DEPARTMENT OF VETERAN AFFAIRS GREAT LAKES ACQUISITION CENTER NETWORK CONTRACTING OFFICE 12 Date: July 8, 2016 From: Farrukh Daniel, Contracting Officer, Great Lakes Acquisition Center (69D/GLAC) Subj.: REQUEST FOR INFORMATION 1. THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is issued solely for information and planning purposes - it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This request for information does not commit the Government to contract for any supply or service whatsoever. Further, the Department of Veteran Affairs is not at this time seeking proposals and will not accept unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party's expense. Not responding to this RFI does not preclude participation in any future RFQ or RFP, if any is issued. If a solicitation is released, it will be synopsized on the Federal Business Opportunities (FedBizOpps) website. It is the responsibility of the potential offerors to monitor these sites for additional information pertaining to this requirement. 2. The Government is seeking Veteran Owned Small Businesses who can provide the following supplies and services. GENERAL REQUIREMENTS 1.0 REQUIRED TESTS AND ESTIMATED ANNUAL REQUIRED VOLUMES 1.1 Test volume and test type chart (informational purposes only; please use this information to provide quotes for items outlined in the 'schedule of items'). Annual Test Volumes QunatiFERON-TB Gold Testing 3,600 2.0 DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK 2.1 SCOPE OF PROCUREMENT The VISN 12 Hines General Diagnostics Core Laboratory provides medical care services and diagnostic laboratory testing for the VISN 12 network. The performance of QuantiFERON-TB Gold testing is an essential part of the work performed in this laboratory to aid in the diagnosis of latent tuberculosis infection and to determine medical treatment for preventing tuberculosis disease. The contractor shall provide one automated test system that has the capability of performing QuantiFERON-TB Gold testing using a peptide cocktail simulating ESAT-6, CRP-10, and TB7.7(p4) proteins to stimulate cells in heparinized whole blood. The requested instrument system for QuantiFERON-TB Gold testing for the General Diagnostic Core laboratory located at the following Government facility: 1. Edward Hines, Jr. VA Hospital, Hines, Illinois The equipment and test methodology must perform as described below and 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). The test system must include the instrumentation/work stations (computers, monitors, etc.) necessary to perform testing and produce test results. 2.2 PROGRAM REQUIREMENTS 2.2.1 Technical Features - The system shall meet the following specified standards: 2.2.1.1 A fully automated Microplate System with the ability to perform QuantiFERON-TB Gold testing 2.2.1.2 Have the on board capacity of at least 100 samples. 2.2.1.3 An open system where different vendor kits can be used 2.2.1.4 At least a 2 to 4 plate capacity, with at least 2 plates that can run simultaneously 2.2.1.5 On board dilution 2.2.1.6 Accommodates original kit reagent bottles 2.2.1.7 On board incubation, washing and reagent dispensing 2.2.1.8 Automatic bar code scanning 2.2.2 Operational Features 2.2.2.1 The assay QuantiFERON-TB Gold must be used with the instrumentation to detect Mycobacterium Tuberculosis and disease. It is intended for use in conjunction with risk assessment, radiography and other medical and diagnostic evaluations. 2.2.2.2 The system must have the ability to interface with the automated QuantiFERON Miccroplate System so that test results are transmitted to the main frame computer (VistA). 2.2.2.3 The system must be able to operate in the broadest range of environmental conditions with the minimum requirements as follows: Temperature: functional between 18-24°C. Relative humidity: functional at <70% RH, non-condensing. 2.2.2.4 Operator maintenance of the equipment must be minimal. 2.2.3 Hardware Features 2.2.3.1 The system, when installed in the listed VISN 12 laboratory, shall not impose any negative effects on the functionality/operations of the given laboratory and shall not require significant and/or costly infrastructure changes to the laboratories. 2.2.3.2 An uninterruptible power supply (UPS) must be provided for the system that is installed. 2.2.4 Support Features 2.2.4.1 Training shall be coordinated with and 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. Training shall include system operations, data manipulation and basic troubleshooting/repair. If training is to be conducted off-site, the cost shall be all-inclusive (e.g. air fare, auto rental/transportation, room and board, training materials, etc.) for each customer participating. The cost associated with the training opportunities shall be incurred by the Contractor. 2.2.4.2 The contractor shall provide with the delivery and/or installation of the equipment all applicable reference manuals customarily issued to other equivalent commercial customers for the successful operation and maintenance of the system. 2.2.5 Supplies 2.2.5.1 The Contractor shall provide a detailed list of consumable/disposable items, parts, accessories and any other item included on the list of supplies required to establish the instrument for operation. The detailed list must include pricing, an indication as to whether the product exists on a Federal Supply Schedule and an estimate of usage volumes based on the estimated volumes listed in Section 1.1 above. 