NOI_75N91023Q00108.pdf

Notice of Intent to Sole Source

GENERAL INFORMATION/CLASSIFICATION

Title: Intent to Sole Source Preventive Maintenance Services for Illumina

NovaSeq 6000 Notice Type: Pre‐Solicitation Solicitation Number: 75N91023Q00108 Posted Date: 06/22/2023 Response Date: 06/29/2023 by 10:00 AM PSC Code: J066 (Maint/Repair/Rebuild of Equipment – Instruments and

Laboratory Equipment) NAICS Code: 811210 (Other Electronic Equipment Repair and Maintenance)

ISSUED BY: National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions (OA)

DESCRIPTION:

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 a government owned Illumina NovaSeq 6000 Sequencing System (Serial No.: A01064) from:

Illumina, Inc.

5200 Illumina Way San Diego CA 92122, USA

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 (Other Electronic Equipment Repair and Maintenance) and the business size standard is $34.0 Million.

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 ability to fix any unexpected issues encountered at any time. Any slight deviation from the design specifications during the required services will

Notice of Intent to Sole Source compromise the integrity of data for ongoing clinical research studies. Additionally, the annual preventive maintenance is required to maintain laboratory accreditation with Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) and 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, and as such Illumina is the only source capable of providing timely responses to service calls. Lastly, as apart of Illumina’s maintenance service plan, they will replace reagents lost due to a hardware malfunctions at no additional cost to the Government.

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 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 Contracting Officer, John Russell, at John.Russell3@nih.gov no later than 10:00 A.M. EST on Thursday, June 29, 2023 (06/29/23). 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 75N91023Q00108 on all correspondence.

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