FAR6_JA_OVER_SAT.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 09 Page 1 of 3 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C250-20-AP-2956

1. Contracting Activity: Department of Veterans Affairs, VISN 10, Cleveland VA Medical Center.

Network Contracting Office (NCO 10), 3140 Governors Place Blvd, Suite 210, Kettering, Ohio 45409.

2237 No: 541-20-3-778-0145.

2. Nature and/or Description of the Action Being Processed: TheraSphere, Y-90 glass microsphere is a therapeutic agent used to treat unresectable primary Hepatocellular Carcinoma. It consists of microscopic glass spheres that are attached to a radioactive isotope (Y-90) and then injected into the patient. The spheres are trapped in the liver where they can treat liver cancer. Will be awarded as a new requirement open market.

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This is a request for a new contract with BTG International Canada Inc. for the purpose of purchasing TheraSphere, Y-90 glass microsphere doses. TheraSphere is a radioactive therapeutic pharmaceutical used to treat patients with unresectable Hepatocellular Carcinoma. TheraSphere is manufactured by Nordion (Canada) Inc. who has an exclusive contract with BTG International Canada Inc., Biocompatibles Division for the distribution of the doses.

4. Statutory Authority Permitting Other than Full and Open Competition:

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): TheraSphere Y-90 Glass Microsphere doses for therapy of Hepatocellular Carcinoma. It consists of microscopic glass spheres that are attached to the radioactive isotope (Y-90) and then injected into the patient. The spheres are trapped in the liver where they can treat liver cancer. This request is to purchase fifteen (15) doses on an as needed basis for one (1) year. The total estimated value is $255,000.00. Accordingly, Biocompatible, Inc. (BTG) is the only firm capable of providing the supplies described in #2 above without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements. Additionally, TheraSphere Y-90 glass microsphere doses are proprietary and patented, and are only available from one distributor, Biocompatible, Inc. (BTG). BTG is the sole distributor of TheraSphere in the United States and holds the exclusive licenses for the distribution

OFOC SOP Revision 09 Page 2 of 3

Revision 09 Date: 04/17/2020 of Thera sphere. Based on the unique circumstances, BTG is the only firm capable of providing the supplies without experiencing unacceptable delays in fulfillment of this requirement.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Only one responsible source, since it is this survey of the market place that confirms our assumptions regarding the capability of industry to meet our needs. Biocompatible, Inc. (BTG). BTG is the sole distributor of TheraSphere in the United States and holds the exclusive licenses for the distribution of TheraSphere. Based on the unique circumstances, BTG is the only firm capable of providing the supplies without experiencing unacceptable delays in fulfillment of this requirement.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: This acquisition is for 15 doses of TheraSphere Y-90 Labeled Glass Microsphere for the Cleveland VA Medical Center. Pricing was compared to the IGCE at $255,000.00 and the past purchase history under contract 36C25019P1402, PO# 541A90136 awarded to Biocompatibles, Inc.

Based on this comparison of past awards, pricing was determined fair and reasonable.

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 on Unicor, AbilityOne, VA NAC Pharmaceutical and GSA Advantage, along with VIP and the open market. Market research was also conducted, to include, reaching out to Biocompatibles Inc. requesting a list of SDVOSB/VOSB distributors. Biocompatibles Inc does not work with any SDVOSB or VOSB distributors.

Biocompatibles Inc also provided a sole source letter stating they do not work with any third-party organizations. No SDVOSB/VOSB sources could meet the requirements; therefore, the Rule of Two cannot be met.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Only one responsible source, since it is this survey of the market place that confirms our assumptions regarding the capability of industry to meet our needs. Biocompatible, Inc. (BTG). BTG is the sole distributor of TheraSphere in the United States and holds the exclusive licenses for the distribution of TheraSphere.

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:

Since this is a proprietary radiopharmaceutical (drug) it is not possible to overcome the use of a sole distributor.

OFOC SOP Revision 09 Page 3 of 3

Revision 09 Date: 04/17/2020

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.

/////Signature on File///// ________________________ Marie Dean Date Nuclear Medicine Technologist Cleveland VA Medical Center

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. 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.

Chris Callihan Date Contracting Officer

NCO 10

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Adam Weber Date Branch Chief

NCO 10

http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx