JA Sole Source_Definity_Redacted.pdf

Control Number: 21-RHCO-C-13

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: Regional Health Contracting Office – Central (RHCO-C)

2. Description of Action:

Total Award value of the solicitation is $580,732.00. Definity currently has a one (1) year shelf life.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Supplement 207.103 (d)(i)(B).

The government will continue to monitor the marketplace for new entrants.

Period of Performance: Unit Price Number of Units

Estimated Totals

Base Year 1 October 2020 – 30 September 2021 $1,116.10 115 $128,351.50 Option 1 1 October 2021 – 30 September 2022 $1,116.10 125 $139,512.50 Option 2 1 October 2022 – 30 September 2023 $1,116.10 135 $150,673.50 Option 3 1 October 2023 – 30 September 2024 $1,116.10 145 $161,834.50

TOTAL CONTRACT COST $580,732.00

3. Description of Supplies/Services: Definity (Perflutren Lipid Microspheres) NDC:

11994-0011-16 is a Cardiac MRI Contrasting Agent. Total estimated contract value is $580,732.00.

4. Authority Cited:

5. Reason for Authority Cited: Definity (Perflutren Lipid Microspheres) is sole source product, manufactured and sold by Lantheus Medical Imaging, Inc. Failure to award a contract to Lantheus Medical Imaging, Inc. for Definity (Perflutren Lipid Microspheres) could jeopardize the BAMC Department of Pharmacy’s mission of providing timely and quality care to its beneficiary population.

Definity is comprised of a synthetic phospholipid-coated microspheres filled with octafluoropropane gas, ranging in size of 1.1 to 3.3 microns, with 98% of microspheres

Control Number: 20-RHCO-C-

Definity Lantheus Medical Imaging, Inc.

(See FAR 2.101 and 3.104-4) sized at less than 10 microns, allowing passage through the pulmonary capillaries. Due to the diffusion of the gas through the microsphere, this product persists longer within the body, thus enhancing the imaging window longer from about 3.4 -7.1 minutes.

Which allows for less need of repeat imaging that results in delayed patient care.

Definity does not contain any sulfur or human / animal materials which have the potential for adverse reactions in certain patient populations.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201. A Sources Sought was posted on beta.SAM for 7 days with no responses. Based on market research, competition is not anticipated for the requirement. The government will continue to assess the market for new entrants.

7. Actions to Increase Competition: After award, this justification will be available at betSAM.gov. If in the future other compatible 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 any renewal related to this requirement. Pricing, availability, and any alternative solutions will be the focus of that research. The contract file will be properly documented with any findings. In accordance with FAR Subpart 19.705-2, the Contracting Officer has taken actions to determine whether the proposed contractual obligation requires a sub-contracting plan.

8. Market Research: In accordance with FAR Part 10, market research has been conducted for this acquisition. Research was completed using public search engines Google and Bing. The search was done by using the key words such as “perflutren microspheres” – The only results found were Lantheum Medical Imaging. Conducted Dynamic small business search using key words “perflutern microspheres” and NAICS Code 325412; with no results.

9. Interested Sources: A Notice of Intent to Sole Source for this action to Lantheus Medical Imaging, Inc. was posted to beta.SAM 18 Jun 2020 with no responses. Future requirement of this type will be researched within the market to ascertain if additional vendors have entered the market offering compatible products. To date, no other sources have written to express interest in this acquisition.

10. Other Facts:

a. Procurement history.

(1) Previous Contract:

W81K00-19-P-0333

Previously Competed: No, Sole Source

W81K00-18-P-0449 Previously Competed: No, Sole Source

(2) There are no other authorized vendors that could provide the required Definity.

(3) The statutory authority permitting other than full and open competition is 41 United States Code 1901 as implemented in FAR 13.501(a(1)(ii), sole source (including brand name) under the authority of the simplified acquisition procedures for certain commercial items.

(4) Previous 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) 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) 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

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: __________

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.

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. A price analysis will be conducted to compare the proposed price to competitive contracts within RHCO-C for the same or similar requirements.

This determination will be made using the following: IGCE

As a part of this basis, in accordance with FAR 15.403(b)(3) certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

74967 Date: 2020.07.09 15:51:50 -05'00'

7/9/2020

74967 Date: 2020.07.09 15:54:17 -05'00'

7/9/2020

14. Contracting Officer Certification:

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

Date: 2020.07.13 16:18:19 -05'00' 7/13/2020

Date: 2020.07.13 16:18:37 -05'00' 7/13/2020