36C257-25-AP-3441-FY25-1113 JOFOC NCO17 BioFire Torch - HCA Approved.pdf

Effective Date: 11/15/24 Page 1 of 6

REVISION: 01

Acquisition ID#: 36C257-25-AP-3441

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C257-25-AP-3441 RPOW Tracking Number: FY25 – NCO 17 – 1423

1. Contracting Activity: Department of Veterans Affairs (VA), Network Contracting Office (NCO) 17, located at 5441 Babcock Rd., Ste 302, San Antonio, TX 78240, in support of the Laboratory and Pathology Laboratory Medicine Service (P&LMS), VA North Texas Healthcare System (NTX), located at 4500 S. Lancaster Rd., Dallas, TX 75216.

Purchase Request Number: 549-25-4-4-190-0204.

2. Nature and/or Description of the Action Being Processed:

This procurement is for the rental of analyzer modules, purchase of reagents, and an extended warranty for the new and existing modules in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

This requirement will be a new, single award, firm fixed price, indefinite delivery indefinite quantity (IDIQ) contract. NTX has a requirement for reagents, analyzer modules, and an extended warranty for the modules to conduct testing to detect multiple respiratory and gastrointestinal conditions and assist in the diagnosis of meningitis and/or encephalitis in patients.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

This requirement is for the items below.

Line Item Item Description/ Part Number Unit of Measure

Quantity

1 VC Torch Ignited by FIREWORKS/ 4707787 EA 1

2 Filmarray Torch Duplex Module Box/ HTFA-ASY-0002 EA 1

3 Filmarray Torch Module Box/ HTFA-ASY-0003 EA 2

4 BioFire RP2.1 Panels 30 Tests/Kit/ 423742 KT 30

5 Filmarray GI Panels 30 Tests/Kit/ RFIT-ASY-0116 KT 23

6 BioFire BCID2 Panel 30 Tests/Kit/ RFIT-Asy-0147 KT 25

7 Filmarray ME Panels 30 Tests/Kit/ RFIT-ASY-0118 KT 2

8 Extended Warranty BioFire Torch Base/ 4706468 YR 1

9* Extended Warranty BioFire Torch Modules / 4706470 YR 6

* Extended Warranty in Ordering Period 1 does not include item 9, quantity of 2, as one-year warranty in included in initial purchase of analyzer modules.

The IDIQ will have five, one-year ordering periods from 9/30/2025-9/29/2030 and one option to extend services up to six months.

Total Estimated Value: $1,865,997.22 As testing volumes have increased over time, the IDIQ ceiling will be set at $2,000,000.00.

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Acquisition ID#: 36C257-25-AP-3441

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The BioFire Torch System (also called “BioFire Filmarray Torch System”) is the only Food and Drug Administration (FDA)-approved Polymerase Chain Reaction (PCR) diagnostic system for pathogenic microorganisms and panels for different specimen types (respiratory, GI, blood from positive cultures, and others). Additionally, due to the complexity of the testing required, the modules and reagents must be compliant with the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

The CLIA are federal standards laboratories must meet to conduct moderately and highly complex testing, to be reevaluated biennially. If a CLIA compliant analyzer is required but not used, the NTX laboratory could be at risk of losing their capability to perform the testing and would incur extensive costs to send the specimen to a third-party laboratory. To ensure that this does not occur, a CLIA-compliant analyzer is required for this testing.

There is currently a BioFire Torch System being rented at the facility. The equipment is highly specialized and the original manufacturer, BioFire Diagnostics (who merged their company with Biomerieux, Inc., in 2014), does not authorize any other vendors to provide supplies or services as third-party distributors.

Market research was conducted (see section 8 below), and a proprietary letter was provided by Biomerieux, Inc., which states that the BioFire Torch and its reagents are only available through Biomerieux, Inc. There were no Service-Disabled Veteran-Owned Small Businesses (SDVOSBs), Veteran-Owned Small Businesses (VOSBs), or any small businesses found which would be authorized to provide the required contract items. The use of competition would not provide any additional value and would result in substantial duplicated costs as there is only one (1) vendor that is able to provide the rental of the equipment, reagents, and warranty services for the testing to be conducted at the NTX facility.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Market research was conducted in accordance with FAR part 10 and VAAR part 810 to determine if there are any SDVOSBs, VOSBs, or small businesses that could provide the required analyzer modules, reagents, and warranties at a fair and reasonable price. Market research results are

Effective Date: 11/15/24 Page 3 of 6

Acquisition ID#: 36C257-25-AP-3441 detailed in Section 8 below. Only one (1) large business, Biomerieux, Inc., was found to be able to provide the required supplies and extended warranty services.

As a sole source letter was provided by Biomerieux, Inc., a Notice of Intent (NOI) to Sole Source was issued in place of a Sources Sought Notice. The NOI, 36C25725Q0595 was issued on 5/30/2025 and closed on 6/6/2025. Upon closure of the NOI, no responses were received.

Additionally, searches for similar analyzers with FDA approval and CLIA compliance were conducted.

