P03 - PM_Part813.106_Atch1_SingleSourceJustification_MPT-SAT - 36C246-24-AP-2440 - signed - redacted.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT (36C246-24-AP-2440)

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: 36C246-24-AP-2440

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 06, VISN 06, on behalf of the Hampton VA Medical Center, 100 Emancipation Drive, Hampton, VA 23667-0001. 2237 No. 590-24-2-023-0122.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Hampton Pathology and Laboratory (P&LMS) will place an Open Market purchase order to acquire Hologic Panther supplies. These supplies will be used for sampling and testing Hologic equipment, Polymerase Chain Reaction (PCR) for COVID testing, reagents, consumables, and supplies. These tests are necessary and to be administered to all veterans before surgery. P&LMS is currently leasing the Hologic Panther System. Hologic will continue to support any required equipment services and promptly notify the service provider whenever a replacement is needed. The estimated period of performance for this requirement is 04/30/2024 – 12/31/2024. The total estimated price of the proposed action (including option years) is $219,150.00.

Hampton VA Medical Center Product # Description Price/Kit Total Price

PRD-06419 Aptima SARS-CoV-2 Assay, EUA, 250-Test 24 $ 8,000.00 $ 192,000.00 PRD-06420 Aptima SARS-CoV-2 Controls 20 $ 230.00 $ 4,600.00

PRD-06997 Hologic Direct Load Tube, 100 per Bag 60 $ 350.00 $ 21,000.00

PRD-04339 Fusion Specimen Lysis Tubes, 100 per Pack 10 $ 125.00 $ 1,250.00

303096 Panther Run Kit 6 No Charge $ 0.00

303085 Panther Advanced Cleaning Solution 10 No Charge $ 0.00 103036A Non-Penetrable Caps 3 No Charge $ 0.00

105668 Aptima Penetrable Caps 3 $ 100.00 $ 300.00

CL0040 Spare Caps, TCR + Select 250 kit 1 No Charge $ 0.00 CL0041 Spare Caps, AMP & Probe 100 & 250 kit

Enzyme 100 kit

No Charge

$ 0.00

501604

Spare Caps, TCR + Select 100 kit

No Charge

$ 0.00

$ 219,150.00

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT (36C246-24-AP-2440)

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

CHELLRY

Digitally signed by CHELLRY

WHITTIER

-04'00'

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Hampton P&LMS is currently utilizing the Hologic equipment on-site. The Hologic Panther System is used for molecular testing, with high-performing assay and throughput automation. This vendor is the only one on the market that can offer Polymerase Chain Reaction (PCR) for COVID-19 testing used on the Hologic Panther analyzer. The equipment requires certain supplies that only Hologic can provide.

Hologic is the manufacturer of these reagents and supplies, and there are no comparable alternatives available. The Contracting Officer contacted the Original Equipment Manufacturer (OEM) Hologic, Inc., requesting authorized distributors; the CO was provided documentation stating that they do not have authorized distributors for the Panther system or disposables.

4. Description of market research conducted and results or statement why it was not conducted: Market Research was performed using SBA VetCert, VIP, NSSL, SCMC, NAC, GSA, FPDS-NG, and the Internet. SBA VetCert on 04/10/2024 using NAICS 325413 resulted in 86 SDVOSB and VOSB vendors; further search using VIP, NAICS 325413, and keywords “Molecular Testing” to narrow the search revealed no SDVOSB or VOSB vendors. Based on market research, the VA Rule of Two cannot be met. Hologic, Inc (LB) (OEM) is the sole authorized distributor.

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.

Chellry Whittier Contracting Officer NCO6 – Supply/Services 5