1. Scientific Technologies Corporation Implementation of On-Line VAERS Reporting from State Immunization Registries A Project funded in part by the RWJ Center for Innovation in Health Information Systems

2. Agenda  Background and rationale  Methods (why not HL7?)  Issues  Demonstration  Discussion

3. Background  STC currently has 6 web-based, statewide immunization registries which collectively have: 4.5 million patient records 33 million shot records 1800 sites reporting –1200 private provider sites –600 public sector sites  All STC systems could note that an adverse event occurred, but none reported it to VAERS  STC approached CDC in Nov 2001 to discuss on- line automation of VAERS reporting

4. Current Status of VAERS Reporting  Significant underreporting suspected  Primarily paper-based (on-line reporting now available)  Managed by Analytical Sciences, Inc (ASI) under contract to CDC and FDA  No link to immunization registries

5. STC VAERS Objectives  “ Drive” providers to immunization registries by continuing to offer “one-stop reporting”  Eliminate duplicate data entry—capture as much data as available from registry  Allow on-line entry for any data not collected by the registry by needed by VAERS  Expedite complete data delivery to VAERS in a format they could currently use  Create a standard-based method that could be used by other registries or patient management systems

6. Issues  Format for HL7 VAERS Message issued 4/2002 ASI (VAERS) could not accept HL7 formatted message  VAERS needs medical history data not maintained by registries Registry core data elements account for only about 40-50% of data needed for a VAERS report  VAERS uses FDA vaccine codes Not compliant with the CMX and MVX code sets Not a 1:1 match between code sets Conversion is necessary

7. Methods  Adobe Acrobat Toolkit—free shareware PDF form created FDF (Java) pulls information from registry client and loads it to PDF form  Populates form and convert codes  Dynamic PDF form is presented for on-line entry of remaining data by physician or other reporter  API created--can be used by other systems 5 to 30 hrs. programming time for configuration

8. Process  Web-based system sends data directly to VAERS  VAERS returns a “submission number” to the registry that is stored with the patient record  Data entered into VAERS database for investigation  Registry does not store complete VAERS report, only that a report was submitted and the submission number

9. Advantages  Gives important new functionality for providers to use immunization registry Makes VAERS reporting easier and may increase reporting Minimizes data entry  Sends data in format that VAERS can use now  Will be implemented in at least one state immunization registry by Dec 2002

10. For Further Information Terry Hughes 602.241.1502 terry_hughes@stchome.com

11. Provider Retrieves Child’s History Clicking on specific shot brings up background data

12. The Record is Edited to Note the Adverse Event

13. Adverse Event Selected from Pull Down List

14. Event Recorded, Report to VAERS Option

15. The VAERS pdf Form is Populated and allows on-line entry of more data