Description
The Department of Veterans Affairs is seeking a contractor to provide testing and certification of primary engineering controls and clean rooms used for preparation of compounded sterile preparations at various VA facilities in the VISN 15 network. The contractor will also provide personnel training, evaluation, and requalification to compound sterile preparations in accordance with USP <797> and <800> standards. The contract will be for a period of 5 years with 12-month ordering periods. The contractor must have experience in providing similar services and must be registered with the Controlled Environment Testing Association (CETA). Some key services include:
• Testing and certification of primary engineering controls (PECs) such as biological safety cabinets, laminar airflow workbenches, and compounding aseptic containment isolators
• Clean room certification and testing
• Personnel training and competency assessment for compounding personnel
• Environmental wipe sampling for hazardous drug residue
• Reporting and documentation of test results and certification
The contractor must provide a written description of their testing and certification procedures, as well as their personnel training and competency assessment procedures.