2.2.6 Equipment Preventative Maintenance/Repair Service - The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all instrumentation and any incremental support equipment offered according to the terms below. There will be at least a one year warranty period where the cost of equipment repair service based on the terms outlined below will be at no charge to the Government. 2.2.6.1 A technical assistance center must be available by telephone 24 hours per day with a maximum call back response time of two hours. 2.2.6.2 Equipment repair service must be available during regular business hours, Monday - Friday, 8:00AM - 4:30PM. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. Arrangements for repair service will be coordinated between the contractor and Government laboratory personnel. 2.2.6.3 Maintenance/service must be performed by an authorized representative of the instrument manufacturer who can provide documentation that they are trained and competent in carrying out the appropriate procedures for repair or service of the instrumentation, and who have access to the necessary parts required for repair or service. 2.2.6.4 Repair service response time will be no more than 24 hours. 2.2.6.5 The number of scheduled preventative maintenance calls per year must be in accordance with the manufacturer's recommendations and no less than what is provided to other equivalent commercial customers. 2.2.6.6 A field service report shall be supplied to the COR at the completion of each preventative maintenance inspection. 2.2.6.7 A malfunction incident report shall be furnished to the respective Government Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: " Date and time notified " Date and time of arrival " Serial number, type and model number of equipment " Time spent for repair, and " Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. 2.2.6.8 Each notification for an emergency repair service call will be treated as a separate and new service call. 2.2.6.9 If the repair record of any individual piece of the contractor's equipment reflects a downtime of 5% or greater of the normal working days in one calendar month, the designated representative may make a determination to have the contractor replace the malfunctioning equipment with new equipment at no charge to the customer. The contractor is ultimately responsible for ensuring its equipment is furnished in good condition in accordance with manufacturer's instructions. The customer is ultimately responsible for ensuring the manufacturer's recommended daily, weekly, monthly and any periodic maintenance is performed appropriately. 2.2.7 Upgrades - The contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state of the art technology. These must be provided as they become commercially available and at the same time as they are being offered and/or provided to commercial customers. The price of the upgrade(s) must not exceed the amount that is offered to other commercial customers. 2.2.8 Ancillary Support Equipment - The Contractor shall provide, install and maintain, as indicated, any and all ancillary support equipment to fully operate the QuantiFERON-TB Gold Microplate System as defined in these specifications, e.g. tables or stands to support/house the analyzer (if necessary), computer systems/keyboards for data analysis/manipulation, etc. In addition, the vendor will include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, uninterruptable power supply (UPS), etc. 2.2.9 Computer Interfacing Requirements - A fully operational interface (both hardware and software) must be available to connect to the QuantiFERON-TB Gold Microplate testing platform via Data Innovations Instrument Manager. 2.2.10 Commercial Offerings - The Contractor shall provide the Government laboratories any additional support material that is routinely provided to equivalent commercial customers and will assist in regulatory compliance, e.g. template for writing standard operating procedures (SOPs), electronic procedure manual, online procedure manual in the instrument software, training documents, competency sheets, and validation protocols. 2.2.11 Commercial Marketing - The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, "current production" shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. 2.2.12 Delivery of the system must occur no earlier than 90 days and no more than 150 days after contractor award. 2.2.13 Waste Characterization - The Contractor shall provide a description of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal regulations Title 40 "Protection of the Environment" Part 261 et al. The description shall address the following: " Waste toxicity (Reference 40CFR261.11 and 40CFR261.24) " Waste ignitability (Reference 40CFR261.21) " Waste corrosivity (Reference 40CFR261.22) " Waste reactivity (Reference 40CFR261.23) " Hazardous waste from non-specific sources (F-listed) (Reference 40CFR261.31) " Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33) 2.3 PROPOSALS 2.3.1 It is the clear intent of the Government to award this procurement to a single contractor for the QuantiFERON-TB Gold Microplate system defined in this solicitation. 2.3.2 The Government will entertain recommendations only for new state-of-the-art equipment unless the installation of either remanufactured or refurbished equipment is deemed to be in the best interests of the Government. 2.3.3 Contractors shall provide a fully completed Price Schedule (Attachment A) listing all consumable supplies required to operate the equipment acquired and produce the testing defined in Section 1.1. 2.3.4 Contractors shall provide commercial literature and other information describing their compliance with the technical specifications. If the commercial literature does not directly address specific specifications identified in this solicitation, the Contractor is required to indicate compliance with those specifications in written format. 2.3.5 Contractors shall provide documentation and/or certification that the instrumentation offered will perform testing with a precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical Laboratory Standards Institute (CLSI). 2.3.6 Contractors shall provide at least three (3) references. References will include, if possible, references from other VA medical facilities as well as non-VA facilities. Information should include: name of customer, contact person, phone number, brief description of equipment and service provided, and beginning and ending dates when service and equipment was provided. 2.3.7 Contractors shall provide a description of all ancillary support equipment that is needed to operate the instrumentation as defined in these specifications and offered as a part of this agreement. 2.3.8 Contractors shall provide a summary of operator-performed and vendor-performed maintenance procedures including an estimate of time spent in the performance for each category of maintenance. The offeror must include the amount of time it takes to achieve full testing functionality from a cold startup (i.e. after maintenance is performed or after any instrument downtime). 2.3.8.1 Operator-performed - Offerors must summarize their maintenance procedures and provide an estimate of time spent in performance for each category, e.g. daily, weekly, monthly, semi-annually, etc. The estimate of time spent on daily maintenance would take into consideration starting the equipment from a cold start-up. 2.3.8.2 Vendor-performed - Offerors must describe the frequency of preventive maintenance and provide an estimate of the time required to perform the maintenance. 2.3.9 Contractors shall provide a copy of the General Supply Schedule or Federal Supply Schedule contract for which the offer for equipment is based, if applicable. This copy shall become part of the contract file. 2.3.10 Contractors shall provide, if applicable, an estimate of the travel costs associated with training by category, i.e. transportation, lodging, and meals. This information is necessary as an employee is required to stipulate this information when requesting authorization/approval to travel, even though the cost associated with training opportunities shall be incurred by the Contractor. 2.3.11 Contractors that offer multiple types of repair service packages that are different than the minimum requirements stated in the specifications are encouraged to offer for consideration after contract award. 2.4 EVALUATION OF OFFERS 2.4.1 Minimum Requirements - Each respondent for award shall meet all the minimum specifications as outlined in General Requirements. 2.4.2 Evaluation Factors - The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: 2.4.2.1 Technical 2.4.2.1.1 Ability to interface with the government information system VistA via Data Innovations Instrument Manager 2.4.2.1.2 Functionality at the broadest allowable environmental conditions. 2.4.2.1.3 The system footprint and its impact on the current laboratory layout. 2.4.2.1.4 The time from cold startup of the equipment to full system functionality (i.e. when system is turned off, the time to come to a full functionality is minimal). 2.4.2.1.5 Technical Features as described in 2.2.1. 2.4.2.2 Past Performance 2.4.2.3 Price 2.4.2.4 Socio-economic considerations 2.4.3 The satisfaction of the Technical Factors and Past Performance, when combined, are significantly more important than price. As technical factors and past performance become more equal, the importance of price may become more significant. 2.4.4 Options - The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the options. 2.4.5 Required Information - For the VA to evaluate firms on these factors, firms must provide the technical information described in the section above that is entitled "Proposals", in addition to their pricing information. Not providing this information may prevent full consideration of the quotation. Responses Interested parties are requested to fill out the information below: (Contractor's Name) ______________________________________ (Address) ______________________________________ (City-State-Zip) ______________________________________ (Point of Contact/Title) ______________________________________ PHONE NUMBER ______________________________________ FAX NUMBER ______________________________________ E-MAIL ADDRESS ______________________________________ DUNS NUMBER NO. ______________________________________ FSS/GSA/CONTRACT NO. ______________________________________ Expiration Date of Contract: ____________________________________ . Other Requested Information: 1. Business type (large business, small business, small disadvantaged business, 8(a)-certified small disadvantaged business, HUBZone small business, woman-owned small business, very small business, veteran-owned small business, service-disabled veteran-owned small business) based upon North American Industry Classification System (NAICS) code 541512, Computer Systems Design Services. "Small business concern" means a concern, including its affiliates that are independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria and size standards in 13 CFR part 121. Summary THIS IS A REQUEST FOR INFORMATION (RFI) ONLY to identify sources that can provide QuantiFERON TB Gold Testing for Veterans Integrated Service Network (VISN) 12 Hines General Diagnostics Core Laboratory.

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