P03 - Part813.106 - Brand Name Justification MPT-SAT (36C246-24-AP-6318) - REDACTED.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source 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: 36C246-23-AP-6318

1. Contracting Activity: Department of Veterans Affairs, VISN 06, Durham VA Medical Center, Purchase Request No. 558-24-1-056-0001.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Durham VA Health Care System (HCS), 508 Fulton Street, Durham, NC 27705-3875 Pathology & Laboratory Services requires fifty (50) ThyroSeq Genomic Classifier tests. The ThyroSeq test is a critical laboratory test essential to prevent unnecessary thyroid surgery. Thyroid Fine Needle Aspiration (FNA) biopsies with atypical/inconclusive results are commonly encountered in medical practice (5-15% of all thyroid FNA biopsies). ThyroSeq testing allows for comprehensive genomic profiling of atypical thyroid nodules to help determine which nodules need to be surgically acted upon versus those that can be surveilled. The total estimated price of the proposed action is $100,000.00.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The ThyroSeq test is intended for a genomic profile to improve the detection of malignancies in indeterminate cases, identify molecular signatures of more aggressive cancers and to give insight into therapeutic efficacy based on the molecular profile. These molecular tests of an indeterminate thyroid nodule can stratify patients into those who may or may not need a surgical procedure. ThyroSeq is a test that looks for unique genetic alterations in your thyroid nodule to help your doctor determine if your nodule is benign (non-cancerous) or malignant (cancerous). ThyroSeq uses Next Generation Sequencing to analyze genes essential for cancer development. ThyroSeq uses cells already collected during the veteran’s FNA procedure and sequences the hundreds of gene regions in one tube. The Pathology & Laboratory Service interprets genetic alterations found to determine the risk of cancer in the veteran’s thyroid nodule.

4. Description of market research conducted and results or statement why it was not conducted: Market Research revealed no SDVOSB or VOSBs were found using the NAICS 621511 and keywords THYROSEQ TEST KITS through the SBA VetCert and VIP query. There are no mandatory nor nonmandatory contracts for this requirement. There were three (3) results for the SCMC query and two (2) results for FPDS-NG; all were CBL.

Cytopath Biopsy Lab, Inc. is a Large business that has provided a letter of exclusivity stating that they have no authorized distributors. The VA Rule of Two cannot be met. It is determined that the most appropriate way to meet the needs of the government is through a sole source award. The requirement has been determined to be a commercial good and will be solicited and evaluated as an Open-Market, sole-sourced, Firm-Fixed-Price award.

https://www.acquisition.gov/?q=/browse/far/13

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

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

CHELLRY

Digitally signed by CHELLRY

WHITTIER

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.

Contracting Officer NCO6 - Supply II Date: 31 October 2023 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466

Acquisition Plan Action ID: 36C246-23-AP-6318