InfrascanJA.pdf

Page 1 of 620120507

Control No. N-14-45

Justification and Approval For Other Than Full and Open Competition

For actions over $650,000 but not exceeding $12.5M

Program/Equipment: Infrascanner 2000 Modifications Enabling Monitoring and Meas

Authority:10 U.S.C. 2304(c)(1) Amount $ 3,761,139.00

Prepared By:

Typed Name:

DSN:

Title:

Date: 6/18/14

Contracting Officer:

Typed Name: Kevin Parker

DSN: 233-6175

Date Reviewed:

Technical Representative:

Typed Name:

DSN:

Title:

Date: Reviewed: 6/19/14

Requirements Representative:

Typed Name:

DSN:

Title:

Date: Reviewed: 6/19/14

Page 2 of 620120507

Reviews:

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

Director (GS-15 equivalent), Program Manager or PEO (PEO signature required if program managed be PEO):

Typed Name:

DSN:

Signature:

Date: 01 JUL 2014

Legal Counsel:

Typed Name:

DSN:

Signature:

Date:

Page 3 of 620120507

Justification and Approval

For Other Than Full and Open Competition

1. CONTRACTING ACTIVITY

Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division, ATTN: CCAP-SCN, Kansas Street, Natick, MA 01760

2. DESCRIPTION OF ACTION

Approval is requested to solicit on the basis of other than full and open competition for a new contract.

The contract is in support of:

Marine Corps Systems Command (MARCORSYSCOM) Type of contract contemplated: Cost No Fee.

Reason for type of contract:

Effort is R&D in nature and lacks precise specifications in order to accurately estimate costs Funding information:

Fiscal Year: 14 Type of Money to be used:

Research Development Test and Evaluation.

3. DESCRIPTION OF SUPPLIES/SERVICES

Approval is requested to award a follow-on to contract number W911QY-10-C-0136 for Portable Near-Infrared Technology (NIR) for Detection of Traumatic Brain Injuries in Operational Environments to extend the existing capabilities of the Infrascanner 2000, a commercial portable near infrared based head trauma screening device, to allow for reliable monitoring and measurement of local tissue oxygen, edema and brain bleeding simultaneously at the site of injury and produce a ruggedized prototype available for testing in simulated battlefield situations. Estimated value for this effort is $3,761,139.00 for a thirty-six month period of performance with one (1) twelve (12) month option period.

4. AUTHORITY CITED

The statutory authority permitting other than full and open competition is 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:

The Infrascanner system is based on the patented research discoveries of Dr. Britton Chance and Dr. Claudia Robertson regarding the use of diffuse near-infrared light to detect intracranial hematomas. Dr. Chance was the Eldridge Reeves Johnson University Professor Emeritus of Biochemistry and Biophysics, and also Professor Emeritus of Physical Chemistry and Radiological Physics at the University of Pennsylvania School of Medicine. Dr. Claudia Robertson is the Medical Director of the Neurosurgical ICU at Ben Taub General Hospital in Houston, Texas. InfraScan, Inc. was formed around this NIR technology to develop a medical device to detect hematomas. Dr. Chance owns patents relevant to the hematoma detection method and brain oximetry. Dr. Chance and Dr. Robertson jointly own the basic methodology

Page 4 of 620120507 patents. All of these patents and their international counterparts are exclusively licensed to InfraScan, Inc.

In collaboration with Drexel University, InfraScan, Inc. designed and developed the Infrascanner 2000 device, which obtained FDA 510(k) approval in January 2013. For this particular effort, InfraScan, Inc. is again teaming with Drexel University to extend the Infrascanner 2000's capabilities to include monitoring of local tissue oxygen, edema and brain bleeding. This team's unique and specialized expertise along with their intimate knowledge of the Infrascanner 2000's design and functionality cannot be obtained from any other vendor.

The potential benefits to the Government if this effort is successful are substantial. Specifically, the effort will result in an integrated portable NIR based hand-held point-of-care system for effective triage and resuscitation on the battlefield where 70% of all head injuries are due to blasts. One of the most common effects of blast, in addition to intracranial hematomas, is brain edema. This technology would be non-invasive and would provide critical baselines for monitoring and assessment of trauma victims during triage and resuscitation efforts. No other organization besides InfraScan, Inc. has the extensive breadth and depth of technical expertise with the Infrascanner 2000 technology required to perform the work.

6. EFFORTS TO OBTAIN COMPETITION:

MARCORSYSCOM, Family of Field Medical Equipment (FME) conducted a Sources Sought survey on 2 May 2014 (Solicitation Number W911QY-14-R-IS14) to determine industry capabilities in modifying/upgrading the existing Infrascanner 2000 system. After posting for thirty days, only one response to the sources sought notice was received from InfraScan, Inc.

7. ACTIONS TO INCREASE COMPETITION:

Current contract requirements will support MARCORSYSCOM's efforts to finalize establishment of capability requirement specifications by FY18. It is expected that a capability review will take place at the onset of FY19 in an effort to then generate a request for commercial procurement, via a Request for Proposals, to field procurement-ready technology satisfying the performance specification and capability gap by FY19.

8. MARKET RESEARCH

MARCORSYSCOM, Family of Field Medical Equipment (FME) conducted a Sources Sought survey on 2 May 2014 (Solicitation Number W911QY-14-R-IS14) to determine industry capabilities in modifying/upgrading the existing Infrascanner 2000 system. One response to the sources sought notice was received from InfraScan, Inc. In addition, market research was conducted on 18 Jun 2014 via internet searches for the keyword "infrascanner" that identified InfraScan, Inc., MedLogic, LLC and Bresslergroup, Inc. as potential sources. Upon further investigation, it was determined that MedLogic, LLC is a distributor of the Infrascanner product and did not submit a response to the RFI. Bresslergroup, Inc. is a medical product design firm that supported the industrial design and mechanical engineering aspect in the development of the Infrascanner product. They too did not submit a response to the RFI.

9. INTERESTED SOURCES:

A notice of intent to award this sole source contract to InfraScan Inc. was issued on FedBizOpps.

No responses were received from other sources.

Page 5 of 620120507

10. OTHER FACTS:

Discuss any other facts supporting use of other than full and open competition, such as the following:

a. Procurement History Contract W911QY-10-C-0136 awarded 28 Jun 2010 to InfraScan, Inc. Contract was completed on time and all requirements were fulfilled. Prior contracts for the development of the Infrascanner concept were awarded via ONR under the SBIR program.

b. Acquisition Data Availability

N/A

c. Unusual and Compelling Urgency

N/A

d. Subcontracting Competition

N/A

e. Follow-on Contracts

N/A

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:

Date: 6/19/14

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:

Date: 6/19/14

Title:

Page 6 of 620120507

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.

The techniques to be used to determine fair and reasonable prices are:

cost analysis.

As Part of the basis, certified cost or pricing data will be required.

If one of the exceptions in FAR 15.401 applies, please indicate.

Typed Name: Kevin Parker

Date:

Title: Contracting Officer

Signature:

14. CONTRACTING OFFICER CERTIFICATION:

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

Typed Name: Kevin Parker

Date:

Title: Contracting Officer

Signature:

APPROVAL

Based on the foregoing justification, I hereby approve the procurement of:

Infrascanner 2000 Modifications Enabling Monitoring and Measurement of Local Tissue Oxygen, Edema on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c)(1), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Special Competition Advocate

Date: