RFQ 36C24826Q0337_1.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

36C24826Q0337 02-26-2026

Yolanda Glover 352-381-5712 03-09-2026 4:00 pm EST

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Ste. 160 Tampa FL 33637

X

621511

$41.5 Million

N/A

X

36C675

Department of Veterans Affairs Network Contracting Activity 8 Reference Section B.3 for delivery locations.

Orlando FL 32827

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Ste.160

Department of Veterans Affairs Financial Services Center

P.O. Box 149971 Austin TX 78714-9971

1-877-353-9791

See CONTINUATION Page

This is a solicitation for a requirements contract to provide Thyroid Cancer Molecular Test to the Caribbean VA Healthcare System and Orlando VA Healthcare System.

Period of Performance: a base year plus four (4) one-year options.

See attached B.2 price/cost schedule for required supplies.

See CONTINUATION Page

X X

X 1

36C24826Q0337

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCK

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

B.4 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-21 REQUIREMENTS (OCT 1995)

C.5 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 23

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.9 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)

C.10 VAAR 852.222-71 COMPLIANCE WITH EXECUTIVE ORDER 13899

(DEVIATION)(APR 2025)

C.11 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.12 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

E.2 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (DEVIATION AUG 2025)

E.3 ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (DEVIATION AUG 2025)

E.4 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

SECTION B - CONTINUATION OF SF 1449 BLOCK

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C248 Jessica M. Kiser, jessica.kiser@va.gov

Contract Specialist 36C248, Yolanda Glover, yolanda.glover@va.gov

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Ste. 160

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly in Arrears

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

https://www.fsc.va.gov/einvoice.asp

5. FSC MANDATORY ELECTRONIC INVOICE SUBMISSION INSTRUCTIONS: 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

i. 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.

mailto:jessica.kiser@va.gov mailto:yolanda.glover@va.gov https://www.fsc.va.gov/einvoice.asp

a. 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.

b. 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)

ii. 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.

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

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

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

d. FSC e-invoice email: vafsccshd@va.gov

6. CONTRACT MODIFICATIONS: The Contractor is advised that only the Contracting Officer, acting within the scope of the contract and his/her duties and responsibilities and after advice and consultation with the point of contact has the authority to make changes that will affect contract prices, quantity, quality, delivery terms and conditions, or the term of the contract. In no event shall any understanding or agreement, modification, change order, or other matters in deviation from the terms of this contract between Contractor and a person other than the Contracting Officer be effective or binding upon the Government. All such actions must be formalized by the proper contractual document executed by the Contracting Office.

7. CONTRACT COORDINATOR: The Contractor shall identify in writing to the CO their contact person(s) who shall serve as liaisons between the Contractor and VA and who shall ensure that services are performed in accordance with the contract specifications. The Contractor’s contact person(s) shall be available during VA regular administrative work hours, exclusive of national holidays.

8. ESTIMATED QUANTITIES: All quantities listed in the Price Schedule are estimates only and are not to be considered a minimum or maximum. A delivery order shall be issued at the start of each performance period.

The Government does not guarantee or imply that any fixed number of orders/referrals for services will be placed under the resultant contract.

9. GUARANTEED MINIMUM: The Government will order at least $1,000.00 in supplies during the base year of the contract. (Note: The guaranteed minimum order amount applies to the base year only. Award of the additional option years is not guaranteed nor is there a guaranteed minimum order amount in any given option year that is exercised.)

10. ORDERING PROCEDURES: The VA Contracting Officer may place Delivery Orders utilizing any of the procedures to the Ordering Clause.

