Inactive Total Small Business Set-Aside (FAR 19.5)

B-1 Background The Denver Laboratory and the Pacific Northwest Laboratory require additional QIACube units so that the new instrument could be used for automated extractions for complex environmental ... B-1 Background The Denver Laboratory and the Pacific Northwest Laboratory require additional QIACube units so that the new instrument could be used for automated extractions for complex environmental samples for EHEC (Enterohemorrhagic E. coli) analysis, a routine regulatory analysis, in addition to the current use for Whole Genome Sequencing for regulatory isolates. These units could also potentially be used for any other pathogen analyses that require an extraction step. The ability to provide a more consistent DNA yield as compared to manual extraction methods and throughput by automating this step helps conserve time and resources, as well as protect against potential contamination routes inherent in manual extraction. B-2 Statement of Work QIACube and accessories and service from Qiagen (multiple catalog numbers see below). Minimum Technical Requirements System Requirements Altitude- Unit must be able to function at high altitude, or up to 6500ft. Centrifuge- Centrifuge component must be able to maintain 10,640 rpm maximum, 12,00g maximum, a swing-out rotor maximum of 45° and have at least 12 rotor positions. Environmental Class- Unit should be 3K2 (IEC 60721-3-3). Instrument Dimensions- Unit should be approximately as follows: width 65cm (25.6 in.), height 58cm (22.8 in.), depth 62cm (24.4 in.) with hood closed; width 65cm (25.6 in. ), height 86cm (34 in.), depth 62cm (24.4 in.) with hood open; QIACube Connect Mass of 71.5kg (157.6 lb.) and Mass of accessories of 3kg (6.6 lb.). Operating Temperature- Unit must have operating temperature range of 18-28°C (64.4-82.4°F). Pipetting System- Unit must have a syringe size of 1mL with a pipetting range of 5-900uL. Place of Operation- Unit must be for indoor use only. Pollution Level- Unit must have a pollution level of only 2. Relative Humidity- Unit must work in relative humidity range of 15-75% (non-condensing). Shaker- Shaker component must be able to operate at a speed of at least 100-2000rpm, amplitude 2 mm, heating range of ambient temperature to 70°C (158°F), ramp-up time of <5 minutes from ambient temperature to 55°C(±3°C) with the difference in the temperature detected by the internal sensor and the temperature of the sample liquid being approximately -2°C. Special Feature- The handheld scanner to be used with this unit must be included and conform to the following: the scan pattern must have an area image of at least 838 x 640-pixel array, a motion tolerance of up to 610cm/ s (240 in/s) for 13 mil UPC at optimal focus, a symbol contrast of 20% minimum reflectance difference and a decode capability to read standard 1D, PDF, 2D, Postal and OCR symbology. Storage Conditions- Unit must be able to be stored in a temperature range of 15 to 30°C (59 to 86°F) in manufacturer’s package, at a relative humidity maximum of 75% (non-condensing) and be an Environmental class of 1K2 (IEC 60721-3-1). Table capacity- The unit must have a table capacity of up to 12 samples per run. Technical Data- The unit must have power of 100-240 V AC, 50/60 Hz, 650 VA for up to 2 seconds during the centrifuge acceleration and can reach an approximate value of 1000 VA; Fuse: 2x T6.3A L 250V, and be overvoltage category II. Touchscreen: Touchscreen component must be 10.4” TFT Touchscreen with an active area of 211.2 x 158.mm and resolution of 800*600 SVGA. Transportation Conditions- Unit must be able to be transported in a temperature range of -25 to 60°C (-13 to 140°F) in manufacturer’s package, in maximum 75% relative humidity (non-condensing) and environmental class 2K2 (IEC 60721-3-2). UV Lamp- The UV Lamp component must have a wavelength of 278nm and optical power of 200 to 300mW. Trade and Service Specifications The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. FOB Point destination to include inside delivery and clean-up of area after installation. The entire system must be warranted for parts and labor for 12 months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. The system must include at least a one (1) year warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts. Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and trouble-shooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/Operation qualification (IQ/OQ) certification. Contractor shall provide, at no cost to the government, one (1) Periodic Maintenance in accordance with the manufacturer’s recommendations at the end of the warranty period. EQUIPMENT PURCHASES QIACube Connect MDx System Quantity Unit Price Total Cost QIACube Connect MDx System FUL 1 (9003076) Includes device, installation, 1 year warranty, 1 full year service coverage and 1 Preventatve Maintenance at end of warranty period 3 Component (if priced separately) n/a Installation & Training included 12 mos maintenance included Trade In (if applicable) n/a Warranty included Service Agreement-QIACube Connect Service Agreement (9245232)- IQOQ 3 MATERIAL/SUPPLIES: (List Below) ITEM NAME Quantity Unit Price Total Cost Elution Tubes 1.5mL (1050875) 3 O-Ring Change Tool for QIACube Connect (9026181) 3 Reagent Bottle Rack, Grey, QC2 (9026197) 3 Filter Tips 200 I 1024 (990332) 3 Filter Tips 1000 I 1024 (990352) 3 Sample Tubes RB 2 mL (990381) 3 Sample Tubes CB 2 mL (990382) 3 Rotator Adapter Holder (990392) 3 Reagent Bottles 30 mL 6 (990393) 3 Rotor dapters 10x 24 (990394) 3 Filter Tips 100 I wide bore 1024 (990452) 3 Security/Privacy Requirements/Risk Assessment Safety precautions will be taken prior to and during installation. Contractor will be cleared by security as a visitor upon arrival to both laboratories. Coordinator must inform contractor of this process before their arrival. Section 2 of FDA Security and Privacy Language does not apply to procurements for only hardware and software licenses. Records and Reports The Contractor shall, commensurate with the completion of each service call relating to the first year warranty, provide the end-user of the equipment with a copy of the field corrective service report identifying the equipment name, manufacturer, model number, and serial number of the equipment being repaired and detailing the reason for the warranty call, a detailed description of the work performed. The parts and the test equipment used to repair the system shall be on the report. This will include the name (s) and contact information of the engineer who performed the repair, and for information purposes, the on-site hours expended, and parts/components replaced. Deliverables Deliverable Quantity Delivery Date Complete QIACube, or equal, system 3 Within 60 days of award Installation and IQ/OQ Certification 3 Within 30 days of delivery Periodic Maintenance 3 Within 30 days from the expiration of the warranty period. Corrective action to fix the system under any failures during warranty Within 15 days of request for service due to any inoperability of the system. Field Service Report Upon completion of each repair or periodic maintenance Period of Performance One full year from date of formal acceptance by the government. Place of Performance/Shipping Destination Food and Drug Administration- 2 Systems Denver Federal Center 6th Avenue and Kipling Street Building 20 Entrance W10 Denver, CO 80225