P03_JOFOC 36C257-25-AP-2637-FY25-1253 JOFOC NCO17 Olympus Scopes - HCA Approved__Redacted.pdf

Effective Date: 11/15/24

REVISION: 01

Acquisition ID#: 36C257-25-AP-2637

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN

ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C257-25-AP-2637

JOFOC: FY25 - NCO 17 – 1103

1. Contracting Activity: Department of Veterans Affairs (VA), Network Contracting Office 17, located at 5441 Babcock Rd, Suite 302 San Antonio, TX 78240, in support of Veterans Integrated Service Network (VISN) 17, South Texas Veterans Health Care System (STVHCS), Audie L. Murphy VA Medical Center at 7400 Merton Minter Boulevard San Antonio, TX 78229-4404.

2237: 671-25-4-039-0337

2. Nature and/or Description of the Action Being Processed: This procurement is for the STVHCS which requires the lease of endoscopes and peripheral equipment to include full-service maintenance that includes loaner equipment to maintain its Gastroenterology Endoscopy lab functionality. Procurement is in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items, specifically, FAR 13.501, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6. This procurement of leasing equipment and maintenance services for endoscopes and peripheral equipment will be awarded as a new firm-fixed price contract for a period of performance of a twelve-month base plus two twelve-month options. This procurement includes Federal Acquisition Regulation (FAR) clause 52.217-8, Option to Extend Services that will allow for extension up to six months if needed at time of contract expiration.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The chart below is the equipment and quantities requiring lease and included in the full-service maintenance plan.

Quantity Model Equipment Description One (1) ARIETTA 850 AT ARIETTA 850 AT Excl OLY Conf/Adv Feature One (1) AR850EXTWAR2YR AR850ExtWar2yr Four (4) GFUCT180CBEZ3-ALL GF-UCT180 SCOPE CABLE & ALL DEV w/o HOLE Four (4) GF-UCT180 Curvilinear EUS scope, 3.7 mm Four (4) NA-U200H-8025 EZ Shot 3 Plus 25G Asp Needle Four (4) NA-U200H-8022 EZ Shot 3 Plus 22G Asp Needle 5/bx Four (4) NA-U200H-8019 EZ Shot 3 Plus 19G Asp Needle 5/bx Four (4) MAJ-2056 DETACHABLE CABLE FOR EUS&EBUS S Two (2) GIF-XP190N GIF-XP190N ULTRA-SLIM SCOPE, 4-WAY, NBI Two (2) GIF-1100 GIF-1100 EVIS X1 Gastroscope Six (6) OFP-2 OFP-2 FLUSHING PUMP

Eight (8) OEV321UH OEV321UH UHD 4K 32 inch Monitor Eight (8) FLP-0002-17C MOUNTING ADAPTOR FOR FLAT PANEL Eight (8) IS40123 ZeroWireG2 Pair Eight (8) IS40116 ZeroWire G2 Pair Transm & Receiver

Sixteen (16) MAJ-2011 ATTACHMENT FOR UWIT Eight (8) IS40126 Adapter plate kit for ZeroWire G2 Seven (7) MAJ-2426 12G-SDI cable 1.5M

Acquisition ID#: 36C257-25-AP-2637

Seven (7) MAJ-2429 12G-SDI cable 8.5M Six (6) 3GDA 3GDA Mini-Converter Six (6) HDP3 HDP3 Mini Converter

Twelve (12) 9100 AJA Medical Grade PSU - 5VDC 5A One (1) CV-190 CV-190 EVIS EXERA III VIDEO PROCESSOR Six (6) CV-1500 CV-1500 Video System Center

Eight (8) PCF-HQ190L4AWS-ECV PCF-HQ190L Lower Kit Eight (8) PCF-HQ190L SLIM COLONO W/ DUAL FOCUS NBI Eight (8) PROTECHL ProTech Large Tip Protector 100/Box

Forty-Eight (48) ARV110 Endocuff Vision Med Blue I.D. 11.0 8/bx Twenty-Four (24) 345SVVO4 DISP 4 PC AWS VALVE SET 25/BX

One (1) GIF-1TH190-TTSTENT GIF-1TH190 TTS Stent Kit One (1) GIF-1TH190 EVIS Exera III gastroscope One (1) RWHS-3545I "REVOWAVE 0.035" "450cm STR HARD" One (1) ECBA-20-120-230 HANAROSTENT ESO TTS FC 20 DM 12CM 230 One (1) CLV-190 CLV-190 100V W/ POWER CORD (US) Six (6) UCR UCR WITH CYLINDER HOSE (US)

