Statement of Work for the Testing and the Certification of the PVAHCS Laboratory Fume Hoods, Laboratory Biosafety Cabinets, Transaction number:___________________________________ a. The semi-annual testing and certification services for the Carl T. Hayden VAMC Pathology & Laboratory Services Management (P&LMS) biosafety cabinets and chemical fume hoods, the annual ventilation pressure assessment of the BSL-3 Suite located in the Lab in accordance with ASHRE 110-2016 and one Baker biological safety cabinet USP 800 located in the Room 2340 Research Pharmacy. Coordination of work will be necessary with the POC in P&LMS and the POC in Research. The scope of testing must be completed within 3 days. Upon completing the testing of each hood, a final test report will be generated and a certification label will be affixed to each hood that successfully meets its respective acceptance criteria. Provide cost per the breakdown below: Item Description Unit Cost Qty Item Cost Testing of Biological Safety Cabinet for P&LMS 5 Testing of Biological Safety Cabinet for Research Pharmacy 1 Viable Air Testing (Bacteria) of Biological Safety Cabinet for Research Pharmacy 1 Viable Air Testing (Fungi) of Biological Safety Cabinet for Research Pharmacy 1 Viable Surface Testing (Bacteria) Viable of Biological Safety Cabinet for Research Pharmacy 1 Viable Surface Testing (Fungi) of Biological Safety Cabinet for Research Pharmacy 1 BSL-3 Suite Ventilation Assessment 1 Total Cost: b. The semi-annual testing and certification services for the Carl T. Hayden VA Medical Center Phoenix, Building 21 for the Research Service for the semi-annual biosafety cabinets and chemical fume hoods. This will be a Base Year plus 4 Option Year Contract. Coordination of work will be necessary with the POC in Research Service. The scope of testing must be completed within 3 days. Upon completing the testing of each hood, a final test report will be generated and a certification label will be affixed to each hood that successfully meets its respective acceptance criteria. Provide cost per the breakdown below: Item Description Unit Cost Qty Item Cost Testing of Biological Safety Cabinet for Research 8 Testing of Chemical Fume Hoods for Research 7 Total Cost: c. The semi-annual testing and certification services for the Carl T. Hayden VA Medical Center Phoenix, In-Patient Pharmacy Cleanroom Suite and associated USP 800 compounding hoods ensure that the USP 800 semiannual testing and certification is conducted on time as required per VA directives and USP 800. Coordination of work will be necessary with the POC in the In-Patient Pharmacy. The scope of testing must be completed within 3 days. Upon completing the testing of each hood, a final test report will be generated and a certification label will be affixed to each hood that successfully meets its respective acceptance criteria. Provide cost per the breakdown below: Listed is the table below is a breakdown of the total costs: Item Description Unit Cost Qty Item Cost Testing of Chemo Safety Hood (BSC) Testing of Laminar Flow Hood Testing of Pharmacy Isolator Testing of Pharmacy Cleanroom Suite Viable Air Testing (Bacteria) Viable Air Testing (Fungi) Viable Surface Testing (Bacteria) Viable Viable Surface Testing (Fungi) 2. Service for potential repairs to all PVAHCS laboratory chemical fume hoods, biological safety cabinets and USP 800 Pharmacy drug compounding hoods. Service may or may not be required. 3. Specifications: a. The Contractor is required to have the following current accreditations: NEBB (National Environment Balancing Bureau) Cleanroom Performance Testing CETA Registered Cleanroom Professional for Sterile Compounding Facilities NSF Standard 49 (National Sanitation Foundation) Class II Biological Safety Cabinets American Board of Industrial Hygiene CIH (Certified Industrial Hygienist) Copy of current accreditations must be submitted with your proposal. b. The work is to be performed in accordance of the following standards: American Society for Heating, Refrigeration and Air-conditioning Engineers (ASHRAE) 110-2016 Standard 110-2016 -- Method of Testing Performance of Laboratory Fume Hoods to ensure that Face velocities of 0.4 m/sec to 0.6 m/sec (80 ft/min to 120 ft/min) generally provide containment if the hood location requirements and laboratory ventilation criteria of this standard are met. National Sanitation Foundation (NSF) Standard 49 for the testing and certification of class II biological safety cabinets. The U.S. Pharmacopeia s (USP 800) General Chapter , Pharmaceutical Compounding Sterile-Preparations establishes the minimum standards required for a facility to perform high quality compounded sterile preparations (CSPs). Controlled Environment Testing Association (CETA), which provides work practices and guidelines for industry professionals working with equipment such as cleanrooms, laminar flow devices, fume hoods, biological safety cabinets, isolation rooms and other controlled environments.

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