J_ _A_for_Pelagique_-SBIR_Phase_III.pdf

DEPARTMENT OF THE ARMY

U.S. ARMY MEDICAL RESEARCH ACQUISITION ACTIVITY

820 CHANDLER STREET

FORT DETRICK MD 21702-5014

Control No: JA16338

Justification Review Document for Other Than Full and Open Competition

Services: “Ultrasound Training for the Military Health System: Initial Sentinel Prospective Validation Study”

Authority: 10 U.S.C. 2304(c)(5), as implemented by FAR 6.302-5: Authorized by Statue.

Amount: $2,000,000.00

Prepared by:

Typed Name: Jennifer Tait DSN: 32190 Title: Contract Specialist Date: 06 September 2016 E-mail:

Contracting Officer:

Typed Name: Micaela L. Bowers DSN: 32173 E-Mail: Date Reviewed: ____________

Technical Representative:

Typed Name: Hugh Connacher DSN: 38089 Title: Contracting Officer Representative Date Reviewed: ___________

Requirements Representative:

Typed Name: _Hugh Connacher DSN: 38089 Title: Contracting Officer Representative Date Reviewed: _________________

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Legal Counsel Typed Name: James M. Miller DSN: 32167

Signature: ______________________ Date: ______________________

Special Competition Advocate Typed Name: Christopher E. Sherman DSN: 32933

Signature: ______________________ Date: ______________________

Control No: JA16338

SBIR Phase III Justification for Other Than Full and Open Competition

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD in support of the Congressionally Directed Medical Research Program (CDMRP).

2. Description of Action: This is a justification for approval to award a Small Business Innovative Research (SBIR) Phase III. In June 2007, Pelagique, LLC was awarded SBIR Phase I, contract W81XWH-07-C-0080, and was subsequently awarded Phase II, same contract number; SBIR solicitation

2006.3 included Phase I and Phase II evaluation criteria. The performance period for Phase I began 01 June 2007; Proposal No.O063-H12-3241, Topic No. OSD06-H12. Phase II Proposal No. 02-0711 was awarded via modification to contract W81XWH-07-C-0080 with a performance period beginning 08 July 2008; the contract has been modified to add a Phase II Enhancement, which extended the contract through 17 July 2012. Pelagique, LLC received a Phase III award, contract W81XWH- 11-C-0529, on 01 October 2011. Under Phase III, it is intended that non-Federal capital be used by the small business to pursue commercial applications of the research or development. Also, under Phase III, Federal agencies may award non-SBIR funded follow-on contracts for products or processes, which meet the mission needs of those agencies.

3. Description of Supplies/Services: The procurement provides funds to support the SonoSim Ultrasound Simulator SBIR Phase III effort to include (1) development of an ontology-based probabilistic model of user performance and integration into SonoSim® automated assessment technology; (2) performing a skill-decay study that assesses user knowledge, skills, and attributes (KSAs) continuously over time; (3) supporting the validation of models and guide model updates based on data collected in the study; (4) design and development of an ontology editing and mapping tool; (5) extending SonoSim® KSA ontology to other courses; and (6) customizing ultrasound proficiency parameters to Military Health System (MHS) requirements. Phase I supported the initial sentinel study with independent academic institution follow-up studies and was a critical aspect of external acceptance and adoption of the SonoSim® Ultrasound Training Solution during Phase I and II work. The combination of an initial prospective validation study, followed by independent institution validation studies was a key aspect of Pelagique’s Phase II effort during development of the SonoSim® Ultrasound Training Solution technology. Upon conclusion of Phase III Sentinel Prospective Validation Study, the OSD’s SBIR program will have successfully transitioned a Phase I concept (the need for a computer-based, widely deployable combat casualty care didactic and hands-on training solution) into a consumer product (SonoSim® Ultrasound Training Solution) that is scalable across health systems. The Phase III work derives from, extends, or completes efforts performed under Phase I and Phase II. The contract type is firm-fixed price (FPP) Level of Effort (LOE). Please note a FFP LOE Waiver has been drafted for the file. The total estimated value of this acquisition is $2,000,000.00. No Options will be included. FY16, Defense Health Program (DHP) Development, Testing & Evaluation Enhanced 2-year funding is anticipated to be allocated as follows:

CLIN 0001- Phase III Proposal- 23 months x $83,333.33= $1,916,666.59 CLIN 0002- Phase III Final Report- 1 month x $83,333.41 = $83,333.41

4. Identification of Statutory Authority: 10 U.S.C. 2304(c) (5), as implemented by FAR 6.302-5:

Authorized or Required by Statute. The following SBIR Phase III support text has been pulled from the Federal Register, Vol. 77, No. 151, dated Monday, August 6, 2012, Part II, PDF version, pages 46819 through 46820, located at the following cite: https://www.federalregister.gov/articales/2012/08/06/2012-https://www.federalregister.gov/articales/2012/08/06/2012-18119/samll-business-innovation-research-program-policy-directive

18119/samll-business-innovation-research-program-policy-directive 4(c). Phase III. SBIR Phase III refers to work that derives from, extends, or logically concludes effort(s) performed under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. Phase III work is typically oriented towards commercialization of SBIR research or technology 4(c) (1) (ii). SBIR-derived products or services intended for use by the Federal Government, funded by non-SBIR sources of Federal funding.

