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Page 6 of 6 Page 1 of Sources Sought - BRAND NAME OR EQUAL Immunoassay Analyzer at the Omaha VA Health Care System NAICS Code: 334516 Sources Sought Number: 36C26322Q0015 Notice Type: Sources Sought T... Page 6 of 6 Page 1 of Sources Sought - BRAND NAME OR EQUAL Immunoassay Analyzer at the Omaha VA Health Care System NAICS Code: 334516 Sources Sought Number: 36C26322Q0015 Notice Type: Sources Sought This is a Request for Information (RFI) only; this not a request for quotations or offers. 52.215-3 -- Request for Information or Solicitation for Planning Purposes (Oct 1997) (a) The Government does not intend to award a contract on the basis of this solicitation or to otherwise pay for the information solicited except as an allowable cost under other contracts as provided in subsection 31.205-18, Bid and proposal costs, of the Federal Acquisition Regulation. (b) Although proposal and offeror are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal. (c) This solicitation is issued for the purpose of: conducting market research to identify potential sources for a potential procurement of BRAND NAME Eye Clinic Equipment as indicated below at the Minneapolis VA Health Care System located at One Veterans Drive, Minneapolis, MN 55417. See attached item specifications This is a request for information and sources only, which may or may not lead to a future solicitation. This is not a request for proposal (RFP). The VA will not pay for any information received resulting from this sources sought notice. Information should be forwarded to the Contract Specialist. Any questions should be addressed to the Contracting Officer, in writing, at the email address provided. Because this is a request for information only, answers to questions will not be posted. If your organization has the capability to provide these supplies/services and is interested in this opportunity, please respond to Wendy Hoeschen, Contracting Officer, via e-mail at wendy.hoeschen@va.gov. Please address the following in your responses: Point of contact, DUNS Number, complete mailing address, telephone number, and email address for your company/entity. Socioeconomic status of your company/entity. If applicable - GSA/FSS/ECAT/NASA SEWP contract number that these products or services are available under. Product information/specifications of the systems that you can provide that meet the requirements of the DRAFT Specification-Statement of Work. Proof of Authorized Distributorship for any product that is not manufactured by your company/entity. **Please note that the government will not accept any gray market items. Manufacture Information of the product that your company/entity can provide to include: Manufacturer Name, Address, and DUNS Number. 852.212-72 Gray Market and Counterfeit Items (MAR 2020) (DEVIATION) GRAY MARKET AND COUNTERFEIT ITEMS (MAR 2020) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided. This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory. No counterfeit supplies or equipment/parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics. Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. The deadline for this information is 12 PM Central Time on, 10/13/2021. STATEMENT OF WORK- BNOE Operational Features - The specialty immunoassay testing instrumentation must have: The capability of performing analysis QuantiFERON-TB, varicella IgG, measles IgG, mumps IgG, and H. Pylori IgG on a fully automated platform with random access capability. Additionally, the ability of adding other testing such as direct renin and aldosterone is highly desired. Enough capacity and throughput to meet the volume and service demands as well as provide for volume growth. 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. 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 Omaha VA Medical Center facility laboratory currently uses the Data Innovation systems. To achieve connection with this system, the awarded vendor will be responsible for the cost of the interface. Refer to the following section entitled Support Features Computer Interfacing Requirements for specific details. Specialty immunoassay analyzer must have a footprint that does not negatively impact current laboratory operations. 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. Hardware Features - The specialty immunoassay instrumentation must have the following: Printer No batching restrictions. Can load any number of samples at any time High throughput, process up to 200 samples per 8-hour shift, to keep pace with high volume workload High-resolution touch screen for easy interaction Expanded ancillary reagent and fluid capacity Data archive feature reduces time for administrative tasks Universal sample rack design eliminates manual tasks The ability to run multiple assays simultaneously Runs controls and calibrators once every 24 hours User interface adjusts for customized ergonomics Minimal daily startup with automated maintenance features Support Features a) Supplies - The vendor must provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the contract and required to establish instruments for operation. The vendor will perform, to the satisfaction of the Government, 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 at no cost to the Government. The vendor will perform all of the statistical analysis and report data in an organized, clearly comprehensible format. b) Training - The vendor will provide training for two operators for each model of instrumentation placed. Utilization of the training slots will be mutually agreed upon between the Omaha VA Medical Center facility laboratory and the vendor. A training program that involves off-site travel shall include the cost of roundtrip airfare, ground transportation, hotel accommodations and meals for each participant. d) Equipment Preventative Maintenance/Repair Service - The vendor must be able to provide emergency equipment repair and preventative maintenance on all instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms: 1. A technical assistance center must be available by telephone Monday -Friday during routine business hours with a maximum call back response time of 2 hours. 2. Equipment repair service must be provided during routine business hours. 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. 3. Equipment response time will be no more than 12 hours. 4. A minimum of two scheduled preventative maintenance calls per year. 5. A malfunction incident report shall be furnished to the installed site upon completion of each repair call. The report shall include, as a minimum, the following: (a) date and time notified (b) date and time of arrival (c) serial number, type and model number of equipment (d) time spent for repair, and (e) proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. 6. During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 2% 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 98% in each month of the term of the agreement. 7. Each notification for an emergency repair service call will be treated as a separate and new service call. Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, menu changes, technological upgrades, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually with communication to the vendor for modification of the contract. A high incidence of problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. Removal of instrument by the vendor shall be performed within 60 days after request. The vendor must 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. f) Ancillary support equipment - The vendor will provide, install and maintain, as indicated, any and all ancillary support equipment to fully operate the specialty immunoassay analyzer as defined in these specifications, e.g. installation of telephone lines for modem operations, cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, 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, tables/stands, etc. g) 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 vendor is responsible for providing 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 (see requirements below). Likewise, the vendor will provide any and all necessary software support for ensuring 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 the 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 the 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. h) Commercial offerings - The vendor will provide to the VA facility 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. i) Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed as soon as feasible, based upon system availability. 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 include 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 the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. PROPOSALS 1. It is the clear intent of the Government to award to a single vendor for the Omaha VA Medical Center supplemental specialty immunoassay testing business. 2. The Government will entertain recommendations only for new state-of-the-art equipment, approved by the FDA. 3. The Government will make the contract award considering the equipment configuration option that best meets the operational needs of the Omaha VA Medical Center facility and its compliance with the evaluation factors of this solicitation. Optional proposals/packages will be considered once the award is completed. 5. Vendors must provide in their offer the following: a) 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 vendor is required to indicate compliance with those specifications in written format. b) documentation and/or certification 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). c) a reference list of all commercially sold systems in the United States. References should 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. d) vendors must provide a description of all ancillary support equipment that is needed to operate the specialty immunoassay testing analyzers as defined in the specifications and offered as a part of this agreement. e) list of VA references currently using the VistA software interface for instruments offered and certification that there is a commercially available and immediately implementable vendor computer interface to the VA VistA computer system that is deliverable at the same time of equipment receipt. It is the sole responsibility of the vendor to insure successful development of the vendor to VA VistA interface. f) an equipment installation schedule. g) a transition plan describing timeframe for the full implementation of the equipment including installation, training and correlations and validations. h) mean failure rate (in days) of each offered piece of equipment i) summary of operator-performed and vendor-performed maintenance procedures including an estimate of time spent in the performance for each category of maintenance. 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. Vendor-performed: Offerors must describe the frequency of preventive maintenance and provide an estimate of the time required to perform the maintenance. j) a copy of the Federal Supply Schedule contract, if applicable, for which the offer for equipment is based. This copy shall become part of the BPA file. k) 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. 6. Vendors that offer multiple types of repair service packages that are different than the minimum requirements stated in the specifications are encouraged to offer an associated adjusted price per reportable. 7. Vendors offering third party products (reagents or consumables) where the cost is included in the CPT must individually specify the product, source and reference information, indicate whether the third party reagents will be procured by the offeror and the costs are included in the quoted CPT and certify their technical support of the third party method on their equipment systems. G. ORDERING/DELIVERY: Omaha VA Medical Center will issue their unique purchase order to the contractor. All orders placed against this Agreement shall be by authorized individuals within the scope of their authority as designated by the facility participating in this agreement. The Government estimates, but does not guarantee, the volume of purchases using this BPA. This BPA does not obligate funds. The Government is obligated only to the extent of authorized purchases actually made under the BPA. Orders under this BPA can be for any amount authorized under the FSS Schedule contract, if applicable. Orders will be placed against this BPA using Electronic Data Interchange (EDI), FAX, paper, or oral communications. Unless otherwise agreed to, all deliveries under this BPA must be accompanied by delivery tickets or sales slips that contain the following information as a minimum: Contractor Name FSS Schedule contract number, if applicable BPA number and any delivery/task order number assigned under that BPA. Date of purchase Date of shipment Description of each item, including (when applicable) model number and Special Item Number (SIN) Quantity for each item in the order Unit price and extended (quantity x unit price) price for each item.