P03_13.5 Sole Source Justification_BC Signed_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24 Page 1 of 3

REVISION: 01

Acquisition ID#: 36C241-25-AP-3354

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C241-25-AP-3354

1. Contracting Activity: Department of Veterans Affairs, VISN 01, Providence Medical Center

Healthcare Technology Department; 2237: 650-25-3-7440-0068.

2. Nature and/or Description of the Action Being Processed: This procurement is for Stryker ProCare Services 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 Acquisitions Proceduares are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This will be awarded as a new firm-fixed priced contract to include a base plus two (2) option years; for the base and each option year for a total contract value of

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The contractor shall provide all tools and equipment necessary to properly and safely perform preventative and maintenance services set forth to ensure uptime capability of the Stryker Operating Room (OR) integration system, ProCare. This shall include, but is not limited, to all Personal Protective Equipment (PPE), tools, replacement parts, and authorized personnel which may be required for the work to be completed in a safe manner.

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 (applicability of authority): The Stryker equipment in place at Veteran Affair Medical Center(VAMC) Providence to fall under this service agreement require only Stryker-authorized technicians to perform the work. Stryker does not sell or otherwise make available to any non-Stryker certified repair parties new or used repair parts of any sort that

Effective Date: 11/15/24 Page 2 of 3

Acquisition ID#: 36C241-25-AP-3354 requires Stryker training for installation. Without specific factory training, factory-authorized repair parts, and a comprehensive knowledge of the validated repair process, a significant decline in performance and reliability could result from a noncertified repair and may have considerable patient safety ramifications. Additionally, Stryker confirms, via an email exchange with Ken Baer, Sr.

ProCare Client Manager, it reserves the right to invalidate product warranties and attachment replacement coverage if repairs are performed by any party other than authorized Stryker service technicians. An additional sole source letter dated March 14, 2023 was provided.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: In response to the initial market research survey, the Original Equipment Manufacturer (OEM), Stryker, provided a sole source letter stating only authorized Stryker service technicians can perform the services requested. This requirement is pending the results of an intent to sole source posted 4/30/2025, 36C24125Q0426. No responses have been received to date.

6. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: AddsUP (Analytics, Data and Decision Support Unified Platform) was surveyed and the proposed pricing was found to be consistent with a previous acquisition 36C26122P0896 for $15,440.63 per month.

7. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: A search on Sam.gov with NAICS 811210 was conducted with 0 results. A Sam.gov search with keyword “Stryker” resulted in 6 Tier 1 vendors. A search on Vetcert with NAICs 811210 resulted in 320 results. A search in DSBS with NAICs 811210 results in 167 Tier 1 vendors. A narrower search on DSBS with keyword “Stryker” yielded 0 results. A search on SCMC with keywords “Stryker Procare” resulted in 14 contracts awarded to OEM Stryker. A search on GSA Advantage services with keyword “Stryker” resulted in 32 vendors. A search in GSA elibrary with keyword “Stryker Procare” yielded 0 results. A search in GSA eLibrary for 65 II A-9 contracts resulted 36 vendors; however the contracts listed were not relevant to this requirement. A search in Addsup resulted in two Service Disabled Veteran Owned Small Businesses (SDVOSBs). A market research survey was conducted with Large Business (LB) OEM. The OEM confirmed only authorized Stryker service technicians are able to perform the services due to applicable technician certifications and sole source nature of repair and replacement parts. A sole source letter to support this statement is included in this report and on file.

This requirement is pending the results of an intent to sole source posted 4/30/2025, 36C24125Q0426. No responses have been received to date.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition: Individuals conducting installation and/or servicing of Stryker Communications are subject to the FDA regulations and must be certified by an authorized Stryker representative. Doing so without certification risks a void in the warranty of the Stryker Communications product and subject to full price for any and all repairs.

9. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: N/A

10. 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

Effective Date: 11/15/24 Page 3 of 3

Acquisition ID#: 36C241-25-AP-3354

Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future service, maintenance and support procurments to be competed. All future requirements will be handled on a case-by-case basis to determine any future acquisition strategy.

11. 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.

Nicole Quintal Date Clinical Engineer VAMC Providence, RI

12. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. 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.

Ashley Kenyon Date Contracting Officer NCO 1 / RPO East

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Sheryl Anthony Date Branch Chief

NCO 1 / RPO East

NICOLE QUINTAL

Digitally signed by NICOLE

QUINTAL

Date: 2025.04.29 16:26:51 -04'00'

ASHLEY KENYON Digitally signed by ASHLEY KENYON Date: 2025.04.30 06:25:29 -04'00'

SHERYL ANTHONY Digitally signed by SHERYL ANTHONY Date: 2025.04.30 08:02:37 -04'00'