P03_J and A Cytopathology and ThyroSeq Testing-Lebanon.pdf

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

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 3 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:______________36C244-21-AP-29274_____________________________

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Lebanon VA Medical Center

Under PR number 595-21-3-024-0057, The Lebanon VA Medical Center has a requirement for cytopathology and ThyroSeq testing.

2. Nature and/or Description of the Action Being Processed: This procurement is for cytopathology and ThyroSeq testing are in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This is a new requirement for the Lebanon VA Medical Center. The proposed contract with be a (5) Indefinite Delivery, Indefinite Quantity contract. Individual task orders will be issued against the IDIQ contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Lebanon VA Medical Center has a need for cytopathology and ThyroSeq testing. The ThyroSeq test is intended for genomic profile to improve detection of malignancies in indeterminate cases, identify molecular signature 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. The yearly estimated value of each yearly task order is $99,000 to encompass an estimated (5) year total of $495,000. The total period of performance will be June 1, 2021-May 31, 2026. The first task order will be effective June 1, 2021-May 31, 2022.

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

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Text Box 5-year Indefinite Delivery, Indefinite

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 3

Revision 03 Date: 02/11/2021

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Cytopath Biobsy Lab, has an exclusive license to market and sett the ThyroSeq test. As a resul,t no other company can provide both required cytopathology and ThyroSeq testing.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Sources Sought Number: 36C24421Q0574 was issued on April 13 for for Cytopathology and ThyroSeq Testing. The Sources sought closed on April 20th. Ony one vendor responded to the sources sought: RV Global Solutions. This company is an 8(a), small business.

However, this vendor is an information tech and management solutions and is not listed under NAICS code 621511. Additionally, neither VET BIZ nor GSA Library listed companies that could provide both of these types of tests.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Cytopath has current and past contracts with other VA Medical Centers and is pricing the TjyroSeq test at the same price of $2000.00 per test.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Sources Sought Number: 36C24421Q0574 was issued on April 13, 2021 for Cytopathology and ThyroSeq Testing. The Sources sought closed on April 20th.

Ony one vendor responded to the sources sought: RV Global Solutions. This company is an 8(a), small business. However, this vendor is an information tech and management solutions company and is not listed under NAICS code 621511.

Additionally, Market Research was completed on 04/02/2021. FPDS was searched for historical purchase information using the keyword “ThyroSeq”. The FPDS search netted 42 contract actions, 33 with VA and 9 with DoD, all to Cytopath Biopsy Lab, Inc. The 33 contract actions were from 9 contracts that VA had with Cytopath Biopsy Lab, Inc. A search of USA Spending using keyword “ThyroSeq” revealed 9 previous contacts, all with Cytopath Biopsy Lab, Inc. A search of GSA Advantage, GSA eLibrary, NAC, and SAC revealed 0 results. VetBiz was searched using the NAICS 621511 which which identified 124 SDVOSB and VOSB vendors, but 0 are able to provide ThyroSeq Testing.

A representative of CBLPath has stated that they have the exclusive rights to offer ThyroSeq Testing.

( See attached Proprietary letter).

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

Cytopath has exclusive license to market and sell the TyroSeq test. No other company can provide this type of test.

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

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: Not Applicable

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 3

Revision 03 Date: 02/11/2021

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.

Name Noelle Irish Date Title: Contract Specialist Facility:

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.

Name Kevin Balser Date Title Contracting Officer Facility

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.

Name Seth Custer Date NCO4/ Division Chief

Facility https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

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Typewritten Text 4/23/2021