Rees Scientific Environmental Monitoring System Preventative Maintenance Services.

Rees Scientific Environmental Monitoring System Preventative Maintenance Services.

NAICS Code: 811210- Electronic and Precision Equipment Repair and Maintenance (The small business size standard is $34,000,000.)

Product Service Code: J065 – Maintenance, Repair, Rebuild of Equipment-Medical, Dental and Veterinary Equipment and Supplies

Place of Performance:

National Institutes of Health

Clinical Center

Bethesda, MD 20892

POTS: 25-000074-1

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 Department of Laboratory Medicine intend to award a follow-on fixed price contract to Rees Scientific for preventative maintenance service on the existing Rees Environmental Monitoring System for a one-year period of performance.

The Department of Transfusion Medicine (DTM), Center for Cellular Engineering (CCE) operates several current Good Manufacturing Practices (cGMP) facilities which are utilized to manufacture cellular and gene therapies for patients enrolled on Clinical Trials at the National Institutes of Health. To be compliant with 21CFR 211.67 (Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart Equipment Maintenance and Cleaning), a service contract is required for the Rees Scientific Environmental Monitoring System that monitors the environmental conditions within facilities used to manufacture cell therapies, as well as the performance of all critical equipment used in manufacturing and storage of cell therapies.

The Department of Laboratory Medicine has a requirement for a follow-on preventative maintenance service contract for maintenance, inspection, calibration, system and software upgrades, adjustments, and safety and operational checks. A service contract is required for the environmental system that monitors the environmental conditions within facilities used to manufacture cell therapies, as well as the performance of all critical equipment used in manufacturing and storage of cell therapies. To ensure the safety and integrity of the clinical and research products and samples, and to meet cGMP requirements, equipment used in manufacturing processes must be monitored for performance to ensure the processes have not been compromised. Due to the criticality of this system, only trained technicians, certified, and trained on the Rees system, are allowed to service the inputs and software used in the facilities. Rees is the approved qualified vendor by the Quality Assurance group. Rees Scientific Corporation is the original equipment manufacturer and the only source that can perform these services, repairs, or upgrades to the system due to the proprietary nature of the equipment. Rees Scientific does not have any third-party service providers. As it is a proprietary system any alternate vendor would need to install their own hardware and wiring. This would be disruptive to the cleanrooms requiring the facilities to be shut down for the duration of the works and an extensive validation of the system. In addition, data is captured from the Rees system automatically in other applications, so interfaces would need to be developed, tested, and approved for security flaws prior to use of the system. The expense and time taken would not be beneficial to the government.

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 at sheri.eiri@nih.gov by the due date November 17, 2024 by 12:00 pm Noon EST and time marked in this notice.