Justification for Sole source to post.pdf

MD Clone Synthetic Data VA-21-00064067

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition, and Logistics Technology Acquisition Center 23 Christopher Way

Eatontown, New Jersey 07724

2. Description of Action: The proposed action is for a firm-fixed price delivery order to be awarded under the National Aeronautics and Space Administration (NASA) Solutions for an Enterprise-Wide Procurement (SEWP) V to Thundercat Technology (Thundercat) for brand name MD Clone ask-discover-act-measure-share (ADAMS) Platform which consists of MD Clone ADAMS Platform, the integrated MD Clone Platform XL and MD Clone Associated Business Services software licenses. In addition, the proposed action includes MD Clone ADAMS Platform set up.

3. Description of the Supplies or Services: VA is interested in further unlocking data access to engage the widest possible audience in innovation, research, and quality improvement efforts across a wide range of opportunity areas to include Corona Virus Disease (COVID) response. VA requires the MD Clone ADAMS Platform to pair with its existing synthetic data generation solution, MD Clone Platform XL, for increased access to data insights discoverable by VA staff who are not data analysts or data scientists or otherwise expert in their fields. This can be accomplished with the use of software technology that supports initial data discovery through visualization, automated analysis, and insight generation to support increased access to quality improvement and operational insights to improve quality of care. This resource, paired with synthetic data generation, will dramatically increase access to meaningful use of VA data to serve Veterans through quality improvement and innovation efforts. Synthetic data generation, which drastically speeds up the rate of data analysis, is not readily available in VA without the use of MD Clone Platform XL and creates a choke point for rapid data analysis on fast moving clinical and social issues, to include the COVID pandemic. The combination of continued synthetic data generation via MD Clone Platform XL plus supported visualization, insight generation, and the ability to share models and insights via the MD Clone ADAMS Platform will rapidly accelerate the pace of a learning healthcare system, which can iterate from insight to insight, improving the quality of care for our Veterans.

The brand name MD Clone ADAMS platform enables operationalization, visualization and sharing of insights generated by a wide variety of end users of the synthetic data generation portal and consists of MD Clone ADAMS Platform, the integrated MD Clone Platform XL and MD Clone Associated Business Services software licenses. VA requires this platform to be used with VA’s existing data warehouses. VA will utilize this platform to provide synthetic data to innovate, research, and improve quality and speed of efforts across a wide range of opportunity areas without compromising personally identifiable information. The MD Clone ADAMS Platform will provide the following:

automated data discovery, measurement, insight generation for a wide variety of end users, thereby increasing access to operational and innovation insights for the majority of VA staff who are not expert data scientists or data analysts. In addition, the MD Clone ADAMS Platform will be able to operate on VA based cloud or VA infrastructure and provide data support for use cases where VA has identified a critical area of need.

Furthermore, access to the user interface for quality assurance and clinical improvement purposes will not be limited among VA staff which will enable collaboration with its users to create large, privacy preserving healthcare data sets to unlock insights and provide improvements to care. This will expand VA’s current capabilities by allowing collaboration and sharing of information across Veterans Integrated Service Networks within VA and will allow for potential collaboration with external agencies, if needed. As part of this proposed action, training will be provided to Veterans Health Administration training coordinators who can assist MD Clone Platform XL end users in utilizing the MD Clone ADAMS platform. All delivery, installation, configuration, testing, and go-live shall be completed within 95 days from award. The base MD Clone ADAMS Platform software subscription shall be for 12-months from date of go-live. Also included are two 12-month option periods for software subscription renewal for both MD

Clone ADAMS Platform and MD Clone Platform XL.

4. Statutory Authority: The statutory authority permitting an exception to fair opportunity is Section 41 U.S.C. 4106(c)(2) as implemented by the Federal Acquisition Regulation (FAR) Subpart 16.505(b)(2)(i)(B), entitled “Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.”

5. Rationale Supporting Use of Authority Cited Above: The proposed source for this action is Thundercat Technology, 1925 Isaac Newton Square E, Suite 180, Reston, VA 20190. Based on extensive market research as described in Section 8 of this document, it was determined that there is no competition among vendors. Thundercat Technology is the sole reseller for both the MD Clone ADAMS Platform and MD Clone Platform XL.

