Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF MAY 08, 2016 FBO #5280
DOCUMENT

65 -- Y-90 Theraspheres Notice of intent to sole source - Attachment

Notice Date

5/6/2016
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;Ralph H. Johnson VA Medical Center;109 Bee Street;Charleston SC 29403-5799
 

ZIP Code

29403-5799
 

Solicitation Number

VA24716R0454
 

Archive Date

6/20/2016
 

Point of Contact

Michael Giffon
 

E-Mail Address

9-6682<br
 

Small Business Set-Aside

N/A
 

Description

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>$150K) Acquisition Plan Action ID: VA247-15-AP-7813 1.Contracting Activity: Department of Veterans Affairs, VISN 7, VA Medical Center 2.Nature and/or Description of the Action Being Processed: Department of Veterans Affairs, VISN 7, Ralph H. Johnson VA Medical Center needs to purchase Y-90 Therasphere radioactive microspheres, direct patient supply items, to be used in Interventional Radiology at the Ralph H. Johnson VA Medical Center located in Charleston, SC. Yttrium-90 microspheres known as Theraspheres are used to treat primary liver cancer. Each dose is calibrated to be patient specific and is intended to prolong the patient's life while awaiting liver transplant. Biocompatibles, Inc. is the only company that can provide this type of radioactive sphere specific to primary liver cancer (hepatocellular cancer (HCC)) that is FDA approved. Due to the manufacturer's proprietary technology, there are no alternate vendors. This product can only be purchased from Biocompatibles, Inc., the manufacturer located at 115 Hurley Road, Building 3F, Oxford, Connecticut 06478. This request is for an IDIQ contract with a base year plus four option years for a total estimated value of $3,058,020.00. 3.Description of Supplies/Services Required to Meet the Agency's Needs: Year Timeframe Description/Part Number Qty PriceExtended Amount Base Year4/1/16-3/31/17YTTRIUM-90 THERASPHERES 3GBq-20GBq36$16,000.00$576,000.00 Option 14/1/17-3/31/18YTTRIUM-90 THERASPHERES 3GBq-20GBq36$16,480.00$593,280.00 Option 24/1/18-3/31/19YTTRIUM-90 THERASPHERES 3GBq-20GBq36$16,974.00$611,064.00 Option 34/1/19-3/31/20YTTRIUM-90 THERASPHERES 3GBq-20GBq36$17,483.00$629,388.00 Option 44/1/20-3/31/21YTTRIUM-90 THERASPHERES 3GBq-20GBq36$18,008.00$648,288.00 Total$3,058,020.00 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): Biocompatibles, Inc. is the only company that can provide Yttrium-90 Theraspheres that are FDA approved to treat primary HCC. There is no other company that can offer this product. There are no alternative outpatient treatment options for these specific patients that Y-90 is used being used for. It is a time-sensitive procedure and delay in treatment can impact a patient's disease progression. There are no other companies or brands generic or otherwise that can provide this highly specific and time sensitive treatment to these specific patients. This is a highly specialized procedure and only specific brand name Yttrium-90 Theraspheres provided by Biocompatibles, Inc., the manufacturer of this proprietary technology, can meet the patient's needs. This acquisition is essential to the government's requirements, thereby precluding consideration of a product manufactured by another company. Market research was conducted and Biocompatibles, Inc. is the only company that can provide this type of Yttrium-90 microspheres, known as Theraspheres, that can be used to treat primary hepatocellular carcinoma and is FDA approved. Although one other company, Sirtex Medical Limited, was found to offer Y-90 for treatment of liver tumors, Biocompatibles, Inc. is the only FDA-approved company for treatment of unresectable metastatic liver tumors from primary hepatocellular cancer. We would not be able to use the Y-90 product from Sirtex Medical Limited for treatment of our patients with HCC. 6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Sources Sought Notice will be posted to FedBizOps of the Government's intent to sole source this acquisition to Biocompatibles, Inc. This will allow any other firms that can meet this need and is FDA approved to submit their technical capabilities and be considered. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: Biocompatibles, Inc. is the sole source manufacturer of Yttrium-90 microspheres known as Theraspheres. Pricing offered will be compared to previous orders for this product. 8.Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market Research was conducted and Biocompatibles, Inc. is the only company that can provide this type of Yttrium-90 microspheres known as Theraspheres used to treat primary hepatocellular carcinoma and is FDA approved. Although one other company was found that offers Y-90 for treatment of liver tumors, they are only FDA approved for treatment of unresectable metastatic liver tumors from primary colorectal cancer. We would not be able to use this product for our patients with HCC. In addition, as described in Section 6 above and in accordance with FAR Part 10, market research will be conducted by publicizing a Sources Sought Notice of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. 9.Any Other Facts Supporting the Use of Other than Full and Open Competition: Use of Y-90 microspheres such as Theraspheres require extensive training and certification by the end user to use the product in patient care. This training is very specific to the exact product being used and cannot be replaced with training provided by another vendor. The Ralph H. Johnson VAMC has undergone months of training to implement a Y-90 program and has received approval from the National Health Physics Program (NHPP) for the use of Theraspheres. Use of a product by any other vendor would not only be unable to treat our patients with primary hepatocellular carcinoma, but it would require more extensive training and program approval before moving forward. As previously mentioned, this is a time-sensitive procedure and any delay in treatment can impact disease progression for our patients. 10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None. 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: The Ralph H. Johnson VAMC will continue to research new and innovative technologies to determine if any other vendors will be able to provide the FDA-approved supplies for any future procurements. 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. _____________________________ ________________________ 13.Approvals in accordance with the VHAPM, Volume 6, Chapter VI: OFOC SOP. a.Contracting Officer's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ b.Director of Contracting /Designee (Required $150K and above): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ c.SAO (If over 650K): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/ChaVAMC/VAMCCO80220/VA24716R0454/listing.html)
 

Document(s)

Attachment
 

File Name: VA247-16-R-0454 VA247-16-R-0454_2.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2717676&FileName=VA247-16-R-0454-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2717676&FileName=VA247-16-R-0454-000.docx

 

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

Record

SN04108980-W 20160508/160506234552-4d76cd0a40508653f682ecc877d8c07d (fbodaily.com)
 

Source

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

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |