Inactive

Miltenyi CliniMACS Prodigy® Preventative Maintenance Services NAICS Code: 811210-Electronic and Precision Equipment Repair and Maintenance (Small Business Size Standards $34M Average Annual Receipts) ... Miltenyi CliniMACS Prodigy® Preventative Maintenance Services NAICS Code: 811210-Electronic and Precision Equipment Repair and Maintenance (Small Business Size Standards $34M Average Annual Receipts) PSC/FSC: J066 – Maintenance/repair/rebuild Of Equipment- Instruments and Laboratory Equipment Place of Performance: National Institutes of Health Clinical Center 10 Center Drive Building 10, Room TBD Bethesda, MD 20892 POTS: 24-003940 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 Laboratory Medicine, Center for Cellular Engineering intends to award a firm-fixed contract to Miltenyi Biotec located in Gaithersburg, Maryland 20878 on a sole source basis to provide CliniMACS Prodigy® Automated Cell Processing System preventative maintenance services. Period of Performance: 02/15/2024-02/14/2025 List of equipment: CliniMACS Prodigy Serial Number 1223 -Quantity 1 The purpose of this requirement is to acquire a service agreement needed for the CliniMACS Prodigy® System. The Center for Cellular Engineering manufactures cell-based therapies for patients that have either had or exhausted all other standard treatment options. The manufacturing operations are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the FDA in 21 CFR 210, 211, 600 and 1271. The Food and Drug Administration (FDA) mandates that critical equipment used in the manufacturing, processing, and testing of drug products must be maintained in a controlled manner under a preventative maintenance program (21 CFR 211.63, 21 CFR 211.67). Miltenyi Biotec is the manufacturer of the ClinMACS Prodigy® that is proprietary in nature and requires software updates. Miltenyi Biotec is the only source capable of providing authorized, trained service technicians with the knowledge and expertise to perform these services. Any failures due to service errors could negatively impact on patient care. The failure of the system being operational could result in the loss of extensive research efforts, and the current and future needs of investigators. A preventative maintenance agreement is required to maintain and ensure the equipment is fully operational. Use of a third-party service provider or unauthorized parts, maintenance, or repairs, may invalidate the warranty or any existing service agreement. 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, by email at sheri.eiri.nih.gov by the due date January 29, 2024, and time 12:00 pm Noon EST (Local Time) marked in this notice.