Final SSJ - Thyroid Testing.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24 Page 1 of 3

REVISION: 01

Acquisition ID#: 36C250-26-AP-0039

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-26-AP-0039

1. Contracting Activity: Department of Veterans Affairs, VISN 10, 583 – Richard L. Roudebush VA

Medical Center, Pathology and Laboratory Medicine Services, submits a procurement request to Network Contracting Office 10, Services Team 3 for Tyroseq Esoteric Thyroid Testing. Funding is provided under 2237# 583-26-1-057-0001.

2. Nature and/or Description of the Action Being Processed: This is a new requirement for ThyroSeq v3 Genomic Classifier testing for the Richard L. Roudebush VA Medical Center, Pathology and Laboratory Medicine Services. This test is needed in order to test for thyroid nodules and cancer that have been first diagnosed as indeterminate cytology. Using advanced technology, this testing offers the most accurate diagnosis . The ThyroSeq test helps Providers to determine if surgery would be required and aids in selecting the most appropriate surgery which helps improve the quality of patient care and efficiencies with the VA facility. This is planned to be awarded as a firm fixed price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The ThyroSeq v3 Genomic

Classifier Test is needed to test for 35 nodules per year for a base plus four, one-year option years for an estimated total of $386,785.00.

Base Year $2,000.00 ea $70,000.00 Option Yr 1 $2,100.00 ea $73,500.00 Option Yr 2 $2,205.00 ea $77,175.00 Option Yr 3 $2,315.00 ea $81,025.00 Option Yr 4 $2,431.00 ea $85,085.00

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

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The ThyroSeq v3 Genomic Classifier test is a highly specialized test that is able to most accurately identify malignancy with thyroid nodules in indeterminate cytology. This test is only offered through CBL Path, and has the ability to rule out cancer by testing over 100 genes for mutations and eliminates the need for diagnostic surgery.

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Acquisition ID#: 36C250-26-AP-0039

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

After a survey of the market place no additional sources were found and confirmed that there is only one responsible source capable of meeting the needs of this requirement.

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

It is determined by the CO that the anticipated cost to the Government will be Fair and Reasonable.

The Contracting Officer will use the price analysis techniques in FAR 13.106-3(a)(2) to determine the price to be fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market research conducted using NAICS 621511 and keyword “Thyroseq” and seperately “thyroid” found not two or more SDVOSBs or VOSBs capable of providing the required services. The VA’s Rule of two can not be met. Market research also found not two or more small businesses capable of providing the required services. The SBA’s Rule of Two can not be met. The highly specialized test is trademark of University of Pittsburgh Medical Center (UPMC) and is exclusively offered through CBL Path, which is a Sonic Healthcare laboratory.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Cytopath Biopsy Lab, Inc dba CBL Path 760 Westchester Ave Rye Brook, New York 10573-1341 https://www.cblpath.com/ POC: Thomas Shaw

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:

A sole source effort is required for a base plus four, one-year option years due to the ThyroSeq v3 Genomic Classifier registered trademark and it only being offered by CBL Path, Inc which is a Sonic Healthcare USA Laboratory. There are no other available sources at this time.

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.

Date

Contract Services Team 3, NCO 10

KRISTINA PEART Digitally signed by KRISTINA PEART Date: 2025.09.04 08:23:58 -04'00'

Effective Date: 11/15/24 Page 3 of 3

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Acquisition ID#: 36C250-26-AP-0039

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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.

Date

Contract Services Team 4, NCO 10