36C10G18R0203-001.docx

36C10G18R0203

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C10G18R0203 08-22-2018 Katharine Lindner 202-632-9077 09-06-2018 11:00am 36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 X 621511 $32.5 Million X N/A X

36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

VAFSC

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

(see Section B.3 invoicing/payment) Austin TX 78714-8917 1 (877) 489-6135 See CONTINUATION Page Title: Genomic Sequencing Testing Services This Request for Proposal (RFP) is for genomic sequencing testing services for the Department of Veterans Affairs (VA) Veterans Health Administration's (VHA) National Precision Oncology Program (NPOP).

See Section B for Price/Cost Schedule and Statement of Objectives (SOO) for additional information regarding this requirement.

See CONTINUATION Page X X

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: COMPANY

b. GOVERNMENT: Contracting Officer

Fredericksburg, VA 22408 Brian.Shepard@va.gov

Fredericksburg, VA 22408 Katharine.Lindner@va.gov

Program Office POC – TBD

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with 52.232-33, Payment by Electronic Funds Transfer—System For Award Management.

3. INVOICES: Invoices shall be submitted monthly in arrears based upon delivery and acceptance:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Request.

5. FSC MANDATORY ELECTRONIC INVOICE SUBMISSION: Contractors are required to submit payment requests in electronic form in accordance with the submission instructions below.

TUNGSTEN ELECTRONIC INVOICE SUBMISSION

FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

Contracting POC: <to be provided at time of contract award> COR (Contracting Officers Representative): <to be provided at time of contract award> Contract/Task Order Number: <to be provided at time of contract award> Purchase Order Number: <to be provided at time of contract award>

a. Vendor Electronic Invoice Submission Methods:

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.

1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

2. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org)

b. Vendor e-invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below.

1. Tungsten e-Invoice Setup Information: 1-877-489-6135

2. Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

3. FSC e-Invoice Contact Information: 1-877-353-9791

4. FSC e-invoice email: vafsccshd@va.gov See https://www.fsc.va.gov/einvoice.asp for more information.

B.2 PAYMENT TERMS AND CONDITIONS

a) The Government is obligated only to the extent of authorized purchases made under the resultant contract. The terms and conditions included in this contract apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this contract and the Contractor’s invoice, the provisions of this contract will take precedence.

b) Purchase/Ordering Limitation:

Orders placed against this contract are limited to FAR Clause 52.216-19 Order Limitations, as noted in the contract. The estimated total quantities are listed in the Price/Cost Schedule. The quantities provided are estimates only, and VA makes no guarantee regarding the actual quantities that may be purchased.

c) Delivery Tickets:

The following provisions apply to all shipments:

Inspection: Destination Acceptance: Destination Shipping: Free on Board (FOB) – Destination Ship To and Mark For: Deliveries shall be marked and shipped to various VHA locations identified in each order placed against the contract.

All shipments, either single or multiple container deliveries, shall bear and contain on the delivery tickets or sales slips (external shipping labels and associated manifests or packing lists) the following at a minimum:

(i) Name of supplier

(ii) Contract number

(iii) Date of purchase

(iv) Itemized list of supplies or services furnished

(v) Quantity, unit price, and extension of each item, less applicable discounts (unit prices and extensions need not be shown when incompatible with the use of automated systems, provided the invoice is itemized to show this information).

(vi) Date of delivery or shipment

In the case of multiple container deliveries, a statement readable near the VA Order number will indicate total number of containers for the complete shipment (ex. “Package 1 of 2”), clearly readable on manifests and external shipping labels.

Packing Slips/Labels and Lists shall include the following:

IFCAP PO # ____________ (i.e., 166-E11234) Total number of Containers: Package ___ of ___. (i.e., Package 1 of 3)

d) Reports:

Quarterly Report:

To track compliance, VA requires the contractor to submit the quarterly report of sales in the approved format listed in Attachment B – Quarterly Reporting Tool based on the Governments fiscal calendar year. See below.

The contractor agrees that they shall adhere to this requirement. The contractor shall provide a quarterly report, no later than 60 calendar days after the end of each fiscal quarter ending December, March, June, and September. Reports shall be sent electronically to the SAC BPA Government points of contact until the contractor is notified, in writing, of a different point of contact.

1. Project Manager;

1. Contracting Officer’s Representative;

1. Contract Specialist;

1. Financial Management Analyst at SACPAY@va.gov;

B.3 BUSINESS ASSOCIATE AGREEMENT(S) (BAA)

A National Business Associate Agreement (BAA) shall be established within 60 days of contract award.

When the Government engages the services of contractor to create, receive, maintain, or transmit individually-identifiable health information on its behalf, the contractor becomes a business associate under HIPAA. As a result, the Government and the contractor must enter into a HIPAA-compliant Business Associate Agreement (BAA), and the contractor is both contractually liable for meeting the terms of the BAA and directly liable for compliance with the applicable requirements of the HIPAA Rules.

VHA is the only administration of the Department of Veterans Affairs’ (VA) that is a Covered Entity under the HIPAA Privacy Rule.

Although VHA is the Covered Entity under HIPAA, other VA Administrations and Staff Offices may have access to PHI and EPHI during performance of certain functions or activities on behalf of, or providing certain services to VHA through a Business Associate Agreement (BAA). A BAA must be in place for VHA to disclose PHI or EPHI to a VA component that is Business Associate.

Failure to comply with all aspects of HIPAA requirements applicable to Business Associates can result in non-compliance with Federal law, which carries penalties for VA and potentially for individual(s) responsible for non-compliance. All Business Associates also understand that they are subject to periodic HIPAA compliance reviews conducted by VHA.

While a BAA may be required in connection with a SAC-executed contract, as a general rule, SAC contracting officers due not have the authority to enter into a BAA. The VHA Privacy Office, VHA NDS/HIA Office, VA Facility Director, Contracting Officer, Privacy Officer, Information Security Officer, and Contracting Officer Representative work together to ensure BAAs are enacted for all Business Associates. See VHA HANDBOOK 1605.05 for more information on how BAAs are established and administered.

See RFP Attachment C – Sample Business Associate Agreement

B.4 TECHNOLOGY REFRESH

The Contractor shall provide improved items within the awarded product/service line as appropriate as new industry technologies emerge and obsolete items are replaced. New industry technologies may be added without removing obsolete. By mutual agreement the Government Contracting Officer and the Contractor, the Contractor shall add the new or improved items to the contract. The revised product/service listing shall be in writing and approved by both parties.

Further, the Contractor shall ensure that all Genomic Sequencing services offered are state-of-the-art. "State-of-the-art" is defined as the most recently designed method approved by the FDA and are announced for marketing purposes.

The Contractor shall ensure that all new services are approved in accordance with the pre-market notification under the Food and Drug Administration (FDA) process and labeled appropriately. The Contractor shall provide the Contracting Officer the following information as items become obsolete:

(1) A list of specific awarded items to be updated;

(2) Product literature for the new items and a detailed description of the differences between the awarded items and the new items, and a specific analysis of the comparative advantages/disadvantages of the items involved;

(3) Proper identification of any new product requirements and/or procedures related to those new products; and

(4) Suggested new Item pricing.

New products replacing awarded items and released to the market during the period of performance shall be offered to the Government at a discounted price. The Contracting Officer will complete a Price Fair and Reasonable Price Determination prior to adding product to the contract. The price determination will be added to the contract file. The Government reserves the right to not accept the new products. The Contractor shall continue to supply the Contracted item(s) as originally identified.

B.5 PRICE/COST SCHEDULE

ITEM INFORMATION

The quantities listed in the CLIN table are only estimated quantities and the Government is not required to purchase the quantity stated in the CLIN table. Funded orders will be placed directly to the Contractor by the individual VA Medical Center.

In accordance with FAR 16.504(a) the maximum aggregate dollar value for all task orders awarded under this single-award IDIQ is $TBD, and the minimum dollar guarantee for the single awardee is $5,000.00. The IDIQ will be funded for the amount of the minimum at the time of award using the fiscal year funds of the year of contract award.

