6640--FY26| Thyroid Cancer Molecular Test| Orlando VA & San Juan| New Requirement

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial items seeking quotations for a "FY26 Thyroid Cancer Molecular Test" requirement for the Caribbean VA Healthcare System and Orlando VA Healthcare System. This announcement is the only solicitation, and a written solicitation document will not be issued.

• Procurement of Thyroid Cancer Molecular Test as defined in the Statement of Work (SOW).

• The contract will have a Base period and Four (4) 12-month option periods.

• This is a Request for Quote (RFQ).

• Quotations are due by 01-20-2026 at 4:00 PM EASTERN TIME, NEW YORK, USA.

• Questions must be submitted in writing via email no later than 01/12/2026 at 12:00 PM EST.

• The Government will evaluate quotations using the Comparative Evaluation process (FAR 13.106-2), which may consider award to other than the lowest priced or highest technically rated offeror.

• Amendments will be posted to the SAM.gov website only.

• Late proposals will not be accepted.

• This requirement is solicited as a Service-Disabled Veteran Owned Small Business (SDVOSB) set-aside.

• Offerors must be verified in the U.S. Small Business Administration Page (https://veterans.certify.sba.gov/).

• Offerors must be registered in System for Award Management (SAM) at https://www.sam.gov.

• The NAICS code is 621511 with a small business size standard of $41.5M.

• The FSC/PSC is 6640.

• Refer to Section B.2 for Price/Cost Schedule and Section B.4 for the Statement of Work.

• See Offerors Checklist under 52.212-2 Evaluation – Commercial Items for quote preparation.

• Attached documents include: 36C24826Q0145_010726_JMK, D.1 Business Associate Agreement, and D.2 Handbook_6500.6_Appendix C.

Form / Attachment / Pricing Sheet

This document is a Business Associate Agreement (BAA) between the Department of Veterans Affairs (VA) Veterans Health Administration (VHA) and a Business Associate. Its purpose is to establish the requirements for the use and disclosure of Protected Health Information (PHI) in accordance with the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH Act), and related HIPAA Rules.

• Definitions: Clarifies terms such as Business Associate, Covered Entity, Protected Health Information (PHI), and Subcontractor as defined by HIPAA Rules.
• Use and Disclosure of PHI: Outlines permitted uses and disclosures of PHI by the Business Associate, emphasizing compliance with HIPAA and Covered Entity's policies, including the "minimum necessary" standard.
• Obligations of Business Associate: Details requirements for safeguarding PHI, reporting breaches or security incidents within specified timeframes (24 hours for discovery, 10 business days for written report), mitigating harm, using compliant subcontractors, and facilitating individual rights requests (access, amendment, accounting).
• Obligations of Covered Entity: Specifies the Covered Entity's responsibilities, including not requesting impermissible uses/disclosures of PHI and notifying the Business Associate of relevant changes.
• Termination: Addresses automatic termination, termination for cause, and the survival of obligations post-termination.
• Return or Destruction of PHI: Mandates the return or destruction of all PHI upon completion or termination of the agreement, unless retention is required by law or permitted by the Covered Entity.

This BAA is crucial for any vendor that will handle Protected Health Information (PHI) on behalf of the VA/VHA. Bidders must understand and agree to these terms to ensure compliance with HIPAA and HITECH regulations. It outlines the strict requirements for data handling, security, breach notification, and data disposition, which will be a contractual obligation if awarded.

Form / Attachment / Pricing Sheet

This document, Appendix C of VA Handbook 6500.6, provides mandatory Information and Information System Security and Privacy Language for inclusion in VA contracts. It outlines requirements for contractors regarding data security, privacy, system access, and incident reporting.

