RFP 36C10G24R0013 Tumor Molecular Testing.pdf

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. UEI: EFT:

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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C10G24R0013 12-08-2023

Michelle Bailey 01-31-2024

13:00 EST

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

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

X

621511

$41.5 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 Molecular Services

This Request for Proposal (RFP) is for Tumor Molecular 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 Objectives (SOO) for additional information regarding this requirement.

RFP Questions are due January 5, 2024, by 2pm EST

RFP Closing date is January 31, 2024, by 1pm EST

$0.00 See CONTINUATION Page

36C10G24R0013

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PAYMENT TERMS AND CONDITIONS

B.3 HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)

BUSINESS ASSOCIATE AGREEMENT(S) (BAA)

B.4 TECHNOLOGY REFRESH

B.5 PRICE/COST SCHEDULE

B.6 CONTRACT MINIMUM AND MAXIMUM DOLLAR VALUES

B.7 CONTRACTOR PERFORMANCE

B.8 Performance Work Statement

SECTION C - CONTRACT CLAUSES

C.1 MANDATORY WRITTEN DISCLOSURES

C.2 SAC 18-01 – SAC Service Level Agreement Fee and Submission of Quarterly Sales Reports; Open Market (January, 2016)

C.3 52.202-1 DEFINITIONS (JUN 2020)

C.4 52.204-27 PROHIBITION ON A BYTEDANCE COVERED APPLICATION (JUN

2023)

C.5 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAR 2023)

C.6 52.216-18 ORDERING (AUG 2020)

C.7 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.8 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.9 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.10 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) . 42

C.11 VAAR 852.204-71 INFORMATION AND INFORMATION SYSTEMS SECURITY

(FEB 2023)

C.12 VAAR 852.211-76 LIQUIDATED DAMAGES - REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023)

C.13 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (OCT 2019)

C.14 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.15 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.16 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 54

C.17 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.3 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAR 2023)

E.4 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

E.5 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.6 ADDENDUM to FAR 52.212-2 EVALUATION – COMMERICAL ITEMS

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

E.8 52.216-1 TYPE OF CONTRACT (APR 1984)

E.9 52.217-5 EVALUATION OF OPTIONS (JUL 1990)

E.10 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.11 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

E.12 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE

RESOLUTION (OCT 2018)

E.13 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.14 VAAR 852.273-70 LATE OFFERS (NOV 2021)

E.15 VAAR 852.273-74 AWARD WITHOUT EXCHANGES (NOV 2021)

E.16 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR: COMPANY: _____________________________

POC: _____________________________

TITLE: _____________________________

EMAIL: _____________________________

PHONE: _____________________________

DUNS: _____________________________

b. GOVERNMENT: Contracting Officer 36C10G

OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg, VA 22408-2697 Zachary.wilcox@va.gov

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

Program Office POC – TBD

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

AMENDMENT NO DATE

3. 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.

mailto:Zachary.wilcox@va.gov mailto:Michelle.Bailey@va.gov

36C10G24R0013 Tumor Molecular Testing

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

5. 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.

6. 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:

COR (Contracting Officers Representative):

Contract/Task Order Number:

Purchase Order Number:

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 http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.x12.org/

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.

mailto:VA.Registration@Tungsten-Network.com mailto:vafsccshd@va.gov https://www.fsc.va.gov/einvoice.asp

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 based on the Governments fiscal calendar year. See below.

QUARTER PERIOD OF SALES SUBMISSION DUE DATE

1st October – December Due last day in February 2nd January – March May 31st 3rd April – June August 31st 4th July – September November 30th

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.

a. Project Manager;

b. Contracting Officer’s Representative;

c. Contract Specialist;

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

B.3 HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT

(HIPAA) 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 mailto:SACPAY@va.gov

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 do 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 5 – Sample HIPAA Business Associate Agreement

B.4 TECHNOLOGY REFRESH

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

Further, the Contractor shall ensure that all Tumor Molecular Testing 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 services become obsolete:

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

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

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

(4) Suggested new service pricing.

New industry technologies may be added without removing obsolete services, by mutual agreement and 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/service to the contract. The price determination will be added to the contract file. The Government reserves the right to not accept the new products/services. 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 a VA Contracting Officer.

B.6 CONTRACT MINIMUM AND MAXIMUM DOLLAR VALUES

The minimum guaranteed amount is $2,500.00 for the awarded contract. Test request shall be determined by department needs. The Government has no obligation to award test request beyond the minimum guaranteed amount. The Government’s obligation for the minimum guaranteed amount applies during the first 12 months of the contract. If the Contractor receives total test request for less than the minimum amount in year one, the Government will pay the difference between the amount ordered and the minimum amount guaranteed for the initial 1st 12 months of the awarded contract.

B.7 CONTRACTOR PERFORMANCE

Attachment 2 - Contractor Discrepancy Report (CDR), may be issued by a CO or COR to document less than acceptable performance by the contractor at any point during the period of performance. It should be noted that issuance of a CDR should not be the first form of communication or plan of resolution unless the seriousness of the situation warrants such formal documentation from onset. The CO, COR and contractor shall maintain open and effective communications to avoid the issuance of CDRs to the maximum extent practicable. All parties acknowledge that a finalized CDR will become part of the official file and will be used to report on annual performance under the IDIQ.

If use of a CDR is warranted, the CO/COR shall complete the CDR, citing the IDIQ and/or Delivery Order (DO) number and the specific IDIQ and/or DO section or clause related to the performance issue. The CO/COR shall provide a detailed and descriptive narrative of the background and issue. Upon receipt of the CDR, the contractor shall provide a timely and detailed response by the contractor. The contractor’s response

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

QTY UNIT

PRICE

AMOUNT

0001 See Attachment 3 – Excel Product/Price Schedule for details

GRAND TOTAL

shall include any important or relevant information or justification for the performance issue and a proposed resolution. The CO/COR will review the response from the contractor and the CO will issue a final recommendation or plan of action. The CO, COR, and contractor will maintain communication to ensure that the recommendation or plan of action is carried out.

The contractor’s performance on the IDIQ will be reported to the Contractor Performance Assessment Reporting System (CPARS) on an annual basis. The CO and COR will make use of information from CDRs, as well as any additional knowledge and information available to them with respect to the contractor’s performance, to complete the CPARS. Contractors shall familiarize themselves with the CPARS process and be prepared to respond to reports entered by the CO and COR.

B.8 Performance Work Statement

For

TUMOR MOLECULAR PROFILING SERVICES

DEPARTMENT OF VETERANS AFFAIRS

VETERANS HEALTH ADMINISTRATION

NATIONAL ONCOLOGY PROGRAM (NOP)

On behalf of the Department of Veterans Affairs (VA), the National Oncology Program (NOP) intends to secure specialized, comprehensive reference laboratory-based tumor molecular profiling services for clinical care. Services should include test offerings spanning both solid and hematological malignancies using methods such as next generation sequencing (NGS) panels, NGS comprehensive genomic profiling (CGP) as well as complementary tests to support NGS such as immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) for biomarkers such as PD-L1, MMR, HER2 etc. all used to guide clinical care for Veterans with cancer. All services provided shall be in accordance with the costs, terms, and conditions of this contract.

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 primary place of performance will be at the contractor’s location.

Contract Type and Term The government anticipates award of a Firm Fixed Price (FFP) Indefinite Delivery, Indefinite Quantity (IDIQ) contract. Contract use will be available to specified providers within the VA nationwide. Weekly reports from the contracted laboratory are required to facilitate auditing performed by 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 perform 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, maintain compliance with regulations of the Health Insurance Portability and Accountability Act (HIPAA) and the Clinical Laboratory Improvement Act (CLIA), and comply with the accreditation standards of the College of American Pathologists (CAP)and/or The Joint Commission (TJC) as well as the relevant laboratory and personnel state licensure(s) offering testing across the United States and its territories.

Objectives The objective of this request is to ensure access to tumor molecular 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 There are currently approximately 132 VA facilities that provide oncology services that order Tumor Sequencing tests. The Contractor must demonstrate capacity to service all VA oncology practice sites including growth as additional Medical Centers and other practice sites needing testing services. The contractor’s laboratory shall have the ability to perform sample collection kit delivery, sample intake, processing, analysis, interpretation, clinical reporting, and raw data delivery for one or more tumor molecular tests, as described herein.

