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Page 2 of 2 Testing and Certification of Pharmacy Sterile Clean Room Montana VA Health Care System Fort Harrison MT 59636 BRIEF SCOPE OF WORK (This is for information only) This RFI (Request for Infor... Page 2 of 2 Testing and Certification of Pharmacy Sterile Clean Room Montana VA Health Care System Fort Harrison MT 59636 BRIEF SCOPE OF WORK (This is for information only) This RFI (Request for Information) is for information only. No award will be made from this RFI. The Department of Veterans Affairs, Montana VA Health Care System (MTVAHCS) has a requirement for a CETA certified contractor to perform numerous testing procedures to establish an industry-based minimum set of criteria appropriate for performance evaluation and certification of facility s Pharmacy Sterile Clean Rooms used for compounding sterile preparations. Location of Performance: Fort Harrison Medical Center (VAMC) 3687 Veterans Drive Fort Harrison, MT 59636 Equipment: Biological Safety Cabinet Compounding Aseptic Isolator in Unclassified Compounding Area Laminar Flow Hood Ante Room Hazardous Sterile Compounding Buffer Room Positive Pressure Sterile Compounding Buffer Room Dr. J Medicine Crow VA Community Based Outpatient Clinic (CBOC) 1775 Spring Creek Lane Billings, Montana 59102 Equipment: Compounding Aseptic Isolator in Unclassified Compounding Area A. CONTRACTOR RESPONSIBILITIES Vendor and Technicians performing certification must be CETA certified. Provide a CETA Certified Report and recommendations on any findings. Resampling is required for recertification if the original samples recovered unacceptably high CFU counts or highly pathogenic organisms. If viable samples exceed guideline levels, attempt to identify microorganism to the genus level with the assistance of a microbiologist. Develop a process for environmental sampling data evaluation with appropriate staff to determine action levels and any necessary documentation of notification and action plans (Highly pathogenic microorganisms must be immediately remedied regardless of CFU counts.). Recertify PEC and SEC ad hoc in the instances of alteration of the room design or equipment movement, repair or replacement, in response to identified problems/trends, in response to changes that could impact the sterile compounding environment, or after corrective action performed. Certify contingency PEC and SEC ad hoc in the event either the entire or part of the current clean room suite/equipment is unusable. The contractor may be required to conduct an environment sampling following any servicing of facilities and equipment and in response to identified problems with end products or staff techniques. Environmental sampling must be completed two times a year with six-month iterations. Perform testing frequencies in pursuant to USP <797> and USP <800> standards. Must provide a video of the smoke pattern test & it must be reviewed with compounding personnel. The smoke pattern tests required in USP <797> and in the CETA CAG standards must be performed in situ and under static and dynamic conditions as appropriate to ensure unidirectional air flow is achieved in the PEC. The smoke test must be of sufficient duration to identify all procedure requirements set forth in USP <797> and CETA CAG standards. Conduct viable air samples, surface samples, HEPA Filter Leak Test, Airflow Testing, Non-Viable Particle Counting, total air changes per hour (ACPH), ACPH from HVAC, ACPH contributed from PEC for each area, room pressure differential in doorways and any other necessary testing procedures defined in most current CETA (CAG)-003-2006, CAG-002-2006, USP 797, USP 800 and/or most current industry accepted guidelines. Viable Air Sampling completed with at least 1000 liters of air. Active air sampling via air impaction device is required vs passive air sampling. Document date and time of day sampling preformed. Viable air and surface sampling must be done under dynamic conditions. Verify PEC maintaining ISO Class 5 or better conditions for 0.5 micrometers particles under dynamic conditions. Document the number of personnel present in each PEC and SEC during total particle count tests and dynamic airflow smoke pattern tests. Verify buffer areas maintain at least ISO Class 7 & ante-areas at least ISO Class 7 ISO Class conditions for greater or equal to 0.5 micrometers particles under dynamic conditions. Provide certification stickers on hoods indicating a pass or fail result and date of service. Provide certificate of analysis (COA from media manufacturer that must verify devices meet expected growth promotion, pH, and sterilization requirements). The Contractor is responsible for ordering, delivering, changing all HEPA filters and providing any necessary repairs to the PEC. The Contractor shall be responsible to verify criteria for the buffer area (hazardous and non-hazardous) meets the minimum requirements in the VA HVAC Design Manual 2017. The Contractor shall be responsible for ensuring all sterile compounding equipment and rooms utilized in sterile compounding are monitored, tested, and certified using the most current procedures or per future changes to procedures in the Controlled Environment Testing Association (CETA) certification guide for Sterile Compounding Facilities, FDA rules/guidelines, USP 797, USP 800 and/or other customarily accepted industry guidelines/standards. IMPORTANTR NOTE: This RFI (Request for Information) is for information only. No award will be made from this RFI. Please communicate via e-mail to Lance.Davis2@va.gov by COB March 17, 2020 as to your company s ability to perform service per this brief Scope of Work. If interested, please provide the following: Please state your company s business size Please provide DUNS number If you have a FSS/GSA contract that includes this service Provide FSS/GSA contract number if applicable