A02 - JEFO FINAL redacted_Redacted.pdf

CUI

Control Number: JA-24-02-1492

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

Justification for an Exception to Fair Opportunity Under FAR 16.505(b)(2)

Contracting Activity: The Contracting Activity responsible for this action is the United States Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD in support of the United States Army Telemedicine and Advanced Technology Research Center (USA TATRC).

Description of Action: This approval is for a new Cost Plus Fixed-Fee (CPFF) Research and Development (R&D) support services contract to establish a Data Interoperability and Autonomy Coordinating Center (DIACC) working group. This DIACC will ensure that the USA TATRC Autonomous Casualty Care (AC2) Research Portfolio is executed in a fashion that allows both intramural and extramural R&D work to be conducted using a data interoperability framework, where all performers are working on the same standards and data formats, to ensure that the resulting work can be aggregated into a common data repository and used for Machine Learning (ML) and Artificial Intelligence (AI) development deliverables for casualty care.

Approval is requested to leverage an existing Centers for Medicare & Medicaid Services (CMS) Federally Funded Research and Development Center (FFRDC) Indefinite- Delivery, Indefinite-Quantity (ID/IQ) contract vehicle to award a sole source contract to the MITRE Corporation, the FFRDC operator. This existing CMS contract, 75FCMC-23- D-0004, was awarded as a sole source, single award ID/IQ on 25 September 2023, with an approved J&A using the authority under Federal Acquisition Regulation (FAR) 6.302- 3, Industrial mobilization; engineering, developmental or research capability; or expert services. The specific authority cited by CMS is FAR 6.302-3(a)(2)(ii), To establish or maintain an essential engineering, research, or development capability to be provided by an educational or other nonprofit institution or a federally funded research and development center. This Health FFRDC performs research and analysis on various topics in the health domain and provides an enterprise approach to supporting achievement of the core missions of the Department of Health and Human Services (HHS), its various operating and staff divisions, and federal agencies outside of HHS (non-sponsoring agencies) that have healthcare missions. The USA TATRC is one such example of a non-sponsoring agency that would qualify to leverage this FFRDC contract mechanism.

Research, Development, Test & Evaluation (RDT&E) funding will be utilized for this requirement.

3. Description of Services: The USA TATRC requires a multi-disciplinary group, such as the DIACC working group, to help define use cases for advanced technology solution sets for wound healing in prolonged casualty care environments that will leverage the best of breed R&D solutions through a series of focused workshops. These focused workshops will require the same management and coordination functions that the USA TATRC lacks from the in-house government resources to execute successfully without the support of an FFRDC partner. This will result in an order issued off an existing FFRDC contract, 75FCMC-23-D-0004, with a period of performance of thirty-six months. The estimated value for this requirement is: $1,955,000.

4. Authority Cited: Pursuant to 10 U.S.C. 2304(c)(1) as implemented by FAR 16.505(b)(2)(i)(B) – Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

5. Reason for Authority Cited: FFRDC’s exist to meet specialized long-term research or development needs which cannot be met as effectively by existing in-house or contractor resources. FFRDC’s enable agencies, including the USA TATRC, to use private sector resources to accomplish tasks that are integral to the mission and operation. Relationships between FFRDCs and government research teams are beneficial because FFRDCs have the ability to recruit and retain scientific and technical expertise and provide in-depth knowledge and the capability to rapidly respond to the R&D needs of federal agencies along with the capacity to offer independent and objective recommendations to the government.

The USA TATRC has a specific, specialty need to establish a DIACC working group.

This DIACC will ensure that the USA TATRC AC2 research portfolio is executed in a fashion that allows both intramural and extramural R&D work to be conducted using a data interoperability framework, where all performers are working on the same standards and data formats, to ensure that the resulting work can be aggregated into a common data repository and used for ML and AI development deliverables for casualty care. To accomplish this goal, it is important that the DIACC working group consist of experts from within the government, academia and industry. Ensuring that the correct Subject Matter Experts (SMEs) are recruited for membership in the DIACC, as well as being able to provide timely input, are management and coordination functions that the USA TATRC does not have the internal resources to sustain.

Because the existing CMS FFRDC ID/IQ contract aligns with the USA TATRC requirements for this DIACC workgroup function for their AC2 research portfolio, it is advantageous and efficient to leverage this existing contract vehicle. Without the support of a FFRDC partner, the successful execution of this R&D requirement is at risk. If the Government did not leverage the use of this CMS FFRDC, a novel service contract could be initiated. However, this course of action would not result in the level of quality required and it would not provide the inherent benefits that an FFRDC brings to the government. The execution of the USA TATRC's AC2 research portfolio will be in

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

CUI

Source Selection Information - See FAR 2.101 and 3.104-4 jeopardy if the Government does not issue a task order off of the existing FFRDC IDIQ for the establishment of this DIACC working group.

