D.1 Performance Work Statement 2026-2031 Sterile Compounding Services Contract

PERFORMANCE WORK STATEMENT

South Texas Veterans Health Care System
Certification of Sterile Compounding Services
South Texas Veterans Health Care System
Audie L. Murphy Memorial VA Hospital
7400 Merton Minter Blvd.
San Antonio, TX
1. BACKGROUND: The United States Pharmacopeia (USP) establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of Compounded Sterile Preparations (CSPs). The Joint Commission (TJC) established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. Additionally, the Food and Drug Administration (FDA) has the authority to inspect VA medical facilities using the USP standards.
VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Sterile Preparations, dated February 14, 2024, defines organizational responsibility for USP <797> and USP <800> standards for cleanroom design and engineering controls, environmental monitoring and cleaning of primary and secondary engineering controls, and the core competencies for personnel involved in the processes of compounding sterile preparations including HDs (both sterile and nonsterile dosage form preparations). It is VHA policy that each VA medical facility that provides CSPs have a pharmaceutical CSP program in place that conforms to the standards in USP Chapter <797> “Pharmaceutical Compounding‐Sterile Compounding” and USP <800> “Hazardous Drugs – Handling in Healthcare Settings.” According to VHA Directive 1108.12, and that all VA medical facilities must establish a separate and dedicated contract for all applicable USP <797> and USP <800> CSP performance evaluations, testing, and certifications requirements. 2. OBJECTIVE: South Texas Veterans Healthcare System seeks a contractor, for testing and certification of the Audie L. Murphy Memorial VA Hospital Pharmacy Service’s primary engineering controls (PECs) and secondary engineering controls (SECs) used for preparation of Compounded Sterile Preparations (CSPs) in addition to testing of compounding personnel for aseptic technique by gloved fingertip and thumb sampling and media fill testing. PECs include biological safety cabinets (BSCs) and laminar airflow workstations (LAFWs) hoods. Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter <797> and <800> guidelines using Controlled Environment Testing