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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 31, 2013 FBO #4267
DOCUMENT

65 -- RECOVERY 65--HeartWare VAD Implant Kits - Justification and Approval (J&A)

Notice Date

7/29/2013
 

Notice Type

Justification and Approval (J&A)
 

NAICS

334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 6;100 Emancipation Drive;Hampton VA 23667
 

ZIP Code

23667
 

Solicitation Number

VA24613R1120
 

Archive Date

6/30/2013
 

Point of Contact

Darryl Person
 

E-Mail Address

8-7020<br
 

Small Business Set-Aside

N/A
 

Award Number

VA246-13-C-0093
 

Award Date

5/1/2013
 

Description

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1.Contracting Activity: Department of Veterans Affairs, VISN 6, Network Contracting Office, VA Medical Center, Richmond, Virginia. The 2237 number is 652-13-2-164-0035. 2.Nature and/or Description of the Action Being Processed: This is an other than full and open competition request for procurement of two HeartWare ventricular assist device units for implantation in patients at the McGuire VA Medical Center. 3.Description of Supplies/Services Required to Meet the Agency's Needs: The McGuire VA Medical Center presently has cardiac patients waiting to undergo Left Ventricle Assist Devices (LVAD) placement surgery. There are only two LVAD long term devices approved by the FDA in the United States; HeartMate and Thoratec implantable devices. These units are now in use for end-stage heart failure patients. The Medical Center has a need to have both devices ready and available at all times. VAMC Richmond is the only VA Medical Center in the country that is implanting and managing patients with LVADs. There are certain clinical indications which would make the HeartWare a more suitable option for patients than the Thoratec unit; conversely some patients are better candidates for Thoratec unit. A separate VA Form 90-2237 (652-13-2-164-0045) has been issued by the service for the purchase of the Throratec implantable Device. The HeartWare system offers our Veterans an alternative (and in certain cases, more clinically appropriate) option for their left ventricular device implant. Estimated Cost: $263,450.00 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): HeartWare is the sole manufacturer of this equipment and is currently the only company capable of providing the required maintenance and service to their devices. 6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Sources Sought was issued on FBO. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The cost is deemed fair and reasonable as it represents a 10% discount off the list price. 8.Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Sources Sought Published to FBO. Thoratec the only other company that make long term LVAD's responded to the Sources Sought. 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: Thoratec Corporation. 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: Under the authorities and actions cited above, there are no actions to be taken to overcome barriers to competition. 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. ____________________ Kevin Buser Date Chief, Materiel Management Service RiCVAMC ? 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. _____________________________ __________________________ Darryl T. PersonDate Contracting Officer VISN 6 NCO b. NCM/PCM: I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ SIGNATURE DATE JEFFERY A. BENTON VISN 6, COMMODITY TEAM LEAD (DESIGNEE)
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/HaVAMC/VAMCCO80220/VA24613R1120/listing.html)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA246-13-R-1120 VA246-13-R-1120_3.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=902264&FileName=VA246-13-R-1120-001.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=902264&FileName=VA246-13-R-1120-001.docx

 

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

Record

SN03129893-W 20130731/130729234439-9cf5948a672257db440f01d004c1f26c (fbodaily.com)
 

Source

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

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