SPECIAL NOTICE
66 -- Notice of Intnent to Sole Source This is not a request for quote Brand name or equal to Cepheid Genexpert XVI R216 Module Configuration
- Notice Date
- 4/19/2019
- Notice Type
- Synopsis
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 4;Lebanon VA Medical Center;1700 South Lincoln Avenue
- ZIP Code
- 17042
- Solicitation Number
- 36C24419Q0566
- Archive Date
- 5/4/2019
- Point of Contact
- andrew.taylor3@va.gov
- Small Business Set-Aside
- N/A
- Description
- Notice of Intent to Sole Source Lebanon VA Medical Center (LVAMC) has a requirement for an FDA approved, CLIA Moderately Complex, fully-integrated and automated molecular instrument to perform definitive, rapid, real-time polymerase chain reaction (PCR) which integrates a complete on-board nucleic acid purification system with amplification and detection of select pathogens in a self-contained system. This testing is necessary to provide diagnostic and treatment information to providers and support Infection Control with disease management. Please provide your entities capability statement to equip Altona VA Medical Center with a brand name or equal to a Cepheid GeneXpert XVIR2-Fully automated molecular analyzer with 16 active modules or an authorized distribution letter, to Andrew Taylor, Contract Specialist by April 24, 2019 by 4:00 pm email andrew.taylor3@va.gov. Reference solicitation number 36C24419Q0566 in the subject of the email. Scope The Contractor shall provide, transport, install, and test all listed equipment/instrumentation. All products must meet all salient characteristics defined in this statement of work. The Contractor shall furnish all supplies, equipment, facilities and services required for delivery and installation of the analyzer. The Contractor shall furnish all parts, accessories and other items/peripherals required for the successful operation of the analyzers. The Contractor shall provide shipping, transport, installation, and reagents/product necessary to the test the analyzers for successful operation and function. All products must meet the salient characteristics defined in this statement of work. The analyzer and installation must meet manufacturer s and VA specifications. All necessary reagents and related consumables, supplies, controls and calibrators must be available for purchase and must be FDA approved. The Contractor is responsible for any missing parts and components not included that are required for installation. The analyzer will interface with the government s computer system to allow complete result transfer to the patient s electronic record using acceptable VA OI&T processes. Brand Name or Equal to a Cepheid GeneXpert XVIR2-Fully automated molecular analyzer with 16 active modules (Includes analyzer, standard one-year warranty, power saving BACK-UP-UPS, Desk top computer and DX Software.) Technical Specifications: The contractor shall provide all equipment, parts, accessories, and any other items required for the operation of the analyzer and peripherals necessary for the generation of a Molecular Diagnostic Testing System for Methicillin Resistant Staphylococcus aureus (MRSA), Methicillin resistant Staphylococcus aureus/Staphylococcus aureus (MRSA/SA), Chlamydia trachomatis/Neisseria gonorrhea (CT/NG), Clostridium difficile and Epidemic 027 Strain (C.difficile/Epi) and Xpert Xpress FLU/RSV. Contractor will allow flexibility for the possibility of future expansion of testing menu using the same instrumentation footprint and software. The Contractor shall be responsible for all costs associated with updates needed to support test menu expansion. The molecular platform must allow rapid testing, and multiple assays to run separately on the same instrument at the same time, to increase productivity, reproducibility, and reduced turn-around-times. Sequential Testing Capability: The system shall be able to run individual samples without the need for batching. The system must use unprepared samples with little or no preparation time (measured in minutes). Contractor shall provide reagents that can be stored at room temperature. The system must be able to conduct the test and give results rapidly (measured in hours including preparatory time). The system must have the ability to start and run multiple assay protocols simultaneously without stopping current runs. User Friendliness: a) Should not require a molecular trained technologist to operate the analyzer or to perform the test; b) Must provide software and/or supporting instrumentation required to maintain, or improve levels of data retrieval, which can be used for epidemiology, or cost-decreasing measures; c) Must have ease in handling and resolving errors. The instrument must meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Each system s models/modules must provide accurate test assay results for sample specimens up to the manufacturer s defined maximum test per hour without excessive malfunctions, breakdowns, or service calls. Testing equipment must be new, state-of-the-art equipment. Remanufactured and discontinued modules will not be accepted. The Contractor shall provide all upgrades to the equipment hardware and operating system software as it is made available, at no charge to the US Government during the lifetime of the instrument. These enhancements shall be delivered and installed within 30 days of issuance to the commercial market. The system being offered is in current production as of January 2019. For purposes of this solicitation., current production shall mean that the clinical laboratory analyzer is being manufactured as new equipment. Discontinued models/modules that are only being made available as remanufactured equipment will not be acceptable. Analyzers must conform to the listed facility s laboratory space. The Bench space is 4-foot-Long by 30 inches wide. Instruments must have a 120-220-volt UPS system provided and serviced by the contractor. The contractor shall provide all necessary startup reagents, organisms and supplies to complete a full validation and correlation study. The Contractor shall provide all necessary software to allow complete result transfer to the patient s electronic record using acceptable VA OI&T processes Characterization of hazardous waste-The contractor shall provide a statement and description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations that addresses the elements and criteria listed in the Code of Federal Regulations Title 40 Protection of the Environment Part 261 et al. The description shall address the following: 2.19.1 Waste toxicity (Reference 40CFR261.11 and 40CFR261.24) 2.19.2 Waste Corrosivity (Reference 40CFR261.21) 2.19.3 Waste reactivity (Reference 40CFR261.23) 2.98.4Hazardous waste from non-specific sources {F-Listed} (Reference 40CFR261.31) 2.19.5 Discarded commercial products (acutely toxic or P-Listed and toxic or U-Listed) {Reference 40CFR261.33} 2.20 Starter Kit and validation material for GeneXpertXV1R2, validation, and correlation. 2.21 Onsite Training for VA technical staff on GeneXertXVIR2 2.22 Operation, Technical, and Maintenance Manuals 2.23 Shipping, Delivery, and Installation for GeneXpertXVlR2 2.24 Black and white printer with USB cable for the GeneXpertXVlR2 2.25 Standard Service Agreement for 1 year for the GeneXpertXVlR2 2.26 PRO APC Power-Saving BACK-UPS 1500/120V for the GeneXpertXVIR2. 2.27 DELIVERY AND INSTALLATION 3. Delivery The Contractor shall deliver all equipment/analyzers and accessories to the Lebanon VA Medical Center, Main Laboratory Building 1 Room 3. Deliver materials to job in manufacturer s original sealed containers with brand name marked thereon. Packaged to prevent damage or deterioration during shipment, handling, storage, and installation. Maintain protective covering in place and good repair until removal is necessary. Deliver analyzer and specified items only when the site is ready for installation work to proceed. Store products in dry condition inside enclosed facility. Any Government requested delayed delivery up to 90 days after initial award delivery date, shall be at no additional cost to the US Government. A pre-delivery meeting will be conducted 30 days prior to initial award delivery date for verification of delivery and installation dates. Delivery and Installation will be coordinated through the Lab Manager and COR. The Contractor shall conduct a joint inspection with the COR upon delivery of the equipment. Installation Install all equipment to manufacturer s specifications maintaining Federal, and Local Safety Standards. Installation must be completed 90 days after the award of the contract. All work shall be completed between 8:00 am and 4:30 pm, Monday -Friday. All federal holidays, excluded. Federal Holidays are available at the Federal Holiday OPM Site. The Contractor shall coordinate all deliveries, staging areas, installation with the COR and or Lab Manager. The Contractor shall remove all related shipping materials, debris, and cleanup any construction associated with delivery and installation of the specified items. Contractor shall remove all packaging from the VA Lebanon Medical Center premises after instrument installation. The Contractor shall be responsible for any damage to the building that occurs due to Contractor s error or neglect. Site Conditions Smoking, eating or drinking inside the hospital will be contained to authorized areas only. 5. Inspection and Acceptance 5.1 The Contractor shall conduct a joint inspection with the COR upon delivery. 5.2 The Contractor shall provide the VA COR a list of missing and damaged items found upon inspection and have those items replaced at no cost to the US Government. 5.3 Contractor shall provide dates of completion of punch list items and replacement parts and/or short shipped items form the manufacturer(s). 5.4 The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the VA Contracting Officer. 6. Deliverables 6.1 Operation and Maintenance Manuals The Contractor shall provide a set of printed service, technical, operating manuals upon delivery and installation of equipment. The Contractor shall provide a set of digital service, technical, operating manuals upon delivery and installation of equipment. The Contractor shall deliver a compilation of all manufacturer recommended maintenance schedules and operation materials packaged in binder to the COR upon completion of installation. The Contractor shall provide and deliver all clinical organisms, reagents, calibrators, controls, consumables, disposables items, parts, and accessories required to establish operation and perform all validation studies and method comparison studies. 7. Operator Training 7.1 The Contractor shall provide Vendor Led, on site, instrument training at the time of the instrument installation. This training shall include training of ALL technical staff on the operation of the hardware and software systems, data manipulation, basic trouble shooting and repair. The Contractor shall coordinate training so that it is timely to the equipment installation, be consistent with the size and scope of the facility s services and be minimally equivalent to that offered in the commercial marketplace. 8 Protection of Property 8.1 The Contractor shall protect all items from damage. The Contractor shall take precaution against damage to the building(s), ground and furnishings. The Contractor shall repair or replace any items related to building(s) or grounds damaged accidently or on purpose due to actions by the Contractor. 8.2 The Contractor shall be responsible for security of the areas in which the work is being performed prior to completion. 9. Warranty 9.1 The Contractor shall provide a one-year manufacturer s warranty on all parts and labor. 9.2 The warranty shall include all travel and shipping costs associated with any warranty repair. 9.3 The Contractor shall provide standard warranty response on instrumentation, and software as required which shall include preventative maintenance during the warranty period. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (19-APR-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/VA/PiVAMC646/PiVAMC646/36C24419Q0566/listing.html)
- Record
- SN05287563-F 20190421/190419230028 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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