Wednesday, May 12, 2004
5370

Enhancing Vaccine Safety Initiatives in Immunization Registries with National Exchange Standards

Ronald Van Duyne1, Pete Gruenberger2, Francis M. Bezzina, Sean Shadomy1, Warren Williams1, and Robert T. Chen3. (1) National Immunization Program, ISD, Centers for Disease Control and Prevention (CDC), Immunization Registry Support Branch - Informatics, 12 Corporate Square MS E-62, Atlanta, GA, USA, (2) Constella health Sciences, 8401 Colesville Road, Suite 200, Silver Spring, MD, USA, (3) NIP/ESD/VSDA, Centers for Disease Control and, 1600 Clifton Road, MS E-61, Atlanta, GA, USA


BACKGROUND:
Vaccine safety concerns have become more prominent in recent years with the continued success of immunization programs in reducing vaccine-preventable diseases. The Vaccine Adverse Event Reporting System (VAERS) is the nation's main sentinel for detecting post-marketing vaccine safety concerns. This project explores how registries can also work to enhance vaccine safety by providing more accurate and timely reports to VAERS and denominators for calculating VAERS reporting rates. CDC is designing and implementing electronic VAERS reporting, generation of Vaccine Adverse Event (VAE) 'Alerts' and denominator data for calculating rates. The project strives to utilize the American National Standards Institute (ANSI) standard Health Level 7 (HL7) electronic messaging. Immunization Registries promote and adopt HL7 Standards.

OBJECTIVE:
Describe the project and how it is implementing electronic VAERS reporting. Illustrate how HL7 is used to capture VAERS data elements.

METHOD:
To implement electronic VAERS reporting, the CDC system will complete: (1) the detailed message structure and options needed to report VAERS information from Immunization Registries; (2) mapping of VAERS manufacturer codes and antigen codes to the standard HL7 code sets used by Immunization Registries (MVX and CVX); (3) secure transfer and receipt, parsing, and entry of multiple and individual VAERS reports; (4) issue an updated HL7 Implementation Guide for use by Immunization Registries.

RESULT:
A sample HL7 VAERS message has been tested. An HL7 parser read the message. Data element specifications meet the basic message structure and VAERS reporting needs.

CONCLUSION:
These capabilities can increase the accuracy, timeliness, utility, acceptability, and sensitivity of the VAERS system, and enrich vaccine safety initiatives for immunization programs in the US.

LEARNING OBJECTIVES:
Become familiar with requirements and process of submitting VAERS reports utilizing a standard HL7 message.