190. Regulation of the Federal Minister for Health, Family and Youth concerning tissue vigilance (tissue vigilance regulation-GVVO)

On the basis of § § 30 Z 10 and Z 12 and 32 (3) of the tissue safety law, BGBl. I n ° 49/2008, shall be ordered:

Scope

§ 1. This Regulation shall apply to the reporting of serious adverse reactions in the production of human cells or tissues, to the reporting of serious adverse reactions in the use of these products and to the notification of such adverse reactions. serious adverse events related to the collection, processing, storage or distribution of human cells or tissues for human use.

Definitions

§ 2. (1) "Serious adverse reaction" means an unintended reaction, including a communicable disease, in the donor or recipient in connection with the production or use of cells and tissues which are fatal or is life-threatening, has a disability or a loss of ability, or requires or extends a hospital stay, or is leading to a disease or prolongs it.

(2) 'serious incident' means any undesirable event relating to the collection, testing, processing, storage and distribution of tissues and cells which are responsible for the transmission of a contagious disease, death or may result in a life-threatening condition, disability or loss of ability of donors or recipients, may require or extend a hospital stay, or may lead to or prolong a disease.

(3) In the case of measures of medically assisted reproduction, any misidentification or confusion of a germ cell or of an embryo is also considered to be a serious incident.

(4) "establishment" means any organisational unit for the production of human cells or tissues.

(5) 'tissue bank' means any institution in which activities relating to the processing, storage or distribution of human cells and tissues are carried out for human use.

(6) "Responsible person" is a person within the meaning of Section 9 of the Tissue Safety Act (GSG), BGBl. N ° 49/2008.

(7) "Users" means hospitals or medical doctors or dentists who are responsible for the use of human cells or tissues in humans.

Notifications of serious adverse reactions

§ 3. (1) Each institution shall have all suspected serious adverse reactions occurring in the living donor and may affect the quality and safety of the cells and tissues of the tissue bank to which the cells or tissues are to be treated. have been passed on without delay. This report shall contain the nature of the cells or tissues obtained and the nature of the suspected serious adverse reaction.

(2) In the light of the suspected cases referred to in paragraph 1, the establishment of the tissue bank shall immediately submit a notification of the conclusions of the investigation of the serious adverse reaction. This has the clinical outcome (complete recovery, minor sequellations, serious sequellations or death), the result of the examination and the conclusions drawn from it and any recommendations for prevention and control of the disease. Corrective measures to be included.

(3) Users shall have all suspected serious adverse reactions occurring in the recipient during or after use, and which may be related to the quality and safety of the cells and tissues, the tissue bank, where the cells or tissues were obtained, or in the case of direct use of the body from which the cells or tissues were obtained, to report immediately. This report shall contain the nature of the cells or tissues involved in the suspected serious adverse reaction and the nature of the suspected serious adverse reaction.

(4) After the investigation of the suspected cases in accordance with paragraph 3, the user of the tissue bank or the establishment of a report on the conclusions of the investigation of the serious adverse reaction. This has the clinical outcome (complete recovery, minor sequellations, serious sequellations or death), the result of the examination and the conclusions drawn from it and any recommendations for prevention and control of the disease. Corrective measures to be included.

(5) Each tissue bank or In case of direct use of any institution, the Federal Office for Safety in Health Care shall immediately notify all suspected serious adverse reactions pursuant to paragraph 1 and (3). These reports have the nature of the cells or tissues obtained, or to contain the nature of the cells or tissues involved in the suspected serious adverse reaction and the nature of the suspected serious adverse reaction. Where appropriate, it should also be reported which measures have been taken with regard to other affected cells or tissues which are distributed for human use.

(6) After the investigation of suspected cases, the tissue bank or in the case of direct use, the establishment of the Federal Office for Safety in the Public Health department immediately to submit a report on the conclusions of the investigation of the serious adverse reaction. This has the clinical outcome (complete recovery, minor sequellations, serious sequellations or death), the result of the examination and the conclusions drawn from it, and any preventive and corrective measures to be taken and corrective measures taken. .