Contract Period: Base POP Begin: 09-28-2018 POP End: 09-27-2019

Contract Period: Base

Contract Period: Base

Contract Period: Base

Contract Period: Base

Contract Period: Base

Contract Period: Base

Contract Period: Base

Contract Period: Base

Contract Period: Base

Contract Period: Base

Contract Period: Base

Contract Period: Option 1 POP Begin: 09-28-2019 POP End: 09-27-2020

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 2 POP Begin: 09-28-2020 POP End: 09-27-2021

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 3 POP Begin: 09-28-2021 POP End: 09-27-2022

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

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Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 4 POP Begin: 09-28-2022 POP End: 09-27-2023

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

(In accordance with FAR 52.217-8, Option to Extend Services (NOV 1999)) Contract Period: Option 5 POP Begin: 09-28-2023 POP End: 03-27-2024

(In accordance with FAR

Services (NOV 1999)) Contract Period: Option 5

(In accordance with FAR

Services (NOV 1999)) Contract Period: Option 5

(In accordance with FAR

Services (NOV 1999)) Contract Period: Option 5

(In accordance with FAR

Services (NOV 1999)) Contract Period: Option 5

(In accordance with FAR

Services (NOV 1999)) Contract Period: Option 5

(In accordance with FAR

Services (NOV 1999)) Contract Period: Option 5

(In accordance with FAR

Services (NOV 1999)) Contract Period: Option 5

(In accordance with FAR

Services (NOV 1999)) Contract Period: Option 5

(In accordance with FAR

Services (NOV 1999)) Contract Period: Option 5

(In accordance with FAR

Services (NOV 1999)) Contract Period: Option 5

(In accordance with FAR

Services (NOV 1999)) Contract Period: Option 5

B.6 STATEMENT OF OBJECTIVES

STATEMENT OF OBJECTIVES

For

GENOMIC SEQUENCING TESTING SERVICES

For

DEPARTMENT OF VETERANS AFFAIRS

VETERANS HEALTH ADMINISTRATION

NATIONAL PRECISION ONCOLOGY PROGRAM

I. PURPOSE

To provide genomic sequencing testing services to Department of Veterans Affairs (VA) Clinicians and Hospitals nationwide.

II. SCOPE OR MISSION

The Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide comprehensive genomic sequencing testing services and related support services, using current commercially available technology, to VA Clinicians and Hospitals nationwide.

III. PERIOD AND PLACE OF PERFORMANCE

The period of performance shall be for one (1) base year of 12 months and four (4) 12-month option years.

The Government reserves the right to extend the term of this contract at the prices set forth in Section B in accordance with the terms and conditions contained in clause 52.217-9 entitled, “Option to Extend the Term of the Contact”.

Services will be provided at the Contractor location.

IV. BACKGROUND

The Department of Veterans Affairs (VA), Veterans Health Administration’s (VHA) National Precision Oncology Program (NPOP) is responsible for the development and oversight of the implementation of Precision Oncology VA-wide procurement initiatives, such as the procurement and oversight of Genomic Sequencing testing services throughout the VA.

Precision Oncology is the practice of biologically directed cancer care. For example, the mutations in a cancer’s genome (the cancer’s DNA), can significantly impact the treatment options available to treat that cancer and the likely outcomes after treatment. By knowing the cancer genome, Oncologists and patients are able to choose therapies that specifically target the patient’s cancer.

The NPOP has identified Genomic Sequencing testing services as a candidate for a VHA-wide contract to provide consistent laboratory analysis and reporting for Veteran oncology patients nationwide.

For the purposes of this procurement, Genomic Sequencing testing services includes genomic analysis (targeted, with the potential for expansion to whole exome, whole transcriptome analysis, and testing of germline DNA) of human tumor tissue and/or blood. It is expected that a significant portion of tumor samples will be derived from fine needle aspiration and core needle biopsy. The majority of samples will be from the initial tumor biopsy that documents the presence of cancer and will be stored as formalin fixed paraffin embedded (FFPE) samples.

In general, the NPOP’s goals are to establish Genomic Sequencing testing as a part of the VA healthcare system’s standard of clinical oncology care. The program intends to incorporate molecular testing and analysis as a new standard of care across the VA healthcare system, define and disseminate Precision Oncology best practices, and reduce disparities in rural health. As a result, NPOP will improve cancer care at the VA through the following:

· Generating knowledge on effective, and conversely ineffective therapies

· Understanding cost and effectiveness of using molecular testing to guide treatment decisions

· Increase opportunities for clinical trial participation

V. OBJECTIVES

At a minimum, this SOO supports the following objectives:

OBJECTIVE 1: Collaborative Workspace

A collaborative workspace, such as SharePoint, that allows all members of the team to interact with various aspects of the project. This environment should be accessible to all members of the team and consideration of VA firewall issues must be considered. At a minimum, this collaborative environment should provide all users the capability to file share various versions of project files, transfer large (<1G) audio and video files and post messages. Collaborative workspace is to be updated and maintained at least weekly, or as needed.

