797800 USP Certification

This is a source sought announcement only. The purpose of this notice is to conduct market research and obtain information from qualified potential offerors. No formal solicitation document exists at this time. The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to these sources sought synopsis request.

This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued.

The Department of Veterans Affairs Durham VA Medical Center (VAMC) located at 508 Fulton St, Durham, NC 27705 has the need for a service contract for semiannual testing and certification of U.S. Pharmaceutical Convention (USP) equipment and rooms.

Certification of Primary Engineering Controls (PEC)/Hoods Contractor shall provide testing and certification of all the Durham VA Health Care System pharmacy hoods either once a year (every 12 months +/- 30 days) or twice per year (every 6 months +/- 20 days) as described in the price/cost schedule. The term Hoods refers to all of the following:

Biosafety cabinets, chemical fume hoods and HEPA units. The contractor shall also provide testing and certification of all primary engineering controls (PECs) and pharmacy compounding rooms/suites used for preparation of Compounded Sterile Preparations (CSPs). PECs include biological safety cabinets (BSCs), laminar airflow workstation (LAFW) hoods, compounding aseptic containment isolators (CACI), and compounding aseptic isolators (CAI).

Testing and certification of all PECs and compounding rooms/suites will be completed in accordance with the latest version of United States Pharmacopeia (USP) Chapter 797, and USP Chapter 800 or current guidelines. g) Certification procedures defined in CETA CAG-003-2006 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months (+ or - 20 days) or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

Buildings will be occupied during performance of work. Coordinate alteration work in areas occupied by Department of Veterans Affairs so that Durham VAHCS operations will continue during the installation period.

The NAICS code for this procurement is 541380, This industry comprises establishments primarily engaged in performing physical, chemical, and other analytical testing services, such as acoustics or vibration testing, assaying, biological testing (except medical and veterinary), calibration testing, electrical and electronic testing, geotechnical testing, mechanical testing, nondestructive testing, or thermal testing. The testing may occur in a laboratory or on-site. Small Business Size Standards 19 million. Responses to this source sought notice should include the following:

name and address of company, business size (large or small): identify whether or not firm falls into any of the following socioeconomic categories-8(a), HUBZone, Services Disabled Veteran-Owned/Veteran-Owned Small Business; provide a brief description of qualifications and any other pertinent information which demonstrates the ability to meet the above requirement. Subject line must reflect: Keeler Vantage Plus Sources Sought. All responses shall be submitted in writing no later than 9:00 AM, Wednesday, July 30, 2025, to the attention of:

Ricardo McIntosh at Ricardo.McIntosh@va.gov.