SPECIAL NOTICE
99 -- Notice of Intent - Sole Source
- Notice Date
- 6/18/2018
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- TBI-HK-KITS-18Jun18
- Archive Date
- 7/18/2018
- Point of Contact
- Herbert Caj Keen, Phone: 3016191011
- E-Mail Address
-
herbert.e.keen.civ@mail.mil
(herbert.e.keen.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT The United States Army Medical Research Acquisition Activity (USAMRAA) intends to issue a Firm Fixed-Price sole source contract under the authority of FAR 6.302-1 (a) (2) - Only One Responsible Source and No Other Services will Satisfy Agency Requirements, on or about 30 August 2018 to Banyan Biomarkers, 16470 West Bernardo Drive, Suite 100, San Diego, CA 92127 on behalf of the United States Army Medical Materiel Development Activity (USAMMDA). The Neurotrauma and Psychological Health Program Management Office of the United States Army Medical Materiel Development Activity has a requirement to obtain a commercialized FDA-approved blood assay using two protein biomarkers (Ubiquitin Carboxy-terminal Hydrolase-L1 or UCHL-1 and Glial Fibrilliary Acidic Protein or GFAP) that provide objective data to healthcare providers when evaluating patients with suspected traumatic brain injury (TBI). The blood test assay shall be compatible with the government-owned BioTek Synergy 2 ELISA software and hardware system. In addition, the government requires protocol-specific training on the proper use of the assay, to include system set-up, installation, and performance calibrations. Specific requirements include: - Produce and store two-hundred (200) Banyan BTI TM kits (referred to as "Kits") to be incrementally shipped to one Contiguous United States (CONUS) military installation to-be-identified by the government from the following: FT Bragg, FT Carson, FT Hood, FT Benning, Joint-Base San Antonio, Camp Pendleton, FT Bliss, FT Campbell, Camp Lejeune. Shipments will continue over the period of performance in quantities to be determined by the government. - Maintain temperature-controlled storage and shipment of the kits in accordance with the manufacturer's specifications. - Provide protocol-specific training packages through the Aviation and Missile Research Development and Engineering Safe Access File Exchange (AMRDEC SAFE) prior to conducting training. - Travel to the identified training location prior to the shipment of kits and perform a one-day Precision Qualification Package to include Installation Qualification Procedure and Checklist/Operational Qualification Procedure/Performance Qualification Procedure (IQ/OQ/PQ) on the Banyan Brain Trauma Indicator (BTI) system to certify the system is properly calibrated to process the Banyan BTI kit. A report indicating the outcomes of this procedure will be provided to the government. - Provide a one-day protocol training on the Banyan BTI kit to on-site personnel immediately following a successful system qualification. Banyan has developed a TBI assay, using their proprietary biomarkers, for use on a benchtop device that has been submitted to the FDA for approval. Once the assay is approved by the FDA, it will be the only assay of blood based markers for TBI. Banyan has patents on the use of these markers for the evaluation of brain injury. The Banyan TBI Detection Assay is a qualitative, chemiluminescent, enzyme linked immunosorbent assay (ELISA) for the detection of UCH-L1 and GFAP in serum. The assay is used in conjunction with standard clinical practice to aid in the evaluation of patients over the age of 18 presenting with suspected traumatic brain injury (Glasgow Coma Scale 9-15) within 12 hours of injury to assist in determining the need for a CT scan of the head. Any sources that believe they are eligible to provide these services must respond in writing. Responses must be supported with clear and convincing evidence articulating the ability to meet the requirements outlined above. A request for documentation will not be considered an affirmative response. Information received will be considered solely for the purposes of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects fifteen (15) days after the publication of this notice, the contract will be awarded without further remark. Interested parties who believe they can meet this requirement shall submit information about their capabilities no later than 4:30 PM EST, 03 August 2018. All questions and responses concerning this notice shall be emailed to Herbert Caj Keen at herbert.e.keen.civ@mail.mil. All information shall be furnished at no cost or obligation to the Government. Telephone inquiries will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/TBI-HK-KITS-18Jun18/listing.html)
- Place of Performance
- Address: Fort Detrick, Maryland, 21701, United States
- Zip Code: 21701
- Zip Code: 21701
- Record
- SN04958884-W 20180620/180618230950-122f934fe98524898c472ab2a521061e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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