Inactive

Notice of Intent - Ortho Clinical Reagents and Supplies NAICS Code: 325413-In Vitro Diagnostic Substance Manufacturing (Small Business Size Standard 1,250 Average Number of Employees) PSC/FSC: 6550-In... Notice of Intent - Ortho Clinical Reagents and Supplies NAICS Code: 325413-In Vitro Diagnostic Substance Manufacturing (Small Business Size Standard 1,250 Average Number of Employees) PSC/FSC: 6550-In Vitro Diagnostic Substances, Reagents, Test Kits and Sets Place of Performance: Bethesda, MD 20892 POTS: 25-000043 Description: This is a notice of intent, not a request for a quotation. A solicitation document will not be issued, and quotations will not be requested. The National Institutes of Health, Clinical Center, Office of Purchasing and Contracts on behalf of the Department of Transfusion Medicine intends to award a fixed price contract for a twelve (12) month base year to Ortho-Clinical Diagnostics, Inc., 1001 US Highway 202, Raritan, New Jersey 08869-1424 on a sole source basis to supply analyzer supplies and reagents. The Department of Transfusion Medicine, Transfusion Services Laboratory provides blood products in support of transfusion therapy for patients being treated at the Clinical Center. These blood products, per the Food and Drug Administration requirements, must be both safe and effective when treating patients. To be safe and effective, the blood products must at least match or be compatible with the ABO/Rh of the patients, and in addition, be a match or compatible with extended antigen typing beyond ABO/Rh. To accomplish this, specific Ortho Clinical reagents are required which will not only be used for testing of patients, but also for testing and compatibility testing of donors who provide the blood products. These reagents have been approved and have unique red cell antigen composition and the amount of red cell donors available per panel. Large-scale validation studies have been performed to support the use of these reagents for clinical testing. These reagents are the only compatible reagents to use with the Ortho Vision analyzer. In addition, Ortho Clinical Diagnostics does not have any authorized third-party resellers or distributor of its products. Use of a reagent from another source would require new validation studies, and thereby would delay clinical patient testing. FAR 52.232-18 Availability of Funds Funding is not presently available for this contract. The Government’s obligation for this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer. Requirement is pending FY2025 Funding. This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1). For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Interested Parties: Interested parties capable of providing the same or similar products or services described in this notice may submit a capability statement outlining their capability to perform the described work. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. The determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Comments: Comments to this announcement, referencing this posting number, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Sheri Eiri, Contract Specialist, sheri.eiri.nih.gov by the due date September 22, 2024, 12:00 pm EST and time marked in this notice. No phone calls will be accepted.