Haemovigilance

Definition and objectives

Haemovigilance can be understood as a monitoring system that covers the entire transfusion chain from donor through processing and transport to administration of blood and blood products to the patient. The aim of a haemovigilance system is to minimise the risks and hazards associated with blood donation and transfusion of blood and blood products.

Official Announcement

Here you will find the latest official news.

Further current publications and general information on communicable diseases can be found under the following links:

European Monitoring Authority ECDC

Federal Ministry of Labour, Social Affairs, Health and Consumer Protection

Austrian mosquito monitoring of the AGES

Notification of a suspected adverse reaction

Serious adverse reaction' means an unintended reaction in the donor or in the recipient associated with the collection, testing or transfusion of blood or blood components that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity.

The following forms and information shall be used for reporting suspected serious adverse reactions:

The following documents serve as an aid for the classification of reactions in the context of transfusion or donation:

Notification of a suspected adverse event

A "serious adverse event" is any untoward occurrence related to the collection, testing, processing, storage or distribution of blood or blood components that could affect the quality or safety of blood or blood components and is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity.

The following form is used for reporting an adverse event:

Notification of a Near Miss Event

A Near Miss Event is an error or a deviation from regulations or procedures.

The following form is used for reporting a Near Miss Event:

Notification of the transfusion of an incorrect blood component

A transfusion of an incorrect blood component is any adverse event in which the recipient is not administered the blood or blood components or parts thereof intended for him or her.

Please note that transfusion of an incorrect blood component without reaction must only be reported once a year in the course of the annual report. If a reaction takes place, the notification of a reaction must be reported to the Federal Office for Safety in Health Care in addition to the annual report.

The following documents shall be used in the notification of a transfusion of an incorrect blood component:

Email

Further inquiry note

haemovigilanzbasg.gvat
Emergency Phone Number (24-Hours):: +43 (0)664 831 28 43
Fax: +43 (0)50 555-36408

Annual report

In accordance to the national Regulation of Haemovigilance, the reporting establishments must submit a complete report of the previous year of all serious adverse reactions, events and the transfusion of incorrect blood components to the Federal Office for Safety in Health Care. Deadline is the 30th April of the following year.

The annual report is divided into the following sub-areas:

Notify Library

The "Notify Library" is a database containing worldwide vigilance cases of blood, tissue and cells. Case studies can thus be viewed and serve as tools for research, training and further education. This library aims to support  investigations by providing a historical overview of documented cases of adverse reactions and events with a structured analysis by international experts.

What has to be reported?

Reactions:

When indicating the serious adverse reaction of the recipient, a distinction shall be made between the following types:

  • immunological haemolysis due to AB0 incompatibility,
  • immunological haemolysis due to other isoantibodies,
  • non-immunological haemolysis,
  • delayed haemolytic transfusion reaction,
  • transfusion-borne bacterial infection,
  • Anaphylaxis/hypersensitivity,
  • transfusion-associated acute lung disease (TRALI),
  • transfusion-transmitted viral infection (HBV),
  • transfusion-transmitted viral infection (HCV),
  • transfusion-transmitted viral infection (HIV-1/2),
  • transfusion-transmitted viral infection (specify),
  • transfusion-transmitted parasitical infection (Malaria),
  • transfusion-transmitted parasitical infection (specify),
  • Post-transfusion purpura (PTP),
  • transfusion-associated graft-versus-host disease (GvHD),
  • febrile non-haemolytic transfusion reaction,
  • other allergic reactions,
  • other serious adverse reactions.

When indicating the serious adverse reaction in the donor, a distinction shall be made between the following species:

  • Nerve and vascular injuries,
  • pathological reactions,
  • cardio-vascular events,
  • other complications associated with apheresis,
  • Death within seven days of donation,
  • other serious adverse reactions,
  • serious adverse reactions associated with apheresis requiring emergency medical attention,
  • serious adverse reactions associated with apheresis requiring hospitalisation.

Who is required to report a reaction?

are notifiable:

  1. the medical director of a hospital blood bank, where such a bank does not exist, the medical director of a hospital,

  2. established physicians, including group practices, and

  3. the medical director of a blood establishment.

Who has to report an event?

are notifiable:

  1. the responsible person in an establishment processing, storing or distributing human blood or blood components intended for transfusion,
  2. the medical director of a blood establishment,
  3. the medical director of a hospital blood bank where such a bank does not exist, the medical director of a hospital, and
  4. established physicians including group practices

What is the reporting process of a transfusion reaction like?

Once the reaction has taken place, the treating physician must report the reaction to the blood depot or the medical director. The latter shall, where appropriate, report the incident to the competent blood establishment (or manufacturer) and to the Austrian Haemovigilance Register.

Where can I find the hospital and company identification number?

The list of hospital and company identification numbers can be found under the following link (.pdf).

When and how do I have to report a transfusion of an incorrect blood component?

Incorrect transfusions without the patient's reaction must be reported collectively once a year in the annual report (.pdf) of the hospital.

What is the reporting procedure for an event?

An event that has occurred is forwarded directly to the haemovigilance department. Incidents that could be identified and corrected by a CAPA system (Corrective and Preventive Action System) are not reportable.

What happens if the classification of the transfusion reaction given first changes over time?

Often reactions are reported which are ultimately classified differently. This can happen because the symptoms of some patients are not always clear at the time of the reaction. The notification shall be reclassified and closed after receipt of the final results.

Reports

Haemovigilance report

The cases reported in Austria are published in an annual summary report.

Reporting to the European Commission

Member States are required to submit an annual summary report to the European Commission. In order to harmonise the data, all member states use the Common Approach, which is prepared by the European Commission in cooperation with the member states.

The European Commission publishes its publications on its website. This includes the annual summary report of all haemovigilance data of the Member States.

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