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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 09, 2017 FBO #5557
DOCUMENT

65 -- Consignment St Jude Medical - 660 554 - Justification and Approval (J&A)

Notice Date

2/7/2017
 

Notice Type

Justification and Approval (J&A)
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office;NCO 19;4100 E. Mississippi Avenue, Suite 900;Glendale CO 80246
 

ZIP Code

80246
 

Solicitation Number

VA25917Q0139
 

Archive Date

1/28/2017
 

Point of Contact

KIM COOPER
 

E-Mail Address

OPER3@VA.GOV<br
 

Small Business Set-Aside

N/A
 

Award Number

VA259-17-A-0009
 

Award Date

12/29/2016
 

Description

Chapter VI: Other Than Full and Open Competition (OFOC) SOP Attachment 3: Request for Sole Source Justification Format >$150K OFOC SOP Revision 05 Page 2 of 3 Original Date: 03/22/11 Revision 05 Date: 05/02/2016 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>$150K) Acquisition Plan Action ID:_ VA259-16-AP-4685 and VA259-17-AP-0889 Contracting Activity: Department of Veterans Affairs, VISN 19, on behalf of Salt Lake City Medical Center and Denver VA Medical Center Nature and/or Description of the Action Being Processed: The VA Salt Lake City Health Care System (VASLCHCS) and VA Eastern Colorado Health Care (VHAECHS) are requesting a consignment agreement for the selected St Jude Medical Tissue mechanical valves. The proposed action is for a sole source acquisition with St Jude Medical. VASLCHCS and VHAECHS have a need for prosthetics implant appliances based upon a physician s determination of medical necessity for use during surgical services and/or procedures. The objective is to ensure availability of implants for usage and to enhance the quality of care we provide to our veterans, leverage spending, and maximize efficiency. Description of Supplies/Services Required to Meet the Agency s Needs: The supplies to be acquired are various types of medical tissue (heart) mechanical valves under Just-In-Time (JIT), and Consignment delivery methods. Under the JIT delivery method, the Medical Treatment Facility (MTF) will contact the respective St Jude Medical representative when a surgery is scheduled to discuss the case, make a product selection from St Jude Medical product line, and inform the sales representative of the surgery date and time. The sales representative will transport the implants, auxiliary products and back-up components necessary for surgery to the designated site at the scheduled time. The period of performance is a 2 year Blanket Purchase Agreement with Consignment and JIT language. The estimated value of this acquisition is $352,000.00. This estimate is based on historical pricing and a vendor-provided quote. 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; Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): In accordance with 38 U.S.C. 8123, the Secretary may procure prosthetic appliances and necessary services required in the fitting, supplying, and training and use of prosthetic appliances by purchase, manufacture, contract, or in such other manner as the Secretary may determine to be proper, without regard to any other provision of law. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Utilizing the authority in 38 U.S.C, 8123 and 41 U.S.C. 253(c)(5), it is appropriate to award this acquisition to St Jude Medical without regard to any other provisions of law, to include full and open competition. As required by Far 5.2, this action will be synopsized through FedBizOpps. In addition, this justification will be published with the solicitation in accordance with FAR 6.305(a). Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: Determination of fair and reasonable pricing will be made at the time of award. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted with implant manufacturers, and it revealed that each manufacturer s implants and surgical procedures are unique and proprietary. A physician s decision to use a particular manufacturer s implant is based on physician determination of medical necessity/experience. Using a particular manufacturer s prosthetic implants requires highly specialized training on the part of the physician. Once trained and comfortable with a particular manufacturer s implants, the physician will likely use that manufacturer s product for the duration of their career. In addition, auxiliary products are distributed by the manufacturer since they are an essential part of the procedural package and required at the time of surgery. This provides the physician with all necessary products needed to complete the surgery. Any Other Facts Supporting the Use of Other than Full and Open Competition: A physician s decision to use a particular manufacturer s implants is based on the technical characteristics of the implant that is expected to produce a higher quality of life for the patient or achieve certain therapeutic results. The use of a particular manufacturer s implants requires highly specialized training on the part of the physician. In the prosthetic implant industry, product selection is based on physician preference/experience ; whereby, other factors that would normally affect the decision to purchase an item, such as price and delivery, are not considered when ordering. Once trained and comfortable with a particular manufacturer s implants, the physician will likely use that manufacturer s products for the duration of their career. There are no other manufacturers or distributors other than St Jude Medical who can provide VA hospitals with the complete procedural package for surgery with a representative available onsite, if needed, to answer questions on St Jude implant products. The St Jude sales representatives are experts on the vendor s product and are a vital part of helping to ensure that the patient is getting the necessary treatment. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None. 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: At this time there are no other actions that can be taken to increase competition. The requirement for St Jude Medical products are based on physician determination of medical necessity/experience. 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. _____________________________ ________________________ Name Date Title Facility _____________________________ ________________________ Name Date Title Facility Approvals in accordance with the VHAPM, Volume 6, Chapter VI: OFOC SOP. Contracting Officer or Designee s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ David Geary Date Supervisory Contracting Officer NCO-19 Commodities West Director of Contracting /Designee (Required over$150K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ Curtis Jordan Date NCO-19 Director of Contracting or Designee NCO-19
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VARMCCC/VARMCCC/VA25917Q0139/listing.html)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA259-17-Q-0139 VA259-17-Q-0139.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3259970&FileName=VA259-17-Q-0139-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3259970&FileName=VA259-17-Q-0139-000.docx

 

File Name: VA259-17-Q-0139 P03 JA.doc (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3259971&FileName=VA259-17-Q-0139-001.doc)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3259971&FileName=VA259-17-Q-0139-001.doc

 

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

Record

SN04393785-W 20170209/170207235031-be4625f135543c0717c9985dee0e76c0 (fbodaily.com)
 

Source

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

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