P03 PG_Part808.405-6_Atch2_Limiting_Sources_Justification_OVER_SAT 2.pdf

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Abbott iSTAT Reagents - BPA
Solicitation number
36C26326A0003
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This Limited Sources Justification document details a contract for the Department of Veterans Affairs, specifically Veterans Integrated Service Network 23 (VISN 23), to acquire Abbott i-STAT test cartridges, controls, and calibration materials. The proposed order is against Federal Supply Schedule (FSS) Contract Number 36F79721D0233 with Abbott Laboratories Inc, located in North Chicago, Illinois. The contract has two ordering periods from 10/01/2025 to 09/30/2027, with an estimated total value of $533,857.88 and a contract ceiling of $740,000.00.

The justification emphasizes that Abbott Laboratories is the sole source for these proprietary reagents, as they are the original equipment manufacturer of the iStat Handheld Analyzer. The document notes that the existing analyzers are currently owned by multiple sites within VISN 23, and replacing the equipment would be costly. Market research confirmed Abbott's exclusive capability to provide these supplies. The agency commits to monitoring the marketplace for future competitive solutions and potentially including interoperability requirements in upcoming acquisitions.

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Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C263-24-AP-5119

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C263-24-AP-5119

(1) Contracting Activity:

Department of Veterans Affairs, Network/Program Contracting Office 23, in support of Veterans Integrated Service Network 23 (VISN 23).

2237: Funded through BPA Calls

(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).

VISN23 requires a new iStat reagent contract to support various VA medical facilities.

Order against: FSS Contract Number: 36F79721D0233

Name of Proposed Contractor: ABBOTT LABORATORIES INC

Street Address: 100 Abbott Park RD

City, State, Zip: North Chicago, Illinois

Phone: (224)416-2858

(3) Description of Supplies or Services:

The estimated value of the proposed action is:

Ordering Period 1: 10/01/2025 – 09/30/2026 - $266,928.94 Ordering Period 2: 10/01/2026 – 09/30/2027 - $266,928.94

Estimated Total Value: $533,857.88 Contract Ceiling: $740,000.00

VISN 23 has a requirement for Abbott i-STAT test cartridges, controls, and calibration material.

This testing is performed on the Abbott i-STAT point of care analyzer.

https://www.acquisition.gov/far/part-8#FAR_8_405_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

VHAPG Part 808.405-6 Limiting Sources Page 2 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C263-24-AP-5119

(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.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): 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.

FAR 8.405-6(a)(1)(C): 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.

FAR 8.405-6(b): 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 FAR 8.404(d) to aid the contracting officer in making this best value determination:

The continued acquisition of reagents, controls and calibrators for the iStat handheld analyzer is critical to the healthcare of veterans. It allows for the testing of multiple assays at any qualified department or clinic.

Abbott Laboratories is the original equipment manufacturer of the iStat Handheld Analyzer as well as the reagents, controls and calibrators used by the instrument. They currently have zero distributors nor does the instrument allow for any substitutions. As demonstrated in the Market Research Findings, Abbott Laboratories Inc is the only vendor able to provide these supplies and have also provided a letter confirming these claims.

https://www.acquisition.gov/far/part-8#FAR_8_405_6

VHAPG Part 808.405-6 Limiting Sources Page 3 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C263-24-AP-5119

(6) Describe the Market Research Conducted:

a. Conducted a search on the GSA eLibrary for Items: “36F79721D0233” which garnered one (1) results on the GSA website. Verifying that Abbott has a current FSS contract.

b. Conducted a search on the NAC for Items: “36F79721D0233” which garnered one (1) results on the NAC website with their entire reagent list.

c. Conducted a search on Federal Procurement Database Systems (FPDS) using keywords: “NAICS Code:” 334516” DEPARTMENT_FULL_NAME: ”VETERANS AFFAIRS,DEPARTMENT OF” and produced 86,864 results showing contracts awarded by the Department of Veterans Affairs.

Conducted a search on Federal Procurement Database Systems (FPDS) using keywords: “UEI:

”L3AXXYLB3V56” DEPARTMENT_FULL_NAME: ”VETERANS AFFAIRS,DEPARTMENT OF” and produced 3,131 results showing contracts awarded by the Department of Veterans Affairs to Abbott Laboratories INC.

d. Conducted a search on DSBS SBA using NAICS Code: 334516. The search listed 492 SBA certified 8(a) or 8(a) JV, HUBZone, WOSB, EDWOSB, VOSB or VOSB JV, or SDVOSB or SDVOSB JV, and designated small in NAICS code(s) 334516.

(7) Any Other Facts Supporting the Justification:

The iStat Handheld Analyzers used to perform this testing are currently owned by multiple sites within VISN23. The reagents used are proprietary to this instrument and make it impossible to compete. Seeking out new equipment before the end of the equipment’s lifecycle would be a huge loss to the Department of Veterans Affairs.

(8) A Statement of the Actions:

The agency will continue to monitor the marketplace for competitive solutions and include interoperability and open-platform requirements in future acquisitions, where feasible. The requiring service will assess the feasibility of competitive replacements during future planning cycles.

VHAPG Part 808.405-6 Limiting Sources Page 4 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C263-24-AP-5119

(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. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

08/06/2025 Date

Chasity Vigliotti Laboratory Manager / HSS

VISN 23

(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.

______________________ 08/06/2025 Steve Ashby Date

CONTRACTING OFFICER

NCO 23 / SST2

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

______________________ 08/06/2025 Curt LaRose Date Branch Chief

NCO 23 / SST2

https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx

2025-08-06T11:51:31-0500
CHASITY VIGLIOTTI
2025-08-06T12:15:16-0500
STEVEN ASHBY
2025-08-06T13:33:17-0500
CURT LAROSE

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