Three (3) apheresis units, blood donor [23-134] for the NATO Role III Multinational Medical Unit (MMU) in Kandahar, Afghanistan

The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (FAR 13.106-1(b)(1)), soliciting from a single source. The proposed source is Terumo BCT, Inc. of 10811 West Collins Avenue Lakewood, CO 80215-4440. The requirement is for The Naval Medical Logistics Command has a requirement for three (3) apheresis units, blood donor [23-134] for the NATO Role III Multinational Medical Unit (MMU) in Kandahar, Afghanistan. The apheresis units shall be automated blood collection units that perform plateletpheresis, plasmapheresis, erythrocytapheresis, and leukapheresis to separate whole blood into platelet, plasma, and Red Blood Cell (RBC) components. The units shall be capable of extracorporeal collection, separation, and reinfusion of patient blood components and required components shall be collected in storage bags. The units shall continuously monitor and automate the removal of desired blood components. The units shall be capable of separating blood components by means of centrifugation. The units shall be Food and Drug Administration (FDA) approved to collect the following products in any combination: platelets pheresis and Leukocyte reduced platelet pheresis (single, double, or triple units), plasma (volume varies by patient) and Leukocyte reduced plasma (volume varies by patient), and AS-3 RBCs and Leukocyte reduced AS-3 RBCs (single or double units). The units shall be FDA approved for collecting the following components in both Leukocyte reduced and standard forms: - Platelets only (single, double, or triple) - Plasma only (volume varies by patient) - RBCs only (single or double) - RBCs (single) with Plasma (volume varies by patient) - Platelets (single, double, or triple) with Plasma (volume varies by patient) - Platelets (single, double, or triple) with RBCs (single) - Platelets (single, double, or triple) with Plasma (volume varies by patient) and RBCs (single) The storage bags shall appropriately store blood cell components for transfusion into patients. The units shall recommend the blood components that can be collected based on the donor's blood volume, hematocrit, and platelet count entered. The units shall have a minimum inlet range of 0 to 142 mL/min. The units shall be capable of a minimum of seven (7) days of platelet storage and a minimum of 42 days for RBC storage. Each unit shall include a tubing cutter/seal system to seal a standard tube or to cut a tube while simultaneously sealing both severed ends. The units shall be capable of using disposable tubing sets. The units shall include an anticoagulant detector, RBC spillover detector, and fluid-leak detector. The units shall be capable of providing the user with real time monitoring information and warning alarms via visual and audible information presented to the user. The power requirement is 220 VAC, 50 Hz, single phase. 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. The systems 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. There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 339112. 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. If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Justin Robertson at justin.d.robertson12.civ@mail.mil. Closing date for challenges is no later than 9:00 AM ET on 6 March 2020. No phone calls will be accepted.