Certification of Sterile Compounding Facilities Services

The South Texas Veterans Health Care System (STVHCS) is seeking a firm-fixed-price contractor to perform testing, certification, and environmental sampling at the Audie L. Murphy Memorial VA Hospital in San Antonio, Texas. The scope of work encompasses both primary engineering controls (PECs), such as biological safety cabinets and laminar airflow workstations, and secondary engineering controls (SECs). These services ensure strict compliance with VHA Directive 1108.12, USP <797>, USP <800>, and Joint Commission standards for sterile and hazardous drug compounding. The selected contractor must provide CETA-certified technicians and utilize an ISO/IEC 17025 accredited laboratory to perform semi-annual certifications, monthly viable environmental sampling (air and surface), and semi-annual hazardous drug residue wipe testing. Additionally, the contractor will conduct monthly personnel testing, including garbing competency assessments, gloved fingertip/thumb sampling, and media-fill testing. Detailed physical and electronic reporting, complete with pass/fail designations, room sketches, and video-recorded smoke visualization studies, must be delivered to the Chief of Pharmacy Service within specified timeframes. The contract features a 12-month base period (tentatively beginning October 11, 2027) with four 12-month option years. At the time of bidding, contractors must submit proof of CETA and NSF-49 certifications, standard operating procedures, and past performance reports from at least two state or federal government medical facility contracts within the last five years.

The Department of Veterans Affairs, Network Contracting Office 17, has issued a Sources Sought Notice (Solicitation Number 36C25726Q0894) for market research to identify qualified businesses capable of providing testing and certification services for sterile compounding facilities. The services are required for the South Texas Veterans Health Care System at the Audie L. Murphy Memorial VA Hospital in San Antonio, Texas. The scope of work involves the testing and certification of the pharmacy service's primary engineering controls (PECs)—such as biological safety cabinets and laminar airflow workstations—and secondary engineering controls (SECs) used in preparing Compounded Sterile Preparations (CSPs). Additionally, the contractor will conduct aseptic technique testing for compounding personnel via media fill and gloved fingertip/thumb sampling. All services must comply with USP <797> and <800> guidelines, as well as VHA Directive 1108.12. Performing technicians must be registered with the Controlled Environment Testing Association (CETA) as Registered Certified Professionals for Sterile Compounding Facilities (RCP SCF). This notice aims to make a set-aside determination, particularly targeting SDVOSBs, VOSBs, SBA Section 8(a), WOSBs, and other disadvantaged small businesses, though all business sizes may respond. The applicable NAICS code is 541380 (Testing Laboratories and Services) with a $19 million size standard. Interested parties must submit a capability statement, company details, business classification, and federal contract availability to Contract Specialist Stephanie Reeves at stephanie.reeves@va.gov by September 14, 2026, at 9:00 AM Central Time.