808.405-6 Justification_MPT-SAT Ultrasound Bronchoscope red.pdf

Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 3 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C248-26-AP-4791

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID:

1. Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office

08, VISN 8 South Team Contracting Office, in support of VA Caribbean Healthcare System located at 10 Casia Street, San Juan, Puerto Rico, 00921,for Pulmonary Section.

2237 Number:

2. Description of Action: The VA Caribbean Healthcare System (VACHS), Pulmonary Section, requires the acquisition of an Ultrasound Bronchoscope to support diagnostic and interventional pulmonary procedures. This action is a new requirement and will be awarded as a firm-fixed price (FFP) Federal Supply Schedule (FSS) order.

Order against: FSS Contract Number: 36F79721D0168

Name of Proposed Contractor: Olympus America Inc.

Street Address: 3500 Corporate Pkwy City, State, Zip: Center Valley, PA 18034 Phone: (484) 896-5833

3. Description of Supplies or Services:

The estimated value of the proposed action is with no options included.

The VA Caribbean Healthcare System (VACHS), Pulmonary Section, requires the purchase of one

(1) Olympus America Inc. BF-UC190F Ultrasound Bronchoscope and one (1) Olympus America Inc. MAJ-2056 Detachable Cable for Endoscopic Ultrasound (EUS) and Endobronchial Ultrasound (EBUS) systems. These items are essential to support diagnostic and interventional pulmonary procedures, including EBUS-guided biopsy and mediastinal staging.

This procurement is for brand-name equipment, as the specific features, functionality, and full compatibility required for VACHS’s clinical systems are proprietary to Olympus America Inc. and necessary to meet the Government’s minimum requirements. The proposed action is a new, firm-fixed-price (FFP) Federal Supply Schedule (FSS) order. No options are included, and the requirement is not a modification of an existing order.

Market research was conducted in accordance with FAR Part 10 and VAAR 810.001-70. In alignment with the Veterans First Contracting Program (38 U.S.C. §§ 8127 and 8128) and VAAR

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Acquisition ID#: 36C248-26-AP-4791

Subpart 819.70, the Contracting Officer evaluated the mandatory order of priority—first considering verified Service-Disabled Veteran-Owned Small Businesses (SDVOSBs), followed by verified Veteran-Owned Small Businesses (VOSBs)—when identifying potential sources under the Federal Supply Schedule.

Market research determined that the required brand-name equipment is manufactured exclusively by Olympus America Inc. A market survey completed on July 10, 2026, identified one SDVOSB authorized to resell Olympus America products on an open-market basis.

However, I am not confident that fair and reasonable pricing will be received through a formal competitive solicitation. No other manufacturers or alternate products were identified that meet the Government’s minimum technical, performance, or compatibility requirements.

4. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

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

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)(i)(B));

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405- 6(a)(1)(i)(C)); or

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

5. Rationale/explanation to support cited authority: This acquisition is being conducted in accordance with FAR 8.405-6(b) because the Government's minimum needs can only be satisfied by a specific brand-name product.

The VA Caribbean Healthcare System (VACHS), Pulmonary Section, requires the purchase of an Olympus America Inc. BF-UC190F Ultrasound Bronchoscope and Olympus America Inc.

MAJ-2056 Detachable Cable for Endoscopic Ultrasound (EUS) and Endobronchial Ultrasound

VHAPG Part 808.405-6 Limiting Sources Page 3 of 3

Acquisition ID#: 36C248-26-AP-4791

(EBUS) Systems. These items must be fully compatible with the Olympus Premier Plus Ultrasound Processor (EU-ME2), Olympus light sources, imaging tower, and Olympus ultrasound endoscopes currently installed and in clinical use at VACHS.

The Olympus BF-UC190F bronchoscope is specifically designed to integrate with the existing Olympus endoscopic ultrasound platform. Due to the proprietary design and interface requirements of the Olympus system, no other manufacturer's endobronchial ultrasound bronchoscope is compatible with the Government's existing equipment. Use of a different manufacturer's bronchoscope would not interface with the current Olympus processor, light source, imaging tower, or associated ultrasound components and would therefore fail to meet the Government's minimum compatibility and operational requirements. Procuring an alternate brand would require replacement of the existing Olympus platform, resulting in unnecessary duplication of equipment, additional costs to the Government, and disruption to patient care and clinical operations.

Market research identified other manufacturers that produce endobronchial ultrasound bronchoscopes; however, those products cannot be used because they are not compatible with the existing Olympus Premier Plus Ultrasound Processor (EU-ME2) and related proprietary Olympus equipment currently in service at VACHS. Accordingly, only the Olympus BF-UC190F Ultrasound Bronchoscope and the associated MAJ-2056 Detachable Cable satisfy the Government's minimum needs.

The required brand-name products are available under Federal Supply Schedule (FSS) Contract No. 36F79721D0168 with Olympus America Inc., which is the only authorized source for these items under the applicable FSS contract.

6. BRAND NAME ONLY: This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on e-Buy, as required by FAR 8.405-1(e).

7. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.