Redacted J A HT942524C0104.pdf

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Control Number: JA-24-05-1543

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

Justification and Approval for Other than Full and Open Competition FAR Part 6

1. Contracting Activity: U.S. Medical Research Acquisition Activity (USAMRAA), 808 Schreider Street, Fort Detrick, MD 21702-5014

2. Description of Action: The United States Air Force (USAF) 59th Medical Wing Science and Technology (59th MDW/ST) Office located at Joint Base San Antonio Lackland Air Force Base, Texas requests a sole source non-commercial firm fixed-price type contract with the University of Colorado (CU) Anschutz Medical Campus for the Advancement of Military Medicine for a research and development requirement.

3. Description of Supplies/Services: The USAF 59th MDW/ST Office has a requirement for research and development services. This is a follow-on research study titled, Comparison of In Vitro Laboratory Characteristics for Various Blood Products

Administered Through Commercial Fluid Warmers in a Pragmatic Extreme Cold Field Transfusion Model .

The intent for this requirement is to compare blood warming devices to identify the most effective device for out-of-hospital field use that does not alter the quality of the transfused blood product and prevents hypothermia in the transfused patient. While there are warming devices available there is no current standard to warm blood outside of a controlled hospital setting.

The main objectives of this study include:

1. Characterize the impact transfusing cold stored (1-6 C) whole blood on thermoregulation in large swine.

2. Characterize the impact transfusing cold stored (1-6 C) whole blood using a blood warming device on thermoregulation in large swine.

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Source Selection Information - See FAR 2.101 and 3.104-4

This study is the second phase of the , Performance of Fluid Warmers for Blood Product Administration in an Arctic Environment provide medics and first responders with the most effective method to prevent life threatening hypothermia when transfusing blood in a cold, austere environment. By evaluating pre-hospital capabilities for blood transfusion in Arctic temperatures, the project addresses a critical gap for whether this life-saving intervention is feasible in cold-weather missions (Air Force Gap #37 Hypothermia Prevention and Treatment). The second phase of the study will continue the collaboration between CU in Aurora, Colorado and the 59th MDW/ST Office.

4. Authority Cited: 10 USC 3204(a)(1) as implemented in Federal Acquisition Regulation (FAR) 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements with application at FAR 6.302-1(a)(2)(iii).

5. Reason for Authority Cited:

a. As described at FAR 6.302-1(a)(2), when the supplies or services required by the agency are available only from one responsible source, or for DoD, NASA and the Coast Guard, from only one or a limited number of responsible sources, and no other types of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

b. Furthermore, FAR 6.302-1(a)(2)(iii) states that for DoD, services may be deemed to be available only from the original source in the case of follow-on contracts for the continued provision of highly specialized services when it is likely that award to any other source would result in substantial duplication of cost to the Government that is not expected to be recovered through competition or unacceptable delays in fulfilling the

c. CU is the only source that can provide the required research and development services. This requirement is an intramural research project at the 59th MDW/ST Office which will use CU as an extramural collaborator. CU is the only extramural source that can collaborate on this project as they partially own the Intellectual Property (IP) rights to the work conducted, and results of, of the initial phase of the research and this requirement is a direct continuation of the prior phase. In addition, the subject research protocol was collaboratively designed by CU. This protocol was approved by the 59th MDW/ST Directors and the Defense Health Agency (DHA) who approved and funded the research study contingent upon CU being an extramural collaborator. Funds were received from DHA to support the protocol as written with the intent to work with CU and the use of any other vendor would conflict with the programmatic funding decision.

In addition, award to a collaborator other than CU would infringe on their IP rights and it would result in unacceptable delays and duplication of cost and effort for another vendor

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Source Selection Information - See FAR 2.101 and 3.104-4 to repeat the initial phase of research. Award of the subject requirement to any source except for CU would lead to unacceptable outcomes for the Government.

