SOURCES SOUGHT
65 -- 589-18-4-8874-0195 - CO - CellChek 36V255-19-AP-1493
- Notice Date
- 5/31/2019
- Notice Type
- Synopsis
- NAICS
- 339115
— Ophthalmic Goods Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office (NCO) 15;3450 S 4th Street Trafficway;Leavenworth KS 66048
- ZIP Code
- 66048
- Solicitation Number
- 36C25519Q0497
- Response Due
- 6/17/2019
- Archive Date
- 6/27/2019
- Point of Contact
- 913-946-1982
- Small Business Set-Aside
- N/A
- Description
- THIS REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this RFI In Accordance With (IAW) FAR Part 15.201(e). SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a RFI/sources sought only. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 334510 (size standard of 1250 Employees). Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 15 Network Contracting Office, is seeking sources that can provide the following, or brand name equal, Konan Cellchek XL: Brand Name Info: Konan Cellchek XL Specular Microscope System. Background: Clinical Specular Microscope for Monitoring Corneal Endothelial Cell Health in Live Rabbits required for the completion of Aim-1 and Aim-2 of the project which are focused on the development of Id3 and HGF+BMP7 gene therapy for vision restoration: For the complete evaluation of short- and long-term safety profile of gene-based nanomedicine careful examination of the health of the corneal endothelial cells in live animals is required. The primary objective of our funded Merit grant is to optimize nanomedicine approaches by studying the short- and long-term safety profile in addition to evaluating the efficacy of therapeutic genes (BMP7, HGF, Ids, TGIF etc.) capable of reversing corneal damage and restoring vision. Accomplishing this goal requires a time-dependent monitoring of the health of all corneal cells including the endothelial cells in rabbit eyes with authentic microscopic imaging tools in rabbits. With the use of a clinical specular microscope, we can capture full thickness scans, consisting of a series of digital images on anesthetized rabbits to quantify endothelial cell density in the cornea. The current ConfoScan microscope is very old and worn out and often does not provide high quality accurate digital images that are needed for clinically precise measurement of safety profile. We request a replacement current machine from the Konan Medical, as they are known to provide quality microscopes for eye clinical practice and clinical trials. We request a CellChek XL model which provides the most precision assessment of the critical layer of the cornea, the endothelium, that plays primary role in maintaining corneal transparency by regulating hydration (water content) in the cornea. Konan Specular microscope is a fully automated analyzer tool, which features Center MethodTM and Flex-CenterTM analysis tools with large areas of visible cells. Center Method is considered being the gold standard described by the FDA for independent assessment of corneal endothelial analytics for the achievement of high precision and repeatability. Scope and methodology: Specular microscopy is a non-invasive in vivo technique for the assessment of the corneal endothelium health. It is a standard method for determining cell loss or changes in cell size (polymegethism) or cell shape (pleomorphism) in healthy and disease conditions. Analysis of the corneal endothelium is especially importantto study the progression the progression as well as the extent of the endothelial cell loss. The analysis of endothelial cell densities after damage and drug treatment is important because low endothelial cell densities are significantly associated with increased corneal thickness and an increased risk of vision loss. Tasks and Associated Deliverables: CellChek XL Specular Microscopy system: Technology: CellChek XL is a patented technology to detect and precisely focus on the corneal endothelium based on the changes observed in the refractive index of the cornea endothelial tissue and aqueous humor in the eye. The system is very sophisticated and uses a push button system to quickly focus, shoot and store corneal endothelium images on the computer hard disk of the system. Advantages: CellChek XL Specular Microscopy system allow us to non-invasively monitor the progress of the endothelial cell damage in the rabbit eye. It comprises of rich set of analytic tools for reliable assessment of the entire spectrum of corneal endothelial damage. Required specifications: It is the only clinical grade specular microscope available for the evaluation of rabbit eyes. It has automatic as well as manual photographic capability. It is a state-of-the-art non-contact, auto-alignment, auto-focus, auto capture and auto endothelial cell count system. It can be used as a pachymetry to measure corneal thickness. Measurement accuracy of ±10mm or better. It has an analytical accuracy of ±5% using center method. It has an integrated touch-screen with built-in CCD image sensing camera. The Center MethodTM provides high precision and repeatability for specular images in which relatively small continuous areas of cells are present. The Flex-CenterTM method is an additional tool for advanced stage diseased corneas in which only a very few cells are visible. The information identified above are intended to be descriptive, not restrictive, and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications, or brand name equal. If you are interested, and are capable of providing the sought out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? Does your company have an FSS contract with GSA, VA NAC, NASA SEWP, or any other federal contract, that can be utilized to procure the requirement listed above? If so, please provide the contract number. Please submit your capabilities that show clear, compelling, and convincing evidence that you can meet the requirement described in the attached SOW. Please provide your DUNS number. Responses to this notice shall be submitted via email to Philip Bouffard at Philip.bouffard@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Monday, October 11, 2018 at 0800 PDT. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this sources sought. Responses to this sources sought notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (31-MAY-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/VA/LeVAMC/VAMCKS/36C25519Q0497/listing.html)
- Place of Performance
- Address: Harry S. Truman Memorial Veterans Hospital;800 Hospital DR;Columbia, MO
- Zip Code: 65201-5275
- Country: United States
- Zip Code: 65201-5275
- Record
- SN05327883-F 20190602/190531230022 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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