Seven (7) USB-3.5-10 CV-1500 - Provation Trigger Cable 10ft Twelve (12) CF-EZ1500DL EVIS X1 Video Colonoscope

Ten (10) GIF-EZ1500 EVIS X1 Video Gastroscope

Estimated value:

Base year: 9/23/2025 - 9/22/2026 Option year 1: 9/23/2026 – 9/22/2027 Option year 2: 9/23/2027 – 9/22/2028

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above The endoscope lease and services must be compatible in all aspects, form, fit, and function with the Olympus equipment currently used at all STVHCS stations in the Gastroenterology section. Procuring or leasing from a different vendor or utilizing a brand of endoscopes not compatible with the already owned and utilized equipment at STVHCS would require facility-wide replacement of VA owned Olympus equipment, to include replacement of consumable single use supplies that are currently compatible with existing equipment. This would cost the government over to replace.

Acquisition ID#: 36C257-25-AP-2637

While Olympus does sell equipment through third parties, their lease agreements for equipment with the U.S. Government are offered solely by Olympus as stated in their policy letter dated April 25, 2025. Further, repair of Olympus scopes requires the use of Olympus repair parts to retain scope image and scope safety. Per Olympus’ policy letter, Olympus does not sell repair parts to third parties; nor do they warranty scopes repaired by third parties as they do not authorize third party repairs. Accordingly, Olympus, a large business, is the only company capable of providing the services described in section three above without interrupting patient care and without duplication of costs that could not be expected to be recovered through competition.

Listed below is what the facility currently owns, is in use and what the leased items need to be compatible with.

• Towers (8)

• Workstations (13)

• Pillcam Recorders (2)

• Endoscopes (5)

• Esophagogastroduodenoscopy (EDG) (8)

• Endoscopic CO2 Regulation Units (6)

• Evis Exera Colonovideoscopes (8)

• Evis Excera Gastroscopes (12)

• Evis Exera III Colonoscopes (10)

• Evis Exera III Xenon Light Source (2)

• Monitors (12)

• Light Source (5)

• Olympus Flushing Pump (1)

• Video Duodenoscopes (2)

• Video monitors (6)

• Video Processors (5)

• Curvilinear EUS Scope 3.7MM (2)

• Adapters, blocks and tips for Olympus scopes

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: In accordance with FAR Part 10, market research was conducted from January 2025 to July 2025. The findings of the Market Research indicate that while other companies provide Olympus scopes for purchase, per Olympus’ policy letter, their lease agreements as well as their maintenance services with the U.S. Government are offered solely by Olympus. With current Olympus VA owned equipment in place, the customer must utilize Olympus scopes to maintain consistent patient care in the facility, without interruption, and at the least cost to the Government.

Due to the proprietary nature of Olympus leasing services, no further market research efforts were made as this requirement must be procured via sole source. Justification will be posted in accordance with FAR 13.501 and FAR 6.305.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The anticipated cost of this procurement is expected to be fair and reasonable, determined by comparing pricing to current General Service Administration (GSA) pricelists where prices are already determined fair and reasonable (FAR 13.106-3(a)(2)(iii)), by comparing to previously priced services for the same and similar services (FAR 13.106-3(a)(2)(ii)), and comparison to the Independent Government Cost Estimate (FAR 13.106-3(a)(2)(vi)).

Acquisition ID#: 36C257-25-AP-2637

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted through queries on U. S.

Small Business Administration’s Veteran Small Business Certification (VetCert) and Dynamic Small Business Search (DSBS), General Service Administration (GSA), Federal Procurement Data System (FPDS), National Acquisition Center (NAC) Contract Catalog Search Tool (CCST), Defense Logistics Agency Electronic Catalog (ECAT), UNICOR Federal Prison Industries, U.S. AbilityOne Commission, and VA Supply Chain Master Catalog.

• FPDS: Searched “Olympus Video Scope Lease” which resulted in 10 entries, all with

OLYMPUS AMERICA INC. None of the findings are viable options for this requirement.

• GSA: Searched “Olympus Video Scope Lease” which produced 1 result. The result found was

Olympus contract 36F79721D0168. 36F79721D0168 is an FSS contract in place with Olympus. This contract has terms and conditions that legal previously determined are not in the best interest of the government, therefore this FSS contract will not be utilized for this requirement.

• GSA: Searched under FSC Group 65, Part II A-9 resulted in 34 possible contractors, 12 of which are SDVOSBs. None were contacted due to the proprietary nature of the equipment leasing. The only vendor capable is Olympus and has an FSS contract, 36F79721D0168. This contract has terms and conditions that legal previously determined are not in the best interest of the government, therefore this FSS contract will not be utilized for this requirement.

