36C10G22R0020_2.docx

36C10G22R0020

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

36C10G22R0020 Michelle Bailey 202-746-1241 07-05-2022

10:00AM

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 X

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

VA

22408-2697

VAFSC

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

(see Section B.3 invoicing/payment) Austin

TX

78714-8917 1 (877) 489-6135 See CONTINUATION Page Title: Minimal Residual Disease (MRD) Testing Services This Request for Proposal (RFP) is for MRD Testing services for the Department of Veterans Affairs (VA) Veterans Health Administration's (VHA) National Precision Oncology Program

(NPOP).

See Section B for Price/Cost Schedule and Statement of Objectives (SOO) for additional information regarding this See CONTINUATION Page X Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

36C10G22R0020

Page 1 of Page 1 of

B.1 CONTRACT ADMINISTRATION DATA

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

b. GOVERNMENT: Contracting Officer 36C10G

Program Office POC – TBD

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

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, Page 1 of Page 1 of

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

a. Vendor Electronic Invoice Submission Methods:

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

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

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

b. Vendor e-invoice Set-Up Information:

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

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

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

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

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

B.2 PAYMENT TERMS AND CONDITIONS

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

b) Purchase/Ordering Limitation:

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

c) Delivery Tickets:

The following provisions apply to all shipments:

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

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

(i) Name of supplier

(ii) Contract number

(iii) Date of purchase

(iv) Itemized list of supplies or services furnished

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

(vi) Date of delivery or shipment

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

Packing Slips/Labels and Lists shall include the following:

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

d) Reports:

Quarterly Report:

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

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

1. Project Manager;

1. Contracting Officer’s Representative;

1. Contract Specialist;

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

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

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

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

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

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

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

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

See RFP Attachment C – Sample Business Associate Agreement

B.4 TECHNOLOGY REFRESH

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

Further, the Contractor shall ensure that all MRD 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 items become obsolete:

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

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

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

(4) Suggested new Item pricing.

New products/services replacing awarded items and released to the market during the period of performance shall be offered to the Government at a discounted price. The Contracting Officer will complete a Price Fair and Reasonable Price Determination prior to adding product/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.

GRAND TOTAL

B.6 CONTRACT MINIMUM AND MAXIMUM DOLLAR VALUES

The minimum guaranteed amount is $2,500.00 for the awarded contract.. Orders shall be determined by department needs. The Government has no obligation to award orders 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 orders 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 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.

The VA’s National Oncology Program supports Molecular Residual Disease Testing (MRDT) testing for Veterans with cancer or at risk for cancer across ~130 VA Medical Centers. The National Oncology Program (NOP) has identified MRDT as a candidate for VHA-wide (otherwise referred to as “national”) standardization and intends to secure specialized, comprehensive reference laboratory services and support from contractor(s) with the capability and expertise to provide molecular testing.

B.8 STATEMENT Of OBJECTIVE

STATEMENT OF OBJECTIVES (SOO)

For

MOLECULAR RESIDUAL DISEASE TESTING

For

DEPARTMENT OF VETERANS AFFAIRS

VETERANS HEALTH ADMINISTRATION

NATIONAL ONCOLOGY PROGRAM

Purpose and Scope

On behalf of the Department of Veterans Affairs (VA), the National Oncology Program (NOP) intends to secure specialized, comprehensive reference laboratory services and support from contractors with the capability and expertise to provide testing for minimal residual disease (MRD) in solid tumors. The VA invites proposals from contractors providing minimal residual disease (MRD) testing in solid tumors with a focus on assessment and recurrence monitoring for patients previously diagnosed with cancer. Minimal testing intended for non-invasive early cancer screening is not within scope for this RFP. 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 one (1) 12-month option year. The primary place of performance will be at the contractor’s location.

Contract Type

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 NOP staff or NOP designated VA employees 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). Since the MRD testing field is nascent and dynamic, when a new type of test or test methodology is released that is relevant to the required clinical areas, the VA will have access to that offering by modification to the contract.

Background

The VA’s NOP supports minimal testing for Veterans with cancer or at risk for cancer across ~130 VA Medical Centers through the National Precision Oncology Program (NPOP). Minimal testing includes next generation sequencing based tests (somatic and germline), immunohistochemistry, microarray, FISH and other standard and emerging test types and methodologies performed for patients with cancer.

Objectives

At a minimum, this SOO supports the objectives described in this section. Contractors must submit a proposal that, at a minimum, accomplishes these objectives.

Objective 1: MRD testing services

The National Oncology Program seeks to contract with a College of American Pathologists (CAP) accredited, Clinical Laboratory Improvement Amendments (CLIA) certified reference laboratory that can regularly receive and process samples, and report clinical test results for one or more MRD testing applications listed below:

· MRD detection after surgical resection across tumor types

· Tumor monitoring for therapy response and effectiveness in both the adjuvant and metastatic setting

Test technologies proposed must meet the following criteria:

1. A clinically validated, tumor informed, ultra-sensitive circulating cell-free plasma derived tumor DNA (ctDNA) approach to MRD testing is required.

2. Initial tumor testing (for tumor informed approach) must be performed with a robust, comprehensive tumor panel or whole exome approach to ensure the best chance of identifying candidate tracer mutations for MRD detection.

3. The clinically validated testing approach should be clearly laid out in the proposal and must have sensitivity appropriate for detection of ctDNA as soon after surgical resection as possible and span ctDNA detection across multiple cancer stages and types.

4. Evidence of adequate test sensitivity for the intended ctDNA application must be provided based on clinical evidence through retrospective or prospective clinical studies.

The technical proposal must also provide:

· Sample requirements

· Turnaround time for results

· Sampling frequency considerations by tumor type (i.e timing of testing and how often patients will need to be tested)

· Test performance metrics of specificity, sensitivity, limit of detection, reproducibility, repeatability and other relevant analytical validation measures.

· The proposal must also list known test limitations.

· One or more example clinical reports across different cancer types to highlight test results for clinicians.

Objective 2: Evidence of clinical utility

In addition to providing evidence of analytical and clinical validity for the proposed tests as outlined in Objective 1, the proposal must provide information on studies addressing clinical utility (i.e., is there value to having MRD information in a patient’s care plan?). This may include data from completed studies, studies in progress or future planned studies. Ongoing or future studies must be described with a study completion timeframe, description of study design, accrual to date and endpoints being measured.

The proposal must clearly illustrate the cancer type, stage of disease and the specific MRD application being evaluated in the study. If expansion into additional cancer types, stages of disease or modified application are expected, details around the expansion and timelines for completion must also be included in the proposal.

Objective 3: Custom VA ordering and tests status reporting to the National Oncology Program

The contract is intended to support testing VA wide with a central program management function within the National Oncology Program. In order to support this function, the contractor must demonstrate the ability to meet NPOP’s requirements below.

· Laboratory test request forms and any online order mechanism must be customized to include information required by the VA listed below. These fields should also be available on the final clinical report. Ordering forms must be provided in both paper based and online ordering formats and must at a minimum include:

a. Ordering provider information

b. Ability to include multiple (at least 2 other individuals) on the test order and 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. test(s) to be performed

vi. specimen collection date/time

vii. specimen type

viii. VA facility station name

ix. VA facility station ID

· Provide a secure online portal for ordering tests and viewing test results with the following capabilities.

a. Portal should automatically alert providers and relevant VA staff when test results are available.

b. Portal test ordering fields must be customizable and able to support VA specific fields (e.g, VA station ID and ability to limit fields to only those available under the VA contract)

c. 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

d. The portal must allow for a clinical results search feature to query patients by patient identifiers, panel, disease, gene and variant.

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

f. The portal must include 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.

g. The portal must have the ability to filter orders by provider and VA site.

h. The portal must have the ability to indicate if a previous report has been updated from when it was first issued to ease review for providers assessing impact of report updates to patient care.

· Provide at least weekly summary reports that contain information regarding VA test orders, order status, sample status and results at the patient and test level to NPOP. 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.

· Weekly summary report requirements include but are not limited to: 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, patient VA facility station name, patient VA facility station ID and cost. These reports should be submitted in a Microsoft Excel or similar format to NPOP. Prepare an annual report that summarizes MRD test utilization and costs overall and by ordering provider and VA facility.

Objective 4: Structured data return to VA

The proposal must demonstrate contractor’s ability to send raw molecular data files (e.g., FASTQ, BAM, BAI and VCF files) generated as a result of the testing process as well as final reported data files in NPOP specified structured data formats (report json, xml, csv, txt) within 3 months of contract award. Additionally, patient results in aggregate (at a weekly frequency) with patient and test identifiers, individual variant results with associated annotations that represent the final reported results shall be delivered to the National Oncology Program in excel/csv formats that are compatible with and can be easily loaded into SQL tables. These data files are to be provided to NPOP rather than individual VA facilities or providers. In addition to clinically validated test results, NPOP also has interest in any research use only data generated by the contractor. 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.

Contractor must have the ability to securely perform cloud-based transfer of these files to NPOP via the VA cloud electronically on a weekly basis. All formats must use standard formats. Contractor must provide technical files and detailed documentation describing the format of each file, including BED files (as applicable).

Proposed data storage location and transfer mechanisms must comply with VA’s IT security and privacy requirements which are based upon NIST standards. Additionally, the vendor must also have the ability to interface with the VA’s electronic health record systems (Vista CPRS and Cerner) for clinical text results and provide a plan for this in the proposal.

Contract Requirements

Sample shipment and residual sample return: 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.

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

Meeting Support: The contractor shall be capable of meeting the government’s need for frequent interaction between the contractor and the COR or other designated NPOP staff, as there are often issues of service delivery that require in-depth discussion. Such interactions usually occur with short notice (24 hours). Moreover, the contractor shall attend various NPOP meetings identified by the COR which use information provided by the contractor in planning further activities. The Contractor shall support regularly scheduled and impromptu formal and informal meetings including, but not limited to weekly meetings, monthly meeting, informal review meetings, and formal presentations. Access to a field team of local account representatives, medical science liaisons will also be provided.

Confidentiality: The VA will provide the Contractor with access to pertinent patient medical information, with the existing privacy rules and regulations, for the purpose of performing work within the scope of the contract. The Contractor shall ensure the confidentiality of all patient information and shall be held liable in the event of a breach of confidentiality. Any person, who knowingly or willingly discloses confidential information, may be subject to fines of up to $20,000.00. Any contract resulting from this solicitation will be subject to the provisions of the Privacy Act of 1974. Federal Acquisition Regulations 52.224-1 Privacy Act Notification and 52.224-2 Privacy Act apply.

The Contractor will be required to sign a Business Associate Agreement. The agreement is in accordance with Business Associate Protected Health Information (PHI) and Electronic Protected Health Information (EPHI) that is subject to protection under regulations issued by the Department of Health and Human Services, as mandated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Title 45 Code of Federal Regulations (CFR) Parts 160 and 164, Subparts A and E, the Standards f or Privacy of Individually Identifiable Health Information (“Privacy Rule”), and 45 CFR Parts 160 and 164, Subparts A and C. The Contractor is not authorized to release any medical record information. The VA is the sole entity authorized to release this information upon written request from the patient.

I. CONSTRAINTS

Contractor Laboratory shall:

(a) Have all licenses, permits, accreditation certificates required by Federal law 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). 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 qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA, CAP and NY State Department of Health standards.

(c) The Contractor must provide specifically demonstrated history of testing samples from patients in New York State for each test included in the proposal.

(d) 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.

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

(f) 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.

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

II. DELIVERABLES

Summary of Key Deliverables:

1. Provide evidence of current CAP/CLIA accreditation with certificates and NY State Department of Health approval for each test.

2. Provide analytical and clinical validation of proposed tests in line with the following standards:

a. FDA guidance on ctDNA: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-circulating-tumor-deoxyribonucleic-acid-early-stage-solid-tumor-drug-development-draft-guidance

b. AMP Validation Guidelines and Best Practices: https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S1525157817300259?returnurl=https:%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1525157817300259%3Fshowall%3Dtrue&referrer=

3. Offer testing and results interpretation on site or at wholly own subsidiaries

4. Provide ordering fields and an online portal customizable to VA’s needs as described in the SOO.

5. Provide sample clinical reports in line with the requirements described in the SOO. Examples should include multiple cancer types for which the test is indicated.

6. Provide evidence of appropriate Medical Director qualifications as described in the Constraints section.

7. Provide documentation addressing how the testing facility, processes and methodologies meet the requirements described in the SOO.

8. Provide access to a field team of local account representatives and medical science liaisons to support testing, training/education and results interpretation for providers and the NPOP team.

9. Provide evidence of ability to meet VA’s weekly data and reporting requirements described in the SOO.

10. Provide evidence of ability to transfer raw data generated from genetic testing to VA through secure delivery mechanisms as described in the SOO.

11. Provide a weekly summary report that provides information to the VA regarding test orders, order status, sample status and results at the test level.

12. Provide an annual report (for contract performance period) to NPOP.

B.9 PRICE/COST SCHEDULE

ITEM INFORMATION

GRAND TOTAL

SECTION C - CONTRACT CLAUSES

C.1 MANDATORY WRITTEN DISCLOSURES

Mandatory written disclosures required by FAR clause 52.203-13 to the Department of Veterans Affairs, Office of Inspector General (OIG) must be made electronically through the VA OIG Hotline at http://www.va.gov/oig/contacts/hotline.asp and clicking on "FAR clause 52.203-13 Reporting." If you experience difficulty accessing the website, call the Hotline at 1-800-488-8244 for further instructions.

C.2 SAC 16-01 – SAC Service Level Agreement Fee and Submission of Quarterly Sales Reports; Open Market. (January, 2016)

a. Service Level Agreement Fee.

The Service Level Agreement (SLA) fee is established by the Supply Fund Board and is provided as a means of reimbursement for customary acquisition-related services necessary to obtain contractor services and/or supplies as required. The SLA is reimbursed to the SAC based on rates established by the supply fund board and are recouped based on a percentage of total quarterly sales. The Supply Fund Board may change the percentage at any time, but typically not more than once per year. Upon a change in the SLA, the Contracting Officer (CO) shall issue a unilateral modification to apply the change to CLIN prices based upon the SLA rate change. The SAC will provide reasonable notice prior to the effective date of the change.

In order to facilitate SLA reimbursement, offerors must include (imbed) the SLA fee into their prices; therefore, the fee will be reflected in the total amount charged and transparent to ordering activities.

The current SLA which applies to this contract action is 3.0%. This SLA Fee shall be imbedded in the awarded contract/agreement price(s), and offers submitted in response to this solicitation shall include this SLA Fee in the price of every line item offered.

b. Quarterly Sales Reports.

The Contractor shall report all contract sales under this contract and submit collected SLAs as follows:

(1) The Contractor shall accurately report the dollar value, in U.S. dollars and rounded to the nearest whole dollar, of all sales made under this contract by calendar quarter (January 1–March 31, April 1–June 30, July 1–September 30, and October 1–December 31). Reported sales must include all sales made to all authorized contract or agreement users, whether shipped directly to the users or through Prime Vendor contractors. The report shall reflect sales by contract line item and shall segment sales by the Department of Veterans Affairs (VA) and Other Government Agencies (OGA). The reported contract sales shall include the SLA Fee and each quarterly report shall show the total SLA Fee amount collected on the reported sales. The Contractor shall maintain a consistent accounting method of sales reporting, based on the Contractor’s established commercial accounting practice. The Contractor shall consistently use only one of the following acceptable points at which sales may be reported-—

i. Receipt of order;

ii. Shipment or delivery, as applicable;

iii. Issuance of an invoice; or

iv. Payment.

(2) Sales under this contract/agreement shall be reported to the SAC within 60 calendar days following the completion of each reporting quarter. The Contractor shall continue to furnish quarterly reports, including “zero” sales, through physical completion of the last outstanding order of the contract/agreement.

(3) The sales report signed by an authorized representative of the contractor shall be emailed to the appropriate individual(s) listed in the terms and conditions of the contract or agreement.

c. SLA Remittance

The Contractor shall remit the SLA fee to the SAC in U.S. dollars within 60 calendar days after the end of the reporting quarter and final payment shall be remitted within 60 days after physical completion of the last outstanding task order or delivery order of the contract.

The SLA Fee amount collected and due shall be paid electronically. To ensure that the payment is credited properly, the contractor shall electronically transmit the SLA fee at www.pay.gov (VA Strategic Acquisition Center (SAC)); specific instructions shall be provided when the contract action resulting from this solicitation is awarded (i.e. post-award/BPA issuance conference and/or post-award letter when used in lieu of a conference.

The Government reserves the right to inspect, without further notice, such records of the Contractor as pertinent to sales under any contract or agreements resulting from this solicitation. Failure to remit the full amount of the SLA within 60 calendar days after the end of the applicable reporting period constitutes a contract debt to the United States Government under the terms of Federal Acquisition Regulation (FAR) Subpart 32.6. The Government may exercise all rights under the Debt Collection Improvement Act of 1996, including withholding or setting off payments and interest on the debt (see FAR clause 52.232-17, Interest). Should the Contractor fail to submit the required sales reports, falsify them, or fail to timely pay the SLA, the Government shall have, in addition to the rights and remedies described in this clause, all other rights and remedies permitted by Federal law and statutes.

(End of Clause)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (MAY 2022) (JUL 2020) (DEVIATION)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115–232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[X] (1) 52.203–6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

[X] (2) 52.203–13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).

[] (3) 52.203–15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

[X] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (5) [Reserved] [] (6) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (7) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (8) 52.209–6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).

[X] (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

[] (10) [Reserved] [] (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR 2020) (15 U.S.C. 657a).

[] (ii) Alternate I (MAR 2020) of 52.219-3.

[X] (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (MAR 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (ii) Alternate I (MAR 2020) of 52.219-4.

[] (13) [Reserved] [] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-6.

[] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-7.

[X] (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

[] (17)(i) 52.219–9, Small Business Subcontracting Plan (JUN 2020) (15 U.S.C. 637(d)(4)).

[] (ii) Alternate I (NOV 2016) of 52.219-9.

[] (iii) Alternate II (NOV 2016) of 52.219-9.

[] (iv) Alternate III (JUN 2020) of 52.219–9.

[] (v) Alternate IV (JUN 2020) of 52.219–9.

[] (18)(i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

[] (ii) Alternate I (MAR 2020) of 52.219-13.

[X] (19) 52.219-14, Limitations on Subcontracting (MAR 2020) (15 U.S.C. 637(a)(14)).

[] (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

[] (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (MAR 2020) (15 U.S.C. 657f).

[X] (22)(i) 52.219-28, Post Award Small Business Program Rerepresentation (NOV 2020) (15 U.S.C 632(a)(2)).

[] (ii) Alternate I (MAR 2020) of 52.219-28.

[] (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (MAR 2020) (15 U.S.C. 637(m)).

[] (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (MAR 2020) (15 U.S.C. 637(m)).

[] (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).

[] (26) 52.219-33, Nonmanufacturer Rule (MAR 2020) (15 U.S.C. 637(a)(17)) [X] (27) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

[] (28) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (JUL 2020) (DEVIATION) (E.O. 13126).

[X] (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (30)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[] (ii) Alternate I (FEB 1999) of 52.222-26.

[X] (31)(i) 52.222–35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

[] (ii) Alternate I (JULY 2014) of 52.222-35.

[X] (32)(i) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

[] (ii) Alternate I (JULY 2014) of 52.222-36.

[X] (33) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

[X] (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

[X] (35)(i) 52.222-50, Combating Trafficking in Persons (OCT 2020) (22 U.S.C. chapter 78 and E.O. 13627).

[] (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

[X] (36) 52.222-54, Employment Eligibility Verification (OCT 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

[] (37)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C.6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

[] (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

[] (40)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (OCT 2015) of 52.223-13.

[] (41)(i) 52.223-14,…