Description
D.1 STATEMENT OF WORK The contractor shall provide all labor, personnel, equipment, transport of materials to certified lab, reporting of results, disposal of hazardous/nonhazardous waste materials, proof of licensing, documentation of required service and permits when required to provide testing, tools, materials, supervision, and other items necessary to provide annual preventive maintenance and corrective repair service on-site for the equipment and systems listed in Section 3 below for the Southern Arizona VA Health Care System (SAVAHCS) and as defined in this Statement of Work (SOW). SERVICE/WORK TO BE PERFORMED : The contractor will perform on-site certification testing on equipment/systems as provided for in the contract agreement. Since there are multiple types of hoods and certification requirements, the standards for each device and room are listed in the equipment table below. Service engineer/technicians must be Controlled Environment Testing Association (CETA) registered cleanroom certification professionals. Travel and labor included. All test equipment requiring calibration is traceable through the National Bureau of Standards. Certification: All primary engineering controls (PEC) and secondary engineering controls (SEC) and passthrough certification are completed no less than every 6 months or whenever changes to the area such as redesign, construction, replacement or relocation of any PEC, or alteration in the configuration of the room that could affect airflow or air quality. PEC, SEC and passthroughs will be retested if they fail to meet standards of USP 797 and USP 800. Certification will occur under dynamic operating conditions. Testing for certification includes: Airflow testing (PEC and SEC) HEPA filter integrity testing (PEC and SEC) Total particle count testing (PEC, SEC and passthroughs) Dynamic airflow smoke pattern testing (PEC and SEC) Viable air sampling (PEC, SEC and passthroughs) Viable surface sampling (SS) of all PEC and SEC are performed no less than monthly and after every personnel medial fill (MF) testing. Compounders and personnel with direct observation of compounding will need to be retested if they fail to meet standards of USP 797. IV room, anteroom, hazardous drug (HD) room and segregated compounding area (SCA) PEC, all SEC and passthroughs will need to be retested if viable SS testing fails to meet standards of USP 797. Personnel gloved fingertip (GFT) testing shall occur no less than every 6 months for compounders and no less than annually for direct observation of compounding. Personnel GFT testing is performed after donning of garb and MF testing. Personnel GFT testing is performed three times after each donning of garb for initial personnel certification and once for recertification. Compounding and personnel with direct observation of compounding will need to be retested if they fail to meet USP 797 standards. Environmental wipe sampling for hazardous drug residue is performed no less than every 6 months or more frequently as needed to verify containment per the standards of USP 800. The kits used to complete wipe sampling must be verified prior to use to ensure the sensitivity and validity of the methods and reagents used to recover a specific percentage of known marker drugs. A minimum of 6 surface samples will be completed per certification. Facilities can elect to expand beyond the minimum number of samples, but coordination with the contractor will be required prior to the certification visit. Surface sampling should include the following areas: Interior of containment primary engineering control (C-PEC) and any equipment contained inside the C-PEC Pass-through chambers Surfaces in staging or work areas near C-PEC Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging, and dispensing area) Areas immediately outside the hazardous drug buffer room or C-SCA Patient administration areas No less than 5 commonly used chemotherapy drugs will be tested at your facility at the time of testing. EMERGENCY LINE ITEM: Service calls with on-site response within 24 hours (Monday to Friday 8:00 AM to 5:00 PM). Emergency Designated Response time 24 hours unless otherwise agreed upon by COR or designee: Completed as needed and price added separately. Response: All requests for repair service will be considered requests for emergency service unless a statement to the contrary is made by the COR, POC or designee. A competent service representative adequately equipped with tools, test instruments, service manuals, and repair parts will arrive at the SAVAHCS within the designated response time. The service representative may contact VA staff by phone before arrival at the SAVAHCS. Such contacts, however, will not serve to alter the requirements for arrival on-site except when the request for service is withdrawn by