SPECIAL NOTICE
65 -- Platelet Blood Donor Apheresis Unit
- Notice Date
- 7/26/2017
- Notice Type
- Special Notice
- NAICS
- #339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N6809617RC23025
- Archive Date
- 8/10/2017
- Point of Contact
- Kerry McKean,
- E-Mail Address
-
kerry.a.mckean.civ@mail.mil
(kerry.a.mckean.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.501) with Terumo BCT, Inc. of 10811 W Collins Ave, Lakewood, CO 80215-4440, as the only responsible source that can provide that can provide platelet blood donor apheresis units that are compatible with the Cerus INTERCEPT pathogen reduction system and that can help maintain the Blood Program accreditation. This acquisition is being conducted under the FAR 13 Simplified Acquisition Procedures. Provisions and clauses in effect through Federal Acquisition Circular 2005-95 are incorporated. Items being purchased in this acquisition: The requirement is for two (2) platelet blood donor apheresis units [23-135]. The units shall be capable of collecting apheresis platelets from healthy blood donors for use in critically-ill patients requiring platelet transfusions. The units shall be compatible with the Cerus Corporation INTERCEPT pathogen reduction system. The units shall be in compliance with Food and Drug Administration (FDA) guidelines and the Operational Procedures for the Armed Services Blood Program Elements to maintain Blood Program accreditation. The vendor shall be responsible for providing both operator and biomedical engineering technician (BMET) training. The power requirements are 100-240 V, 60 Hz. 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 system, including claims made for the product, shall be compliant with FDA regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. 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 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. 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 1,000 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 shall submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by closing of this notification 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. Based on the above information, the only technically acceptable platelet blood donor apheresis unit is provided by Terumo BCT, Inc. Submit email capability statements (using PDF, MS Word, Excel attachments) to Kerry McKean at kerry.a.mckean.civ@mail.mil. Statements are due no later than 1000 ET 10 August 2017. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N6809617RC23025/listing.html)
- Record
- SN04599587-W 20170728/170726232448-995b045422939970666778a6db0e14ab (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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