JA 22-RHCO-P-175_final__Redacted.pdf

CUI//SP-PROCURE

Control Number: 2 -RHCO-P-

CUI//SP PROCURE

1 SEP 2021

Justification Review Document For Sole Source - FAR Part 13.501*

(*Format follows FAR 6.303-2, but modified to reflect FAR subpart 13.5 procedures)

Program/Equipment: Theraspheres Y-90 Glass Microspheres

Authority: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

Amount: (total price includes a 5-month base period and 4 one year option periods)

(base) (each option)

Prepared by:

Typed Name: DSN:

Title: Supervisor, Diagnostic Rad Tech, IR Service Date: 14Mar22

E-mail:

Contracting Officer:

Typed Name: Phone#:

Date Reviewed: __________________ E-Mail:

Technical Representative:

Typed Name:

Title: Date Reviewed:

Controlled by: USAHCA Controlled by: RHCO-P

CUI Category: PROCURE Limited Dissemination Control: FED ONLY

POC:

SM

CUI//SP PROCURE

Control Number: 22-RHCO-P-

(Theraspheres Y 90 Glass Microspheres, TAMC)

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2 SEP 2021

Requirements Representative:

Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Legal Counsel

Typed Name: __ _______________________DSN: ______________________

Signature: __ Date: ______________________

Command Advocate for Competition

Typed Name: _ _______DSN: ______________________

Signature: _________________________________ Date: ______________________

(Theraspheres Y 90 Glass Microspheres, TAMC)

CUI//SP PROCURE

3 SEP 2021

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Regional Health Contracting Office – Pacific (RHCO-P), 146 Clark Road, Building 339, Fort Shafter, Hawaii 96858

2. Description of Action: This requirement is for a new Indefinite Delivery-Indefinite Quantity (IDIQ) contract with firm fixed-prices with Operation and Maintenance – DHP funds.

3. Description of Supplies/Services: This supply requirement is for Therasphere Y-90 Glass Microspheres for Tripler Army Medical Center, Hawaii. This is a cancer therapy for cancer affecting the liver, but most commonly for metastatic colorectal carcinomas and for hepatocellular carcinomas.

The total estimated value, including a 5 month base period and 4 one year option periods, is . The period of performance (POP) is from 01 May 2022 to 30 September 2026.

Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items: Only one source is Capable.

Reason for Authority Cited: Boston Scientific Corporation is the only manufacturer of the Therasphere Y-90 glass microspheres. Boston Scientific does not use distributors in the United States. Although Sirtex does manufacture Y-90 microspheres, they only produce resin microspheres, not glass microspheres. The Sirtex spheres consists of resin microspheres coated with Y-90 while the Boston Scientific Thereaspheres contains insoluble glass microspheres with Y-90 as an intricate part of the glass matrix. The Boston Scientific Therasphere is the only glass microsphere that can complete infusions 100% as opposed to the Sirtex resin microspheres that only deliver 63-96% of the prescribed dose. The Sirtex beads are larger and have a higher rate of plugging the vessels before the full dose is delivered. , the Boston Scientific Therasphere Y-90 Glass Microspheres are the only FDA approved microspheres which is a requirement

Efforts to Obtain Competition:

Effective Competition. The Contracting Officer shall publish the notices required by FAR 5.201 on the SAM.gov website and any quotation received shall be considered. Although the Government intends to issue a sole source award to

4 SEP 2021

Control Number: 22-RHCO-P-

(Theraspheres Y 90 Glass Microspheres, TAMC) Boston Scientific a sources sought notice was posted on SAM.gov on 17 March 2022, inviting all responsible sources to submit a capability statement. No inquiries were received from any potential sources.

Market research was conducted, details of which are in the market research section of this document. None of these efforts have yielded additional potential sources. There is no competition anticipated for this procurement.

b. Subcontracting Competition. The supplies manufactured by Boston Scientific are proprietary in nature and therefore, they do not subcontract any of their manufacturing to other firms. After considering this information, the Contracting Officer has determined that subcontracting possibilities do not exist for this requirement in accordance with FAR 19.705-2(c).

Actions to Increase Competition: Ongoing market research will be performed to determine if alternative sources of this supply become available.

Market Research: Market research conducted in the past 12 months over the internet has shown that this type of cancer therapy is commercial in nature and Boston Scientific Corporation is the only manufacturer of the Therasphere Y-90 Glass Microspheres. There are no comparable glass microspheres in the market place. This product is not on a Defense Acquisitions Pricing Agreement (DAPA) and not available through the Prime Vendor Program.

Interested Sources: See Paragraph 6 for the synopsis information. Government will consider all statements of interest and capability received. To date, no other sources have written to express an interest.

Other Facts: None

Procurement history.

Contract numbers and dates of all awarded contracts for these same requirements.

None

(2) The competitive status of these actions.

N/A.

(3) Authority previously cited if less than full and open competition was used.

N/A

(Theraspheres Y 90 Glass Microspheres, TAMC)

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5 SEP 2021

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

N/A

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

N/A

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

N/A

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

N/A

b. Other facts. None

(Theraspheres Y 90 Glass Microspheres, TAMC)

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6 SEP 2021

11. Technical Certification:

I certify 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

Title:

12. Requirements Certification:

I certify 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: _ Date:

Typed Name: Title:

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. The basis for this determination will be price analysis in accordance with FAR 15.404-1(b).

Signature: __Date: ________________________

Typed Name: Title: Contracting Officer

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature: __Date: ________________________

Typed Name: Title: Contracting Officer

0'

(Theraspheres Y 90 Glass Microspheres, TAMC)

CUI//SP PROCURE

7 SEP 2021

Approval

Based on the foregoing justification, I hereby approve the procurement of Therasphere Y-90 Glass Microspheres for the estimated total dollar value of on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the supplies herein described have otherwise been authorized for acquisition.

Signature: _ __Date: ________________________

Typed Name: Title: Command Advocate for Competition