“Brand Name or Equal” Miltenyi Biotec, MACSima Imaging System

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) is issuing this source sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER) in order to determine if there are existing small business sources and other than small business sources capable of providing an “Brand Name or Equal” MACSima Imaging System with four (4) (1-year Post-Warranty Maintenance and Repair service option periods), meeting the requirements below. 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 CBER Microscopy and Imaging Core Facility has a requirement for a an “Brand Name or Equal” MACSima Imaging System (part number 130-121-164). CBER supports all FDA scientists and laboratories for their morphological studies and microscopic imaging. It’s primary function is to analyze host – pathogen (e.g. virus, bacteria, parasites) interaction using fluorescent labeled cell, tissue or pathogen in immunological responses, vaccine related studies or drug related imaging and analysis. The Core requires an ultrahigh-content imaging platform system to acquire more than 100 channels to identify and phenotype specific cells in tissue or cell samples. The ultra-high content imaging system us novel technology to stain and erase the same sample and acquire unlimited multicolor channels and will dramatically improve our multi-channel fluorescence imaging capabilities. The MACSima imaging system is critical for our agency’s mission to acquire ultrahigh-content multi-color fluorescence imaging that are important to the regulatory research and review programs of this Center. This requirement is configured as Brand Name or Equal: Miltenyi Biotec, MACSima Imaging System, part number 130-121-164 constructed to meet the below minimum technical requirements. Minimum Technical Requirements: Shall be 1210 x 750 x 650 mm (LxWxH) and ~165kg weight to fit into limited lab space. Shall be capable for high content imaging technology, based on use of erasable fluorescent conjugated antibodies with repetitive cycles of staining, imaging and erasing to obtain minimum of two hundred of markers on one sample. Shall have capability of simultaneous handling of 8 slides for shared use at core facility. Shall be able to handle standard microscopic slides for staining and imaging process for existing various animal and human samples slides. Shall include 1.5L fluid containers for automatic operation over several days (what defines several? 3 to 5??) without exchange containers. Shall have fully automated high content imaging system with auto focus function and provides walk-away function. Shall be equipped with 3 objective lenses (2x (NA0.08), 20x (NA 0.45) and 20x (NA0.75) for overview and image acquisition, and sCMOS camera for high resolution multi-color fluorescence imaging with or without coverslip. Shall include data analysis software while the experiment is running (on-the fly). Shall include 2 software licenses and 2 floating software licenses to support our users. Shall have 5 different emission filters and 6 different excitation LED as light source. Shall have dual (IR laser-based hardware and image-based) autofocus function for accurate imaging. Shall have fully automated liquid handling module with washable stainless-steel needle and syringe pump for automated accurate volumetric staining and signal erasing. Shall have dual fully automated liquid handling and fluorescence staining, image acquisition and erasing. Shall have 100 nm resolution automated stage with sample loading and clamping of all sample carriers for repetitive staining /imaging /erasing. Shall be able to analyze various kind of samples such as tissue, adherent cells and suspension cells. Shall include instrument controller with integrated redundant storage and full HD tiltable display. Shall include a optical table for microscope, size 1290x986x858 mm 540kg capacity with manual level adjustment. Shall have UV405 for counterstained nuclei detection for image positioning as well as breaching signals when needed. Shall include 1, 2 and 4 imaging frames for flexible user’s sample loading. Shall include 24 imaging plates for flexible user’s sample loading. Shall include MACSwell Micro slides. Shall include 20x aluminum sealing foils and Deepwell plates to reduce reagent evaporation. Shall include REA(what does this stand for??) Screen reagent, running and system buffer solutions. Shall include one-year warranty. The Contractor shall provide updates and upgrades for 12 months from date of installation. The Contractor shall provide access to technical support for this upgrade via email or telephone for 12 months from date of installation. Contractor shall provide the installation of the unit and ensure they meet or exceed original equipment manufacturer (OEM) operating standards. Installation, Training and Warranty: : Upon delivery and installation, the Vendor shall coordinate with the Contracting Officer Representative (COR) to demonstrate functionality and schedule a training session with program office points of contacts to conduct the training. The training shall be detailed and capture full functionality of the machine. At the end of the training, the vendor shall transition over training aids, materials and technical guides to support utilization/maintenance of the machine. Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s). Post-Warranty Service Minimum Performance Requirements: The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visits 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 by the service engineers who are trained and certified by the Original Equipment Manufacturer (OEM). The service provider should follow the OEM specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc. The Contractor shall include software and firmware updates required during on-site instrument repair and instrument’s performance check during preventive maintenance during the coverage period(s). The Contractor shall provide factory-certified replacement parts. The Contractor shall include unlimited technical support (via phone and email) on software and hardware and trouble-shooting with the equipment issues, Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Eastern Time. All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc for the 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 60 calendar days from date of award. 4 (1-year Post-Warranty Maintenance and Repair Option periods): Option Year 1: 12 consecutive months commencing upon expiration of initial warranty; Option Year 2: 12 consecutive months commencing upon expiration of Option Year 1; Option Year 3: 12 consecutive months commencing upon expiration of Option Year 2; Option Year 4: 12 consecutive months commencing upon expiration of Option Year 3; Warranty shall commence upon acceptance of the MACSima imaging system. Post-warranty Preventative maintenance and repair service, if exercised, shall commence, upon expiration of the warranty period and continue for a year, which may be extended in annual increments. If/when Option Period 1 is exercised; the periods of performance for all options will be firmed via bilateral modification. 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-CBER Bldg. 52/72, Rm. 1233 10903 New Hampshire Ave. Silver Spring, MD 20993 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 January 31, 2023 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-116205. 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.