A03-20180129_MEDHUB_JA_NCD_18_14x_approved.pdf

Control No: NCD-18-14 Contractor: Sierra Nevada Corporation

Program/Equipment: MEDHUB

Version – February 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Program/Equipment: The development of First Article Testing prototypes of a Medical Hands-Free Ultra-Wideband Broadcast (MEDHUB) device capable of meeting airworthiness, DoD Information Assurance protocols (DISA Risk Management Framework), and FDA medical device clearance.

Authority: 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Amount: $ . M

Prepared by: Jay Wang DSN: 343-9836 Product Manager Transport Telemedicine System Date: 18 December 2017 Email: jay.y.wang.civ@mail.mil

Contracting Officer: Richard Totten DSN: 343-2446 Contracting Officer Date:

Email: Richard.w.totten2.civ@mail.mil

Technical: Jay Wang DSN: 343-9836 Product Manager Transport Telemedicine System Date: 18 December 2017 Email: jay.y.wang.civ@mail.mil

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

Program Manager:

Typed Name: Jay Wang

DSN: 343-9836

X Jay Wang Program Manager

Program/Equipment: MEDHUB

Version – February 2017 FOR OFFICIAL USE ONLY

Small Business Programs:

Typed Name: Christopher Sao Christopher.v.sao.civ@mail.mil

X Right-Click "Signature Setup"

Legal Counsel:

Typed Name: Elizabeth Kafel Elizabeth.l.kafel.civ@mail.mil

X Right-Click "Signature Setup"

ACC-APG-Ft Detrick Branch Chief:

Typed Name: Larry Mize lawrence.e.mize.civ@mail.mil

X Right-Click "Signature Setup"

ACC-APG-Chief of Contracting:

Typed Name: Thomas Bouchard Thomas.j.bouchard2.civ@mial.mil

X Right-Click "Signature Setup"

KAFEL.ELIZABETH.

LANE.1365244410

Digitally signed by

KAFEL.ELIZABETH.LANE.13652

44410 Date: 2018.04.09 11:05:54 -04'00'

BOUCHARD.THOMAS.J.122

8533277

2018.04.10 09:19:41 -04'00'

Program/Equipment: MEDHUB

Version – February 2017 FOR OFFICIAL USE ONLY

FAR Part 6 Justification and Approval for Other than Full and Open Competition

1. Contracting Activity: Army Contracting Command Natick, Ft. Detrick Division

2. Description of Action: US Army Medical Materiel Agency requests a cost-reimbursement contract with Sierra Nevada Corporation, Sparks, Nevada. The Government projects award for February 2018. Fiscal year 2017, Research, Development, Test and Engineering funds will be used.

The required acquisition plan has been approved at one level above the Contracting Officer in accordance with FAR 7.103(j).

3. Description of Supplies/Services: The Project Management Office – Medical- Evacuation Mission Equipment (PJM MME) is developing the Medical Hands-Free Ultra- Wideband (MEDHUB) system to meet several high risk Army Capability Needs Assessment (CNA) gaps. MEDHUB is a single device that automatically captures and stores medical data from multiple patient care devices through a wireless connection.

The critical characteristic of this system is to allow for the hands-free/voice free electronic creation and transmission of the Tactical Combat Casualty Care (TC3) Card (A DD 1380, TC3, is the current manual process for tracking and reporting patient information) and essential medical data elements to the receiving Deployed Medical Treatment Facilities (MTFs) and Electronic Health Records (EHR). This information is captured from initial patient contact, to complete transfer of the patient to the MTF. The system must be able to transfer the medical data of a patient from the medical evacuation platform to the receiving medical treatment facility using Blue Force Tracker or Joint Battle Command Platform (DoD requirement).

This action requires the engineering of a mature First Article Testing (FAT) prototype(s) MEDHUB that integrates commercially available FDA approved devices with engineered novel non-medical devices (drug and tourniquet sensors) utilizing automated (hands-free, voice-free) software to capture TC3 card information to transmit this data over the DoD tactical satellite network for MTFs, utilizing software capable of integrating with the the DoD tactical network to receive and display data in a standard hospital Intensive Care Unit (ICU) dashboard format. This requirement must meet airworthiness, DoD Information Assurance protocols (DISA Risk Management Framework), and FDA medical device clearance.

Base Period: Jun 2018 to Jun 2021 Value: $6,750,004.

Option Period 1: Mar 2021 to Sep 2022 Value: $2,004,022.

