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

Solicitation / RFP / RFQ

This is a Request for Quotation (RFQ) for molecular testing services for thyroid cancer. The services are required by the VA Caribbean Healthcare System (VACHS) in San Juan, Puerto Rico, and the Orlando VA Healthcare System (OVAHCS) in Orlando, Florida. The contract will establish a base year with four one-year option periods for specialized reference laboratory services.

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

• The test must detect point mutations, gene fusions, copy number variations, and other genomic signatures relevant to malignancy risk and treatment decisions.

• Testing must be performed in a CLIA-certified and CAP-accredited molecular laboratory.

• The contractor must provide a clinically validated thyroid mutation molecular panel.

• Reports must be comprehensive, structured, and clinically actionable, suitable for tumor boards and multidisciplinary case reviews.

• The contractor shall provide all materials for specimen collection and transport, including collection kits, shipping boxes, prepaid shipping labels, and detailed instructions.

• Turnaround time for testing and reporting is 10 to 14 business days from specimen receipt.

• Contract Type: Firm-Fixed-Price Indefinite Quantity.

• Period of Performance: 12 months base period, with four (4) one-year option periods.

• Estimated Value: Not explicitly stated, but a guaranteed minimum order of $1,000.00 is mentioned for the base year.

• Quotes must be submitted electronically to yolanda.glover@va.gov by March 9, 2026, 4:00 PM EST.

• The subject line must be "RFQ 36C24826Q0337- Thyroid Cancer Molecular Test."

• Email/Attachment size is limited to 20MB.

• Offers will be evaluated based on Technical Acceptability, Past Performance, and Price.

• Technical Acceptability includes Clinical Efficacy and Technical Capability, Clinical Validity and Diagnostic Performance, Clinical Utility, Reporting format and Molecular and Genetic Markers, Technical Performance, Cost and Economic Considerations, and Vendor Qualifications and Regulatory Compliance.

• Offerors must demonstrate a minimum of three (3) years of experience.

• The offeror's initial offer should contain their best terms from a price and technical standpoint.

• This acquisition is an unrestricted set-aside.

• NAICS Code: 621511 (Medical Laboratories)

• Size Standard: $41.5 Million

• Questions must be submitted in writing via email to yolanda.glover@va.gov by March 2, 2026, no later than 12:00 PM EST.

• A consolidated response to questions will be issued via solicitation amendment.

• The contract includes FAR clauses such as 52.212-4 (Contract Terms and Conditions) and 52.212-5 (Contract Terms and Conditions Required to Implement Statutes or Executive Orders).

• Electronic submission of payment requests is mandatory.

Form / Attachment / Pricing Sheet

This document, Appendix C of VA Handbook 6500.6, provides VA Information and Information System Security and Privacy Language for inclusion in contracts. It outlines the requirements and expectations for contractors regarding the security and privacy of VA data and systems.

• General Requirements: Contractors must adhere to federal laws, regulations, VA directives, and handbooks concerning information security and privacy.
• Data Rights: Government generally receives unlimited rights to data/intellectual property 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, segregation, and sanitization requirements.
• Audits and Investigations: VA reserves the right to conduct audits and investigations of contractor IT resources.
• Security Incident Reporting: Contractors must immediately report suspected security/privacy incidents to the VA OIT's Enterprise Service Desk and the COR/CO.
• Training: Contractors requiring access to VA information systems must complete specific privacy and security awareness training.
• System Development & Hosting: Requirements for designing, developing, hosting, operating, maintaining, and using information systems, including compliance with various federal standards and VA directives.
• Product Integrity: Requirements related to product authenticity, anti-counterfeiting, and anti-tampering for acquired products.
• Viruses and Malware: Contractors must ensure software and patches are free of viruses and malware.
• Cryptographic Requirements: Documentation on how cryptographic systems protect confidentiality, data integrity, and authentication.
• Patching Governance: Requirements for patch management, vulnerability management, and remediation of vulnerabilities.
• Specialized Devices: Compliance requirements for medical devices, special purpose systems, and research scientific computing devices.

This document is critical for any bidder whose opportunity involves access to, development of, or management of VA information systems or data. It details the stringent security and privacy obligations contractors must meet, including data handling, incident reporting, training, and system security requirements. Understanding these requirements is essential for developing compliant proposals and for successful contract performance.

Other / Unclassified

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 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), and related HIPAA Rules.

This BAA outlines the responsibilities and obligations of a business associate when handling Protected Health Information (PHI) on behalf of the VA/VHA. Key aspects for potential bidders include:

• Use and Disclosure of PHI: Strict limitations on how PHI can be used or disclosed, generally requiring compliance with the VA's minimum necessary policies.
• Business Associate Obligations: Requirements for implementing safeguards, reporting breaches or security incidents within strict timelines (24 hours for discovery, 10 business days for a written report), mitigating harm, and ensuring subcontractors also comply with HIPAA.
• Data Handling: Mandates that PHI must be handled by contractors and subcontractors located within the United States, and PHI cannot be removed from this jurisdiction without prior written approval.
• Return or Destruction of PHI: Upon contract completion or termination, all PHI must be returned or destroyed, with written assurance provided to the VA/VHA.
• Liability: The business associate is liable for civil or criminal penalties imposed on the VA/VHA due to violations of HIPAA Rules or the BAA.
• Subcontractor Agreements: Business associates must enter into BAAs with their subcontractors, ensuring terms are at least as restrictive as the primary BAA.

Understanding these requirements is crucial for any vendor whose work may involve accessing, creating, maintaining, or transmitting PHI for the VA/VHA.

Solicitation / RFP / RFQ

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

The core requirement is the provision of Thyroid Cancer Molecular Test services as defined in the Statement of Work (SOW). Specific details of the SOW are not included in this notice but are referenced as the basis for the requirement.

• Contract Type: Firm-Fixed Price (FFP)

• Period of Performance: Base period of 12 months, with four (4) 12-month option periods.

• Solicitation Method: Request for Quote (RFQ)

• Response Date/Time: All quotations are due no later than March 9, 2026, at 4:00 PM EST.

• Questions Deadline: Questions must be submitted in writing via email no later than March 2, 2026, at 12:00 PM EST to yolanda.glover@va.gov.

• Submission Method: All quotations and questions should be submitted via email to the Contract Specialist, Yolanda Glover.

• Evaluation: Offerors are advised to review the "Offerors Checklist" under FAR provision 52.212-2 for evaluation details.

• Late Submissions: Late proposals will not be accepted or considered, per FAR 52.212-1(c).

• Set-Aside: This requirement is solicited as Unrestricted.

• NAICS Code: 621511 (Medical Laboratories) with a size standard of $41.5 Million.

• FSC/PSC Code: 6640

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

• Amendments to the RFQ will be posted exclusively on the sam.gov website. Vendors are responsible for checking for updates.

• No hard copies will be mailed.

• The solicitation will be advertised on or before February 26, 2026.