6. Efforts to Obtain Competition: A Request for Information (RFI) was posted to the Government Point of Entry (GPE), SAM.gov, on 10 April 2024 for a period of 3 days. No qualified responses to the sources sought notice were received. The requirement was synopsized to the GPE (SAM.gov) via a Notice of Intent to Sole Source (NOI) on 18 April 2024 for a period of 15 days. No qualified responses to the sources sought notice were received. Please reference Paragraph 8 of this document, for further discussion of market research.

a. Effective competition. No effective competition is anticipated.

b. Subcontracting competition. CU is acting as the prime contractor on this contract; however, the contract is being put in place so that they may serve as an extramural collaborator with the researchers at the 59th MDW/ST Office. Since CU is already serving in a subcontractor-like role with the 59th MDW/ST Office, no additional subcontracting opportunities exist. Based on these facts, no further subcontracting competition is expected.

7. Actions to Increase Competition: Based on the results of the market research and the known history of this requirement, no further actions have been taken to increase competition as CU is the only source available to provide these research services to continue the second phase of the study. The USAF 59th MDW/ST Office will continue to monitor the marketplace for contractors with the necessary knowledge base to provide the unique support services required. If similar or related requirements in the future may be fulfilled via competitive acquisition procedures, the USAF 59th MDW/ST Office and USAMRAA will pursue the appropriate level(s) of competition.

8. Market Research: The Contracting Office posted an RFI on SAM.gov, as discussed above in Section 6, and received no responses. As a result, the Contracting Office posted a Notice of Intent to Sole Source to CU on SAM.gov on 18 April 2024. No correspondence was received in response to this notice. No additional market research was conducted for this contract, as CU is the only contractor that can provide these services.

9. Interested Sources: The notices required by FAR 5.201 have been published and no correspondence was received in response to the Request for Information nor the Notice of Intent to Sole Source. In addition, this justification shall be posted to SAM.gov within 14 days after contract award in accordance with FAR 6.305(a). In accordance with 5.207(c)(16)(ii), inquiries from any interested offerors would have been evaluated accordingly prior to issuance of the sole source contract.

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Source Selection Information - See FAR 2.101 and 3.104-4

10. Other Facts:

a. Procurement history.

(1) The prior phase of this work was performed by CU as a subcontractor under prime contract number . by the U.S.

General Services Administration (GSA).

(3) The previous prime contract was open to all 8(a) businesses; therefore, no justification was prepared to limit competition.

(4) The previous prime contract was open to all 8(a) businesses; therefore, no justification was prepared to limit competition.

(5) GSA utilized a time-and-materials contract vehicle which essentially allowed the prime 8(a) contractor to issue orders to various subcontractors as needed by the 59th MDW/ST Office based on funded research requirements. This contract strategy has changed now that the 59th MDW/ST Office is using USAMRAA as their contracting agency; therefore, this sole source contract is being issued to the extramural collaborator, CU, rather than a subcontract being made by a prime contractor.

(6) No unusual patterns have been discovered.

(7) The previous prime contract was open to all 8(a) businesses; therefore, no justification was prepared to limit competition. There have been no significant changes to the requirement, only the method of procurement as discussed in 10.a.(5).

b. Other facts. Not applicable.

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Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

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.

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 based on a price analysis of the proposal. Cost or pricing data will not be required based on FAR 15.403-4(a)(1).

14. Contracting Officer Certification:

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

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Source Selection Information - See FAR 2.101 and 3.104-4

Approval

Based on the foregoing justification, I hereby approve the procurement of the above research and development services in the amount of $722,799.00 on an other than full and open competition basis pursuant to the authority of 10 United States Code 3204(a)(1) as implemented in Federal Acquisition Regulation 6.302-1(a)(2)(iii)(A), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for this acquisition.

Signature: _____________________________ Date: __________________________ Typed Name: Douglas A. Medcalf Jr. Title: Contracting Officer