LSJ-TDP_18-016_Redacted.pdf

Log #18-10082

Form 02.4G.AA 18 Apr 2016

LIMITED SOURCE JUSTIFICATION

FOR FEDERAL SUPPLY SCHEDULE ORDER

1. Identification of agency and contracting activity, and specific identification of the document as a “Limited Source Justification (LSJ).”

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

2. Nature and/or description of contract action being approved.

This action is conducted under the authority of the Multiple Award Schedule Program (Title III of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 251, et seq.) and Title 40 U.S.C.

501, Services for Executive Agencies). This is a limited source action to be awarded as a new Federal Supply Schedule (FSS) order and/or modification of an existing order to the other than small business identified in paragraph 3 below. The placement of a Firm, Fixed-Price order is anticipated.

3. Description of the supplies or services required to meet the agency's needs (including the estimated value).

The Naval Medical Logistics Command has a requirement for endoscopy equipment: one (1) endoscope, gastrointestinal tract, upper tract, video/ultrasound [25-503], nine (9) gastroscopes, flexible video [17- 663], five (5) colonoscopes, video [17-665], one (1) duodenoscope, video [17-654], and four (4) video systems, endoscopic [15-967] for Naval Medical Center San Diego (NMCSD). The proposed solution shall provide endoscopy equipment for inpatient and outpatient adult gastrointestinal endoscopic procedures. The requirement shall include the aforementioned endoscopy equipment, as well as the additional accessories, as outlined in the table below:

All equipment shall be compatible with the installed base of Olympus endoscopy equipment (i.e.

Olympus video system towers, gastrointestinal endoscopes, and automated endoscope processor), and the endoscope sterilization equipment existing in the Gastroenterology and General Surgery Departments at NMCSD. The requirement shall have the vendor establish service maintenance agreements and provide on-site user support during working hours. The requirement shall include two (2) operation manuals and two (2) service manuals for the endoscopy equipment (i.e. endoscopes and video systems). The power requirements are 120 VAC, 60 Hz.

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.

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

Item/Description Qty.

Endoscopes (Total) 16

• Endoscope, gastrointestinal tract, upper tract, video/ultrasound 1

• Gastroscopes, Flexible, Video

-eight (8) gastrointestinal videoscope -one (1) therapeutic gastrointestinal videoscope

• Colonoscopes, Video 5

• Duodenoscope, Video 1

Video Systems, Endoscopic (Total) 4 Accessories (Total) 82

• Connector (for automated endoscope processor) 1

• Footswitch 1

• Roll stands 4

• Outlet Power Strips and Cable Cleats 4

• Wireless Transmitters 4

• Wireless Receivers 4

• Attachments (for wireless transmitters/receivers) 8

• Light Sources 4

• Interface Convert Devices 4

• Remote Cable Peripheral Devices 4

• Carbon Dioxide (CO2) Regulation Units 4

• Endoscopic CO2 Regulation Units 4

• Gastrointestinal CO2 Standard Sets 4

• Cylinder Hoses with Switchovers 4

• Support Rails 4

• Footswitch Holders 4

• Universal Storage Containers 4

• High Definition Display Monitors 4

• Suction Pumps 4

• Rail Clamps 4

• Side Shelves 4

• Videoscope Cables 4 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.

The proposed source is Olympus America, Inc. of 3500 Corporate Parkway, Center Valley, PA 18034.

Navy Operation and Maintenance Fiscal Year 18 funds in the amount of will be used to procure the endoscopy equipment.

4. The authority and supporting rational (see 8.405-6(a)(1)(i) and (b)(1)) and, if applicable, a demonstration of the proposed contractor's unique qualifications to provide the required supply or service.

The statutory authority which permits restricting consideration of schedule contractors to fewer than that required in FAR 8.405-1 is 41 U.S.C. 251, as implemented by FAR 8.405-6.

Olympus America, Inc. (Olympus) is the only manufacturer capable of meeting the minimum requirements of the Government. Olympus is the only manufacturer capable of providing endoscopes, gastroscopes, colonoscopes, duodenoscopes, and endoscopic video systems that are compatible with the installed base of Olympus endoscopy equipment (i.e. gastroscopes, endoscopic video systems) in the Gastroenterology and General Surgery Departments at Naval Medical Center San Diego (NMCSD). Only Olympus endoscopes can directly interface with Olympus endoscopy video systems, and only Olympus video endoscopy video systems can directly interface with Olympus endoscopes. Endoscopes and endoscopic video systems provided by other manufacturers cannot directly interface with the Olympus endoscopes and endoscopic video systems. NMC San Diego has an installed base of Olympus endoscopy towers (i.e. video processors and light sources), and Olympus endoscopes (including colonoscopes, gastroscopes, gastroduodenoscopes, etc.) valued at a total of $3,258,161.74. Procurement of an alternative manufacturer would require additional, redundant costs to the government. Thus, Only Olympus can provide equipment that meets the minimum requirement of the Government and is available on the Federal Supply Schedule.

5. A determination by the ordering activity contracting officer that the order represents the best value consistent with 8.404(d).

GSA has determined the prices of supplies and the schedule contracts to be fair and reasonable for the purpose of establishing the schedule contract. Therefore, ordering activities are responsible to make a separate determination of fair and reasonable pricing for individual orders. The Naval Medical Logistics Command Contracting Officer will determine, using the procedures in FAR 15.404-1 that the prices are fair and reasonable and will document such determination with a level of detail commensurate with the complexity and circumstances of each order.

6. A description of the market research conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Market research was conducted from February 2018 to March 2018. Research included references and information derived from Internet searches via Google, Defense Medical Logistics Standard Support (DMLSS), GSA Advantage, and the ECRI Sourcebook. It was determined that endoscopy equipment can be provided by the following manufacturers: FujiFilm, Karl Storz Endoscopy-America, Inc. (Karl Storz), Olympus America, Inc. (Olympus), and Pentax of America, Inc. (Pentax).

The endoscopy equipment must directly interface with the existing Olympus gastroscopes and Olympus endoscopic towers, which include the video (processor) systems and additional Olympus accessories (i.e.

light sources) at Naval Medical Center San Diego (NMCSD. In addition, endoscopic systems manufactured by Olympus are only compatible with endoscope models manufactured by Olympus. Only Olympus can manufacture endoscopes, gastroscopes, colonoscopes, duodenoscopes, and respective endoscopic video systems and accessories purchasable on the Federal Supply http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/08.htm#P286_49080 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/08.htm#P83_13798

Schedule. Thus, only Olympus manufactures endoscopy equipment that meets the minimum requirements of the Government.

7. Any other facts supporting the justification.

This procurement uses a GSA Schedule and will be solicited and awarded in accordance with FAR Subpart 8.4.

8. A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

All future requirements will be handled on a case-by-case basis.

TECHNICAL AND REQUIREMENTS CERTIFICATION

Required by FAR 13.106-3(b)(3)

I certify that the facts and representations under my cognizance which are included in this justification, which form a basis for this justification, are complete and accurate.

Phone Date Technical Cognizance

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

Contracting Officer

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Approval and found to be legally sufficient, based on these facts, to the best of my knowledge and belief.

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000 to $12.5M)

Competition Advocate

APPROVAL BLOCK COMPETITION ADVOCATE