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FBO DAILY - FEDBIZOPPS ISSUE OF JANUARY 04, 2015 FBO #4789
DOCUMENT

65 -- Transcatheter Heart Valves Edwards Lifesciences - Justification and Approval (J&A)

Notice Date

1/2/2015
 

Notice Type

Justification and Approval (J&A)
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Ann Arbor Healthcare System;Network 11 Contract Office;2215 Fuller Road;Ann Arbor MI 48105
 

ZIP Code

48105
 

Solicitation Number

VA25115Q0092
 

Archive Date

4/11/2015
 

Point of Contact

Robert Kay
 

E-Mail Address

5-5591<br
 

Small Business Set-Aside

N/A
 

Award Number

VA251-15-C-0023
 

Award Date

1/2/2015
 

Description

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>$150K) 1.Contracting Activity: Department of Veterans Affairs, VISN 11, VA Ann Arbor Medical Center Network 11 Contracting, 506-15-1-041-0311. 2.Nature and/or Description of the Action Being Processed: Sole Source Justification for a new, Firm Fixed price contract for 12 ea Edwards Lifesciences Saipen XT Transcatheter heart valves, related equipment. $390,000.00. FAR13.5 Test Program: This procurement is for Transcatheter Heart Valves in accordance with FAR 13.5 Test Program for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. 3.Description of Supplies/Services Required to Meet the Agency's Needs: 12 ea Edward Lifescience Transcatheter Heart Valves, Saipen XT, Transfemeral and Direct Aortic, 23, 26 and 29mm sizes, and related equipment and training, delivered by 1/6/2015. $390,000.00. Edwards Lifesciences, 1 Edwards Way, Irvine, CA 92614. 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; FAR13.5 Test Program: The authority for applying the Commercial Test Program of FAR 13.5 is (Section 4202 of the Clinger-Cohen Act of 1996) and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2). 5.Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Edwards Lifesciences is the only vendor that assists their customers with the training process, on-site support, and hands-on experience that is required when starting this process as new users of transcather heart valves. Edwards provides on-site and off-site training at no cost to the organization. All of the physicians that will be implanting these valves have been trained by Edwards Lifesciences. Edwards has already provided 5 days of on-site training and support for the nursing and technical staff in our Cath Lab. They will continue to be on-site in order to assist the staff through the first 20 procedures. Medtronic does not offer any of this on-site training and ongoing on-site support for new users and new clinics. Medtronic's sales model is to sell their transcatheter heart valves to clinics already experianced in this procedure. Our new clinic with so many inexperienced staff members, we can only use the Edwards Sapian XT heart valves as Edwards provides superior training and support. 6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A market study of FSS and open market sources was conducted and an intent to sole source was published to FBO, with negative responses. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The Price for the valves are fair and reasonable based on prices other VA's have paid, The San Antonio VAMC purchased Sapian XT heart valves for similar pricing, VA257-12-C-0137 for $260,000.00. 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, both GSA and open market, there are two maufacturers FDA approved for transcatheter heart valves, Edwards Lifesciences and Medtronic. An Intent to sole source was published to FBO, with negative responses. 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: Edwards Lifesciences. 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. _____________________________ ________________________ NameDate Title Facility 13.Approvals in accordance with the VHAPM, Volume 6, Chapter VI: OFOC SOP. 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 Facility b.Director of Contracting /Designee (Required $150K and above): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ NameDate NCO/PCO XX Director of Contracting or Designee Facility
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VAAAHCS506/VAAAHCS506/VA25115Q0092/listing.html)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA251-15-C-0023 VA251-15-C-0023_2.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1796711&FileName=VA251-15-C-0023-001.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1796711&FileName=VA251-15-C-0023-001.docx

 

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

Record

SN03607664-W 20150104/150102233431-8c1358b4c48c4c5b8510cf35f920df78 (fbodaily.com)
 

Source

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

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