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Frequently Asked Questions About the Hemovigilance Module

Hemovigilance Module Basics

What is the Hemovigilance Module of NHSN?

The Hemovigilance Module in the Biovigilance Component of NHSN is used to collect data about two types of transfusion-related adverse events: incidents (e.g., errors and near misses) and patient adverse reactions. The component is comprised of several data collection forms including the Annual Facility Survey, the Monthly Reporting Plan, Monthly Incident Summary as well as the Monthly Reporting Denominators, Adverse Reaction and Incident forms. The data collected by the Biovigilance component ranges from demographic information about your facility to total number of transfused units and adverse reactions that are used to calculate adverse event rates.

Who can participate in the Hemovigilance Module?

Enrollment in the Hemovigilance Module is open to all types of U.S. healthcare facilities where patients receive transfusions. Facility types include acute care hospitals, long-term acute care hospitals, psychiatric hospitals, rehabilitation hospitals, outpatient dialysis centers, ambulatory surgery centers, and long-term care facilities.

Does participation in the NHSN Hemovigilance Module cost anything?

NHSN is free for U.S. healthcare facilities. Facilities are responsible for the personnel and computer equipment necessary to collect and report data to NHSN. Financial support for the operation and maintenance of NHSN is provided by CDC.

Does a facility have to report to CDC, FDA, and the state regulatory authority if they are participating in NHSN?

The NHSN Hemovigilance Module data reported to CDC will be used for public health purposes only. A facility is not required to report NHSN Hemovigilance Module participation to any agency unless required to by state law. Reporting hemovigilance data to CDC does not replace the mandatory or regulatory reporting requirements of FDA, your state, or any other agency that you may be required to report.

How does a facility benefit from participating in the Hemovigilance Module?

Participants can use the data they enter into NHSN to monitor adverse reactions and incidents that occur in their facilities; these data allow facilities to identify areas needing prevention interventions and to tailor and evaluate prevention strategies. Once sufficient data is reported for CDC to publish aggregate surveillance data, facilities will be able to compare their adverse event rates to aggregate data from facilities of similar size and characteristics.

Who has ownership of the Hemovigilance Module data, and who has access to the Hemovigilance Module data?

Each facility owns the data they enter into the Hemovigilance Module. As a requirement of participation in NHSN, facilities agree to share this data with CDC for public health surveillance purposes. In addition, facilities may choose to share their data with entities that have formed Groups in NHSN. CDC will not share facility Hemovigilance Module data with any outside entity.

How does a facility ask questions about the Hemovigilance Module of NHSN?

The NHSN User Support team may be reached by email. Emails sent to this address are monitored regularly during business hours Monday-Friday, and facilities should expect a response within one or two business days.

Hemovigilance Module Enrollment and Trainings

How does a facility get started in the Hemovigilance Module?

Before beginning the NHSN enrollment process, the facility must determine whether or not they are already enrolled in NHSN for another reporting purpose. If the facility is enrolled, the NHSN Facility Administrator will activate the Biovigilance Component and add users for the Biovigilance Component. If the facility is not enrolled, they will need to begin the NHSN enrollment process. Each potential user should start by completing the required training for the Hemovigilance Module.

How does a facility determine whether or not they are already enrolled in NHSN?

The interested user should contact the infection prevention team or hospital epidemiologist at their facility. More than 4,000 facilities are currently enrolled in NHSN to report central line-associated bloodstream infections (CLABSIs) in the Patient Safety Component of NHSN. Because participation in NHSN is confidential, CDC is unable to publish a list of enrolled facilities. If you are unable to determine whether or not your facility is enrolled in NHSN, contact the NHSN User Support team at CDC.

What training is required for participation in the Hemovigilance Module?

Each facility user is required to review the Biovigilance Component Protocol [PDF – 332 KB], the six data collection forms and their accompanying instructions, and training slides for the Hemovigilance Module.

Hemovigilance Reporting Guidelines

What are the reporting requirements for the Hemovigilance Module in NHSN?

Participating facilities must report all transfusion denominators, incidents associated with transfusion reactions, and all adverse reactions as defined in the Biovigilance Component Protocol. All facilities must report their data using the same case definitions and reporting requirements in order for CDC to make valid adverse event estimations from the data that facilities report.

If a facility is only interested in adverse reactions, do they have to report incidents?

Yes, facilities must report both adverse reaction and incident data as a requirement of participation.

What if a facility’s adverse reaction definitions aren’t exactly the same as those defined in the Hemovigilance Module of NHSN?

The case definitions in the Hemovigilance Module are surveillance definitions only and are not intended to be used for clinical care decisions. In order to make valid comparisons of adverse reaction rates, all participants must report their data in the same manner. All facility personnel involved in reporting to the Hemovigilance Module should complete the Hemovigilance Module surveillance trainings to ensure consistent and accurate data reporting.

What if a facility misses a month of data reporting?

If a facility misses a month of data entry, they may still enter data at a later date. Facilities can enter data as far back as January of the year that they enrolled. If a facility misses a month of data collection and are unable to complete the data reporting, that facility’s data may be excluded from aggregate analysis.

Can a facility transfer transfusion adverse event data that they enter into their transfusion software to the NHSN Hemovigilance Module?

CDC is developing a data transfer capability that will enable facilities to transfer data from compatible software systems using data formats called Clinical Document Architecture (CDA). This will be specifically available for facilities reporting the total quantity of transfused units. CDA capability for the Hemovigilance Module is expected to be available in 2017.

Hemovigilance Definitions

How should the location of an adverse event be determined, and what is a CDC location?

The location for the adverse event is the patient care area to which a patient is assigned while receiving care in the healthcare facility. A CDC location is a CDC-defined designation given to a patient care area housing patients who have similar disease conditions or who are receiving care for similar medical or surgical specialties. Each facility location that is monitored is “mapped” to one CDC Location. The specific CDC Location code is determined by the type of patients cared for in that area according to the 80% Rule. That is, if 80% of patients are of a certain type (e.g., pediatric patients with orthopedic problems) then that area is designated as that type of location (in this case, an Inpatient Pediatric Orthopedic Ward). The admission/transfer diagnosis should be used when determining the appropriate location mapping. The admission diagnosis is considered the most accurate depiction of the patient’s illness and reason for being admitted to a particular unit. (See also virtual location in the Locations and Descriptions chapter.)

For detailed instructions on how to map locations, see “Instructions for Mapping Patient Care Locations in NHSN” in the Locations and Descriptions chapter.