P03_JA_OVER_SAT SIRSr_Redacted.pdf

Part 806.3 Other Than Full and Open Competition (OFOC) Attachment 7: Request for Sole Source Justification Format >SAT

Rev: 13 Effective Date: 02/01/22 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C261-22-AP-3455

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 21 on behalf VISN

21, VA Palo Alto Healthcare System

PR: 640-23-1-053-0003

2. Nature and/or Description of the Action Being Processed: The action being reviewed and approved is for a new sole source fixed price contract with 2 option years valued at

FAR 13.5 Simplified Procedures for Certain Commercial Items: This procurement is for Yttrium-90 (Y-

90) Sir-Spheres, in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format FAR 6.303-2

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Yttrium-90 Sir-Spheres is needed to therapeutically treat patients with primary and metastatic liver cancer (Hepatocellular Carcinoma [HCC]. The Yttrium 90 microspheres/treatment, and minimally embolic for the purposes of the VA PAHCS Y-90 Radioembolization Program. The total estimated use is 8 patients during a 12-month period.

Period of Performance

Base Period : October 01, 2022 – September 30, 2023

Option Period 1: October 01, 2023 – September 30, 2024

Option Period 2: October 01, 2024 – September 30, 2025

Effective Date: 02/01/22 Page 2 of 4

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 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

FAR 13.5 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):

Only One Responsible Source (FAR 6.302-1) no other supplies or services will satisfy agency requirements. SIR-Spheres Y-90 resin microspheres is the only FDA approved microsphere radiation therapy in the United States for the treatment of colorectal cancer that has the potentential to spread to the liver. This is a highly specialized treatment for VAPAHCS Y-90 Radioembolization Program. SIR-Spheres Y-90 resin microspheres therapy is a minimally invasive outpatient procedure and patients usually go home hours after the procedure is completed.

There are no other known alternatives. Sirtex Medical, Inc. is the manufacturer and sole distributor of the Y-90 SIR-Spheres for the treatment of Neuroendorine cancer. SIR-Spheres Y-90 resin microspheres is essential to the service and VAPAHCS patients currently undergoing treatment using SIR-Spheres. Any delay in award would be a risk to patient care.

Accordingly, Sirtex Medical is the only firm capable of providing the supplies and services described above without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Sources Sought Synopsis: A sources sought notice had been released on contract opportunities under ID 36C26122Q0730_1 stating that the Department of Veterans Affairs (VA) is conducting a market research survey to identify potential qualified sources capable of providing Y-90 Sir-spheres 1 year estimated supply from 06/21/2022- 06/27/2022. The Statement of Work was included in the notice, which stated that the VA is interested in a multi-year contract. No responses were received.

Sirtex Medical had sent a previous pricing letter during the initial station partner’s market research process that indicates they are still capable of providing the Sir-Spheres treatments.

Effective Date: 02/01/22 Page 3 of 4

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The anticipated cost will be considered fair and reasonable utilizing the information based on a comparison of proposed prices with prices found reasonable on previous purchases and based on a comparison with similar items. The VA has at least three active contracts for Sir-Spheres that the contract price will be fair and reasonable as a comparison will be made with current contracts as well as the IGCE.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

According to market research results pursuant to FAR Part 10, VA Acquisition Regulation (VAAR) 810.001-70 Market Research Policy, and PPM 2016-05, the “Rule of Two” will not be met as two or more service-disabled veteran-owned businesses (SDVOSBs) and veteran-owned small businesses (VOSBs) were not found. A VIP search utilizing NAICS code 339113 provided 550 SDVOSB/VOSB matches. However adding the keyword “Yttrium”, 0 results were found.

Market research efforts included a sources sought notice, VIP, FPDS, Contract Opportunities, VA NAC Pharmaceutical Catalog, GSA Advantage, and SAM. As described previously, market research, in accordance with FAR Part 10, was conducted by synopsis 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:

Sir-Sphere Yttrium-90 microspheres are used as a treatment for selected patients with unresectable cancers. The treatment involves injecting tiny microspheres of radioactive material into the arteries that supply the tumor. Estimated 8 doses per year dose. Sirtex Medical Inc is the only distributor for this requirement, this treatment is proprietary.

Radiopharmaceuticals are highly regulated by multiple federal, state, and local agencies. The Nuclear Regulatory Commission (NRC) has authority to license and regulate the possession, use, and disposal of nuclear by-product materials, including nuclear radiopharmaceuticals. In order to produce or distribute radiopharmaceuticals, the contractor must have a license from the NRC. There are therefore no distributors of the Y-90 Sir-Spheres.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Sirtex Medical Inc has been awarded this requirement previously, and has provided a pricing list for FY23.

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:

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No other vendor will provide this particular product, because it is proprietary. Y-90 radioembolization with Sir-Spheres is one option for treatment of primary and metastic liver cancer.

It is a viable treatment method and may have some advantages for certain individuals over other potential alternatives like liver transpnatation, surgical resection, thermal ablation, transarterial chemoembolization, and systemic molecular/immunotherapies. In the future, if another vendor supplies this product, the Government will evaluate their qualifications. A sole source effort is required for the planned time duration because transarterial radioembolization is a long term clinical treatment program requiring a significant investment in time and resources to obtain internal regulatory approval from the local Institutional Review Board and National Health Physics program, build standard operating procedures, and perform staff training.

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.

Rodney Rodriguez Espada Date Nuclear Med-Tech VA Palo Alto Healthcare System

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.

Maxwell Derck Date Contracting Officer, Supply II

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Angela M. Oppenheimer Date Branch Chief, Supply I, NCO 21

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