Veracyte Decipher SOW.docx

Naval Medical Center Anatomic Pathology San Diego, California 92134

DECIPHER PROSTATE GENOMIC CLASSIFIER TEST

PERFORMED BY VERACYTE, INC.

STATEMENT OF WORK

1.0 INTRODUCTION

1.1 Organization:

The Naval Medical Center San Diego (NMCSD) and its affiliated Branch Medical Clinics (BMCs) located in San Diego, California are responsible for providing members of the U.S. Armed Forces and their dependents with reliable, high-quality health care. In addition to maintaining premier health care providers military beneficiaries, NMCSD is responsible for supporting the histology workload for NH Camp Pendleton, NH 29 Palms and NH Lemoore.

1.2.1 Background and Objective:

The contractor shall provide the Decipher Prostate Genomic Classifier testing services to the government at the NMCSD.

The Decipher Prostate test is used to determine how likely the patient’s cancer is to metastasize within the next five years:

· The test is performed on tissue samples obtained during biopsy or surgical removal of the prostate.

· The Decipher Prostate test is designed to give physicians and their patients clarity and confidence in developing a personalized treatment plan.

· The Contractor shall provide all required services, transportation, materials, equipment, and supplies as required.

· All tests shall be executed at the contractor’s premises, or within the Contractor's network of laboratories (affiliate or qualified subcontractor).

· The Contractor shall provide the Anatomic Pathology department with results and treatment recommendations which follow the 2024 National Comprehensive Cancer Network (NCCN) guidelines.

2.0 REQUIREMENT

2.1 Task Description and Deliverables:

2.1.1. Testing:

The contractor shall provide the full range of genetic testing capabilities to execute the required test (Decipher Prostate). All clinical reference laboratory testing shall be executed in accordance with standard industry practices.

2.2. Contractor Laboratory Information System

2.2.1 The Contractor’s shall provide:

2.2.1.1. The Decipher Prostate Biopsy Test Report which includes:

· the Decipher Genomic Score

· the risk estimates for the patient’s risk group

· a graphic interpretation of the patient’s risk when compared to others with similar clinical and pathologic features.

1. 2.2 Task Personnel Requirements

2.2.1 U.S. Citizenship:

U.S. citizenship is preferred, but not required.

2.2.2 Technical and Personal Skills:

All technical staff employed by the contractor must have backgrounds in laboratory technologies. The contractor must provide a rigorous training and credentialing program used to assess competency of and proficiency for those skills necessary to successfully perform the Decipher Prostate Genomic Classifier test.

3.0 Classification - Unclassified

Privacy Act Statement:

“Pursuant to Title 5 United States Code 552a(m)(1), the contractor and all employees of the contractor working under this contract are required to comply with the requirements of 5 U.S.C. 552a (“The Privacy Act of 1974”).

5.0 Travel:

No travel required by NMCSD personnel.

6.0 Period of Performance:

Base year with four option years with base year date to begin once contract is awarded. Proposed base year is 1 July 2024 – 30 June 2025.

7.0 Personal Services

NON PERSONAL SERVICES STATEMENT:

Contractor management will ensure that employees properly comply with the performance work standards outlined in the statement of work. Contractor employees will perform their duties independent of, and without the supervision of, any Government official or other Defense Contractor. The tasks, duties, and responsibilities set forth in the task order may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the United States Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR). The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

8.0 Invoice Schedule

Contractor may invoice monthly in arrears.

Invoices shall be submitted once a month for services rendered, shipping, during the previous month. No more than one invoice may be submitted per month. Invoices must identify the invoicing period. If charges against more than one line item have occurred during the invoicing period, all charges must be combined into one invoice and correlated with a specific CLIN item listed in the purchase request. Specific invoicing instruction will be provided in the contract award. The contractor’s failure to include the necessary information or a more frequent invoice submission than authorized will result in invoices being rejected. Payment will be processed by Wide Area Work Flow (WAWF).