LSJ.pdf

Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 3 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C250-26-AP-2988

DEPARTMENT OF VETERANS AFFAIRS

LIMITED SOURCES JUSTIFICATION

Order >SAT

GSAR 538.7104-3

Acquisition Plan Action ID: 36C250-26-AP- 2988

1. Contracting Activity: Department of Veterans Affairs, NCO10, Northern Indiana VAHCS, Marion, IN, submitted 2237 # 610-26-3-087-0042 for Roche Tests.

2. Description of Action: The Northern Indiana VAHCS is requesting Roche Tests.

Order against: FSS Contract Number: V797D-70105 (Expires Mar 15, 2027)

Name of Proposed Contractor: Roche Diagnostics Corp.

Street Address: 9115 Hague Rd City, State, Zip: Indianapolis, IN 46256 Phone: 317-854-2958

3. Description of Supplies or Services:

The estimated value of the proposed action is $564,293.89 The Period of Performance is 5/1/2026 – 10/31/2026.

The Northern Indiana VAHCS is requesting a 6-month bridge contract for tests that are required to perform on the Roche Cobas Pros that are currently in use.

4. Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service:

GSAR 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

GSAR 538.7104-3(b)(1)(ii): 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;

The tests are required to perform on the Roche Cobas Pros that are currently in use.

Accordingly, items can be procured by only one vendor, Roche Diagnostics Corp.

(OEM), as they are the only supplier of the tests.

GSAR 538.7104-3(b)(1)(iii): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

VHAPG Part 808.405-6 Limiting Sources Page 2 of 3 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C250-26-AP-2988

GSAR 538.7104-4: Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

5. Describe Why You Believe the Order Represents the Best Value consistent with GSAR 538.7102-2(b)(4) to aid the contracting officer in making this best value determination:

FSS includes specialized commercial pricing for the Big Four government agencies: VA, DoD, Public Health Service (PHS) (including Indian Health Service) (IHS)), and Coast Guard. This order represents best value to the government since FSS has already negotiated the best price for the government, and the items can be procured by only one vendor, Roche Diagnostics Corp.

6. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

SBA SBS queried using NAICS code 334516 and keywords “roche” with 0 SD/VOSB’s located.

Conducted a SBA SBS query by same NAICS with 332 results. The product is not on the Non- Manufacturer Rule Class Waiver list. Items on FSS contract V797D-70105. Items can be procured by only one vendor, Roche Diagnostics Corp., as they are the only supplier of the tests. Neither the VA Rule of Two nor SBA Rule of Two can be satisfied.

7. Any Other Facts Supporting the Justification: N/A

8. A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

Market research will continue to be conducted to determine if other sources are available to satisfy the Government’s requirements.

9. 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Rebecca K. Mcgauley Date Supervisory Clinical Laboratory Scientist Fort Wayne VAMC

VHAPG Part 808.405-6 Limiting Sources Page 3 of 3 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C250-26-AP-2988

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

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Todd Cress Date Contracting Officer Services and Commodities Team 6 Network Contracting Office 10

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Christopher Gundy Date Branch Chief Services and Commodities Team 6 Network Contracting Office 10