Final_Justification_and_Approval_(FBO)_FAR_Part_13.5_SIRTEX.pdf

Control Number: 19-RHCO-C-709 Contractor: SIRTEX

Program/Equipment: SIR-Y90 Spheres Brooke Army Medical Center

Version – March 2017 FOR OFFICIAL USE ONLY

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

1. Contracting Activity: US Army Medical Command, Regional Health Contracting Office – Central (RHCO-C), 3160 McIndoe Road, JBSA – Fort Sam Houston, Texas.

2. Description of Action: The Interventional Radiology Service at Brooke Army Medical Center requests a firm fixed price contract with SIRTEX. The Government projects award for 1 October 2019, fiscal year 2020, subject to the availability of Defense Health Program, Army FY20 funds. An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

3. Description of Supplies/Services: This requirement is to obtain SIR-Spheres Y-90 Microspheres manufactured by SIRTEX for the Interventional Radiology Service, Department of Radiology, San Antonio Military Medical Center (SAMMC), JBSA – Fort Sam Houston, Texas. The purpose of this product is to deliver targeted internal radiation therapy directly to liver tumors via the hepatic artery. This therapy is called Selective Internal Radiation Therapy (SIRT) and it’s performed using minimal invasive surgical techniques by an interventional radiologist. The estimated total dollar value, including four (4) options is $3,967,440.00.

Base Period: 1 Oct 2019 to 30 Sept 2020 Value: $793,488.00 Option Period 1: 1 Oct 2020 to 30 Sept 2021 Value: $793,488.00 Option Period 2: 1 Oct 2021 to 30 Sept 2022 Value: $793,488.00 Option Period 3: 1 Oct 2022 to 30 Sept 2023 Value: $793,488.00 Option Period 4: 1 Oct 2023 to 30 Sept 2024 Value: $793,488.00 Total: $3,967,440.00

4. Authority Cited: The statutory authority permitting other than full and open competition is 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.

5. Reason for Authority Cited: The Interventional Radiology Service at Brooke Army Medical Center is listed as one of the treatment centers here in San Antonio, Texas and the only facility authorized by SIRTEX to administer SIR-Y90 Spheres to patients with liver tumors from primary colorectal cancer. The total estimated number of patients that are treated are approximately 48 patients per year. Acquisition history, as well as current market research to include a sources sought notice, has not revealed any vendors that could provide the required products that the Government seeks. Failure to award a contract to SIRTEX would result in a lapse in patient treatment that is life threatening as time lapses, further resulting a potential mission failure in providing health care services to the beneficiary population.

Program/Equipment: SIR-Y90 Spheres

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201. A Sources Sought Notice was posted to FedBizOpps on 7 August 2019 and closed on 15 August 2019. Only SIRTEX expressed interest in this requirement and no responses were received from any other interested parties.

Subsequently, a Notice of Intent to Sole Source was posted on FedBizOpps on 16 August 2019, advising that the government intended to make a sole source award to SIRTEX. To date, no responses have been received indicating that the companies are interested in providing SIR-Y90 Spheres or any other similar products.

a. Effective competition. Based on market research, acquisition history, and the results of the Sources Sought Notice, competition is not anticipated for this requirement. The Government will continue to assess the market for new entrants.

b. Subcontracting competition. As per FAR 19.705-2, if a subcontracting possibility exist, the contractor will be required to submit a subcontracting plan.

7. Actions to Increase Competition: After award, this justification will be posted to FedBizOpps. Prior to expiration of the contemplated contract, market research will be performed to determine if other sources exist that meet or exceed the Government’s requirements. Pricing, availability, and alternative solutions will be considered. Further the solicitation will require SIRTEX to submit a subcontracting plan (or sufficient evidence that no subcontracting opportunities exist) as part of the offer.

8. Market Research: Market research was conducted by Interventional Radiology Service and the Contracting Office via Web and telephonic inquiries in the weeks prior to the Sources Sought Notice and the Notice of Intent to Sole Source. As of today, there are not known vendors that can provide this product or similar products. In addition, any hospital or clinic that wants to use this product must be authorized by SIRTEX to administer it on patients.

9. Interested Sources: To date, no other sources have written to express interest in the acquisition. As stated in paragraph 6 above, the notices required by FAR 5.201 were published prior to execution of this sole source justification, and there are none that could provide the entirety of the governments

10. Other Facts: The following facts support the use of other than full and open competition:

a. Procurement History:

(1) Purchase order W81K00-18-P-0007 was issued for delivery period of 20 October

2017 to 30 September 2018 and awarded to SIRTEX in the amount of $144,000.00. Notice of intent to award as a sole source requirement was posted on 11 October 2017 and no responses were obtained. The Justification and approval was approved and signed on 16 October 2017. Contract number W81K00-18-P-0600 was issued for delivery period of 1 October 2018 to 30

Program/Equipment: SIR-Y90 Spheres

September 2019 and awarded to SIRTEX in the amount of $594,000.00 due to increase in patient treatments. Sources sought notice for resulting contract W81K00-18-P-0600 was posted on FBO on 16 May 2018 and no responses were obtained. A second notice to award as a “sole source” was posted on 21 May 2018 and no responses were obtained either. A justification and approval was approved and signed on July 19, 2018.

(2) Both actions were awarded as sole source requirements due to lack of responses on the Sources Sought and Notice of Intent to Award as a Sole Source.

(3) Authority previously cited if less than full and open competition was used. This J&A cites 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii).

(4) Previous justifications’ description of actions to increase competition: As stated above; efforts have been made to seek competition only resulting in a sole source contract. It is unlikely that another vendor will be able to meet this requirement since SIRTEX is the only company that can provide SIR-Spheres Y-90 microspheres for the Interventional Radiology Service.

(5) Previous solicitations were issued as sole source due to the lack of responses.

Notifications were posted on current procurement and there has been no responses to date.

(6) There has been no unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

(7) Previous justifications were prepared to support procurement efforts made to seek competition. However, history shows that SIRTEX is the only company that can meet this requirement. There has been no significant changes at the present time.

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Program/Equipment: SIR-Y90 Spheres

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.

Typed Name: Armando Ramirez III Date: 18 September 2019 Title: Supervisor Signature:

Interventional Radiology Service

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.

Typed Name: Armando Ramirez III Date: 18 September 2019 Title: Supervisor Signature:

Interventional Radiology Service

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Program/Equipment: SIR-Y90 Spheres

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable. A price analysis will be conducted to compare the proposed prices to competitive actions and historical data, as well as the Independent Government Estimate, for the same or similar requirements.

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Typed Name: MAJ Deven Gaston Date: 18 September 2019 Title: Contracting Officer Signature:

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: MAJ Deven Gaston Date: 18 September 2019 Title: Contracting Officer Signature:

GASTON.DEV

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Digitally signed by

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A.1262552787 Date: 2019.09.19 10:21:51 -05'00'

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GASTON.DEVEDigitally signed by GASTON.DEVEN.ROSINA

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Date: 2019.09.19 10:21:37 -05'00'

Program/Equipment: SIR-Y90 Spheres

Approval Based on the foregoing justification, I hereby approve the procurement of SIRTEX SIR- Y90 Spheres for the Interventional Radiology Service at Brooke Army Medical Center, in the amount of $3,967,440.00 (base and all option periods) on a sole source basis pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5, subject to availability of funds, and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Liza J. Esmond Date:

Special Advocate for Competition Signature:

ESMOND.LIZA ESMOND.LIZA.J.1016102

Digitally signed by

X .J.1016102195 Date: 2019.09.25 09:25:58 -05'00'