141. Regulation of the Federal Minister of health on the Organvigilanz (Organvigilanzverordnung - OVVO)
On which I shall become article 14 para 4 and 17 para 2 of the organ transplant law, BGBl. No. 108/2012, prescribed:
§ 1. This Regulation shall apply to the transmission of information on the characterization of donors/donors and institutions, providing the information necessary to ensure the traceability of organs and the notification of serious adverse events and serious adverse reactions.
2. (1) the definitions of section 3 of the organ transplant law (OTPG), Federal Law Gazette I no. 108/2012, in its up-to-date version, find on this regulation application.
(2) Moreover, a term in the meaning of this Regulation: 1. "authorized body" a body, in accordance with article 17 paragraph 1 of the directive 2010/53/EU quality and safety standards for human organs intended for transplantation, OJ No. L 207 of the 06.08.2010 p.14, as amended by the amending OJ No. L 243 of September 16, 2010 p. 68, tasks were transferred or a European Organization for exchanges of organs, in accordance with article 21 of Directive 2010/53/EU tasks have been transferred
2. "National donor / recipient identification number" the identification code that para 2 of Directive 2010/53/EU; maps to a donor or recipient in accordance with an identification system established at national level referred to in article 10
3. "Specification of the organ" the anatomical description of an institution, including its type (E.g., heart, liver), if necessary, its position (left or right) in the body and whether it is a full body or a part of an organ, with indication of the lobe or segment of the body.
§ 3. The authorized body of the Republic of Austria within the meaning of this regulation is the Eurotransplant International Foundation.
Information on the characterisation of donors/donors and organs
4. (1) the corresponding sampling unit undertakes the Eurotransplant International Foundation the information collected for the characterization of the donor/donor and the provided organs in accordance with the annexes A and B OTPG immediately to submit.
(2) if some of the information to be submitted pursuant to paragraph 1 are not available at the time of the first delivery, but will be available only later, the sampling unit has this information in sufficient time to provide that medical decisions can be made.
Information to ensure of the traceability of organs
5. (1) the corresponding sampling unit is obligated to ensure of the traceability of organs, the Foundation Eurotransplant international 1 the specification of the organ, 2. the national donor identification number, 3. the date the withdrawal and 4. the name and the contact details of the sampling unit to transmit.
(2) the corresponding transplantation Centre is obliged to ensure of the traceability of organs, the Foundation Eurotransplant international 1 national recipient identification number or, if the organ was not transplanted, details of the final use of the institution, 2. If necessary, the date transplantation and 3. the name and the contact details of the transplant centre to transmit.
Notification of serious adverse events and serious adverse reactions
6. (1) the corresponding sampling unit and/or the corresponding transplantation Centre are obliged to immediately inform the Eurotransplant International Foundation, which relates to one/one egg donor/donor, institutions in the country were taken from a of a serious incident or a serious adverse reaction, and to submit a first report with the information referred to in annex I the Eurotransplant International Foundation.
(2) the corresponding transplantation Centre is obliged, Eurotransplant International Foundation were immediately about a serious incident or a serious adverse reaction that is donor/donor in connection with a a removed organs not domestically, to teach and deliver the Eurotransplant International Foundation first report with the information referred to in annex I if they are available.
(3) further information are known in the cases referred to in paragraphs 1 and 2, these are immediately at the Eurotransplant International Foundation to forward.
(4) the respective sampling unit and/or the corresponding transplantation Centre are required to submit a final report containing the information referred to in annex II the Foundation Eurotransplant international within three months after submission of the first report.
Sampling units and transplant centers are § 7 (1) in accordance with article 14, paragraph 1 OTPG committed to serious incidents, which can impact on the quality and safety of organs and are attributed to the deployment, characterisation, preservation or the transportation of organs and serious adverse reactions that during or after the transplant can be observed and attributed to the deployment, characterisation, preservation or the transportation of organs , to report within three business days of Gesundheit Österreich GmbH.
(2) the measures taken in the event of a serious incident or a serious adverse reaction must be reported OTPG pursuant to § 14 para 2 within three business days of Gesundheit Österreich GmbH.
Form of delivery
8. (1) the transmission of information under this regulation has to comply with the following requirements: 1, either electronically or by fax, 2nd in a language that is familiar to the sender and the recipient or, in the absence thereof, in a language agreed, was no language agreed upon in writing, in English, 3 without delay, the date and the time of delivery to contain 4. , 5. the contact details of the person to contain that is responsible for the delivery, and to contain 6 following note: "contains personal data. Protect from unauthorized dissemination and access by unauthorised persons. "."
(2) in case of an emergency, a verbal exchange of information under this regulation but has to follow a written submission, which meets the requirements referred to in paragraph 1, is allowed.
(3) the information referred to in paragraph 1 are to document that they can be made available on request.
§ 9. Through this regulation, the implementing directive is 2012/25/EC laying down procedure for the exchange of certain transplant organs between Member States, OJ No. L 275 of the 10th of October 2012 S. 27, implemented.
First report about suspected of serious adverse events or serious adverse reactions 1. reporting fact tender Member State 2. report number: country 3. contact data of the reporting authority (competent authority or authorized body in the rapporteur Member State) (ISO) / national number: phone number, email address and fax number if applicable 4 report shall end/reporting instead of end of sampling unit/transplant centre 5. contact details of coordinating site/contact person (Transplant Center in the rapporteur Member State): phone number, email address, and fax number if applicable 6 7 date and time of the report (yyyy/MM/dd hh/mm) Member State of origin 8 national donor identification number pursuant to § 5 para 1 Z 2
9. all the Member State of destination (if known) 10 national recipient identification number pursuant to § 5 para 2 Z 12 1 11 date and time of occurrence of serious incident or the adverse reaction (yyyy/MM/dd hh/mm) date and time of the finding of serious incident or of serious adverse reaction (yyyy/MM/dd hh/mm) 13 description of the serious incident or the serious adverse reaction 14 actual/proposed emergency measures Appendix II
Final report on serious incidents or serious adverse reactions 1 reporting fact tender Member State 2. report number: country 3. contact data of the reporting Office (ISO) / national number: phone number, email address, and fax number if applicable 4. 5. date and time of the report (yyyy/MM/dd hh/mm) number (s) of the first report / the first report (annex I) 6 case description 7 concerned Member States 8 test results and conclusions 9 preventive and corrective measures 10 conclusions/follow-up , if necessary