V797P-2065D-071.docx

VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >$150K FedBizOpps Justification and Approval Notice

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* = Required Field FedBizOpps Justification and Approval Notice Rev. March 2010 Q 36C24718F0703 Olympus Urology/ENT Scope Lease 35233 N 339113 Department of Veterans Affairs Birmingham VA Medical Center 700 South 19th Street Birmingham AL 35233

FAR 6.302-1

V797P-2065D 36C24718F0703 $207,596.83 03-01-2018

OLYMPUS AMERICA INC.

3500 CORPORATE PKWY

CENTER VALLEY

PA

18034 connie.ganier@va.gov Contracting Officer Email Address

LIMITED SOURCES JUSTIFICATION

ORDER >$150,000

FAR PART 8.405-6

Acquisition Plan Action ID: VA247-18-AP-1204

1. Contracting Activity: Department of Veterans Affairs, VISN 07, Birmingham VA Medical Center. Purchase order number 521-18-1-237-0006.

2. Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501).

Order against: |X| FSS Contract Number: V797P-2065D

3. Description of Supplies or Services:

The estimated value of the proposed action is for base and 2 option years.

Supplies and Services to be provided include - Olympus video ureteroscopes, Olympus video cystoscopes, Olympus dual action lithotripter. Olympus visera elite video platform with NBI, Olympus scope trays and accessories Olympus ENT rigid Sinuscopes and Olympus flexible rhinolaryngoscopes.

Lease of Urology and ENT specialties at the Birmingham VA Medical center through Olympus America, INC for standardization in accordance with VHA Integrated National Standardization Memorandum dated December 6 2010 and VHA Integrated Product Team Standardization guidance summary for Veterans Integrated Networks and VA Medical Centers Dated November 15, 2010. The standardization mandates compliance. This will be awarded as firm fixed contract for a period of 3 year (base plus 2-year options). This requirement is limited to one source due to this being a leased proprietary requirement.

(4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and (C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE.

|_| An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.

|X| Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

Olympus America, Inc. is the only company that can provide this requirement. The Birmingham VA Medical center is mandated to standard this equipment. This equipment offers NBI (Narrow Band Imaging) and is compatible with our existing video tower equipment. URF-V2/URF-V distal chip video ureteroscopies- minimum working channel diameter- 3.6fr +/- .4 fr. Minimum deflection of 250 degrees +1-s degrees tolerance. Minimum insertion tube size- 8.5fr +/- .5fr tolerance. Must also work with existing Visera elite video system. CYF-V2 Video cystoscopes-Minimum deflection up & down 200/120 degrees. +/- 10 degrees. Minimum working channel size of 5.4fr, tolerance of +/- 1.2 fr. Minimum working length 380mm. Tolerance +/- 20mm. The scopes must offer Narrow Band Imaging Capabilities. Must be compatible with existing Olympus video processor. CLV-s190- 300w xenon bulp. +/- 100w. Compatible with existing Olympus surgical video scopes. OTV-5190 processor-Compatible with existing Olympus surgical video scopes. Compatible with existing Olympus surgical light source and light guide cables. Provides Narrow Band Imaging Capabilities. High definition and analog video signals. Shockpulse lithotripsy system- Single lumen probe design. Proprietary pulsating energy frequency. Integrated hand controls for suction and energy. Minimum ultrasonic energy 20,000H5 (+1- 5,000hz) ENF-P4-3.4mm diameter. 130 degree angulation. 300mm in length. 2.7mm rigid telescope- Autoclavable. Three tube lense design for durability. Sterilization trays- Must be Sterrad NX and ETO compatible. Must be able to safely transport flexible endoscopes.

|_| In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

|X| Items peculiar to one manufacturer:

|X| A patent, copyright or proprietary data limits competition. The proprietary data is: Narrow Band Imaging By Olympus (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.)

|_| These are “direct replacements” parts/components for existing equipment.

|X| The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

Our current Olympus ENT and Urology endoscopes simply plug into the existing Olympus video processing equipment. The requested equipment will plug into this existing equipment as well. The newer video platform requested for 3k clinic will support existing scopes as well as the requested scopes and is compatible with all other devices on site. The lithotripter requested will work with all existing on site equipment.

(5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.404(d) TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION:

This equipment works with all of our existing Olympus video equipment. This equipment is fairly priced. This equipment offers proprietary Narrow Band Imaging that assists with diagnostics to treat veterans. It has been determined that there are currently no distributors that can provide this Olympus Lease requirement. The price has been determined to be fair and reasonable. An RFI was posted to FBO with no responses. In accordance with FAR 8.404(d) no other determination is necessary, however, additional discounts will be sought.

(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

This equipment is part of the Blanket Purchase Agreement with Olympus which has been mandated. Olympus is our current provider and offers a streamlined solution to surgical Urology and ENT products. Market Research was conducted and with this being a VHA National Standardization requirement from VHA Directive 2009-004 Handbook 176.1 and our services having been provided by Olympus America, Inc., contact was made with the provider (Olympus America Inc.) to determine if there were any distributors that could provide this service. It was determined that there are currently no distributors that can provide the Olympus Lease requirement. An RFI (36C24718Q9004) was also posted to FBO with no response.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION:

Olympus is currently in compliance with the VHA National Standardization policy. With this being a VHA National Standardization requirement from VHA Directive 2009-004 Handbook 176.1 and our services having been provided by Olympus America, Inc., contact was made with the provider (Olympus America, Inc.) to determine if there were any distributors that could provide this service. It was determined that there are currently no distributors that can provide the Olympus Lease requirement. An RFI (36C24718Q9004) was also posted to FBO with no response.

(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:

VISN7 is currently supported by Olympus and will ensure compliance with the present mandate and will continue to review Mandate for updates and/or changes. The Birmingham VA will continue to look for additional provides and/or distributors.

(9) REQUIREMENTS CERTIFICATION: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

NAME TITLE SERVICE LINE/SECTION

FACILITY

(10) APPROVALS IN ACCORDANCE WITH THE VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification

a. CONTRACTING OFFICER’S CERTIFICATION (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

b. One Level Above the Contracting Officer (Required over$150K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

NAME

NCO/PCO XX Duty Title

VHAPM Part 808.405-6 Limiting Sources Page 5 of 5 Original Date: 08/30/2017