Decree No. 6 / 2014 Coll.
Decree amending Decree No. 111 / 2013 Coll., laying down requirements for the establishment of working procedures for ensuring the quality and safety of human organs intended for transplantation
Valid
Effective from 10.04.2014
6
DECLARATION
of 9 January 2014
amending Decree No 111 / 2013 Coll., laying down requirements for the establishment of working procedures for ensuring the quality and safety of human organs intended for transplantation
According to Article 25 (4) of Act No. 285 / 2002 Coll., on Donation, Collection and Transplantation of Tissue and Organ and on the Amendment of Certain Laws (Transplant Act), as amended by Act No. 44 / 2013 Coll.:
Decree No 111 / 2013 Coll., laying down requirements for the establishment of working procedures for ensuring the quality and safety of human organs intended for transplantation, is amended as follows:
1. At the end of footnote 1, the sentence "Commission Implementing Directive 2012 / 25 / EU of 9 October 2012 laying down information procedures for the exchange of human organs for transplantation between Member States' is added.
2. in Paragraph 3 (2) (a) (3):
"3. the identification of the organ within the anatomical description, the anatomical name of the organ, or its position in the body to the left or to the right, and an indication of whether it is the whole organ or part of the organ, specifying the lobe or segment of the organ, ';
3. In Article 3 (2), the following point 5 is added at the end of point (a):
"5. identification of the transplant centre in which the transplantation was carried out, within the scope of the name, address and contact telephone number and date of the transplantation; and ';
4. In Article 3, the following paragraph 3 is added:
"(3) In order to ensure traceability in the case of organ exchanges between Member States, working procedures for the transmission of information referred to in paragraphs 1 and 2 shall be established. The coordination centre of transplantation shall, when transmitting this information to the competent authority or delegated body of the Member State with which it is exchanged, also provide information on the unique donation identification number or the unique recipient identification number which means the number generated when registering the recipient at the Coordination Centre of Transplants. Information on its end-use shall also be transmitted if the organ has not been used for transplantation. For the purposes of organ replacement between Member States, the donor's birth number shall not be entered. ';
5. Paragraph 4 (3) reads as follows:
"(3) When establishing working procedures, where an exchange of organs between Member States has taken place,
(a) where serious adverse reactions or serious adverse reactions are detected, paragraph 2 shall apply mutatis mutandis; or
(b) in the event of the detection of serious adverse reactions or serious adverse reactions for the purpose of transmitting information to the competent authority or delegated body of the Member State with which the exchange took place, the Coordination Centre shall ensure that:
1. the report on these effects or reactions contained data in the scope of Part A and Part C (I) of the Annex to this Decree; and
2. the final report on these events or reactions included data in the scope of Part C (II) of the Annex thereto. ';
6. The following Section 4a is inserted after Section 4:
Common working procedures to ensure traceability and reporting of serious adverse reactions and serious adverse reactions in the event of organ replacement between Member States
Common working procedures to ensure traceability and reporting of serious adverse reactions and serious adverse reactions must be established in such a way that, in the event of an exchange of organs between Member States,
(a) the information has been transmitted:
1. without delay;
2. in writing in electronic form or by fax; and
3. In urgent cases, by oral procedure, the latter being subsequently transmitted in writing;
(b) information
1. have been written in a language which is understood both by the consignor and the addressee, unless such language is such, in a language mutually agreed or, failing that, in an English language,
2. are recorded and may be provided upon request; and
3. accepted by the addressee have been confirmed by their consignor,
(c) the information contained:
1. date and time of transmission,
2. contact details of the person responsible for the transfer; and
3rd warning: "Includes personal data. It shall be protected against unauthorised communication or access. '; and
(d) The coordination centre of transplants has been able to address emergency situations continuously and to receive and transmit the necessary information without delay. ';
7. In Annex A, point 3:
'3. Date and time of notification (year / month / day / hour / minute) '.
8. In Annex A, point 8:
"8. Date and time of serious adverse reaction or effect (year / month / day / hour / minute)."
9. The following part C is added at the end of the Annex:
I. When exchanging organs between Member States, the report on serious adverse reactions or serious adverse reactions and the report of measures to address them shall include the following information:
1. the reporting Member State,
2. message identification number: country (ISO) and national message identification number granted by the Coordination Centre of Transplants,
3. contact details of the Coordination Centre of Transplants: telephone number, e-mail and fax, if applicable;
4. the transplant centre reporting, his phone number, e-mail or fax,
5. the Member State in which the authority was withdrawn;
6. unique donation identification number,
7. All Member States to which the authorities have been sent, if any,
8. the unique identification number of the beneficiary;
9. Date and time of onset of a serious adverse event or serious adverse reaction (year / month / day / hour / minute); and
10. immediate measures taken or proposed.
The report shall be transmitted without delay to the competent authority or delegated body of the Member State with which the exchange was made; if further relevant information has been found after the transmission of the report, that information shall also be transmitted without delay.
II. When exchanging organs between Member States, the final report on serious adverse reactions or serious adverse reactions shall include the following information:
1. the reporting Member State,
2. message identification number: country (ISO) and national message identification number granted by the Coordination Centre of Transplants,
3. contact details of the Coordination Centre of Transplants: telephone number, e-mail or fax, if applicable,
4. date and time of reporting,
5. identification number of the first message,
6. description of the case,
7. the Member States concerned,
8. The result of the investigation and the definitive conclusion,
9. Precautionary and corrective measures taken; and
10. Conclusion including follow-up measures, if required.
The final report shall be transmitted to the competent authority or delegated body of the Member State with which the exchange took place following the collection of the relevant information from all Member States concerned, as a general rule within 3 months of the first notification of a serious adverse event or serious adverse reaction to all competent authorities of the Member States concerned. ';
Efficacy
This Decision shall enter into force on 10 April 2014.
Minister:
MUDr. Holcat, MBA, Rev.
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Regulation Information
| Citation | Decree No. 6 / 2014 Coll., amending Decree No. 111 / 2013 Coll., laying down requirements for the establishment of working procedures for ensuring the quality and safety of human organs intended for transplantation |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 17.01.2014 |
|---|---|
| Effective from | 10.04.2014 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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