ja_(002)_Redacted.pdf

Control Number: 18-RHCO-C-503

For Official Use Only (See FAR 2.101 and 3.104-4)

(25 February 2016)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: This requirement is for San Antonio Military Medical Center (SAMMC), Department of Radiology, JBSA – Fort Sam Houston, TX. 78234.

2. Description of Action: The Regional Health Contracting Office - Central requests approval for a sole source purchase to SIRTEX Medical Inc. for SIR-Spheres microspheres, for the Department of Radiology at San Antonio Military Medical Center (SAMMC), JBSA Fort Sam Houston, Texas. This requirement is for a new firm fixed priced contract utilizing Department Health Program Operation and Maintenance, funds.

3. Description of Supplies/Services: SIR-Spheres microspheres which are indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intrahepatic artery chemotherapy (IHAC) of FUDR (Floxuridine). SIRTEX Medical Inc. is the only FDA approved Y-90 products for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable. The total estimated cost is at for a twelve (12) month base period from 1 October 2018 through 30 September 2019 and four 12 month options, which are based on historical data on the number of patients’ surgeries.

Period of Performance Estimated Annual Totals Base Year 1 Oct 2018 – 30 September 2019

1st Year 1 Oct 2019 – 30 September 2020

2nd Year 1 Oct 2020 – 30 September 2021

3rd year 1 Oct 2021 – 30 September 2022

4th Year 1 Oct 2022 – 30 September 2023

Estimated total

4. 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".

(Sir-Spheres Microspheres Brook Army Medical Center)

(See FAR 2.101 and 3.104-4)

5. Reason for Authority Cited: Market research reveals there are no other FDA approved Y-90 products for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable metastatic liver tumors. SIRTEX carries the only FDA approved product SIR-Spheres microspheres are indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intrahepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).

6. Efforts to Obtain Competition: A Sources Sought notice was posted to the government point of entry (FedBizOpps) on 15 May 2018 – 21 May 2018. This notice resulted no interested source responding. The hospital will continue to survey the market for products for competition.

a. Effective competition. It is anticipated that only one vendor is capable of meeting this particular requirement due to FDA approved products. However the Government will continue to survey the market to ensure that there aren’t other products that are FDA approved capable of fulfilling the requirement.

b. Subcontracting competition. No Subcontracting Plan required in accordance with FAR 19.702(a)(1).

7. Actions to Increase Competition: After contract award, this justification will be available at the Government Point of Entry, www.fedbizopps.gov. If in the future other compatible FDA approved SIR-Spheres microspheres products become available, market research will be performed to consider other sources that meet or exceed the current requirement. Additionally, an evaluation of the market will be conducted prior to award related to these reoccurring requirements. Pricing, availability and any alternative solutions will be the focus of that research.

The contract file will be properly documented with any findings.

8. Market Research: Market research was conducted via internet, literature review, a comprehensive analysis of different imaging contrast agents, and historical usage data. Market research on the internet showed only one company provided FDA approved SIR-Spheres microspheres and the company sells direct and does not distribute this product. Market Research was conducted on 1 June 2018.

9. Interested Sources: A Notice of Intent to Sole Source this action to SIRTEX Medical Inc.

was posted to the GPE on 21 May 2018. No responses were received, future requirements of this type will be researched within the market to ascertain if additional vendors have entered the market offering the required products.

10. Other Facts: Discuss any other facts supporting the use of other than full and open competition, such as the following:

a. Procurement history. Reasonable efforts to retrieve the following items from computer records, contract files, competition advocate office files or other sources:

(1) Contract numbers and dates of the last several contracts for these same requirements.

W81K00-18-P-0007, awarded on 19 october 2017 as a Sole Source procurement.

(2) The competitive status of these actions. Sole Source

(3) Authority previously cited if less than full and open competition was used. A justification was utilized, authority cited FAR 13.106-1(b)(1)(i).

(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. Searches for Microspheres via the internet confirm Sirtex Medical is the only manufacturer of these types of microspheres on the market.

(5) There have been no unusual patterns related to this requirement regarding urgency or competition.

(6 ) 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. Sirtex Medical is the only known manufacturer of this drug. This drug is used to treat liver tumors (bone forming malignant growth), with one injection every week, for a total of four weeks. The hematology/oncology and radiation/oncology physicians of the patients that will undergo this treatment has determined that Sirtex is the only available treatment for these patients.

b. Other facts. Provide any other facts necessary to justify limiting competition that were not previously stated.

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: Date:18 July 2018

Typed Name: Title: Deputy Chief, Supply Chain Management

12. Requirements Certification: Include the following statement:

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:18 July 2018

Typed Name: Title: Deputy Chief, Supply Chain Management

Only the most senior persons within the organization responsible for acquiring the supplies or services described in the justification (e.g. program manager, depot commander, or senior program engineer) and with specific knowledge of the individual requirement (commodity, technology, and/or function) shall sign the technical and requirements certifications.

nd complete to the best o

13. Fair and Reasonable Cost Determination: Include the following determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. The IGE, historical procurement data and market research was used to determine that the price was fair and reasonable. Certified cost or pricing data is not required per FAR 15.403-1(b)(3).

Signature: _ ______________________ _______

Typed Name: Title:Contracting Officer

14. Contracting Officer Certification: This certification shall be made by the contracting officer who will sign the contract resulting from this justification and approval. Include the following statement:

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

Signature: ___

Typed Name: Title:Contracting Officer

Date: 2018.07.19 10:10:25 -05'00'

Digitally signed by

Approval

Based on the foregoing justification, I hereby approve the procurement of SIRTEX Medical Inc.

brand FDA approved SIR-Spheres microspheres for a total dollar value of on an other than full and open competition basis pursuant to the authority of Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items". Subject to availability of funds, and provided that the products and property herein described have otherwise been authorized for acquisition.

Signature: Date:

Typed Name: Title: USAHCA Special Advocate for Competition

103139 Date: 2018.07.19 11:20:47 -05'00'