6. Efforts to Obtain Competition: No effort will be made to solicit offers from as many potential sources as practicable as a Request for Information (RFI)/Notice of Intent (NOI) was posted on SAM.gov on 13 February 2024 for ten days allowing all contractors an opportunity to submit a capability statement. The RFI/NOI closed on 23 February 2024. In response to the RFI/NOI, zero capability statements were received, and zero other responses were received.

a. Effective competition. Leveraging the CMS FFRDC ensures the correct SMEs are recruited for membership in the DIACC working group to perform management and coordination functions that the USA TATRC lacks. The USA TATRC requires the support of a FFRDC partner to execute the R&D tasks of this requirement successfully.

For this reason, effective competition is not possible for this action.

b. Subcontracting competition. There is potential for subcontracting opportunities through the purchase of materials and supplies under this requirement that would result in effective competition.

7. Actions to Increase Competition: The current acquisition cannot be competed for reasons stated in Paragraph 5. This requirement aligns with TATRC's current research portfolio, AC2; however, the research portfolios are constantly evolving thus resulting in unknown future requirements. This is a unique research situation for which a follow-on requirement may not be considered, and therefore, the future competition is unknown.

In accordance with FAR 35.017, long-term FFRDC relationships are encouraged.

Enclosed is the approved J&A for contract number 75FCMC-23-D-0004 (See Enclosure

1) The specific authority cited in the J&A is FAR 6.302-3(a)(2)(ii), To establish or maintain an essential engineering, research, or development capability to be provided by an educational or other nonprofit institution or a federally funded research and development center. Through a competitive procurement in 2018 and subsequent comprehensive reviews (as required by the FAR), CMS selected The MITRE Corporation (MITRE) as the Health FFRDC Operator. MITRE is a not-for-profit entity chartered to work in the public interest. As the FFRDC Operator and partner, MITRE serves as an objective, independent advisor to sponsors and approved non-sponsors. If possible, future requirements will be competed to the fullest extent practicable.

8. Market Research: In June 2023, market research was conducted to identify other existing FFRDC contracting options, and a second vehicle, sponsored by the Internal Revenue Service (IRS), contract # TIRNO-99-D-00005, was explored as an alternative FFRDC option by the USA TATRC. In terms of base year deliverables, this FFRDC contract was deemed suitable. However, the structure of this IRS FFRDC contract is limited to a single base year and would not suite the USA TATRC’s 36-month requirement. It is essential for both the DIACC and wound health workshop multi-disciplinary membership that the management and coordination services be continuous over the entire period of performance and not be disrupted or discontinued before the work is concluded. Therefore, the IRS contract was found to not meet the requirement specifically due to the time frame limitations. It is also noteworthy that the IRS FFRDC contract was not specifically focused on medical/health requirements as is the CMS Health FFRDC.

Currently, the work being requested cannot be performed in-house by the USA TATRC.

The USA TATRC has considered the expertise and limited number of existing government staff and determined that the agency and its staff do not have the combined substantive and technical expertise, or time required to complete the projects specified in the Statement of Work (SOW).

The work cannot be performed by commercial resources. The USA TATRC has considered a variety of commercial resources, met with various individuals/organizations, and reviewed existing Defense Health Agency (DHA)/DoD contracts for other options. The USA TATRC also assessed the capabilities of current contractors with technical expertise, as well as small business vendors. It was determined that with the novel nature of the effort, which requires an understanding and expertise of health data interoperability requirements for automating care and the evolving/changing health regulatory requirements regarding automating health care, there was a need for strategic and confidential coordination across agencies, including issues around data formatting and quality that is not proprietary by a single commercial vendor, and unanticipated complexities did not lend itself to a commercial contract.

In accordance with FAR 35.017(a)(3)- FFRDCs are operated, managed, and/or administered by either a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit or a parent organization. An FFRDC provides the necessary capabilities that are not available in-house or through commercial contract resources. The required R&D support services are not appropriate to be purchased commercially as described by FAR Subpart 12 or 8, because they are unique to the Government and are based on CMS’ and HHS’ specific needs. Based on this market research review, it has been determined that the CMS sponsored Health FFRDC ID/IQ contract is the only source available with the appropriate and applicable requirements to fulfill deliverables and time frames of the USA TATRC AC2 research portfolio.

9. Other Facts:

a Procurement history. Not Applicable (N/A)

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

(2) The competitive status of these actions. N/A

(3) Authority previously cited if less than full and open competition was used. N/A

(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. N/A

(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. 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) 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. N/A

b. Other facts. This is a new requirement; however, the USA TATRC has leveraged an FFRDC contract vehicle in the past for a parallel effort, using a USAMRAA Contracting Officer (KO) to execute, and its resulting deliverables and SMEs participating resulted in common standards being defined in support of the Food and Drug Administration (FDA) for remote control of both IV pumps and ventilators during the COVID-19 crisis. These same highly specialized services to achieve interoperable of passive sensor inputs for combat casualty care are required for this current novel research portfolio.

Reviews

I have reviewed this justification and find it adequate to support the justification for an exception to fair opportunity.

Concurrence

CUI

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

Approval

Based on the foregoing justification, I hereby approve the procurement of research support services for the USA TATRC’s Autonomous Casualty Care (AC2) Research Portfolio for a total dollar value of $1,955,000 on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c)(1) as implemented by FAR 16.505(b)(2)(i)(B) – Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.