Thermo Fisher Scientific Heracell Vios 160i CO2 Incubators Preventative Maintenance Services

Thermo Fisher Scientific Heracell Vios 160i CO2 Incubators Preventative Maintenance Services

• NAICS Code: 811210- Electronic and Precision Equipment Repair and Maintenance ($34M Average Annual Receipts)


• PSC/FSC Code: J066-Maint/repair/rebuild Of Equipment- Instruments and Laboratory Equipment


• Place of Performance: Bethesda, MD 20892

POTS: 25-001364

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, Clinical Center, Office of Purchasing and Contracts on behalf of the Department of Transfusion Medicine, Center for Cellular Engineering Services intends to award a firm-fixed priced contract to Thermo Fisher Scientific for a preventative maintenance agreement for the 54 Heracell Vios 160i CO2 incubators for a one-year period of performance.

The Department of Transfusion Medicine, Center for Cellular Engineering Services requires a preventative maintenance agreement for 54 Heracell Vios 160i CO2 incubators. The Department of Transfusion Medicine, Center for Cellular Engineering Service manufactures cell-based therapies for patients enrolled on clinical trials. The activities of the Department of Transfusion Medicine, Center for Cellular Engineering Service are regulated by the Food and Drug Administration that mandates critical equipment used in the manufacturing, processing, and testing of drug product be maintained in a controlled manner (21 CFR 211.63, 21 CFR 211.67). Thermo Scientific has been performing these services and is the original equipment manufacturer capable of performing these services and perform software updates. The Food and Drug Administration mandates that all firmware and software used to control devices are kept up to date to prevent security vulnerabilities from being exploited during manufacturing, potentially placing patients at risk. Only the original equipment manufacturer can perform the software and firmware updates. Thermo Fisher has been qualified and validated and the only vendor approved by the Center for Cellular Engineering Quality Assurance Team. Transitioning to a new vendor may cause a stoppage of work. The new vendor would be required to undergo the qualification process which is very lengthy and is not guaranteed should a vendor not meet the specific requirements of the Center for Cellular Engineering’s Quality Assurance Team. To qualify a new vendor would introduce delays to performing preventative maintenance on this critical equipment, which in turn will introduce delays to patient treatments, that could impact patient response to treatment. The equipment could not be used to manufacture patient treatments and patients would need to wait until a new vendor was qualified, the equipment was serviced, and a therapy could be manufactured. For patients with late-stage cancer, these delays are usually insurmountable.

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 16, 2024, by 12:00 pm Noon EST and time marked in this notice. No phone calls will be accepted.