OxyhealJ A.pdf

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Control No. N-12-24

Justification and Approval For Other Than Full and Open Competition

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

Program/Equipment: Hyperbaric Oxygenation Clinical Research Program

Authority:10 U.S.C. 2304(c)(1) Amount $ 12.4M

Prepared By:

Typed Name:

Title: Project Manager, Hyperbaric Oxygen Research, USAMMDA

Date: 11 May 2012

Contracting Officer:

Typed Name:

DSN:

Date Reviewed: 11 May 2012

Technical Representative:

Typed Name:

DSN:

Title: Project Manager, Hyperbaric Oxygen Research, USAMMDA

Date: Reviewed: 11 May 2012

Requirements Representative:

Typed Name:

DSN:

Title: Project Manager, Hyperbaric Oxygen Research, USAMMDA

Date: Reviewed: 11 May 2012

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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: 7 June 2012

Legal Counsel:

Typed Name:

DSN:

Signature:

Date:

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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:

Hyperbaric Oxygenation Clinical Research Program Type of contract contemplated: Fixed Price.

Reason for type of contract:

services are commercial in nature.

Funding information:

Fiscal Year: 12 Type of Money to be used:

Research Development Test and Evaluation.

3. DESCRIPTION OF SUPPLIES/SERVICES

This is a non-competitive three year Research and Development (R&D) follow-on contract for the USAMRMC to conduct a phased clinical study into the effects of hyperbaric oxygenation (HBO2) on mild to moderate traumatic brain injury (TBI) in active duty participants. The subject effort is a component of an over-arching objective to obtain FDA approval for use of the hyperbaric oxygenation in patient treatment. The effort requires the leasing of hyperbaric chambers and operators to facilitate the studies performed. A firm fixed price (FFP) type contract is planned in the amount of $12.4M. Deliverables include progress and technical reports. This is NOT a congressional interest project. This contract was NOT solicited via a Broad Agency Announcement (BAA).

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:

In accordance with FAR 6.302-1 (a) (2) (ii) (A) and (B), only one responsible source exists as using another source would result in a substantial duplication of costs to the Government and unacceptable delays in fulfilling the agency's requirement.

OxyHeal has been performing research studies at Naval Hospital Camp (NHC) LeJeune, NHC Pendleton, Fort Carson and Joint Base Lewis-McCord using its hyperbaric chambers since it was awarded, competitively solicited, contract #W911QY-09-C-0180 in 2009. The hyperbaric chambers were leased under the previous contract, and will be leased under the subject

Page 4 of 720120507 requirement. Replacing the chambers at this time would invalidate the research protocols and existing study data, halt the collection of data, and require the re-performance of previously accomplished studies. Therefore, the work performed under the current contract, including the installation of the chambers and training of chamber technicians would have to be replicated by a new contractor resulting in a duplication of costs estimated at $2.8M and approximately a one year delay.

6. EFFORTS TO OBTAIN COMPETITION:

No efforts have been made to re-compete the requirement as replacing the chambers would result in a duplication of costs and approximately a one year program delay. Six months of studies have been performed to date. Clinical data obtained through efforts must be performed in the same chambers to provide a reliable comparison of data. Re-performance would result in a duplication of costs in the amount of six months of studies, plus infrastructure related changes.

The duplication of costs is estimated at $2.8M in addition to the one year of program delays.

7. ACTIONS TO INCREASE COMPETITION:

Currently the program is intended to establish support for the DoD's position on the impact of Hyperbaric Oxygenation on mild to moderate TBI. Should there be a validated outcome that indicates there is a medically documented positive impact, these results will be used to determine the requirements for a future competitive procurement of hyperbaric chambers to support the delivery of the recommended oxygenation exposure.

8. MARKET RESEARCH

Market Research was conducted January 2012 through May 2012 by Naval Health Research Center (NHRC) in support of USAMMDA. research indicated that other companies exist that could provide similar chambers; however, the ongoing studies performed would be invalidated by switching to different chambers. Furthermore, the Government is unaware of any companies that furnish similar services to those OxyHeal offers for its chambers.

