Preventive Maintenance Services For One Illumina Microarray Scanner (iScan/RoMa) and Two Illumina Sequencers (NextSeq 550Dx)

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR) plans to procure, on a sole source basis, preventive maintenance services for one Illumina Microarray Scanner (iScan/RoMa) and two Illumina Sequencers (NextSeq 550Dx) from:

Illumina, Inc

5200 Illumina Way

San Diego CA 92122-4616

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 13.106-1 (b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 811210 and the business size standard is $34.0 million.

The Laboratory of pathology (LP) at the National Cancer Institute uses an Illumina iScan/RoMa microarray scanner system and two Illumina NextSeq 550Dx sequencing instruments for high-throughput, diagnostic assays and multiplex human genotyping microarrays for whole-genome, targeted genome, and exome analyses. These clinical assays are crucial for patient enrollment in NCI clinical protocols and for patient treatments. To generate accurate data, the microarray system and the sequencing systems must be calibrated correctly and maintained according to the manufacturer’s specifications. No inaccuracy or down-time of these instruments can be tolerated as it would severely compromise patient treatment and safety. All data generated must be comparable to what has been historically reported, since any deviation from the design specifications could compromise data integrity of the ongoing clinical trials.

The Government-owned iScan/RoMa microarray scanner system and NextSeq 550Dx sequencing systems 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, 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. Furthermore, scheduled maintenance and proactive service of diagnostic equipment are requirements for all clinical laboratories performing and reporting complex assays on human materials, to maintain Clinical Laboratory Improvement Advisory (CLIA) and College of American Pathologists (CAP) accreditations and continue to serve the NIH patient population.

The iScan/RoMa system and the NextSeq 550Dx instruments are proprietary to Illumina, Inc., and not available from other sources. Illumina, Inc. is the Original Equipment Manufacturer (OEM) of these equipment systems 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 these instrument systems. The required services are not authorized through any other entity.

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 David Romley, at David.Romley@nih.gov no later than 12:00 P.M. EST on Tuesday, April 2, 2025 (4/2/2025). 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 75N91025Q00032 on all correspondence.

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