RFP Tumor Normal Testing 36C10G21R0015.docx

36C10G21R0015

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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

Lawrence Toperoff 540-735-3854 09-01-2021 15:00

EDT

36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

X

621511 $35 Million

N/A

36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

VAFSC

Financial Services Center

PO BOX 149971

(see Section B.3 invoicing/payment) Austin TX 78714-8917 1 (877) 489-6135

See CONTINUATION Page Title: Tumor Normal Matched Genomic Testing Services

This Request for Proposal (RFP) is for tumor normal matched genomic testing services for the Department of Veterans Affairs (VA) Veterans Health Administration (VHA) National Precision Oncology Program (NPOP).

See Section B for Price/Cost Schedule and Statement of Work (SOW)/Performance Work Statement (PWS) for additional information regarding this requirement.

See CONTINUATION Page

Zachary Wilcox

Table of Contents

SECTION A

A.1 SF-1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B – CONTINUATION OF SF-1449 BLOCKS

SECTION C – CONTRACT CLAUSES

SECTION D – CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENNTS

SECTION E – SOLICITATION PROVISIONS

E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

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SECTION B - CONTINUATION OF SF 1449 BLOCKS

Governing Law Clause Federal law and regulations, including the Federal Acquisition Regulations (FAR), shall govern this Contract/Order. Commercial license agreements may be made a part of this Contract/Order but only if both parties expressly make them an addendum hereto, as permitted by FAR 12.212. If the commercial license agreement is not made an addendum, it shall not apply, govern, be a part of or have any effect whatsoever on the Contract/Order; this includes, but is not limited to, any agreement embedded in the computer software (clickwrap), any agreement that is otherwise delivered with or provided to the Government with the commercial computer software or documentation (shrink wrap), or any other license agreement otherwise referred to in any document. If a commercial license agreement is made an addendum, only those provisions addressing data rights regarding the Government’s use, duplication and disclosure of data (e.g., restricted computer software) are included and made a part of this Contract/Order, and only to the extent that those provisions are not duplicative or inconsistent with Federal law, Federal regulation, the incorporated FAR clauses and the provisions of this Contract/Order; those provisions in the commercial license agreement that do not address data rights regarding the Government’s use, duplication and disclosure of data shall not be included or made a part of the Contract/Order. Federal law and regulation including, without limitation, the Contract Disputes Act (41 U.S.C. § 7101 et seq.), the Anti-Deficiency Act (31 U.S.C. § 1341 et seq.), the Competition in Contracting Act (41 U.S.C. § 3301 et seq.), the Prompt Payment Act (31 U.S.C. § 3901 et seq.), Contracts for Data Processing or Maintenance (38 USC § 5725), and FAR clauses 52.212-4, 52.227-14, 52.227-19 shall supersede, control, and render ineffective any inconsistent, conflicting, or duplicative provision in any commercial license agreement. In the event of conflict between this clause and any provision in the Contract/Order or the commercial license agreement or elsewhere, the terms of this clause shall prevail. The Contractor shall deliver to the Government all data first produced under this Contract/Order with unlimited rights as defined by FAR 52.227-14. Claims of patent or copyright infringement brought against the Government as a party shall be defended by the U.S. Department of Justice (DOJ) in accordance with 28 U.S.C. § 516; at the discretion of DOJ, the Contractor may be allowed reasonable participation in the defense of the litigation. Any additional changes to the Contract/Order must be made by modification (Standard Form 30) and shall only be made by a warranted Contracting Officer. Nothing in this Contract/Order or any commercial license agreement shall be construed as a waiver of sovereign immunity.

B.1

CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C10G

OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

Contracting Specialist Lawrence B Toperoff U.S. Department of Veterans Affairs Strategic Acquisition Center 10300 Spotsylvania Ave., Suite 400 Fredericksburg, VA 22408 Lawrence.toperoff@va.gov

Program Office Point of Contact (POC) – To Be Determined (TBD)

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted monthly in 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 Requests.

