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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 manufacturer is Olympus America, Inc. of 3500 Corporate Parkway, PO Box 610, Center Valley, PA, 18034-0610.
The requirement is for one (1) Scanning System, Ultrasonic, Endoscopic [ECRI Device Code: 20-378] for Naval Medical Center San Diego’s (NMCSD) Pulmonology Clinic and Gastroenterology Clinic. The endoscopic ultrasound (EUS) shall be indicated for use in the diagnosis and staging of cancer of the gastrointestinal tract and lungs, pancreatic diseases, gallbladder diseases, liver diseases, evaluation of lymphadenopathy, evaluation of mesentery, infections, inflammatory conditions, and evaluation of gastrointestinal (GI) tumors. The EUS system shall have the ability to maintain a minimum workload of 500 annual procedures. The EUS system shall be compatible with the currently-installed pulmonology equipment and gastroenterology equipment, listed in Table 1. The EUS shall have at least the following frequency options: 5 MHz, 6 MHz, 7.5 MHz, 10 MHz, and 12 MHz. The EUS shall have the following scanning modes: linear, convex, sector, radial, trapezoidal and Doppler capability. The EUS shall be capable of tissue harmonic imaging (THI), real time tissue elastography, strain capabilities to assess, measure liver fibrosis, and strain histogram measurements. The EUS shall be capable of measuring distance, area, circumference, volume, velocity, flow volume, and strain. The EUS shall allow for high definition imaging.
Table 1: NMCSD Currently-Installed Pulmonology and Gastroenterology Equipment
| Common Model |
| Manufacturer |
| ECN |
| Serial Number (SN) |
| GF-UE160-AL5 360 |
| Olympus |
| 115030 |
| 1111902 |
| GF-UE160-AL5 |
| Olympus |
| 101616 |
| 1811077 |
| GF-UCT180 |
| Olympus |
| 115029 |
| 1110368 |
| GF-UCT 180 |
| Olympus |
| 129626 |
| 7410334 |
| GF-UCT180 |
| Olympus |
| 115029 |
| 1110368 |
| TGF-UC180J |
| Olympus |
| 148547 |
| 7710146 |
| BF-UC180F |
| Olympus |
| 134628 |
| 7621262 |
| BF-UC180F-A |
| Olympus |
| 128560 |
| 7410317 |
| CV-190 |
| Olympus |
| 148527 |
| 7843510 |
| CV-190 |
| Olympus |
| 148528 |
| 7843871 |
| CV-190 |
| Olympus |
| 148526 |
| 7843681 |
| CV-190 |
| Olympus |
| 148525 |
| 7843869 |
| CV-190 |
| Olympus |
| 132637 |
| 7502305 |
| CV-190 |
| Olympus |
| 125133 |
| 7389218 |
| CV-190 |
| Olympus |
| 125134 |
| 7389214 |
The vendor shall provide an EUS system, accessories, cables and adaptors/connectors, including all components listed in Table 2, for full system functionality. The electrical requirements are 110 V and 60 Hz. The vendor shall provide onsite operator training. The vendor shall provide a minimum of twelve (12) month warranty period. The vendor shall provide two (2) operator manuals and two (2) service manuals, each in English.
Table 2: EUS Components
| Description |
| Quantity |
| Minimum Requirements |
| Ultrasound Processor |
| 1 |
| An ultrasound processor capable of integration with the radial probe EBUS (RP-EBUS) and endoscopic ultrasound (EUS) for GI needs |
| Power Strip |
| 1 |
| 4-outlet power strip and cable cleat |
| Wireless Transmitter |
| 2 |
| Wireless transmitters intended for the delivery of video signals over a radio-frequency during procedures |
| Wireless Receiver |
| 2 |
| Wireless receivers intended for the delivery of video signals over a radio-frequency during procedures |
| Rollstand |
| 2 |
| Height adjustable rollstand including a monitor mount |
| 4K Monitor |
| 1 |
| Minimum of fifty-five (55) inch 4K monitor |
| Accessories |
| NA |
| The system shall include all cables/adaptors/connectors for full system functionality |
The system, including claims made for the product, shall be compliant with Food and Drug Administration (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.
Contractor 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.
Upon delivery, the contractor 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. The vendor shall be responsible of de-installation and removal of current equipment. If interim storage is required, the vendor shall make arrangements for the storage. The vendor is also responsible for the initial instrument operational and performance validations.
There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 339112. 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 10 April 2020. No phone calls will be accepted.