SOURCES SOUGHT
66 -- Whole Slide Scanner Instrument
- Notice Date
- 6/23/2015
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1151675
- Archive Date
- 7/14/2015
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 Center for Biological Evaluation and Research (CBER) requirement for a whole slide scanner system. The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the items described herein. 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-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. The Food and Drug Administration (FDA), Center for Biological Evaluation and Research (CBER), Office of Blood Research & Review, Division of Hematology Research & Review, Laboratory of Biochemistry and Vascular Biology requires a whole slide scanner instrument in order to be able to analyze, catalog, and preserve high quality digital images of the Laboratory's microscopy experiments. A major focus of the lab's research centers on the effects of hemoglobin based oxygen carriers (HBOCs) and microbial pathogens on the vascular endothelium in various organ systems (e.g. heart, kidney, brain, lung, and liver) and in cell culture systems. Making detailed observations by brightfield and fluorescence microscopy of animal tissue specimens and cells is a vital part of being able to ascertain the safety and/or efficacy of these biological treatments. The current method of analyzing the data involves taking pictures of processed slide samples with the existing microscope camera. The lab now has to image representative sections of the slide and capture a high volume of images to catalog the whole section, which is very time consuming, inefficient, and a potential source of experimental variability. Additionally, when using fluorescence microscopy, the stained slides have a limited shelf life as the fluorescent signal starts to degrade shortly after the experiment ends. The whole slide scanner is an instrument that can take a whole-slide high quality digital image in a very short amount of time. The high quality and resolution of this "virtual slide" allows the lab to zoom in to any area of the section at any desired magnification, effectively replacing the current method of obtaining images with one that takes a fraction of the time. The analysis of these high quality "virtual" slides will also eliminate a significant source of experimental variability and enhance the accuracy of the data. The whole slide scanner will also allow the lab to capture all the relevant data from a fluorescence experiment before any loss of signal (in the future when the scanner is upgraded to fluorescence capabilities). The slide loader will allow the lab to capture images from an entire experiment quickly and efficiently and without a technician being present to switch every slide. The "virtual" slides obtained will allow the lab to reexamine the data from slides indefinitely into the future - for example to examine the cortex of a kidney vs. the medulla of a kidney - without having to run a new experiment --- which translates into significant savings of personnel and reagent resources. In broader terms, this instrument will be used to evaluate the effect of biologics on various animal tissues and cell culture systems. The instrument will be used to characterize the safety of biologics and evaluate the pathogenic mechanisms of bioterrorism threats. This system will support multiple projects within the Laboratory of Biochemistry and Vascular Biology. Technical Performance requirements: • Shall be able to accept microscope slides of sizes 1X3" or 2X3" • Shall be able to automatically load 6 or more slides • Shall use TDI (Time Delayed Integration) detector technology for extremely high quality image resolution, image fidelity, and sensitivity • Shall be able to capture uncompressed raw file formats for quantitation compatible software outputs such as ImageJ (NIH) and use jpeg image compression • Shall offer magnifications of 20X and 40X without the need to move optical components within the light path • Shall use a 3-chip (with red, green, and blue channels) TDI camera to accurately reproduce colors • Shall use software that is icon based and user friendly • Shall have a Z-stack feature for thick samples • Shall be upgradable to fluorescence capabilities • Computer, monitor and cables as required. • With very limited bench space the instrument should be 63.7cm (h) X 54cm (w) X 64.2cm (d) or smaller. This is equivalent to 25in X 21.3in X 25.3in respectively. Installation, Training and Additional System Requirements. The contractor shall provide in-side delivery, installation and operator familiarization training for the system. The contractor shall provide on-site training (in addition to installation of the system) to include basic operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications in the contract. 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 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. The Contractor shall include all costs associated with the shipping and handling of the equipment, and all travel and field engineer expenses associated with install and on-site training. FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery/installation date is within 60 calendar days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA located at 10903 New Hampshire Ave., Building 52/72, Room 4148, Silver Spring, MD 20993. 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 products and 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. • Three (3) years of 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. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable 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 encouraged. 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 in person, by postal mail or email to the point of contact listed below on or before June 29, 2015 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1151675. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1151675/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Ave., Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN03773396-W 20150625/150623235354-2169a4f0173f71f184a50a191e272a36 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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