Annual reports of serious adverse reactions

§ 4. (1) Each tissue bank or Each institution shall submit, by 30 April at the latest, a full report of all serious adverse reactions pursuant to § 3 from its area to the Federal Office for Health in the Health Sector for the previous calendar year at the latest.

(2) This has the number of serious adverse reactions per tissue or cell type, the total number of cells and tissues distributed, the number of recipients concerned, and the nature of the serious adverse reaction reported. . An assignment to the following points must be made:

1.		transmitted bacterial infections,
2.		transmitted virus infection,
3.		transmitted parasitic infections,
4.		transmitted malignant diseases,
6.		other transfers of disease and
7.		other serious reaction.

Reports of serious incidents

§ 5. (1) Each institution shall immediately notify all suspected serious incidents in the collection which may affect the quality and safety of the cells and tissues, the tissue bank to which the cells or tissues have been passed. report. The message shall be differentiated to the extent that it is a defect in cells or tissues, an equipment failure, human error or any other serious incident.

(2) In the light of the suspected cases referred to in paragraph 1, the establishment of the tissue bank shall immediately submit a notification of the conclusions of the investigation of the serious incident. This has to include an in-depth analysis of the main cause and details of the corrective measures taken.

(3) Users shall have all suspected serious incidents which may be related to the quality and safety of the cells and tissues, the tissue bank from which the cells or tissues have been obtained, or in the case of direct use of the body from which the cells or tissues were obtained, to report immediately. The message shall be differentiated to the extent that it is a defect in cells or tissues, an equipment failure, human error or any other serious incident.

(4) After the investigation of the suspected cases in accordance with paragraph 3, the user of the tissue bank or inform the institution immediately of the conclusions of the investigation of the serious incident. This has to include an in-depth analysis of the main cause and details of the corrective measures taken.

(5) Each tissue bank or In case of direct use of any institution, the Federal Office for Health Security shall immediately notify all suspected serious incidents in accordance with paragraph 1 and paragraph 3. Each tissue bank shall, furthermore, immediately inform the Federal Office for Safety of all suspected serious incidents during transport, processing, storage or distribution, which may influence the quality and safety of the cells and tissues. in health care. The message shall be differentiated to the extent that it is a defect in cells or tissues, an equipment failure, human error, or any other serious incident. Where appropriate, it should also be reported which measures have been taken with regard to other affected cells or tissues which are distributed for human use.

(6) After the investigation of suspected cases, the tissue bank or in the case of direct use, the establishment of the Federal Office for Health Security shall immediately submit a report on the conclusions of the investigation of the serious incident. It has to contain a detailed analysis of the main cause and details of the corrective measures taken.

Annual reports of serious incidents

§ 6. (1) Each tissue bank or no later than 30 April for the previous calendar year, each institution shall submit to the Federal Office for Health Security a full report on all serious incidents in accordance with § 5 of its area.

(2) This has the number of serious incidents, differentiated by reason (defect in cells or tissues, equipment failure, human error or other serious incident) and the total number of distributed cells and Tissue.

Form of notifications

§ 7. Notifications pursuant to this Regulation shall be made by means of forms which are published on the homepage of the Federal Office for Health Security.

Annual reports to the European Commission

§ 8. (1) The Federal Office for Health Security has sent a report to the European Commission by 30 June of the following year on the reports of serious adverse reactions and incidents.

(2) The Federal Office for Health Security publishes on its homepage the summary of the reports received from the Member States by the European Commission.

References to acts of the European Community

§ 9. This Regulation lays down the Commission's Directive 2006 /86/EC of 24 June 2007. 1 October 2006 on the implementation of Directive 2004 /23/EC of the European Parliament and of the Council as regards requirements for traceability, reporting of serious incidents and adverse reactions, as well as certain technical requirements relating to the coding, processing, preservation, storage and distribution of human tissues and cells, OJ L 327, 30.4.2004, p. No. OJ L 294, 25. October 2006 S 32, implemented.

Kdolsky