DOCUMENT
65 -- FDG 18 RADIOPHARMACEUTICAL - Justification and Approval (J&A)
- Notice Date
- 10/2/2014
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 325992
— Photographic Film, Paper, Plate, and Chemical Manufacturing
- Contracting Office
- Department of Veterans Affairs;VA Caribbean Healthcare System;Administrative Building;#10 Calle Casia Suite #4M440;San Juan PR 00921-3201
- ZIP Code
- 00921-3201
- Solicitation Number
- VA24815Q0008
- Archive Date
- 11/1/2014
- Point of Contact
- Rolando Arce
- E-Mail Address
-
81-8700
- Small Business Set-Aside
- N/A
- Award Number
- 672A50005
- Award Date
- 10/2/2014
- Description
- Attachment 2: Request for Sole Source Memo Format DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1.Contracting Activity: Department of Veterans Affairs, VISN 8, VACHS SAN JUAN Medical Center Justification for Other Than Full and Open Competition RQ. 672-15-5-044-0002. 2.Nature and/or Description of the Action Being Processed: Procurement of Radiopharmaceuticals FDG 18 for patient studies this is a new onetime purchase order to be done on a firm fixed price 3.Description of Supplies/Services Required to Meet the Agency's Needs: FDG 18 is a radiopharmaceutical used to conduct patient studies. Estimated quantity to be acquired are 250 units at a cost of $375.00 each total cost will be $93,750.00 to cover the 1th quarter of this FY. 4.Statutory Authority Permitting Other than Full and Open Competition: FAR 6.302-1 (a) (2) (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): There are two companies that can provide the above goods a large business Mallinckrodt and 'LANTHEUS Radiopharmaceutical a small business. To help meet VA socioeconomics goal this procurement will be issued to 'LANTHEUS radiopharmaceutical the only responsible Small business on the local market that can fulfill the service needs. This radiopharmaceutical is licensed by the U.S. Nuclear Regulatory Commission for distribution to persons licensed pursuant to the Code of Federal Regulations (CFR) for radioactive material specified in 10 CFR 35, as appropriate, or under equivalent regulations of an Agreement State or a Licensing State. FDG 18 Radiopharmaceutical after have been diluted to unit dose have a shelf life of 90 minutes, this short life spam makes it impossible to acquire these goods outside of Puerto Rico, by the time the goods arrived the shelf life of these goods will be expired. 6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: These requirement have been competed before and it was found that there are only two companies on the market as stated above and out of these two companies 'LANTHEUS Radiopharmaceuticals has provided the best value to the Government and their company being a small business helps to achieve VA socioeconomic goals. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: Anticipated cost for this order is $93,750.00 price is Fair and reasonable and compare to government estimates and prior procurements. 8.Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Researched mandatory sources and found that the item requested is not under contract; prior procurement shows the goods available on the open market at fair and reasonable pricing. 9.Any Other Facts Supporting the Use of Other than Full and Open Competition: The items requested are used for patient studies, the lack of these goods will require the facility to send these patients to get these studies on a fee basis increasing the cost to the facility and delaying patient care and diagnostic of disease or illness. 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: At this time there are no actions the facility may take to increase competition, we will keep an eye out for new small business companies that may become active and may provide this good. 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. (This signature is the requestor's supervisor, fund control point official, chief of service, someone with responsibility and accountability) _____________________________ 08/28/2014 Bordewyk, MDDate itle : Chief of Nuclear Medicine Facility: VACHS 13.Approvals in accordance with FAR 6.304 This part if filled out by Contracting Staff as part of the Justification a.Contracting Officer's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ 09/02/2014 Name: Rolando ArceDate Title: Contracting Officer Facility: VACHS b.Product Line Supervisor Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ 09/02/2014 Name: Jose HernandezDate Title: PLS San Juan Facility: VACHS San Juan c.CONCUR / NON-CONCUR (over$150,000 o $650,000): I recommend / do not recommend approval. _____________________________ ________________________ NameDate NCO 8 Compliance Officer d.DOC (required $150,000 to$650,000): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ NameDate Director of Contracting VISN 8 Tampa VAMC
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/SJVAMC672/SJVAMC672/VA24815Q0008/listing.html)
- Document(s)
- Justification and Approval (J&A)
- File Name: VA248-15-Q-0008 VA248-15-Q-0008_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1662625&FileName=VA248-15-Q-0008-000.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1662625&FileName=VA248-15-Q-0008-000.docx
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: VA248-15-Q-0008 VA248-15-Q-0008_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1662625&FileName=VA248-15-Q-0008-000.docx)
- Record
- SN03541334-W 20141004/141002235220-5baa9e78791371053cb3ea37188f920c (fbodaily.com)
- Source
-
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