Multiplexing Magnetic Bead-based Plate Reader System with Post-Warranty Preventive Maintenance and Repair Services

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE. The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement in order to determine if there are existing small business sources capable of providing a Multiplexing Magnetic Bead-based Plate Reader System with Post-Warranty Preventive Maintenance and Repair Services. If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1000 employees and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to [email protected]. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements. Background: The FDA, The Division of Biochemical Toxicology is in need of a multiplexing magnetic bead-based plate reader system for the multiplexing quantitative measurements of biomolecules in tissue, cells, and serum from a single sample. A high through-put multiplexing magnetic bead-based reader is crucial for the accurate quantitation of a multitude (up to 500) biomolecules/analytes/RNA complexes within a dynamic range out of a single sample. This multiplexing ability decreases the time spent on analysis and decreases the cost accrued from single ELISA assays. Simultaneous measurements from a single sample allows for accurate comparisons if immunoassayed targets. The Multiplexing magnetic bead-based plate reader will be used to analyze tissue, cells, and serum samples to determine the relation between liver epigenomic phenotype and susceptibility to nonalcoholic steatohepatitis. Minimum requirements for the magnetic bead-based multiplexing plate reader system: Shall be compatible with antibody based magnetic bead immunoassays. Shall have the capability to detect multi-analytes in multiplex immunoassay products in 96-well or greater assay plates. Shall be able to detect up to 500, minimum of 200, potential targets at a single time. Shall have a dynamic range of detection up to 5.5 logarithmic units. Shall have the capability of measuring up to 36 RNA targets for gene expression analysis when using multiplexing immunoassays. Each run for a 384 well plate should not exceed 2 hrs, to ensure sample integrity. Dynamic range should be from 4.5-5.5 logs Results shall be verifiable and instrument validated. Shall have the capability to perform measurements on 96 or 384 well plates. Shall not exceed 770mm H x 590mm W x 620mm D, due to limited laboratory space. Shall include controlling software with an integrated touchscreen PC. Shall include comprehensive onsite training, instructions to include but not limited to operational procedures, method building, data interpretation, and simple trouble shooting. Shall be electrically powered with USA standard 120V 60 Hz. Minimum Performance Requirements: The Contractor shall provide a minimum of one (1) scheduled on-site planned preventive maintenance visit per year. The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days. The Maintenance and Repair activities shall be performed following the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc. The Contractor shall include unlimited software and firmware updates during the coverage period(s). The Contractor shall provide factory-certified replacement parts. The Contractor shall include unlimited technical support Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Central Time. All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. for system. Service Records and Reports - the Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed. Period of Performance: Delivery, installation and training shall occur within 30 days from date of award. Warranty shall commence upon acceptance of the system. Post-warranty Preventative and corrective/remedial maintenance repair service on the system, if exercised, shall commence, upon expiration of the warranty period and continue for a year, which may be extended in annual increments. The period of performance for the option periods in any resultant award will be estimated based on the date of award, required delivery of the system (inclusive of inside delivery, installation, and training), and the offered warranty period. Delivery Location: FDA/NCTR 3900 NCTR Rd Jefferson, AR 72079 Though the target audience is small business vendors or small businesses capable of supplying a U.S. service of a small business vendor or producer all interested parties may respond. At a minimum, responses shall include the following: Business name and bio, unique entity identification (UEI) number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm. Past Performance information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments to include date of sale, description, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include UEI number and size status) if not the respondent. Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above. The offeror shall advise if the product and/or service is on a Best in Class contract. If applicable, the offeror shall clearly identify where the offered product is made. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. If a large business, provide if subcontracting opportunities exist for small business concerns. Standard commercial warranty and payment terms. Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed. Informational pricing is desired. The Government is not responsible for locating or securing any information, not identified in the response. Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before July 7, 2022 by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA | OO | OFBA | OAGS | DAP, Attn: Warren Dutter, email [email protected]. Reference: FDA-SSN-113642. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s). Additional Notes: If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.