Vaccine Code Set Management Services Pilot Stuart Myerburg, JD1 and Paloma Hawry2, Morgan Wisener2, Shannon Davis2 1: Centers for Disease Control and Prevention, National Center for Immunizations and Respiratory Diseases, 2: Deloitte Consulting, LLP BACKGROUND AND PILOT OBJECTIVES The Centers for Disease Control and Prevention (CDC) Immunization Information Systems Support Branch (IISSB) publishes the vaccine terminology code sets used for interoperability and reporting across vaccine delivery communities. A goal of IISSB is to provide enhanced and centralized vaccine code set management and enhanced distribution options for the Vaccine Code Set Management Service (VCSMS) Center. The vaccine code sets include catalogs of codes authored by the CDC, Food and Drug Administration (FDA), and American Medical Association (AMA). CDC also generates maps from the externally-authored codes to the CDC-authored codes. CURRENT STATE CHALLENGES Manual processes for data research, capture, and curation. Standalone Access database without workflow features for consistent data quality and timeliness. Limited distribution and access options beyond CDC website. HYPOTHESIS Implementing a commercial terminology management application will: Enhance CDC’s current vaccine data set and terminology. management processes. Improve data quality and integrity. Provide direct distribution via access to content cloud information. PILOT A commercial terminology management application, Symedical®, was implemented to evaluate the feasibility of migration. Required features include: direct sourcing of content needed for vaccine data set from external entities; catalog curation, mapping and publishing functionality; and automated and subscription-based distribution options. CDC Data Management Process Manual curation, research and entry of code sets and maps into standalone Access database, extracts for website Migrate to New Data Management Platform Convert content, implement processes in hosted, configurable technology management application with publishing features Implement Subscription Options Users subscribe to files through configurable profiles in commercial technology management application Execute Automated Distribution Options Direct, automated distribution of files to subscribers based on their subscription profiles and package selection Current State Future State ROADMAP - VACCINE SERVICES FUTURE STATE - VACCINE CODE SET MANAGEMENT SERVICE User Services CDC-Authored Vaccine Code Sets FDA and AMA Data Feeds Centralized Vaccine Data Set Management Access Content and Reports via Subscription and Distribution Options Data Curation Publishing Content Cloud METHODOLOGY A two part method was applied to the VCSMS pilot: IISSB identified and vetted Immunization Information Systems (IIS), Electronic Healthcare Record System (EHR) vendors, and IIS vendors to participate in the pilot. Pilot Participant #1: Major EHR Vendor Pilot Participant #2: State IIS Pilot Participant #3: IIS Vendor Test pre-configured Content Cloud Agent automated direct distribution to subscribed pilot users for feasibility. Distribution option to meet key evaluation criteria (e.g., ability to use automated method, adherence to security requirements, accessibility to reports). Configure and instantiate existing CDC code sets into the Symedical® data architecture. Perform detailed analysis at the record and field level to confirm feasibility to support all content areas needed for currently published CDC data. Receive and integrate FDA and AMA automated data feeds as core sources for mapping to CDC codes and to populate fields in catalogs used in outputs provided to end users. Compare and categorize field level data changes, introduced as a result of the new data sources, to current field values for content meaning equivalence to determine the feasibility of migrating from manual research to use of content from the automated external data feeds. Categorize degree of agreement and review each not-exact record. Execute content publishing lifecycle. Test end-to-end process for creation, publication, and packaging of content output files to confirm feasibility of extracting content in the form needed by end users. Pilot Participation Content Instantiation and Evaluation RESULTS The quantitative results of the comparisons were further interpreted to reach conclusions regarding pilot content lessons learned, feasibility of implementation, and recommendations for the next steps in preparing CDC content for rollout. Needs and Requirements Content Instantiation and Evaluation Pilot participants identified key requirements to meet their needs. The following are some of the requirements that were tested using the commercial terminology management platform: A key criteria for evaluation of the VCSMS Pilot was to assess if content sourced from the FDA and AMA data sources has sufficient record and field level matching to the data currently stored in the CDC-authored catalogs to support the migration to use automated data sources. The core code sets, as defined in the table below, managed by the IISSB and included in the pilot evaluation are: CVX†, MVX†, NDC†, and CPT†. The following NDC† Unit of Sale evaluation provides an example of one of the code sets evaluated. NDC† Record Match - Units of Sale NDC† Units of Sale FDA File to CDC File ≥80% 100% Automated distribution option to distribute content directly to the end user can be implemented. Current CDC website content and outputs can continue to be produced and distributed. Content packages can be accessed successfully from the content cloud by end users. Users can be subscribed to desired content packages and distribution methods. more vaccine NDC† products found in the FDA files than in CDC files. 25% of CDC NDC† records did not reflect current FDA product status. 34% of field values agree in meaning for records matched from the external catalogs (e.g. FDA NDC† Unit of Sale, FDA NDC† Unit of Use, AMA Vaccine Subset CPT† Codes) to the CDC field level values. of records in the CDC-authored catalogs (CVX†, MVX†) could be implemented in Symedical®, with all the fields and records in the original catalog having no reconciling differences. NDC† Field Level Analysis - Product Status NDC† Units of Sale FDA File to CDC File Conclusion: Automated sourcing of NDCs† from the full FDA files will capture NDC† codes and status changes not readily identified through CDC current individual product search process. The following terms define the agreement evaluation. Agree: Content agrees in meaning exactly, OR agrees in meaning and the external content has additional descriptors with no loss of information when new source is substituted. Disagree: Disagreement in content meaning between CDC Symedical® record; needs review (counted as disagreement). Incomplete: Data is not populated in the CDC data set; cannot review. NDC† Field Level Analysis - Other Descriptive Attributes Overall Content Evaluation Conclusions Content evaluation confirmed the feasibility of: Providing more complete and up-to-date NDC† record information through automated receipt of the drug data files from the FDA. Receiving and integrating external code set data files from the authoring source without loss of meaning from the current data set. Instantiating CDC-authored code sets in the new tool environment. Improving efficiency of the code set management process by leveraging source files. †Core Code Sets Code Description CVX Represents the type of vaccine product used in an immunization. Code is a CDC-authored numeric string and used for public health reporting and analytics. MVX Represents the specific manufacturer of a vaccine. Code is a CDC-authored alphabetical string and used for public health reporting and analytics. NDC Serves as the U.S. product identifier for drugs. Code is a numeric string that is assigned by the Federal Drug Administration (FDA). Code is comprised of three segments; the product (FDA Product Code), the manufacturer or packager (FDA Labeler Code), and the packaging (Unit of Sale and Unit of Use). In the vaccine data set, NDC codes are mapped to CVX and MVX codes. CPT Procedure code used by providers to record vaccine administration to a patient. Code is a numeric string that is assigned by the American Medical Association (AMA) to support billing for services and data analytics. In the vaccine data set, a small subset of the CPT codes are used and mapped to the CDC vaccine CVX codes. FUTURE PLANS Complete Final Data Curation and Reconciliation Establish the complete data set in Symedical®, including legacy data and source feeds. Test outputs to ensure the legacy data is accurately reflected in Symedical®. Establish Content Subscription Process Create a subscription workflow to allow users to subscribe and register to receive vaccine code set content via direct, automated distribution. Release User Communications Inform the vaccine community of the CDC’s rollout of Symedical® in the months preceding the release. Rollout Symedical® Release the system in early 2018 and leverage as the core data management source for the vaccine terminology code sets. Begin Vaccine Services to End Users Allow users to utilize the enhanced VCSMS functionality by accessing the subscription and automated distribution methods provided by Symedical®.