P03- Sole Source Justification Hologic.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 2

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C242-26-AP-0015 – Panther Reagent Kits & Consumables

1. Contracting Activity: Department of Veterans Affairs, VISN 2, Syracuse VA Medical Center 2237: 528-26-1-7307-0004

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The work required is the acquisition of the SARS-COV-2 reagents, Trichomonas reagents, and all consumables and universal fluids needed to run the test assays on the analyzer. The analyzer is already purchased. All listed reagents and consumables on the quote will be needed to perform testing on samples from patients receiving care at Syracuse VA Medical Center. The resulting contract will have a base year and 4 option years. Estimated amount is $114,800.00.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The Syracuse VA Molecular Laboratory purchased the Hologic Panther Fusion analyzer (equipment) in

2024 to assist with expanding SARS-COV-2 testing capacity. The molecular testing provides convenient and appropriate care in an inpatient and outpatient setting. The testing kits and reagents are required for using the analyzer. Use of the test kits and reagents will allow providers to manage patient symptoms sooner and decrease patient admissions and length of stay.

Hologic is the sole manufacturer of the assay kits on the market that can be used with the Hologic Panther analyzer that the Syracuse Lab currently owns. There is no other vendor that can provide the products required. A sole source letter has been received to verify that Hologic Sales and Service, LLC (“Hologic”) is the sole source of the instrument systems, assay kits, and associated kits and reagents needed for this procurement.

4. Description of market research conducted and results or statement why it was not conducted:

FPDS was searched using keywords “SARS-CoV-2 Assay Kit” filtered by date signed. This searched produced 30 different contract actions. Hologic can be seen with multiple different actions. FPDS was searched using keywords “APTIMA TRICH PANTHER” which produced only 1 result. FPDS was searched using keywords “Panther Reagents” filtered by date signed which produced 84 results. Nearly all contract actions can be seen from the vendor Hologic.

GSA was searched using Part No. 303536-CPR (APTIMA TRICH PANTHER) which produced 0 results. GSA was searched using Part No. PRD-06419 (SARS-CoV-2 Assay Kit, 250 test) which produced 0 results.

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 2 of 2

SBA was searched using NAICS code “325413” filtered by keywords “Panther Reagent” which produced 0 results. SBA was searched using NAICS code “325413” filtered by keywords “SARS-COV-2” which produced 0 results.

SBA was searched for SDVOSBs using NAICS code “325413” which produced 104 results. SBA was searched for VOSBs using NAICS code “325413” which produced 112 results. SBA was searched for SDVOSBs using NAICS code “325413” filtered by keywords “Panther Reagent” which produced 0 results.

SBA was searched for VOSBs using NAICS code “325413” filtered by keywords “Panther Reagent” which produced 0 results.

ADDSUP was searched using keywords “Panther Reagent” which produced multiple similar results from the vendor Hologic.

The NAC was searched using Part No. “PRD-06419” which produced 0 results. The NAC was searched using Part No. “303536-CPR” which produced 0 results.

SAM was searched for the vendor Hologic using their SAM UEI Q1NBY5GKN9Z3. The vendor has an active registration in SAM and no exclusions.

Manufacturer Hologic account representative Elicia Clegg was asked whether the products required are available for purchase on GSA or through any other vendors and she responded that they were not available through any other vendors.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

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