SAM #36C10X26R0047

VA procurement of Evoqua portable RO water purification systems and services for hemodialysis

The Department of Veterans Affairs, Strategic Acquisition Center (Frederick), is seeking to procure Evoqua Water Technologies' portable RO water purification systems and related services for hemodialysis across nearly 80 VA medical centers. - Government Buyer: - Department of Veterans Affairs, Enterprise Procurement Office (EPO) - Contract Specialist Daleta Coles and Contracting Officer Jessica Smith - OEM Highlight: - Evoqua Water Technologies, LLC is the sole Original Equipment Manufacturer (OEM) specified - Products Requested: - EON® Portable Reverse Osmosis (RO) Water Purification System (W3T578348) - ROVER ALX® Dialysis Water Transport System (W3T579396) - Multiple filter kits, test kits, cleaning solutions, disinfectants, consumables, and accessories (see detailed line items) - All products are FDA-cleared and intended for clinical hemodialysis use - Services Requested: - Preventative maintenance service agreements (monthly, quarterly, semi-annual) for varying unit counts - Extended annual warranty coverage for devices (0-3 years and 4-6 years old) - Technical and clinical onsite training for up to 8 participants - Onsite installation and startup, including initial AAMI water sample and operator training - Water sampling services (AAMI, microbiology, CFU, LAL) - Unique/Notable Requirements: - Systems must produce dialysis-grade water meeting AAMI/ANSI/ISO standards - Designed for safe, repeatable bedside use in high-risk, non-plumbed environments - Enterprise-level service and support, standardized water safety architecture - Only OEM-validated consumables and maintenance accepted - Strict compliance with clinical and regulatory standards for hemodialysis water quality - Deployment supports enterprise-wide sustainment and standardized water safety across VA medical centers

Description

Presolicitation Notice Presolicitation Notice Presolicitation Notice Presolicitation Notice *=Required Field Presolicitation Notice DESCRIPTION Page 1 of Presolicitation Notice Presolicitation Notice Page 1 of This Notice of Intent to Sole Source is not a request for competitive quotations or proposals. The Department of Veterans Affairs intends to negotiate and award a firm fixed price sole source contract, in accordance with FAR 6.103 1, for the Evoqua Water Technologies, LLC EON® Portable RO Water Purification System. The applicable North American Industry Classification System (NAICS) code is 333310 — Commercial and Service Industry Machinery Manufacturing, Product Service Code: 4610 — Water Purification Equipment, and the associated size standard is 1000 employees. The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) 6.103-1 entitled, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. Interested parties may identify their interest and capability to meet this requirement. Any response must include sufficient detail to demonstrate the ability to provide a product that fully meets the MTRs described below. No solicitation is available, and telephone requests will not be accepted. Responses received will be considered; however, the Government’s decision whether to compete this requirement based on responses to this notice remains solely within the Government’s discretion. The Government will not reimburse any costs incurred by contractors in responding to this notice, nor for the Government’s use of any information received. Requirement Description Water Purification Systems: RO: HEMO: Portable are RO hemodialysis water purification systems designed to produce ultra-pure dialysis grade water that meets current AAMI/ANSI/ISO standards for hemodialysis, and are compact, lightweight, portable systems (e.g., mounted on wheels) with integrated handles allowing for rapid relocation and set-up in multiple clinical environments. These systems are specifically engineered for very high-water volumes and strict contaminant limits required in hemodialysis, where even trace amounts of certain substances (such as aluminum, chloramines, or endotoxin) can cause serious patient harm. Portable hemodialysis RO systems typically include pretreatment (e.g., sediment and carbon filtration for particulate removal and chloramine/chlorine reduction), one or more semi-permeable RO membranes, a high-pressure pump to drive water across the membrane at pressures exceeding the osmotic gradient, and associated controls, monitors, and alarms. The RO membrane is permeable to water but largely impermeable to dissolved salts, organic molecules, microorganisms, and particulates, producing permeate (product water) that is then supplied to the hemodialysis machine via appropriate medical grade tubing and connectors. Compared with general purpose RO units, hemodialysis RO systems incorporate tighter performance specifications, continuous monitoring (e.g., conductivity, pressure), and disinfection capabilities to achieve and maintain very low levels of ions, bacteria, and endotoxin. Given patient exposure to hundreds of liters of water during a single hemodialysis session (as dialysate and substitution fluid), product water quality must be verified regularly through chemical and microbiological testing, using limits and action levels defined in applicable AAMI/ANSI/ISO standards. Facilities typically incorporate upstream pretreatment to address local water characteristics (e.g., hardness, particulates, chloramines) before RO and may add downstream ultrafiltration or endotoxin retentive filters to further control microbiological contaminants. Periodic disinfection of the RO system and distribution tubing is essential to control biofilm, and any deviation from specified water quality requires prompt investigation and corrective action. Contract Line Item Numbers (CLIN) Contract Line Items Manufacturer Part Number Description 0001 Evoqua Water Technologies, LLC W3T578348 EON® Portable Reverse Osmosis (RO) Water Purification System (Includes: Disinfection Bottle, Manual, Hose Kit, Product Hose Assembly, AAMI Kit, Quick Reference Guide, Dialysis Machine Connection Hose, Feed Inlet Hose, Leak Detector, Insulation, and a 1-year Warranty) 0002 Evoqua Water Technologies, LLC W3T579396 ROVER ALX® Dialysis Water Transport System 0003 Evoqua Water Technologies, LLC W3T645898 Kit, Rover ALX®, RPZ, Valve, BF <!-- Additional CLIN entries omitted for brevity --> The VA requires an FDA-cleared, portable RO water purification system specifically intended for hemodialysis, capable of producing dialysis-grade water that meets applicable AAMI/ANSI/ISO standards at the point of use for single-patient hemodialysis treatments in inpatient, outpatient, and long-term care settings. In addition to meeting these clinical and regulatory requirements, the system must support safe, repeatable bedside use in high risk, non-plumbed environments by trained dialysis and nursing staff. Because portable hemodialysis water systems operate across nearly 80 VA medical centers in intensive care units (ICU), emergency departments, inpatient wards, and long-term care units, the minimum requirement also includes the ability to implement a standardized water safety architecture and support model that maintains validated disinfection practices and consistent governance across this enterprise footprint. To support standardized, enterprise-scale deployment across nearly 80 VA medical centers, and to address the specific infection-prevention and operational challenges of portable hemodialysis water systems in non-plumbed, high-risk environments (i.e., Emergency Rooms, ICUs, inpatient wards, and long-term care), the systems and associated services must meet the VA’s minimum technical and clinical requirements as follows: An FDA-cleared portable RO water purification system intended for hemodialysis water production, designed for hospital and clinical use by trained dialysis and nursing staff, and capable of producing water that meets AAMI/ANSI/ISO 23500-series requirements at flow rates suitable for adult single-station hemodialysis (nominally 500–800 mL/min or as specified by dialysis-machine manufacturer) in accordance with the device’s cleared intended use. A mobile, bedside-deployable RO unit (e.g., cart-mounted or equivalent portable configuration) that connects to local feed water and delivers treated product water to the hemodialysis machine via a dedicated product hose, with continuous monitoring of feed and product water quality, feed and product water pressure, product water conductivity, product water temperature, membrane performance (percent rejection), operating status, and with visual and audible alarms and automatic protective shutdown outside manufacturer-defined safe limits to enable safe operation in high acuity, non-plumbed care environments. Disinfection capability that includes an automated disinfection cycle using validated methods that do not introduce chemical disinfectants into the internal product-water pathway, capable of disinfecting the internal product-water pathway (within the RO and through the point of connection to the dialysis machine), sufficient to control microbial growth and biofilm formation for portable point-of-care use by ensuring that all wetted components in the product water path, including outlet assemblies and hoses, are brought to effective disinfection conditions during routine cycles. An automated disinfection program must support multiple disinfection modes, including at a minimum on-demand, timed/scheduled, and an extended self-disinfect option capable of performing disinfection without the need for staff intervention or connection to water source and drain for up to 30 days, to safely manage extended idle intervals (e.g., weekends, holidays, variable census) when portable units may remain filled with water but not in active use. Microbial and endotoxin control, validated by the original equipment manufacturer (OEM), consistent with ultrapure dialysate use per applicable AAMI/ANSI/ISO standards, located in the product-water path or immediately downstream of the RO output, providing a continuous barrier to bacteria and endotoxins (<0.1 CFU/ml and <0.03 EU/mL). Locating endotoxin control under RO-system governance allows VA to standardize water-quality performance across a heterogeneous installed base of dialysis machines and facilities. This integrated endotoxin barrier is necessary to maintain consistent water safety performance across facilities with different dialysis machine models and local infrastructure, and to support a single, OEM validated water safety architecture for portable hemodialysis use. A user interface that presents operating parameters, alarms, and disinfection functions in a manner suitable for clinical environments, and that supports safe, reliable operation, alarm recognition, and basic troubleshooting by trained staff. A built-in and/or remote sensor for leak detection with automated user alert or shutdown. A portable configuration suitable for single-patient bedside deployment by clinical staff, including an integrated mobile platform or cart that allows the system to be moved through standard patient-care areas (e.g., ICUs, step-down units, long-term care rooms) and positioned safely at the point of care without permanent installation. The capability to log and retrieve system data relevant to water-quality management, including disinfection cycles and alarm history, to support water-safety plans, AAMI audit requirements, and local quality-assurance activities. An enterprise-level service and support model appropriate for nationwide deployment, including OEM-authorized installation, clinical training, technical training, preventive maintenance, and technical support, together with availability of OEM-validated consumables (e.g., pretreatment filters, any integrated endotoxin-removal elements, disinfection supplies) sufficient to support enterprise-scale deployment and sustainment across participating VA medical centers for the duration of the contract, including sustainment of the existing installed base concentrated at 67 facilities already operating Evoqua portable RO systems and associated Rover carts and minimizing the need for fragmented support actions.

View original listing