Limiting_Sources_Justification_MPT-SAT Signed.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C263-27-AP-0227

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C263-27-AP-0227

1. Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 23, located at 2501 W. 22nd Street, Sioux Falls, SD 57105, in support of the Department of Veterans Affairs, One Veterans Drive, Minneapolis, MN 55417. VA 2237# 618-27-1-106-0024

2. Description of Action: Procurement of Biofire Panel products

Order against: FSS Contract Number: 36F79724D0020

Name of Proposed Contractor: Biomerieux, Inc

Street Address: 515 S. Colorow Drive.

City, State, Zip: Salt Lake City, UT 84108

Phone: 385-770-2833

3. Description of Supplies or Services:

The estimated value of the proposed action is $636,905.60

0001 EA 30 GI Panel, IVD 30 Tests, Kit RFIT-ASY-0116

0002 EA 10 Blood Culture Identification Panel 2 30 pouch kit, RFIT-ASY-0147

0003 EA 4 BioFire ME Panel 30 pouch kit RFIT-ASY-0118

0004 EA 120 BioFire RP2.1 Panel 30 Pouch Kit 423742

0005 EA 10 BioFire PN Panel 30 Pouch Kit RFIT-ASY-0144

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 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 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; or

FAR 8.405-6(b): Items peculiar to one manufacturer.

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

Revision: 02 Effective Date: 03/02/2026

X A patent, copyright or proprietary data limits competition. The proprietary data is: BioMérieux, Inc. is the sole source manufacturer and service provider of the systems and software listed above.

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

X 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: The statutory and regulatory authority supporting this acquisition is FAR 8.405-6(b), Items Peculiar to One Manufacturer.

The Minneapolis VA currently owns Biomerieux (Bio-Fire) analyzers that utilize Biomerieux GI and Blood culture panel/ kits for laboratory tests. The Biomerieux products analyze body fluids and play a key role in processing lab orders. These items are the only FDA cleared assays for the Minneapolis owned analyzers used for testing GI pathogens, blood culture, respiratory pathogen targets, meningitis/encephalitis targets, and clinically relevant pneumonia targets. No other manufacture’s regent test kits are compatible with the Minneapolis owned Biomerieux analyzers.

Minneapolis VA laboratories currently utilize Biomerieux products and have approved standardized operating procedures and validation processes in place specifically for the Biomerieux brand analyzers and blood products. These test kits are the only kits compatible with the Minneapolis owned Bio-fire analyzers specifically used to perform blood tests. Retaining the current analyzers saves duplication costs of purchasing new equipment, installation, and training of personnel. The Biomerieux analyzers and test panels/ kits are being utilized per regulatory agency requirements, and a lengthy 90-to-120-day minimum crossover period would be required if new analyzers and test kits were purchased from a different manufacturer. If new analyzers and test kits were purchased, the government would incur duplication in costs that are not expected to be recovered through competition, additionally, the VA would likely find itself in another sole source situation with the manufacturer of the new analyzers, supplies, repair services and parts.

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

A query of the SBA database with NAICS code 325413 identified no VOSB/SDVOSB’s. One small business resulted in a search, however, that firm is not an authorized seller/ reseller of Biomerieux brand items. Biomerieux is the only company that can provide the BioFire Panel Kits and associated Biomerieux brand items.

7. Any Other Facts Supporting the Justification: None

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:

9. Requirements Certification: I certify that the requirement outlined in this justification is a

Revision: 02 Effective Date: 03/02/2026

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.)

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.

SIGNATURE DATE

NAME TITLE SERVICE LINE/SECTION

Minneapolis, MN VAHCS

FACILITY

(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.

_ 01 October, 2026____

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE DATE

Scott Morrison, Contract Officer Sioux Falls, SD , NCO 23

NAME AND TITLE FACILITY/NCO/PCO

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.

SIGNATURE DATE

NAME

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

Revision: 02 Effective Date: 03/02/2026

NCO/PCO XX Duty Title