P03 J_A final_Redacted.pdf

Control Number VA-21-00006009

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition, and Logistics Technology Acquisition Center 1701 Directors Blvd Austin, TX 78744

2. Description of Action: The proposed is a firm-fixed price (FFP) brand name Sophic Perpetual Licenses and Sophic Installation Support and Maintenance (Professional Services) requirement for the Department of Veterans Affairs (VA), Office of Information and Technology, Enterprise Program Management Office, Medical Research, Education, and Population Health.

3. Description of Supplies or Services: The proposed action is to provide seven (7) brand name Sophic Perpetual Licenses and professional support. The Sophic software will annotate and report COVID viral strains or variants and its pathogenicity in the VA and send to the Center for Disease Control (CDC). The required Sophic licenses are necessary to ensure interoperability to allow for clinicians to transfer/upload data immediately to the CDC. The professional service will ensure proper install and data integration with the six (6) independent Public Health reference labs used for testing and sequencing of the viral genome. The period of performance shall consist of a base period of 12 months with two (2) additional 12-month option periods. The total estimated value of the proposed action is $

4. Statutory Authority: The statutory authority permitting other than full and open competition is 41 U.S.C. 1903 as implemented by the Federal Acquisition Regulation (FAR) 13.501, entitled “Special Documentation Requirements”.

5. Rationale Supporting Use of Authority Cited Above: Based on extensive market research, as described in paragraph eight (8) of this justification, it was determined that limited competition is viable among authorized resellers of brand name Sophic Perpetual Licenses and Professional Support. Veterans Health Administration (VHA) is initiating a COVID-19 virus genome sequencing effort to identify and estimate the prevalence and evolution of the viral variants. Clinical samples from COVID patients will be sent to sisx (6) different VA Public Health reference labs for testing and the viral genome will be sequenced. The sequenced data will then be used for two (2) main purposes: 1) Generate clinical reports of the variant status to be reported back to the clinical systems and 2) The raw sequence will be analyzed to evaluate the evolution of the viral strain, its prevalence in VA population and its importance in severity of disease development. In addition, this project will enable the VHA to track the longer lasting or lingering effects of the COVID-19.

Sophic is required for this effort in that its unique data model leverage resources that allow Sophic to normalize the data from disparate sources to find and map clinical, scientific, and semantic relationships. Then the relationship between genomic data, Sophic-CoV2 Software and Support Control Number VA-21-00006009 such as COVID, and drugs in the Sophic KnowledgeBase informs VA clinicians and researchers about often hard to find, new constantly evolving evidence. Sophic, then continues to monitor data sources and updates the KnowledgeBase, which allow the application to deliver current information on new, approved treatments and clinical trials.

Other similar software companies, such as Qiagen, located in Frederick, Maryland, and Foundation Medicine, in Cambridge, Maryland offer only parts of what is needed for genome research in comparison to the Sophic software. Qiagen offers a knowledgebase of biology research, clinical studies, disease-specific research, and analysis, but it is static and does not evolve as more information is discovered.

Foundation Medicine has a comprehensive genomic profiling assays to identify molecular alterations but focuses primarily on Cancer therapies and treatments. Sophic software licenses are required because of its access to ontologies, vocabularies, and data standards as we have found no other market software provides this level of efficiency and easy access to critical information that supports improvement in precision medicine, and treatment for veteran care. Ultimately, COVID variant sequencing analysis is time sensitive for clinicians and inadequate research tools will negatively impact the critical care of the veterans infected with the current or new variants of COVID19. It may also lead to extra cost and negative disease outcome for the veteran.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the Government’s requirements. There is no competition anticipated for this acquisition. Additionally, the proposed action will be synopsized on the Contracting Opportunities Page in accordance with FAR 5.201. Any proposals that are received shall be evaluated.

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the market place that would enable future actions to be competed.

8. Market Research:

The Government's technical experts conducted market research in July 2021 to ascertain if sources other than Sophic Perpetual Licenses and Professional Support authorized resellers could meet the VA’s needs. The Government's technical experts found that only the Sophic Perpetual Licenses can be used as described in paragraph five (5) of this justification. The Sophic product is needed because its innovative flexibility will allow for the raw sequencing of the viral strains to be analyzed and evaluate the evolution of COVID. Tracking the viral strain is prevalence and vital to the VA population, the community, and its importance in severity of disease development.

Government experts have researched other medical software, such as Power Analysis and Sample Size (PASS), Number Cruncher Statistic Systems (NCSS) and Qiagen.

PASS data analysis only provides sample size calculations, and can only be used for trial planning and study evaluation. NCSS research software provides analysis and graphics, but this tool is only used to analyze data that has already been collected.

Qiagen provides genomic service to extend in-house resources and can only help with the time-consuming parts. Foundation Medicine is focused exclusively on Cancer. Any

Sophic-CoV2 Software and Support Control Number VA-21-00006009 other applications do not have the unique capability to sequence the viral strains to benefit the VA. Sophic provides education and analysis for all test platform results and covers all major diseases, including COVID. Therefore, the government’s technical experts have determined that only Sophic Perpetual Licenses and Professional Support and its authorized resellers can meet all the VA’s needs.

9. Other Facts: None.