Biovigilance Component
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The Biovigilance Component of the National Healthcare Safety Network is a public/private collaboration between CDC and the transfusion and transplant communities. Biovigilance includes collection of adverse event data to improve outcomes in the use of blood products, organs, tissues, and cellular therapies.
The Hemovigilance Module is the first part of the new Biovigilance Component to be developed in NHSN. The result of a unique public-private partnership between CDC and subject matter experts convened by AABB, this module is designed for staff in healthcare facility transfusion services to track adverse events, including recipient adverse reactions and quality control incidents, related to blood transfusion. Adverse reactions and incidents related to blood transfusion that occur in healthcare can be reported by participating facilities now that standard definitions and criteria for categorizing and reporting adverse reactions and incidents have been developed. Participating facilities will be able to analyze their own data, and, where appropriate, independently compare their data with national aggregate rates in a confidential manner through NHSN.
The NHSN Hemovigilance Module Protocol and Tables of Instructions are provided for your information. This module is being piloted in nine facilities across the United States. Open enrollment for all facilities is planned soon. See topics: About NHSN and NHSN Enrollment for details and requirements of enrollment.
Corresponding Materials
Protocol and Instructions
- NHSN Manual: Biovigilance Component Protocol Hemovigilance Module
Guidelines and procedures for monitoring hemovigilance. March 2009. PDF (523 KB / 32 pages) - Hemovigilance Module Tables of Instructions Feb. 2009 PDF (279 KB / 19 pages)
Training
- Hemovigilance Module Overview
Audience: All NHSN users including Facility Administrators and Group Administrators. - Enrollment for Facility New to NHSN
Audience: Facility Administrators and Group Administrators. - Enrolling an Existing NHSN Facility into Biovigilance and Facility Set up
Audience: Facility Administrators and Group Administrators. - Groups in Biovigilance
Audience: Facilities interested in joining or nominating a Group in NHSN and organizations that become a Group in NHSN - Hemovigilance Incident Reporting
Audience: Staff in Blood Transfusion Services departments collecting and/or entering incident report data into the Hemovigilance Module and for staff who will be analyzing incident report data. - Adverse Reaction Data Collection and Entry
Audience: Blood transfusion services personnel collecting and/or entering information on blood transfusion recipient adverse reactions. If you will be classifying or identifying adverse reactions you must view Adverse Reaction Case Definition Exercises first. - Hemovigilance Module: Introduction to Analysis
Audience: Blood transfusion services personnel collecting and/or entering information on blood transfusion recipient adverse reactions. If you will be classifying or identifying adverse reactions you must view Adverse Reaction Case Definition Exercises first.
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Contact NHSN:
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Centers for Disease Control and Prevention
National Healthcare Safety Network
MS-A24
1600 Clifton Rd
Atlanta, GA 30333 - nhsn@cdc.gov

