Notice of Intent.pdf

Synopsis No. 75N98026Q00174

Hospital and Laboratory Support Division Office of Logistics and Operations (OLAO) Office of Acquisition and Logistics Management (OALM)

Title: Preventative Maintenance Service for Leica BONDRXm Processing Module

Presolicitation

SYNOPSIS

General Information

Document Type: Presolicitation Synopsis Number: 75N98026Q00174

Posted Date: April 6, 2026 Original Response Date: April 14, 2026 Current Response Date: April 14, 2026 Set Aside: N/A NAICS Code: 811210

Contracting Office Address

National Institutes of Health (NIH), Office of the Director (OD) Office of Logistics and Operations (OLAO) Office of Acquisition and Logistics Management (OALM) Hospital and Laboratory Support Division 6701 Rockledge Drive Bethesda, MD 20817

Description

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL

OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to:

Leica Microsystems Inc.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 811210 with a Size Standard $34M.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-99-1, July 16, 2018. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($350,000).

STATUTORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6- Competition Requirements.

GENERAL INFORMATION

1. Title: Preventative Maintenance Service for Leica BONDRXm Processing Module

2. Background Information:

The Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Office of Science and Technology Resources (OSTR), requires preventative maintenance and service support for government-owned Leica BOND RX Research Advanced Staining System(s). These systems provide automated immunohistochemistry (IHC) and in situ hybridization (ISH) capabilities that are essential for supporting basic, translational, and clinical cancer research.

Due to the proprietary nature of the Leica BOND RX system, preventative maintenance, repairs, software updates, and calibration must be performed by Leica Biosystems or its authorized service providers to ensure proper instrument functionality, maintain manufacturer compliance, and preserve data integrity. Continuous service coverage is required to minimize downtime, maintain assay consistency, and support the ongoing research mission of CCR.

The Leica BOND RX Research Advanced Staining System is manufactured by Leica Biosystems. Leica Biosystems is the only responsible source capable of providing maintenance and service for this equipment. The BOND RX system is a highly specialized automated staining platform that incorporates proprietary hardware, software, reagents, and system components unique to Leica Biosystems.

Only Leica Biosystems can provide service performed by factory-trained engineers and supply original equipment manufacturer (OEM)-approved replacement parts required to maintain the system in accordance with manufacturer specifications. The BOND RX software platform is proprietary, and all updates, patches, firmware revisions, and instrument control enhancements are exclusively available from Leica Biosystems.

Accurate calibration and OEM-certified maintenance are critical to ensure staining consistency, assay performance, data integrity, and continuity of ongoing research. Use of non-OEM service providers or unauthorized components would risk instrument malfunction, compromised staining quality, loss of warranty protection, invalidation of research results, and significant disruption to laboratory operations.

As the Original Equipment Manufacturer (OEM), Leica Biosystems uniquely:

• Provides OEM-authorized software, firmware, and hardware updates as released.

• Maintains exclusive access to OEM-approved replacement parts and proprietary reagents.

• Possesses specialized expertise in the proprietary automated staining architecture of the BOND RX system.

• Offers direct technical support and troubleshooting by certified, factory-trained engineers.

Accordingly, Leica Biosystems is the only source capable of meeting the Government’s minimum requirements.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by April 14, 2026 at 7:00 AM Eastern time and must reference solicitation number 75N98026Q00174. Responses may be submitted electronically to David Shen, Purchasing Agent, at david.shen@nih.gov. Fax responses will not be accepted.

All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.

http://www.sam.gov/