Sole Source Redacted_Redacted.pdf

OFOC Tempus Tasso + Assays 36C24E-25-AP-0394 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C24E-25-AP-0394

1. Contracting Activity:

Department of Veterans Affairs Regional Procurement Office (RPO) � East 323 North Shore Drive, Suite 500 Pittsburgh, PA 15212

Requesting Activity:

Department of Veterans Affairs Veterans Health Administration Office of Research and Development 811 Vermont Ave NW, 4th Floor Washington, DC 20571

2. Nature and/or Description of the Action Being Processed:

The Office of Research and Development intends to negotiate a Firm Fixed Price Indefinite Delivery Indefinite Quantity (IDIQ) Commercial Contract on a sole source basis with Tempus AI, Inc. for services to maintain uninterrupted support for integrated, high-throughput molecular testing titled �High-Throughput Sample Processing including Tasso, Methlaytion Profiling, and Bioinformatic Data Analysis & Annotation.� These services support the Million Veteran Program (MVP) under the Genomic Medicine Program.

This contract is for an ordering period of 30 September 2025 to 29 September 2030 with no option periods.

3. Description of Supplies/Services Required to Meet the Agency�s Needs:

The Veterans Health Administration Office of Research and Development (ORD) Center for Data and Computational Science (C-DACS) requires services to manage Tasso+ capillary blood collections and perform high throughput molecular assays specifically targeted methylation panels and genomic profiling�while maintaining continuity of molecular assay specificity, reproducibility and rigorous data accuracy and quality standards.

The required services will consist of processing large sample volumes efficiently, to generate accurate, fully annotated results with accompanying quality metrics and sample metadata and deliver these data within the VA�s specified unit rates and turnaround timelines.

Under this contract, coded human samples will be transferred from the VA�s biorepository to the contractor for analysis. Each sample will be received and logged before performing all standard quality control checks (including sample integrity, concentration, and purity assessments), and ensure that only samples passing QC are processed further.

The contractor will receive Tasso+ capillary blood collection kits to support decentralized, at home sampling when needed, and methylation panels and all other assays may be performed on samples obtained directly from the VA�s biorepository. The contractor will perform targeted methylation panels, as well as additional assays such as targeted DNA panels and gene expression profiling. All assay outputs, accompanied by QC metrics and sample metadata, will be delivered under turnaround Service Level Agreements (SLA).

OFOC Tempus Tasso + Assays 36C24E-25-AP-0394 Page 3 of 5

Given the specialized nature of these ongoing genetic and sample-analysis projects, maintaining continuity of service with this contractor is paramount. Introducing a new contractor would not only require time-intensive onboarding and additional training, involving several C-DACS staff for over 100 hours, but would also necessitate new assay and data pipeline building and validation, consuming more than 1000s of hours. Initial validation of the new assay, which originally required over 10,000 hours and took approximately six months to a year to get operational, would be needed again, followed by another year (approximately 2,000 hours) spent confirming in both wet and dry labs that all data are valid. Any discrepancies could lead to reruns of assays, potentially costing between $200,000 and $500,000 depending on the extent; however, it's important to note that reruns are not always possible, which could result in a loss to a study if the samples are no longer available.

Introducing a new contractor could also lead to inconsistencies in reagent and assay quality, further impacting the reliability of results. The staffing cost for onboarding, training, and validation is estimated to be between $150,000 and $350,000, plus the lost opportunity costs of working on other projects. These factors would inevitably delay ongoing VA research and studies, affecting the overall research efforts. Therefore, the introduction of a new Contractor would require re-validation, certainly delaying existing efforts to support VA research. Continuity is critical to preserving the high-throughput sample processing and molecular assays and the quality metrics essential to C-DACS and VA research.

Therefore, awarding a contract to this contractor is the most viable course of action to ensure uninterrupted, high-quality genotyping services and to sustain the mission-critical objectives of the Department.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

An intent to sole source was posted on Sam on 7/14/2025 and closed 7/28/2025 with no response from industry.

Through market research and continued education of the industry through conferences, Contractor interactions, and networking, and continued refinement of the Government�s requirements and needs determined that no other Contractors have shown or have the ability to deliver the services required at scale. Academic core facilities lack Tasso validation and throughput guarantees, while other Contractors offered only discrete assay types or did not offer the full services required to meet all the needs of the contract.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The previous contract, 36C24E20D0033, was determined fair and reasonable at time of award and the pricing for this requirement is expected to have the same outcome. The Contracting Officer will determine fair and reasonable pricing prior to award and negotiation will occur as required.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market Research was conducted and included reviewing the acquisition history, the Small Business Administration (SBA) Small Business Search (SBS), System for Award Management (SAM) and the sources found in the Veterans Health Administration (VHA) Procurement Hierarchy chart per Federal Acquisition Regulation (FAR) and Veterans Affairs Acquisition Regulation (VAAR). As stated in #6 above, an intent to sole source was published with no responses received. It has been determined that the current Contractor remains the only choice for continuing services, particularly in the specialized field of molecular assays.