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

AMENDMENT NO DATE

http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.x12.org/ mailto:VA.Registration@Tungsten-Network.com mailto:vafsccshd@va.gov

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

ESTIMATED

QUANTITY UNIT UNIT PRICE

ESTIMATED

AMOUNT

80.00 EA ________________ ________________

Molecular Test for Thyroid Cancer- San Juan

Contract Period: Base POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

40.00 EA __________________ __________________

Molecular Test for Thyroid Cancer- Orlando

Contract Period: Base POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

80.00 EA __________________ __________________

Contract Period: Option 1 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

45.00 EA __________________ __________________

Contract Period: Option 1 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Contract Period: Option 2 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

50.00 EA __________________ __________________

Contract Period: Option 2 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and

Contract Period: Option 3 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Contract Period: Option 3 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Contract Period: Option 4 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Contract Period: Option 4 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

ESTIMATED GRAND

TOTAL

B.3 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION

ESTIMATED

QUANTITY

PERIOD OF

PERFORMANCE

0001 SHIP TO: VA Caribbean Healthcare System (VACHS) Attn: Pathology & Laboratory Medicine 10 Casia Street San Juan, PR 00921 3201

USA

80.00 TBD

MARK FOR: TBA

INSTRUCTIONS: See B.2 Price/Cost Schedule for dates TBD.

FOB: DESTINATION

0002 SHIP TO: Orlando VA Healthcare System (OVAHCS) Attn: Pathology & Laboratory Medicine 13800 Veterans Way Orlando, FL 32827

40.00 TBD

1001 SHIP TO: VA Caribbean Healthcare System (VACHS) Attn: Pathology & Laboratory Medicine 10 Casia Street

1002 SHIP TO: Orlando VA Healthcare

Attn: Pathology & Laboratory Medicine 13800 Veterans Way

45.00 TBD

2001 SHIP TO: VA Caribbean Healthcare

Attn: Pathology & Laboratory Medicine 10 Casia Street

2002 SHIP TO: Orlando VA Healthcare

Attn: Pathology & Laboratory Medicine 13800 Veterans Way

50.00 TBD

3001 SHIP TO: VA Caribbean Healthcare

Attn: Pathology & Laboratory Medicine 10 Casia Street

3002 SHIP TO: Orlando VA Healthcare

Attn: Pathology & Laboratory Medicine 13800 Veterans Way

4001 SHIP TO: VA Caribbean Healthcare

Attn: Pathology & Laboratory Medicine 10 Casia Street

4002 SHIP TO: Orlando VA Healthcare

Attn: Pathology & Laboratory Medicine 13800 Veterans Way

B.4 STATEMENT OF WORK

1.0 Purpose

The VA Caribbean Healthcare System (VACHS) in San Juan, Puerto Rico, and the Orlando VA Healthcare System (OVAHCS) in Orlando, Florida, have a requirement for Thyroid Cancer Molecular Testing Services.

The Pathology and Laboratory Medicine Service (P&LMS) provides a comprehensive range of diagnostic services, including Anatomic Pathology and Clinical Laboratory testing. In accordance with federal regulations and accreditation standards, and in support of continuous improvement in care for the Veteran population, P&LMS seeks to establish a base year plus four (4) one-year option periods contract for specialized reference laboratory services.

This contract will support the evaluation of thyroid nodules with indeterminate cytology, where morphological analysis alone is insufficient to determine malignancy. The molecular test will provide a genomic profile to:

• Improve detection of malignancies in indeterminate cases

• Identify molecular signatures associated with aggressive thyroid cancers

• Offer insights into therapeutic efficacy based on molecular characteristics

2.0 Scope

The contractor shall provide molecular testing services on a Cost-Per-Test basis for a period of 12 months, with four (4) additional one-year option periods.

These services will support early detection and risk stratification of thyroid cancer through genomic profiling, ensuring continuity of care for Veterans served by VACHS and OVAHCS.

The test must:

• Assist endocrinologists in identifying patients at high risk for thyroid cancer

• Support surveillance of patients with low-risk genomic profiles

• Reduce unnecessary surgical procedures

• Ensure timely and appropriate surgical intervention

• Provide actionable insights to rule in or rule out thyroid malignancy

All services shall be performed in accordance with:

• Applicable Federal, State, and local regulations

• FDA and manufacturer guidelines

• All terms, conditions, provisions, schedules, and specifications outlined in this Statement of Work

3.0 Technical Requirements

The contractor shall provide molecular testing services for thyroid fine-needle aspiration (FNA) specimens with indeterminate cytology (Bethesda III and IV). Thyroid genomic classifier (Thyroid cancer mutation panel) is a test to detect all driver genetic alterations implicated in thyroid cancer development, including mutations, gene fusions, copy number alterations as well as gene expression alterations.