• VetCert: Searched NAICS Code 532490 which resulted in 382 SD/VOSB potential vendors.

None of the vendors found were contacted based on the current infrastructure of STX and the proprietary nature of leased equipment.

• SBA DSBS: Searched NAICS Code 532490 and “scope” which revealed 1 possible SDVOSB vendor. The vendor found was not contacted based on the current infrastructure of STX and the proprietary nature of leased equipment.

• VA Supply Catalog: Searched “Olympus Video Scope Lease” which produced 166 results.

Only FSS contract 36F79721D0168 appears to be available for use, as the other contracts are specific to other agencies or VISNs. 36F79721D0168 is an FSS contract in place with Olympus. This contract has terms and conditions that legal previously determined are not in the best interest of the government, therefore this FSS contract will not be utilized for this requirement.

• NAC CCST: Searched Olympus “Gastroscope” which produced Olympus FSS contract 36F79721D0168. 36F79721D0168 is an FSS contract in place with Olympus. This contract has terms and conditions that legal previously determined are not in the best interest of the government, therefore this FSS contract will not be utilized for this requirement.

• UNICOR: Searched NAICS code 532490, which produced zero results.

• AbilityOne: Searched Olympus “Gastroscope”, which produced zero results.

• ECAT: Searched Olympus “Gastroscope”, which produced 2 results, SPE2D120D7008 with

Alliant Healthcare Products and SPE2DH24D0011 with Steris. None of the vendors found were contacted based on the current infrastructure of STX and the proprietary nature of leased equipment.

Olympus America, Inc. provided a sole source letter dated 04/25/2025 that stated that Olympus currently partners with one SDVOSB, however, only for equipment sales. The letter also states, “Olympus America Inc. does not have any authorized third-party firms for endoscope repair and maintenance services, nor does Olympus sell original equipment manufacturer parts or tools to any

Acquisition ID#: 36C257-25-AP-2637 third party.” Lastly, the letter states that using third-party for repair services will “invalidate the limited warranty, and it will invalidate the reprocessing (cleaning and disinfection) instructions provided in the device’s instructions.”

After reviewing the searches and in reviewing the Olympus policy letter, it was determined that this procurement must be a sole source due to the proprietary nature of the services and current VA owned equipment listed in section five above that it must be compatible with. Due to this, no further market research was conducted.

The Buy American Statute applies to leased equipment that are non-domestic per FAR 25.100(b).

This requirement does contain equipment that is non-domestic, therefore, the Buy American Statute applies and a determination of domestic non-availability waiver will be completed for all leased equipment that has a country of origin outside the U.S. Due to the current VA owned equipment that the leased equipment must be compatible with and the proprietary nature of that equipment, there are items required where no domestic items will fulfill the requirement.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

In addition to requiring compatibility as stated in section five above, the service owns Olympus manufactured equipment that is nearing end of life for which this procurement will include trade-ins.

Trade-ins can only be afforded when a purchase or lease is being processed. Utilizing a different brand would inhibit the ability to trade-in VA owned equipment estimated to be worth .

The equipment listed below is to be traded in:

Trade-In Equipment

Quantity Model Equipment Description One (1) ARIETTA 850 ARIETTA 850 Excl OLY Config EUS Process Eight (8) CF-HQ190L CF-HQ190L EVIS EXERA III HD COLONOSCOPE Six (6) CV-190 CV-190 EVIS EXERA III VIDEO PROCESSOR

Three (3) GF-UCT180 GF-UCT180 Curvilinear EUS scope, 3.7 mm Three (3) GIF-H190 GIF-H190 EVIS EXERA III HDTV GASTROSCOPE Seven (7) GIF-HQ190 GIF-HQ190 EVIS EXERA III HDTV DF NBI One (1) GIF-XP180N GIF-XP180N 5.5MM GSTROSCPE 4-WAY NBI One (1) GIF-XP190N GIF-XP190N ULTRA-SLIM SCOPE, 4-WAY, NBI Six (6) N3643340 CLV-190 NN EVIS EXERA III LIGHT SOURCE

Five (5) OEV-262H OEV-262H HIGH-DEFINITION LED L CD MONITO Six (6) OFP-2 OFP-2 FLUSHING PUMP

Eight (8) PCF-H190DL PCF-H190DL W/ SCOPEGUIDE

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Olympus America Inc.

3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034-0610 Tel: (800) 848-9024 Fax: (800) 228-4963