DOCUMENT
65 -- PLEURAL SEALANT KIT (PROGEL) NEOMEND - Justification and Approval (J&A)
- Notice Date
- 1/14/2014
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- Contracting Office
- Department of Veterans Affairs;Ann Arbor Healthcare System;Network 11 Contract Office;2215 Fuller Road;Ann Arbor MI 48105
- ZIP Code
- 48105
- Archive Date
- 4/19/2014
- Point of Contact
- Robert Kay
- E-Mail Address
-
5-5591<br
- Small Business Set-Aside
- N/A
- Award Number
- VA251-14-P-0772
- Award Date
- 1/10/2014
- Description
- Attachment 2: Request for Sole Source Memo Format DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1.Contracting Activity: Department of Veterans Affairs, VISN 11, Ann Arbor, VA Medical Center 506-14-1-022-0582, Davol, Inc. 2.Nature and/or Description of the Action Being Processed: Progel, Pleural Air Leak Sealant Kit, Vascular Closure Device. This helps seal any air leaks in the lungs after surgery. 3.Description of Supplies/Services Required to Meet the Agency's Needs: $3,400. Davol, Inc. Delivery date 1/15/2014. Diagnosis of lung cancer often requires surgical removal of lung tumors. After tumors are removed, air leaks can develop around the suture or staples used to close the surgical site. Currently applying a surgical mesh stops the air leak; however some patients' lung tissue is too fragile, for these patients the Pleural Air Leak Sealant Kit-Progel- is used. This provides better patient outcomes. 4.Statutory Authority Permitting Other than Full and Open Competition: (X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; 5.Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Only One Responsible Source (FAR 6.302-1) Davol is the only vendor that offers an FDA approved product--Progel-- for sealing of air leaks following a lung resection. Currently we purchase the accessories for this device from Davol and require the continuity of using the items made to work together. 6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A market study was completed, Henry Schein and Owens and Minor distribute this product according to the manufacturer but were unable to provide this product when contacted. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: $3,400.00. This price is fair and reasonable based on historical pricing for this item, Purchase Order 506A30014 awarded 10/22/2012 shows the same price for this item, $3,400.00 per box. 8.Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: A market study was completed. Davol is the only vendor that offers an FDA approved product--Progel-- for sealing of air leaks following a lung resection. 9.Any Other Facts Supporting the Use of Other than Full and Open Competition: None 10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None 11.A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Should another requisition of this nature reoccur, we would undertake a new market survey. 12.Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ Name:Date Title: Facility: 13.Approvals in accordance with FAR 6.304 a.Contracting Officer's Certification: (required) I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ NameDate Title Network 11 Contract Office b.NCM/PCM (Required $3K and above): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ Name Date NCM/Supervisory Contract Specialist (as appropriate) Network 11 Contract Office
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- Document(s)
- Justification and Approval (J&A)
- File Name: VA251-14-P-0772 VA251-14-P-0772_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1159471&FileName=-2966.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1159471&FileName=-2966.docx
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- Record
- SN03267868-W 20140116/140114234805-7e2e5e5fa8f4c83d56abfc0ebe97952c (fbodaily.com)
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