SAM #36C10X26R0063

Sole Source Procurement of Fresenius 5008X CAREsystem Hemodiafiltration Units and Accessories for VA

The Department of Veterans Affairs, Enterprise Procurement Office (EPO), Contracting Office, is seeking to award a sole-source contract for Fresenius 5008XTM CAREsystem Hemodiafiltration Units and a comprehensive suite of related accessories and services. - Government Buyer: - Department of Veterans Affairs - Enterprise Procurement Office (EPO), Contracting Office - OEM Highlight: - Fresenius Medical Care is the sole Original Equipment Manufacturer (OEM) for all equipment and consumables - Products Requested: - 5008X CAREsystem Hemodiafiltration Units (MPN M204441) with Crit-Line Clip (CLiC) and Clinical Data Exchange (CDX) - Multiple dialyzers: FX CorAL 60, 80, 100, 120 HD/HDF (MPNs F00012969, F00012970, F00012971, F00012972) - Blood tubing sets (standard, CLiC, Twister), medication lines, venous pressure replacement lines, fluid sampling accessories - DIASAFEplus Filters (MPN F00007039), covers, and installation kits - Acid and bicarbonate concentrates (Citrasate, GranuFlo, NaturaLyte, Sterilyte), dry acid dissolution systems - Priming sets, recirculation connectors, antistick needles, saline, prime bags, and a wide range of connectors, tubes, and accessories - Blood temperature monitors, keyboards, support plates, trays, cuffs, hoses, and water inlet components - Microbiological and AAMI water profile kits for dialysis water quality assessment - Services Requested: - Installation and initial clinician training - Formal technician training (Level 1 and Level 2, Dallas and Louisville locations) - Two-year service agreement covering preventative maintenance, repairs, and travel - Quantities: - Many consumables and accessories are ordered in bulk (e.g., 24 dialyzers per type, 1000 antistick needles, 100 priming sets, 200 recirculation connectors) - Unique Requirements: - Brand name only: Fresenius equipment and consumables - Comprehensive service and training package included - Nationwide deployment for VA facilities - Two-year service agreement with formalized contract per facility - Technical requirements include advanced hemodiafiltration features, software integration, and water quality testing

Description

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 Requirements contract, in accordance with FAR 6.103-1(b), to a Large Business for the brand name Fresenius 5008XTM CAREsystem Hemodiafiltration Units and associated accessories. The applicable North American Industry Classification System (NAICS) code is 334510, Electromedical and Electrotherapeutic Apparatus Manufacturing, with a small business size standard of 1,250 employees. The Product Service Code (PSC) is 6515, Medical and Surgical Instruments, Equipment, and Supplies. The statutory authority permitting other than full and open competition is 41 U.S.C. § 3304(a)(1), as implemented by FAR 6.103-1(b), “Authorized or required by statute.”. Interested parties may identify their interest and capability to meet this requirement. Any response must include sufficient detail to demonstrate the ability to provide all line items 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

Hemodiafiltration Units are extracorporeal blood purification units used in renal replacement therapy and designed to combine diffusion and convection to remove uremic toxins, excess electrolytes, and fluid from blood. The unit operates by withdrawing blood from the patient through a vascular access line and circulating it through a dialyzer containing a semi-permeable membrane; small solutes diffuse across the membrane into a countercurrent flow of dialysate, while larger molecular weight substances are removed via convective transport driven by transmembrane pressure, with a controlled volume of plasma water filtered and replaced by sterile substitution fluid. Core components include a blood pump that regulates extracorporeal blood flow, a dialyzer (filter cartridge) that facilitates solute exchange and ultrafiltration, a dialysate delivery system that prepares and circulates electrolyte-balanced fluid, a substitution fluid system that infuses replacement fluid either pre- or post-filter, pressure monitors and sensors, air detectors and venous clamps, anticoagulation systems to prevent clotting within the circuit, and a central control unit with software that coordinates flow rates, pressures, fluid balance, and treatment parameters.

View original listing