Stryker Camera/Endoscopes 695A40060

DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID:

36C252-24-AP-1299 Contracting Activity: Department of Veterans Affairs, VISN 12, Milo C. Huempfner Department of Veterans Affairs Outpatient Clinic, Veterans Health Agency Great Lakes Acquisition Center (NCO 12).

2237: 695-24-2-969-0103.

Nature and/or Description of the Action Being Processed: This is a justification for a firm fixed price procurement for new Stryker Sales, LLC ( Stryker ) replacement endoscopy cameras and light sources in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

Description of Supplies/Services Required to Meet the Agency s Needs: The Milo C. Huempfner Department of Veterans Affairs Outpatient Clinic located in Green Bay, WI has the requirement for new replacement endoscopy cameras and light sources. Delivery is required as soon as possible. The estimated value is [REDACTED].

LIN Item Number Description Qty Unit 0001 1688010000 PKG, 1688 CAMERA CONTROL UNIT (CCU) 4 EA 0002 0220230300 PKG, L11 LED LIGHT SOURCE WITH AIM 4 EA 0003 1688210122 1688 AIM 4K CAMERA HEAD AND AIM 4K COUPLER KIT 8 KT 0004 0233050400 FG, SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY, 5 MM 8 EA 0005 0233050087 ESST HENKE SCOPE ADAPTER 20 EA 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 (X) Unusual and Compelling Urgency (X) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services (X) International Agreement (X) Authorized or Required by Statute (X) National Security (X) Public Interest Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Milo C. Huempfner Department of Veterans Affairs Outpatient Clinic requires replacement cameras and light sources for their endoscopes to be utilized in the Surgery Department.

Only Stryker 1688 AIM Cameras and Light Sources can be utilized for this procurement. The Stryker 1688 system is the only system that utilizes Near Infrared (NIR) imaging in conjunction with Indocyanine green (ICG) dye to create three separate imaging modalities that creates contrast and fluorescence during procedures without additional equipment requirements. These modalities, in addition to the standard white light modality, create four individually capable imaging modalities for different scenarios.

This greatly increases the variety of cases that can be successfully performed. Additionally, the Stryker 1688 AIM is the only brand of video system that is compatible with currently used Stryker rigid endoscopes, arthroscopes, and laparoscopes used the Green Bay Surgery Department. Purchasing another brand would require replacement of all parts and related handpieces.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: This acquisition will be competed among eligible SDVOSB vendors. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Anticipated cost will be considered fair and reasonable IAW FAR 13.106-3(a)(1): whenever possible, base price reasonableness on competitive quotations or offers.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: A VetCert search with NAICS 334510 showed 310 VOSB or SDVOSB results. There are two known authorized SDVOSB distributors for Stryker endoscopy equipment on the open market. Appropriate clause 52.225-1 Buy American-Supplies and provision 52.225-2 Buy American Certificate will be included in the solicitation to ensure Buy American Statute compliance.

Trade Agreement Act are excepted by FAR 25.401(a)(1), set-asides for small businesses. Any Other Facts Supporting the Use of Other than Full and Open Competition: None. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: [REDACTED].

A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

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 and belief. [REDACTED] Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer or Designee s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Jim R. Hedman Contracting Officer NCO 12