Attachment B - SOW.docx

ATTACHMENT B – STATEMENT OF WORK (SOW)

1. 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 Desert Pacific Network Laboratories for reference testing.

2. 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. The VISN22 Desert Pacific Network Laboratories wishes to have additional options to diagnose cancer in thyroid nodules with indeterminate FNA cytology. New testing methods have been developed that allow a stratification of benign and likely malignant diagnosis. This testing method may advise the extent of surgical management (lobectomy vs total thyroidectomy).

3. SCOPE

Period of Performance:

Period of performance to start shortly after award for 1-year base period with 4 option years.

Contractor Responsibilities:

a. Contractor shall provide necessary collection and shipping supplies, including shipping boxes with pre-paid labels, to all VISN22 Pathology departments.

b. Contractor shall perform genetic analysis of fine needle aspirations of thyroid nodules to stratify benign and likely malignant specimens.

c. Contractor shall provide an interpretive Pathologist report via fax and a web-based portal within fourteen (14) days of specimen receipt.

d. List of participating VISN22 Sites:

VA LONG BEACH HEALTHCARE SYSTEM

5901 E. Seventh St Bldg: 126, Rm: W231V Long Beach, CA 90822

FAX: 562.346.3609

VA LOMA LINDA HEALTHCARE SYSTEM

11201 Benton Street Bldg: 2, Rm: 4F04 Loma Linda, CA 92357

FAX: 909.777.3224

VA SAN DIEGO HEALTHCARE SYSTEM

3350 La Jolla Village Drive Bldg: 1, Rm: 1229 San Diego, CA 92161

FAX: 858.642.1084

VA GREATER LOS ANGELES HEALTHCARE SYSTEM

11301 Wilshire Blvd.

Bldg: 500, Rm: 1272 Los Angeles, CA 90073

FAX: 310.268.3559

VA ALBUQUERQUE HEALTHCARE SYSTEM

1501 San Pedro Dr. SE Bldg: 41, Rm: BA-115 Albuquerque, NM 87108

FAX: 505.256.6408

VA NORTH ARIZONA HEALTHCARE SYSTEM

500 AZ-89

Bldg: 164 Rm: 115 Prescott, AZ 86301

FAX: 928.776.6111

VA PHOENIX HEALTHCARE SYSTEM

650 E Indian School Rd.

Bldg: 1, Rm: E222 Phoenix, AZ 85012

FAX: 602.222.2669

VA SOUTHERN ARIZONA HEALTHCARE SYSTEM

3601 S 6th Ave.

Bldg: 57, Rm: BA018 Tucson, AZ 85723

FAX: 520.629.1806

Salient Characteristics

a. Perform genetic testing for the pre-operative assessment of thyroid nodules from a fine needle aspirate with indeterminate cytology

b. Analysis of at least 112 genes and 150 gene fusion types to provides information on cancer prognostication, helping to select the most optimal patient management.

c. Be able to detect all types of thyroid cancer (papillary, follicular, Hurthle cell, medullary) and non-thyroidal lesions (parathyroid, metastases to the thyroid).

d. Assess the risk of cancer recurrence.

e. Identify therapeutic targets for advanced cancers.

f. The reference laboratory must be licensed/accredited by the College of American Pathologists (CAP), as well as any other state regulatory agencies as mandated by federal and state law.

g. Provide all necessary collection and shipping supplies, including shipping boxes with pre-paid labels, to all VISN22 Pathology departments

Specifications:

a. 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 Center for Disease Control, Medicare, as well as any other state regulatory agencies as mandated by federal and state law. 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.

b. 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.

c. 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 Contractor.

d. Be able to detect all types of thyroid cancer (papillary, follicular, Hurthle cell, medullary) and non-thyroidal lesions (parathyroid, metastases to the thyroid).

e. Assess the risk of cancer recurrence.

f. Identify therapeutic targets for advanced cancers.

Test Menu

a. Thyroseq testing is a test for the pre-operative assessment of thyroid nodules with indeterminate cytology, which offers accurate assessment of cancer probability in a given nodule and additionally provides information on cancer prognostication, helping to select the most optimal patient management. Providing analysis of 112 genes and 150 gene fusion types.

b. Current Procedural Terminology (CPT) code: 81479

Business Review Report

a. The Contractor shall provide a semi-annual Business Review Report in a downloadable MS Excel format. This report will contain a cumulative document of all usage by VISN22 Desert Pacific Network Laboratories and an individual break down of each site’s volume of tests performed.

4. HOURS OF OPERATION

a. Normal tour-of-duty hours at all sites are 7:30 am to 5:00 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.

b. 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”

c. 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.

5. TRAVEL

a. All travel shall be responsibility of the contractor.

b. Whenever possible, conference calls and video conferencing should be used.

6. SECURITY

Information Security:

a. The contractor 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 contractor’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.

b. The contractor shall follow The Veterans Affair Acquisition Regulation (VAAR) security clause VAAR- 852.273-75 “SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES”.

(i) 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.

(ii) 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"

7. Contractor Personnel Security:

All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject to 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: https://www.va.gov/securityinvestigationscenter/directives_and_regulatory_guidance.asp (VA Handbook 0710, Appendix A, Tables 1 - 3). Appropriate Background Investigation (BI) forms will be provided upon contract award and are to be completed and returned to the VA Security and Investigations Center (07C) within thirty (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.