P03-Single Source Justification MPT to SAT- cystoscopy trays.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 1 of 3 Acquisition ID#

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 12.102 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($350K)

Acquisition Plan Action ID: Cystoscopy Re-section Sets- 36C24226AP1300

1. Contracting Activity: Department of Veterans Affairs, VISN 2 Albany Stratton VHA Medical Center

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The supply requested is the Olympus Cystoscopy Resection Set, including the compatible Olympus ST-

CR2 Cystoscopy Resection Tray, which is required for rigid cystoscopy and transurethral resection

(TUR/TURBT) procedures performed in the Operating Room and Urology service. The set includes

Olympus rigid cystoscopes, working elements, sheaths, bridges, HF cable interfaces, and the OEM-validated three-section sterilization tray necessary for safe handling, protection, and reprocessing of

Olympus urologic instruments.

The intended use is to support surgical management of bladder tumors, BPH, foreign body removal, hematuria evaluation, and other urologic procedures requiring rigid cystoscopy and electrosurgical resection. These items are compatible only with the Olympus video towers, cameras, processors, light sources, and optical platform currently installed and standardized at this facility. The Olympus resection set and tray are designed specifically for Olympus optics and working elements and are the only OEM-validated, IFU-compliant products that can be used on this existing platform.

The estimated amount for this procurement is $34,791, which includes the complete Olympus cystoscopy resection set and the Olympus ST-CR2 resection tray, as required to maintain safe surgical operations and ensure continuity of urologic care for Veterans.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Olympus Cystoscopy Resection Set and Olympus ST-CR2 Resection

Tray possess unique, OEM-specific characteristics that make them the only supplies compatible with the existing urologic endoscopy platform currently installed at this facility. The facility is fully standardized on Olympus video towers, camera heads, processors, light sources, rigid cystoscopes, and resectoscopes. Olympus instruments utilize proprietary:

-Optical focal lengths and image geometry

-Scope-to-sheath alignment features

-Locking and coupling mechanisms

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Effective Date: 11/15/2024 Page 2 of 3 Acquisition ID#

-Working-element interfaces and electrode designs

-Light-guide connector configurations

-OEM-validated reprocessing and sterilization tray layouts

These characteristics are not interchangeable with other manufacturers such as Stryker, Karl Storz, or

Richard Wolf. Using non-Olympus scopes, sheaths, working elements, or trays would result in incompatibility with the existing video platform, incorrect optical alignment, inability to secure instruments within the resectoscope, and non-compliance with manufacturer Instructions for Use (IFUs).

This would violate AAMI ST79, VA Sterile Processing requirements, and Joint Commission standards.

Only the Olympus ST-CR2 resection tray is validated for use with Olympus rigid cystoscopes and resection instruments. Other trays do not match Olympus’ required geometry, silicone brackets, or reprocessing validations, and therefore cannot legally or safely be used to sterilize Olympus urologic instruments.

For these reasons, no other supplier or manufacturer can provide a product that is safe, compatible, IFU-compliant, or suitable for use with the current Olympus endoscopic system. Olympus is the sole source capable of providing the required cystoscopy resection set and resection tray for this facility.

4. Description of market research conducted and results or statement why it was not conducted:

Market research was conducted to determine whether alternative manufacturers could provide cystoscopy resection sets or resection trays compatible with the facility’s existing Olympus urologic endoscopy platform. The review included major urology instrument manufacturers (Olympus, Karl

Storz, Stryker, Richard Wolf), distributors, and generic tray manufacturers (Case Medical, Aesculap, and others).

The results confirmed that although multiple companies manufacture rigid cystoscopes, resectoscopes, and sterilization trays, none of these products are compatible with the current Olympus video tower, camera system, optics, working elements, sheaths, or OEM-required reprocessing configurations. Each manufacturer uses proprietary optical couplings, locking mechanisms, sheath geometries, working-element interfaces, and reprocessing tray layouts. These design differences prevent cross-compatibility and render non-Olympus products unusable with the facility’s standard platform. Furthermore, Olympus

Instructions for Use (IFUs) specify that Olympus instruments must be reprocessed only in OEM-validated trays, such as the Olympus ST-CR2, to maintain compliance with AAMI ST79, VA SPD requirements, and

Joint Commission standards. No third-party or competitor trays are validated for use with Olympus urology instruments.

GSA was searched for the term “cystoscopy resection tray,” and only 1 result was populated which was the Olympus ST-CR2.

Effective Date: 11/15/2024 Page 3 of 3 Acquisition ID#

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

GSA was searched for the term “cystoscopy tray,” producing 20 results with several of them being non-matching vendors mentioned above.

SBA was searched using the terms “cystoscopy tray,” and NAICS code 339112; yielding 4 small businesses. Olypmus products are not allowed to be distributed by 3rd party vendors however.

ADDS UP was searched for “cystoscopy tray,” and 4 vendors were located. Olympus among them.

FPDS was searched for “ cystoscopy tray,” and the VA has 5 past contracts on file for this item- one of which is through Olympus who no longer distributes through 3rd party vendors.

FPDS was searched for the term “cystoscopy,” and 256 past related contracts were identified through the VA.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR12.102. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Date

Jonathan Kilgore ContractingOfficer