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SOURCES SOUGHT NOTICE # FDA_SSN_1227078 for an automated slide-stainer instrument Posted Date: May 28, 2020 Response Date: June 11, 2020 by no later than 2:00 pm CDT Classification: 6640 – Laboratory ... SOURCES SOUGHT NOTICE # FDA_SSN_1227078 for an automated slide-stainer instrument Posted Date: May 28, 2020 Response Date: June 11, 2020 by no later than 2:00 pm CDT Classification: 6640 – Laboratory Equipment and Supplies NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing MARKET RESEARCH PURPOSES ONLY - NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the imaging equipment described below. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposal, Request for Quotation, or an indication the Government intends to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a Small Business Set-Aside is possible. The appropriate NAICS code for the acquisition is 334516 – Analytical laboratory Instrument Manufacturing; Small Business Size Standards – 1,000 employees. Requirement and Background The U. S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Microscopy and Imaging Core Facility (MICF) supports all FDA scientists and laboratories for their morphological studies and microscopic imaging requirements. Our main work is centered around analyzing the host- pathogen (e.g. virus, bacteria-parasites) interaction using fluorescently labeled cell, tissue or pathogen samples in immunological responses and vaccine-related studies. The MICF at CBER currently employs a Leica BonD-maX automated slide stainer system, S/N: M212198, for multicolor immunofluorescense, Immunohistochemistry slide preparation. However, a replacement system is required which incorporates more sophisticated imaging utilizing novel multi-color hyperplex labeling and in situ hybridization techniques necessary for CBER researchers. The replacement system will accommodate the increased demands within the facility for complex multi-color mouse tissue analysis and shall be capable of using many antibodies for immunohistochemistry, immunofluorescence and in situ hybridization protocols to dramatically improve the lengthy process of slide preparation for researchers. Minimum Technical Requirements The required slide-stainer instrument system shall include and meet the following technical requirements: Capable of IHC staining and automated ISH/FISH/IF testing; Capable of fully-automated baking/dewax/antigen retrieval/staining of slide in less than 2.5 hours for IHC testing; System must include a bonafide open reagent system, use 3rd party probes/detection systems, antibodies, Akoya Bioscience Opal Multiplex IHC assay kit and molecular probes; System must be compatible with existing slide staining supplies and reagent for Leica Bond-maX slide stainer system (disposable tubes, containers, dewax and other solution including ready-made secondary antibody kits). Capable of utilizing predefined protocols and customizing protocols; System shall employ a cover tile technology for preserving tissue & cellular morphology to protect tissue and preventing tissue loss, apply reagents gently to tissue, and to create a reaction chamber; System shall be self-contained with no water or waste hook-ups required and capable of separating hazardous waste from non-hazardous waste; Capable of automated multiplexing of IHC/IF/ISH stains (i.e., ability to review multiple slides simultaneously); Capable of changing heated marker steps and add/remove wash steps as necessary; System shall include graphical user interface and floor-based with physical dimensions not to exceed 31” W by 31” D; Shall be barcode-driven system using OCR (optical character recognition) technology and capable of reading both 2-D & 3-D barcodes; 30-slide capacity (3-drawers of 10-slides/drawer configuration) and capable of holding minimum of 36 reagents; Minimum of 12-month manufacturer’s warranty to include all software and firmware updates, and unlimited e-mail and telephone technical support; Installation and all shipping charges FOB Destination. Delivery Address: U.S. Food and Drug Administration Center for Biologics Evaluation and Research Bldg. 52/72 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing the required slide stainer imaging system meeting the technical requirements set forth above. Although the target audience is small businesses or small businesses capable of providing these systems from another small business, all interested parties may respond. At a minimum, responses in the form of a Capability Statement shall include the following: Business name and bio, DUNS 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 with the capability of providing an instrument offered by another firm; Descriptive literature, brochures, marketing material, etc. detailing the instrument and equipment (to include consumables) which the responding firm is regularly engaged in providing; Information on available service/maintenance plans for the identified equipment; If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SIN’s that are applicable to this potential requirement are also requested. If a large business, provide documentation if subcontracting opportunities exist for small business concerns; Though this is not a request for quote, informational pricing is encouraged. The Government is not responsible for locating or securing any information, not identified in the response. Interested parties shall respond with Capability Statements as described above by e-mail only, before 2:00 pm (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas) on June 11, 2020, to Tim Walbert, Contract Specialist, at the following address: timothy.walbert@fda.hhs.gov. Notice of Intent Responses to this Sources Sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. 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 Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality and Proprietary Information 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).