These services require a CAP accredited, CLIA-certified laboratory, a New York State licensure compliant laboratory or the willingness to perform tests for Veterans Health Administration as a federal entity, regardless of state requirements, with the ability to perform complex molecular tumor testing (as evidenced by staff board certification and current laboratory licenses). Services require the ability to provide comprehensive somatic tumor profiling and companion tests to support Next Generation Sequencing (NGS) such as immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) for biomarkers such as PD-L1, MMR, HER2 etc. In cases where tumor sample is insufficient, the option to run a liquid biopsy should be made available to the VA. The contractor must offer test options to provide the best use of the available patient sample or procure fresh sample, working with the ordering provider and with reasonable urgency such that the clinical care of the patient is not impacted. Test design must be able to reliably detect, at clinically acceptable 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 should also be offered. The VA would like knowledge of and access to any future technology 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 sample processing turnaround times. Clinical results return must occur on a web portal but can also be delivered through use of various methods such as fax etc.

Contractor must have the ability and willingness to work towards test requesting and results return integration with VA Electronic Health Record (EHR) systems (currently VISTA CPRS and in a future state with Cerner) through HL7 messaging, Application Programming Interface (API), Fast Healthcare Interoperability Resources (FHIR) or other technical interface capabilities. Finally, return of all raw and finished data generated as a result of testing (both clinical and Research Use Only (RUO)) to the National Oncology Program (NOP) by the contractor is required. Results return format is specified in Appendix A. Contractor must return un-used or residual blocks and/or slides to send out laboratories and residual nucleic acids (DNA and RNA) to the National Precision Oncology Central Office Laboratory.

Testing and Data Return The National Oncology Program seeks to contract with testing laboratories that can receive specimens, process tests, 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 shall be returned to the National Oncology Program in the specified format described in Appendix A. 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 Oncologic clinical areas supported by the National Oncology Program, the VA will have access to that offering by mutual agreement. In addition to clinically validated test results, the VA also requires collection of any available RUO data generated for emerging clinical biomarkers (e.g.; homologous recombination deficiency (HRD) signatures, neoantigen load, mutational signatures, tumor escape, HLA, LOH, oncoviral detection, gene expression markers). This should 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. Manifests outlining all documents delivered (raw and clinical data) are also required with each delivery (cadence to be determined upon award). These manifests must include date, file type and patient level identifiers allowing linkage across file types and weekly reports (described below) at the patient level. Contractor is required to communicate a plan for delivery of amendments and/or addendums across all impacted file types and must also have clear plan for tracking and identifying addendums and/or amendments from originally distributed file types (either via new identifier, date or other unique ID as laid out by the contractor).

Baseline required methodologies are outlined below. Additional optional methodologies should also be expanded upon in proposal.

• Molecular analyses including (a) DNA-based tests such as next generation sequencing (NGS), and (b) RNA sequencing including quantification of gene and transcript levels, differential gene expression, gene fusion detection by RNA seq.

• Targeted gene panel, large panel, whole exome, or whole genome strategy for providing a comprehensive solid tumor profile and profiling of hematological malignancies.

• Liquid biopsy testing using ctDNA

• Supplementary tests, where NGS testing may be insufficient to include (but are not limited to) fluorescent in situ hybridization (FISH), immunohistochemistry

(IHC).

• Assays’ methodologies coupled with algorithms and computational approaches that enable detection of cancer relevant biomarkers across tumor types. This includes gene alterations, tumor mutation burden, microsatellite instability, loss of heterozygosity (LOH), homologous recombination deficiency (HRD).

Description of Services:

The contractor must provide the following services:

1. Test requisitioning system (online as the primary source and paper-based ordering as a backup if/when needed)

Provide the following for transport of the specimens:

a. Laboratory test request forms customized to include information required by the VA as outlined below:

a. Ordering provider information:

i. Provider Name, address, NPI, associated VA facility name and VA facility ID

b. Ability to include least 2 other individuals VA emails to be copied on results.

c. Patient ICD-10 and ICD-O3 codes (Topology and Histology), in a drop-down selectable format.

d. Patient data

i. full name

ii. date of birth

iii. social security number/Medical Record Number (MRN)

iv. sex (biological)

v. gender

vi. Mailing address (if applicable)

vii. test(s) to be performed

viii. specimen collection date/time

ix. specimen type

x. Patient VA facility station name

xi. Provider VA facility station name

xii. Patient VA facility station ID

xiii. Provider VA facility station ID

2. Specimen collection, handling, storage and shipment instructions

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

4. Specimen collection and labeling supplies for specialized testing

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

6. A courier system that employs a sample tracking and management (i.e., utilizing bar coding) system to ensure security and traceability of VA specimens and maintenance of specimen integrity throughout shipment (if applicable to assay or specimen type).

