SOLICITATION NOTICE
65 -- Drop Shipment
- Notice Date
- 12/17/2019 10:39:49 AM
- Notice Type
- Presolicitation
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- NAVAL MEDICAL LOGISTICS COMMAND FORT DETRICK MD 21702-9203 USA
- ZIP Code
- 21702-9203
- Solicitation Number
- N6847020RCBL001
- Response Due
- 1/2/2020 6:00:00 AM
- Archive Date
- 02/01/2020
- Point of Contact
- Derek J. Bell, Phone: 3016196914
- E-Mail Address
-
derek.j.bell.civ@mail.mil
(derek.j.bell.civ@mail.mil)
- Description
- 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 Grifols Diagnostics Solutions, Inc. (Grifols), 4560 Horton St, Emeryville, CA, 94608-2916. The proposed action is for a drop shipment contract to support donor screening for HIV RNA, HCV RNA, HBV DNA, West Nile Virus RNA and Zika Virus RNA utilizing Nucleic Acid Testing (NAT).�� The drop shipment will be a shipment of reagents every quarter with a fixed quantity.� USNHO PACOM Armed Services Blood Bank Center is one of two DOD donor testing laboratories.� The Procleix Panther System is one of only two FDA-cleared donor testing platforms that utilizes NAT to detect Transfusion Transmitted Infections. The other testing platform that is FDA-cleared is the Roche model, however, due to its size (form factor) will not fit in the layout of the facility without significant construction costs.� This testing equipment will be used to screen blood donors in order to produce FDA-licensed blood products for the Indo-Pacific AOR. The FDA�s approval is required and allows the site to manufacture the Procleix Ultrio Elite Assay through the use of the Panther System.� The Panther was purchased in 1Q FY19 by Naval Medical Center San Diego (NMCSD) on behalf of USNHO PACOM Armed Services Blood Bank Center.� The equipment was installed in July of 2019.� It is currently operating and is almost ready for use as it has undergone a validation process required by regulatory guidelines to ensure the analyzer produces the desired results.� This documentation has already been provided, and these tests are not optional for donor screening. USNHO is in the process of purchasing Ultrio Elite, West Nile Virus and Zaka assay reagent kits for this equipment to sustain donor screening. A drop shipment contract is needed to procure the reagents to conduct blood donor testing.� The Government intends on awarding a Firm, Fixed-Price (FFP) contract. Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the Panther system which the reagents are being provided 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. 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 09:00 AM ET on 02 January 2020.� No phone calls will be accepted.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/c760538f7cfc46f194b5b8bfb19bbf3b/view)
- Record
- SN05519394-F 20191219/191217230153 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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