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Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 5 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C257-26-AP-2909

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C257-26-AP-2909

JOFOC: FY26 - NCO 17- 1054

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 17, located at 124 E HWY 67 Suite 100 Duncanville, TX 75137, in support of VA Texas Valley Coastal Bend Health Care System (VATVCBHCS) at 2601 Veterans Drive Harlingen, TX 78550-8942.

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

This procurement is for the leasing of Gastroenterology (GI) Scopes equipment and maintenance services and will be awarded as a new, firm-fixed price contract for a period of performance of a twelve-month base plus four twelve-month options against the following FSS contract:

Order against: FSS Contract Number: 36F79721D0168

Name of Proposed Contractor: Olympus America, Inc.

Street Address: 3500 Corporate Parkway, PO Box 610 City, State, Zip: Center Valley, PA 18034 Phone: 469-346-6056

(3) Description of Supplies or Services:

The VATVCBHCS, Harlingen Care Center in Harlingen (HCC), Texas, intends to lease 24 GI Scopes, their associated supporting equipment, and service maintenance to ensure mission readiness, provide safe patient care, and achieve compliance with clinical and policy requirements. Without timely access to scopes, the HCC would be unable to perform GI endoscopic procedures. This would stop routine and diagnostic screenings, leading to care backlogs and deferred tests which would lead to delayed or missed disease detection, with health risks for veterans.

The following chart shows the quantity and description for each piece of equipment that is required to be leased and included in the maintenance plan:

Model Equipment Kit Items Quantity

CF-EZ1500DL CF-EZ1500DL 7

GIF-EZ1500 GIF- EZ1500 9

PCF-HQ190L-

AWSBKT2

PCF- HQ190L and Device Kit

BW-412T DISP

COMBO

VHAPG Part 808.405-6 Limiting Sources Page 2 of 5 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C257-26-AP-2909

CLEANING

BRUSH 50/box :

DISP 3 PC AWS

VALVE SET 25/bx:

PCF-HQ190L SLIM

COLONO w/DUAL

FOCUS NBI:

ProTech Large Tip Protector 100/box

CV-1500 CV-1500 Video System Center

OEV321UH OEV321UH UHD

4k 32 inch monitor

GIF-XP190N GIF-XP190N

ULTRA-SLIM

Scope, 4-way, NBI

OFP-2 OFP-2 FLUSHING

PUMP

USB-3.5-10 CV-1500-Provation trigger cable, 10ft

(4) Identify the Authority and Supporting Rationale

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): 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;

FAR 8.405-6(a)(1)(C): 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.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

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

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. The scopes and maintenance services are highly specialized and must be compatible in all aspects, form, fit and function with the existing systems presently installed throughout the facility.

The leased GI scopes must be fully compatible with the existing Olympus GI Carts and associated supporting

VHAPG Part 808.405-6 Limiting Sources Page 3 of 5 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C257-26-AP-2909 equipment, ensuring seamless integration with current systems used for patient diagnostics and treatment. The GI Carts and associated supporting equipment do not accept alternate brands of scopes. Using an alternate product would not be compatible with equipment already purchased/owned and utilized by HCC. Obtaining an alternate product would require facility wide replacement of all VA owned Olympus equipment.

The duplication of cost to the Government is estimated to be . This would represent an unreasonable duplication of cost to the government. In addition to duplication of costs, the VA has some equipment that is at its end of life which has trade-in value at an estimated amount of Procuring a different brand of scope would not only cause a duplication of cost but would also not allow for the benefit of the trade-in value.

(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, Olympus is the only company capable of providing the supplies and services described above without the VHA experiencing a substantial duplication of cost that could not be expected to be recovered through competition in addition to the equipment having technological advances that provide a higher level of patient care.

(6) Describe the Market Research Conducted: Market research was conducted pursuant to RFO Part 10 and VA Acquisition Regulation (VAAR) 810.001-70 Market Research Policy.