designee. PERFORMANCE: Hours: Normal duty hours are 8:00 a.m. through 4:30 p.m., Monday through Friday, not including federal holidays. Whenever contact with Operations Supervisor is required outside of normal duty hours, the Utility System Repair Operator (USRO) may be contacted as an alternate. The hospital operator at extension "0" can contact the USRO via radio. Preventive maintenance will be scheduled with a contact person as assigned by the Contracting Officer’s Representative (COR), Point of Contact (POC) or designee. This PM work must be completed in the month specified during the request unless another date is agreed upon by COR or designee. The Operations supervisor can be contacted at (520) 792-1450 ext. 15020. All contractor personnel (without exception) must report to the Maintenance & Operations Department, Bldg. 2-room B17, to sign in and receive a contractor identification badge before any work is performed and return to the same location to sign out and turn-in said badge along with the documented service report (as described in section 4, DOCUMENTATION) for the service performed. Noncontract Charges: The contractor shall not perform any service that will result in additional charges without prior approval from the Contracting Officer . Payment: Payment will be made in Tungsten , and upon receipt of a properly prepared invoice which references the period for which payment is due, the contract number and/or assigned purchase order number. The invoice must include the correct payment address. Waste Removal: The contractor is responsible to remove and properly dispose of all waste related to the services provide on-site at SAVAHCS. Failure to carry out the above procedures will be considered as a failure to document the service visit and will constitute a failure to perform. All shipping for parts will be included in the cost of the contract. DOCUMENTATION: Service reports will be provided for all service activities including preventive maintenance, emergency repair, and safety inspections, and must contain the following information: Date(s) and time of service. Complete description of equipment serviced including model number and serial number. Complete description of equipment services performed including upgrades, updates and software changes made. Complete list of all materials, parts, or assemblies installed or replaced including serial numbers of parts where applicable. A statement of the complaint that initiated the service call. Total standard labor hours, total overtime/premium hours, and total travel hours expended during the repair. Last calibration date of service equipment. For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information: Company name and contact information. Unit make, model and serial number. Report number Location (e.g., building, room number) Certification date Recertification date Technician signature REMOVAL OF EQUIPMENT: Whenever possible, all repairs and preventive maintenance will be performed at the SAVAHCS. When that is not possible, the COR, POC or designee may give approval for service work to be done at another location. All transportation charges will be borne by the contractor. VA property may not be removed from the SAVAHCS prior to execution, and approval of all documents as required by Logistics Service. Computer hard drives and other storage media items may not leave VA property. Requirements for service reports for designated equipment not at this location are the same as for work done on-site. Service reports for incoming equipment will be presented for signature at the time of delivery. If equipment is returned via commercial carrier, the service report may be included with the shipment. GOVERNMENT REPAIRS: Government employees will work on contract equipment only with authorization of the contractor or following the failure of the contractor to respond. The government is not obligated to perform any work on contract equipment. PRIOR INSPECTION OF EQUIPMENT: Potential contractors may, at their own expense, inspect equipment covered by this solicitation (ref 52.237-1 SITE VISIT). Arrangements must be made in advance with Operations Supervisor. (see section 3, above). GUARANTEE: The contractor will guarantee workmanship and all parts furnished by the contractor for a period of not less than 90 days. EQUIPMENT: EE# LOC. MAKE MDL SN Certification Standards EQU. TYPE AREA 92627 BA080-57 Baker Edgegard VF401 128826 Per Manufacturer's Specifications, CETA Applications Guide 002-2006; Per ISO 14644-1 Positive Isolator Pharm 93003 BA080-57 Baker Edgegard VF601 130072 Per Manufacturer's Specifications, CETA Applications Guide 002-2006; Per ISO 14644-1 Positive Isolator Pharm 88030 BA080-57 Baker SG-304 126553 Per Manufacturer's Specifications, CETA Applications Guide 002-2006; Per ISO 14644-1 Negative Isolator Pharm 98084 BA080-57 Baker CS-500 125183 Per Manufacturer's Specifications, CETA Applications Guide 002-2006; Per ISO 14644-1 Negative Isolator Pharm 92626 BA080-57 Baker Edgegard VF401 128825 Per Manufacturer's Specifications, CETA Applications Guide 002-2006; Per ISO 14644-1 Positive Isolator Pharm 114338 BA086 Baker BCG 401 143302 Per USP 797/800 BSC Biochemgard Pharm Do not have yet BA084 Baker BCG 401 Do Not Have yet Per USP 797/800 BCG Biochemgard Pharm 57903 0B138A-57 BSL III Hood Room Filters HEPA Testing includes air volume, air exchange rates, room pressurization, HEPA filter leak testing BSL III Lab 55366 0B139-57 Ante Room Filters HEPA Testing includes air volume, air exchange rates, room pressurization, HEPA filter leak testing BSL III Lab 0B140-57 BSL III Lab Room Filters HEPA Testing includes air volume, air exchange rates, room pressurization, HEPA filter leak testing BSL III Lab 57903 0BA015-57 Extraction Filters HEPA Testing includes air volume, air exchange rates, room pressurization, HEPA filter leak testing BSL III Lab 76270 107-10 NUAIRE NU-437-400 163682061014 Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II A Direct Inflow Method Research 76272 107-10 NUAIRE NU-437-400 163684061014 Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II A Direct Inflow Method Research 53702 110-10 BAKER SG403A 94853 Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II A Direct Inflow Method Research 76256 110-10 NUAIRE NU-437-500 163685061014 Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II A Direct Inflow Method Research 76269 110-10 NUAIRE NU-430-600 163698061014 Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II B Direct Inflow Method Research 76261 112-78 NUAIRE NU-437-600 163690061014 Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II A Direct Inflow Method Research 76263 113-10 NUAIRE NU-435-400 163692061014 Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II B Direct Inflow Method Research 76259 113-78 NUAIRE NU-437-500 163688061014 Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II A Direct Inflow Method Research 76260 114A-78 NUAIRE NU-437-500 163689061014 Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II A Direct Inflow Method Research 76262 115-78 NUAIRE NU-437-600 163691061014 Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II A Direct Inflow Method Research 53149 116-78 Fisher Scientific 115V 80383682 Smoke Containment/Face Velocity Fume Hood Research 76264 116-78 NUAIRE NU-435-400 163693061014 Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II B Direct Inflow Method Research 56724 138A-78 Thermo Electron C8004055 68013 AIHA/ANSI Lab Ventilation Requirements Downdraft Table Research 30029 111-78 LABCONCO 6900000 255087 Ductless-Smoke Containment/Face Velocity Fume Hood Research 86409 138-78 SAFETY LAB 112537002 171150096 Walk-In Walk-in Research 81099 107-10 LABCONCO 3955200 160728749B Smoke Containment/Face Velocity Fume Hood Research 76271 111-78 NUAIRE NU-3437-400 163683061014 Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II, Type A2 Biological Safety Cabinet Research 76658 0B146-57 MOPEC BF100 BF100H14006 Per Manufacturer's Specifications; Directional Smoke/Face Velocity Fume Hood Lab 86323 0B147-57 NUAIRE NU-435-400 176331092816 Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II B Direct Inflow Method Lab 34107 0B138-57 NUAIRE NU-427-400 77388AFR Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II B Direct Inflow Method Lab 61599 0B133-57 NUAIRE NU-425-600 140865102610 BSL III Lab 34546 0B138-57 NUAIRE NU-427-400 82675AGR Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II B Direct Inflow Method Lab 96063 B146-57 MOPEC MB1060R MB1060R0135661001 Smoke Containment/Face Velocity Fume Hood Lab 96064 B146-57 MOPEC MB1060R MB1060R0135661002 Smoke Containment/Face Velocity Fume Hood Lab 62974 0B146-57 Air Science P5-36 P66066 Ductless-Smoke Containment/Face Velocity Fume Hood Lab 73235 0BA028A-38 Labconco 3440001 130171290C Per Manufacturer's Specifications; Per NSF Standard No. 49 Class II A Direct Inflow Method Lab 102996 0B133-57 Thermofisher Scientific 1300 300429464 Per Manufacturer's Specifications; Per IES-RP-CC-001 Class I Biological Safety Cabinet Lab 103551 0BA045-57 Thermofisher Scientific 1100-2-C 210514 Fume Hood Lab 39668 0BA028B-38 Air Clean Sys AC648LFUVC AC648LFUVC2356 Per Manufacturer's Specifications; Per IES-RP-CC-001 Class I Biological Safety Cabinet Lab 104536 181U-57 PCI G18-E 121-0019 Smoke Containment/Face Velocity Fume Hood SPS 55283 181U-57 PCI G14KA 29590 Smoke Containment/Face Velocity Fume Hood SPS 75491 2756-80 Air Science P30 P70084 Chemical Fume Fume Hood Derm 76657 227-57 Mopec BF100 BF100H14005 Per Manufacturer's Specifications; Directional Smoke/Face Velocity Fume Hood OR 66199 A109-38 Comecer FHR1 50 LAR 40C1C\0111\V11246 Chemical Fume Fume Hood Radiology