Blood Pheresis Sets

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 TerumoBCT, Inc 10811 W Collins Ave, Lakewood, CO 80215-4440.

The Naval Medical Center San Diego has a requirement for an IDIQ contract for blood pheresis sets for NMC San Diego. The items shall be used to collect platelets and plasma to provide blood products in support of service members deployed or stationed overseas. The requested items shall be configured and validated for use with the Terumo BCT Trima Accel Collection System that NMC San Diego currently owns. The items shall be 510 FDA cleared and Armed Service Blood Program (ASBP) approved. The requested item must be one of two approved collection devices, to be used in conjunction with Cerus Intercept Pathogen Reduction technology. The requested items shall include disposable tubing sets and solutions to collect platelets, plasma and red blood cells for extended storage.

The system and all of the 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 equipment and reagents shall be compliance with OSHA requirements.

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.

Upon delivery, the vendor shall be responsible for uncrating the unit/system and transporting it through the facility to the location of intended use for installation. If interim storage is required, the vendor will make arrangements for the storage.

There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 325413. 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 Derek Bell at derek.j.bell.civ@mail.mil. Closing date for challenges is no later than 9:00 AM ET on 08 November 2018. No phone calls will be accepted.

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