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: Lawrence B. Toperoff, email: Lawrence.toperoff@va.gov COR (Contracting Officers Representative): TBD Contract/Task Order Number: TBD Purchase Order: #TBD

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

5. 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/task order. 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:

Limited to FAR Clause 52.216-19 Order Limitations, as noted in the contract. The estimated total quantities are listed in the Schedule of Services. The quantities are estimates only, and the 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 and patient homes, as applicable, 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 # TBD (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 contract Attachment A – 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 the submission due date outlined above. Reports shall be sent electronically to the following SAC IDIQ Government points of contact until the contractor is notified, in writing, of a different point of contact as follow:

a. Project Manager;

b. Contracting Officer’s Representative;

c. Contract Specialist; and

d. 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 B – Sample Business Associate Agreement

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

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B.4 PERFORMANCE WORK STATEMENT (PWS)

Performance Work Statement For

TUMOR NORMAL MATCHED GENOMIC TESTING SERVICES

For

DEPARTMENT OF VETERANS AFFAIRS

VETERANS HEALTH ADMINISTRATION

NATIONAL ONCOLOGY PROGRAM

Purpose

On behalf of the Department of Veterans Affairs (VA), the National Oncology Program (NOP) intends to secure specialized, comprehensive reference laboratory tumor-normal matched genomic testing for clinical care for Veterans with cancer. All services provided shall be in accordance with the costs, terms, and conditions of this contract.

Contract Type and Term The government anticipates award of a single Firm Fixed Price (FFP) Indefinite Delivery, Indefinite Quantity (IDIQ) contract. Contract will be available to VA Medical Centers. Weekly reports from the contracted laboratory are required to facilitate auditing performed by the Director of Precision Oncology and the Director of the National Oncology Program that will ensure specified providers are ordering testing according to evidence-based guidelines or best practices, as outlined by the National Precision Oncology Program (NPOP).

The effective period of the contract shall be from date of award through twelve (12) months with the options to extend the contract for additional 12-month periods, at the discretion of the VA, for up to four (4) additional years. Total contract will not exceed five years.

Description of Services/Introduction

The contractor(s) shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, and other items and services necessary to services as defined in the Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract and maintain compliance with policies and procedures with the Health Insurance Portability and Accountability Act (HIPAA), the Clinical Laboratory Improvement Act (CLIA), and accreditation with the College of American Pathologists (CAP) as well as the relevant laboratory and personnel state licensure to offer testing across the United States and its territories.

Objectives

The objective of this request is to ensure access to tumor-normal matched genomic testing for patients eligible to receive cancer care throughout the VA enterprise, in accordance with testing guidance established by the National Oncology Program (NOP).

Scope

The contractor’s laboratory shall have the ability to perform sample intake, processing, analysis, interpretation, and reporting for one or more tumor-normal matched genomic tests, as described herein. These services require a CAP accredited, CLIA-certified, state licensure compliant laboratory, inclusive of New York State (New York State laboratory accreditation/licensing mandatory), with the ability to perform complex genetic testing. Services require the ability to provide comprehensive somatic tumor profiling with or without a matched normal sample (in cases where a matched normal is unavailable or delayed). In cases where tumor sample is insufficient, the option to run a liquid biopsy should be made available to the VA. The contractor must have workflows in place to accommodate the above scenarios where it may not always be possible to run matched tumor normal samples or a quality assessment by the contractor’s laboratory may deem that the sample is of insufficient quality or quantity to undergo further processing. In case of insufficient tissue sample, the contractor must have the ability to run a liquid biopsy. If a matched normal sample is unavailable, the vendor must offer a tumor only test to provide the best use of the available patient sample. Test design must be able to reliably detect, at clinical sensitivity and specificity, different alteration types such as small variants, fusions/rearrangements and copy number variants that span tumor biomarkers relevant across all cancer types and detectable with next generation sequencing (NGS) based methods. When NGS based methods are not ideal to detect a biomarker, the ability to utilize other technologies to generate a comprehensive tumor profile is preferred. Germline testing and reporting must also be available and integrated with the tumor profile results. Test technology must be as future-proof as possible to allow for additional biomarkers to be incorporated and reported on as evidence and clinical utility emerges. Testing must be supported by the contractor’s field team across the VA enterprise to ensure rapid (approximately two weeks) sample turnaround times. Results return by various methods such as an online portal, fax etc. must be available, but must include an online portal. Finally, delivery of all raw and finished data generated and produced in performance of this contract as a result of testing including (but not limited to) FASTQ, BAM, VCF, PDF, and structured results (XML, JSON, or .txt files) to the National Oncology Program (NOP) by the contractor is required. Once award is made, the method of delivery will be determined in conjunction with the Government and the awardee.

