W81XWH-20-R-0058_JA_FAR-Part6_Redacted.pdf

Program/Equipment: Portable Brain Hematoma Detector

FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Program/Equipment: Portable Brain Hematoma Detector for the U.S. Army Medical Materiel Development Activity (USAMMDA) Warfighter Brain Health Project Management Office (WBH PMO).

Authority: 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Amount:

Prepared by:

Contracting Officer:

Technical:

Requirements:

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

FAR Part 6 Justification and Approval 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 WBH PMO at the USAMMDA.

2. Description of Action: The USAMMDA WBH PMO requests a firm fixed price new contract with Infrascan, Inc., 3508 Market St., Suite 127, Philadelphia, PA 19104. The Government projects award for September 2020 and fiscal year 2020 Defense Health Program Advanced Development Research, Development, Test, and Evaluation (RDT&E) funds will be used.

3. Description of Supplies/Services: Infrascan, Inc. is currently the only U.S. Food and Drug Administration (FDA) cleared manufacturer of a portable near-infrared brain screening device for the detection of subdural, epidural and intracerebral hematomas.

The Government objective is to develop, refine, and evaluate the Infrascanner 2500 to meet U.S. Service Member / end user needs, eventually obtaining manufacturing capability of the device. The specific requirement is for product refinement in the design and software development of the Infrascanner 2500 model to address key issues that were identified during end user testing of the prototypes. If the device demonstrates the capability to satisfy the medical end users performance requirements, the Government will have the option to obtain manufacturing capability of the device, purchase a quantity of devices and maintenance kits, and receive the training necessary for operators to properly use and maintain the devices.

4. Authority Cited: 10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited: As described at FAR 6.302-1(a)(2)(iii), for DoD, NASA, and the Coast Guard, 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-

(A) Substantial duplication of cost to the Government that is not expected to be recovered through competition; or

(B) Unacceptable delays in fulfilling the agency’s requirements.

A follow on contract is only available with the original source as they are the only contractor of this service that can satisfy agency requirements, full and open competition need not be provided for. This is a follow-on acquisition to a previously competed requirement.

Infrascan, Inc. is the sole producer of the Infrascanner 2500, a portable brain screening device for the detection of subdural, epidural and intracerebral hematomas. This technology will be utilized far forward on the battlefield for the identification of traumatic brain injuries that would normally require a computerized tomography (CT) scan for identification. The confirmation of traumatic brain injury (TBI) far forward will result in the earlier identification of Service Members who need advanced medical care. Infrascan, Inc. has completed all regulatory activities required for FDA approval of the Infrascanner 2500 and has submitted for the 510(k). The product refinement of the Infrascanner 2500 capability will provide the highest technology readiness level (TRL) of any other product under development.

It is likely that award to any other source would result in substantial duplication of costs to the Government that is not expected to be recovered through competition, as well as unacceptable delays in fulfilling the agency’s requirements. The Government has already contributed towards the development of Infrascan, Inc.’s Infrascanner 2500 device via contract W81XWH-17-C-0244. Approval is requested to execute a follow-on contract with Infrascan, Inc. for the continued development of this highly specialized equipment. If a contract was awarded on a competitive basis to a contractor other than Infrascan, Inc., at minimum, other vendors would need four years of development time to reach the current level of product maturity currently held by the Infrascanner 2500.

6. Efforts to Obtain Competition: In accordance with Defense Federal Acquisition Regulation Supplement and Procedures, Guidance, and Information (DFARS PGI) 206.302-1(d) a Sources Sought Notice (SSN) was posted to Contracting Opportunities (beta.SAM.gov, formerly known as FBO) on 14 May 2020 for fifteen (15) calendar days.

