Justification and Approval for Other Than Full and Open Competition

1.   Contracting Activity:  Specify the contracting activity responsible for this action:

The Contracting Activity responsible for this action is the U.S. Army Medical Research Acquisition Activity, Fort Detrick, MD.

2.   Description of Action:  State whether approval is being requested for a new contract or a modification.  Include type of contract, type of funds to be used (R&D, OPA, OMA) and, when applicable, the estimated share and ceiling arrangements, and fee or profit.

This approval is being requested for a new cost-reimbursable contract using FY08 RDTE funds from the U.S. Army Medical Materiel Agency (USAMMA) and the Special Operations Command (SOCOM).

3.   Description of Supplies/Services:  Describe the supplies/services.  Include the estimated total value, including options, if any.

The U.S. Army Medical Research and Materiel Command (MRMC), Fort Detrick, MD will use the funds to support development of a small, lightweight battery for use with the Enginivity enFlow IV fluid warmer.  The estimated value of this contract is $628,000.

4.   Authority Cited:  Identify the statutory authority permitting other than full and open competition, followed by the FAR citation, and FAR citation title.

The statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(1).  The FAR citation is 6.302-1(a)(1) and (a)(2)(ii) and the FAR citation title is only one responsible source and no other supplies or services will satisfy agency requirements.  Supplies are deemed to be available only from the original source in the case of a follow-on contract for the continued development or production of a major system or highly specialized equipment, including major components thereof, 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. (See 10 U.S.C. 2304(d)(1)(B) or 41 U.S.C. 253 (d)(1)(B).)

5.   Reason for Authority Cited:  Describe how this action requires the use of the authority cited.  If applicable, identify the proposed or potential contractor(s), and include a discussion of the proposed contractor’s unique qualifications for fulfilling the contract requirements.  If the authority is 6.302-1, include the required delivery schedule and lead-time involved.  If the authority is 6.302-2, include the required delivery schedule and lead-time involved as well as a discussion of the serious injury to the Government which would result if award of a contract is delayed.

The proposed contractor for this action, Enginivity LLC, a subsidiary of Vital Signs, Inc., has been working with the Government since 2005 to develop a portable fluid warmer that can be operated using alternating current (AC) power or from battery power at flow rates suitable for trauma care (over 150 ml/min).  The company has produced commercial FDA-cleared fluid warmers for civilian and military applications and is using a commercial-off-the-shelf battery as an interim measure until development of a smaller, lighter battery pack can be completed.  The current effort is to leverage the technological advances made to date, complete battery development, and fabricate a prototype for required Government test and evaluation.  Given the significant Government investment that has gone into development of this regulatory-compliant fluid warmer technology, and the fact that it can be leveraged to speed development of a more compact battery pack for a portable, battery-powered fluid warmer, it would not be practical for MRMC to turn to another contractor to develop this system, as most of the technological and regulatory hurdles have already been largely overcome through application of proprietary engineering solutions.  Only Enginivity has the expertise and product experience to complete the necessary system development work under the existing timelines.

6.   Efforts to Obtain Competition:  Describe efforts to insure that offers are solicited from as many potential sources as is practicable.  Also describe the extent of effective competition anticipated for this acquisition:

Not Applicable.  No effort will be made to solicit offers from as many potential sources as is practicable as there is only one source capable of fabricating the required test articles for subsequent Government test and evaluation. 

7.   Actions to Increase Competition:  There may be instances when it is not possible to compete the current acquisition.  Include a statement of the action taken, or to be taken, to increase competition (e.g., breakout) before any subsequent acquisition of the supplies or services.

The contractor has been informed that once development and testing of this technology is finished, any subsequent procurement actions will use full and open competition.  This will provide the incentive for all companies to provide best value to the Government.

8.   Market Research:  Describe the extent and the results of the market research (FAR Part 10) conducted to identify all qualified sources.  Research must have been meaningful and conducted within the previous 12 months.

Market research performed by USAMMA in April 2008 identified only two portable fluid warmers that can be powered by batteries and achieve the flow rates necessary for trauma care, including the Enginivity model and one other model.  The other model is not capable of AC-powered operation and is much less cost effective than the Enginivity because the heater/controller unit is completely disposable (rather than reusable, as with the Engivinity model).  Also, the battery for the other model is larger and heavier than even the existing Enginivity battery.

9.   Interested Sources:  Include a list of the sources that have written to express interest in the acquisition.  If applicable, clearly state  “To date, no other sources have written to express an interest.”  If 10 U.S.C. 2304(c)(1) is the authority cited, explain why other sources were rejected.  Also, state that the notices required by FAR 5.201 shall be or have been published, and that any bids or proposals received shall beconsidered.  If a FEDBIZOPPS notice will not be published, state which exception in FAR 5.202 applies. 

