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SOURCES SOUGHT SYNOPSIS The Department of Veterans Affairs is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in, and the resources... SOURCES SOUGHT SYNOPSIS The Department of Veterans Affairs is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in, and the resources to support, a requirement for molecular pathology viral load testing for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) Hepatitis B Virus (HBV), and Cytomegalovirus (CMV) on a cost per test basis for the Edward J. Hines Jr VA Hospital, Hines, IL. The results of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 325413 In-Vitro Diagnostic Substance Manufacturing. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for proposals/quotes; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred. If your organization has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, address, email address, Web site address, telephone number, and size and type of ownership for the organization; and 2) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. The government will evaluate market information to ascertain potential market capacity to provide services consistent in scope and scale with those described in this notice and otherwise anticipated. BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SMALL BUSINESSES OR PROCURED THROUGH FULL AND OPEN COMPETITION. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this Sources Sought Notice by 12:00 PM CST on 21 June, 2019. All responses under this Sources Sought Notice must be emailed to jessica.rasmussen3@va.gov. PERIOD OF PERFORMANCE The estimated period of performance would be a base period with four option years or a total of a 5-year ordering period. SCOPE The instrument must be able to simultaneously perform the complete profile 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 - formerly NCCLS). REQUIRED TESTS AND ESTIMATED ANNUAL VOLUMES Molecular Test Estimated Yearly Volume HCV 3883 HIV 2138 HBV 504 CMV 395 GENERAL REQUIREMENTS 1. Operational Features - The instrumentation offered will have: The capability of performing analysis on 100% of the tests listed in the Test Menu (Attachment A). b) Sufficient capacity and throughput to meet the volume and service demands as defined in the Test Menu (Attachment A). c) Sufficient safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. d) A bi-directional, bar-coded computer interface. The fully operational interface (both hardware and software) must be immediately available for implementation to the VA VistA hospital information system (Refer to Brief Summary of VistA Functionality below) at the time of contract award. If the host system software requires the use of a non-proprietary universal interfacing system to provide bi-directional interfacing capabilities, the VISN12 facility laboratories currently use the Data Innovations Instrument Manager system. To achieve connection with those systems, the awarded Contractor shall be responsible for the cost of the interface. Refer to the following section entitled Support Features Computer Interfacing Requirements for specific details. Brief Summary of VistA Functionality VistA is a proprietary system to the VA whose functionality includes: 1. Management of patient information through a database, 2. Acceptance of test ordering information, 3. Transmittal of patient laboratory test results 4. Storage and retrieval of patient laboratory test results VistA is very limited in its functionality to manage laboratory quality control, provide Levy-Jennings plots or administer an instrument maintenance program. 2. Technical Features The instrumentation must be approved by the Food and Drug Administration (FDA) and must have: a) Minimal daily maintenance such that the analyzer is not required to be down for more than 30 minutes per day (this is not to exclude longer times for periodic maintenance). b) Minimal sample pretreatment. c) A comprehensive quality control package used for daily monitoring of system performance and operator notification upon QC failure. d) Accurate barcode reading with less than 5% read failures. 3. Hardware Features - The instrumentation must have: a) A total equipment footprint that when installed in the VA Hines clinical laboratories will not negatively impact the functionality/operations of that laboratory nor will it require significant and/or costly infrastructure changes. b) A computer with a window-based operating system c) An on-board, adjustable monitor/screen that is easily readable. d) A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient s name and UID (unique identifier). Replacement printers shall be provided as needed, at no additional charge, for the duration of the contract. e) Uninterruptible Power Supply (UPS) with line conditioner to provide uninterruptible electrical power without electrical voltage fluctuation. Replacement uninterruptible power supply with line conditioners shall be provided as needed, at no additional charge, for the duration of the contract. 4. Support Features 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. Supplies - The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation and perform all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity. 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, e.g. water system. A technical assistance center must be available by telephone during routine business hours, Monday through Friday, 8:00am to 4:30pm, with a maximum call back response time of 2 hours. Equipment repair service that cannot be completed through telephone assistance or remote diagnostics will require on-site repair by qualified personnel supplied by the Contractor. . On-site repairs will be conducted during routine business hours. Business hours are listed as Monday through Friday, 8:00AM-4:30PM. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements will be coordinated between the Contractor and VA laboratory personnel. Contractor shall perform emergency repair service within twenty-four (24) hours of the time of notification of the malfunction. A malfunction incident report will be furnished to the installed site upon completion of each repair call. The report shall include, as a minimum, the following: 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. If the repair record of any individual piece of Contractor s equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement. Each notification for an emergency repair service call will be treated as a separate and new service call. Contractor shall provide regular, scheduled maintenance to assure the continued reliable operation of the equipment. These preventive maintenance visits shall be of a frequency that conforms to the manufacturer s operation and maintenance instructions for the supported equipment. Upgrades - The Contractor will be required to 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 at no additional charge to the Government. These must be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer vendor supported, etc. This does not refer to replacing the original piece of equipment; however, it does refer to significant changes in the hardware operational capability. Ancillary support equipment - The Contractor shall provide all ancillary support equipment to fully operate the analyzer(s) as defined in these specifications, e.g. installation of telephone lines for modem operations and cabinetry to support/house the analyzer (if necessary). In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc. Invoicing All invoices will be issued monthly in arrears stating the test name, monthly volume of patient reportable results and the individual cost per reportable price as awarded per contract. Computer Interfacing Requirements - The fully operational interface (both hardware and software) must be immediately available for implementation to the VA VistA hospital information system at the time of contract award. The Contractor shall provide all hardware required for the connection, implementation and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system. VA Hines clinical laboratories currently employ the Data Innovations Instrument Manager system. Likewise, the Contractor shall provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in the chart below. If a site already has a universal interface box, the vendor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the vendor is responsible for the acquisition of the universal interface box and everything else needed to connect with VistA. If there are any software upgrades in the instrument during its life, the vendor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VistA Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and will assist in regulatory compliance, e.g. PC computer diskette of their procedure manual or an on-line procedure manual in the instrument software. Implementation timeframe - The implementation of services/requirements described in this solicitation will be completed no later than 120 days after the award of the contract. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractors will not be penalized for implementation timelines that extend beyond the 120 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. The transition period for the awarded contract to have all equipment and peripherals installed and operational at the participating facility shall be from date of award through 120 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed. Offerors shall provide with its quotation a plan for transitioning services from the incumbent Contractor to the newly awarded Contractor. Contractor s submitted transition plan shall not exceed 90 days for the transition of all services including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to confirm to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. At the end of 120 days from award of the contract, the awarded Contractor shall have full and sole responsibility for services. j) Characterization of hazardous waste The Contractor shall provide a description of the characteristics 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: 1) Waste toxicity (Reference 40CFR261.11 and 40CFR261.24) 2) Waste ignitability (Reference 40CFR261.21) 3) Waste corrosivity (Reference 40CFR261.22) 4) Waste reactivity (Reference 40CFR261.23) 4. Contractors would be required to submit pricing using a Cost per Test (CPT) format, though this is subject to change. The per test price would include costs covering: a) 5 year equipment use, b) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor s equipment and necessary for the collection and generation of a patient test result. It will also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI-formerly NCCLS), c) all necessary maintenance and parts to keep the equipment in good operating condition (element includes both preventive maintenance and emergency repairs), and d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. The Government will make the contract award considering only the basic proposals offered by the Contractor and their compliance with the evaluation factors of this solicitation. Optional proposals/packages will be considered once the award is completed. Contractors shall provide commercial literature and other information describing their compliance with the technical specifications, at least three references, and certification of commercially available vendor computer interface to the VA VistA computer system, as well as an equipment implementation schedule. If the commercial literature does not directly address specific specifications identified in this solicitation, the vendor is required to indicate compliance with those specifications in written format. 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; beginning and ending dates when service and equipment was provided. Contractors would be required to provide documentation that the instrumentation offered will perform analyses with a precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical Laboratory Standards Institute (CLSI formerly NCCLS). Contractors will be required to provide a description of all ancillary support equipment that is needed to operate analyzers as defined in the specifications and offered as a part of this agreement. Contractors will be required to 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. Operator-performed Contractors shall 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. Contractor-performed - Contractors shall describe the frequency of preventive maintenance and provide an estimate of the time required to perform the maintenance. Contractors shall provide delivery, installation and removal of equipment at no additional charge. Contractor must provide information on the following in a full capabilities statement in order to receive additional consideration: type/features of the FDA approved molecular pathology analyzer specimen collection and storage requirements specimen sample size requirements sample preparation requirements primary tube sampling specimen throughput quality of analysis limits of detection genotypes detected control and reagent stability maintenance requirements footprint/physical characteristics/water, electrical and waste requirements type/features of the data information system FDA approval for HCV diagnosis and monitoring of HIV, HBV, CMV and HCV.