0002-SSJ-Alexander.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 4

REVISION: 01

Acquisition ID#: 36C250-26-AP-0211

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-26-AP-0211

1. Contracting Activity: Department of Veterans Affairs, VISN 10, LTC Charles S. Kettles VA Medical

Center, 2215 Fuller Rd., Ann Arbor, MI 48105. The 2237 number is 506-26-1-5279-0002.

2. Nature and/or Description of the Action Being Processed: This is a request for a sole source for a new firm-fixed price contract to Leica Microsystems, Inc. (10 Parkway North, Ste. 300, Deerfield, IL 60015; 214-399-4286). FAR 13.5 Simplified Procedures for Certain Commercial Items: 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.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Leica Microsystems, Inc.

will provide emergency and non-emergency service repairs/replacement, labor, travel, software, technical support, and inspection to the currently owned Leica Microsystems equipment owned by the LTC Charles S. Kettles VA Medical Center (as specified in Silver Maintenance Agreement). The referenced maintenance agreement is for the Leica Silver Service Maintenance Plan which is a full-service coverage plan. This service plan would continue to cover the current equipment for Pathology and the Leica Aperio ScanScope CS2 (software updates only). A base (November 01, 2025

– October 31, 2026) plus four, one-year option years is being requested. Total for the base plus four, one-year option years is estimated at $507,030.58.

Effective Date: 11/15/24 Page 2 of 4

Acquisition ID#: 36C250-26-AP-0211

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): Leica Microsystems, Inc. is the OEM for this equipment and does not sell their proprietary information or replacement parts to 3rd party sources. It is proprietary equipment/software and only the manufacturer is authorized to service/update it. This is highly specialized equipment and is only able to be serviced by the manufacturer. Leica Microsystems, Inc. has provided an OEM Distributor Letter confirming the same.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought announcement was issued on SAM.gov on July 30, 2025 (36C25026Q0009), and only one response was received from Leica Biosystems, which is a part of Leica Microsystems, Inc.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The anticipated cost to the Government was determined to be fair and reasonable by comparing it to the IGCE.

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

Research Was Not Conducted: Even though VetCert database is no longer the program of record, VetCert search was used, to inquire about certified SDVOSBs and VOSBs using NAICS 334516. This query generated 233 results. Even though VetCert produced numerous results, the ability to examine or analyze them further is restricted by its set of single parameters within a limited menu.

An additional search was conducted seeking CVE-verified veteran-owned small business concerns through SBA using NAICS 334516, key words “Leica”. This query generated 2 self-certified owned small business concerns: Medical Equipment Source, LLC and Nexus Group, LLC. A review of all the small businesses uncovered that each small business has the keyword “Leica” in their profile settings. No other information related to Leica was mentioned.

Effective Date: 11/15/24 Page 3 of 4

Acquisition ID#: 36C250-26-AP-0211

Procurement History is as follows:

Contract Dollar Value Period of

Performance

NAICS/ Size std.

Procurement

Method

36C25023P0112 $172,494.06 11/1/2022-

10/31/2025

334516/ 500 employees

Sole Source

36C25019C0016 $280,662.72 10/1/2018-

10/31/2022

334516/

1,000 employees

Sole Source

A review of the Contract Opportunities on SAM.gov uncovered several opportunities for various Leica products/services across various government agencies. A further review of the Entity Information on SAM.gov indicated that Leica Microsystems, Inc., is an active entity and eligible to receive all awards.

A sources sought announcement was issued on SAM.gov on July 30, 2025 (36C25026Q0009), and only one response was received from Leica Biosystems, which is a part of Leica Microsystems Inc.

Additionally, the Service was provided with an OEM Distributor Letter from the Sr. Director of Customer Support of Leica Microsystems, Inc. that confirms that “Leica’s network of field service engineers and Exclusive Regional Dealers (ERD) are strategically located throughout the United States and Canada to support our Biosystems Division (BSD) customer base. These highly trained service engineers are factory certified and have access to the latest service and support information. We are FDA and Health Canada compliant to repair and provide preventative maintenance service on Leica’s BSD equipment. Our commitment to quality is evident not only through our service engineers, but also in our utilization of only OEM parts during repairs or preventative maintenance… As a result, Leica and its ERD networks are the only authorized source of factory trained service engineers to service and repair Leica Biosystems Division equipment.”

With these findings in mind, it’s determined that the VA Rule of Two has not been met for this requirement.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Leica Microsystems Inc.; 10 Parkway North, Ste. 300, Deerfield, IL 60015; 214-399-4286.

11. 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 VA will research the market prior to any purchases for these services to determine if there are any other sources with the capabilities to meet the Government’s requirements. However, until such time as the equipment reaches the end of its useful life or the Government decides to replace the

Effective Date: 11/15/24 Page 4 of 4

Acquisition ID#: 36C250-26-AP-0211 equipment before the end of the equipment’s useful life, there do not appear to be any actions which the Government can take to overcome any barriers to competition.

12. 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.

Katrina M. Radzioch Date Biomedical Engineer LTC Charles S. Kettles VA Medical Center, Ann Arbor, Michigan

13. 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.

Prepared by: Alexis S. Alexander Date Contract Specialist Network Contracting Office (NCO) 10

Cierra S. Joshua Date Contracting Officer Network Contracting Office (NCO) 10

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.

John M. Ryan Date Acting Branch Chief, Services Team #4

Network Contracting Office 10 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx