Preventive Maintenance and Calibration for Intercept Pathogen Reduction Systems at U.S. Naval Hospital Okinawa

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 onsite preventive maintenance services for two Intercept Pathogen Reduction Systems. These services are required for Government-owned Cerus Corporation manufactured Intercept Pathogen Reduction Systems, 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:

CERUS CORPORATION

1220 Concord Ave Ste 600

Concord, CA 94520-4906

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, Cerus Corp. 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 Intercept Pathogen Reduction system used at USNHO meets all manufacturer’s specifications and applicable regulatory requirements. The anticipated period of performance is one base year plus two option periods, from 09 February 2025 to 08 February 2028.

The INTERCEPT Pathogen Reduction system is the only FDA-approved system of its kind in the US, providing broad-spectrum transfusion-transmitted infection (TTI) risk reduction by inactivating bacteria, viruses, protozoans, and leukocytes. This system also allows for the earlier release of platelets compared to other bacterial risk control strategies.

Only Cerus authorized personnel are equipped to perform maintenance support for the INTERCEPT Illuminator. This maintenance requires specialized calibration equipment available exclusively to Cerus authorized personnel. Maintenance or service on the INTERCEPT Illuminators by unauthorized personnel will void any existing warranty or service contract provided with the INTERCEPT Illuminators.

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 8:00am Pacific Standard Time, 10 December 2024.

NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED.