P03 LSJ Decipher Sole Source_edited_Redacted.pdf

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VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID:

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 8, Orlando Commodities Office, located at 2500 Lakemont Ave, Orlando, FL 32814, in support of VA Caribbean Health Care System at 10 Casia Street, San Juan, PR 00921.

Reference 2237:

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). The proposed action is for a

( ) month firm-fixed price (FFP) task order with four (4) twelve month options for Specialized Genomic Reference Laboratory supports testing for Decipher Prostate Cancer Molecular Testing. The proposed effort will be awarded under the

General Services Administration (GSA) Federal Supply Schedule (FSS) Schedule 621 II – Medical Laboratory Testing and Analysis Services.

Order against: FSS Contract Number: 36F79721D0019

Name of Proposed Contractor: Decipher Corporation

Street Address: US 692 Lusk Boulevard, Suite 200

City, State, Zip: San Diego, CA 92121

Phone: (484) 888-5733

(3) Description of Supplies or Services: The government has a need to procure Decipher Prostate for Specialized Genomic Reference Laboratory testing for prostate cancer patients.

Contractor shall provide laboratory services to include specimen packaging and transport of specimens to its laboratories; pre-analytic processing as defined in its Laboratory Testing Manual; performing test for Decipher testing for prostate cancer cases. After the sample is collected, received in the Anatomic pathology laboratory, the container is labeled with patient name, accession number along with the completed requisition form with patient information and type of tests.

The requirement is for a base of month and four-twelve month options.

The base estimated value is and the total estimated value of the proposed action is

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Attachment 2: Request for Limited Sources Justification Format >SAT

(4) Identify the Authority and Supporting Rationale

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

Decipher Corporation offers a highly unique and specialized Genomic Prostate Cancer Classifier test that serves as a prognostic marker of cancer control outcomes in patients who have undergone radical prostatectomy (RP). Decipher is a laboratory developed test (LDT) that was developed and validated in a cohort of high-risk prostate cancer patients after surgery with a high rate of metastases. This laboratory testing is patented and proprietary assay via Deciphers state-of-the-art, Clinical Laboratory Improvement Amendments (CLIA) accredited and College of American Pathologists (CAP) accredited laboratories.

It is these specific characteristics of the service that limits the availability to a sole source. Any level of services below those offered by decipher would lead to increased risk to patient care and not fulfill the Government’s needs. Decipher Corporation is the only known provider capable of offering and meeting the required level of quality testing necessary to provide the best patient care VA has to offer. There are currently no alternatives to using decipher and based on market research there are no other vendors who could fully meet the Government’s requirement.

Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: The anticipated price to the Government for this contract action determination is based on FSS prices that have already been determined to be fair and reasonable for Contract 36F79721D0019, Decipher Corporation, however, additional discounts will be requested.

Attachment 2: Request for Limited Sources Justification Format >SAT

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Any Other Facts Supporting the Justification: Decipher Corporation is the only known provider capable of offering and meeting the required level of quality testing necessary to provide the best patient care VA has to offer. There are currently no alternatives to using decipher and based on market research there are no other vendors who could fully meet the Government’s requirement.

A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made. Not applicable

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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

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Attachment 2: Request for Limited Sources Justification Format >SAT

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

c. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.