Market research was conducted for this project during its initial period in Jun/July 2009. At that time, a competitive RFP was released, four companies responded and OxyHeal was awarded contract W911QY-09-C-0180 as it was the only company with both multiplace chambers and certified hyperbaric chamber technicians to be located at each site.

9. INTERESTED SOURCES:

In 2009 the following vendors, in addition to the contract awardee, responded to the competitive solicitation; ETC, Reimers Systems, Inc., and Mobile Hyperbaric Centers. These vendors were unable to meet the Program requirements in regards to providing chambers at an aggressive time line set by the Government and provide the required CHTs.

Attached hereto is notice of intent to sole source that was posted May 7, 2012. The Government would have considered all sources, however, no parties have expressed interest.

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10. OTHER FACTS:

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

a. Procurement History A competitive RFP was released in 2009 for the award of contract W911QY-09-C-0180 which rendered at least four companies that submitted for the support contract. These entities were OxyHeal Health Group, Inc., (OxyHeal), ETC, Reimers Systems, Inc., and Mobile Hyperbaric Centers. Of those that submitted all could provide hyperbaric chambers. Proposals rendered many that only had monoplace (single person) chambers, a combination of monoplace and multiplace (multiple patients) or out of date chambers that, while still able to be used, did not meet the current DoD standards for multiplace chambers being sought. As a result OxyHeal was the only entity that was able to provide both multiplace chambers and certified, trained chamber technicians.

b. Acquisition Data Availability No acquisition documentation suitable for full and competition is available as replacing the chambers would result in a duplication of costs and approximately a one year program delay.

Six months of studies have been performed to date. Clinical data obtained through efforts must be performed in the same chambers to provide a reliable comparison of data. Re-performance would result in a duplication of costs in the amount of six months of studies, plus infrastructure related changes. The duplication of costs is estimated at $2.8M in addition to the one year of program delays.

c. Unusual and Compelling Urgency

N/A

d. Subcontracting Competition This contract is being awarded under NAICS code 541712 with a size requirement of 500 employees or less. A DD2579 has been prepared and signed by the KO and SBA. OxyHeal Health Group is a small business and no subcontracting opportunities exist under the subject effort. Should any subcontracting opportunities arise, OxyHeal will be made aware of the need to utilize them as appropriate.

e. Follow-on Contracts Previous award (W911QY-09-C-0180) based on competitive solicitation was effective 28 September 2009. Vendor continues to support the Program with hyperbaric chambers and CHTs.

The original chambers were leased from OxyHeal Health Group under a competitive contract.

Due to the regulatory requirements of the program that include careful sustainment of study methodology in order to uphold supporting protocols that includes the supplies and services available to operate and maintain the chambers per specific study requirements, these services are only from OxyHeal Health Group.

In order to compete this requirement, the Government would have to replace the presently leased systems and re-perform six months of studies at an estimated cost of $2.8M. The amount of $2.8M is considered to be a substantial duplication of cost that could not be recovered through competition, and in addition to significant performance delay, would have a negative impact on the studies.

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The interruption of chamber support during an ongoing study is unacceptable to the Department of Defense. Compiled with the additional costs of physically replacing the four chambers, the historical knowledge that has been gained by the CHTs specific to this Program is invaluable.

Training new CHTs to the study specific protocols would cause delays in addition to repetitive costs to the Program.

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: 7 June 2012

Title: Project Manager, Hyperbaric Oxygen Research Program

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: 7 June 2012

Title: Project Manager, Hyperbaric Oxygen Research Program

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13. FAIR AND REASONABLE COST DETERMINATION:

I hearby 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:

price analysis.

As Part of the basis, certified cost or pricing data will not be required.

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

IAW 15.403-1(c)(3) Commercial acquisitions are not subject to certified cost & pricing data.

Typed Name:

Date: 07 JUN 2012

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:

Date: 07 JUN 2012

Title: Contracting Officer

Signature:

APPROVAL

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

hyperbaric chambers and the support services of four CHTs 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: