Biovigilance Component

The Biovigilance Component of the National Healthcare Safety Network is available for enrollment by healthcare facilities in the United States. Biovigilance includes the 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 release of the Biovigilance Component of NHSN, and was developed through a public-private partnership between CDC and subject matter experts convened by AABB. The Hemovigilance Module is designed for transfusion services staff in healthcare facilities to monitor recipient adverse reactions and quality control incidents related to blood transfusion.

The Hemovigilance Module provides standard criteria and definitions to participating facilities to report adverse events related to blood transfusion that will result in aggregate data suitable for trend analyses and benchmarking. Participating facilities are able to independently analyze their data within NHSN and will be able to compare their data with national aggregate rates in a confidential manner through NHSN in the future.

The NHSN Hemovigilance Module Protocol, Data Collection Forms, and Tables of Instructions are provided below.

Important Points Regarding NHSN Enrollment

• Facilities can enroll in NHSN and the Hemovigilance Module only through the CDC website. All the instructions for enrolling are located on the CDC website. See topics: About NHSN and NHSN Enrollment for details and requirements of enrollment
  
• Many facilities are already using NHSN for HAI reporting. If your institution is already enrolled in NHSN, you do not need to initiate the enrollment process again. The NHSN Facility Administrator must activate the Biovigilance Component for you. Contact your Infection Prevention team and ask if they are using NHSN.
  
• In some states, participation in NHSN is required by state law. CDC does not require participation in NHSN.
  
• Only your facility can sign up to participate in NHSN. No other organization can sign up for you.
• Private organizations may ask facilities for a commitment to join NHSN, but such a statement is not required by CDC and is not necessary to join NHSN.
  
• CDC will make every effort to ensure that your facility’s identity will not be disclosed to the extent legally possible. A facility may choose to disclose their participation in NHSN to others.
  
• The group function in NHSN can establish a data sharing relationship between NHSN participants and private organizations outside CDC. Participating facilities can make the choice to join a group, but it is not required for enrolling in the Hemovigilance Module. Facilities can only join a group after they have enrolled in NHSN.
  
• The decision to confer rights to a group is a decision made by a facility administrator. Existence of a group organization in NHSN should not be construed as a recommendation from CDC to join the group. CDC cannot be held accountable for how group users use data access granted to the group by a facility.
  
• If you have questions about this information, please email us at nhsn@cdc.gov.

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Corresponding Materials

Protocol

• NHSN Manual: Biovigilance Component Protocol Hemovigilance Module [PDF - 785 KB]
  Guidelines and procedures for monitoring hemovigilance.
  June 2011.

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Forms

• Hemovigilance Module data collection forms and instructions.

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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.
• 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.
• Hemovigilance Module: Adverse Reaction Case Definition Exercises
  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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