO) water purification system

Configuration

Modular cart-mounted unit; compact design for bedside/in-unit placement

Height

500 mm (1.64 ft) unit only, excluding cart

Width

520 mm (1.71 ft)

Depth

195 mm (0.64 ft)

Weight (Empty)

Approximately 35 kg (77.2 lb)

Weight (Full)

Approximately 37.5 kg (82.7 lb)

Cart Compatibility

Must be compatible with Marcor cart platform; designed for mounting on AquaC Cart US option

Portability

Must be cart-mounted and portable within the clinical environment; no permanent plumbing required

Water Quality Standard

Must meet or exceed ANSI/AAMI RD52 hemodialysis water quality standards for bacteria, endotoxins, and chemical contaminants

Permeate Output

Minimum 85 L/h (±10%) at 15°C (59°F) water inlet temperature

Bacterial / Endotoxin Rejection

Greater than 99% rejection rate for bacteria and endotoxins

Dissolved Salt Rejection

Greater than 96% average rejection rate for dissolved salts

Membrane Type

Spirally-wound RO membrane

Yield (Low Hardness)

Up to 70% at feed water hardness 17.8 ppm CaCO3)

Concentrate Pressure (Max)

Maximum 290.1 psi

Noise Level (SUPPLY mode)

44 46 dB(A) measured at 1 meter distance

Permeate Output (Disinfection)

12 L/h (±10%) during ring heat disinfection cycle

Bacterial / Endotoxin Rejection

Greater than 99% rejection rate for bacteria and endotoxins

Dissolved Salt Rejection

Greater than 96% average rejection rate for dissolved salts

Membrane Type

Spirally-wound RO membrane

Yield (Low Hardness)

Up to 70% at feed water hardness 17.8 ppm CaCO3)

Concentrate Pressure (Max)

Maximum 290.1 psi

Noise Level (SUPPLY mode)

44 46 dB(A) measured at 1 meter distance

Permeate Output (Disinfection)

12 L/h (±10%) during ring heat disinfection cycle

Bacterial / Endotoxin Rejection

Greater than 99% rejection rate for bacteria and endotoxins

Dissolved Salt Rejection

Greater than 96% average rejection rate for dissolved salts

Membrane Type

Spirally-wound RO membrane

Yield (Low Hardness)

Up to 70% at feed water hardness 17.8 ppm CaCO3)

Concentrate Pressure (Max)

Maximum 290.1 psi

Noise Level (SUPPLY mode)

44 46 dB(A) measured at 1 meter distance

Permeate Output (Disinfection)

12 L/h (±10%) during ring heat disinfection cycle

Electrical Supply

120 V AC, 60 Hz, 20 Amp dedicated circuit

Nominal Power Variants

120 V 1000 VA or 120 V 1700 VA (per voltage variant)

Operating Mode

Continuous operation (Standby); SUPPLY mode used periodically during treatment

Electrical Safety Classification

Classified per EN 60601-1:2006 + A1:2013 / IEC 60601-1:2005 + A1:2012

Grounding Requirement

Must be connected to supply network with protective conductor (grounded outlet); no ungrounded connections permitted

Fuse Protection

Internal fuses for voltage component protection; replaceable only by trained/certified personnel

EMC Compliance

Compliant with applicable electromagnetic compatibility (EMC) standards; no stacked installation with other electrical devices

Interface / Connectivity

Fresenius hemodialysis device interface port; LAN port (RJ-45); compatible with Fresenius 2008T BlueStar dialysis machines

Thermal Disinfection Module

Module heat disinfection up to 82°C (179.6°F)

Thermal Disinfection Ring

Ring heat disinfection up to 90°C (194°F)

Membrane Service Life

Minimum expected life of 120 heat disinfection cycles

Chemical Disinfection

Compatible with peracetic acid solution (~0.2% effective concentration); system volume 2.5 L (0.66 gal)

Decalcification

Compatible with approximately 20% citric acid solution; automated decalcification program required

Rinse Interval

Automated rinse cycle: minimum every 4 hours; rinse volume 10 L (3 gal) or 10-minute rinse time

AutoSTART / AutoSTOP

System shall support automatic start in SUPPLY mode via communication cable connection to dialysis machine

Disinfection Validation

System must provide auditable disinfection reporting and daily operational data acquisition logs

Biocompatibility Standard

All components in contact with permeate must be biocompatible per DIN EN ISO 10993-1

Tubing / Piping Material

FEP, silicone, or stainless steel; food-grade with chemical resistance

Sensors

Titanium (Ti), Aluminum Oxide (Al O ), PBT

Module Tube

V4A stainless steel

Membrane Material

PSU/PA (polysulfone/polyamide)

Hydraulic Blocks / Valves

iPP, PVDF, Noryl GTX

Seals

EPDM (ethylene propylene diene monomer)

Sampling Ports

Integrated permeate sampling ports for microbiological and chemical analysis

Permeate Connection

Permeate nipple; optional permeate coupling; compatible with Fresenius hemodialysis machine water inlet

Feed / Concentrate Flow

Feed flow: 0.0 20 L/min (±10%); Concentrate flow: 0.0 20 L/min (±10%)

Permeate Consumption

0 6 L/min (±10%) during normal supply operation

Drain Connection

System drain must connect to available outlet; no recontamination of permeate circuit permitted

Water Supply Hose

Must connect to potable water supply meeting pre-treatment feed water requirements

Installation Type

Portable; no permanent wall or floor mounting required; Marcor cart-based

Stacking / Adjacency

System must NOT be stacked with other electrical devices; minimum separation distances from radiation sources required per IFU

Operational Qualification

Vendor must perform Installation and Operational Qualification (IQ/OQ) at time of installation

Display

Integrated digital display with operating mode status bar; multilingual support

Permeate Conductivity Monitoring

Continuous real-time permeate conductivity measurement and display; alarm on out-of-range condition

Feed Water Conductivity

Continuous real-time feed water conductivity measurement and display

Temperature Monitoring

Permeate and concentrate temperature display; heater temperature 1.0 135°C (±1°C); concentrate temperature 1.0 135°C (±1°C)

Rejection Rate Display

Real-time rejection rate display: 0.0 99% (±1%)

Effective Yield Display

Effective yield display: 0.0 70% (±5%)

Alarm System

Audible and visual alarms for: no water supply, fault drain, conductivity fault, sensor error, and other abnormal conditions; alarm must halt dialysis supply automatically

Operational Data Logging

System must support manual and automated daily operational data acquisition and reporting per AAMI requirements

Visual Status Indicator

Green visual indicator must illuminate to confirm system is ready for treatment

Place of Performance.

The location of delivery and installation will be:

James J. Peters VA Medical Center

130 West Kingsbridge Road

Bronx, NY 10468

Period of Performance.

Purchase of equipment includes one-year manufacturer warranty. Service and maintenance contracts are already in effect for the current equipment. Upon completion of installation of new equipment, the existing service contract will be amended to reflect new equipment.

This procurement is being conducted in accordance with FAR 13.106-1(b) (1)(ii), Soliciting from a Single Source. The NAICS code utilized for this procurement is 334516 , Analytical Laboratory Instrument Manufacturing with a Size Standard of 1,000 employees.

This Notice of Intent is not a request for Proposals or Quotations. No solicitation document exists, and no telephone or email inquiries will be accepted. No contract award will be made on the basis of proposals, or quotations received in response to this notice. Interested persons may identify their interest and capability to respond to the requirement and should furnish detailed data concerning their capabilities to provide services sought including pricing data and technical data sufficient enough to determine that a comparable source to the government is available. The government may consider all Expressions of Interest received prior to July 3rd, 2026. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Responses to this notice must be emailed to jonatan.rondon@va.gov and received by 16:00 hours EST on July 3rd, 2026. Submitters are responsible for ensuring their EOI reaches the designated contracting officer on-time.