7. Performance of pathology reviews that confirm the presence of cancer, percentage of cancer cells in the tissue specimen, determination of tissue quality for testing, and extraction of and quality assessment of DNA and/or RNA. In FFPE tissue specimens, contractor should have the capability to enrich for tumor DNA if tumor percentage is too low over the entire specimen.

8. Analysis of samples and delivery of test result reports within a turnaround time of ~ 2 weeks from specimen shipment date.

9. Overall order status tracking system to allow for tracking test request from the time they are placed to completed and results returned to provider.

This will also include tracking for failed orders and associated reasons for failures in those instances (e.g., Tissue insufficient).I

10. Share established parameters for tissue insufficiency per assay and tissue type.

11. A bi-directional shipping program where the contractor shall assume the cost of all packing material and shipping expenses. This includes the cost of overnight 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 (in batched shipments) back to NOP or designee. These costs are not the responsibility of or billable to the government.

12. Official Invoice delivery will be proceeded with an excel sheet shared with NPOP vis secure email within 14-21 days after the close of the month of service. The Pre-invoice excel shall delineate all testing reported within the specified month and shall include the following information:

a. Account number

b. PO Number (if applicable)

c. Vendor ID (if applicable)

d. Patient Name

e. Patient DOB

f. VA Facility Station name and code where the patient is seen

g. SS# / Medical record number

h. Ordering provider name

i. Ordering provider VA Facility Station Name and code

j. Vendor Test Accession #

k. Test Name

l. Quantity

m. Amount

n. All other information gathered as part of the test request process

o. NPOP will review within 5 business days and if all patients and testing approved, contractor shall submit official invoice for payment.

p. Contractor will also keep the Contracting officer and NPOP leadership informed about any existing contracts with VA facilities for new contracts outside this program.

13. Access to a field team of local account representatives and medical science liaisons for consultation regarding testing and results for VA providers as needed. Field team is also expected to support issues related to sample acquisition and ensure rapid testing turnaround times.

14. A proficiency testing program (e.g., through the College of American Pathologists). The VA reserves the right to confirmation of the completion of any proficiency testing to which the contractor subscribes at any time throughout the duration of the contract.

15. A mutually agreed upon Quality Assurance program to include monthly reporting on (but not limited to):

a. Turn Around Times (TATs) per assay (across project and by VA Facility):

i. Order date to specimen arrival at the lab

ii. Specimen Receipt date to resulted

iii. Order date to resulted

b. Tissue Insufficiently, Order Cancelations and Failures (including reasons)

c. Other metrics as determined in the first year of the contract

Processes and Procedures:

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 operated sites. Contractor must demonstrate ability of the laboratory and associated service infrastructure to handle VA sample volumes (10,000 -15,000 samples/year) 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) Ability to return in batches, on a monthly basis, any residual tissue/slides/sample (to sending VA facility), and on a quarterly basis DNA or RNA sample (to the National Oncology Program) back to the VA. Residual materials return (DNA or RNA) shipments must be accompanied with a manifest generated by the contractor outlining patient level identifiers able to be linked back to raw data delivery manifests and to the weekly reports, lab relevant content related to specimen quality quantity and plate location or tube identification number that allows tracking back to the sample itself. Template residual material return manifest must be shared with NPOP within 105 days of contract award. See below for minimum required fields on residual materials delivery manifest:

o Order ID /Patient ID/ Specimen ID o Limb System ID (if applicable) o Test Type o Material / Specimen Type (DNA / RNA) o % Tumor Nuclei o Extracted Concentration o Estimated Remaining Mass (optional) o Estimated Remaining Volume o Plate Name (if applicable) o Plate Well (if applicable) o Tube ID (if applicable)

(c) Accept orders without requiring signed consent from patients beyond a provider’s attestation on the test requisition form.

