36C25620Q0279-005.pdf

This is an INTENT TO SOLE SOURCE NOTICE only.

The Department of Veteran Affairs, Network Contracting Office (NCO) 16, intends to issue a sole-source contract under the authority of 41 U.S.C 253(c) (1) - FAR 6.302-1 (only one responsible source and no other supplies or services will satisfy agency requirements), to

Veracyte, Inc., located at 6000 Shoreline Court, Suite 300, South San Francisco, CA 94080.

Services will be from 03/01/2020 through 09/30/2020 with four (4) twelve (12) month option periods under NAICS 621511. The Vendor shall provide Afirma Thyroid FNA Analysis services for the Pathology and Laboratory Medicine Service located at the G. V. (Sonny)

Montgomery VA Medical Center, Jackson, MS. This action will result in a firm-fixed-price service contract. The period of performance shall be for six (6) months beginning March 1, 2020 to September 30, 2020 with four (4) twelve (12) month option periods. Clause 52.217-8, Option to Extend Services, and Clause 52.217-9, Option to Extend the Term of the Contract, applies.

This notice of intent is not a request for quotations; interested parties may express their interest by providing a capabilities statement not later than 02/21/2020 at 12:00 PM CST, to rene.impey@va.gov . When responding to this announcement, respondents should refer to number 36C25620Q0279, Notice of Intent in the subject line. The capabilities statement must provide clear and unambiguous evidence to substantiate the capability of the party to provide the required services. Responding as an interested party under the www.fbo.gov website does not constitute convincing evidence of capabilities. A determination not to compete this proposed contract upon responses to this notice is solely within the discretion of the Government. Verbal and facsimile responses are not acceptable and will not be considered. All interested parties are reminded to be registered with System for Award Management (SAM) at https://sam.gov/SAM/ in order to be eligible for award of Government contracts. No telephone calls will be accepted.

If after February 21, 2020, no viable responses have been received in response to this announcement, NCO 16 shall negotiate solely with Veracyte, Inc.

mailto:rene.impey@va.gov mailto:rene.impey@va.gov http://www.fbo.gov/ http://www.fbo.gov/ https://sam.gov/SAM/ https://sam.gov/SAM/

The Government anticipates the award of a firm-fixed-price contract. A determination by the

Government whether to compete the proposed requirement shall be based upon responses received and is solely within the discretion of the government. Information received shall be considered solely for the purpose of determining whether to conduct a competition.

REQUIRED SERVICES:

Contractor to provide Afirma Thyroid FNA Analysis services for the G. V. (Sonny) Montgomery

VA Medical Center, Jackson, MS.

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Original Date: 08/30/17 Revision 01 Eff Date: 04/23/2018

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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:_36C25620AP1181_

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 16, G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS. 2237 #: 586-20-2-042-0424.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The G.V. (Sonny) Montgomery VAMC has a need consultations and analysis of Thyroid Fine Needle Aspirations. This is to perform molecular testing (Veracyte Afirma) on all indeterminate or suspicious thyroid Fine Needle Aspirations. This change in practice will reduce the number of costly and sometimes risky procedures that patients must undergo in obtaining the neededspecimens.

The estimated need is to refer eight to 10 thyroid cases per year at a cost of $3,147.00 each for indeterminates. An additional cost of $626.00 is for suspicious cases requiring additionaltesting.

Estimated annual amount: $32,205.54 (base year) plus four options years total: $170,989.54.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

Other vendors may provide similar services; however, Veracyte, Inc., offers a proprietary Afirma Gene Expressions Classifier (GEC), which employs the required 142-gene signature to preoperatively identify benign nodules among those deemed indeterminate by the cytopathology. This proprietary GEC offered by Veracyte, Inc., will meet our clinical testing needs and provide optimal patient care.

Veracyte, Inc., provided a letter stating they were the sole provider for the Afirma testing.

4. Description of market research conducted and results or statement why it was not conducted:

Market research was conducted to identify any other potential sources. The market research consisted of searching VetBiz Registry, FBO, FPDS, GSA and SBA DSBS. A Sources Sought notice (36C25620P0279) was also issued via FBO and two responses were received. However, one was not capable of meeting the requirement because it was mainly for Engineering and IT services. The other vendor suggested they support laboratory services and molecular (DNA-based) testing.

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Original Date: 08/30/17 Revision 01 Eff Date: 04/23/2018

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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.

Danette R.

Digitally signed by

Danette R. Impey 224540

Date: 2020.02.03

11:28:44 -06'00' 02/03/2020

Danette Rene’ Impey Date Contracting Officer

Impey 224540 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466