NOTICE OF INTENT TO SOLE SOURCE: Preventative Maintenance Services for Various Government-owned Leica Imaging Equipment (LyMB/ TGMB/MIB)

The National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), requires preventative maintenance and emergency services for three (3) government-owned Leica imaging devices and their associated components:

1) One (1) Leica Stellaris 5 confocal microscope at the Lymphoid Malignancies Branch (LyMB) is used extensively in support of ongoing cancer research, particularly to investigate the pathogenesis of lymphoid malignancies and to identify therapeutic vulnerabilities in B-cell lymphoma.

2) One (1) Leica CellDIVE microscope used by the Thoracic and Gastrointestinal (GI) Malignancies Branch (TGMB) for advanced multiplex, multimode, two-dimensional, and three-dimensional imaging for spatial-transcriptomic analysis to investigate complex interactions in the tumor microenvironment.

3) One (1) Leica Aperio GT450 Digital Slide Scanner system located in the Artificial Intelligence Resource (AIR) Group of the Molecular Imaging Branch (MIB). The mission of the MIB is to advance cancer therapies using molecular imaging. The digital pathology slide scanner is used to scan glass slides produced by the clinical pathology laboratories

This equipment is used extensively for clinical work at the Center for Cancer Research (CCR). As such, a comprehensive preventative maintenance and repair contract is essential for continued operation.

The Office of Acquisitions (OA) plans to procure, on a sole source basis, maintenance services from:

Leica Microsystems, Inc. (10 Parkway North, Deerfield, IL 60015) SAM UEI: VN38G4R6FUB9

The response close date of this notice is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 and will be made pursuant to the authority in FAR 13.106-1(b)(2) and, in accordance with FAR 13, is exempt from requirements in FAR Part 6. The North American Industry Classification System (NAICS) code is 8811210 – Electronic and Precision Equipment Repair and Maintenance; and the small business size standard is $34 million.

This acquisition is to acquire maintenance services for three government-owned Leica imaging systems:

• One (1) Leica Stellaris 5 Confocal Microscope (Serial #: 8200000644), equipped with the following light sources
  
  
  
  • One (1) Leica Stellaris 405 laser
  
  
  • One (1) Leica Stellaris 5/STED white light laser (WLL)
  
  
  
  


• One (1) Leica CellDIVE Hyperplexed Immunofluorescence Imager (Serial #: 595324)


• One (1) Leica Aperio GT 450 Digital Pathology Slide Scanner (Serial #: 12581), equipped with client application software Aperio GT 450 Scanner Administration Manager (SAM)

Clinical research within the NCI/CCR is spread across its laboratories. The devices requiring maintenance are used by three separate labs. Each lab is committed to maintaining up-to-date equipment for use by its NCI investigators. Therefore, proper maintenance and responsive emergency service is essential to prevent extended down-time for their Leica imaging devices.

The Lymphoid Malignancies Branch (LyMB) focuses on the mechanisms by which lymphomas develop and identify therapeutic vulnerabilities in lymphoid malignancies using in vivo and in vitro models and whole genome CRISPR screens of lymphoma cell lines.

The Thoracic and GI Malignancies Branch TGMB develops novel immunotherapeutics and uses advanced tissue imaging techniques to understand the three-way interactions among tumor cells, the immune system, and the microbiota in the tumor microenvironment over the course of cancer initiation, progression, and therapeutic response.

The Artificial Intelligence Resource (AIR) Group of the Molecular Imaging Branch (MIB) conducts research in designing, developing and testing new novel targeted imaging agents for the detection and characterization of cancer. The MIB is focused on the clinical translation of targeted imaging and therapy agents for improving cancer therapy.

Leica Microsystems, Inc. is the manufacturer and distributor of these imaging systems. This vendor owns the proprietary software and internal components of these devices. Additionally, Leica is the sole-source for replacement parts and software. Only Leica service technicians are authorized to perform maintenance on their proprietary equipment and software. Leica does not license third party technicians to perform maintenance on its equipment. In the event a non-authorized contractor tries to repair an imaging system or any associated component, the manufacturer will not repair them. This scenario creates undue risk for the Government because if the third-party technician is unable to resolve an issue or provide adequate maintenance then the Government would be unable to return to the manufacturer for maintenance and repair services.

Each of these government-owned Leica devices must be calibrated and maintained according to the manufacturer’s specifications. Any deviation from the specifications could jeopardize the imaging functionality of the equipment which could result in an unacceptable, negative direct impact on the clinical cancer research conducted by each respective lab in NCI/CCR.

The government-owned Leica devices have customized component configurations. The configurations were determined by each respective NCI/CCR lab specifically for their analytical needs. High-quality, consistent imaging is critical to the clinical research of the NCI/CCR. Any interruption of equipment functionality would compromise the image data generated by the devices.

To NCI’s knowledge, only the original equipment manufacturer (OEM) is capable of providing the maintenance services required for these Leica imaging systems. A sole-source award to Leica Microsystems, Inc. will ensure that the government-owned devices receive proper calibration, maintenance, and parts. The manufacturer does not license third party technicians; therefore Leica Microsystems, Inc. is the only provider that can meet the Government’s needs at this time.

This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received no later than 4:00PM EST, December 18, 2024. All responses and questions must be in writing and emailed to Lena Lee, Contract Specialist, via electronic mail at lena.lee@nih.gov. 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 solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: 75N91025Q00009 on all correspondence.

***Please reference the attached Statement of Work for more details pertaining to the nature of the requirement.***