We need a test that can be done in cytology specimens (Fine Needle Aspiration biopsy) and can help the providers to manage the patients that have unconclusive cytologic findings in the needle biopsy.

When the test is high risk, the patient will be submitted to surgical removal of the thyroid. When the results are low risk, the provider keep the patient in surveillance and does not get a surgery. The testing must be performed using a validated genomic classifier that meets the following clinical, technical, and reporting standards:

3.1 Clinical Efficacy and Technical Capability

The contractor must provide a clinically validated thyroid mutation molecular panel capable of detecting genomic alterations associated with thyroid carcinoma. The assay must be performed in a CLIA-certified and CAP-accredited molecular laboratory and must include:

Detection of:

• Point mutations

• Gene fusions

• Copy number variations (CNVs)

• Other genomic signatures relevant to malignancy risk and treatment decisions

• Use of next-generation sequencing (NGS) or equivalent high-resolution molecular technology

• Demonstrated proficiency in molecular oncology testing, with established quality assurance protocols

Performance Metrics:

• High sensitivity for detecting thyroid cancer

• High specificity for identifying benign conditions

Validation Requirements:

• References to published validation studies, including large multi-center clinical trials, must be provided to support assay performance

3.2 Clinical Validity and Diagnostic Performance

The molecular test must demonstrate clinical validity supported by peer-reviewed literature and multi-institutional studies. It must be appropriate for use with indeterminate thyroid cytology specimens (Bethesda III and IV) obtained via FNA.

Required Diagnostic Performance:

• High Negative Predictive Value (NPV) to safely rule out malignancy and reduce unnecessary surgeries

• High Positive Predictive Value (PPV) to support surgical planning when high-risk genomic alterations are identified

3.3 Reporting Format and Molecular Markers

The contractor shall provide a comprehensive, structured, and clinically actionable report for each specimen tested. Reports must be suitable for use in tumor boards and multidisciplinary case reviews.

Each report must include:

• Identified genetic variants and/or fusion events, including but not limited to:

• BRAF (B-Raf proto-oncogene, serine/threonine kinase), BRAFV600E (B-Raf proto-oncogene, serine/threonine kinase, V600E mutation), RAS, RET/PTC (Rearranged during Transfection) mutations for PTC Papillary Thyroid Cancer, MTC (Medullary Thyroid Cancer), PAX8/PPARγ, TERT (Telomerase reverse transcriptase), ALK (Anaplastic Lymphona kinase), TP53

• Clinical interpretation and malignancy risk assessment

• Potential treatment and management implications

• References to clinical guidelines or evidence-based interpretation frameworks

• Gene expression profiling to enhance diagnostic accuracy

3.4 Specimen Collection and Logistics

The contractor shall provide all materials necessary for specimen collection and transport, including:

Complete collection kits, consisting of:

• Collection containers

• Shipping boxes

• Prepaid shipping labels

• Detailed instructions for specimen handling and documentation

• Written notification to the ordering facility for any Quantity Not Sufficient (QNS) specimens

4.0 Period of Performance and Delivery

The period of performance for this requirement shall be 12 months, with four (4) additional one-year option periods.

Delivery Locations:

VA Caribbean Healthcare System (VACHS) Attn: Pathology & Laboratory Medicine Services (113) 10 Casia Street San Juan, PR 00921

Orlando VA Healthcare System (OVAHCS) Attn: Pathology & Laboratory Medicine Services (113) 13800 Veterans Way Orlando, FL 32827

5.0 Responsibilities of Contractor’s Laboratory

The contractor shall provide all personnel, equipment, and materials necessary to perform molecular testing services as referred by the VA Caribbean Healthcare System (VACHS) and the Orlando VA Healthcare System (OVAHCS).

5.1 Testing and Specimen Handling

The contractor shall perform molecular testing as requested by VACHS and OVAHCS.

Specimens will be shipped to the contractor using the vendor’s designated shipping service.

VACHS and OVAHCS are responsible for preparing and sending specimens to the contractor.

5.2 Turnaround Time

Testing shall be completed within the published turnaround times listed in the contractor’s Laboratory Test Directory.

The contractor shall:

• Consistently meet published turnaround times.

• Monitor turnaround time performance as a measure of testing capacity.

• Scale operations (e.g., additional test runs, staffing, or equipment) as needed to meet demand.

5.3 Result Reporting

Test results may be transmitted via fax, encrypted email, or secure online portal. Reports must be accessible to authorized users and ordering providers.

VA Caribbean Healthcare System (VACHS):

Attn: Pathology & Laboratory Medicine Services (113) Phone: TBA Fax: TBA

Mailing Address:

Pathology & Laboratory Medicine Services (113) 10 Casia Street San Juan, PR 00921-3201

Encrypted Email:

TBA

Ordering provider email (as listed on test requisition)

Orlando VA Healthcare System (OVAHCS):

Attn: Pathology & Laboratory Medicine Services (113) Phone: TBA Fax: TBA

Mailing Address:

Pathology & Laboratory Medicine Services (113) 13800 Veterans Way Orlando, FL 32827

5.4 Hours of Operation

Laboratory testing shall be performed Monday through Friday, 8:00 AM to 4:30 PM, excluding federal holidays.

(11) Federal Holidays:

• New Year’s Day

• Martin Luther King, Jr. Day

• Washington’s Birthday

• Memorial Day

• Juneteenth National Independence Day

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving Day

• Christmas Day

6.0 Responsibilities of the VA Caribbean and Orlando VA Healthcare Systems The VA Caribbean Healthcare System (VACHS) and the Orlando VA Healthcare System (OVAHCS) will be responsible for coordinating with the contractor to ensure proper specimen handling, test requisition, and communication throughout the contract period.

6.1 VA Caribbean Healthcare System (VACHS)

Primary Department:

Pathology & Laboratory Medicine Services Phone: TBA Contracting Officer Representative (COR): TBA

Responsibilities include:

• Serving as the primary liaison between the contractor and VACHCS

• Coordinating specimen submissions and test requisitions

• Maintaining records of services rendered

• Certifying invoices for payment

6.2 Orlando VA Healthcare System (OVAHCS)

Primary Department:

Pathology & Laboratory Medicine Services Phone: TBA Contracting Officer Representative (COR): TBA

Responsibilities include:

• Acting as the primary point of contact for contractor coordination

• Overseeing test submissions and result reporting

• Maintaining documentation of services

• Certifying invoices for payment

7.0 Procedures

This section outlines the responsibilities and procedural steps for specimen collection, test ordering, shipping, testing, reporting, and invoicing related to the thyroid cancer molecular testing services.

7.1 Specimen Collection and Test Ordering

Specimen Collection

Specimens shall be obtained via fine needle aspiration (FNA) biopsy of thyroid nodules (unilateral or bilateral).

Samples must be collected in the designated collection tubes or cups provided by the contractor.

Test Ordering Process

Tests shall be ordered electronically through the Computerized Patient Record System (CPRS) under the pathology requisition section.

The ordering endocrinologist will initiate the request in the patient’s electronic medical record.

Upon completion, the molecular test report will be uploaded to VistA Imaging within CPRS by the pathology laboratory.

7.2 Specimen Handling and Shipping

VA Responsibilities

P&LMS staff at VACHS and OVAHCS are responsible for preparing and shipping specimens in accordance with the contractor’s instructions and within the established timeframe.

Each specimen must be:

• Properly labeled with patient information and laboratory accession number (if applicable)

• Accompanied by a completed test requisition form

• Accompanied by a copy of the pathology report, when applicable

Contractor Responsibilities:

• Perform genomic profiling using next-generation sequencing (NGS) technology to detect:

• Point mutations (SNVs)

• Insertions/deletions

• Gene fusions

• Gene expression alterations

• Copy number alterations (CNAs)

• Provide all packing and shipping materials, including:

• Test requisitions

• Collection tubes

• Shipping box with ice pack

• Pre-printed FedEx international airway bill with contractor’s FedEx account number

• FedEx shipping bag

• Cover all shipping expenses

• Include detailed shipping instructions and any other required documentation

7.3 Testing and Reporting

Testing Timeline

The contractor shall complete testing and provide a final report within 10 to 14 business days from receipt of the specimen.

Specimen Validity

The contractor shall not accept specimens collected more than 12 months prior to submission.

Quantity Not Sufficient (QNS) Policy

The contractor shall not charge for QNS specimens.

Written notification must be provided to the laboratory for proper documentation and addendum to the pathology report.

Report Delivery

Final reports must be transmitted to the pathology department via:

• Encrypted email

• Fax

• Mail

All transmissions must comply with HIPAA and VA privacy regulations.

7.4 Invoicing and Compliance

Monthly Invoicing

The contractor shall submit a monthly statement of services performed.

Invoices must include:

• Contractor’s name

• Tax Identification Number (TIN)

• Purchase order/funding obligation number

• Description and period of services

• Total amount due

• Remit-to address

• Payment will be made upon COR certification that services were satisfactorily performed.

• Refer to Section B.2 for detailed invoicing instructions.

Regulatory Compliance

The contractor shall be held responsible for any fines or penalties resulting from violations of federal, state, or local laws.

8.0 Security

BAA required.

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

C.2 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from Date of award through Date of completion.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor’s fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of Clause)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $1,000.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $250,000.00;

(2) Any order for a combination of items in excess of $2,000,000.00; or

(3) A series of orders from the same ordering office within three days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within three days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.4 52.216-21 REQUIREMENTS (OCT 1995)

(a) This is a requirements contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies or services specified in the Schedule are estimates only and are not purchased by this contract. Except as this contract may otherwise provide, if the Government's requirements do not result in orders in the quantities described as "estimated" or "maximum" in the Schedule, that fact shall not constitute the basis for an equitable price adjustment.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. Subject to any limitations in the Order Limitations clause or elsewhere in this contract, the Contractor shall furnish to the Government all supplies or services specified in the Schedule and called for by orders issued in accordance with the Ordering clause. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(c) Except as this contract otherwise provides, the Government shall order from the Contractor all the supplies or services specified in the Schedule that are required to be purchased by the Government activity or activities specified in the Schedule.

(d) The Government is not required to purchase from the Contractor requirements in excess of any limit on total orders under this contract.

(e) If the Government urgently requires delivery of any quantity of an item before the earliest date that delivery may be specified under this contract, and if the Contractor will not accept an order providing for the accelerated delivery, the Government may acquire the urgently required goods or services from another source.

(f) Any order issued during the ordering period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's ordering period;

provided, that the Contractor shall not be required to make any deliveries under this contract after five years.

(End of Clause)

C.5 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

(End of Clause)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days.

(End of Clause)

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 60 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023

52.204-13 52.225-5

SYSTEM FOR AWARD MANAGEMENT MAINTENANCE

TRADE AGREEMENTS

OCT 2018

NOV 2023

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

MAR 2023

C.9 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB

2023)

(a) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided.

This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory.

(b) No counterfeit supplies or equipment/ parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.

(c) Vendor shall be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

(End of Clause)

C.10 VAAR 852.222-71 COMPLIANCE WITH EXECUTIVE ORDER 13899

(DEVIATION)(APR 2025)

(a) The contractor shall comply with Executive Order 13899, Combating Anti-Semitism, pursuant to Title VI of the Civil Rights Act of 1964 (Title VI), 42 U.S.C. 2000d et seq.

(b) The contractor shall timely disclose, in writing, to the Contracting Officer, whenever, in connection with the award, performance, or closeout of this contract or any subcontract thereunder, the Contractor has credible evidence that a principal, employee, agent, or subcontractor of the Contractor has committed a violation under Executive Order 13899, Combatting Anti-Semitism pursuant to the Civil Rights Act of 1964 (Title VI), 42 U.S.C. 2000d et seq.

(c) The contractor shall include the terms and conditions of this clause in every subcontract or purchase order so that these terms will be binding on every…