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This document is a Notice of Intent to Sole Source for preventive maintenance services for the Procleix Panther Nucleic Acid Test system. The Defense Health Agency Contracting Activity (DHACA) intends to award a firm fixed-price contract to Grifols Diagnostic Solutions Inc. for annual maintenance of a government-owned medical diagnostic system located at the United States Naval Hospital Okinawa, Japan. The contract will cover comprehensive preventative maintenance, inspection, calibration, system upgrades, and operational checks, with an anticipated period of performance from 24 August 2025 to 23 August 2030 (one base year plus four option periods).

The sole source justification is based on the proprietary nature of the Procleix Panther system, which is a fully automated, high-throughput blood and plasma screening platform. Only Grifols Diagnostic Solutions Inc. authorized personnel can perform maintenance using specialized calibration equipment. Interested sources can submit a capability statement up to six pages long by 16 April 2025 to adrian.m.nerida.civ@health.mil. The North American Industry Classification System (NAICS) code is 811210, with a business size standard of $34.0 million, and the Product Service Code (PSC) is J065 for medical equipment maintenance.

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Notice of Intent to Sole Source

HT941025N0071

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE NON-PERSONAL SERVICES

CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. The Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division - West (HCD-W), San Diego, intends to negotiate and award a firm fixed price contract for annual preventive maintenance services for Procleix Panther Nucleic Acid Test system. The services are required for Government-owned Grifols Diagnostic Solutions Inc. manufactured Procleix Panther System, Outside the Continental of the United States (OCONUS) in support of United States Naval Hospital Okinawa (USNHO), Japan in accordance with Federal Acquisition Regulation FAR 13.106-1(b)(1)(i), only one source being available to meet the Government’s needs, to:

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

4560 Horton St Emeryville, CA 94608-2916

The North American Industry Classification System (NAICS) code for this requirement is 811210 – Electronic and Precision Equipment Repair and Maintenance and the business size standard is $34.0 millions of dollars. The Product Service Code (PSC) is J065 – Maintenance, Repair and Rebuilding of Equipment: Medical, Dental, and Veterinary Equipment and Supplies.

Based on market research, Grifols Diagnostic Solutions Inc. is the only source that can perform repairs or upgrades to the system due to the proprietary nature of the equipment. No other company was found that has authorized third-party service providers.

The objective of this sole source award is to procure non-personal services to perform comprehensive preventative maintenance, inspection, calibration, system upgrades, adjustments, and safety and operational checks to ensure the Procleix Panther system used at USNHO meets all manufacturer’s specifications and applicable regulatory requirements. The anticipated period of performance is one base year plus four option periods, from 24 August 2025 to 23 August 2030.

The Grifols Procleix Panther system is a fully automated, high-throughput blood and plasma screening platform distinguished by its continuous loading capability, allowing for uninterrupted sample processing and significantly increased efficiency. Unlike traditional batch-loading systems, the Panther minimizes hands-on time, reduces the risk of error, and offers a comprehensive menu of highly sensitive and specific Procleix assays for detecting a broad range of infectious diseases. Its modular design allows for scalability, and integrated data management ensures seamless reporting, making it uniquely suited for high-volume screening environments requiring rapid turnaround times and exceptional reliability.

Only Grifols Diagnostic Solutions Inc. authorized personnel are equipped to perform maintenance support for the Procleix Panther system. This maintenance requires specialized calibration equipment available exclusively to Grifols Diagnostic Solutions Inc. authorized personnel. Maintenance or service on the Procleix Panther system by unauthorized personnel will void any existing warranty or service contract provided with the Procleix Panther system.

This notice of intent is not a request for competitive proposals, and no solicitation document exists for this requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide the required services for United

States Naval Hospital Okinawa. Capability statements shall not exceed six (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on 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 or to proceed with a sole source purchase order.

If a vendor challenges the basis of this requirement, please email capability statements as a Microsoft Word or Adobe PDF attachment to Adrian Nerida at adrian.m.nerida.civ@health.mil. The closing date for challenges is no later than 8:30am Pacific Daylight Time, 16 April 2025.

NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED.

File details come from the government source that posted it. Updated .