Sole_Source_J_A_-_Microsphere_Analysis-Redacted.pdf

Control Number: 19-RHCO-P-586

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: U.S. Army Medical Command, Army Health Contracting Activity, Regional Health Contracting Office – Pacific, 146 Clark Road, Building 339, Fort Shafter, Hawaii 96858-5098.

2. Description of Action: Tripler Army Medical Center, Department of Clinical Investigation is requesting approval of a sole source contract to Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA. This requirement is for a follow-on Firm- Fixed Price purchase order with a 12 month base year plus four (4) one-year option periods. FY19 Army Defense Healthcare Program (DHP) funds will be used for this requirement.

3. Description of Supplies/Services: The Department of Clinical Investigation requires microsphere analysis on both blood and tissue to track microcirculatory blood flow to specific organs for command0approved hemodynamic projects. These services are used to support the advancement of health care as well as the graduate medical education at Tripler Army Medical Center. The estimated total value is The total estimated value includes FAR 52.217-8, Option to extend Services.

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

5. Reason for Authority Cited: Stason Pharmaceuticals, Inc. is the only company that provides the required microsphere analysis on both blood and tissue to track microcirculatory blood flow to specific organs. The technically advanced service is not available through any other company as Stason Pharmaceuticals, Inc. holds the patent to the microsphere analysis they have developed. To date, all prior samples have been processed by Stason Pharmaceuticals, Inc. and comparison by any other means would make it impossible to compare study results. The use of any other service would void years of prior studies and cause all work done to be repeated.

6. Efforts to Obtain Competition: A sources sought notice was issued on 08 August 2019 via https://fbo.gov website and closed on 13 August 2019. Upon closing, there were zero responses from the sources sought notice.

a. Effective competition. Although the Government intends to make a sole source award, a synopsis required by FAR 5.201 shall be published on https://fbo.gov website to allow other companies to submit quotes which shall be considered by the Government. There is no effective competition anticipated for this acquisition.

Microsphere Analysis at Tripler Army Medical Center, Hawaii

(See FAR 2.101 and 3.104-4)

b. Subcontracting competition. There are no subcontracting opportunities for this requirement as all microsphere analysis results will be accomplished by Stason Pharmaceuticals, Inc. in Irvine, CA. Also, Per FAR 19.702(a)(1), Subcontracting plans are only required for contracts expected to exceed $700,000.00. This requirement is valued at which is below the $700,000.00 threshold. Therefore, a subcontracting plan is not required for this requirement.

7. Actions to Increase Competition: The Requiring Activity (RA) will continue to conduct on-going research of the industry marketplace to determine if there are new entrants into the microsphere analysis arena.

8. Market Research: Market research within the last twelve months has shown that this service is commercial in nature. Market research via the Dynamic Small Business Search (DSBS) tool included the following: NAICS 621511 with Microsphere Analysis and Microsphere Analysis. All DSBS searches resulted in no small businesses. Market Research via the internet included the following: Blood and Tissue Microsphere Analysis and Microsphere Analysis. Both internet searches generated results for Microsphere Analysis techniques rather than companies that can accomplish Microsphere Analysis services. The Government believes based on discussion with industry and in-house technical experts that Stason Pharmaceuticals, Inc. is the only company capable of providing the required services in accordance with the Performance Work Statement (PWS).

9. Interested Sources: To date, no other sources have written to express an interest.

Notices required by FAR 5.201 shall be published, and that quotes received shall be considered. Since the closing of the sources sought on https://fbo/gov website, no other sources have written to express interest in the acquisition.

10. Other Facts:

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

(1) Contract Number and Date of Award:

i. W81K02-10-P-0119, awarded on 20 July 2010.

ii. W81K02-14-P-0127, awarded on 17 September 2014.

(2) The competitive status of these actions:

i. Award was made as a 100% small business set-aside under NAICS 621511.

ii. Award was made as a sole source to Stason Pharmaceuticals, Inc.

under NAICS 621511.

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

i. Full and open competition was provided for IAW FAR Subpart 6.2.

ii. The authority cited for award was 41 U.S.C 1901 under FAR 13.5, Test Programs for Certain Commercial Items.

(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: The justification for the procurement prior to this action described the action to increase competition would be to conduct on-going research of the industry market place to determine if there are new entrants into this product service arena. Based on the on-going market research effort no additional entrants into this product service arena were identified.

(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: IMT Stason microspheres were initially tasked for blood and tissue analysis, they are not required for continuity.

Any other type will adversely affect research as there will be much stricter limitations on what is able to be studied and what results are able to be obtained, complied, and utilized. This would also place protocols that are currently in mid collection phase from being able to be completed.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys: There have been no unusual patterns revealed by history for these services.

(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: Previous contract W81K02-14-P-0217 included an approved Sole Source J&A under 13.501. The authority previously cited for W81K02-14-P-0217 was 41 U.S.C. 1901 as implemented in Federal Acquisition Regulation 13.5 under the authority of Test Programs for Certain Commercial Items. There have been no significant changes.

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