OBJECTIVE 2: Genomic Analysis

Genomic analysis that includes the following steps as a minimum:

· Solid tumor next-generation sequencing (NGS), hematologic malignancies NGS panels, liquid biopsy (circulating tumor cell free DNA) for solid tumor and hematologic with the potential for expansion to whole exome, whole transcriptome analysis, and germline testing of DNA) of human tissue samples; and

· Panel testing that also includes TMB (tumor mutational burden) and MSI (DNA Microsatellite Instability status). Testing for PD-L1 protein expression by IHC (immunohistochemistry) is preferred.

OBJECTIVE 3: Bio-sample Shipping and Reporting

Bio-samples that are handled securely from the shipping and tracking of samples through the data reporting phase, as described below:

Shipping:

· Coordination with assigned COR for the applicable facility for the furnishing and delivery of specimen collection and transportation supplies;

· Sample tracking and management (i.e. utilizing bar coding) to ensure security and traceability of VA samples;

· Documentation of sample handling and processing attributes/audit trail, etc. that would address sample mixing and sample error tracking;

· The Contractor’s proposed shipping requirements, e.g., method/conditions for shipping, receipt, and acknowledgement of shipments.

· Specimens are expected to be shipped by the VA Monday through Friday, so the plan should include specimen receipt Tuesday through Saturday; and

· All packing and shipping costs are assumed by the Contractor. This includes the cost of shipment of samples from the VA Medical Centers to the Contractor as well as shipment of residual tissue back to the Medical Center. Return of residual tissue can be batched and shipped quarterly.

· There are currently approximately VHA 80 locations that provide oncology services that perform Genomic Sequencing tests (see Attachment A – Participating Medical Centers). The Contractor must demonstrate capacity for growth as additional Medical Centers become available for Genomic Sequencing.

Reporting:

Bio-sample reporting data is to be securely transferred in a manner that is acceptable to the VA, and include the following:

· Electronically return analysis results and all data files via Secure File Transfer Protocol (SFTP) or via secure web service that is acceptable to VA;

· Real-time tracking, through the collaborative workspace or other electronic means, of testing requests by VA facilities, tracking of sample shipment, and tracking of testing, billing/invoicing that includes patient identifying information, sending VA facility, vendor sample ID number, and cancer type. For each submitted sample, the Contractor shall associate a sample ID, patient identifiers (complete name, complete SSN, DOB, sex), sending VA facility name and number, diagnosis using standardized terms and codes acceptable to VA (e.g., ICD-O-3), test status (complete, failed with reason, or in process with expected completion date) and assemble this information into a secure web service. It is preferable that results files be available within the same electronic delivery system and that there be an API to allow bulk data retrieval by program staff;

· Access to raw data files as well as the summary statistics for the DNA as well as RNA sequencing on every sample to include DNA sequence files (e.g., FASTQ or BAM) through a secure web service;

· Annotated variant file and reference sequence and include PDF report, report content in structured format acceptable to VA (e.g., JSON, XML), variant call file, (VCF) using the most recent VCF format specification and also acceptable to VA;

· Technical information describing file formats and file sizes of annotated variant files, reports (and associated structured components of reports) and reference sequences;

· Completed DNA genotyping data including: raw data (possibly image files- to be discussed at a kick-off meeting), genotype calls, quality scores, and any other relevant data deemed to be useful for analysis/storage/reanalysis purposes for the VA samples. Data for genotype calls (VCF, etc.) should be provided concurrently with the report, which shall include for human readable (i.e., PDF) and structured (e.g., JSON, XML) formats. Data transfer will be by secure electronic transmission;

· Desired retention time of all data files (FASTQ, BAM, Variant) is 1 year minimum;

· Annotated clinical report; and

· Desired timeframe from receipt of human tissue sample to final annotated clinical report sent to both the NPOP and the clinician providing care for the patient is no more than 3 weeks.

OBJECTIVE 4: Histopathology Review and Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) Extraction

Perform pathology reviews that confirm the presence of cancer, percentage of cancer cells in the tissue specimen, determine tissue quality for testing, and extraction of and quality assessment of DNA and possibly RNA.

· Contractors will propose their recommended testing approach among target or whole exome sequencing and using either a laboratory reference or germ-line DNA as the comparator for variant calling. Contractors may also propose performing whole transcriptome sequencing of tumor samples;

· The Contractor is to provide technical plans for DNA and RNA isolation (where applicable) from tumor or blood samples and provide information on assay validation and quality control procedures;

· If applicable, the plan should include the strategy for RNA sequence analysis of tumor samples to identify altered expression of genetic variants that are actionable (such as gene fusions) or validation variants by integration with exome sequencing data; and

· The Contractor should include in their response the outer boundaries of tissue types, sample quality, input DNA necessary, and quantity necessary for testing.

OBJECTIVE 5: Molecular Analysis

Possess the ability to manufacture or purchase and process all the required molecular analysis reagents, chips, and required bioinformatics tools/workflows.

OBJECTIVE 6: Analysis Reports and Molecular Data

Describe the bioinformatics tools and pipelines used for data computations. Provide a data analysis strategy including their plans for sequence analysis, calls against reference builds or germ-line sequences and algorithms for variant calling, copy number analysis, or other genomic alterations.

OBJECTIVE 7: Return Unused Samples and Derivatives and Molecular Data

The VA will provide the Contractor with human samples that the Contractor shall store safely and process as required. At the completion of the testing, all unused samples shall be returned and certified to that fact by the Contractor as specified by VA policies unless otherwise notified in writing by the VA Project Director. All materials and patient samples utilized during the contract are the property of the Department of Veterans Affairs and must be handled in a confidential and secure manner.

Describe the planned lab standard operating procedures (SOPs) methods for handling and securing of samples including paper and electronic documents. The plan should include details of proposed shipping requirements like method/conditions for shipping, receipt, and acknowledgement of shipments.

VI. REQUIREMENTS

Monthly Progress Reports:

At minimum, the Contractor shall provide monthly progress report addressing the status of all active efforts. A separate project tracking report shall also be sent at an approved frequency that tracks the following project parameters, including:

· Project Name and Task Order (TO) Name;

· Overall high-level assessment of TO progress;

· All work in-progress and completed during the reporting period;

· Identification of any TO related issues uncovered during the reporting period and especially those areas with a high probability of impacting schedule, performance goals, and their likely impact on schedule, or performance goals;

· Explanations for any unresolved issues, including possible solutions and any actions required of the Government and/or Contractor to resolve or mitigate any identified issue, including a plan and timeframe for resolution;

· Number of samples for which QA/QC analysis were completed to desired parameters for each of the analysis steps. Source of control material used and the adequacy of the control material must be documented; and

· Sample success rates at each of the analysis steps.

Weekly Status Reports:

At minimum, the Contractor shall provide a weekly status report containing the following information:

· A summary of all Contractor work in progress and performed the previous week;

· An assessment of technical progress;

· Total number of samples submitted and pass/failure rate of each sample.

· A schedule update/status;

· Discussion of any issues, concerns, or problems encountered or anticipated during the reporting period and actions taken, and the results of the actions;

· Other information the Contractor deems appropriate, or that has been agreed upon by the PM, COR, CO, and Contractor.

VII. CONSTRAINTS

The Contractor shall be validated to perform Next-Generation Sequencing (NGS) for the National Cancer Institute – Molecular Analysis for Therapy Choice (NCI-MATCH) study at the time of contract award.

The Contractor shall maintain the following laboratory credentials: College of American Pathologists (CAP).

The Contractor must provide specifically demonstrated history of sequencing samples from patients in New York State, and is preferably certified through Clinical Laboratory Improvement Amendments (CLIA) to service all 50 states to include the District of Columbia and Puerto Rico.

VIII. DELIVERABLES

Weekly Status Reports

By Tuesday of every week

IX. CONTRACT TYPE

The government anticipates award of a Firm Fixed Price (FFP) Indefinite Delivery, Indefinite Quantity (IDIQ) contract.

B.7 HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) COMPLIANCE

a) As a covered entity, the VA is required to by law to obtain satisfactory assurance of a Business Associate that the Business Associate appropriately safeguards protected health information it receives or creates on behalf of the covered entity. Contractors and any Subcontractors must adhere to the provisions of Public Law 104-191, HIPAA to include the Administrative Simplification Provisions of the law and associated rules and regulations published by the Department of Health and Human Services (HHS). The Contractor shall comply with all HIPAA-related rules and regulations to include Electronic Transactions, the Standards for Privacy of Individually Identifiable Health Information, and the Security Standards. This includes both the Privacy and Security Rules published by HHS. As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities. The covered entity component of the VA is the Veterans Health Administration (VHA). Business associates must follow VHA privacy policies and practices. All Contractors and business associates must receive privacy training annually. For Contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training, other VHA approved privacy training or Contractor furnished training that meets the requirements of HHS Standards for Privacy of Individually Identifiable Health information as determined by VHA. For Contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training or other VHA approved privacy training. Proof of training is required.

b) Any violation of HIPAA will be reported to the CO, the COR, and the PM in writing within one (1) business day of the Contractor’s discovery of an occurrence. Included in the report will be a description of the occurrence, patient names (if known), location, date and time. A copy of any filed police report will be provided by the Contractor to the CO within one (1) business day of completion.

c) Security must be designed into the system to protect patient information as required by HIPAA. All external network connects to the remote server shall be via encrypted SSL connects, VPN software and hardware. The process and method in which the transmission or routing of VA image data shall be reviewed and approved in accordance with form VA 6500.6. All patient information remains the sole property of the United States government and shall not be used for any purpose other than those stipulated in this contract. The VAMCs shall act as primary custodian of the patient information (including both the image data and the report) for all purposes related to Government records retention requirements. Patient information, including images shall be retained by the Contractor only for the minimum period of time required to comply with any applicable laws, regulations, and the retention policies stated herein. Upon request, the Contractor shall provide the Strategic Acquisition Center (SAC) CO, assigned COR for the applicable facility, Information Security Officer (ISO), or Privacy Officer (PO) with access to information pertaining to the way the Contractor maintains NPOP/VAMC patient data and the steps taken on an ongoing basis to assure the privacy and security thereof. This includes information regarding computer network architecture, configuration of firewall(s), routers, and other pieces of networking equipment, information about installed security software, and audits of patches of known security vulnerabilities. All relevant security-related patches and anti-virus updates shall be installed with seven (7) days of initial release. Patient lists, no matter how developed, shall be treated as privileged information. Lists and names of patients shall not be disclosed or revealed in any way for any use outside the contract of this PWS. Contractor must meet all VA required security restrictions and Contractor representatives shall undergo all HIPAA/confidentiality related training to comply with V15 requirements.

B.8 FACSIMILE (FAX) PRIVACY STATEMENT

Should the Contractor require the use of facsimile communication during the life of the contract, the VA requires the following statement on all fax cover sheets be included:

“This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribution, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.”

B.9 ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a) A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or Task Order.

b) All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c) Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d) Custom software development and outsourced operations must be located within the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e) The contractor or subcontractor must notify the CO immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The CO must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

B.10 VA INFORMATION CUSTODIAL LANGUAGE

a) Information made available to the Contractor or Subcontractor by VA for the performance or administration of this contract or information developed by the Contractor/Subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the Contractor/Subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b) Prior to termination or completion of this contract, Contractor/Subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/Subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the SAC CO within 30 days of termination of the contract.

c) The Contractor/Subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

d) The Contractor/Subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the contract or to preserve electronic information stored on Contractor/Subcontractor electronic storage media for restoration in case any electronic equipment or data used by the Contractor/Subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

e) If VA determines that the Contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the Contractor or third party or terminate the contract for default or terminate for cause under FAR part 12.

f) If a VHA contract is terminated for cause, any associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

g) The Contractor/Subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

h) The Contractor/Subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

i) Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the Contractor/Subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the SAC CO for response.

j) The Contractor/Subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the SAC CO for response

k) Notwithstanding. the provision above, the Contractor/Subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C.