Miltenyi MACSQuant Tyto Essential Preventative Maintenance Service

Title: Miltenyi MACSQuant Tyto Essential Preventative Maintenance Service

NAICS Code: 811210 - Electronic and Precision Equipment Repair and Maintenance (Small Business Size Standards, $34.0 Average Annual Receipts)

Product Service Code: J066-Maintenance/Repair/Rebuild of Equipment-Instruments and Laboratory Equipment

Place of Performance: Bethesda, MD 20892

POTS: 25-000054

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, Center for Clinical Engineering intends to award a fixed priced sole source purchase order to Miltenyi Biotec, Inc. located in Auburn, California 95602-9562 for a one-year preventative maintenance service agreement.

Anticipated Period of Performance: 12/01/2024-11/30/2025

Description: MACSQuant Tyto Essential Preventative Maintenance Service

The Department of Transfusion Medicine, Center for Clinical Engineering has a requirement preventative maintenance service on government owned Miltenyi MACSQuant Tyto instrument Serial #10076. This instrument is used for manufacturing research and development of cell-based therapies for patients enrolled on clinical trials carried out at the Clinical Center of NIH. The Food and Drug Administration (FDA) regulates facilities that 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. This project is to establish a preventative maintenance service agreement for the MACSQUANT Tyto closed system cell sorter.

Miltenyi Biotec, Inc. is the original equipment manufacturer of the MACSQuant Tyto. Miltenyi Biotech, Inc is the only known source capable of performing preventative maintenance services on the Miltenyi MACSQuant Tyto Instrument. Miltenyi Biotec products are offered exclusively by Miltenyi Biotec B.V. & Co. KG, its subsidiaries and distributors. Miltenyi Biotec software is proprietary in nature and require upgrades and replacement parts. Miltenyi Biotec is the only contractor capable of providing authorized and trained service technicians with the knowledge and expertise to perform these services. Any failure due to service errors could negatively impact on patient care. The failure of the system being in-operable could result in the loss of extensive research efforts. 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, 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 11/01/2024, by 12:00 pm Noon EST and time marked in this notice.