Attachment B - Statement of Work.docx

STATEMENT OF WORK

REFERENCE TESTING: ONCOLOGY

VETERANS INTEGRATED SERVICE NETWORK (VISN) 22

A. INTRODUCTION

The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the successful offeror in relation to the VISN22 for reference testing.

B. BACKGROUND

VISN 22 is one of the most diversified healthcare systems in the nation. They are teaching hospitals, providing a full range of patient services, with state-of-the art technology as well as education and research. They also boost one of the largest and most diverse patient populations in the VA system.

VISN 22 has had an increase in testing requests from providers for oncology testing for breast and colon tissue. These test requirements are recommended by the National Comprehensive Network guidelines for testing and treatment. As such all sites within VISN 22 are requesting to utilize an annual PO for these services.

C. SCOPE

1. Locations: Reference Tests will be utilized by all sites within VISN 22.

West LA VAMC 11301 Wilshire Blvd Los Angeles, CA 90073

SD VAMC

3350 La Jolla Village Dr San Diego, CA 92161

LL VAMC

11201 Benton Street Loma Linda, CA 92357

LB VAMC

5901 E. 7th St Long Beach, CA, 90822

Path & Lab (113) 1501 San Pedro Dr. SE Albuquerque, NM 87108

PVAHCS

Lab 113 650 East Indian School Road. Phoenix, AZ 85012

NAVAHCS

500 N HWY 89

Prescott, Arizona 86313

SAVAHCS 6-113

3601 S 6th Ave Tucson, AZ 85723

2. Period of Performance:

The period of performance shall commence shortly after the awarded contract for one (1) year base period with the Government having the option to exercise four (4) one-year option periods for a total ordering period of five (5) years.

3. Testing Requirements:

Oncotype testing to deliver clinically relevant genomic intelligence to the specific to the individual of a patient’s tumor. Providing analysis of 21 plus genes, genomic assessment and predictive benefits of endocrine therapy.

Test Name

Oncotype DX - Breast

Oncotype DX – Colon

Oncotype DX – Breast DCIS

D. MINIMUM PERFORMANCE REQUIREMENTS

1. Reference laboratory must be licensed/accredited by the College of American Pathologists (CAP) and meet requirement of the Clinical Laboratory Improvement Act (CLIA).

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2. Oncotype DX – Breast

a. Assay shall be able to assess the results of 21 genes (16 known cancer genes and 5 reference genes.

b. Test results must provide quantitative ER score to assess hormonal therapy.

c. Test results must provide PR and HER2 scores.

d. Included in the National Comprehensive Cancer Network (NCCN) guidelines for standard of care testing.

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3. Oncotype DX – Colon

a. Assay shall be able to assess the results of 12 genes, 7 known cancer genes (Ki-67, C-MYC, MYBL2, FAP, BGN, INHBA, and GADD45B) and 5 reference genes (ATPSE, PGK1, GPX1, UBB, and VDAC2).

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E. STATEMENT OF WORK

1. The contractor upon request shall be able to supply at minimum of three example test reports showing negative and positive with a detailed genomic finding.

2. The contractor shall supply test shipping kit that includes shipping container, transport bag and shipping label.

3. LICENSURES: Contractor shall perform specimen testing only in fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing described in this contract. The reference laboratory must be licensed/accredited by the College of American Pathologists (CAP), and other state regulatory agencies as mandated by federal and state statutes. In addition, the Laboratory must be certified as meeting the requirements of the Clinical Laboratory Improvement Act (CLIA) of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information in accordance with Health Insurance Portability and Accountability Account of 1996 (HIPAA) and VA Directives 1106, 1106.01 and 1106.2

4. For each laboratory used, Contractor shall provide copies of all relevant permits/licenses and certification inclusive of any sanctions current or pending throughout the United States of America.

As these documents are reissued or reworded, the Contractor shall supply a copy to the Contracting Officer and each VISN 22 facilities. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary Contractor.

5. Hours of Operation Normal tour-of-duty hours at all sites are 8:00 am to 4:30 pm, Monday through Friday, excluding Federal holidays. However, the service is operating 24/7 and as such there may be instances in which the vendor’s workday may be outside of this period. The vendor is required to coordinate these times with the designated Program Manager.

In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as “Legal Federal official holidays”

When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies.

F. SECURITY

1. Information Security:

The vendor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions laws, and regulations. The vendor’s firewall and web server shall meet or exceed the government minimum requirements for security. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA Project Manager and the VBA Headquarters Information Security Officer as soon as possible. The vendor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation.

The contractor shall follow The Veterans Affair Acquisition Regulation (VAAR) security clause VAAR- 852.273-75 “SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES” sited in section C. Contract Clauses

(a) The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce's National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST's Web site at: http://checklists.nist.gov

(b) To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in "VA Information and Information System Security/Privacy Requirements for IT Contracts" located at the following Web site: http://www.iprm.oit.va.gov

2. Contract Personnel Security All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security and Investigations Center (07C). The level of background security investigation will be in accordance with VA Directive 0710 dated September 10, 2004 and is available at: http://www.va.gov/pubs/asp/edsdirec.asp (VA Handbook 0710, Appendix A, Tables 1 - 3). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award, and are to be completed and returned to the VA Security and Investigations Center (07C) within 30 days for processing. Contractors will be notified by 07C when the BI has been completed and adjudicated. These requirements are applicable to all subcontractor personnel requiring the same access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed, but the contractor will be responsible for the actions of those individuals they provide to perform work for the VA. In the event that damage arises from work performed by contractor personnel, under the auspices of the contract, the contractor will be responsible for resources necessary to remedy the incident.