Option Period 2: Mar 2022 to Jun 2023 Value: $1,223,295.

Total: $9,977,322.

Program/Equipment: MEDHUB

Version – February 2017 FOR OFFICIAL USE ONLY

The anticipated schedule was developed to incorporate advanced development and production of MEDHUBs based on Technology Readiness Level (TRL) and completion of successful testing, allowing the Government to maximize schedule to deliver an innovative product capable of meeting the mandated IOC by 2020. Each phase of development incorporates specific decision points prior to advancing to the next phase.

The base effort consists of development up to the TRL 7 level, which includes; initial prototype design, preliminary design review, build prototypes, complete development testing, and critical design review. It is anticipated this phase of development will require approximately 3 years to complete. Option period 1 requirements include Initial Operational Test and Evaluation ( IOT&E) for the manufacture and testing of systems after successful completion of the base efforts. This phase of development is anticipated to require approximately 18 months of development and includes Initial Operation Capability (IOC) deliveries for field testing. Exercise of options will be determined based on successful production of an Operational Testing prototype, successfully exiting TRL 7.

The schedule identifies an option exercise prior to the completion of the base effort, allowing for completion of the technical data packages and close out the base effort.

Option Period 2 development will include Full Operational Capability (FOC) deliveries and include First Article Testing (FAT), anticipated to last 15 months. The decision to exercise options will be determined based on successful completion of operational testing and successful exit from TRL 8. Option 2 may be exercised prior to completion of Option Period 1 to allow for production, and finalization of technical data packages.

Options preclude the Government from committing to post engineering system testing until design testing is successfully completed.

The Independent Government Cost Estimate (IGCE) estimate used identifies direct and indirect costs for anticipated tasks/requirements contained in the Statement of Objectives (SOO). Estimates were based on historical development costs incurred, and anticipated future engineering efforts.

4. Authority Cited:

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: As described at FAR 6.302-1(a)(2)(ii), Supplies may be 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. This follow-on effort with SNC is to continue advanced development of a MEDHUB with accelerated deployment of a prototype capable of meeting the Governments requirements for FAT, in addition to unlimited rights to the source code upon completion of the engineering phase. SNC is the sole owner of this unique and highly specialized software used in deployment. The MEDHUB allows the ability to pair patient interventions (sensors for monitoring tourniquets, IV’s, drugs …) using automated hands free technology, analogous to a self-

Program/Equipment: MEDHUB

Version – February 2017 FOR OFFICIAL USE ONLY driving car. The system wirelessly monitors and records information to a central hub, which then transfers the data real time to an MTF. The provider is not required to interact with system (hands-free/voice free) once the devices are deployed. This critical highly specialized design is key to the MEDHUB, allowing providers to immediately focus on treatment rather than capturing/transmitting data. Additionally, the software connects to the medical treatment facility automatically, via Blue Force Tracker or Joint Battle Command Platform (DoD requirement) creating a true hands-free system. No other vendor has been identified with this capability. The software was independently developed by SNC exclusively in support of previous Government contracts. The Government currently does not have rights to this key technology. Technical data packages suitable for full and open competition have not been developed and are not available.

Excessive delays and duplication of cost would result from the cost/schedule necessary to design a similar software. SNC is the sole developer of this highly specialized and DoD certified software design that is the key attribute and the foundation of the MEDHUB. No other vendor has a comparable software creating a purely hands-free/voice free system.

Duplication of cost and schedule were estimated at $10M for a minimum of 3 years, predicated on previous development efforts and timelines identified in paragraph 10. This cost is not expected to be recovered through competition. The delays resulting from designing, testing, and integrating the software to the current maturity are estimated at 14 months to design, with subsequent beta testing in the system expected to last an additional 8 months, all of which is unacceptable. The additional 12 months is to account for risks expected in the development of IT products in a fast changing industry, and risks of changes to DoD policies for software deployable on DoD networks. The estimate for duplicative costs was based on the cost to bring the current software to this level of maturity, including both contractor costs, $7.3M, and Government overhead $2.7M.

These costs are not expected to be recouperated through competition. The cost/schedule impact would delay the deployment of a mature product ready for the engineering phase of development. The delays in development would be irrecoverable since the software is a critical component the system functionality is based on.

