JA_RevMedx_XSTAT_Final_Redacted.pdf

Log #19-10020

Form 02.4G.AB 18 Apr 2016

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a

“Justification for other than full and open competition.”

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD, on behalf of the Navy to meet Naval Medical Research Unit San Antonio (NAMRU-SA) requirements.

2. Nature and/or description of the action being approved.

The proposed action is for the delivery of service, training and support in execution of a 15 center quality improvement assessment using consumable X-STAT technology for a base period of twelve (12) months for

NAMRU-SA. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is

RevMedx, Inc. 25999 SW Canyon Creek Road, Suite C Wilsonville, OR 97070.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The proposed acquisition is to engage 15 major trauma centers in the United States and selected deploying military commands to receive the XSTAT-30 and XSTAT-12 products. These products are to be utilized at the point of injury by Emergency Medical Services (EMS) personnel as well as the devices will be made available for

Emergency Department treatment. Site selection shall include establishing institutional review board approvals for the assessment of retrospective data and EMS personnel use surveys, and approvals such as inclusion/exclusion criteria as necessary for Naval Medical Research Unit San Antonio (NAMRU-SA). Traumatic hemorrhage remains the leading cause of potentially survivable deaths of warfighters. Completion of this project will markedly improve the prehospital care and transportation management of non-compressible truncal/torso hemorrhage not amenable to tourniquet treatment, an injury responsible for approximate 70% of hemorrhage related mortalities. This contract will be used to evaluate and improve data available for a medical device (XSTAT) specifically designed to treat this injury type. To directly address this knowledge shortfall, this contract will generate a significant dataset of human-use outcomes with XSTAT. Data from XSTAT's currently approved indication of use (4 hours) will be acquired from ease-of-use reports and used to enhance fielding of the product.

The contractor shall provide initial training equipment and instruct local personnel on the use of XSTAT. The vendor shall also manage the collection of provider use data including: (a) perceived strengths/weaknesses of

XSTAT use; (b) potential use modifications; and (c) future refinements.

The contractor shall consult a statistician to perform post-market analysis on the de-identified retrospective ease-of-use data including: (a) life/death outcomes; (b) patient demographics; (c) travel distance/duration; (d) mode of transportation; (e) injury type/severity; and (f) regional location. The vendor shall provide NAMRU-SA with electronic data sets.

The contractor shall submit all associated manuscripts, reports and presentations to journals, societies and meetings to NAMRU-SA for review and clearance prior to submission.

The contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

Defense Health Program (DHP), Procurement Fiscal Year 2019 funds in the amount of .

4. An identification of the statutory authority permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1) and FAR 13.501(a), Sole Source Acquisitions.

5. A Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

RevMedx, Inc. is the sole manufacturer of the XSTAT product and the only company with the appropriate expertise to provide product, training, trauma center affiliations, and data collection. Additionally, RevMedx, Inc. is the collaborative partner with NAMRU-SA on a major DoD funded project; “Expanding the Duration and Indication of

Use for XSTAT Using Retrospective Human and In Vivo Animal Model Data.” In order for this study to be properly executed in line with the mission, it is essential that RevMedx, Inc. be the recipient of this contract.

Furthermore, the agency has extensive familiarity working with the XSTAT product with other Government agencies. Given the information above, RevMedx, Inc. is the only vendor capable of providing the appropriate expertise to provide product, training, trauma center affiliations, and data collection meeting the minimum requirements of the Government.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to

FedBizOpps in accordance with FAR 5.202.

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the equipment covered by this

Justification and Approval will be fair and reasonable by conducting a price analysis prior to award. In addition, the

Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. A description of the market research conducted (see Part 10) and the results, or a statement of the reason market survey was not conducted.

NAMRU-SA conducted market research in January and February 2019. This research consisted of using search engines to review open market contractors and Federal Supply Schedule contractors and contacting potential vendors. Search engines utilized included Google, GSA Advantage and the MedSurg Catalog (VA). Three vendors were contacted by email and/or phone as well as through their respective websites to obtain a quote for

XSTAT and the associated services described above in this document. RevMedx, Inc., BiostatMEDIC and

Medline.

BiostatMEDIC was contacted through their website to obtain a quote but nothing was received. Their Celox -A product, while similar to XSTAT, is not a brand name or equall product and will not meet the Government need regardless of the associated services they may or may not be able to provide.

Medline was contacted by phone to obtain a quote for XSTAT and the required services. They were unable to provide a quote for the product or services required to meet the needs of the Government.

RevMedx, Inc. provided a quote and are able to meet the minimum needs of the Government.

Further market research conducted by the Contract Specialist which revealed four (4) additional vendors capable of distributing the XSTAT product. Panakeia, Phokus, Alpha First Aid, and Concordance Healthcare

Solutions. None of these vendors have been contacted at this point in time. According to their websites, they are capable of providing the required XSTAT product. None of these vendors have the appropriate expertise to provide product, training, trauma center affiliations, and data collection.

Panakeia holds contract number V797D-40152 for XSTAT products listed in VA as well as GSA Advantage.

RevMedx, Inc. is the sole manufacturer of the XSTAT product and the only company with the appropriate expertise to provide product, training, trauma center affiliations, and data collection. Additionally, RevMedx, Inc. is the collaborative partner with NAMRU-SA on a major DoD funded project; “Expanding the Duration and Indication of

Use for XSTAT Using Retrospective Human and In Vivo Animal Model Data.” In order for this study to be properly executed in line with the mission, it is essential that RevMedx, Inc. be the recipient of this contract.

Given the information above, RevMedx, Inc. is the only vendor capable of providing the XSTAT product as well as conducting the required study. RevMedx, Inc. is the only vendor capable of meeting the minimum requirements of the Government.

9. Any other facts supporting the use of other than full and open competition.

None.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. Any sources expressing interest in response to the synopsis will receive consideration.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.