Organvigilanzverordnung - Ovvo

Original Language Title: Organvigilanzverordnung – OVVO

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141. Ordinance of the Federal Minister of Health on the Health and Safety of the Environment (Ordinance on the vigilance of the organisation of the vigilance

On the basis of § § 14 (4) and 17 (2) of the Organ Transplantation Act, BGBl. I No 108/2012, shall be arranged:

Subject matter

§ 1. This Regulation shall apply to the transmission of information on the characterisation of donors and organs, the transmission of the information necessary for ensuring the traceability of the institutions and the transmission of information to the institutions. Notification of serious adverse events and serious adverse reactions.

Definitions

§ 2. (1) The definitions of § 3 of the Organic Transplant Act (OTPG), BGBl. I n ° 108/2012, as amended, shall apply to this Regulation.

(2) In addition, for the purposes of this Regulation, the following definitions shall apply:

1.

"authorised body" means a body which, in accordance with Article 17 (1) of Directive 2010 /53/EU, on quality and safety standards for human organs intended for transplantation, OJ L 327, 28.5.2010, p. No. 14., as amended by the corrigendum OJ L 207, 6.8.2010, p. No. 68, tasks have been delegated or a European organisation for the exchange of organs has been entrusted with tasks in accordance with Article 21 of Directive 2010 /53/EU;

2.

"national donor/recipient identification number" means the identification code assigned to a donor or recipient in accordance with an identification system established at national level in accordance with Article 10 (2) of Directive 2010 /53/EU;

3.

"specification of the institution" means the anatomical description of an organ, including its type (e.g. the heart, liver), if necessary its position (left or right) in the body, and whether it is a complete organ or part of an organ, with indication of the lobe or segment of the institution.

Authorized Office

§ 3. The authorized body of the Republic of Austria within the meaning of this Regulation shall be the Foundation Eurotransplant International.

Information on the characterization of donor organs and organs

§ 4. (1) The respective sampling unit is obliged to provide the Eurotransplant International Foundation with the information collected for the characterization of the donor/donor and the institutions provided in accordance with the Annexes A and B OTPG shall be transmitted immediately.

(2) In the event that some of the information to be transmitted in accordance with paragraph 1 is not available at the time of the first transmission but becomes available only later, the sampling unit shall transmit this information in sufficient time to ensure that medical Decisions can be made.

Information on ensuring the traceability of organs

§ 5. (1) The respective sampling unit shall be obliged to ensure the traceability of organs, the Foundation Eurotransplant International

1.

the specification of the institution,

2.

the national donor identification number,

3.

the date of removal; and

4.

the name and contact details of the sampling unit

shall be transmitted.

(2) The respective transplant centre shall be obliged to ensure the traceability of organs, the Foundation Eurotransplant International

1.

the national receptionist identification number or, if the organ has not been transplanted, information on the final use of the institution,

2.

where appropriate, the date of the transplant

3.

the name and contact details of the transplant centre

shall be transmitted.

Reporting of serious adverse events and serious adverse reactions

§ 6. (1) The respective removal unit and/or the respective transplant centre shall be obliged to immediately release the Eurotransplant International Foundation from a serious incident or serious adverse reaction. shall inform the donor/donor whose bodies have been withdrawn domestiy and the Eurotransplant International Foundation shall submit a first report containing the information referred to in Annex I shall be transmitted.

(2) The respective transplant centre shall be obliged to immediately inform the Eurotransplant International Foundation of a serious incident or serious adverse reaction with a donor/donor in the The Commission shall inform the Eurotransplant International Foundation of a first report containing the information referred to in Article 1 (2) of the European Parliament's Annex I , provided that they are available.

(3) If further information is disclosed in the cases referred to in paragraphs 1 and 2 above, these shall be forwarded without delay to the Foundation Eurotransplant International.

(4) The respective removal unit and/or the respective transplant centre shall be obliged to submit a final report to the Eurotransplant International Foundation within three months of the submission of the first report, containing the information referred to in Annex II shall be transmitted.

§ 7. (1) Pick-up units and transplant centres are required in accordance with Article 14 (1) of the OTPG, serious incidents which affect the quality and safety of organs and on the provision, characterisation, preservation or the the transport of the organs can be attributed and serious adverse reactions observed during or after transplantation and attributed to the provision, characterization, preservation or transport of the organs , within three working days of the health of Austria GmbH, report.

(2) The measures taken in the event of a serious incident or a serious adverse reaction shall be reported in accordance with Section 14 (2) of the OTPG (OTPG) within three working days of health Austria GmbH.

Form of transmission

§ 8. (1) The transmission of information pursuant to this Regulation shall comply with the following requirements:

1.

in writing, either in electronic form or by fax,

2.

in a language that is known to the sender and the recipient or, in the absence thereof, in an agreed language, no language has been agreed, in English,

3.

without delay,

4.

to include the date and time of transmission,

5.

to contain the contact details of the person responsible for the transmission, and

6.

the following note:

" Contains personal data. Protect against unauthorised disclosure and access by unauthorised persons. ".

(2) An oral exchange of information pursuant to this Regulation shall be permitted in case of emergency, with the following of a written transmission which complies with the requirements of paragraph 1.

(3) The information referred to in paragraph 1 shall be documented in such a way that it can be made available on request.

Implementation Notice

§ 9. This Regulation provides for the implementation directive 2012/25/EU laying down information procedures for the exchange of organs intended for transplantation between Member States, OJ L 327, 22.12.2000, p. No. OJ L 275, 10.10.2012 p. 27.

Stöger

Annex I

First report on suspected cases of serious adverse reactions or serious adverse reactions

1.

Rapporteur Member State

2.

Report number: Country (ISO) /national number

3.

Contact details of the rapporteur (competent authority or authorized body in the rapporteur Member State): telephone number, e-mail address and, where appropriate, fax number

4.

Rapporteur/Rapporteur/Rapporteur: Unit/Transplantation Centre

5.

Contact details of the coordinating body/contact person (transplant centre in the rapporteur Member State): telephone number, e-mail address and, where appropriate, fax number

6.

Date and time of report (YYYY/MM/DD hh/mm)

7.

Country of origin

8.

National donor identification number according to § 5 (1) Z 2

9.

all Member States of destination (if known)

10.

national receptionist identification number (s) pursuant to § 5 (2) (1) (1)

11.

The date and time of the occurrence of the serious incident or the adverse reaction (YYYY/MM/DD hh/mm)

12.

Date and time of determination of the serious incident or serious adverse reaction (YYYY/MM/DD hh/mm)

13.

Description of the serious adverse reaction or adverse reaction

14.

Actual/proposed emergency measures

Annex II

Final report on serious adverse events or serious adverse reactions

1.

Rapporteur Member State

2.

Report number: Country (ISO) /national number

3.

Contact details of the rapporteur's office: telephone number, e-mail address and, where appropriate, fax number

4.

Date and time of report (YYYY/MM/DD hh/mm)

5.

Number (n) of the first report/reports (Annex I)

6.

Case Description

7.

concerned Member States

8.

Examination results and conclusions

9.

Preventative and corrective measures

10.

Conclusion/follow-up, if necessary