Pursuant to FAR part 5, Publicizing Contract Actions, an announcement of the Government’s intent to initiate this contract shall be placed in the Federal Business Opportunities (FedBizOpps) via the Army Single Face to Industry.  Inquiries from any interested offerors shall be evaluated accordingly by the Contracting Officer prior to the issuance of a sole source contract award.

10. Other facts:  Discuss any other facts supporting the use of other than full and open competition, such as the following: a.  Procurement history.  Reasonable efforts to retrieve the following items from the computer records, contract files, competition advocate office files or other sources are expected:             i.  Contract numbers and dates of the last several awards.

W81XWH-05-2-0052, 1 February 2005 to 30 September 2007


ii.  Competitive status of these actions.

W81XWH-05-2-0052 – competitive under the USAMRC BAA. 


iii.  Authority previously used for less than full and open competition.

Not applicable.

iv.  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.

Not applicable.

v.  If any prior award was accomplished by full and open competition, a detailed explanation of the changed circumstances.

Cooperative Agreement W81XWH-05-2-0052 was awarded to develop a portable, AC/DC-powered fluid warmer capable of infusing warmed resuscitative fluids or blood to trauma patients suffering from hypovolemic shock.

A sole source RDTE contract is being requested in this instance so that the proprietary technology originally developed under W81XWH-05-2-0052 may be modified to make the battery pack more suitable for use in far forward situations and Special Forces operations.  A contract is being used instead of an assistance agreement because the Army seeks to procure the prototype of a usable end item in furtherance of its mission. 

vi.  An explanation of any unusual patterns which may be revealed by the history, e.g., several consecutive urgent buys.

Not applicable.

vii.  If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the buy and whether there have been any significant changes.

Not applicable.

b.  Acquisition data availability.  Explain why technical data packages, specifications, engineering descriptions, statements of work or purchase descriptions suitable for full and open competition have not been developed or are not available.  Describe actions taken or planned to remedy this situation.

The contractor owns the intellectual property developed under W81XWH-05-2-0052 and is currently marketing a fluid warmer capable of warming resuscitative fluids and blood.  MRMC does not hold a licensing agreement with the contractor.


c.  Unusual and compelling urgency.  When FAR 6.302-2 is cited, provide data, estimated cost or other rationale to explain the nature and extent of the injury to the Government.  If the delay associated with the requirement for first article testing is the principal reason for not awarding the contract on a full and open basis, clearly describe the reasons that first article testing is required on this procurement and why other means of assuring quality are not being used.

Not applicable.

d.  Subcontracting competition.  In single source situations, address efforts to be taken by the Government to assure that the prime contractor obtains as much competition as possible in its subcontracting.

Not applicable, there are no anticipated major subcontractors for this procurement.

11.  Technical Certification:  Include the following statement: 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:
  Patricia M. Dubill         Date:

  Product Manager                                   Signature: 12.  Requirements Certification:  Include the following statement:  I certify that the following data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief. Typed Name: Patricia M. Dubill                      Date:

Product Manager                                   Signature: 13.  Fair and Reasonable Cost Determination:  Include the following determination: I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable. Provide the basis for this determination (e.g., describe techniques to be used to determine fair and reasonable price, such as cost analysis, price analysis, audit, should cost, independent Government estimate, etc.). 

The total price established for the required services will be determined to be fair and reasonable.  The Government will be conducting a detailed cost analysis.

Typed Name: Gilbert W. Hovermale                           Date:

Title:  Contracting Officer                                Signature:

14.  Contracting Officer Certification.  This certification shall be made by the Contracting Officer from this justification and approval.  Include the following statement: I certify that this justification is accurate and complete to the best of my knowledge and belief. Typed Name:
Gilbert W. Hovermale                           Date:

Title:  Contracting Officer                                Signature:

15.  I hereby determine this Justification and Approval for Other than Full and Open Competition to be Legally Sufficient. Typed Name:  Dorothy M. Guy                      Date:

Legal Counsel                            Signature:


Based on the foregoing justification, I hereby approve the procurement of the further development and prototype of a lightweight battery for the Enginivity enFlow IV fluid warmer on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c)(1) and FAR Part 6.302-1 (a)(1) and (a)(2)(ii), only one responsible source and no other supplies or services will satisfy agency requirements, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Date:  Name and title:  Robert Bishop, Competition Advocate Signature: