Miltenyi CliniMACS Prodigy Preventative Maintenance Services

Title: Miltenyi CliniMACS Prodigy Preventative Maintenance Services

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: 25-000110

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, Office of Purchasing and Contracts on behalf of the Center for Cellular 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: CliniMACS Prodigy Essential Preventative Maintenance Service

List of Equipment: CliniMACS Prodigy Serial Numbers: 1223, 1326, 1415, 1855, 611, 917006, 0146, 0327.

The Center for Cellular Engineering manufactures cell-based therapies for patient who either have no or have exhausted all other standard treatment options. The manufacturing operations are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the Food and Drug Administration in 21 CFR 210, 211, 600 and 1271.

Miltenyi Biotec, Inc. is the original equipment manufacturer of the MACSiniMACS Prodigy instruments. Miltenyi Biotech, Inc is the only known source capable of performing preventative maintenance services on the eight (8) Miltenyi CliniMACS Prodigy instruments. 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:

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 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 November 28, 2024, 12:00 pm EST and time marked in this notice. No phone calls will be accepted.