Cleanroom Certification

Sources Sought Notice
THIS IS A SOURCES SOUGHT NOTICE REPRESENTING A MARKET SURVEY AND IS NOT A REQUEST FOR PROPOSALS OR INVITATION FOR BIDS
The National Institutes of Health (NIH) is conducting a MARKET SURVEY to determine the availability of Small Business concerns capable of providing cleanroom certifications for three areas on the Bethesda campus.
The NAICS code is 541380 Calibration and Certification testing laboratories or services with a size standard of $16,500,000.00.
Tentative Certification Date:
21 November 2019

DESCRIPTION OF THE REQUIREMENT:
PROJECT DESCRIPTION
The contractor shall provide cleanroom certification of the National Institutes of Health, NIH, Interim - Intravenous Admixture Unit, 1-IVAU, 2J Cell Processing, and 1B42 Viral Vector Lab. Certification will include ISO certification of the Immunotherapy Preparation Room and initial certification of a new biologic safety cabinet (BSC3). The contractor shall furnish all labor, materials, equipment, and supervision necessary to accomplish the work. The contractor shall ensure that all personnel are qualified, trained, and experienced in the types of equipment and cleanrooms, requirements, and processes as described herein. The contractor shall follow all facility requirements, e.g. facility entry standard operating procedures. Work may be after-hours and/or multiple mobilizations.

The contractor shall coordinate and provide clean room testing and certification report to include the fo11owing and as detailed in the Deliverables and Schedule section. The testing shall be performed in an At­ Rest-Facility condition or Operating-Facility condition as coordinated with the APF End User. The contractor shall perform all testing and provide test result documentation in accordance with ISO Standards 14644-1:2015, 14644-2:2015, and 14644-3:2005. Testing for the biologic safety cabinet will also include ce1tification requirements as set forth in current version of NSF Chapter 49. If any testing is found non-compliant, the contractor shall notify the APF End User and the Project Officer immediately at conclusion of testing. ISO Classified Zones include the ISO Classified Room and ISO Classified and Biosafety Cabinet (BSC).

ANY INTERESTED SOURCES SHALL PROVIDE THE FOLLOWING INFORMATION IN THEIR RESPONSE:

1) Company name, address, phone number, primary contact(s), e-mail address,
NAICS code(s), and DUNS Number.

2) Contractors shall indicate if they are a large or small business (if small, please indicate any applicable socioeconomic status).

3) Provide a Statement of Capability (no more than 5 pages) that CLEARLY demonstrates the offeror's ability to successfully provide the services requested above.

4) Include earliest potential performance start date.

5) Submit Capability Statements by the closing date/time of this notice to shariyun.lawson@nih.gov.