4(c) (2). The competition for SBIR Phase I and Phase II awards satisfied any competition requirements of FAR Part 6. Therefore, an agency that wishes to fund a SBIR Phase III project is not required to conduct another competition in order to satisfy those requirements. As a result, in conducting actions relative to a Phase III SBIR award, it is sufficient to state for purposes of a Justification and Approval pursuant to FAR 6.302-5, that the project is a SBIR Phase III award that is derived from, extends, or logically concludes efforts performed under prior SBIR funding agreements and is authorized under 10 U.S.C.

2304(b) (2) or 41 U.S.C. 253(b) (2). 4(c) (3). Phase III work may be for products, production, services, R/R&D, or any combination thereof.

5. Demonstration that Proposed Contractor’s Unique Qualifications or Nature of Acquisition Requires Use of Authority Cited: The nature of the acquisition requires the use of the authority cited.

The SBIR/STTR Programs are structured in three phases. Phase I (project feasibility) determines the scientific, technical and commercial merit and feasibility of the ideas submitted. Phase II (project development to prototype) is the major research and development effort, funding the prototyping and demonstration of the most promising Phase I projects. Phase III (commercialization) is the ultimate goal of the SBIR/STTR Programs. Because the Phase III work derives from, extends, or completes efforts performed under Phase I and Phase II, use of the authority cited is required.

The proposed contractor for this action is Pelagique, LLC. Pelagique, LLC has completed the Phase I, II, and II Enhancement SBIR portions of contract, W81XWH-07-C-0080, titled “Multimedia Combat Injury Management Training” and is presently working on their Phase III SBIR work scope contract, W81XWH-11-C-0529 contract, titled “Ultrasound Training for the Military Health System.”

Pelagique, LLC possesses the intellectual property rights necessary to extend and modify the design of the system being used as the basis for the research and development described in the proposed statement of work. Other companies/organizations lack these IP rights and significant time and expense would be required to create a non-infringing alternative system that would allow them to develop similar technical capabilities.

The existing system used for this research effort is highly specialized and has already been developed in a previous series of DHP SBIR awards over a 6 year period, therefore competing this requirement would result in substantial duplication of costs and unacceptable delays.

The work to be performed during this Phase III effort derives from efforts performed under the preceding and current SBIR contracts and is authorized under 10 U.S.C. 2304(b) (2) and/or 41 U.S.C. 253(b) (2).

6. Description of Efforts Made to Ensure Offerors Were Solicited From as Many Potential Sources as Practicable/Public Notification through Government Point of Entry (GPE): As described above, only Pelagique, LLC is being considered for Phase III award due to the nature of the acquisition. In accordance with FAR 5.202(a) (7), this proposed contract action does not require the submittal of a pre-solicitation notice to the GPE.

https://www.federalregister.gov/articales/2012/08/06/2012-18119/samll-business-innovation-research-program-policy-directive

The Government will inform other companies that may potentially be interested in the program once manufacturing processes are obtained for this system, any subsequent procurement actions will seek competition if deemed applicable under the SBIR program guidelines.

7. Description of Market Research or Statement of the Reason Market Research was not conducted:

FAR 10.001(a) (2) indicates that market research appropriate to the circumstances must be conducted.

SBIR Phase III procurements are such that traditional market research to identify alternative sources is generally unnecessary. Market Research may have been conducted by the Solicitation Topic Author, but we do not have access to this as solicitations are coordinated, through the DOD and posted, evaluated under the DOD SBIR guidelines. Once the solicitation closes, and selections are made, no alternative sources are permissible under the program. As described above, the Phase III work derives from, extends, or completes efforts performed under Phase I and Phase II.

8. Statement of Actions Taken to Remove Barriers to Future Competition:

The Contracting Officer anticipates that competitors will enter the market once the product is commercialized. It is likely that future acquisitions will be competed using full and open competition and commercial item acquisition procedures. The Contracting Officer is not aware of any specific actions that would further remove barriers to competition.

9. Interested Sources:

Not applicable.

10. Other Facts:

Not applicable.

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: Hugh Connacher Date: ________________

Title: Signature: ____________________________________

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: Hugh Connacher Date: ________________

Title: Signature: ____________________________________

13. Fair and Reasonable Cost Determination:

I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

A cost analysis will be conducted to determine if the proposed budget is fair and reasonable. Certified cost or pricing data will be required in accordance with FAR 15.403.

Typed Name: _______________________ Date: _____________

Title: Signature: _____________________________________

14. Contracting Officer Certification.

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

Typed Name: Micaela L. Bowers Date: ______________

Title: Contracting Officer Signature: __________________________

15. Legal Sufficiency

I hereby determine this Justification and Approval for Other than Full and Open Competition to be Legally Sufficient.

Typed Name: _______________________________ Date: ________________

Title:______________________________ Signature:______________________________________

Approval

Based on the foregoing justification, I hereby approve the procurement of “Ultrasound Training for the Military Health System: Initial Sentinel Prospective Validation Study” on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c) (5), as implemented by FAR 6.302-5: Authorized or Required by Statue, subject to availability of funds, and provided the services and property herein described have otherwise been authorized for acquisition.

Date: Signature: ____________________________________________