36C24826Q0145 0001_1.docx

SUBJECT*

FY26| Thyroid Cancer Molecular Test| Orlando VA & San Juan| New Requirement

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Ste. 160 Tampa, FL 33637

POINT OF CONTACT*

Contract Specialist Yolanda Glover yolanda.glover@va.gov 352-548-4462

PLACE OF PERFORMANCE

Orlando VA Healthcare System

POSTAL CODE

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

This is Amendment A0001 to Solicitation 36C24826Q0145 Thyroid Cancer Molecular Test to provide B.2 Revised Price/Cost Schedule, B.4 Revised Statement of Work, Vendor Questions & Answers, Revised Opportunities Description, Revised SF1449 and extend the quotation due date from January 20, 2026, 4:00pm EDT to January 22, 2026, 4:00pm EDT. All Offerors must acknowledge this amendment and submit their quotations on B.2 Revised Price/Cost Schedule included in this amendment. Please submit all Quotations to the Contracting Officer, Yolanda H. Glover, at yolanda.glover@va.gov by Thursday January 22nd ,2026 no later than 4:00 pm, EDT. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(c).

Amendment to a Previous Combined Solicitation

Amendment to a Previous Combined Solicitation

Page 1 of

Amendment to a Previous Combined Solicitation

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 01-12-2026 None 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Ste. 160 Tampa FL 33637

To all Offerors/Bidders

36C24826Q0145 01-07-2026

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to: 01-22-2026 4:00 PM EST The purpose of this amendment is to provide B.2 revised price/cost schedule, B.4 revised statement of work, answer vendor questions, revised solicitation description, revised SF1449 and update quotation due date. As a result:

1. The hour and date of receipt of offers is extended from January 20, 2026, 4:00pm, EDT to January 22, 4:00pm, EDT

2. See B.2 revised Price/Cost Schedule updated period of performance to "TBA".

3. See B.4 revised Statement of Work for updated 4.0 months, with four additional one-year option periods.

4. See Vendor Questions and Answers.

5. See attachment for revised solicitation description for updated requirement is solicited as "Unrestricted".

6. See attachment for revised SF1449 for updated offer due date block number 8.

7. All offers are due to Yolanda Glover no later than 01/22/2026 at 4:00 PM, EDT.

Page 1 of Page 1 of

B.2 (REVISED) PRICE/COST SCHEDULE/ITEM INFORMATION

QUANTITY

AMOUNT

Molecular Test for Thyroid Cancer- San Juan Contract Period: Base POP Begin: TBA POP End: TBA PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

SIC CODE: 8071 - MEDICAL LABORATORIES

NATIONAL STOCK NUMBER: None

Molecular Test for Thyroid Cancer- Orlando Contract Period: Base POP Begin: TBA POP End: TBA PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

Molecular Test for Thyroid Cancer- San Juan Contract Period: Option 1 POP Begin: TBA POP End: TBA PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

Molecular Test for Thyroid Cancer- Orlando Contract Period: Option 1 POP Begin: TBA POP End: TBA PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

Molecular Test for Thyroid Cancer- San Juan Contract Period: Option 2 POP Begin: TBA POP End: TBA PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

Molecular Test for Thyroid Cancer- Orlando Contract Period: Option 2 POP Begin: TBA POP End: TBA PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

Molecular Test for Thyroid Cancer- San Juan Contract Period: Option 3 POP Begin: TBA POP End: TBA PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

Molecular Test for Thyroid Cancer- Orlando Contract Period: Option 3 POP Begin: TBA POP End: TBA PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

Molecular Test for Thyroid Cancer- San Juan Contract Period: Option 4 POP Begin: TBA POP End: TBA PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

Molecular Test for Thyroid Cancer- Orlando Contract Period: Option 4 POP Begin: TBA POP End: TBA PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

B.4 (REVISED) STATEMENT OF WORK

Thyroid Cancer Molecular Testing

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). 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, RAS, RET/PTC, PAX8/PPARγ, TERT, 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.

Request for quotation (RFQ) Number: 36C24826Q0145 Questions & Answers

Refer to Revised Solicitation Description changed to read, “This requirement is solicited as Unrestricted”.

No, the BAA is not required for consideration, However, a Business Associate Agreement (BAA) is required upon contract award.

Refer to E.1 – 52.212-1 – Instructions to Quoters and E.2 – 52.212-2 – Evaluation of Quotes for more information.

Refer to Revised Statement of Work, period of performance changed to read. “period of performance is 12 months, with four (4) additional one-year option periods”.

I recommend contacting the sam.gov help desk for navigating sam.gov.

See attached document: revised SOLICITATION-DESCRIPTION_011226.

See attached document: Revised SF1449_Thyroid Cancer Molecular Test_011226.