36C10G21R0019_1.docx

Contract Opportunity Presolicitation Notice

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Required Field Contract Opportunity Presolicitation Notice Dialysis Systems and Associated Maintenance Services and Consumables (VA-21-00023786) 22408-2697 36C10G21R0019 07-02-2021 12:00

EASTERN TIME, NEW YORK,

USA

N 333318 U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 Contract Specialist Adam Vulgamore Adam.Vulgamore@va.gov https://www.va.gov/opal/sac/index.asp To learn more about SAC and its mission, please click here The Veterans Health Administration (VHA) Equipment Life Cycle Management (ELCM) Program has identified Dialysis Systems and Associated Maintenance Services and Consumables as a candidate for the Department of Veterans Affairs (VA)-wide (otherwise referred to as “national”) contract award. The Department of Veterans Affairs (VA) Veterans Health Administration (VHA) requires dialysis systems and associated maintenance services and consumables for VA facilities throughout the United States that perform dialysis. The requirement includes water purification and distribution systems (central and portable), integrated water purification and dialysate delivery systems, hemodialysis (HD) systems, Continuous Renal Replacement Therapy (CRRT) systems, and peritoneal dialysis (PD) systems. VA requires the option to purchase systems for in-center use and lease systems for home use. Properly functioning equipment is critical to VA’s ability to deliver high-quality and safe dialysis to Veterans with kidney failure.

Dialysis is a life-saving treatment for kidney failure that rids the body of unwanted toxins, waste products, and excess fluids by filtering a patient’s blood.

A critical component to quality dialysis is the provision of safe purified dialysis water. Dialysis water purification systems produce water for the preparation of dialysis fluid (dialysate) by removing chemical and microbial contaminants from city water. Water purification systems are either central (stationary system that produces dialysis water for multiple patients) or portable (mobile system that produces dialysis water for a single patient). Central systems are located in a medical facility. The majority of portable systems are used in a medical facility; however, use for home dialysis also occurs.

An integrated dialysis water purification and dialysate delivery system combine water purification and dialysate production into one device. An integrated dialysis water purification and dialysate delivery system is a mobile device typically used in a medical facility Intensive Care Unit (ICU) or Community Living Center (CLC); however, the device may also be used for home dialysis.

Dialysis water purification systems are connected to hemodialysis systems; which filter a patient’s blood using a dialysate solution to remove waste products and balance electrolytes. The majority of hemodialysis is performed in a medical facility; however, hemodialysis may also be performed in a patient’s home.

Continuous Renal Replacement Therapy (CRRT) systems provide continuous fluid removal and are used for critically ill patients.

A peritoneal dialysis system filters a patient’s blood and removes waste and toxin, using a peritoneal catheter. Peritoneal dialysis is always performed in a patient’s home.

VA requires systems that have received Food and Drug Administration (FDA) 510(k) approval as a medical device for dialysis. FDA 510(k) approval indicates that the device is substantially equivalent in safety and effectiveness to a predicate device legally marketed in the United States. The FDA regulations relevant to this acquisition:

· Sec. 876.5665 Water purification system for hemodialysis

· Sec. 876.5820 Hemodialysis system and accessories

· Sec. 876.5860 High permeability hemodialysis system

· Sec. 876.5630 Peritoneal dialysis system and accessories This acquisition is for multiple award Indefinite Delivery, Indefinite Quantity (IDIQ) contracts with Firm Fixed Price (FFP) orders IAW with FAR 16.504. The type of Dialysis Systems required for this program have been identified as most advantageous to the Government to be incorporated into a national contract.

Vendors that can furnish one or more of the required systems or services will be considered. The capability to furnish systems, services, and consumables to the entire VA network of dialysis facilities in the United States including Alaska, Hawaii, and Puerto Rico is preferred, but not required.