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.

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

• Publications of the ECDC
• Weekly reports on disease outbreaks and threats

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

• Website of the Federal Ministry of Labour, Social Affairs, Health and Consumer Protection

Austrian mosquito monitoring of the AGES

• Overview of the observation of the mosquito flight of the AGES

All haemovigilance notifications must be submitted to the Federal Office for Safety in Health Care (BASG) via the eService "Haemovigilance and Tissue Vigilance".

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 notification of suspected adverse reaction takes place in the eService by selecting one of the following notification types:

• Notification of a transfusion reaction
• Notification of a reaction in the context of a donation/apheresis (haemovigilance)

To the online submission
(The online reporting is only available in German.)

Please note that the form "Reporting a transfusion reaction to the hospital blood bank" was not a mandatory reporting form to the BASG, but served as an example of an internal hospital template. If you need it for internal forwarding to your hospital blood bank, please feel free to request it at [email protected]. (The form is only available in German)

International Society of Blood Transfusions definitions

ISBT_Transfusion-associated circulatory overload (TACO) Update 2018

International Haemovigilance Network (IHN) standards for surveillance of complications of blood donation

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 notification of a suspected adverse event takes place in the eService by selecting the following notification type:

• Reporting of an event (haemovigilance)

To the online submission
(The online reporting is only available in German.)

Near misses, or near miss events, are not subject to mandatory reporting. A near miss is an error or deviation from regulations or procedures that was discovered prior to the start of the transfusion and would have resulted in an incorrect transfusion or transfusion reaction (SHOT 2009).

The notification of a Near-Miss Event takes place in the eService by selecting the following notification type::

• Reporting of a Near-Miss event (Haemovigilance)

To the online submission
(The online reporting is only available in German.)

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.

Notification of an incorrect blood component transfused without reaction

Please note that transfusions of an incorrect blood component without reaction are only to be reported once a year in the course of the annual reporting.

The notification of an incorrect blood component transfused without reaction takes place in the eService by selecting the following notification type:

• Annual Report/Activity Report (Haemovigilance)

To the online submission
(The online reporting is only available in German.)

Notification of an incorrect blood component transfused with reaction

If a reaction occurs due to an erroneous transfusion, the reporting of a transfusion reaction must additionally be made in addition to the annual reporting (annual reporting).

The notification of an incorrect blood component transfused with reaction takes place in the eService by selecting the following notification type:

• Reporting of a transfusion reaction (Haemovigilance)

To the online submission
(The online reporting is only available in German.)

From 01.1.2022, according to § 4 as well as § 6 Hemovigilance Regulation, the reporting parties are obliged to submit a complete report of the previous year on all serious adverse reactions, all transfusion errors as well as all serious adverse events that have affected the quality or safety of blood and blood components via the eService "Hemovigilance and Tissue Vigilance" to the Federal Office for Safety in Health Care (BASG).

Please note that the submission deadline for annual reporting is 30.04. of the following year!

The annual report is submitted in the eService by selecting the following notification type:

• Annual report/activity report (Haemovigilance)

To the online submission
(The online reporting is only available in German.)

From 01.1.2022, blood establishments (according to HäVO as amended) are obliged to submit an annual activity report on the collection and distribution of blood and blood components to hospitals, hospital blood depots and establishments that manufacture, control or market medicinal products to the Federal Office for Safety in Health Care via the eService "Hemo- and Tissue Vigilance".

For assistance in calculating incidence and prevalence, please refer to the "Guideline on epidemiological data on blood transmissible infections".

Please note that the submission deadline for annual reporting is 30.04. of the following year!

The annual activity report is submitted in the eService by selecting the following notification type:

• Annual report/activity report

To the online submission
(The online reporting is only available in German.)

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?

Who is required to report a reaction?

Who has to report an event?

What is the reporting process of a transfusion reaction like?

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

What is the reporting procedure for an event?

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

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.

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.

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

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.

Incorrect transfusions without the patient's reaction must be reported collectively once a year in the annual report of the hospital (form: Annual report of serious adverse reactions part 2 (F_I394)).

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.

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.

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.