Testing and Data Return

The National Oncology Program seeks to contract with testing laboratories that can receive, process, and report results for at least one or more of the test types and methodologies as described. In addition to performing testing and generating clinical result reports all raw and finished data generated as a result of testing including (but not limited to) FASTQ, BAM, VCF, PDF, and structured results (XML, JSON, or .txt files) shall be delivered to the National Oncology Program. Once award is made, the method of delivery will be determined in conjunction with the Government and the awardee. Since the cancer molecular testing field is dynamic, when a new type of test or test methodology is released that is relevant to the required clinical areas and is not currently on the schedule, the parties will add it to the contract by mutual agreement. In addition to clinically validated test results, the VA also has interest in any research use only data generated for emerging clinical biomarkers (neoantigen load, mutational signatures, tumor escape, HLA, LOH, oncoviral detection, gene expression markers). This must be provided separate from the clinical results, ideally as raw data in structured or semi-structured formats as well as through data visualization tools via an online portal or similar interactive system.

Methodologies required must include:

· Molecular analyses including (a) DNA-based tests such as next generation sequencing, and (b) RNA sequencing including quantification of gene and transcript levels, visualization, differential gene expression, alternative splicing, functional analysis, gene fusion detection.

· Molecular test types include, but are not limited to, whole exome, whole genome, comprehensive gene panels, whole transcriptome for tumor profiling. Targeted panels for germline testing in line with ACMG/ESMO/NCCN recommendations for testing of patients with cancer across a range of tumor types. NGS based tests, particularly those that are whole exome or genome based, must provide adequate sequence coverage for clinical sensitivity in key cancer-relevant genes/loci. Supplementary tests where NGS testing may be insufficient to include (but are not limited to) fluorescent in situ hybridization (FISH), immunohistochemistry (IHC), PCR, and capillary electrophoresis.

The contractor must provide the following services:

1. Test requisition form (online and paper-based ordering) Provide the following for transport of the specimens:

a. Laboratory test request forms (vendor must customize forms to include information required by the VA).

a. Ordering provider data

b. Ability to include multiple (at least 2 other individuals) on the test order to be copied on results.

c. Patient ICD-10 and ICD-O-3 codes.

d. Patient data

i. full name

ii. date of birth

iii. social security number, Medical Record Number (MRN) or a second identifier

iv. sex (biological)

v. gender

vi. test(s) to be performed

vii. specimen collection date/time

viii. specimen type

ix. VA facility station name

x. VA facility station ID

2. Special instructions for handling of specimen

3. Description of specimen types that can be accepted for each test

4. Specimen collection supplies for specialized testing

5. Mailing account number to cover the costs of shipping within the US and territories.

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

7. 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 RNA.

8. Analyze samples and report within a turnaround time of ~ 2 weeks.

9. The Contractor must demonstrate capacity to service all VA Medical Centers.

10. Contractor shall assume all packing and shipping costs. 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 and residual nucleic acids to NOP or designee.

11. Provide an invoice for tests completed within a month of service. Invoicing must identify ordering provider and VA location.

12. Provide access to a field team of local account representatives, medical science liaisons (for tumor profiling results), a genetic counselor (for consultation regarding germline test results) as needed.

13. A variant evaluation/interpretation program, which at a minimum conforms to American College of Medical Genetics and Genomics (ACMG) Standards and guidelines for the interpretation of sequence variants for germline testing.

14. A proficiency testing program (e.g. CAP). The VA reserves the right to request the results of any proficiency testing to which the contractor subscribes at any time throughout the duration of the contract.

The Contractor Laboratory shall have the following processes and procedures in place:

(a) Ensure testing is completed at the prime Contractor’s facilities, to include wholly owned subsidiaries, but not subcontractor or joint venture operated sites. Ensure that samples are not further transported to any other facility for testing, nor interpreted by any other personnel than prime contractor employed, medical directors, laboratory or medical geneticists, or molecular pathologist. These professionals must be employees of the Contractor’s facility or wholly owned subsidiary and be available at the site to remedy quality concerns, and testing challenges. Contractor must demonstrate ability of the laboratory and associated service infrastructure to handle VA sample volumes within the required turnaround time and appropriate backup or disaster plans in case of natural disasters, power outages or other events that may impact testing.

(b) Return in batches, at least on a quarterly basis, any residual tissue (to sending VA practice site), DNA or RNA sample (to the National Oncology Program) back to the VA.

(c) Accept and store the National Provider Identifier (NPI) for ordering providers. All are licensed healthcare providers in the VA, including genetic counselors, nurse practitioners, and physicians.

(d) Accept orders for germline testing without requiring additional signed consent from patients beyond a provider’s attestation on the test requisition form.

(e) Provide a secure online ordering portal. Full list of genes for each panel must be listed online. Portal should automatically alert providers and relevant VA staff when test results are available. Portal must not only provide the ability to limit test results to ordering providers (and those copied on order) but also the ability to broaden access to VA employees managing the overall contract that may need national access to results for clinical operations. Test results must, at a minimum, be searchable by patient name, DOB, ordering provider as well as by gene or genetic alteration and classification (pathogenic, likely pathogenic etc.). The portal should also provide the ability to bulk download or export search results. Portal should automatically alert providers and relevant VA staff when test results are available.

(f) Perform analytical testing for VA patients for the tests requested. The Contractor shall bill only for the tests specified in the request sent by VA laboratory service.

(g) Provide reflex test options such as a liquid biopsy in the case of insufficient tumor sample. Have the ability to run tumor only samples when a matched normal sample is unavailable.

(h) When test results are reported as “qualified”, provide retesting with a fresh sample at no additional cost to the VA.

(i) Provide a reference test manual and report of analytical test results, upon award, describing the full scope of its laboratory operations.

(j) Provide VA with laboratory supplies (collection tubes, postage-paid transport packaging, etc.) not customarily utilized by VA laboratories. These supplies are to be used by VA laboratories only in connection with specimens being sent for testing to the contractor.

(k) Carry out the functions described herein in full compliance with all local, state, and federal laws or regulations.

(l) Provide test report electronically or by fax in a secure fashion compliant with VHA requirements.

(m) Ability to send raw molecular data files (e.g., BAM, BAI and VCF files) as well as final reported data files in a structured data format to be determined by VA (e.g. report json, xml) is required. Contractor must have ability to securely transfer electronically by method acceptable to VA. All formats must use standard formats (and recent version) or a format acceptable to VA. Contractor to provide technical files describing the format of each file, including BED files. Contact information to be provided upon contract award. Ability to interface with the VA laboratory information system to facilitate test ordering and reporting is preferred.

(n) Provide a point of contact including names and telephone number(s) to make inquiries on weekdays of Laboratory Directors, technicians, and other laboratory personnel available for consultation.

(o) Maintain the minimum acceptable service, reporting systems, and quality control as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency.

(p) Ensure test results are not released to anyone other than the ordering healthcare provider, staff associated with the order (including the VA facility where the specimen collection originated) or designated VA National Oncology Program staff. The only exception to release of results is for select VA staff in charge of oversight. Prior to release to a VA oversight unit, permission must be granted from NOP. All records shall be treated as confidential, to comply with all state and federal laws regarding the confidentiality of patient’s records. This provision shall survive termination of the resulting contract award.

(q) Certify and ensure that all laboratory employees, officers, or agents comply with standards set forth in the Health Insurance Portability and Accountability Act (HIPAA).

(r) Deliver a weekly summary reports that provide information to the VA regarding test orders, order status, sample status and results at the test level. Summary reports must provide an in process test summary, broken down by test type and at the test level indicating the stage each sample is at in the testing process (e.g., analysis started, sample not received etc.) in addition to an aggregate count of how many samples are in each stage of that process. The report shall also include an indication of whether orders are via the online portal or a paper-based mechanism. Tests on hold due to the sample not being received should be highlighted with an indication of how many days have elapsed since the order was received. For reported samples, the summary should also indicate the turnaround time for each sample and whether that aligns with contracted expectations.

(s) Reporting requirements include: patient first and last name, social security number, MRN or other secondary identifier, ordering provider name and NPI, date of specimen collection, tumor type using ICD-O-3 codes (or other classification system acceptable to VA), sample type, sample status, date of test result report, test name, procedure, VA facility station name, VA facility station ID and cost. These reports should be submitted in a Microsoft Excel, or similar format as determined by VA. Prepare an annual report that summarizes germline genetic test utilization and costs overall and by ordering provider and VA facility.

Test Sample Preparation The VA laboratories shall be responsible to provide laboratory specimens prepared in accordance with the contractor’s Laboratory User’s Manual. All specimens will be properly identified and labeled for testing to include at least two identifiers (e.g., patient name, medical record number, date of birth). The contractor shall provide an adequate supply of requisition forms, special instructions, and a current list of tests with specimen requirements. These requirements shall be defined in the laboratory user’s manual.

Transport of Specimens The contractor laboratory client Services will provide a mailing account number to send specimens directly to the contractor’s laboratory.

The contractor laboratory must send saliva kits and/or buccal swab kits directly to a patient’s home and provide packaging/mailing supplies postage pre-paid for the patient to send a specimen directly back to the contractor laboratory for germline paired normal testing if saliva is a supported sample type for testing. The contractor laboratory will not use patient address for any other purpose beyond mailing specimen collection supplies.

Reporting of Test Results A report is defined as a printed final copy of a test result interpreted by individuals with training and licensure in molecular pathology, genetics and signed out by an American Board of Medical Genetics and Genomics (ABMGG) board-certified geneticist or American Board of Pathology (ABP) board certified molecular genetic pathologist. Reports shall be sent by contractor electronically or by fax to the ordering provider and VA laboratory. Each report must have the following information:

a. Patient’s full name

b. Patient’s date of birth

c. Patient’s unique medical record number

d. VA facility station name

e. VA facility station ID

f. Ordering provider’s name

g. Ordering provider’s NPI

h. Purchase order account number

i. Test(s) ordered

j. Date/time of specimen collection (when available)

k. Date/time specimen received in Reference Lab

l. Date test signed and reported

m. Type of specimen/source

n. Test result(s)

o. Flag abnormal results

p. Conform to a standardized reporting scheme for tumor profiling results with alterations/biomarkers tiered into a level of evidence model such as AMP/ASCO, OncoKB Levels of Evidence or other equivalent framework.

q. Highlight clinical trial eligibility based on patient tumor type and biomarker and patient location. Trials active at individual VA medical facilities, VA system wide trials or sponsored by NCI should be highlighted in the report for physicians.

r. For germline testing, comments on interpretation for variants of uncertain significance, likely pathogenic, and pathogenic results, which may include but are not limited to: Clinical summary, comments on familial testing, variant effect on protein, ClinVar entries, in silico models, experimental studies, reference to population databases.

s. Methodology used and limitations of listed methodology

t. Name of testing laboratory (contractor and/or wholly owned subsidiary), address, CLIA number

u. Testing laboratory specimen number

v. Information that may indicate a questionable validity of test result

w. Unsatisfactory specimen shall be reported with reason as to its unsuitability for testing

x. Tumor type using ICD-0-3 codes (or other classification system acceptable to VA).

y. Identifiers to indicate electronic or other valid sign off of clinical report by an ABMGG board-certified geneticist or ABP board-certified molecular genetic pathologist as relevant to report type.

Licensing and accreditation – Contractor Laboratory shall:

(a) Have all licenses (which includes New York State Licensing), permits, accreditation certificates required by Federal and State law.

(b) Maintain Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 (CLIA) certification and accreditation by the College of American Pathologists (CAP) or the American College of Medical Genetics and Genomics (ACMG). Copies of all professional certifications, licensures and renewal certifications shall be provided and updated as needed to the Contracting Officer to include the contractor laboratory’s Laboratory Director(s) and/or Medical Director(s).

· Medical Director(s) shall have suitable Molecular Genetics, Molecular Pathology qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA, ACMG and CAP standards.

(c) Have personnel assigned to perform the services covered by the contract who are eligible to provide these services and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on the contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board.

(d) Comply with the regulatory requirements of Health and Human Services Health Care Financing Administration, Centers for Medicare and Medicaid (CMS).

(e) Maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

(f) Notify the Contracting Officer immediately, in writing, upon its (or any of its subsidiaries’) loss of any required certification, accreditation, or licensure.

Contract Performance Monitoring: Quality Control: The contractor shall operate a successful quality assurance program as required by CAP/CLIA. Services are to be performed in accordance with the PWS. The quality control program shall include procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program is how the contractor laboratory assures that work complies with the requirement of the contract.

The contractor shall permit the VA to examine its facilities, methodologies, and quality control during the life of the contract.

Quality Assurance: The Contractor shall comply with all applicable Occupational Safety and Health Administration (OSHA), Federal and State laws and regulations required for performing the type of services described herein and provide that quality assurance plan. The government shall evaluate the contractor’s performance under the contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

Hours of Operation: The contractor is responsible for providing services 8:00am – 5:00pm Monday – Friday, local time, except for Federal Holidays. The Contractor shall always maintain an adequate workforce for the uninterrupted performance of all tasks defined within the PWS. When hiring personnel, the Contractor shall hire in a manner congruent with the established stability and continuity of the workforce.

Physical Security: The contractor shall be responsible for safeguarding all government equipment, information, and property provided to the contractor laboratory.

Contractor Furnished Items and Responsibilities: The Contractor shall furnish all supplies, equipment, facilities, and services required to perform work as outlined in this contract.

Periodic reporting. Provide at least monthly utilization/cost reports and an annual report (for contract performance period) to the Director of Precision Oncology and Director of the National Oncology Program. The reports shall be in Microsoft excel or equivalent format and include at minimum the following for each test ordered: patient first and last name, social security number or other secondary identifier, medical record number, ordering provider name and NPI, date of specimen collection, sample type, sample status, date of test result report, test name, procedure, VA facility station name, VA facility station ID and cost. Summary reports must provide an in process test summary, broken down by test type and at the test level indicating the stage each sample is at in the testing process (e.g., analysis started, sample not received etc.) in addition to an aggregate count of how many samples are in each stage of that process. The report shall also include an indication of whether orders are via the online portal or a paper-based mechanism. Tests on hold due to the sample not being received should be highlighted with an indication of how many days have elapsed since the order was received. For reported samples, the summary should also indicate the turnaround time for each sample and whether that aligns with contracted expectations.

Summary of Deliverables:

1) Patient report with integrated tumor normal results reported and delivered to the VA electronically or by fax.

2) All raw and finished data generated and produced in performance of this contract, as a result of testing, including FASTQ, BAM, VCF, PDF, and structured results (XML, JSON, or .txt files) shall be submitted to the National Oncology Program (NOP) daily.

3) Any residual tissue (to sending VA practice site), DNA or RNA sample (to the National Oncology Program).

4) A weekly summary report that provides information to the VA regarding test orders, order status, sample status and results at the test level.

5) Monthly utilization/cost reports and an annual report (for contract performance period) to the Director of Precision Oncology and Director of the National Oncology Program.

TECHNOLOGY REFRESH, ITEM ADDITION, PRICE ADJUSTMENTS

The contractor shall provide improved testing within the awarded period of performance as appropriate new industry technologies emerge and/or products become obsolete during the term of the contract. A revised product listing and documentation identified below shall be submitted in writing to the CO, CS and COR.

The contractor shall provide the following information to the CO, CS and COR for review and approval (All products submitted as a technical refresh will undergo a technical evaluation by Government personnel):

(1) A complete modification request form that includes a list of specific awarded item(s) to be updated

(2) Product literature for the product/testing;

(3) A detailed description of the differences or benefits of products refreshed as compared to the item(s) being discontinued or added;

(4) Proper identification of any procedures related to the product requirements and/or procedures related to those product(s) proposed;

After all pricing is determined to be fair and reasonable by the Contracting Officer and the product/testing is determined to be within scope of the contract, may be added to the contract via bilateral modification.

B.5 HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) COMPLIANCE

a) As a covered entity, the VA is required 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…