Notice to Sole Source - Thermo Orbitrap.docx

GENERAL INFORMATION/CLASSIFICATION

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), plans to procure, on a sole source basis, service to provide all labor, material and equipment necessary to maintain and provide preventive maintenance for the following equipment system:

from: Thermo Electron North America LLC 1400 Northpoint Pkwy Ste 10 West Palm Beach, FL 33407

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 Clinical Cancer Metabolism Facility at the National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), utilizes a Thermo Orbitrap Lumos mass spectrometer system for time-sensitive metabolic analyses of clinical tissue samples to support treatment of patients enrolled in clinical trials conducted at the NIH Clinical Center. This mass spectrometer system is heavily used and must be maintained to ensure peak functionality and maximum productivity.

To generate accurate data, the mass spectrometer system must be calibrated correctly and maintained according to the manufacturer’s specifications. No inaccuracy or down-time of this instrument system 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. 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 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 Orbitrap Fusion Lumos system is proprietary to Thermo Electron, and not available from other sources. Thermo Electron is the Original Equipment Manufacturer (OEM) of this mass spectrometer system and thus is the only source that can provide authorized service technicians and software. As OEM, Thermo Electron 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 Monday, March 3, 2025 (3/3/2025). 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 75N91025Q00014 on all correspondence.

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