Justification_Posting_Redacted_1.pdf

SOL # 140D0426Q0306

Many of the sequencing systems covered under this requirement are highly configurable and may include custom configurations or upgrades installed specifically to meet NCI research needs. These systems are periodically updated with Illumina hardware and software enhancements that remain under factory warranty. To preserve these warranties and ensure optimal performance, all maintenance and repairs must be performed by Illumina or Illumina-authorized personnel. Use of non-OEM parts, unauthorized service providers, or non-validated software configurations would void applicable warranties and could compromise sequencing accuracy, data integrity, and system reliability.

Illumina-manufactured reagents, flow cells, lasers, imaging components, and instrument-specific consumables are engineered and validated for use exclusively within Illumina sequencing platforms. In the event of component failure, Illumina provides OEM replacement parts that meet factory specifications and maintain validated system performance. Only Illumina-approved components can be installed without voiding warranties and without jeopardizing instrument calibration, run quality metrics, or regulatory compliance requirements.

For these reasons, Illumina, Inc. is uniquely qualified and the only responsible source capable of providing the required maintenance and service support for Illumina sequencing systems in use within CCR facilities.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as possible, including whether a notice was or will be publicized as required by part 5 and, if not, which exception under part 5 applies.

To confirm sources, a Notice of Intent to Sole Source was posted on SAM.gov on April 1, 2026. No responses were received by the April 8, 2026 due date

In accordance with RFO 5 and RFO 12, a combined synopsis and solicitation will be published on SAM.gov

7. A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

The contracting officer determines that the anticipated price will be fair and reasonable based on a review of the informal market research quotes provided by the program office, consideration of historical pricing for comparable OEM support across the marketplace (not limited to a single manufacturer), and confirmation that the proposed amounts appropriately account for both the required services and any necessary OEM replacement parts.

8. The market research conducted (see Part 10) and the results or a statement of the reason market research was not conducted.

SOL # 140D0426Q0306

The fully executed Market research report dated March 30, 2026 was conducted jointly by the Contracting Officer and the program office. Market research included a review of historical data related to past NCI requirements for maintenance services on similar equipment types. This review was supplemented with current pricing information obtained through preliminary informal market research quotes provided by the program office, publicly available pricing data, and standard industry terms and conditions.

Market Research also included an examination of required and recommended sources in accordance with RFO Part 8. No viable sources were identified that could provide the required services for the specific equipment types. To further validate the marketplace, no responses were received by the April 8, 2026 Notice of Intent to sole source due date. In accordance with RFO 5 and RFO 12, a combined synopsis and solicitation will be published on SAM.gov

9. Any other facts supporting using other than full and open competition.

Given the volume and critical nature of the sequencing efforts supported by these facilities, prolonged instrument downtime is not acceptable. Any interruption in service would result in significant delays to ongoing research, potential loss of high-value and often irreplaceable samples, and possible financial harm to the Government due to failed or compromised sequencing runs. Rapid service response is therefore essential to maintain operational continuity and protect research integrity.

10.A listing of the sources, if any, that expressed, an interest in the acquisition in writing.

No responses were received; please see Section 8 for details.

11.A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

To remove barriers to competition in future acquisitions, the Contracting Officer will work with the Contracting Officer’s Representative to monitor the market, re-assess performance requirements for opportunities to broaden vendor participation, and evaluate options such as refining specifications or seeking additional technical data rights should new sources emerge.

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