SSJ LP_IlluminaSeq6000Maint_Redacted.pdf

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title.

Preventive Maintenance Services for NovaSeq 6000 (Silver Support Plan)

b. Project description.

See Statement of Work (SOW) attached.

Requirement type.

Support services (non-R&D)

Type of action.

Follow-on 75N91023P00569

Proposed contract/order type.

Firm-fixed-price

Acquisition identification number.

c. Total estimated dollar value and performance/delivery period.

Estimated period of performance:

Base Period: August 1, 2024 – July 31, 2025 Option Period 1: August 1, 2025 – July 31, 2026 Option Period 2: August 1, 2026 – July 31, 2027 Option Period 3: August 1, 2027 – July 31, 2028 Option Period 4: August 1, 2028 – July 31, 2029

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of FAR subpart 13.5 in accordance with 41 U.S.C. 1901 or 1903.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Illumina, Inc.

5200 Illumina Way San Diego, CA 92122

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The Laboratory of Pathology (LP) at the National Cancer Institute uses an Illumina NovaSeq 6000 instrument for clinical sequencing assays in support of patient enrolment in NCI clinical protocols and for patient treatments. LP requires maintenance services to have this instrument operating at optimal levels, generate data comparable to what has been historically reported, and maintain accreditations.

The Government-owned NovaSeq 6000 sequencing system must be calibrated accurately and maintained according to the most recent manufacturer’s specifications by authorized OEM trained service engineers. Accurate and trustable data generation is the most important requirement of a clinical assay, and it can be achieved through regular maintenance, proactive monitoring of the systems, and the ability to fix any unexpected issues encountered at any time. Any slight deviation from the design specifications during the required services will compromise the integrity of data for ongoing clinical research studies. Additionally, the annual preventive maintenance is necessary to provide the highest standard of performance for complex clinical and scientific instruments used for clinical testing. Without proper service agreements, mission critical clinical work may be compromised due to instrument failure.

The NovaSeq 6000 instrument is proprietary to Illumina, Inc., and not available from other sources. Illumina, Inc. is the Original Equipment Manufacturer (OEM) of this equipment system and thus is the only source that can provide authorized service technicians and software. As OEM, Illumina, Inc. is the distributor and the sole provider of preventive maintenance service, emergency service, proprietary firmware maintenance/upgrades, genuine OEM replacement parts, and OEM-trained technical support for troubleshooting and diagnosing issues that arise during regular operation of the instrument. The required services are not authorized through any other entity. Thus, Illumina is the only vendor known to NCI that can meet the Government’s needs at this time.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a SAM.gov notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR

5.202 applies.

The NCI Office of Acquisitions (OA) made a public posting # 75N91024Q00031 on SAM.gov of the Government’s intent to sole source the required maintenance services on 02/08/24 thru 02/14/24. In response to this posting one (1) response was received from a small business expressing interest in the requirement. However, upon assessing their capabilities statement and supporting information, it was determined that the contractor was not able to provide the services in a manner consistent with the Statement of Work (SOW).

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The Contracting Officer will make a determination that the price is fair and reasonable prior to award. This determination will be conducted in a manner deemed appropriate and in accordance with the procedures prescribed under FAR Subpart 13.106-3. For this requirement, it is anticipated that determination for a fair and reasonable price will be based on historical data for similar past awards, as well as information obtained by the Government during market research.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research by the Program Office and Office of Acquisitions consisted of (i) conducting internet searches for potential service providers online; (ii) searching required or recommended sources prescribed under FAR Part 8; (iii) reviewing historical data for similar past awards; (iv) a publicly posted notice of intent to sole source on SAM.gov; and (v) reviewing capabilities statements from potential vendors.

9. Any other facts supporting the use of other than full and open competition.

All facts have been stated above.

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

Only one (1) vendor enterprises expressed interest in writing regarding this requirement. However, as previously stated under Section 6 above the vendor was determined as not being capable of fulfilling the requirement as stated in the

SOW.

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

The NCI fully anticipates their needs to be met through this procurement action.

Should this need arise again in the future the Office of Acquisitions will work closely with the program office to closely assess any changes within the marketplace that will allow for or remove any potential barriers to competition.

These efforts will include synopsizing any future follow-on requirements through SAM.gov.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.