Responses were due by 29 May 2020. The Government did not receive any responses to the SSN.

a. Effective Competition. The Government has identified only one responsible source and no other supplies or services will satisfy agency requirements. The results of the SSN support this assertion; therefore, this requirement will not be competed.

b. Subcontracting Competition. Infrascan, Inc. will be held to the statutory requirements of FAR 19.702, which states that any contractor receiving a contract with a value greater than the simplified acquisition threshold must agree in the contract that small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns will have the maximum practicable opportunity to participate in contract performance consistent with its efficient performance. To ensure adherence to this requirement the clause at FAR 52.219-8--Utilization of Small Business Concerns will be included in the solicitation and resultant contract. As established at FAR 19.702(b)(1), Infrascan’s status as a small businesses exempts the firm from the requirement to submit a subcontracting plan.

7. Actions to Increase Competition: Market research and the results of the SSN both indicate that there are no other viable sources to compete for this award at this time.

The Product Manager will continue to monitor any emerging development efforts that could provide for competition.

8. Market Research: A literature search on TBI diagnostic solutions was conducted from December 2019 to April 2020. The literature search included scientific literature databases (e.g., PubMed); repositories of research supported by the DoD (e.g., Defense Technical Information Center, Small Business Innovation Research, and Small Business Technology Transfer); U.S. and international clinical trials reporting sites (e.g., Clinicaltrials.gov and Clinicaltrialsregister.eu); and U.S. and international regulatory agency websites (e.g., U.S. FDA, European Medicines Agency, the U.S. Patent and Trademark Office, and Google/Google Scholar).

The market research identified one candidate being developed by industry utilizing Near- Infrared Spectroscopy that would be able to perform portable brain screening for the detection of subdural, epidural and intracerebral hematomas. This technology is currently at TRL 5/6 and would require pivotal trials to gain FDA approval. No other technology was identified at TRL 9 for this indication for use. Furthermore, the SSN did not generate any interest from the vendor community.

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

10. Other Facts:

a. Procurement history. Contract W81XWH-17-C-0244 was issued to Infrascan, Inc.

on 07 July 2017 with a period of performance starting on 27 September 2017 and ending on 26 September 2019. Contract W81XWH-17-C-0245 was issued to on 07 July 2017 with a period of performance starting on 27 September 2017 and ending on 28 February 2022.

Solicitation W81XWH-17-R-0040 for “Point of Injury Device to Measure and Monitor Physiological Parameters Relevant to Moderate and Severe Traumatic Brain Injury (POI TBI)” was released to the vendor community via FedBizOpps (FBO) on 07 July 2017 as a full and open competitive requirement. As stated in the solicitation, the Government anticipated award of up to (but not greater than) five (5) contracts. Further stated within the solicitation it specified, “…the Government intends to down select, potentially to a single product, and award a second contract for pilot and pivotal studies to finalize and prepare for U.S. Food and Drug Administration submission and production.” Solicitation W81XWH-17-R-0040 resulted in the award of two contracts, W81XWH-17-C-0244 and W81XWH-17-C-0245. Contract W81XWH-17-C-0244 is complete and can be awarded a second contract to finalize the product for potential production. Contract W81XWH-17- C-0245 is still ongoing and a final prototype has not been delivered for comparison on the ability to function as a “Point of Injury Device to Measure and Monitor Physiological Parameters Relevant to Moderate and Severe Traumatic Brain Injury”. As stated in the original solicitation, there is a desire to shorten the time between program start and product fielding by utilizing a higher TRL device. The contract resulting from this J&A will be the down select to a second contract for Infrascan Inc., an initial awardee from the first solicitation, for further product refinement and production capabilities.

b. Other facts. All facts necessary to justify limiting competition have been stated above.

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 or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: cost analysis price analysis should cost IGCE audit: other:

As a part of this basis, certified cost or pricing data:

will be required.

will not be required and the following exception applies (FAR 15.403):

Prices that will be agreed upon are based on adequate price competition.

Prices that will be agreed upon are based on prices set by law or regulation.

A commercial item is being acquired.

A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

The contract action is a modification to a contract or subcontract for commercial item(s).

The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Approval Based on the foregoing justification, I hereby approve the procurement of portable brain hematoma detector development for the estimated amount of 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 Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, subject to availability of funds, and provided that the services or property herein described have otherwise been authorized for acquisition.