• General Security & Privacy: Contractors must adhere to federal laws, regulations, VA directives, and handbooks concerning information security and privacy.
• Data Rights: The government generally receives unlimited rights to data first produced under the contract.
• Information Use: VA information made available to contractors is for contract performance only and cannot be used otherwise without prior written approval.
• Data Protection: VA information must not be commingled with other data, and contractors must ensure compliance with data protection, encryption, and segregation requirements.
• Audits & Investigations: VA reserves the right to conduct audits and investigations of contractor IT resources.
• Information System Access: Contractors require logical or physical access only to the extent necessary for contract performance. Background investigations and security clearances are mandatory.
• Training: Contractors must complete VA Privacy and Information Security Awareness training.
• Incident Reporting: Contractors must report security incidents or vulnerabilities within specified timeframes.
• System Design & Development: Security and privacy controls must be integrated into the system development lifecycle.
• Viruses & Malware: Contractors must ensure provided software is free of viruses and malware.
• Cryptographic Requirements: Contractors must document how their cryptographic systems protect data confidentiality, integrity, and authentication.
• Patching Governance: Contractors must manage patches and updates for procured products.
• Specialized Systems: Requirements for Medical Devices, Special Purpose Systems, and Research Scientific Computing Devices are outlined.

This document is critical for any bidder responding to a VA solicitation that involves access to VA information systems or data. It details the stringent security and privacy obligations contractors must meet, which will impact their operational procedures, costs, and compliance efforts. Bidders must carefully review these requirements to ensure they can comply and factor them into their proposals.

Solicitation / RFP / RFQ

This solicitation is for a Requirements Contract to provide Molecular Testing Services for Thyroid Cancer to the Caribbean VA Healthcare System (San Juan, PR) and the Orlando VA Healthcare System (Orlando, FL). The services are intended to assist endocrinologists in evaluating thyroid nodules with indeterminate cytology, improving the detection of malignancies, identifying aggressive cancer signatures, and guiding therapeutic efficacy.

• Provide molecular testing services for thyroid fine-needle aspiration (FNA) specimens with indeterminate cytology (Bethesda III and IV).

• Utilize a validated genomic classifier with Next-Generation Sequencing (NGS) or equivalent technology.

• Detect point mutations, gene fusions, copy number variations (CNVs), and other relevant genomic signatures.

• Demonstrate high sensitivity and specificity for detecting thyroid cancer and identifying benign conditions.

• Provide comprehensive, clinically actionable reports suitable for tumor boards.

• Supply all necessary specimen collection and transport materials.

• Contract Type: Firm-Fixed-Price Requirements Contract.

• Period of Performance: Base Year (02/01/2026 – 01/31/2027) with four (4) one-year option periods.

• Estimated Value: Approximately $41.5 Million (for informational purposes, not a guarantee).

• Offers must be submitted electronically via email to yolanda.glover@va.gov by the due date specified in Block 8 of SF 1449.

• Key deadlines: Questions due by January 12, 2026, 12:00 PM EST.

• Evaluation Factors: Technical Acceptability (Clinical Efficacy, Clinical Validity, Clinical Utility, Reporting Format, Technical Performance, Cost-Effectiveness, Vendor Qualifications), Past Performance, and Price.

• This acquisition is unrestricted.

• Offerors must be responsible parties with the ability to provide the required services.

• Vendors must be OEM, authorized dealers, distributors, or resellers, and maintain CLIA and CAP accreditation.

• The solicitation incorporates FAR and VAAR clauses by reference.

• Electronic invoice submission is mandatory.

• A Business Associate Agreement (BAA) is required.

Solicitation / RFP / RFQ

This solicitation is for a new requirement for Thyroid Cancer Molecular Test services for the Orlando VA Healthcare System and Caribbean VA Healthcare System. The acquisition will be a Firm-Fixed Price (FFP) contract.

• Procurement of Thyroid Cancer Molecular Test services.

• Contract Type: Firm-Fixed Price (FFP).

• Performance Period: Date of award to date of completion.

• Response Date/Time/Zone: December 29, 2025, 4:00 PM Eastern Time, New York, USA.

• The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-06 (10/01/2025).

• Offerors must be registered in the System for Award Management (SAM) at www.sam.gov to be eligible for award.

• It is the responsibility of the quoter to monitor the SAM.gov website for amendments, updates, or changes.

• Set-Aside: Service-Disabled Veteran-Owned Small Business (SDVOSBC).

• Primary NAICS Code: 621511 (Medical Laboratories).

• Small Business Size Standard: $41.5 Million.

• The solicitation is expected to be posted on or about December 15, 2025.

• Contact: Yolanda Glover, Contract Specialist, at Yolanda.Glover@va.gov or 352-381-5712.