Research was conducted by reviewing the results of recent market research undertaken to meet similar requirements, reviewing the Veteran Small Business (SBA) Certifications on the SBA Dynamic Small Business Search(DSBS) portal, querying the Governmentwide database of contracts and other procurement instruments intended for use by multiple agencies to include AbilityOne, Federal Prison Industries, Defense Logistics Agency Electronic Catalog (ECAT), reviewing the Federal Procurement Data System (FPDS), VA Supply Chain Master Catalog (SCMC), and General Services Administration (GSA). The Made in America Office “Make Onshoring Great Again” portal was also used to specifically identify domestic manufacturers for this procurement, and vendors were directly emailed for their capabilities to fulfill this need. No viable alternatives were located. Additional details follow:

Previous market research report revealed Federal Supply Schedule (FSS) contract 36F79721D0168. 36F79721D0168 is an FSS contract in place with Olympus and all items are on contract.

A Sole Source Letter was requested from Olympus America, Inc. The letter, dated 04/23/2026, states the following: “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 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.”

SBA DSBS: The database was searched using the following criteria: NAICS code- 532490; SBA Certifications- Veteran Owned Small Business (required) and/or Service- Disabled Veteran Owned Small Business (required). There were two results returned as active, but when the keyword “scope” was added to the search, zero results were returned.

FPDS Search: Searched “Olympus GI Scopes” which produced 18 results, none of which can be used for this procurement.

Searched AbilityOne by keyword “endoscope lease”; no results were returned.

Searched UNICOR by keyword “endoscope lease services”; 83 results were returned, VHAPG Part 808.405-6 Limiting Sources Page 4 of 5 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C257-26-AP-2909 however none fit the requirement.

Searched VA SCMC by keyword “Endoscope Lease”; then filtered by vendor “Olympus

America INC”; 55 results were returned. All listed contracts were specific to agencies and VISNs outside of VISN 17.

Searched GSA eBuy on 65IIA, Category A-200. Searched by keyword “Olympus” and “Endoscopy”. On 65IIA, category A-200 there were 47 contractors, however none will be utilized due to the proprietary nature of the requirement.

Directly emailed five entities for domestic comparability: Karl Storz Endoscopy-America Inc; Stryker & Co Inc; Medtronic Inc.; Boston Scientific; Johnson & Johnson Health Care Systems Inc. Only Boston Scientific responded with a ‘No’ on 5/19/26. There were no other responses received from the other entities.

Market Research report for contract 36C25726P0177 for similar equipment was reviewed. Results indicate there is only one source capable of providing the requirement, no domestic sources available, a BAA waiver was approved, and the MRR is not more than 12 months old.

Searched the Manufacturing Extension Partnership (MEP) National Network Open Supplier Scouting Opportunities on nist.gov for endoscopes. None were listed.

Searched manufacturing.gov by keyword “endoscopes”. No results returned.

Searched MIAO.gov “Make Onshoring Great Again Portal”-www.thomas.net” by key phrase :“endoscopy lease”, country of origin: “USA”; Industry: Medical/dental. 44 results were returned; none were accurate for this requirement.

(7) Any Other Facts Supporting the Justification: In addition to the form, fit, and function requirement in section five above, due to the Clinic’s need for treating patients within the HCC, it is necessary to continue using Olympus scopes to eliminate the need to retrain and to meet the Standard of Care requirements.

Moreover, the Veterans Health Administration (VHA) has a national directive mandating the standardization of endoscopes following infection control failures and patient safety risks discovered at some VA facilities in the late 2000s. All endoscopes, including those for cystoscopy procedures, must be reprocessed according to specific directives. Procuring scopes from the same vendor, when the other elements of the system is currently in place, allows for the integration of imaging and data into a single system, avoiding the complexity and risks of maintaining multiple, non-integrated systems (GAO 11-391).

(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: Ongoing market research will be conducted during the life of the contract to determine any market changes. Should the facility have a new requirement for similar items and services that do not require compatibility with existing equipment, further market research will be completed to determine availability of such items/services in the marketplace.

(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