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FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 17, 2017 FBO #5777
DOCUMENT

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

Notice Date

9/15/2017
 

Notice Type

Justification and Approval (J&A)
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 10;3140 Governor ™s Place Blvd. Suite 210;Kettering OH 45409-1337
 

ZIP Code

45409-1337
 

Solicitation Number

VA25017Q0697
 

Archive Date

10/13/2017
 

Point of Contact

Angie Carpenter
 

Small Business Set-Aside

N/A
 

Award Number

VA250-17-P-4296
 

Award Date

9/13/2017
 

Description

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >$150K Acquisition Plan Action ID: VA250-17-AP-9436 OFOC SOP Revision 06 Page 1 of 4 Original Date: 03/22/11 Revision 06 Date: 08/30/2017 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>$150K) Acquisition Plan Action ID: VA250-17-AP-9436 Contracting Activity: Department of Veterans Affairs, VISN 10, Louis Stokes Cleveland VA Medical Center, Network Contracting Office 10. The 2237 is #541-17-3-924-6067. Nature and/or Description of the Action Being Processed: Sole source justification and approval (J&A) for awarding a new firm-fixed price, one-year contract for the acquisition of St. Jude Heart Valves and Annuloplasty Rings to support the cardiac surgery program. Description of Supplies/Services Required to Meet the Agency s Needs: St. Jude prosthetic heart valves are required and indicated for use as replacement valves in patients with a diseased, damaged, or malfunctioning native or prosthetic valve so that they can be inserted quickly to preserve life and reduce risk to patients. The estimated value is $696,711.00 and the estimated delivery date is to be one (1) day after receipt of order. The Cleveland VA Medical Center requires lifetime dating on their products, resulting in no expiration and no future re-sterilization fees. 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): a. Only One Responsible Source (FAR 6.302-1) The requested products are of a proprietary nature, St. Jude Medical is the only known source. St. Jude Medical Aortic and Mitral Replacement Heart Valves of various models and sizes are required. Surgeons choose the brand, model, and size of valve to be used during their consult with the patient and when the patient is in the operating room. This determination by the surgeon is made to give the patient the best chance at the best outcome possible. Additionally, 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. Additionally, a sources sought was submitted through FBO which returned no responses. Based on the above information, additional research and solicitation would add unacceptable delays in fulfilling the agency s requirements. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: During market research, a search was conducted through VIP, VA NAC, GSA, and other contract schedules to identify any products under contract. A Sources Sought Notice, RFQ #VA250-17-Q-0697, was posted to FBO on Friday, August 4th 2017, and closed on Friday, August 11th 2017. The notice was submitted for the purpose of conducting market research to determine if there was a sufficient number to determine a set-aside; in addition, salient characteristics were submitted for various sizes of heart valves and annuloplasty rings. No responses were received from the Sources Sought Notice. An internet search was conducted on the open market which identified one large company, St. Jude Medical, that carried these products. There is no competition anticipated for this acquisition. The requested replacement heart valves are only available from one source. 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 Subpart 5.2, this action will be synopsized through FedBizOpps. Further, this justification will be published within 14 days after contract award in accordance with FAR 6.305(a). Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Based on the comparison to the manufacturers pricelist and the independent market research, along with previously awarded contracts, it is anticipated that the proposed pricing will be fair and reasonable and in the best interest of the Government. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: As described in Section 6 above, market research, IAW FAR Part 10, was conducted by synopsis of the proposed acquisition, advising the industry of the pending acquisition and soliciting inquiries from interested parties. A Sources Sought Notice was submitted through FBO to identify any other sources that carried these specific heart valves. 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: 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: St. Jude Medical, S.C., Inc., Americas Division, 6300 Bee Cave Road, Bldg 2, Ste 100, Austin, TX 78746 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: Based on the professional medical judgement of the surgeons at Louis Stokes Cleveland VA Medical Center, an alternative product would not meet all of the specifications necessary to treat veterans congruent with their needs. In the future, new technology will be considered by other competitors and continuous market research is being conducted to overcome barriers while still meeting the needs of the patients. 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. Supervisory Management & Program Analyst Surgical Service Louis Stokes Cleveland VAMC Approvals in accordance with the VHAPM Part 806.3 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. _____________________________ ________________________ GINA CRANK Date Contracting Officer Network Contracting Office (NCO) 10 One Level Above the Contracting Officer (Required over$150K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ CONNIE MCKAY Date Branch Chief Supply Team #2 Network Contracting Office (NCO) 10
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/DaVAMC552/DaVAMC552/VA25017Q0697/listing.html)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA250-17-Q-0697 VA250-17-Q-0697_4.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3798148&FileName=VA250-17-Q-0697-001.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3798148&FileName=VA250-17-Q-0697-001.docx

 

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

Record

SN04679930-W 20170917/170915231530-f02f334091d2b35a0e9f0651962546f5 (fbodaily.com)
 

Source

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

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