(d) Provide a list of tests currently available with a price list.

(e) Full list of genes, genetic markers, and/or other biomarkers for each panel must be listed online on contractor’s webpage.

(f) Provide a secure online user-friendly web-based ordering portal specific to the

VA to support this contract, demonstrated to NPOP within 30 days of contact award. If during the demo it is determined that the existing contractor portal does not meet NPOP specific needs (as outlined in this PWS), contractor will make, test, validate and demo all needed modifications to the portal within 105 days of contract award. Customized VA NPOP portal must include:

o Ability to order and limit ordering to tests within scope of the contract.

o Automatic alert to providers and relevant VA staff when test results are available.

o Portal must have the ability to limit test results to ordering providers (and those copied on order), specific VA facilities but also the ability to broaden access to VA employees managing the overall contract that may need national access to results for clinical operations.

o The portal must include tiered access controls that allow NOP system wide access to all VA orders under the contract. Ability to control user access by VA station or at the level of the individual provider is also required, as well as view only options for support staff. Vendor must also have the ability to capture and provide audit logs when requested related to access patterns for individual users or sites.

o Portal organizational structure must be customized, allowing for providers to place orders and review results at either individual sites, multiple sites or nationally as needed. NPOP staff must be able to see all orders as soon as they are placed for all accounts.

o Test results must, at a minimum, be searchable by patient name, DOB, ordering provider, VA facility name as well as by diagnosis, gene, genetic alteration and variant classification.

o The portal should also provide the ability to bulk download data/reports or export search results.

o Portal test ordering fields must be customizable for VA’s needs to only include tests covered under this contract and ensure all required data fields are collected at the time an order is placed.

o The portal must have the ability to track sample status from placement of an order to a clinical report being issued and returned to the provider.

o The portal must allow for user-friendly download of report PDFs and search queries described above.

(g) Work with NPOP for portal account set up only with approved providers as identified by NPOP, and limit access to only VA providers/ clinical staff with a va.gov addresses.

(h) 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.

(i) Provide test options such as a liquid biopsy in the case of insufficient tumor sample. If applicable, have the ability to run tumor only samples when a matched normal sample is unavailable.

(j) When test results are reported as “qualified”, notify the VA ordering provider and NPOP and provide retesting with a fresh sample at no additional cost to the VA.

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

(l) Provide VA with laboratory supplies (collection tubes, postage-paid transport packaging, etc.). These supplies are to be used by VA laboratories only in connection with specimens being sent for testing to the contractor.

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

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

(o) Ability to send raw molecular data files to VA (e.g., FASTQ, BAM, BAI, BED and VCF files) as well as clinically reported results in a structured data format (e.g.

report JSON, xml, csv, txt) is required within 3 months of contract award.

Contractor must have ability to securely transfer data electronically by method acceptable to VA (which is typically through AWS cloud-based transfer mechanisms). All data delivered must use standard formats (and recent version) or a format acceptable to VA. Contractor to provide technical example files representing all test offerings as well as data dictionaries describing the format, content, and definitions of each data element in each file delivered within 60 days of contract award. Refer to Appendix A for further detail.

(p) Have the ability to interface with VA electronic health record (EHR) systems (Vista CPRS and Cerner Millennium) to facilitate test ordering and reporting within 9 months of award.

(q) 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.

(r) Maintain the minimum acceptable service, reporting systems, and quality control as specified herein.

(s) Immediate (within 24 hours) notification must be given to the Contracting Officer, Contracting Officer Representative (COR) and National Precision Oncology Leadership VA upon adverse action by a regulatory agency.

(t) 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 staff persons will be specified in individual orders. 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 NPOP. 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.

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

(HIPAA).

(v) Provide at least 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.

(w) Refer to Appendix B for details on Summary reporting requirements, which include but are not limited to:

o Patient first and last name o Social security number / MRN / other secondary identifier o Patient DOB o Vendor assigned Requisition number (specific to the patient) o Specimen number (specific to the received specimen for that patient) o Vendor Billing/Account code (if applicable) o Ordering provider

Name Email VA Facility Station Name VA Facility ID

NPI

o Patient VA facility station name and VA facility ID o Specimen type o Date of specimen collection o Tumor type using ICD-O-3 and ICD-10 codes o Diagnosis (entered by ordering provider). Diagnosis must conform to a standardized disease ontology.

o Diagnosis (confirmed by contractor as assigned in provided pathology report and following vendor pathology review). Diagnosis must conform to a standardized disease ontology.

o Cancer Stage o Sample status (e.g., in progress, reported etc.)

o Date of sample status o Date Clinical Report is issued o Order status and associated dates with current order status indicated o Procedure/test name o Indication of reflex testing (when applicable) o Summary of results o Cost

(x) These summary reports should be submitted in a Microsoft Excel or similar format. Prepare an annual report that summarizes test utilization and overall costs broken out by VA ordering provider and VA Medical Facility.

(y) Monthly reports will expand on above to include a structured breakdown of results from the validated clinical report (to be discussed more upon award to span all eligible test types covered in this contract).

(z) Weekly reports shall be available no later than 3 business days after the end of the week. Monthly reports shall be available within 10 calendar days after the end of each month. These reports should be submitted in Microsoft Excel or similar format.

(aa) NPOP will generate and provide the contractor with regular lists of approved providers who can then place orders upon contract award. NPOP will oversee development and communication on guidelines outlining when testing is appropriate for ordering per evidence-based guidelines. Weekly reports from the contracted laboratory as outlined above are required to facilitate an auditing of both providers and test types to ensure 1.) only approved providers place orders and 2.) that tests ordered follows our programmatic guidelines for patient eligibility. This will be performed by NOP staff or NOP designated VA employees again to ensure specified providers are ordering testing according to evidence-based guidelines or best practices, as outlined by the National Precision Oncology Program (NPOP).

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.

If matched normal samples are required for testing, the contractor laboratory must have the ability to send saliva kits and/or buccal swab kits directly to a patient’s home and provide packaging/mailing supplies 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 clinical report is defined as a printed final copy of a test result interpreted by individuals with training and licensure in Molecular Genetic Pathology and signed out by an American Board of Pathology (ABP) board-certified molecular genetic pathologist.

Reports shall be sent by contractor electronically or by fax or EHR integration to the ordering provider and VA laboratory. Each report shall, at a minimum, indicate the following information:

a. Patient’s full name

b. Patient’s date of birth

c. Patient’s unique medical record number

d. Patient’s VA facility station name

e. Patient’s VA facility station ID

f. Ordering provider’s name

g. Ordering provider’s NPI

h. Ordering Provider’s VA Facility station name

i. Ordering Provider’s VA Facility station ID

j. Test(s) ordered

k. Date/time of specimen collection

l. Date/time specimen received in Reference Lab

m. Date test signed and reported

n. Type of specimen/source

o. Patient diagnosis

p. Test result(s). For SNV and small insertions/deletion mutations, test results should include gene name(s), transcript(s), variant allele frequency, and cDNA and protein changes using current HGVS nomenclature. For fusion genes, results should include gene names listed in 5’ to 3’ partner order, exon breakpoints (for RNA or DNA based tests), and genomic location of breakpoints (for DNA based tests).

q. Pertinent negative findings

r. 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.

s. 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 regardless of location.

t. Flag and date for any associated amendments or addendums or report limitations (i.e. qualified report, low coverage)

u. Methodology used and limitations of listed methodology. Reports should be clear as to the method by which a fusion gene is detected (e.g. DNA, RNA, FISH, etc.).

For biomarker testing (e.g. PD-L1), the antibody clone and scoring method should be specified.

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

w. Testing laboratory specimen number

x. Information that may indicate limitations to the interpretation for a specific sample result (e.g.; low coverage regions)

y. Unsatisfactory specimen shall be reported with associated reason as to its unsuitability for testing and include a suggested next step (e.g., repeat testing with another specimen type, targeted testing for a specific biomarker, etc.).

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

Reporting of Clinical Structured Data and Raw Data:

In addition to performing and returning clinical test reports (as outlined above) and providing weekly and monthly operational and results summary reports, all raw and finished data generated as a result of testing under this contract shall be delivered to the COR and National Precision Oncology Program Office.