DOCUMENT
65 -- Vascular Sealants - Attachment
- Notice Date
- 3/24/2015
- Notice Type
- Attachment
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- U.S. Department of Veterans Affairs;Strategic Acquisition Center;10300 Spotsylvania Ave;Fredericksburg VA 22408
- ZIP Code
- 22408
- Solicitation Number
- VA11915Q0159
- Response Due
- 4/7/2015
- Archive Date
- 6/6/2015
- Point of Contact
- Bonnie Sheehan
- Small Business Set-Aside
- N/A
- Description
- Subject: Request for Information (RFI), Synopsis for Vascular Sealants, for the Department of Veterans Affairs (VA), Veterans Health Administration (VHA). The VHA National Standardization Surgical Instruments integrated Product Team (IPT) has identified Vascular Sealants as a viable candidate item for standardization. The purpose of standardization is to obtain uniform, quality products at the best prices possible. The product VHA is seeking is designed to be used after surgery or traumatic injury as adjuvant therapy for hemostasis of large blood vessels. The response from this RFI may result in the issuance of a solicitation. This RFI encourages potential sources to submit a non-binding statement of interest and documentation substantiating they have a product they feel meets the stated Minimum Technical Requirements (MTR) at Attachment 1. Further, it is intended to assess industry's capability to support and/or develop an adequate solution to the Governments continuing need(s). The Strategic Acquisition Center (SAC) is requesting responses from qualified business concerns; the qualifying NAICS code for this effort is 339113 Surgical Appliance and Supplies Manufacturing. This RFI is issued to gain knowledge of potential qualified sources and their size classifications (Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), Hub zone, 8(a), small disadvantaged, women owned small business, or large business) relative to NAICS code 339113 (500 employees). Responses to this notice will be used by the Government to make appropriate acquisition decisions. After review of the responses to this notice, a solicitation announcement may be published. Responses to this RFI are not considered adequate responses to any corresponding solicitation announcement. All interested offerors must respond to any resulting solicitation announcement to be considered for award. PLEASE INDICATE WHETHER YOU HOLD A GSA FEDERAL SUPPLY SCHEDULE CONTRACT THAT COVERS THESE PRODUCTS AND, IF SO, THE CONTRACT NUMBER. Provide BUSINESS SIZE AND SOCIO-ECONOMIC STATUS; (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group, and whether your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) (e) Include the DUNS number of your firm. (f) State whether your firm is registered with the System for Award Management (SAM) at http://www.sam.gov and /or the VetBiz Registry (g) Provide current commercial pricing for each type and dosage (and applicable discounts) (h) Link to the respondent's General Services Administration (GSA) schedule, or attached file of same, if applicable (i) Citation of any current or past customers (i.e., within the past two years) to include contract number, point of contact telephone number or e-mail address (j) Material relevant to establishing core competencies of the firm. (k) Company information on warranty and the return of unsatisfactory products (l) Limit responses to ten pages Reponses are due by 12 pm EST, Monday, April 7, 2015. Please submit e-mail responses to. Bonnie Sheehan, Contract Specialist, at email address: bonnie.sheehan@va.gov. Your response should include the STATEMENT OF CAPABILITY, GSA SCHEDULE INFORMATION, and BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained above. Please place "Attention: Vascular Sealants" in the subject line of your email. Disclaimer: The purpose of this RFI is to assist VA in conducting market research to determine potential sources of supply, and does not commit or bind the Government under any circumstances. This RFI does not constitute any obligation whatsoever on the part of the Government to procure these commodities/supplies, to issue a solicitation, or to notify respondents of the results of this notice. No solicitation documents exist at this time. VA is neither seeking proposals nor accepting unsolicited proposals. Responses to this RFI cannot be accepted by the Government to form a binding contract. Any information the vendor considers proprietary should be clearly marked as such. The U.S. Government will not pay for any information or administrative cost incurred in response to this RFI. ? Minimum Technical Requirements Vascular Sealants: Albumin and Glutaraldehyde Tissue Adhesiveused only as adjuvant therapy for hemostasis of large blood vesselsEvaluation Method MTR 1Must bond to tissue in 2-3 minutesLiterature Review and Physical Inspection MTR 2Polymerization occurs in approximately 5 - 180 secondsLiterature Review MTR 3Demonstrated to seal leak pressures of [660 +/- 150] mmHg Literature Review MTR 4Sealing and hemostasis unaffected by patient's coagulation statusLiterature Review MTR 5Successfully adheres to synthetic materialsLiterature Review MTR 6Does not produce an adverse tissue response and resorbs fully in 4 weeksLiterature Review MTR 7Self-contained, disposable delivery system requiring no thawing, reconstitution or manual mixing. Literature Review MTR 9If product is packaged sterile; label must indicate that the product is sterile.Literature Review and Physical Inspection MTR 10Must be marked as single use.Literature Review and Physical Inspection MTR 11Sterility date/expiration date must be clearly marked on the exterior packaging.Literature Review MTR 12Lot/serial number must be clearly marked on the exterior packaging.Literature Review and Physical Inspection MTR 13Must be in a single use dosage measuring from a range of 1 ml to 10 mlLiterature Review
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/95d51a40599aed7c2502198ddfbbf8fb)
- Document(s)
- Attachment
- File Name: VA119-15-Q-0159 VA119-15-Q-0159_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1936039&FileName=VA119-15-Q-0159-000.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1936039&FileName=VA119-15-Q-0159-000.docx
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: VA119-15-Q-0159 VA119-15-Q-0159_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1936039&FileName=VA119-15-Q-0159-000.docx)
- Record
- SN03677763-W 20150326/150324235540-95d51a40599aed7c2502198ddfbbf8fb (fbodaily.com)
- Source
-
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