Attachment B SOW.docx

Statement of Work- Greater Los Angeles Healthcare System Next Generation Sequence Reagents & Supplies

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 VA Greater Los Angeles Healthcare System for next generation sequence testing.

1.1 Background

The VAGLAHS at 11301 Wilshire Blvd, CA 90073 is part of the Desert Pacific Healthcare Network (VISN 22), and is one of the most diversified tertiary health care providers in the VA. It is a teaching hospital, providing a full range of patient services, with state-of-the art technology as well as education and research. It also boosts one of the largest and most diverse patient populations in the VA system.

The section has become a reference lab for other facilities within VISN 22 for molecular oncology testing. This has allowed VISN 22 to benefit from reduced cost of send outs as well as improved turnaround time. In order to maintain the in-house laboratory, the cytogenetics department requires the use of specific probes and reagents utilized for testing. The specific material is essential to continued function as they have been validated, which is a requirement for initial use and ongoing testing. Due to the cost and volume of the reagents and supplies needed an annual PO is most efficient for ordering purposes. It would be utilized as needed, based on the samples sent to the department for testing.

2. Scope

Obtain reagents and consumables that are compatible with Ion Torrent S5, Ion Torrent Chef System and Ion Torrent Genexus for the performance of DNA and RNA Myeloid testing and DNA Solid Tumor testing.

Must include the following Genes:

Myeloid Gene Identification: ABL1 BRAF CBL CSF3R DNMT3A FLT3 GATA2 IDH1 IDH2 JAK2 KIT KRAS MPL MYD88 NPM1 NRAS PTPN11 SETBP1 SF3B1 SRSF2 U2AF1 WT1 ASXL1 BCOR CALR CEBPA ETV6 EZH2 PHF6 RUNX1 STAG2 TET2 TP53 ZRSR2 SMC1A

Solid Tumor Gene Identification: AKT1 ALK AR BRAF CDK4 CTNNB1 DDR2 EGFR ERBB2 ERBB3 ERBB4 ESR1 FGFR2 FGFR3 GNA11 GNAQ HRAS IDH1 IDH2 JAK1 JAK2 JAK3 KIT KRAS MAP2K1 MAP2K2 MET MTOR NRAS PDGFRA PIK3CA RAF1 RET ROS1 SMO

Products Required to meet these needs:

3. Hours of Operation

· Normal tour-of-duty hours at VAGLAHS is 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.

· 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.

4. Security

4.1 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

4.2 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.