A02_-_ANAM4_JA-19-01-0055_redacted.pdf

Control No: JA-19-01-0055

Sole Source Justification (SSJ) in accordance with FAR subparts 13.5 using Simplified Acquisitions Procedures (SAP)

1. Contracting Activity:

The Contracting Activity responsible for this action is the US Army Medical Research Acquisition Activity (USAMRAA), 845 Chandler Street Fort Detrick MD 21702.

2. Requiring Activity:

The Requiring Activity for this action is the Office of The Surgeon General (OTSG) Falls Church VA.

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a) ** See FAR 12.207(b).

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

* Firm Fixed Price: ________ **Time & Materials: ________

* Cost: ________

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

Fiscal Year of Funds: FY19

Estimated Total Dollar Value including Options: $

4. Contractor Name:

Name of Proposed: Vista Partners LLC Street Address: 5645 Saddle Creek TRL STE 100 City, State, Zip: Parker, CO. 80134-5308 Phone: 888-733-8804

DUNS: 191819023

Cage Code: 39KV3

5. Description of Supplies/Services: The supplies to be provided under this contract are an enterprise agreement for the Automated Neurological Assessment Metrics 4 (ANAM4) software product and the associated licenses to use this software. The ANAM4 software was developed and advanced for more than two decades by the Department of Defense, and is commercialized exclusively by Vista LifeSciences, a company of Vista Partners. ANAM4 is a computer-based neurocognitive assessment tool designed to detect the speed and accuracy of attention, memory, and thinking ability, and record a Service Member’s performance through responses provided on a computer. The ANAM4 test system consists of a library of tests designed for a broad spectrum of clinical and research applications; this library of computer-based tests was constructed to meet the need for objective measurement of cognitive processing efficiency in a variety of psychological assessment contexts that include neuropsychology, readiness to perform, neurotoxicology, pharmacology, and human factors research.

The enterprise license agreement and software licenses to be provided under this contract allow for the continued use of the ANAM4 product software by DoD/MHS entities, individual services, and other entities of the DoD including TRICARE. This requirement also provides upgrades to the existing software as well as a renewal of the existing licenses. It shall include enterprise-wide use for MHS/DoD Service Members and use of the assessment tool for approximately 200,000 tests per year. These military health entities employ the ANAM4 software product to conduct pre-deployment assessments, post-deployment assessments, and the assessment of injured service members, particularly those with blast injuries, concussion, and suspected traumatic brain injury.

The period of performance for this award shall be March 27, 2019 -- July 2, 2019 with two (2) twelve (12) month option periods. The total estimated value of this requirement for a three month base period plus two option years is

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name);

OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: The use of ANAM4 software is essential to the Government's requirements, and thereby precludes consideration of another product. ANAM4 is a mission critical Neurocognitive Assessment Tool (NCAT) which has been in use since 2008. As a deployed application, it is used to perform baseline NCAT testing on deploying personnel, as well as NCAT assessment following a diagnosed concussion or mild TBI (mTBI). Post-injury NCAT assessments can be compared to Service Member baseline NCAT assessments, to inform return-to-duty decisions by medical providers. The current NCAT solution, ANAM4 has been developed, tested, implemented, and deployed for 6 years. Without sustaining the current ANAM4 solution, the DoD will lose this critical and essential capability to capture baseline and post-injury NCAT testing for deployed service members. Access to this product ensures continuation of the critical pre-deployment assessments, post-deployment assessments, and the assessment of injured service members. Inability to use the ANAM4 tool would debilitate the Services' abilities to provide for Traumatic Brain Injury/Behavioral Health (TBI/BH) screening at all echelons of healthcare. Accurately and efficiently monitoring the neurocognitive status of U.S. war fighters under diverse operational and experimental conditions is of critical importance to the ongoing mission and network-centered initiatives of the United States military. These screenings are a mandatory requirement for all Service members.

In accordance with the Department of Defense Instruction (DoDI) 6490.13, September 11, 2015, the Automated Neuropsychological Assessment Metrics (ANAM4) is the DoD-designated neurocognitive assessment tool supporting the policy requirement to implement a comprehensive neurocognitive assessment program in the military. The use of the this tool will remain in effect until such time as evolving science and medical best practice guidelines inform a change in policy. Vista Partners LLC, is the only contractor that can provide its proprietary services and equipment for the ANAM4 Neurocognitive Assessment Tool (NCAT). The ANAM4 application is developed by and sold by only one vendor; Vista Partners LLC. Vista Partners LLC has not licensed the resale right to maintain or sustain the ANAM4 application to any other contractors.

This acquisition is a sole source, as (a) under the terms of its standard commercial license, the developer of ANAM4 Software, Vista Partners LLC, retained the data rights to the ANAM4 source code (b) access to the source code is necessary to accomplish the sustainment services covered by the contract (c) due to the proprietary nature of the ANAM4 source code, no other vendor could legally provide maintenance, or sustainment of the system (d) it is critical that the contractor in place is able to access the code to troubleshoot and correct issues.

8. Efforts to obtain Competition: To date, no other sources with legal access to ANAM4 proprietary source code have expressed written interest in the proposed acquisition.

9. Actions to remove or overcome barriers Competition: The OTSG Program Office will continue to survey the market of the neurocognitive assessment field to identify state-of-the-art technology or software that may become available. At present, the ANAM4 product is the only solution to meet the NCAT requirements and due to Vista Partners exclusive commercial licensing rights, no actions can be implemented to increase competition. Future competition may be appropriate when the NCAT requirements evolve and require re-competition of the software solution. Working in collaboration with the Contracting Officer, the OTSG Program Office will seek competition to the greatest extent practicable.

10. Market Survey: Market research, to include Vendor searches in SAM and Online searches, indicates that the only available source is Vista LifeSciences. Additionally DODI 6490.13 does not allow for an alternate source. A CHESS SONA and ITAS Waiver will be completed prior to award.

11. Interested Sources: To date, no other sources have written to express an interest.

12. Procurement History and any other facts:

(1) Contract numbers and dates of the last several awards:

a.) The current contract

(2) Competitive status of these actions:

a.) was a Sole Source contract

The Army has been identified as the lead proponent for the Automated Neuropsychological Assessment Metrics 4 (ANAM4) Software Licensing Agreement Contract. Agencies within the DoD, may request to utilize the ANAM4 for purposes not outlined in DoDI 6490.13 (Comprehensive Policy on Neurocognitive Assessments by the Military Services). However, the request will be submitted to the designated COR (Contracting Officer's Representative) or KO (Contracting Officer) and the Neurocognitive Assessment Branch Director/Manager or ANAM Program Director/Manager. These requests will be vetted and adjudicated to ensure proper and legal processes are followed. Responses (approvals or denials) will be provided by the COR/KO after all potential legal matters are considered. Additionally, the equipment to administer the ANAM4 to any DoD agency will be coordinated through the ANAM Program Manager at OTSG so an accurate count of ANAM assessments are maintained.

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price/ cost to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.

15. I hereby determine this SSJ to be Legally Sufficient.

Approval

Based on the foregoing justification, I hereby approve the procurement of enterprise agreement for the Automated Neurological Assessment Metrics 4 (ANAM4) software product and the associated licenses on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901, as implemented by FAR subpart 13.501(a)(1)(i), subject to availability of funds, and provided that the products and property herein described have otherwise been authorized for acquisition.