Hemodialysis Units

DEPARTMENT OF THE NAVY NAVAL MEDICAL LOGISTICS COMMAND NOTICE OF INTENT The Naval Medical Logistics Command intends to negotiate on a sole source basis IAW FAR 13 with NxStage Medical, Inc., 350 Merrimack St., Lawrence, MA 01843-1748, as the only responsible source that can provide two (2) Hemodialysis Units onboard U.S Naval Fleet to meet USNS Mercy's requirement. The USNS Mercy has a requirement for two (2) hemodialysis units. Units shall be capable of providing hemodialysis blood flow rate of a minimum of 10-600mL/min, dialysate flow rate of at least 200mL/min, arterial pressure of a minimum of -50 to -500mmHg, and venous and pre-filter pressure of a minimum of 0-1,500 mmHg. Unit shall be capable of operating without the use of external utilities access, a reverse osmosis (RO) tank and/or carbon tank. Unit shall be portable and shall not exceed 90lbs, and shall not exceed 16" (H) x 15" (W) x 19" (D) for exterior dimensions. Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. Regulatory Requirements: The system and all its components shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America; even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements. Upon delivery, the vendor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. This acquisition is being conducted under simplified acquisition procedures IAW FAR 13. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 339112 with a small business size standard of 500. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on 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. Submit capability statements via email (using PDF, MS Word, Excel attachments) to Christina Boyd-Brown at Christina.BoydBrown.civ@mail.mil. Statements are due not later than 4:00 P.M. ET on 26 March 2015. No phone calls accepted.