About this file

This Federal Supply Schedule Limited-Sources Justification documents a sole-source procurement for a Sysmex XN450 Hematology Analyzer for the Indian Health Service (IHS) Laboratory Department at the Uintah-Ouray Service Unit in Fort Duchesne, UT. The acquisition is for a Cost Per Test Supplies and Service Agreement with a base year and four option years, utilizing Other Funds (IHS1506801) with a firm-fixed price structure. Sysmex America Inc. is the sole proposed contractor, as they are the exclusive manufacturer of the Sysmex line of hematology analyzers and reagents used in the United States, with service engineers specifically trained and certified to service Sysmex equipment.

The procurement was initiated through Sources Sought Notices posted on GSA eBuy and SAM.GOV from July 18 to July 28, 2025, during which only one mandatory source response was received from Sysmex America Inc. under VA Contact No. V797D10234. The contract will be awarded against the Federal Supply Schedule using the Multiple Award Schedule Program authority, with justification based on the unique and specialized nature of the supplies, as Sysmex is the sole manufacturer of these specific hematology analyzers and associated supplies used in clinical laboratory settings.

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FEDERAL SUPPLY SCHEDULE

LIMITED-SOURCES JUSTIFICATION

Acquisition Title: Sysmex NX-450 H ematology Cost-Per-Test, One Base Year and Four Option Years

Agency: �IIH_s _____ �

Acquisition Year: �l20_2_s __ �

Author: I

2. Description of Action:

Nature: [gJ New Requirement D Follow-on Requirement

D Modification to Existing Purchase Order/Contract Num ber:

Pricing: [gJ Firm-Fixed Price D Time & Materials D Cost

D Other:

Funds: □ OMA [gJ Other Funds: IHS1506801

Name of Proposed Contractor(s):�ls_y _s _m _e _x _A _m_e_r _ic _a _ln_ c _______________________ � Street Address: �I5 _7 _7 _A_p _ta_k_is_ic_R_d ________________________ �

City, State, Zip: luncolnshire, IL 60069

3. Description of Supplies or Services:

Sysmex XN450 Hematology Analyzer, Cost Per Test Supplies and Service Agreement for the Laboratory Department at the Uintah-Ouray Service Unit located in Fort Duchesne, UT.

Briefly describe the supplies or services to be provided, including make & The estimated value of the proposed action, including all options, is $ model number where appropriate. Indicate whether the item to be procured is peculiar to one manufacturer (e.g., a particular brand name, product, or a feature of a product, peculiar to one manufacturer). If applicable, include quantities of supplies or period of performance for services. Provide information for any options included in the order. If the action is a modification to an existing order, distinguish clearly between the work covered by the basic order and the work to be obtained by the proposed modification.

4. Authority:

[gJ ORDER AGAINST FSS: Authority of the Multiple Award Schedule Program, Title Ill of the Federal Property and

Administrative Services Act of 1949 (41 U.S.C. 251, et seq.); Title 40 U.S.C. 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception and for each discuss how the cited authority applies in accordance with FAR 8.405-6(c)(2)(iv).

D An urgent and compelling need exists, and following the procedures would result in unacceptable delays (FAR

8.405-6(a)(1 )(i)(A));

Name:

Position Title:

Email address:

Laboratory Supervisor/Manager

Signature

Date:

9. Best Value Determination. By my signature below, after review of the relevant documents, I have determined that the order subject to this Limited-Sources Justification represents the best value for the Government as set forth in FAR 8.404(d), and constitutes a fair and reasonable price. The basis for my determination is as follows:

The VA Contracting Officer has already determined the prices for supplies under Schedule VA Contract V797D10234 to be fair and reasonable, FAR 8.404(d) Pricing.

10. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this sole source justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Name: Phone:

Signature: I Date:

11. Legal Review:

All J&As equal to or greater than $68 million must have a legal review from the General Law Division of the Office of the General Counsel prior to sending it to the Department.

12. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name: Phone:

Signature: Date:

13. Office of Small and Disadvantaged Business Utilization

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name: Phone:

Signature: Date:

14. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million value calculated including all options)):

I Name:

I

Phone:

Signature: Date:

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