Thermofisher Scientific Sorvall Legend Centrifuges and Incubators PM

Thermo Fisher Scientific Sorvall Legend Centrifuges and Heracell Vios 160i CO2 Incubators Preventative Maintenance Services

• Product Service Code: J066-Maint/repair/rebuild Of Equipment- Instruments and Laboratory Equipment
• NAICS Code: 811210- Electronic and Precision Equipment Repair and Maintenance ($34M Average Annual Receipts)
• Place of Performance: Bethesda, MD 20892

POTS:  25-001812

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 Department intends to award a firm-fixed priced contract to Thermofisher Scientific to perform preventative maintenance services on Heracell Vios 160i CO2 incubators and Sorvall centrifuges.

List of Equipment:
Thermofisher Heracell Vios 160i CO2 incubators Quantity 36
Thermofisher Sorvall Centrifuges Quantity 17

Serial Numbers

43072425            

43095884            

43107182            

43049226            

43107185            

43095886            

43124291            

43136687            

43049225            

43098091            

43134068            

43095882            

43107160            

43095885            

43107183            

43095881            

43124292            

43134069            

43072430            

43068198            

43072424            

43072422            

43079838            

43068216            

43068215

43068212

43068225

43072431

43067007

43079842

43068207

43068214

43089823

43089824

43068224

43072420

43072429

43068219

43079839

43072419

43068218

43076993

43072427

43068222

43079843

43068220

43072423

43072421

43089825

43089829

43068221

43068201

43068223

The Department of Transfusion Medicine, Center for Cellular Engineering Services requires continued preventative maintenance services on fifty-three combined Thermo Fisher Scientific Sorvall Legend Centrifuges and Heracell Vios 160i CO2 incubators used for testing in support of patient care.  The Department of Transfusion Medicine, Center for Cellular Engineering Service manufactures cell-based therapies for patients enrolled on clinical trials. The manufacturing operations of the Center for Cellular Engineering Services 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.  The Food and Drug Administration mandates that critical equipment used in the manufacturing, processing, and testing of drug product must be maintained in a controlled manner (21 CFR 211.63, 21 CFR 211.67).  Thermo Fisher Scientific is the original equipment manufacturer and the only source 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 Scientific 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 Services 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) and 41 U.S.C.

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 30, 2024 by 12:00 pm Noon EST and time marked in this notice.

No phone calls will be accepted.