The MD Clone Platform XL generates synthetic data sets and provides curated, mathematically detectable, computational validity automatically. The MD Clone Platform XL either makes corrections autonomously or suggests corrections to the data scientists managing the data set generation. This is a unique capability that only the

MD Clone Platform XL can provide. This unique capability, to provide automated synthetic data generation, makes for faster and easier inclusion of the most recent data ensuring relevancy to potential solutions. Synthetic data, through use of the MD Clone Platform XL, can reduce cycles of discovery from months and years to hours and days through the user portal and access to synthetic data without the need for institutional review board approval. The MD Clone Platform XL is used to extract data from MD Clone’s synthetic data through queries. These queries aid research on social and clinically exigent problems; both critical and pressing problems. The MD Clone Platform

XL interface masks the complexity of the data making it easier to be understood by non-clinical, non-researcher and non-data scientists. MD Clone’s synthetic data and the integrated MD Clone XL will ultimately provide VA a single process for the rapid generation of multiple synthetic data sets and the democratization of access for a larger diverse pool of research, business and clinical staff.

The MD Clone ADAMS Platform enables operationalization, visualization and sharing of insights generated by a wide variety of end users of the synthetic data generation portal.

The MD Clone ADAMS Platform is designed to work seamlessly with the MD Clone Platform XL, which can generate synthetic data upon query. This is a unique capability that only the MD Clone ADAMS Platform can provide. This unique capability, to provide automated synthetic data generation, makes for faster and easier inclusion of the most recent data ensuring relevancy to potential solutions. Synthetic data, through use of the MD Clone Platform XL, can reduce cycles of discovery from months and years to hours and days through the user portal and access to synthetic data without the need for institutional review board approval. The MD Clone ADAMS Platform combines seamlessly with the MD Clone Platform XL to automate data visualization, insight generation, and initial data discovery; further increasing the ability of non-data experts to glean insights from the data. These tools together will further democratize access to the use of VA data for operational, quality improvement, and research insights. A known bottleneck for VA to truly become a learning healthcare system is the ability to glean insights from the vast data that VA collects. Automating initial data discovery, visualization and insight generation as well as the ability to share models and insights will rapidly expand the possibilities for testing and scaling best practices across the enterprise. MD Clone’s synthetic data and the integrated MD Clone XL software will ultimately provide VA a single process for the rapid generation of multiple synthetic data sets and the democratization of access for a larger diverse pool of research, business and clinical staff.

There is currently no other software platform that can provide the required automated data set generation with fully curated and mathematically proven computational validity and meaningful clinical relationships accessible through a self-service user query portal.

Currently, even after the lengthy (several weeks to several months) process by which data analysts might obtain approval to access data and curate the data set; there is an additional process and expertise required to manually complete the data analysis. The training for a wide variety of data analysis techniques and use of VA data requires both years of training and at least several months of experience with the specific VA data set to understand the data. This data analyst effort is very time consuming and takes multiple months to complete once the data is accessible. This effort needs to occur each time a data set is curated. As a result, the data sets become historical and unable to embrace changes in current data.

All other approaches to data visualization, measurement, and model generation cannot meet VA requirements as they cannot provide the required automated data set generation with fully curated and mathematically proven computational validity and meaningful clinical relationships accessible through a self-service user query portal.

Additionally, even if there were an alternative solution capable of meeting VA requirements, it would require extensive configuration to test for potential compatibility with the MD Clone synthetic data generation platform. Though many research organizations can analyze data, the provided output is proprietary and secure, principally for data scientists, and access is limited. Therefore, the need to perform extensive configuration to establish potential connections between tools would need to occur. This would require extensive data architectural knowledge and time to implement. Specifically, this would result in a multiple month delay, with no certainty that a different platform would be compatible. This would result in waste of Government funding on a platform that may not even be usable.

VA’s only avenue to avoiding these delays and avoiding potential waste of Government funding is through the continuing use of the MD Clone Platform XL and through utilizing MD Clone ADAMS Platform. VA requires the MD Clone ADAMS Platform, to provide

VA a single process for the rapid generation of data insights and the democratization of access for a larger diverse pool of research and clinical staff. The MD Clone ADAMS Platform is the only platform that can bypass the need for an extended process each time data sets need to be generated by providing VA with automatically curated data insights, including visualizations, measurements and model generation compatible with the synthetic data generation engine within minutes.

No other platform can provide VA this functionality and meet the need to rapidly increase the rate of response and analysis on fast moving clinical and social issues, to include the COVID pandemic. Additionally, no other platform is capable of providing software capable of integrating with a user query portal, rapid synthetic data generation, and automatic data insights and visualization for the rapid iteration necessary for a learning healthcare system. The MD Clone ADAMS Platform allows for more users to unlock insights about emerging data concerns like the COVID pandemic and how to respond. No other platform can meet this requirement.

The ability to provide this automated data insight in addition to secure synthetic data is critical for VA to provide adequate care to Veterans in a learning healthcare system.

The automated data insight generation available via the MD Clone ADAMS Platform is critical to VA’s COVID response to provide the very best in-patient care based on evidence the data provides. Failure to continue use of MD Clone Platform XL and procure MD Clone ADAMS Platform will degrade the ability for VA to provide quick and efficient response to fast moving clinical and social issues, most notably the COVID pandemic. Specifically, VA requires continued support to better assess healthcare and patient data to more adequately understand quality standards. VA is currently adding new data sets, including Veteran generated data, to improve insights on health and well-being issues with directly affect Veterans. Automating the analysis of this new data will significantly increase speed with which VA can implement quality improvement efforts for our Nations Veterans which is especially critical during the required COVID response efforts.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in section 8 of this justification. This effort did not yield any additional sources that can meet the Government's requirements. There is no competition anticipated for this acquisition. In accordance with FAR 16.505(a)(4)(iii)(A)(2), this justification will be provided with the solicitation to all appropriate NASA SEWP V contract holders.

Furthermore, in accordance with FAR 5.301, 16.505(b)(2)(ii)(D), and 16.505(a)(4)(iii), the justification for this action will be posted on the Contracting Opportunities website within 14 days of award.

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be fully competed. Currently, Thundercat has exclusive rights to sell and support the brand name MD Clone ADAMS Platform which consists of MD Clone ADAMS Platform XL and MD Clone Associated Business Services software licenses.

8. Market Research: The Government’s technical experts conducted market research by reviewing other similar platforms. This market research is an ongoing process and continuously being conducted through May 2021. The data sets created with available free open source software (i.e. CorGAN, MedGAN and Synthea) do not meet VA’s requirements as they have to be manually curated. All other potentially comparable approaches to synthetic data generation require significant manual effort of a trained data science expert to curate a data set, generate synthetic data and then evaluate the data for privacy and quality. Use of any other sources platform to provide synthetic data will result in a multiple month delay each time a new synthetic data set is needed which will not enable VA with the ability to analyze current trends and provide optimal COVID response. These products do not meet the requirements as outlined in Section 5 as they require either manual data analysis by an experienced data scientist or cannot confirm compatibility with the synthetic data model; which would take many months to test and evaluate by an experienced data architect and may not result in compatibility.

Manual analysis of data sets takes multi-months to develop making them historical and unable to incorporate current data which will not enable VA with the ability to analyze current trends and provide timely COVID response.

Based on reviews of these products, the Government’s technical experts determined that no other platform could meet the Government’s requirements as outlined in this

Justification. Additionally, none of these other products can offer the single integration automated data set generation with mathematically proven privacy while simultaneously maintaining computational validity and meaningful clinical relationships. Based on all of these market research efforts, the Government’s technical experts have determined that only brand name MD Clone ADAMS Platform which consists of MD Clone ADAMS Platform and MD Clone Associated Business Services software licenses can meet all of VA’s needs.

Additionally, the Contract Specialist posted a request for Information (RFI) on the Contracting Opportunities website on May 10, 2021. The RFI was posted to identify any other providers or similar products that can meet VA’s requirements identified above.

The RFI closed on May 17, 2021, with one response received from Thundercat.

ThunderCat confirmed they can meet the requirements and are the sole resellers of the required MD Clone products and services.

Moreover, the Government representatives received confirmation from MD Clone on May 20, 2021, through a signed letter confirming that Thundercat is the sole reseller of the MD Clone ADAMS platform. Furthermore, MD Clone confirmed the only way to purchase its products is via NASA SEWP V contract vehicle to Thundercat. Therefore, there is no competition anticipated for this acquisition.

9. Other Facts: None.