P03 FAR 13.5 Sole Source Justification - Over SAT Testing R2.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 3

REVISION: 00

Acquisition ID#: 36C249-24-AP-1822

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN

ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C249-24-AP-1822 Thyroseq Testing

Contracting Activity: Department of Veterans Affairs, VISN 09, Lt. Col. Luke Weathers, Jr. VA Medical Center, Memphis, TN.

2237: 614-25-1-025-0005.

Nature and/or Description of the Action Being Processed: The Pathology and Laboratory department of the Memphis VA Medical Center has a requirement for a vendor to provide consultation and analysis of DNA sequencing of thyroid specimen services. This testing will provide assessment of cancer possibility for veteran patients at the Memphis VA Medical Center. Estimate Contract value:

Base Year: 10/01/2024 through 09/30/2024 cost Option Year 1: 10/01/2025 through 09/30/2026 cost Option Year 2: 10/01/2026 through 09/30/2027 cost Option Year 3: 10/01/2027 through 09/30/2028 cost Option Year 4: 10/01/2028 through 09/30/2029 cost

Total Cost:

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The objective of the requirement is to provide thyroid testing services to assess cancer possibility for veteran patients using the ThyroSeq v3 genomic classifier (GC), which is proprietary to Cytopath Biopsy Lab, Inc. (CBLPath). The service will include all labor, tools, equipment, materials and training required to perform this highly specialized medical reference laboratory testing..

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): A letter has been provided by CBLPath to verify their proprietary status.

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Acquisition ID#: 36C249-24-AP-1822

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: VetCert was checked to see if any SDVOSB/VOSB provided the service with no results. The vendor verified via letter that the ThyroSeq v3 Gene Classifier (GC) is proprietary to CBLPath

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

The anticipated cost to the government is considered fair and reasonable due to comparison of historical pricing viewed on FPDS. The subject matter expert, the Contracting Officer's Technical Representative (COR), estimated the number of anticipated tests when generating the Independent Government Cost Estimate (IGCE) which was similar to previous purchase order pricing viewed on VISTA.

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. VetCert was queried and no SDVOSB were identified who could provide these services. Research was reviewed on prior contracts identified by FedDataCheck.net. Further FPDS market research revealed that other VAMC's have sole sourced the same/similar requirement in the past, based on CBLPath's proprietary status.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The ThyroSeq v3 genomic classifier (GC) is the most recent and advanced version of the test and was launched for clinical use toward the end of 2017 - beginning of 2018. The ThyroSeq v3 GC uses next-generation sequencing technology to analyze 112 genes, providing information regarding >12,000 mutation hotspots and >120 fusion types. It detects 5 different classes of genetic alterations: 1) mutations (single nucleotide variants);

2) insertions and deletions; 3) gene fusions; 4) gene expression alterations; and SJ copy number alterations. This advanced testing is required for optimal patient care.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Cytopath Biopsy Lab, Inc.

(CBLPath) has provided a quote.

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: The government could conceivably use a lab that does not offer this highly specialized testing. However, veteran beneficiaries would not benefit from this innovative advance testing.

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.

David E. Huhman

Date

Health Specialist COR Memphis VAMC

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification

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.

Effective Date: 02/01/2022 Page 3 of 3

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Acquisition ID#: 36C249-24-AP-1822

Diane Ziegler Date Contracting Officer

NCO 9

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.

Roxie Keese Date Branch Chief

NCO 9

DIANE ZIEGLER Digitally signed by DIANE ZIEGLER Date: 2024.09.23 10:43:03 -05'00'

ROXIE

KEESE

Digitally signed by

ROXIE KEESE

Date: 2024.09.23 12:09:45 -04'00'