Loren Data's SAM Daily™

FBO DAILY ISSUE OF SEPTEMBER 15, 2011 FBO #3582
DOCUMENT

65 -- Impella 5.0mm set - Justification and Approval (J&A)

Notice Date

9/13/2011
 

Notice Type

Justification and Approval (J&A)
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

Department of Veterans Affairs;VA Boston Healthcare System;Contracting Officer (90C);940 Belmont Street;Brockton MA 02301
 

ZIP Code

02301
 

Solicitation Number

VA24111RQ1223
 

Archive Date

8/29/2011
 

Point of Contact

Christopher Humphrey
 

Small Business Set-Aside

N/A
 

Award Number

VA523A10866
 

Award Date

8/15/2011
 

Description

Attachment B: 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 1, Boston VA Medical Center 2.Nature and/or Description of the Action Being Processed: This request is for an Impella 5.0 catheter-base device providing the most clear and important clinical advantages for cardiac surgery patients as described in #3. 523-11-4-7910-2570 3.Description of Supplies/Services Required to Meet the Agency's Needs: This device is used to meet specific even life-saving patient needs relating to: 1.Hemodynamic support and reduced workload on the heart during invasive cardiac procedures 2.Intravascular microaxial blood pump delivering up to 5.0 L/min of forward flow blood from the left ventricle to the aorta. 3.Also may be used in lieu of open chest procedures 4.The availability of the Impella recently may have been contributed to avoiding a patient death. Immediate purchase will ensure that the maximum benefit to these types of challenging cases. 4.Statutory Authority Permitting Other than Full and Open Competition: ( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; ( x ) (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): Contractor is manufacturer of this specific device. This device is need as soon as possible for upcoming procedure. 6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Abiomed is the sole producer and provider of an FDA approved minimally invasive cardiac support systems for use with low cardiac output after cardiac surgery. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The total cost of this requirement is $28,055.00. Market research was performed. The Impella products are trademarked by Abiomed. The Contracting Officer determined that the anticipated price will be fair and reasonable based on the fact that Abiomed is the sole manufacturer of this set and the set is not available for sale through any other vendor. In addition the set is needed for an upcoming procedure and any delay will affect patient care. 8.Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: In addition to extensive consideration of contracted sources, this specific device is not available from non-contracted sources. 9.Any Other Facts Supporting the Use of Other than Full and Open Competition: In that no other product is available, other surgical procedures have been considered and eliminated as viable possibilities. 10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: See Section VI above. 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: Contracting Activity will continue to encourage brand name of equivalent specifications.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/BoVAMC/VAMCCO80220/VA24111RQ1223/listing.html)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA-241-11-RQ-1223 VA-241-11-RQ-1223.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=255215&FileName=VA-241-11-RQ-1223-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=255215&FileName=VA-241-11-RQ-1223-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN02574474-W 20110915/110914000602-f03f91dda6d6fd5a67d6ec721422cb8c (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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