No similar analyzers were found.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The CO anticipates that pricing will be fair and reasonable. The test panels are currently available under a Federal Supply Schedule (FSS) contract managed by the VA, who previously determined these prices to be fair and reasonable. Pricing for reagents under this IDIQ will be compared to the FSS contract pricing. The modules and warranties are open market items and will be compared to the contract expiring on 9/30/2025.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

Market research was conducted in accordance with FAR part 10, VAAR part 810, and PPM 2016-05 (Revised AUG 2019) between May and June 2025.

Searches were conducted on the Small Business Administration’s (SBA) Dynamic Small Business Search (DSBS), General Services Administration’s (GSA) eLibrary, Ability One, Federal Prison Industries (UNICOR), and Internet inquiries were made to determine if there were any SDVOSBs, VOSBs, other small businesses, or large businesses were able to provide this requirement at a fair and reasonable price. Additionally, the Contracting Officer applied their experience in procuring this particular requirement.

a. DSBS: A search was made using North American Industry Classification System (NAICS) Code

325413 and keyword “BioFire.” This provided 0 results.

b. GSA eLibrary: A search using keyword “BioFire” resulted in FSS 555-6, Microbiology. An additional search was conducted in the schedule for “BioFire,” which resulted in one (1) vendor, Biomerieux, Inc. A review of the schedule did not indicate that the modules and extended warranties were available through the FSS contract.

c. Ability One: A search was conducted using keyword “BioFire,” which provided 0 results.

d. UNICOR: A search of the list of Product or Service Codes (PSC) UNICOR is capable of providing was searched. PSC 6550 is available but no items were found under the PSC.

e. Internet Search:

i. A search for “BioFire reagents” resulted in two vendors, Biomerieux, Inc., and BioFire. As BioFire is now incorporated into Biomerieux, Inc., only Biomerieux, Inc., was found to provide the required items.

ii. A search for “analyzer for BCID testing” was conducted. This resulted in two large business vendors, Biomerieux, Inc., and Roche Diagnostics Corporation. The analyzer provided by Roche Diagnostics Corporation is CLIA-waived, meaning the analyzer does not perform moderately or highly complex testing. Based on this information, the Roche Diagnostics Corporation testing was determined not to meet the CLIA-compliant requirement.

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Acquisition ID#: 36C257-25-AP-3441

f. Sole Source Letter: A sole source letter was provided to the Microbiology Section Supervisor during her market research for this requirement. The letter states that only Biomerieux, Inc., can provide the required items for the United States Government. No date was included on the letter but was provided on the company’s letterhead.

g. NOI: See Section 6 above for results.

h. Contracting Officer’s Personal Knowledge:

i. The Contracting Officer currently administers the current contract, 36C25723C0105, a base plus one option year contract, for the same reagents and extended warranties. The previous procurement was awarded as a sole source using authority FAR 13.501(a) to Biomerieux, Inc., who at the time had provided a proprietary letter indicating that they are the only vendor in the United States that could provide this requirement. This contract expires on 9/29/2025. The current contract value, including options and modifications, is $674,520.79.

ii. At the time this contract was made, the Contracting Officer found that BioFire became incorporated into Biomerieux, Inc., its parent company, in 2014. As BioFire was no longer its own entity, a sufficient number of vendors to allow for competition was unable to be obtained.

iii. The primary difference between the contract expiring in September 2025 and the new requirement are the additional modules purchased. Contract 36C25723C0105 was shorter in length as the original plan was to replace the system and modules, but by replacing some of the modules and proper maintenance of the BioFire Torch System, the facility is able to continue use of the existing system without the additional costs of procuring a new one.

Buy American Act (BAA) and Trade Agreements Act (TAA):

a. Buy American Act (BAA): In accordance with (IAW) FAR 25.101 and 25.103, the BAA applies to this requirement. The modules and reagents are manufactured in the United States.

b. Trade Agreements Act (TAA): This requirement is exempt from the TAA, per FAR 25.401(a)(5), as this requirement will be acquired as a sole source under FAR 13.501(a).

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

None

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Biomerieux, Inc.

515 S. Colorow Dr.

Salt Lake City, UT 84108 federalgovtcontracts@biomerieux.com

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required:

When the previous requirement was approved, the P&LMS had determined that only two years of effective use were remaining on the existing analyzer. Prior to the CO conducting market research, the CO contacted the P&LMS at NTX to confirm new equipment would be required under this IDIQ.

As the equipment has been maintained, the useful life of the BioFire Torch base has been able to be extended.

Additional market research will be conducted prior to the issuance of new orders and when the existing equipment is near the end of their effective useful life. If it is determined that other

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Acquisition ID#: 36C257-25-AP-3441 analyzers are available and/or other compatible reagents can be acquired with an overall cost savings to the Government, then a solicitation will be issued in place of issuing a new order under this IDIQ.

12. 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 and belief.

Mary J. Ramirez Date Microbiology Supervisor Pathology & Laboratory Medicine Service VA North Texas Healthcare System

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Acquisition ID#: 36C257-25-AP-3441

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Delphia Schoenfeld Date Contracting Officer, Lab Services Support Network Contracting Office 17

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Michael J. Tusinger Date Branch Chief, Lab Services Support

c. Director of Contracting Review and Approval: I certify the justification meets requirements for other than full and open competition.

Mark A. Layman Date Director of Contracting

d. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Curtis M. Jordan Date Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA) https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx VHASTXSchoeD Typewritten Text 6/17/2025