The Department of Veterans Affairs (South Texas Veterans Health Care System) is seeking a qualified contractor to perform testing, certification, and ongoing recertification of primary and secondary engineering controls (PECs and SECs) used in the Audie L. Murphy Memorial VA Hospital’s sterile compounding pharmacy. The work includes airflow, HEPA filter integrity, particle counting, smoke pattern testing, pressure differentials, environmental (viable and non‑viable) monitoring, hazardous drug residue wipe sampling, and personnel competency testing (gloved fingertip, thumb, and media‑fill testing) on a semi‑annual basis. All testing must be performed by CETA‑certified professionals and comply with USP <797>/<800>, NSF/ANSI 49, and related CETA application guides. Detailed reporting, immediate notification of failures, and provision of certification stickers are required. The contractor must also supply all equipment, travel, and documentation, and maintain SOPs, certifications, and qualified personnel throughout the contract.
• Perform semi‑annual certification of BSCs, LAFWs, and related cleanroom spaces (PECs & SECs) per CETA CAG‑003‑2026.
• Conduct HEPA filter leak, airflow, particle count, smoke pattern, pressure, temperature, humidity, and vibration testing.
• Provide viable and non‑viable environmental monitoring, including monthly air and surface sampling.
• Execute hazardous drug wipe sampling every six months.
• Test and certify compounding personnel (gloved fingertip/thumb and media‑fill) initially and every six months.
• Deliver comprehensive reports within two weeks of testing, including pass/fail status, data, sketches, and corrective action notifications.
• Supply all required certifications (CETA CNBT, NSF‑49, ISO/IEC 17025 lab accreditation) and maintain qualified staff throughout the contract.