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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 17, 2016 FBO #5381
DOCUMENT

65 -- 506-16-4-984-1423 - Heart Valve Replacement - Justification and Approval (J&A)

Notice Date

8/15/2016
 

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 Contracting Office 10;2215 Fuller Road;Ann Arbor MI 48105
 

ZIP Code

48105
 

Solicitation Number

VA25016Q0539
 

Archive Date

9/12/2016
 

Point of Contact

Michele R. Bartelt, Contract Specialist
 

Small Business Set-Aside

N/A
 

Award Number

VA250-16-Q-0539
 

Award Date

8/13/2016
 

Description

JUSTIFICATION FOR SINGLE SOURCE AWARDS IAW FAR 13.106-1 (OVER MICRO-PURCHASE THRESHOLD($3.5K) BUT NOT EXCEEDING THE SAT ($150K)) IAW FAR13.104, COs must promote competition to the maximum extent practicable to obtain supplies and services from the source whose offer is the most advantageous to the Government, considering the administrative cost of the purchase. When competition is not practicable, IAW FAR13.106-1(b), COs solicit from a single source for purchases not exceeding the simplified acquisition threshold. COs may solicit from one source if the CO determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). IAW FAR13.106-3(b)(3),COs are required to include additional statements explaining the absence of competition (see 13.106-1 for brand name purchases) if only one source is solicited and the acquisition does not exceed the simplified acquisition threshold (does not apply to an acquisition of utility services available from only one source) or supporting the award decision if other than price-related factors were considered in selecting the supplier. This template when completed can be used to document single source awards IAW FAR13.106-3(b)(3). Note: Statements such as "only known source" or "only source which can meet the required delivery date" are inadequate to support a sole source purchase. 1. ACQUISITION PLAN ACTION ID: VA250-16-AP-59971A. PROJECT/TASK No. Not Applicable1B. ESTIMATED AMOUNT: $32,500.00 2. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE: This solicitation is to purchase the surgical implant supplies already in place within the Cardiology Department that includes the following products: one (1) Transcatheter Heart Valve, Saipen XT, Transfermeral and Direct Aortic, 29mm. Surgically implanted products are specified by the clinical team to meet the unique and comprehensive needs of each Veteran patient with an identified medical indication. These items are purchased directly from Edwards Lifesciences located at 1 Edwards Way, Irvine, CA 92614. This item is required on or before August 17, 2016. 3. UNIQUE CHARACTERISTICS THAT LIMIT AVAILABILITY TO ONLY ONE SOURCE, WITH THE REASON NO OTHER SUPPLIES OR SERVICES CAN BE USED: The Transcatheter Heart Valve, Saipen XT, Transfermeral and Direct Aortic Valve, 29mm has been determined by the clinical team to be the best product to treat the Veteran patient's medical condition and functional limitations. Substituting an implant with other than that specifically prescribed is detrimental to the treatment of the Veteran patient. In this case the Transcatheter Heart Valve, Saipen XT, Transfermeral and Direct Aortic Valve, 29mm is the specific prescription and method of treatment required for the Veteran-patient. Every surgery is unique to the Veteran requiring different components to be used based on the needs of the veteran. This item is proprietary to Edwards Lifescience, located at: 1 Edwards Way, Irvine, CA 92614, which is the sole distributor and manufacture of this implantable device. In addition, Edwards Lifesciences is the only vendor that assists customers with the training process, on-site support, and hands on experience that is required when starting this process as new users of the Transcatheter Heart Valves. This is done at no cost to the VA. 4.DESCRIPTION OF MARKET RESEARCH CONDUCTED AND RESULTS OR STATEMENT WHY IT WAS NOT CONDUCTED: Market Research was conducted based on the medical determination described within this single source justification and none of the small businesses located under NAICS Code 339112 are not authorized to receive or deliver orders for this product. 5.Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Note: COs are required to make a determination of price reasonableness IAW FAR 13.106-3. See the Commercial Supply and Service SOP for Price Reasonableness templates. Digitally signed by Michele R. Bartelt 949984 DN: dc=gov, dc=va, o=internal, ou=people, 0.9.2342.19200300.100.1.1=michele.bartelt@va.gov, cn=Michele R. Bartelt 949984 Date: 2016.08.13 16:26:53 -04'00' Signature:Date: 08/13/2016 Name: Michele Bartelt Title: Contract Specialist Facility: Network 10 Contracting Office James J. Hallock 320728 Digitally signed by James J. Hallock 320728 DN: dc=gov, dc=va, o=internal, ou=people, 0.9.2342.19200300.100.1.1=james.hallock@ va.gov, cn=James J. Hallock 320728 Date: 2016.08.13 17:08:41 -04'00' Signature:Date: 08/13/2016 Name: James J. Hallock Title: Supervisory, Contracting Officer Facility: Network 10 Contracting Office
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VAAAHCS506/VAAAHCS506/VA25016Q0539/listing.html)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA250-16-Q-0539 VA250-16-Q-0539_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2942524&FileName=VA250-16-Q-0539-001.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2942524&FileName=VA250-16-Q-0539-001.docx

 

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

Record

SN04224901-W 20160817/160815235859-b9feef922be98acdd5fe0b9c2e1232f1 (fbodaily.com)
 

Source

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

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