Inactive

Title: Elutra, and 7 Cobe 2991 Cell Processing/Apheresis Equipment Preventative Maintenances Services Product Service Code: J066-Maint/repair/rebuild Of Equipment- Instruments and Laboratory Equipment... Title: Elutra, and 7 Cobe 2991 Cell Processing/Apheresis Equipment Preventative Maintenances Services Product Service Code: J066-Maint/repair/rebuild Of Equipment- Instruments and Laboratory Equipment NAICS: - 811210-Electronic and Precision Equipment Repair and Maintenance Small Business Size Standards: $34 Million Place of Performance: Bethesda, MD 20892 POTS: 23-008005 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), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Transfusion Medicine (DTM), Center for Cellular Engineering intends to award a one (1) year firm-fixed price sole source purchase order to Terumo BCT, Inc. located at 10811 W. Collins Avenue, in Lakewood, Colorado 80215-4440 for equipment preventative maintenance services. The Center for Cellular Engineering utilizes Cobe 2991, and Elutra Therapeutic apheresis devices to process mononuclear cells from patient apheresis material. These purified mononuclear cells are then used as the starting materials to manufacture patient specific cell-based therapies for patients enrolled on clinical trials at the NIH Clinical Center. The FDA regulates equipment that is used to manufacture cell-based therapies in accordance with the following codes of Federal Regulations 21 CFR 210,211,600 and 1271. 21 CFR 211.67 which state that all equipment shall be maintained as appropriate. The CCE requires preventative maintenance service for the three (3) Elutra, and 7 Cobe devices. Terumo BCT is the sole manufacture of its equipment and proprietary software. Therefore, only Terumo BCT is capable of providing trained and approved service technicians to service the equipment and perform software updates and upgrades. If a third-party service provider performed services on the equipment, Terumo BCT Inc. cannot guarantee the integrity of the equipment. Furthermore, it would negatively impact patient care and devices during manufacturing runs of cell-based therapies for patients with advanced metastatic cancer and other life-threatening conditions. 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, may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Sheri Eiri, Contracting Specialist sheri.eir@mail.nih.gov by the due date and time marked in this notice.