Preventive Maintenance Services for NovaSeq 6000 (Silver Support Plan)

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Pathology (LP) plans to procure, on a sole source basis, maintenance services for one (1) Government owned Illumina NovaSeq 6000 from:

Illumina, Inc.
5200 Illumina Way
San Diego, CA 92122 

The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.501(a) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 811210 (Electronic and Precision Equipment Repair and Maintenance) and the business size standard is J066 (Maint/Repair/Rebuild of Equipment- Instruments and Laboratory Equipment).

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 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. 

This notice is not a request for competitive quotations. However, if any interested party, especially a small business, believes it can meet the Government’s needs, it may submit a capability statement, proposal, or quote for the Government to consider. The response and any other information furnished must be in writing and must contain sufficient details to allow NCI to determine if the party can perform the requirement. Responses to this notice shall be submitted via email to Contract Specialist, John Russell, at John.Russell3@nih.gov no later than 10:00 A.M. EST on Wednesday, February 14, 2024 (02/14/24). A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered for the purpose of determining whether to conduct a competitive procurement. The Government reserves the right to use the information provided by respondents for any purpose deemed necessary and legally appropriate. To receive an award, Contractors must be registered and have valid certification through SAM.GOV. Please reference the notice number 75N91024Q00031 on all correspondence. 

***Please reference attached Statement of Work for more details pertaining to the nature of the work to be performed. ***