Justification and Approval_HDTRA120C0041.pdf

Defense Threat Reduction Agency 8725 John J. Kingman Road, Stop 6201

Fort Belvoir, VA 22060-6201

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Nature and/or Description of Action

The Defense Threat Reduction Agency contracting activity proposes to procure, without using full and open competition, the rapid operational fielding of the Rapid Analysis of Threat Exposure (RATE) algorithm to support healthcare personnel and critical DoD staff maintain mission capability during the Coronavirus Disease 2019 (COVID-19) pandemic, and assess / validate the existing capability.

2. Description of the Supplies/Services Required

The proposed effort will be a follow-on to a DTRA funded Other Transaction Authority (OTA) – Prototype contract called “RATE” awarded by the Defense Innovation Unit (DIU) in April 2018 to Royal Philip’s Healthcare. During that effort, the performer developed the RATE algorithm which is capable of identifying hospital acquired infections (HAIs) 48 hours prior to clinical suspicion. The delivered algorithm has demonstrated performance in line with blood-based breast and prostate cancer diagnostic screening tests, an enzyme immunoassay based first-tier Lyme disease test, among others. The algorithm is based on non-invasive vital sign measurements

Data was collected on patients that were admitted to the emergency room or intensive care unit and had a diverse set of co-morbidities. The algorithm has yet to be validated in an out-of-clinic setting, which is a critical next step for ultimate deployment and use among military personnel.

Concurrently, in the existing environment of the COVID-19 pandemic, the healthcare sector and critical DoD mission workforce have been dramatically impacted. Current COVID-19 infection screening is reliant on onset of fever, and no pre-symptomatic testing or alerting has yet been implemented. This effort will rapidly operationalize and assess the existing RATE algorithm as necessary for ultimate military use, leveraging the COVID-19 outbreak by deploying commercial off the shelf (COTS) devices to collect physiological data on participants. The algorithm will provide an index score of possible infection during the asymptomatic phase of the infection and train / validate the RATE algorithm.

The Base Period tasks will include purchasing appropriate wearable devices, retraining the RATE algorithm, integration of the algorithm, developing a data application, deploying devices, and refinement of a RATE-COVID algorithm. The Base Period will entail initial deployment of up to 1,000 devices and use data collected to improve the RATE algorithm over a 12-month period of performance (PoP) with a not to exceed (NTE) value of .

The effort will include 18 optional tasks, each with a PoP of 3 months, providing flexibility to increase the number of devices provisioned and allow for additional data collection to further improve the RATE algorithm. These optional tasks will be accomplished within the 12-month PoP and each optional task will provide either 1,000 (12 total optional tasks) or 2,500 (six total optional tasks) additional devices for a potential of 27,000 devices across all optional tasks. Each optional task will also include the capability, as needed, to provide subject matter expertise through virtual or on-site instruction to assist in provisioning the devices. Optional Tasks 1-12 are estimated with a NTE value each and Optional Tasks 13-18 are estimated with a NTE value each. The total effort has a ceiling price NTE .

3. Statutory Authority

The statutory authority for this action is 10 U.S.C. 2304(c)(2) or 41 U.S.C. 253(c)(2), as implemented by FAR 6.302-2, Unusual and Compelling Urgency.

4. Applicability of Authority

As the emerging COVID-19 disease continues to threaten the United States and global regions, it has become apparent that frontline workers require monitoring in order to earlier identify the disease given the asymptomatic transmission. Further, installations have begun institutionalizing routine discrete measurements of temperatures to provide situational awareness of the incoming and outbound work force. Although these measures are potentially capable of providing an immediate indication, the lack of continuous monitoring provides an opportunity for fevers to be missed.

Therefore, due to the dynamic and time-critical nature of the current COVID-19 climate, any delays in award would not only significantly impact the utility of the capability, it would prevent DoD critical mission personnel and the healthcare work force from receiving a tool capable of aiding in the national response to the pandemic by operationalizing a tool capable of identifying COVID-19 during the preclinical phase and thus minimizing pathogen spread.

The effort will expedite work that was already planned within the Chemical and Biological Defense Program (CBDP) and is a follow-on to operationalize an existing algorithm developed by the performer in a previous effort. While this effort is a follow-on, the original award was solicited via the DIU OTA with the maximum possible competition. Due to the fact that Philips Healthcare has already developed the RATE algorithm, in conjunction with the urgency of the need during the COVID-19 pandemic per FAR 6.302-2, preparing a full and open competition to solicit bids or proposals would inhibit the ability to operationalize the capability in time to address the needs of end users to identify COVID-19 positive patients prior to symptoms onset.

Furthermore, not limiting award to a single sole source follow-on would additionally injure the Government initiative to deploy and refine the capability, as award to a new performer would require spending an estimated minimum of 18 months (the duration in which the original algorithm was developed), plus associated costs, duplicating the effort to recreate the already established algorithm capability. The Government has government purpose rights to the algorithm but does not own the hospital patient physiological data that feeds into the algorithm, as it comes from proprietary Philips technology and thus cannot provide it to other contractors to perform the work. Additionally, because of the potential for the algorithm to predict COVID-19 infection up to 48 hours prior to fever onset, containment and life-saving treatment could drastically be improved to those outfitted with the tool, and thus potentially saving countless lives. Because no other capability yet exists that alerts to infection prior to fever, this is the only planned acquisition that could achieve these conditions from early identification.

The following units have already requested this technology as rapidly as possible: Palo Alto Veteran Affairs (VA) Hospital, Air Force 412 Training Wing, National Center for Medical Intelligence (NCMI), Cyber National Mission Force (CNMF), Walter Reed Army Institute of Research – New York City (WRAIR – NYC), Guam Air Force Medical Response Teams, and the National Guard Bureau (NGB). In order to deliver the capability in the needed timeline to support these units this effort has been given DTRA-CBDP’s highest priority. It is also a priority of the partnering agencies which are providing additional funding to deploy the capability to the locations. These agencies include the DIU, Defense Advanced Research Projects Agency (DARPA), unit specific funding, and potentially U.S. Health and Human Services (HHS) - Biomedical Advanced Research and Development Authority (BARDA).

Due to the urgent nature of this requirement and in accordance with FAR 6.302-2, this justification was prepared subsequent to the issuance of an undefinitized contract action as it otherwise would have unreasonably delayed the acquisition.

5. Effort to Solicit Potential Sources

In accordance with FAR 5.202(a)(2), this contract action will not be synopsized due to the urgency of the requirement. However, a Request for Information (RFI) was posted via the DIU- OTA in 2018 for the original effort. Responses were received and reviewed, and it was determined that all respondents other than the incumbent performer failed to demonstrate the requisite capabilities to complete the desired tasks outlined in the RFI. As a result, Philips Healthcare was awarded the contract in April 2018. At contract end, the predictive RATE algorithm was developed and delivered to the Government. Additionally, this concept was in part proposed during the FY20 Broad Agency Announcement (BAA) HDTRA119-CBI-02-1- 0007 as an operational demonstration of the RATE algorithm, though non-COVID specific.

During the review process for HDTRA119-CBI-02-1-0007, Royal Philips Healthcare was selected for a potential contract award. Those negotiations are currently underway, and while related to this effort, will follow normal acquisition procedures.

6. Fair and Reasonable Costs

The anticipated cost/price of this contract action to the Government will be determined to be fair and reasonable based on the request of a qualifying proposal to serve as the basis for definititzing the letter contract. Once in receipt of the qualifying proposal, DTRA will perform cost and pricing analysis which will include a technical evaluation from the DTRA Program Office to further determine the reasonableness of the proposed costs.

7. Market Research

Historical acquisition information was examined and the prior effort that developed the original RATE algorithm by Royal Philip’s Healthcare was procured via an OTA – Prototype contract awarded by DIU in April 2018 in support of DTRA and the CBDP. This topic and concept was part of the CBDP Science and Technology (S&T) plan for the portfolio, but was not specific to COVID19, nor was it as rapid as the need is currently. As discussed in section 5, the concept was also in part proposed during the FY20 BAA HDTRA119-CBI-02-1-0007 as an operational demonstration of the RATE algorithm and was part of the proposal.

Additionally, a review of internet sources was conducted and revealed that the RATE algorithm developed by Philips Healthcare is unprecedented and currently state-of-the-art for a pre-symptomatic alerting algorithm based on physiological data. Commercial devices have been developed for physiological data collection, and internet searches on those devices (such as the OURA Ring, Garmin Fenix 6, and Empatica E4) proved there are viable devices capable of collecting the data most indicative of infection as analyzed in previous efforts. However, no commercial device, nor current capability exists that implements an algorithm for early warning of potential infection or exposure to a pathogen. Furthermore, this operationalization is to specifically assess the RATE algorithm that was previously developed by DTRA, and thus cannot be performed by any other existing capability.

Lastly, DTRA Program Management has extensive personal knowledge in procuring this type of service as it is a follow-on effort. Additionally, physiological-based acquisitions from historical BAA’s including FRCall12-7 and BAA HDTRA1-12-17-FRCWMD which procured an effort with Massachusetts Institute of Technology – Lincoln Laboratory (MIT-LL), as well as CBCall18-CBI-08-1 in concert with BAA HDTRA118-CBI-08-1 which procured an effort with Biotechnology High Performance Computing Software Applications Institute (BHSAI), and CBCall14AMD3 in concert with BAA HDTRA114-AMD3 which procured an effort with Sandia National Laboratory (SNL), all based on analysis of physiological data collected from wearable devices.

8. Other Facts

A statement of work (SOW) has been developed in addition to a NTE data package, which will be followed up with a full technical proposal. Furthermore, the DTRA program management has conducted and continues to conduct market research on ideal COTS devices to be procured for the effort. As discussed in section 4, soliciting to outside performers would engender duplication of cost and effort in order to develop an algorithm similar to the current RATE algorithm, and thus would cause significantly increased cost to the Government.

9. Interested Sources

Not applicable