Notice of Intent to Sole Source - One (1) Ultrasonic Liver Stiffness Scanning Unit

From: Federal Government(Federal)
N62645-16-R-0061

Basic Details

started - 27 Jun, 2016 (about 7 years ago)

Start Date

27 Jun, 2016 (about 7 years ago)
due -

Due Date

N/A
Bid Notification

Type

Bid Notification
N62645-16-R-0061

Identifier

N62645-16-R-0061
Department of the Navy

Customer / Agency

Department of the Navy
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The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.106-1(b)(1)). The proposed source is Echosens North America, Inc., 1050 Winter Street, Waltham, MA 02451. Naval Medical Center (NMC) San Diego, CA has a requirement for one (1) ultrasonic liver stiffness scanning unit. The unit shall be capable of Vibration Controlled Transient Elastography (VCTE) for non-invasive measurement of liver fibrosis and cirrhosis. The unit shall be capable of diagnosis and surveillance of chronic liver diseases, such as Hepatitis B, Hepatitis C, Autoimmune Hepatitis and Fatty Liver Disease, by utilizing VCTE to measure shear wave velocity passing through liver tissue. VCTE shall be performed with an external handheld probe, which emits a low-amplitude, low-frequency signal in the direction of the human liver. Probes for adults and overweight patients shall be included. The requirement shall include installation and user training.The system, including
claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, regarding 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 of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. The vendor shall be responsible for all necessary labor and materials for installation, as well as the removal of the old sterilizers.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.This notice of intent is not a request for competitive proposals; however, if a vendor challenges the basis of this requirement, please email challenges and product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Jayme L. Fletcher at jayme.l.fletcher2.civ@mail.mil, reference solicitation number N62645-16-R-0061. Closing date for challenges is no later than 1300 Local Time, 13 July 2016. No phone calls will be accepted. Please note that a determination by the Government not to compete this proposed contract based upon 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. Contact Information: Jayme L. Fletcher, Email jayme.l.fletcher2.civ@mail.mil Office Address :693 Neiman Street FT Detrick MD 21702-9203 Location: Naval Medical Logistics Command Set Aside: N/A

Naval Medical Logistics CommandLocation

Place Of Performance : Naval Medical Logistics Command

Country : United States

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Classification

NAISC: 334510 GSA CLASS CODE: 65