LSJ_Redacted.pdf

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BIO PLEX 2000 SYSTEM
Solicitation number
36C25026F0612
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This is a Justification for Limiting Sources (LSJ) document for a Federal Supply Schedule (FSS) delivery order issued by the Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 10, Louis Stokes Cleveland Veterans Affairs Medical Center (CLE VAMC), Network Contracting Office (NCO) 10.

CLE VAMC intends to award a firm fixed-price delivery order to Government Scientific Source, Inc. for one Bio-Rad BioPlex 2200 System, including one BPX Battery UPS, with a required delivery date of February 25, 2026, through February 24, 2027. The BioPlex 2200 is a fully automated multiplex immunoassay analyzer designed to perform antinuclear antibody (ANA), Celiac Panel, MMRV Panel, and Rapid Plasma Reagin (RPR) testing to replace an existing analyzer that has reached end-of-life. The order is placed against FSS Contract Number 47QSMS25D00A9. The contracting officer determined that only one source is capable of providing the supplies at the required quality level because the BioPlex 2200 is a proprietary product manufactured by Bio-Rad Laboratories with proprietary reagents, assay panels, software, calibrators, controls, and consumables that are exclusive to this platform. Market research reviewed GSA eLibrary, National Contracts, ECAT, SAM.gov, and other federal databases using keywords "Bio Plex," yielding only Government Scientific Source Inc. as a result. SBA SBS searches under NAICS Code 334516 produced zero results. The Nonmanufacturer Rule applies under NAICS 334516 with SBA waiver availability; the OEM has one small business distributor. The negotiated price is $286,928.80, compared to the OEM price of $270,000.00.

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Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 3 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C250-26-AP-2359

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C250-26-AP-2359

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service

Network (VISN) 10, Louis Stokes Cleveland Veterans Affairs Medical Center (CLE VAMC), Network Contracting Office (NCO) 10.

Transaction: 541-26-2-250-0137

2. Description of Action: CLE VAMC intends to award a new firm fixed- price, Delivery Order (DO) to Government Scientific Source, Inc., for a Bio Plex 2200. e system is capable of performing multiple assays, including ANA, Celiac Panel, MMRV Panel, and RPR, to support laboratory operations and patient care.

Order against: FSS Contract Number: 47QSMS25D00A9 Name of Proposed Contractor: Government Scientific Source, Inc.

Street Address: 12355 Sunrise Valley Drive, Suite 400 City, State, Zip: Reston, VA 20191 Phone: (800) 248-8030

3. Description of Supplies or Services: The CLE VAMC requires one (1) Bio-Rad BioPlex 2200

System, including one (1) BPX Battery UPS, to replace an existing analyzer that has reached the end of its service life. The BioPlex 2200 is a fully automated multiplex immunoassay analyzer used to perform antinuclear antibody (ANA), Celiac Panel, MMRV Panel, and Rapid Plasma Reagin (RPR) testing in support of patient care. The BioPlex 2200 is a proprietary product manufactured by Bio-Rad Laboratories. There are no options associated with this acquisition, and this is a new equipment purchase, not a modification to an existing order.

ESTIMATED DOLLAR VALUE:

REQUIRED DELIVERY DATE: February 25, 2026, through February 24, 2027

4. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, VHAPG Part 808.405-6 Limiting Sources Page 2 of 3

Acquisition ID#: 36C250-26-AP-2359

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:

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

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)(i)(B));

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405- 6(a)(1)(i)(C)); or

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

5. Rationale/explanation to support cited authority: The BioPlex 2200 System is a proprietary multiplex immunoassay platform manufactured by Bio-Rad Laboratories and is specifically designed to perform fully automated ANA, Celiac Panel, MMRV Panel, and RPR testing using Bio-Rad proprietary reagents, assay panels, software, calibrators, controls, and consumables. The system utilizes Bio-Rad's proprietary multiplex bead technology to perform multiple assays on a single integrated platform, improving laboratory workflow and efficiency. Although other manufacturers produce immunoassay analyzers, they do not provide the BioPlex 2200 platform or utilize Bio-Rad-specific reagents and FDA-cleared assay kits designed exclusively for use on the BioPlex 2200 System. Bio-Rad Laboratories has authorized Government Scientific Source, Inc. to offer Bio-Rad products under its GSA Schedule contract. Therefore, only the BioPlex 2200 System satisfies the Government's requirement for this proprietary testing platform.

Market research was conducted by the Contracting Officer and the service to determine if there were other vendors capable of providing a Bio Plex 2000 System that meet CLE VAMC's specific requirements. The following sources were reviewed:

The following sources were reviewed on April 6, 2026.

a. GSA eLibrary, National Contracts, ECAT, SAM.gov, Interagency Contract Directories, NAC, SEWP, FPDS, SCMC, OMB, BIC and FDA:

Keywords Used: "Bio Plex"

VHAPG Part 808.405-6 Limiting Sources Page 3 of 3

Acquisition ID#: 36C250-26-AP-2359

Results: There was one result, Government Scientific Source Inc., FSS Contract # 47QSMS25D00A9. The price on GSA was $497,210.16, and I negotiated it down to $286,928.80 which is reasonable compared to the OEM at $270,000.00.

b. SBA SBS:

NAICS Code Searched: 334516 Keywords Used: "bio plex" Results: There were zero results.

The Nonmanufacturer Rule (NMR) does apply to this procurement under NAICS 334516 and SBA does provide a waiver. Market research has determined that the VA and SBA Rules of Two cannot be met for this requirement, the OEM has one small business distributor, Government Scientific Source Inc., FSS Contract #

47QSMS25D00A9.

6. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

Rachelle J. Hamer Contracting Officer

NCO 10

RACHELLE

HAMER

Digitally signed by

RACHELLE HAMER

Date: 2026.06.30 16:41:46 -04'00'

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