Mini_Inline_fluid_warmer_JA_Final_-_Signaturex_Redacted.pdf

Control Number: NCD-16-56

JUSTIFICATION REVIEW DOCUMENT

FOR OTHER THAN FULL AND OPEN COMPETITION

Program/Equipment: LifeWarmer, Mini-Inline Fluid Warmer

Authority: 10 U.S.C2304(c)(1) and FAR 6.302-1 Amount: $3,173,500

Prepared by: 20 May 2016

Contracting Officer: 20 May 2016

Technical/Requirements Representative 20 May 2016

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

Branch Chief, 25 May 2016

Legal Counsel

27 May 2016

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Agency/Contracting Activity: ACC APG-NCD, Ft. Detrick, Frederick, MD 21702

2. Description of Action: This approval is being requested for the issuance of a Research and Development (R&D) contract to LifeWarmer Inc., utilizing and (RDT&E) funds. This will be a Firm Fixed Price (FFP) contract with a three (3) year development effort with delivery of an optional 200 field ready kits.

Nature: New Requirement X Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: X Firm-Fixed Price Time & Materials Cost

For Hybrid Contracts, list percentage of each type of pricing:

Firm Fixed Price:

Time & Materials:

Cost:

Funds: Operations and Maintenance, Army (OMA) X Other Funds: RDT&E

Fiscal Year of Funds: FY15-18

Name of Proposed Contractor(s): Life Warmer Inc.

Street Address: 840 F Ave suite 104 City, State, Zip: Plano, TX 75074 Phone:

3. Description of Services or Supplies:

The research, development, testing, and manufacturing required to achieve a Food and Drug Administration (FDA) cleared fluid warming system that is light weight, rugged, and can be rapidly employed by all medical personnel at the Point of Injury (POI). The total value of this requirement is $3,173,500.00 for a three (3) year development effort including delivery of an optional 200 field ready kits.

4. Authority: 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) (2) (ii), because this is a follow on contract for the continued development of highly specialized equipment.

Actions other than simplified acquisition procedures (select one):

X FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 10 USC 2304(c)(1)

FAR 6.302-2: Unusual and compelling urgency, 10 USC 2304(c)(2)

FAR 6.302-5: Authorized or Required by Statute, 10 USC 2304(c)(5)

Other: insert appropriate authority here

5. Reasons for Authority Cited:

LifeWarmer Inc. was identified for its promising prototype of the highly portable normothermic infusion therapy. In far forward, pre-hospital, and combat situations, require capabilities for urgent resuscitation to reduce the mortality and morbidity associated with major battlefield wounds and injuries. The deadly physiological effects of hypothermia in trauma patients are well described in military and civilian casualty care. A lethal triad of hypothermia, coagulopathy, and acidosis results in 100% mortality when body temp drops to 32°C. The mortality of combat injuries who were hypothermic is nearly double that of normothermic casualties with similar injuries, with 80% of non survivors having had a body temp of 34°C or less. Even the presence of mild hypothermia (36°C to 34°C) causes substantial coagulopathic and metabolic disturbances with resulting increased morbid events, greater need for blood products, cardiac instability, delayed drug metabolism, and increased rates of post-operative wound infections.

Preventing hypothermia is easier than treatment and needs to start at the time of injury. Warming Intravenous fluids and blood products is a critical early intervention. The LifeWarmer device (which includes a Thermal Tubing Set (TTS), Power Controller Unit (PCU) and Battery) provides lifesaving intervention medics require to treat casualties at the POI. Under Fiscal Year 2013 funding, the prototype device demonstrated substantial capability in the Smallest Size, Weight, and Power (SWaP). User feedback suggests that the device has enormous potential to improve the standard of care provided to casualties at POI, far-forward, and austere locations. Current fluid warmers are too large to carry at the objective where the POI traditionally occurs or in far-forward and austere locations.

This sole source requirement is deemed to be available only from LifeWarmer Inc. as a follow-on contract. The initial contract for development of this product originated from a competitive Broad Agency Announcement (BAA). Further competing this requirement would result in substantial duplication of costs estimated at over $680,000, which are not expected to be recovered through competition, and unacceptable delays of approximately 1.5 years, to get another product to the level of development of the Life Warmer device. The basis of these estimated costs and delay is derived from the previous contract costs and performance schedule. It is estimated that any company who would have a similar product would require at least the same amount of funding and at least the same amount of time to develop another highly specialized device to this level of maturity. These costs and delay in providing the warfighter with the urgently needed means to reduce the mortality and morbidity associated with major battlefield wounds and injuries is unacceptable. Warming intravenous fluids and blood products is a critical early intervention. Currently medical personnel cannot carry existing fluid warmers into many operational scenarios.

6. Efforts to Obtain Competition:

a. A sources sought notice was posted on 5 Feb 2016 which resulted in no responses received. A notice of intent to solicit on an other than full and open competition basis will be posted as required by FAR Subpart 5.2 and all offers received shall be considered.

b. The Government will address efforts to ensure competition in subcontracting by including FAR 52.219-8 Utilization of Small Business Concerns and FAR 52.244-5 Competition in Subcontracting in the award document.

7. Actions to Increase Competition:

This is considered to be a one-time requirement to take this product to approval by the FDA with optional line item procurement of 200 devices. Any subsequent acquisition for this product will be competed to the maximum extent possible.

8. Market Research:

Based on the reasons mentioned above under Authority Cited, market research was conducted by the Program Manager through the process of reviewing the

, Internet, open source literature, contact with industry, trade associations, and publications. Between May 2014 – Sep 2015, conducted market research but has not found a Food and Drug Administration (FDA) approved Commercial Off The Shelf (COTS) system with the fluid warming capability within the SWaP of the LifeWarmer system. A market research report was issued on 26 Oct 2015, see attached. The market research found the COTS fluid warmers:

All three COTS fluid warmers are significantly larger in size and weight, do not heat fluids as efficiently, and have been evaluated or fielded but none are carried by medics on the objective or in far-forward and austere locations where Prolonged Field Care (PFC) scenarios are common. As stated in paragraph 6 above, a sources sought notice was posted on FedBizOpps on 5 Feb 2016 which resulted in no responses received.

9. Procurement History:

Previous Purchase Order(s) or Contract(s): X Yes No

(1) Contract numbers and dates of awards:

W81XWH-14-C-0063 – Highly Portable Normothermic Infusion Therapy.

Period of Performance: 12 MAY 2014 – 21 SEP 2015

(2) Competitive status of these actions:

The initial contract for development of this product originated from a competitive Broad Agency Announcement (BAA) (NHRC BAA 15-001).

(3) The initial contract awarded was for Phase 1 development of the device, to include design and fabrication of a novel thermal tubing system, development of an efficient closed loop thermal control system, development and fabrication of a proof of concept system enabling point of injury delivery of normothermic infusions, testing and end user analysis.

This acquisition will provide for the further development of this highly specialized device to the final design and production stage. Performance of safety and efficacy testing that is required to submit a 510K application for medical devices to the FDA for clearance will be conducted as well as other types of testing and development efforts to ensure that this device meets ruggedness and aircraft air worthiness (safe to fly release requirements) in accordance with Military Standards.

10. Additional Information to support the justification.

N/A

11. Technical / Requirements Certification: I certify that the supporting data under my cognizance which is included in this abbreviated J&A is accurate and complete to the best of my knowledge and belief.

Submitted By:

Position Title:

Email address:

Signature:

Date:

12. Fair and Reasonable Price Determination: As contracting officer, I hereby determine that the anticipated cost to the government for this contract action will be fair and reasonable.

A cost/price 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.

SIGNATURE: DATE:

NAME:

TITLE: Procuring Contracting Officer

13. Reviews: I have reviewed this justification and find it legally sufficient.

Legal Counsel

SIGNATURE:____ _DATE:

NAME:

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

SIGNATURE: DATE:

TITLE: Procuring Contracting Officer

Approval

Based on the foregoing justification, I hereby approve the procurement of the above mentioned services to LifeWarmer Inc. for $3,173,500.00 on an Other Than Full and Open Competition basis pursuant to the authority of Title 10 United States Code Section 2304(c) (1), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

SIGNATURE: DATE:

TITLE: Competition Advocate

9 June 2016