Competition would require the redesign of an already mature system capable of pairing patient interventions. The impact of moving this program back to the development phase to redesign this capability would be unreasonable and prohibitive. This system gained the attention of the Office of the Secretary of Defense and the FY 17 NDAA identified the Transport Telemedicine program as a Congressional Special Interest (CSI) program, injecting funding to accelerate the development with an Initial Operational Capability (IOC) of FY 20. Delays resulting from redesign would seriously impact the ability to meet IOC by FY 20.

The development of this system under the previous contract, W911W6-12-D-0005, issued 6 Jun 2012 to Sierra Nevada Corporation, 444 Salomon Circle, Sparks, NV

Program/Equipment: MEDHUB

Version – February 2017 FOR OFFICIAL USE ONLY

89434, CAGE: 8X691 (SNC), resulted in a candidate capable of entering into the engineering phase with high potential for completing FAT. SNC specializes in communications, information assurance security, aviation platform integration, and telemedicine, and owns the intellectual property necessary to pair patient interventions required to capture patient information into a single device. Additional prior contracts with SNC included the Close Area Medical Integration Technology (CAMIT) program with Ultra-Wide Band (UWB) radio technology, a program deployable in a “Jammers” environment, each utilizing SNC’s preexisting software integrating automated hands-free, voice-free capability that auto-populates a novel electronic TC3 card with vital signs and data from non-medical sensors and interventions, a key attribute of the MEDHUB prototype. This capability allows capturing data from interventions including a novel drug sensor to indicate which drug was used on which patient, onto a single platform for hands free management by the first responder. The patient data captured is transmitted through the blue force tracker is functional on the DoD tactical network, with which SNC is fully integrated. The proprietary software is key to performance of the MEDHUB and no other manufacturer has this capability without duplication of effort. PJM MME were the engineers behind the creation and design of the MEDHUB, utilizing development of the software/hardware integration under previous contracts and creating a functional system ready for engineering and follow-on FAT.

This system gained the attention of the Office of the Secretary of Defense and the FY 17 NDAA identified the Transport Telemedicine program as a Congressional Special Interest (CSI) program, injecting funding to accelerate the development with an Initial Operational Capability (IOC) of FY 20.

6. Efforts to Obtain Competition: IAW FAR 5.201, a sources sought notice was published on FedBizOpps on 28 Dec 2017 and resulted in 5 responses with only one response from a vendor capable of meeting this requirement.

Effective Competition: Because this is a sole source action, effective competition is not applicable.

Subcontracting Competition: Subcontracting competition will be achieved by review/approval of a small business participation IAW FAR 19.704. SNC is a large business under NAICS 541715. The following subcontracting clauses will be incorporated in the contract:

52.219-8 Utilization of Small Business Concerns 52.226-1 Utilization of Indian organizations and Indian-Owned Economic Enterprises 52.224-2 Subcontracts 52.224-5 Competition In Subcontracting 52.244-6 Subcontracts for Commercial Items 252.209-7004 Subcontracting With Firms That Are Owned by The Government of a Terrorist Country

Program/Equipment: MEDHUB

Version – February 2017 FOR OFFICIAL USE ONLY

252.219-7003 Small Business Subcontracting Plan (DoD Contracts)

7. Actions to Increase Competition: The MEDHUB was designed by the Government.

Currently, no commercial or non-commercial technologies capable of meeting the MEDHUB requirements exist. Once this engineered prototype has successfully completed FAT, it is anticipated production will be conducted under full and open competition by either purchasing the software rights or paying royalties for use of the software. The Government must be able to demonstrate a functional system capable of closing the gap in technology prior to investing in the rights to the software. This acquisition will require unlimited rights to the data generated in performance of the contract IAW DFARS 252.227-7013, 252.227-7022, and 252.227-7028, and will include the acquisition of the SNC proprietary source code and/or unlimited licenses, allowing future modifications of the software through the Aviation and Missile research, Development and Engineering Center (AMRDEC) lab, and allow for competitive follow-on acquisitions for production. SNC will be encouraged to further develop the software commercially, synergistically benefiting the government. The MEDHUB is innovative with an anticipated large commercial market in addition to military requirements. Negotiation of the rights to the source code/licenses is not expected to be constraining or cost prohibitive since the system design itself was created by the Government. SNC only has rights to the proprietary software. Completion of this effort should allow for future full and open competition. Competition will also exist for the break-out of non-medical devices, other hardware components used in performance of the system, and sustainment of the MEDHUB itself. Program management during sustainment will be managed by USAMMA under a competitive contract. The Government shall ensure all major subcomponents procured by the prime Contractor are approved by the Government, subject to the Subcontracting clause in the contract, and obtained competitively.

8. Market Research:

The PJM MME enabled a Market Research Working Group (MRWG) to continually survey industry to identify and research new technologies and similar capabilities during the development phase. Recent focused market research included journal articles, online searches, technology demonstrations conducted by other agencies, conference attendance, and requirement review meetings. Since Oct of 2016, PJM MME team has been very active in identifying any existing systems or ongoing development that can meet the capability to provide a hands-free/voice-free system capable of entering into the engineering phase of development. The PJM MME team issued two prior Requests For Information (RFI) posted on Federal Business Opportunities (FEDBIZOPPS):

Army: W81XWH-16-RFI-TJK1, October 2016 USAF: 161103_CMC_RFI, November 2016 Army: W911QY-18-S-0003, December 2017

Results of the searches were negative, only identifying commercial and developmental systems/units with limited automated capability, all only involving patient vital signs, adding no value to the requirement to reduce medic burden by automating the Tactical Combat Casualty Care (TC3) card and pairing of patient interventions. The capability to

Program/Equipment: MEDHUB

Version – February 2017 FOR OFFICIAL USE ONLY process data real time and hands-free/voice free only exists in the software developed by SNC. A functionality Congress has a strong interest in as noted above.

In accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.302-1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302-1(d), a Sources Sought Notice (SSN) was submitted in FedBizOpps on 28 Dec 2017 under notification W911QY-18-S-0003 for 17 days with 5 viable responses. To date, PJM MME subject matter experts have confirmed that only SNC has the software capable of continuing the advanced development of the MEDHUB. This is a follow-on effort and no other entity is capable of meeting the Government’s requirements without duplicating costs and incurring unacceptable program delays. Responses and results of the SSN are documented in the Market Research Report appended to this J&A.

9. Interested Sources:

On 28 December 2017 a SSNI was released and six companies expressed an interest in this acquisition.

1) Athena GTX

2) Bernoulli Health

3) BioMojo

4) Grand Slam Universal (GSU)

5) SNC

6) ViiMED

Responses submitted by Athena GTX, Bernoulli Health, BioMojo, GSU, and ViiMED in response to the FedBizOpps notice have been reviewed by the requiring activity SME’s concluding that Athena GTX, Bernoulli Health, BioMojo, GSU, and ViiMED cannot meet the requirements for this follow on effort. These companies only addressed the questions that their existing products could meet and ignored the questions they could not meet or only provided a product sheet ignoring the questions all together.

SNC was the only company that addressed the questions and provided a solution that could meet the follow-on requirements.

IAW FAR 5.203(a), an announcement shall be publicized prior to the issuance of any solicitation, and any response shall be considered.

10. Other Facts:

a. Procurement History:

This action is a follow-on to contract W911W6-12-D-0005. That contract was not competed under authority 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1.

Paragraph, “Actions to Increase Competition” of the previous justification, stated: For the reasons discussed in paragraph 5 of J&A W911W6-12-D-0005, “there is no action to increase competition due to lack of technical data and computer software documentation to support a competitive procurement. It would take an estimated at least three years

Program/Equipment: MEDHUB

Version – February 2017 FOR OFFICIAL USE ONLY and 10 million dollars to develop an equivalently mature capability to SNC's T2 system.

This estimate is based upon previous development efforts with Sierra Nevada Corporation to develop this capability and how much it cost the Army along the way”.

Actions to increase competition were conducted through continued market research and technical research conducted by PJM MME, in addition to participation in technical demonstrations. To date, no other vendor has the technical capability or maturity to meet this requirement. Previous efforts developed a system with the maturity to enter into the engineering phase with follow-on FAT testing. J&A W911QY-12-D-0005 is appended to this document.

1. Previous sole source procurements of telemedicine enabling technology were conducted via contracts to include the following:

Contract No Title Period of Performance

Amount Type Agency

W81XWH-15-C-0108 NOELLE

Research Project

9/24/2015- 6/30/2017

$2,517,369.97 Sole Source

USAMMA

/ JWMRP

W911W6-12-D-0005 T2RW/CAMIT 12/8/2014-

7/31/2017

$4,745,256.00 Sole Source

AATD

W58RGZ-09-D-0130 OSAS II 3/25/2010-

6/30//2011

$1,481,523.00 Sole Source

AATD

W52P1J-07-D-0039 OSAS I 6/8/2008-7/1/2009 $1,583,169.00 Sole Source

AATD

2. The contracts were awarded on a sole source basis. The authority cited was 10USC 2304 (c)(1); only one responsible source and no other supplies or services will satisfy agency requirements. Justification was based on the demonstrated technical expertise, sole possession of the technical data package necessary to provide the required system, and facilities to perform the required effort.

3. While these contracts were sole sources, the scope of work did differ:

A. CAMIT scope of work is: “This SOW covers the work required for the development of a Point of Injury (POI) Closed Area Medical Integration Technology (CAMIT) capability. The intended use is for Army Medics, which are dismount from the Black Hawk UH-60 MEDEVAC, to wirelessly communicate with medical devices at the POI, and seamlessly communicate back to the MEDEVAC Platform from the POI.” The CAMIT technology acts more of a modem for line of sight tactical radios than an

Program/Equipment: MEDHUB

Version – February 2017 FOR OFFICIAL USE ONLY automated hands-free, voices-free capability to provide clinicians a medical dashboard with beyond line of sight capability.

B. The NOELLE research project was a feasibility study to integrate CAMIT with NETT-Warrior and did not have the scope of this MEDHUB contract.

4. Prior J&A paragraph 7 identified no actions to increase competition due to lack of technical data and computer software documentation. Sierra Nevada Corporation has been deemed to be the only source with the technology and expertise. The government does not own, nor is the contractor willing to sell the rights to information necessary to prepare technical data packages, specifications, and engineering descriptions.

5. No prior contracts were accomplished under full and open competition.

6. The non-competitive strategy apparent in this justification is a consequence of the type of research being conducted, the innovative nature of the MEDHUB, and the narrow band of opportunity. The development combines several different types of engineering, exceeding individual vendor’s capabilities. The strategy has essentially developed a vendor to meet the requirement, and design a technology adaptable to the Governments envisioned MEDHUB.

7. As stated in paragraph 5, CONGRESSIONAL SPECIAL INTEREST (CSI) FUNDING FOR TRANSPORT TELEMEDICINE: The House of Representatives Report (H.R) 114-537 (National Defense Authorization Act) For Fiscal Year 2017 Report of the Committee on Armed Services House of Representatives on H.R.

4909 included a specific provision for Telemedicine Capabilities. Language contained within states: "The committee encourages the Department to continue to experiment with and examine ways to utilize emerging telemedicine capabilities....Further, the committee believes the Department should examine existing technology and requirements for in-transit telemedicine capabilities to determine how best to leverage best-of-breed existing capabilities to support current needs" Based on this information $7.5 Million of CSI Funding was earmarked for Transport Telemedicine. This funding was received by PJM MEDEVAC through the General Fund Enterprise Business System (GFEBS) on 17 July 2017.

Program/Equipment: MEDHUB

Version – February 2017 FOR OFFICIAL USE ONLY

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.

Product Manager Transport Telemedicine System Jay Wang jay.y.wang.civ@mail.mil

Signature:

X Right-Click "Signature Setup"

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.

Product Manager Transport Telemedicine System Jay Wang jay.y.wang.civ@mail.mil Signature:

X Right-Click "Signature Setup"

Program/Equipment: MEDHUB

Version – February 2017 FOR OFFICIAL USE ONLY

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable. Cost or pricing data will be evaluated to determine realism, reasonableness utilizing cost analysis techniques. Certified cost or pricing data is required.

This determination will be made using cost analysis, price analysis, and to include comparison of the IGCE.

As a part of this basis, certified cost or pricing data will be required.

Richard Totten Contracting Officer Signature:

X Right-Click "Signature Setup"

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

Richard Totten Contracting Officer Signature:

X Right-Click "Signature Setup"

Program/Equipment: MEDHUB

Version – February 2017 FOR OFFICIAL USE ONLY

Approval Based on the foregoing justification, I hereby approve the procurement of Medical Hands-Free Ultra-Wideband (MEDHUB) system on an other than full and open competition basis pursuant to the authority of 10 U.S.C.2304(c)(1), as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, subject to availability of funds, and provided that the services or property herein described have otherwise been authorized for acquisition.

Advocate for Competition:

Dennis P. Longo Dennis.p.longo.civ@mail.mil

Signature:

X Right-Click "Signature Setup"

LONGO.DENNIS.P

AUL.1229314129

Digitally signed by

LONGO.DENNIS.PAUL.122931412

Date: 2018.04.10 14:10:30 -04'00'