JandA - Attachment - Sole Source Justifcation GSAM.71043(b) over SAT-_Redacted.pdf

Request for Sole Source Format >SAT GSAM/R 538.7104-3(b) Sole Source Justifications - Federal Supply Schedule Ordering

Procedures

SOLE SOURCE JUSTIFICATION

GSAM/R 538.7104-3(b)

This justification aligns with the deviation outlined in the Revolutionary FAR Overhaul (RFO) for FAR 8.4 - Ordering under the Federal Supply Schedule and GSAM/R 538.71, as required by Executive Order (E.O.) 14275, Restoring Common Sense to Federal Procurement, signed April 15, 2025. Deviation effective date: November 3, 2025.

Acquisition Plan Action ID:_36C247-26-AP-1233

1. Contracting Activity: Department of Veterans Affairs, VISN 07, Tuscaloosa, AL Medical

Center, 3701 Loop Rd, Tuscaloosa, AL 35404 2237 # (679-26-3-028-0011).

2. Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). This is to procure a new Cost Per Test Urinalysis Solution for the Tuscaloosa VA Medical Center Laboratory for Chemistry and Microscopy Reportable.

Order against: FSS Contract Number: _ V797D-40235

Name of Proposed Contractor: SYSMEX AMERICA, INC

Street Address: 577 APTAKISIC RD

City, State, Zip: LINCOLNSHIRE, IL 60069

Phone: 847-996-4500

3. Description of Supplies or Services:

The Tuscaloosa VA Medical Center has a need for two Automated Urinalysis Analyzers, a primary and back-up analyzer for urinalysis testing. Analyzers are needed to conduct urinalysis tests on a Cost-Per-Test (CPT) / Cost-Per-Reportable-Result (CPRR) (including all calibrators, quality controls, etc.) lease for an integrated automated urinalysis system.

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.

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

GSAM/R 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;

GSAM/R 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.

GSAM/R 538.7104-3(b)(1)(iv): It is necessary to place the order with a particular FSS contractor to satisfy a minimum guarantee established in the FSS BPA; or

GSAM/R 538.7104-3(b)(1)(v): A law expressly authorizes or requires that the purchase be made from a specified source.

GSAM/R 538.7104-4: Items peculiar to one manufacturer:

5. Describe Why You Believe the Order Represents the Best Value consistent with GSAM/R 538.7102-2(4) to aid the contracting officer in making this best value determination: The service equipment UN-3000N-111 is compatible with the Clinitek. The CLINITEK Novus can be configured and integrated with the Sysmex UN-Series, providing a customized and scalable urinalysis testing solution. While the CLINITEK Novus and CLINITEK Status (to be used in the urgent care clinic) analyzers use different physical reagent strip formats, both are manufactured by Siemens and use harmonized dry-chemistry test pad formulations and analyte methodologies. Maintaining a single-manufacturer urinalysis chemistry platform ensures better cross-platform correlation, reduces result variability, and minimizes the validation burden compared to mixing Siemens point-of-care urinalysis (Status) with a different manufacturer’s main-lab urinalysis system. Using a non-Siemens analyzer for main-lab urinalysis would require ongoing cross-manufacturer correlation studies, increased QC divergence tracking, expanded staff training, and increased risk of interpretive variation in patient results. Selecting the Sysmex integrated solution therefore supports standardization, operational efficiency, and clinical reliability across point-of-care and core laboratory workflows. This helps prevent the need for additional equipment and minimizes the risk of procedural errors through standardization and the reduction of manual processes. While some offer a microscopic solution, others do not. With other brands the specimen can be contaminated. The lack of contamination allows for specimens to be used for testing in other areas of the laboratory. UDM, is an intelligent data management program that provides users with an intuitive and streamlined interface for urinalysis test results. Additionally, the BCQM program increases laboratory efficiency with automated urinalysis quality control management. The CLINITEK Novus uses common dry pad analytes, ensuring standardized results across your laboratory network regardless of testing volumes.

Base Year June 19, 2026 – June 18, 2027

1st Option Period June 19, 2027 – June 18, 2028

2nd Option Period June 19, 2028 – June 18, 2029

3rd Option Period June 19, 2029 – June 18, 2030

4th Option Period June 19, 2030 – June 18, 2031

Total

6. Describe the Market Research Conducted among schedule holders and the results, or a statement of the reason market research was not conducted. Market research was conducted. The Contracting Officer reviewed the SBA database under the applicable NAICS code to identify verified SDVOSB/VOSB firms capable of supplying Sysmex Urinalysis Solution. No verified SDVOSB or VOSB firms in SBA are authorized to manufacture or distribute Sysmex urinalysis reagents. Sysmex maintains proprietary control over its analyzer consumables, and only Sysmex or a Sysmex-authorized distributor may supply the required solution. The urinalysis reagent formulation is specific to Sysmex analyzers used at the facility; therefore, no equivalent alternative exists. Review of prior procurement history, GSA/FSS availability, and commercial catalogs confirmed that the required Sysmex reagents are not competitively available.

7. Any Other Facts Supporting the Justification:

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: The agency will continue to monitor advancements in urinalysis platforms

Sysmex is the sole manufacturer and proprietary rights holder of the Urinalysis Solution required to operate the facility’s Sysmex urinalysis analyzer system. The formulation, calibration compatibility, and quality control parameters are unique to Sysmex and are not shared with or available to third-party manufacturers. Because the analyzer system requires Sysmex-branded reagents for proper calibration and validated operation, no specification can be developed that would allow for full and open competition without risking system failure, invalid test results, warranty violations, or unacceptable clinical risk to patient care. The wagon feature allows for easier placement within the laboratory.

Currently there is limited spacing and the laboratory will only be removing a counter to accommodate system placement and will be done by the Engineering Department at no cost to the laboratory.