Ortho Clinical Reagents and Testing Supplies

Ortho Clinical Reagents and Testing Supplies Product Service Code:

6550 NAICS Code: 325413-In Vitro Diagnostic Substance Manufacturing (Small Business Size Standards-1,250 Average Number of Employees)

Place of Performance: National Institutes of Health Clinical Center 10 Center Drive Building 10, Room TBD Bethesda, MD 20892 POTS:

24-004671 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 (NIH), Office of Purchasing and Contracts on behalf of the Department of Transfusion Medicine, Transfusion Services Laboratory intends to award a one-year firm-fixed priced contract to Ortho Clinical Diagnostics on a sole source basis to provide reagents and testing supplies.

Proposed Contractor: Ortho Clinical Diagnostics 1001 US Route 202 Raritan, NJ 08869 The mission of the Department of Transfusion Medicine (DTM) is to provide high quality patient care and hospital services in support of clinical research programs, to pursue research that contributes to the knowledge and practice of transfusion medicine and related technologies, and to provide advanced training in transfusion medicine. the Department of Transfusion Medicine provides 24/7 transfusion support for patient care and research.

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. These panels must be manufactured on demand and are in limited number. Use of a reagent from another source would require new validation studies, and thereby would delay clinical patient testing.

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 may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number on the email subject line, 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 February 16, 2024, by Noon (12:00 pm EST Local Time) and time marked in this notice.