Inverted Confocal Microscope

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the National Center for Toxicological Research (NCTR) requirement for an inverted confocal microscope. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required services. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The associated North American Industry Classification System (NAICS) Code is-333314- Optical Instrument and Lens Manufacturing; Small Business Size Standard is 500 employees. Statement of Work (SOW): Inverted Confocal Microscope. The NCTR has a need for a microscope that is capable of imaging under a number of different conditions and modalities. An inverted confocal microscope fits the needs of the center well because it is versatile and upgradeable, which will maximize the number of users. There are a number of facets that are essential to the confocal microscope. First, the microscope must be inverted . Live-cell imaging of small structures over time is best done with an inverted scope because this decrease the distance between the objective and the sample. Importantly, inverted confocal microscopes can still be used to image fixed tissue, for example, a brain slice or cells on a slide. The microscope will need to be able to maintain focus of the sample during longitudinal experiments despite changes in temperature and/or addition via the addition of reagents etc. The inverted scope offers greatly flexibility. The microscope must have an environmental chamber to facilitate live-cell imaging. The environmental chamber helps to control humidity, temperature, and can also control CO2 and O2 levels to help maintain live cells under optimal conditions. Importantly, the environmental chamber does not prohibit users from imaging fixed tissue. The chamber shall encapsulate the microscope except for the eyepiece, which will allow the inside of the chamber to be sterilized if necessary. The confocal microscope must be outfitted with the following lasers : approximately : 405 nm, 488 nm, 561 nm, and 640 nm; with built-in acousto-optic tunable filter (AOTF). Alternative configurations of lasers are possible but shall include 4 lasers that are similar to those listed above. A vendor may offer a package of 4 lasers that includes a 647 nm laser instead of a 640nm laser, as well as the 405, 488, and 561 nm lasers and this is acceptable. The maximum pixel size shall be 4096 x 4096, and scanning speeds capable of 1-10 fps. The confocal microscope must be outfitted at minimum with the following filters : 4’6-diamidino-2-phenylindole (DAPI), Texas Red, and green fluorescent protein (GFP). The microscope shall have a 4-channel fluorescent detector with at least 2 gallium arsenide phosphide (GaAsP) PMT (photomultiplier tube) and 2 mixed-alkali high-sensitivity PMTs. The microscope will need a transmitter light detector. The microscope will need a number of objectives with Differential Interference Contrast (DIC) components to achieve imaging of a variety of sample types from different Principle Investigators. Importantly, the microscope must be outfitted with 10x, 20x, 40x, and 60-63x plan apochromatic objectives that roughly achieve numerical apertures of 0.5, 0.9, 1.3, and 1.45, respectively. The objective may need oil, water, or glycerol corrected-objective (depending on recommendations from manufacturer to be included in the quote), e.g., the 10x may need to be glycerol corrected and the 60x may need to be oil corrected. Nanocrystal coating on the objectives is required as it will lower refractive indices to provide better light transmission. To facilitate using the microscope, a fully electronic stage , a joystick to control the stage, and an antivibration table to hold the microscope and all necessary parts that are sensitive to vibration shall be included. The microscope will need a specialized computer and software . The computer should have at least 64 to 128 mb of RAM, at least a 2 TB hard drive, dual HD monitor setup, a 4.0GHz processor or higher, and a graphics card similar to the NVDIA Quadro P5000. The software shall be able to easily help researchers with measurement, time lapse imaging, z-stacking, extended focus with autofocus, colocalization, spectral unmixing, 3d reconstruction/rendering, video splicing, cell counting. The components and/or equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration. 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. Installation, Training and Additional System Requirements. The contractor shall provide in-side delivery, installation and operator familiarization training for the system. Installation and training will be performed by the manufacturer. This shall include training during the installation visit (to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements) and a second visit to help optimize sample visualization. The second visit shall last up to 3 days and include training for no more than 2 specified users. Sample types: this microscope shall be able to accurately image ex vivo live isolated cerebral capillaries from mice, rats, non-human primates, and human brain samples (generally 4-10 um in diameter and 100-300um in length); fixed imaging brain sections on slides from mice, rats, and non-human primates (anywhere from 10 to 1000 um in thickness); and live and fixed cells in culture dishes or mounted on slides (10-500 um thickness). Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include trouble-shooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of 1-year. Post-Warranty Preventative Maintenance Agreement shall, at a minimum, include the following -Minimum of one (1) planned preventative maintenance visit per contract period. -Unlimited phone and email support during the contractor’s normal operating hours. -Unlimited on-site corrective/remedial maintenance, service/repair visits which again includes all labor, parts, and travel costs. Provide on-site service response within three business days of notification if issue cannot be corrected remotely within 8 hours from call for service. - Preventative maintenance shall include all labor, travel, and parts (except consumables); - Performance by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. -Access by the FDA Contracting Officer’s Representative (COR), Technical Representative (TR) and system operator personnel to the manufacturer’s call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. -System software and firmware updates required for reliability improvements and correction of any defects; -Service Records and Reports The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer 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. Anticipated Applicable Section 508 standards. Must meet WCAG 2.0 A and AA E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements) E203 Access to Functionality (Appendix A, Application and Scoping Requirements) E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements) E205 Electronic Content (Appendix A, Application and Scoping Requirements) 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/ , or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html . Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative. E206 Hardware (Appendix A, Application and Scoping Requirements) E207 Software (Appendix A, Application and Scoping Requirements) E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements) Chapter 4 Hardware (Appendix C, Functional Performance Criteria and Technical Requirements) Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements) Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements) Period of Performance FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery/installation/training shall be completed within 120 calendar days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA located at 3900 NCTR Road, Jefferson, AR 72079. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: Business name, 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 if responding to provide a product manufactured by another firm); Sufficient descriptive literature that unequivocally demonstrates that offered services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Information on available service/maintenance plans. Provide recent (within the last three (3) years) and relevant past performance information for the manufacture and/or sale and maintenance support in which the offeror has provided same or substantially similar system solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of 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 DUNS number and size status) if not the respondent. Respondents who do not provide a valid email address for the POC may be evaluated negatively. Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC) . If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable for each item to this potential requirement. Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. If a large business, identify the subcontracting opportunities that would exist for small business concerns; Standard commercial warranty and payment terms; and Though this is not a request for quote, informational pricing is required. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties shall respond with capability statements which are due by email to [email protected] on or before April 17, 2020 by 13:00 hours (Central Time in Jefferson, Arkansas). Reference FDA1227165. 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 FedBizOpps. 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). Questions and Answers: Question: The document states: The confocal microscope must be outfitted with the following lasers: approximately : 405 nm, 445 nm, 458nm, 488 nm, 514 nm, 532 nm, 561 nm, 594 nm, 640 nm, and 647 nm. Currently, there are no confocal microscope systems on the market that can utilize 10 lasers lines specified in the document. Could you please get clarification from the users on which specific lines they need for their research? Response: The government requires 405nm, 488nm, 561nm, and 640nm lasers. Alternative configurations of lasers are possible but shall include 4 lasers that are similar to those listed above. A vendor may offer a package of 4 lasers that includes a 647 nm laser instead of a 640nm laser, as well as the 405, 488, and 561 nm lasers and this is acceptable. Questions and Answers: Please list the amount of Lasers with Voltage and Wavelength. The Spec states both 445/458, 514/532, & 640/647: Are these Duplicates? Response: 4 lasers that are 405, 488, 561, and 640. If you can’t provide this exact package of lasers, then we’d need to know which lasers you could provide (e.g., replacing the 640 with the 647 for example). How many Fluorescent Detectors? Are any GaSap? How many are Spectral? Response: 4-channel fluorescence detection, at least 2 shall be GaAsp (gallium arsenide phosphide) and the others shall be high-sensitivity PMTs (photomultiplier tubes). Is there a Transmitted Light Detector included? Response: Yes, it shall have a transmitted light detector. Is DIC (Differential Interference Contrast) need to be included? If Yes on which Objectives? Response: Yes, all objectives shall come with DIC when available. Is thermal drift compensation (ZDC) needed? Response: Yes, the microscope shall be able to counter focal drift to maintain sample focus for longitudinal imaging.