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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 24, 2014 FBO #4564
DOCUMENT

65 -- 580-14-3-167-0411 - TVC Imaging System (Houston) - VA256-14-AP-5418 - Justification and Approval (J&A)

Notice Date

5/22/2014
 

Notice Type

Justification and Approval (J&A)
 

NAICS

334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing
 

Contracting Office

DEPARTMENT OF VETERANS AFFAIRS;ALEXANDRIA VA HEALTH CARE SYSTEM;P&C DEPARTMENT (90C);PO BOX 69004;ALEXANDRIA LA 71360-9004
 

ZIP Code

71360-9004
 

Solicitation Number

VA25614Q0899
 

Archive Date

6/21/2014
 

Point of Contact

Paul G Filhiol
 

E-Mail Address

6-4206<br
 

Small Business Set-Aside

N/A
 

Award Number

VA256-14-P-2521
 

Award Date

5/22/2014
 

Description

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 16, Division II Supply Team, Site 502 Alexandria VAHCS proposes to issue a Purchase Order on a basis of Other Than Full and Open Compeition for the Cardiology Department at Michael E. DeBakey VA Medical Center (MEDVAMC), Houston, Texas; Transaction 580-14-3-167-0411 2. Nature and/or Description of the Action Being Processed: A new contracting action for issuing a firm fixed price simplified purchase order solicited to a single source, Infraredx Corp., a Small Business Manufacturer of Medical Cardiovascular Electrosurgical Equipment IAW FAR 13.106-1(b). 3. Description of Supplies/Services Required to Meet the Agency's Needs: This requirement is for the purchase of the TVC Imaging System. It is a unique and powerful diagnostic tool that will be used for thorough assessment of plaque structure and composition. This is the only dual mode catheter on the market for interrogating the coronary arteries. The system combines IVUS and NIRS technology to provide the only FDA indicated catheter used in detecting lipid core plaques (LCP's.) These LCP's have been shown in peer reviewed journal articles to complicate stenting procedures. In addition, there are case reports and new clinical research that indicates these LCP's may affect short and long term stent durability. Ultimately, this technology and infraredx are focused on identifying vulnerable plaques. These are marginal lesions with thin caps and large lipid pools which are prone to rupture. These vulnerable plaques are the cause of 2/3 of all MI's occurring in the world today. The system works in much the same way our traditional IVUS system and catheter works, but provides broader, more comprehensive information about the patient's arteries. This device is compatible with the interventional cardiology OCT and IVUS imaging machine owned by the MEDVAMC. a)TVC Imaging System MC8: 1 each at $95,000.00 each = total estimated cost of $95,000.00 b)TVC Insight Catheter MC8: 3 each at $2550.00 = total estimated cost of $7,650.00 c)TVC Sterile Accessory Kit MC8: 3 each at $0 = total estimated cost of $0 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): This transaction is for the purchase of the TVC Imaging System. It is a unique and powerful diagnostic tool that will be used for thorough assessment of plaque structure and composition. This is the only dual mode catheter on the market for interrogating the coronary arteries. The system combines IVUS and NIRS technology to provide the only FDA indicated catheter used in detecting lipid core plaques (LCP's.) These LCP's have been shown in peer reviewed journal articles to complicate stenting procedures. In addition, there are case reports and new clinical research that indicates these LCP's may affect short and long term stent durability. Ultimately, this technology and infraredx are focused on identifying vulnerable plaques. These are marginal lesions with thin caps and large lipid pools which are prone to rupture. These vulnerable plaques are the cause of 2/3 of all MI's occurring in the world today. The system works in much the same way our traditional IVUS system and catheter works, but provides broader, more comprehensive information about the patient's arteries. This device is compatible with the interventional cardiology OCT and IVUS imaging machine owned by the MEDVAMC. a.Only One Responsible Source (FAR 6.302-1) Infraredx, Inc is the only company capable of providing the supplies and services decribed in Section III above without the Veteran's Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirments. 6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The MEDVAMC Cardiology staff is very cognizant of products on the market for these type of interventional cardiology procedures. At this time, Infraredx has the only TVC Imaging System that is compatible with the MEDVAMC's OCT and IVUS imaging machine. 7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: This item is sold on the commercial market and a commercial pricing comparison can determine the pricing to be fair and reasonable. Two systems have been purchased by the VHA in 2012 and 2013 which can be compared to the pricing offered on this purchase. 8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The MEDVAMC Cardiology staff is very cognizant of products on the market for these type of interventional cardiology procedures. At this time, Infraredx has the only TVC Imaging System that is compatible with the MEDVAMC's OCT and IVUS imaging machine. 9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Infraredx is an SBA Certified Small Business. 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: We will continue to survey the market for competitive items which may offer an equal or higher standard of care for our Veteran population. 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. _____________________________ ________________________ Jeremiah Jackson Date Supervisory Health System Specialist Michael E. DeBakey VA Medical Center, Houston, TX 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. _____________________________ ________________________ PAUL FILHIOLDate Contracting Officer NCO 16, Division II Supply, Site 502 Alexandria b. P&C: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ MICHEL E. LEWISDate Chief, Purchasing And Contracting NCO 16 DIVISION II SUPPLY SITE 502 ALEXANDRIA
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/AlVAMC502/AlVAMC502/VA25614Q0899/listing.html)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA256-14-P-2521 VA256-14-P-2521_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1379938&FileName=-3683.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1379938&FileName=-3683.docx

 

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

Record

SN03374599-W 20140524/140522235829-5bc738cfda4bff1869860133fdb3acf7 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
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