Bio-Rad Laboratories IQ & OQ Services

Bio-Rad Laboratories, Inc. one-time installation qualification and operation qualification service

NAICS Code: 811210- Electronic and Precision Equipment Repair and Maintenance
Product Service Code: J066- Maint/repair/rebuild Of Equipment- Instruments and Laboratory Equipment
Place of Performance:
The National Institutes of Health
10 Center Drive
Building 10, Room TBD
Bethesda, Maryland 20892-0003

POTS:  24-000382

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, Office of Purchasing and Contracts on behalf of the Department of Transfusion Medicine, Center for Cellular Engineering intends to award a firm-fixed award to Bio-Rad Laboratories, Inc. for relocation and a one-time installation qualification and operation qualification and calibration services on the Bio-Rad Bio-Plex 200 System and QX200 Droplet Digital PCR System.

Proposed Contractor:
Bio-Rad Laboratories, Inc. (Bio-Rad)
2000 Alfred Nobel Drive
Hercules, California 94547-1804

List of Equipment:
Bio-Rad Bio-Plex 200 ELISA System Serial Number LX10021228421
Bio-Rad QX200 Droplet Digital PCR System Serial Number 773BR2063/771BR4088.

The Department of Transfusion Medicine, Center for Cellular Engineering has a requirement for a one-time move and a one-time installation qualification and operation qualification service for the Bio-Rad Bio-Plex 200 System and QX200 Droplet Digital PCR System.  The Qx200 Droplet Digital PCR System will be relocated within Building 10 from Room 1N322 to 3N204 and the Bio-Plex 200 System will be relocated within Building 10 from Room 1C724 to 3N206. 

Both instruments are used in the cell therapy and the QX200 Droplet Digital PCR System and Bio-Plex200 ELISA System are routinely used clinical sample lot release assays and clinical research protocols respectively for CAR-T cell and other engineered cell products that manufactured.  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.  Bio-Rad Laboratories, Inc. is the manufacture of the Qx200 Droplet Digital PCR System and the Bio-Rad Bio-Plex 200 ELISA System and only capable source of performing the installation qualification and operation qualification (IQ/OQ) and calibration services.  Bio-Rad is a qualified vendor by the CCE’s Quality Assurance Team.  There are no other vendors capable of performing these services.

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 Noon 12:00 pm EST, November 12, 2023, and time marked in this notice.