Tissue vigilance

Definition and objectives

Tissue vigilance can be understood as a monitoring system that covers the entire transplant chain from donation, processing and transport to transplantation of human cells and tissues to the patient.

The aim of a tissue vigilance system is to minimise risks and hazards associated with the use, production, processing, storage or distribution of human cells or tissues.

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 gnat monitoring programme by AGES

Notification per eService (only available in German)

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

ThemaLinks
Guidance notes Online ServicesGuidance note eService Hameo- and Tissue Vigilance (Available in German only)
Guidance note eService Haemo- and Tissue Vigilance annual reports (Available in German only)
Other Guidance notes
Registrationcustomer registration
For the "Letter of Authorization" (LOA) you can use our template (only available in German).
FAQ eServices registration
Submission / AccessLogin
Instructions for use Online ServicesInstruction for use

 

Notification of a suspected reaction

„Serious adverse reaction" means an unintended response, including a communicable disease, in the donor or recipient associated with the procurement or human application of cells and tissues that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation, or morbidity.

The notification of a suspected reaction takes place in the eService by selecting the following notification type:

  • Notification of a reaction (Tissue Vigilance)

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

Notification of a suspected event

A "serious adverse event" means any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients, or which might result in, or prolong, hospitalisation, or morbidity.

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

  • Notification of an event (Tissue Vigilance)

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

Email

Further inquiry note

gewebevigilanz@basg.gv.at
Allgemein Fax:: +43 (0)50 555-36408
Notfalltelefonnummer (24-Stunden):: +43 (0)664 831 28 43

Annual reports

From 01.01.2022, every tissue bank or procurement center is obliged (according to § 4 as well as § 6 Tissue Vigilance Regulation) to submit a complete report of the previous calendar year to the Federal Office for Safety in Health Care (BASG) about all suspected serious adverse reactions and serious adverse events from their area via the eService "Haemo- and Tissue Vigilance".

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

TThe annual 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.)

Annual report on activities of tissue establishments

From 01.01.2022, tissue banks are obliged (according to § 16 (6) Tissue Safety Act) to submit an annual report on activities of tissue establishments of the previous calendar year to the Federal Office for Safety in Health Care via the eService "Haemo- and Tissue Vigilance".

To assist with the specifications for the quantity of tissues and cells, please use our information sheet (only available in German).

Please note that the submission deadline for the annual report on activities of tissue establishments 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

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

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.

Eustite Vigilance Tools

The Eustite Vigilance Tool can be used for the classification of vigilance cases of  tissue. This tool makes it easier to determine the severity of the reaction and the probability associated with the tissue and cells product. It can also be used to classify adverse events.

What has to be reported?

The „Eustite Vigilance Tool“can be used to assist in the classification of reactions and events.

What is the reporting process of a reaction at the donor?

All suspected serious adverse reactions occurring in the donor must be reported immediately to the tissue establishment. The tissue establishment then issues a vigilance report to the Federal Office for Safety in Health Care (BASG).

In the case of direct use, it is the respective institution that shall submit the notification to the Federal Office for Safety in Health Care (BASG).

What is the reporting process of a reaction by the recipient?

Users shall immediately report any suspected serious adverse reactions to the tissue establishment. The tissue establishment then issues a vigilance report to the tissue vigilance of the BASG.

In the case of direct use, it is the respective institution that is to send the notification to the BASG.

What is the reporting procedure for an event?

Each establishment shall immediately report all suspected serious adverse events to the tissue establishment. The tissue bank or, in the case of direct use, each establishment shall then submit a vigilance report to the Federal Office for Safety in Health Care (BASG).

When must the annual report on reactions and events be submitted at the latest?

Annual reports must be sent to the Federal Office for Safety in Health Care (BASG) by 30 April at the latest for the previous calendar year.

When must the activity report be submitted at the latest?

Annual reports must be sent to the Federal Office for Safety in Health Care (BASG) by 30 April at the latest for the previous calendar year.

Reports

Summarizing report on activities of the Austrian tissue establishments

A summarizing report on activities of the Austrian tissue establishments may be consulted publicly.

Further reports

A report on the reports of serious events and serious adverse reactions shall be submitted to the relevant Federal Ministry.

Furthermore, the transplant advisory board (GÖG) to submit a report on the activities of tissue establishments.

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 tissue vigilance data of the Member States.

Email

Further inquiry note