N6264520RC97002-Endoscopic Scanning-Olympus-SD-Attachment V-JA_FINAL_REDACTED.pdf

Log #: 20-00023

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JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity.

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD, on behalf of the Navy to meet the requirements of Naval Medical Center San Diego (NMCSD).

2. Description of the Action Being Approved.

The Government intends on awarding a Firm, Fixed-Price (FFP) contract. Award of a contract on a sole source basis for one (1) Scanning System, Ultrasonic, Endoscopic [ECRI Device Code: 20-378] in support of NMCSD from Olympus America, Inc. of 3500 Corporate Parkway, PO Box 610, Center Valley, PA, 18034-0610 is anticipated.

3. Description of Supplies/Services.

The Naval Medical Logistics Command has a requirement 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 Manufacture 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

N6264520RC97002/TDP 20-073 Page 2 of 3 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.

4. Statutory Authority Permitting Other Than Full and Open Competition.

The statutory exception permitting other than full and open competition for this acquisition is 41 U.S.C. 1901 (see also FAR 13.501(a)).

5. Rationale Justifying Use of Cited Statutory Authority.

Olympus is the only vendor that can provide an EUS solution that has an FDA Clearance for 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.

Compatibility with the currently-installed pulmonology and gastroenterology equipment at NMCSD, stated in Table 1, will also reduce the total procurement cost and reduce safety risks to patients. If a different EUS system were to be procured, then additional pulmonology and gastroenterology equipment would have to be procured at an estimated value of $831,532.08. Alternatives to an EUS system compatible with the currently installed pulmonology and gastroenterology equipment include diverting cases to other hospital departments for 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 alternative of diverting cases to other hospital departments will increase patient care time. An EUS system can complete the same required procedures with less safety risks to the patient.

Olympus is the only vendor that can provide an EUS solution that can function and interface with the currently-installed pulmonology equipment and gastroenterology equipment at NMCSD stated in Table1.

Olympus is the only vendor that can provide a complete EUS solution that meets the minimum requirements of the Government.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

Market research was conducted by technical experts from December 2019 to January 2020. This research consisted of reviews of similar previous procurements and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Bing, GSA Advantage and the ECRI sourcebook catalog. Vendors that can provide an EUS system include Olympus America, Inc. (Olympus), Boston Scientific, Pentax Medical Company (Pentax), Fujifilm Endoscopy (FUJI), CONMED Corporation (CONMED), Cook Medical Incorporated (Cook), Medtronic, Richard Wolf, and Cogentix Medical, Inc. (Cogentix).

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Boston Scientific, CONMED, Cook, Medtronic, and Richard Wolf cannot provide a fully functional EUS system, because Boston Scientific, CONMED, Cook, and Medtronic can only provide endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) and EUS accessories. Boston Scientific, CONMED, Cook, and Medtronic cannot provide the required components of a fully functional EUS system such as but not limited to ultrasound processor, wireless transmitter, wireless receiver, 4K monitor. Boston Scientific, CONMED, Cook, and Medtronic cannot provide a fully functional EUS system that 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. Thus, Boston Scientific, CONMED, Cook, and Medtronic do not meet the minimum requirements of the Government.

Cogentix and Richard Wolf can provide an EUS systems that is indicated for use in Trans-nasal Esophagoscopy, Cystoscopy, Bronchoscopy, Nasopharyngoscopy, Gynecology, Pulmonology, Spine Surgery, Thoracic, Surgery, or Urology procedures. The EUS solutions manufactured by Cogentix and Richard Wolf are not approved for evaluation of gastrointestinal (GI) tumors. Thus, Cogentix and Richard Wolf do not meet the minimum requirements of the Government.

Pentax and FUJI can provide an EUS solutions that is indicated for use in GI procedures. The EUS solution manufactured by Pentax and FUJI are not indicated for diagnosis and staging of cancer of the lungs, pancreatic diseases, gallbladder diseases, liver diseases, evaluation of lymphadenopathy, and evaluation of mesentery. Thus, Pentax and FUJI do not meet the minimum requirements of the Government.

Olympus is the only vendor that can provide an EUS solution that can function and interface with the currently-installed pulmonology equipment and gastroenterology equipment at NMCSD stated in Table 1. Olympus is the only vendor that can provide and EUS solution that 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. Olympus is the only vendor that can provide a complete EUS solution that meets the minimum requirements of the Government. This requirement will be posted to betaSAM in accordance with FAR 5.201(b)(1)(i). A Notice of Intent (NOI) is projected to be posted on or about 26 March 2020. Any sources expressing interest in response to the synopsis will receive consideration. If necessary, the J&A will be amended to address any responses to the NOI.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer has determined the anticipated cost to the Government of the supplies covered by this J&A will be fair and reasonable.

8. Actions to Remove Barriers to Future Competition.

For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contacts for the types of supplies covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible. Future requirements will be synopsized in accordance with FAR 5.203.