P03 BioFire J and A 4 Signed - WCS -_Redacted (1).pdf

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For Limiting Sources (<SAT)

Acquisition Plan Action ID:36C244-22-AP-4995

PR/2237: 595-22-4-024-0079

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Lebanon VA Medical

Center, 1700 South Lincoln Avenue, Lebanon, PA 17042

2. Description of Action: The Limited Source Justification and Approval is for the award of a IDIQ contract to BioFire Diagnostics, LLC, without the benefit of competition under the authority of the Multiple Award Schedule Program; the proposed effort will be awarded under VA Federal Supply Schedule (FSS) contract #V797D-30085.

Order against: FSS Contract Number: __V797D-30085_____________________

Name of Proposed Contractor: BioFire Diagnostics, LLC Street Address: 515 Colorow Drive City, State, Zip: Salt Lake City, UT 84108-1248 Phone: (801)736-6354, Ext. 1556

3. Description of Supplies or Services:

The estimated value of the proposed action is

Lebanon VA Medical Center has a requirement to purchase a brand-name Respiratory Panel RP2.1-Reference: 423742, manufactured by BioFire Diagnostics by Biomerieux. The BioFire Assays are for use with the BIOFIRE Torch System. The Respiratory panel assays are intended to aid in the diagnosis or ruling out of respiratory infections to include COVID-19. On an average, Lebanon VA Medical Center performs about 201-250 Influenza testing per year. Given the new epidemic with the coming Winter will increase testing capabilities.

Part number Description Quantity

423738 Test Kits, R2.1 Panel, BioFire (30 Tests) 6 Kits / year

Period of Performance: 09/28/2022 through 09/27/2027 (Yearly Task Orders will be placed against the

IDIQ).

Base Year: 09/28/2022 – 09/27/2023 Option (1): 09/28/2023 – 09/27/2024 Option (2): 09/28/2024 – 09/27/2025 Option (3): 09/28/2025 – 09/27/2026 Option (4): 09/28/2026 – 09/27/2027

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, 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:

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));

5. Rationale/explanation to support cited authority: The BioFire RP2.1 test kits are the only test kits compatible or can be used on our existing BioFire FilmArray Torch System which is the latest advancement in molecular infectious disease diagnostics. All tests are FDA approved. BioFire Diagnostics, LLC is the sole manufacturer and exclusive distributor in the hospital-based acute care and in-patient hospital settings for the BioFire Torch System and BioFore Respiratory Panel 2.1 (RP2.1) Test Kits. BioFire Diagnostics has confirmed Via email that they are the only distributor of this product.

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.

Prepared By:

McDaniel Brayboy III William Schlobohm Nco 4 Contract Specialist- Services 6 Contracting Officer

Date: 8/25/2022 Date: _______________

McDaniel Brayboy 1636080

Digitally signed by McDaniel Brayboy 1636080 Date: 2022.08.25 15:32:10 -04'00'

William C.

Schlobohm 193444

Digitally signed by William C. Schlobohm 193444 Date: 2022.08.25 15:47:14 -04'00'