Apheresis Units, Blood Donor

The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR 13.501(a), Only One Responsible Source. The proposed source is Terumo BCT, Inc., 10811 West Collins Avenue, Lakewood, CO 80215-4440. The contract shall have an ordering period of five (5) years. The requirement is for an Indefinite Delivery Indefinite Quantity (IDIQ) for apheresis units, blood donor [ECRI Institute Device Code: 23-134 for all CONUS and OCONUS Navy and DHA MTFs to include but not limited to, the ; Federal Health Care Center (FHCC) Great Lakes, Great Lakes IL, Naval Medical Center Camp Lejeune, Camp Lejeune, NC, United States Naval Hospital (USNH) Guam, Naval Medical Center Portsmouth, Portsmouth, VA, and Naval Medical Center San Diego, San Diego, CA.. The IDIQ scope will include all CONUS and OCONUS Navy and DHA MTFs, within the specific ordering authority of the Contracting Officer. The IDIQ shall have a minimum value of $2,000,000.00 and a maximum ordering capacity of $5,000,000.00. 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 apheresis 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 apheresis units shall also 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 store blood cell components for transfusion into patients. The apheresis 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 real time monitoring and warning alarms via visual and audible information presented to the user. 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 units shall be compliant with the 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 units 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 all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. There are no set aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 339112 with a Small Business Size Standard of 1000 employees. 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 the synopsis will be considered by the Government. A determination by the Government not to compete based on the response 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 wishes to provide a capability statement please email product capability statements, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Curtis E. Cardoza at curtis.e.cardoza.civ@mail.mil. Closing date for capability statements in response to this notice is no later than 3:00 PM Eastern Time on 05 August 2020. No phone calls will be accepted.