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Performance Work Statement (Monthly Sampling of Clean Rooms/Compounding Cabinets and Semiannual Certification of Clean Rooms/Compounding Cabinets) Introduction The White River Junction VA Medical Cent... Performance Work Statement (Monthly Sampling of Clean Rooms/Compounding Cabinets and Semiannual Certification of Clean Rooms/Compounding Cabinets) Introduction The White River Junction VA Medical Center (WRJ VAMC) prepares and compounds intravenous medications, chemotherapeutic agents, hazardous agents and other sterile/non-sterile products to patients. As a VAMC facility, the pharmacy is required to provide products according to all relevant USP compounding guidelines including USP 797/800. Environmental monitoring (on site sampling, laboratory analysis and reporting, and staff competency testing) services are required for the WRJ VAMC pharmacy. Compounding of IV fluids, nutritional parenteral compounds, and IV-administered chemotherapeutic agents must be accomplished according to Industry Standards, VHA Directives, standard operating procedures (SOP), and applicable USP guidelines. Scope The Contractor shall provide all necessary personnel, supervision, labor, equipment, materials (Including gowning materials/sterilized jumpsuits and environmental monitoring tools) and disposal necessary to successfully support the WRJ VAMC pharmacy 797/800 compounding area environmental monitoring requirement. The contract will cover a minimum of twelve (12) months from start date and (4) option years. The Contractor must be able to provide primary services as outlined in this statement of work by WRJ VAMC pharmacy. The contractor (per evaluation by the Contracting Officer) must be financially responsible, show evidence of their reliability, ability and experience performing in sterile compounding environments and USP 797/800 environmental monitoring. The contractor must render prompt, detailed service in accordance with the applicable directives referenced in this document. All Vendors used to conduct primary and secondary engineering controls certifications/assessments must be registered with Controlled Environment Testing Association (CETA). All persons who perform work, but meet CETA guidelines/USP 797/800 and VHA Directive 1108.12: Management and Monitoring of Pharmaceutical Compounded Sterile Preparations. Each service person designated by the Contractor to perform work under this contract shall be cleared for access through restricted areas of customer s facilities. The Contractor shall conform to all Federal, State, VA and local regulations governing Environmental Monitoring in USP environments. This includes the use of any related chemicals and equipment. The company must furnish a copy of state certification to perform contracted service. The company must provide this documentation to the Contracting Officer prior to performing any work under the contract. All chemical (MSDS) or control substance used to perform service must be submitted and filed with the Contracting Officer s Representative (COR). All company service persons shall have their name and their company s name indicated on their uniform or a name badge while at the facility so they are easily recognizable as a contractor employee. Description of Services: Environmental Monitoring (on-site sampling, laboratory analysis/reporting, testing) to be performed monthly and Recertification of compounding areas to be performed semi-annually at WRJ VAMC Pharmacy, Building 39, Room 236, Services must comply with industry standards and USP General Chapter 797/800. Environmental sampling will be performed in Pharmacy compounding spaces monthly and Recertification in the same areas will occur semi-annually: This will include the following: Two Anterooms (Room # 236 E and Chemo anteroom (Room # 236G) Two buffer rooms iso class 7 (Chemo hood Room # 236H and IV compounding Room# 236F) One laminar airflow workstation (LAFW Room # 236F) One biosafety cabinet (BSC Room # 236H) Two compounding isolators (CAI and CACI) (Room #236 segregated compounding areas) One non-sterile hazardous isolator Room 236H (requires certification only) Room sampling (See chart diagram below: Width is 12 9 and length is 24 6 x 12 walls = Approximately 3,764 square feet total) Microbiological Air and surface Monitoring Requirements: Total airborne particles must be taken in each PEC at locations where there is greatest risk to the exposed CSPs, containers, and closures. When conducting sampling of the PEC, care should be taken to avoid disturbing the unidirectional airflow within the PEC. Measurements of total airborne particles in other classified areas, including the buffer room(s) and ante-room(s), should be taken at representative locations that reflect the quality of air in the room(s). Sampling and reporting will meet all requirements in the most recent edition of USP General Chapter 797 Pharmaceutical Compounding- Sterile Preparations and USP General Chapter 800 Hazardous Drugs- Handling in Healthcare Settings. Recertification Requirements: Recertification must be done following procedures in the current Controlled Environment Testing Association (CETA) certification guide for Sterile Compounding Facilities or an equivalent guideline. Re-certification indicates that the compounding area is meeting its design and air quality specifications (see Table). It is important to place special emphasis on certifying the ISO Class 5 areas. Recertification must be performed at least every 6 months and must include: Airflow testing: Airflow testing is performed to determine acceptability of the air velocity and volume, the air exchange rate, and the room pressure differential in doorways between adjacent rooms to ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions. The ACPH from HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report. HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again after installation and as part of recertification. Total particle count testing (Total Airborne Particle Sampling): Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment. Dynamic airflow smoke pattern test: Smoke pattern tests must be performed for each PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation(s). Re-certification and reporting will meet all requirements in the most recent edition of USP General Chapter 797 Pharmaceutical Compounding- Sterile Preparations and USP General Chapter 800 Hazardous Drugs- Handling in Healthcare Settings. ISO Classification of Particulate Matter in Room Air