Amendment 0001 | H966- | 36C261-26-AP-0279 | PHARMACY USP 797 800 CERTIFICATION TESTING/ SERVICE

The Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 21 is procuring pharmacy certification testing and services for the VA Central California Healthcare System. Specifically, the VA requires semi-annual United States Pharmacopeia (USP) 795, 797, and 800 compliance testing of sterile compounding clean rooms performed by a Controlled Environment Testing Association (CETA) certified technician. Key contract requirements include ensuring compliance with USP standards, ISO 14644, and VHA Directives, with the contractor located within 250 miles of the Fresno VA Medical Center and capable of dispatching a certified technician on the same business day. The contractor must maintain a minimum of three CETA-certified staff members and possess verifiable experience with USP 797 and 800 standards within the last five years. Evaluation criteria include technical qualifications and CETA certifications, past performance on similar contracts, Small Business status (SDVOSB/VOSB), and pricing. The Pre-Solicitation Notice was posted on December 22, 2025, with Amendment 0001 issued on December 30, 2025, and the deadline for submitting responses is January 6, 2026 at 4:00 PM Pacific Time.

This procurement carries no set-aside designation, and the amendment clarifies that interested vendors should check SAM.GOV to determine whether an incumbent contractor currently performs these services. The contract is structured as a base year beginning February 1, 2026, with four one-year option periods extending through January 31, 2031, for a total potential performance period of five years. Testing will be conducted semi-annually in August and February at two separate buildings within the healthcare system, with comprehensive testing requirements including airflow volume measurements, HEPA filter integrity testing, biological safety cabinet certification, particulate counting, differential pressure measurements, and viable particle sampling. The contractor must submit detailed testing reports within 24 hours and 30 days of service completion. The Quality Assurance Surveillance Plan mandates 100% compliance with all testing, reporting, and personnel certification requirements, with failure to meet standards resulting in potential termination for default.