Cost Per Test-Platelet/Plasma Set

Added: Aug 08, 2013 1:50 pm The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.501) with TerumoBCT, Inc 10811 W Collins Ave, Lakewood, CO 80215-4440, as the only responsible source that can provide Blood Pheresis Sets at Naval Medical Center San Diego.

The blood pheresis sets by TerumoBCT is the only one that is configured and validated for use with CardianBCT Trima Accel Collection system that NMCSD currently owns. TerumoBCT, Inc is the only manufacturer and distributor of the TerumoBCT blood pheresis sets. NMC San Diego's Blood Donor Center has performed extensive validation testing and is licensed by the FDA to use the Terumo BCT blood pheresis sets with the Cardian BCT Trima Accel collection system. The TerumoBCT blood pheresis sets are the only FDA and Armed Service Blood Program (ASBP) approved collection kits that can be used with the CardianBCT Trima collection system that NMC San Diego currently owns. At this point another manufacturers system is unable to replace the one currently onsite because NMCSD would lose their FDA licensure. No other unit can meet the minimum requirements of the government. Base period shall be for one (1) year. Option years shall be available for four (4) consecutive year terms after the base year. The total contract amount for a base plus four option years is estimated at $1,180,680.00.

Regulatory Requirements: 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.

This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-Cohen Act of 1996). There are not 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.

Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to Derek Bell at derek.bell@med.navy.mil. Statements are due not later than 3:00 PM on 23 Aug 2013. No phone calls accepted.