JA_IR Symedicalv6_Redacted.pdf

Symedical User licenses CONTROL NUMBER VA-25-00071539

JA template - FAR Part 6_(17-JAN-2024)

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition, and Logistics

Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

2. Description of Action: The proposed sole source action is for a firm-fixed price (FFP) contract award to Clinical Architecture, LLC for the purchase of Symedical User licenses.

3. Description of Supplies or Services: The Electronic Health Record Modernization Integration Office (EHRM-IO) is responsible for managing the deployment of the Oracle Health Millennium system to VA Medical Centers. EHRM-IO has a requirement for Medical Terminology Software to facilitate the mapping and maintenance of existing terminology codes to the Oracle Health platform in support of migration of data from VA’s legacy VistA to Millennium and syndication of data back from Millennium to VA systems. The proposed action will renew five (5) annual licenses currently in use for Symedical, a medical terminal management software application. The licenses include software updates, patches, and help desk support for the installation and use of the application. EHRM-IO is responsible for managing the transition from the legacy VistA EHR to the commercial product from Oracle Health, i.e. Millennium. As part of this work, EHRM-IO is required to transfer patient data from VistA to Millennium in advance of each site go-live. This process is called data migration. In addition, EHRM-IO receives data back from live Millennium sites to populate the clinical data warehouse for research purposes and ensure that legacy VistA sites have a complete patient record during the transition. This process is known as syndication. Much of the patient data is stored with codes selected from more than 20 industry and proprietary terminology sets in VistA or Millennium. This data is needed to support data migration and data syndication, as well as Interoperability. VA personnel must correlate the codes used in each VistA with the correct inbound and outbound code sets used in Millennium. These mappings are used to build the data migration and syndication rules, troubleshoot data errors or data migration or data syndication anomalies, and support Interoperability. VA requires a solution thatwill enable the EHRM-IO Data Migration team to manage the mapping of standard and proprietary terminology data sets - such as Systematized Nomenclature of Medicine (SNOMED ), Logical Observation Identifiers Names and Codes (LOINC), International Classification of Diseases (ICD-10) , Health Level Seven (HL7), American Society for Testing and Materials (ASTM) health informatics standards, Current Procedural Terminology (CPT), Unified Medical Language System (UMLS) between Veterans Health Information Systems and Technology Architecture (VistA), and Oracle Health Millennium as patient data is migrated from VistA to Oracle Health.

The total estimated value of the proposed action, including options, is

The overall Period of Performance is 36 months which consists of one 12-month base year for five end user licenses and two 12-month option periods to renew the five end user licenses.

4. Statutory Authority: The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) 6.302-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

5. Rationale Supporting Use of Authority Cited Above: The proposed source for this proposed action is Clinical Architecture, LLC. of 11611 N Meridian St, Carmel, IN 46032. Based on market research, as described in Section 8 of this document, the Government has determined that Clinical Architecture, LLC is the only source capable of providing the required User Subscription software licenses; therefore, there is no competition for this acquisition. Clinical Architecture LLC’s Symedical application provides a unique set of capabilities that support VA’s adoption of the Oracle Health Millennium Electronic Health Record System.

Clinical Architechture LLC provides a medical terminology mapping solution which supports all major industry code sets; automatically maps terminology set with a high-level of accuracy supporting creation and validation of mappings; allows multiple users to propose, review, approve and publish code mapping; supports multiple maps so that mapping for individual VistA instances to Millennium can be maintained; automatically creates a discrete component level definition of each mapping (e.g., medication = ingredient + strength + unit of measure + dose form) to facilitate searching, modeling and other informatics tasks. Clinical Architecture LLC’s Symedical application is a medical terminology mapping solution that allows for these required capabilities.

Specifically, the Symedical application provides unique functionality required to accomplish these tasks in VA’s existing environment. The Symedical application automatically downloads changes to reference terminology data as industry terminology sets are updated. The effect of changes to the terminology sets can be reviewed before the changes are applied to prevent errors in mapping. The Symedical application enhances the terminology sets with semantic information that enables the reviewers to understand the meaning and use of each code more easily.

The Symedical application provides a workflow process that allows data mapping to be proposed, reviewed, and published ensuring that in progress mappings are never available to data engineers working on production systems. The Symedical application can capture information about each mapping decision for later reference and understanding. Symedical provides a robust security environment that ensures users are authenticated, provided access to functionality limited to their role and that all user’s actions are logged producing a clear audit trail of changes to the system.

The mapping of the terminology allows VA to programmatically migrate medication orders (and other clinical items) from VistA to Oracle Health at go live. Without this programmatic migration, all the orders would need to be keyed in by hand.

If the VA switched to an existing terminology management product, the cost would fall in the range of $5 million over 3–5 years based on previous acquisition history.

Because the VistA system has spanned many decades, different medical vocabularies have been used to describe patient care. There are many terminologies in use in medicine today, HL7, LOINC, ASTM, CPT, UMLS, SNOMED etc. Symedical allows one vocabulary on the input side to be translated to another terminology. In each vocabulary there can be thousands of terms, procedure, drugs, lab test, genomics etc. and this software aids a clinician in preparing mappings to allow VistA data to be correctly mapped to Oracle Health. Without the procurement of an automated system, clinicians would have to redirect efforts away from patient care to do these translations, there would be an increased risk of errors and, most importantly, patient safety issues since tests, procedures, diagnosis etc. may be coded incorrectly (human error).

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 could meet the Government’s requirements. There is no competition anticipated for this acquisition. Additionally, the proposed action will be synopsized on the Federal Business 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 marketplace that would enable future actions to be competed.

8. Market Research: The Government ’s technical subject matter experts routinely review the marketplace for medical terminology management solutions, research for this effort was most recently conducted in January 2025. In addition to a web-based search for alternative products, Government Experts have reviewed thirteen other software solutions including Microsoft Excel, Microsoft Access, RELMA, International Health Terminology Standards Development Organization’s (IHTSDO) Mapping Tool, Wolters Kluwer Map Manager, Health Language, 3M, Apelon, Intelligent Medical Objects (IMO), Commonwealth Scientific and Industrial Research Organization (CSIRO), iNTERFACEWARE, Rhapsody, and Intersystem. Based on the review, the Government’s technical subject matter experts have concluded that no alternative software could meet all of VA ’s functional requirements as detailed in Section 5 of this justification. The products listed above do not meet the requirements due per the Government SMEs. Exact missing functionality for each of the above software is stated below.

Most vendors focus on offering terminology mapping as a service rather than providing robust tools, which means organizations still need internal SMEs to validate the work. Products like those from Health Language, 3M, and Apelon are primarily service-driven with only limited tool support, while Wolters Kluwer’s Map Manager and HLI’s tools offer minimal runtime capabilities, automation, or scalability, making them insufficient for VA’s complex needs. Other options, such as IHTSDO’s SNOMED tool, RELMA for LOINC, and IMO’s proprietary platform, are restricted to narrow vocabularies. Broader integration vendors like CSIRO, iNTERFACEWARE, Rhapsody, and InterSystems provide only basic mapping features and lack true terminology management. General purpose tools like Excel and Access lack reference data, master data management, and automation. Overall, none of these options deliver the comprehensive mapping and large-scale data management required by the VA.

Based on market research, it was determined that Clinical Architecture LLC’s Symedical application is the only medical terminology solution that can meet VA’s requirements. Clinical Architecture, the manufacturer of Symedical, confirmed that they are still the only developer, owner and seller for Symedical User software licenses or services on December 10, 2024.

9. Other Facts: N/A

10. Technical/Requirements Certification I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

11. Fair and Reasonable Cost Determination I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable based on the procurement history of this software and price analysis, to include an analysis of proposed level of effort and mix of labor, will be conducted and subsequent negotiations held as necessary.

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

Approval

In my role as procuring activity Advocate for Competition, based on the foregoing justification, I hereby approve the acquisition of Symedical User licenses on an other than full and open competition basis pursuant to the authority cited in Section 4 above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition.