SOW.docx

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6550--Reagents and consumables for Oncology
Solicitation number
36C26226Q0319
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This is a Statement of Work (SOW) for reagents and consumables procurement for the VA Greater Los Angeles Healthcare System (VAGLAHS), located at 11301 Wilshire Blvd, Los Angeles, CA 90073, which is part of the Desert Pacific Healthcare Network (VISN 22). The cytogenetics department requires specific probes and reagents for molecular oncology testing that have been validated for initial use and ongoing testing. An annual purchase order structure is specified as the most efficient ordering method, with materials to be utilized on an as-needed basis according to sample volume.

The scope requires reagents and consumables compatible with Ion Torrent S5, Ion Torrent Chef System, and Ion Torrent Genexus platforms for DNA and RNA Myeloid testing and DNA Solid Tumor testing. The required product list includes 24 line items encompassing Oncomine Precision Assay kits, Genexus sequencing and associated consumables (barcodes, pipette tips, template strips, bottles, and primer pools), hard shell plates, adhesive foil seals, Qubit assay kits for nucleic acid quantification, and SeraseQ quality control reagents for mutation, tumor, and fusion RNA testing. Specific genes to be identified include 33 myeloid genes (such as ABL1, BRAF, FLT3, NPM1, TP53) and 39 solid tumor genes (including EGFR, KRAS, MET, PIK3CA, ROS1). Hours of operation are 7:30 am to 5:00 pm Monday through Friday, excluding federal holidays, though 24/7 service coordination with the Program Manager may be required. The vendor must comply with VA information security standards, FISMA requirements, and contractor personnel security requirements including background investigations through the VA Security and Investigations Center.

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Statement of Work- Greater Los Angeles Healthcare System 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 reagents and consumables for oncology.

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:

Item #
Description/Part Number*
Product Number
1
ONCOMINE PRECISION ASSAY GX COMBO
A46291
2
GENEXUS BARCODES 1-32 HD KIT
A40261
3
GENEXUS BARCODES 1-96 AS COMBO
A40257
4
ONC MYELOID DNA ASSAY GX V2 32 Samples
A50753
5
ION GX5 CHIP AND GXS COUPLER KIT
A40269
6
GENEXUS SEQUENCING KIT COMBO
A40271
7
GENEXUS PIPETTE TIPS 12 RACK/96
A40266
8
GXS TEMPL STRIPS 3-GX5 AND 4 Combo
A40263
9
ION TORRENT GENEXUS BOTTLE 2 Each
A40273
10
GENEXUS BOTTLES 1 AND 3 KIT
A40274
11
GENEXUS STRIPS 3B-GX5 AND 4 KIT Each
A49782
12
96-WELL HARD SHELL PLATE CLEAR ,20 PCS PK
4483354
13
ADHESIVE FOIL SEALS FOR MICROP LATES OR PCR PLATES
AB0626
14
QUBIT DSDNA HS ASSAY KIT, 500 1 KIT
Q32854
15
QUBIT RNA HS ASSAY KIT, 500 1 KIT
Q32855
16
GENEXUS PRIMER POOL TUBES EACH
A40262
17
QUBIT DSDNA HS ASSAY KIT 500
Q32854
18
QUBIT RNA HS ASSAY KIT 500
Q32855
19
SERASEQ MYELOID MUTATION DNA
NC1600058
20
SERASEQ TUMOR DNA MIX V2 AF7
NC1784980
21
SERASEQ FUSION RNA MIX V4
NC1778303
22
SERASEQ NTRK FUSION RNA MIX
NC2749767
23
QUBIT ASSAY TUBES SET OF 500
Q32856
24
EP LOBND GNOMC TB 1.5ML 250/PK
13698791

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”

New Year’s Day
January 1st
Martin Luther King’s Birthday
Third Monday in January
President’s Day
Last Monday in January
Memorial Day
Last Monday in January
Independence Day
July 4th
Labor Day
First Monday in September
Columbus Day
Second Monday in October
Veteran’s Day
November 11th
Thanksgiving Day
Fourth Thursday in November
Christmas Day
December 25th

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.

(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.

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