Advanced Search

Change Search. To Ensure The Quality Of Human Organs For Transplantation

Original Language Title: změna vyhl. o zajištění jakosti lidských orgánů pro transplantace

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.
6/2014 Sb.



DECREE



of 9 June. January 2014,



amending Decree No 111/2013 Coll., laying down the requirements for the

create workflows to ensure a quality system and

safety of human organs intended for transplantation



The Ministry of health shall lay down pursuant to § 25 para. 4 of law No.

285/2002 Coll., on the donation, subscriptions and transplantation of tissues and organs, and the

amendments to certain acts (the Transplant Act), as amended by Act No.

44/Coll.:



Article. (I)



Decree No 111/2013 Coll., laying down the requirements for the establishment of working

the procedures for ensuring the quality and safety of human organs

for transplantation, is amended as follows:



1. At the end of footnote 1, the following sentence "the implementing

Commission directive 2012/25/EU of 9 June. October 2012, laying down the

information procedures for the exchange of human organs intended for transplantation

between the Member States. ".



2. In article 3, paragraph 3. 2 (a). and) point 3 is added:



"3. the identification of the authority in the scope of the anatomical description of the anatomical name for the

authority, or its location in the body of the left or right, and an indication of whether it is

about the whole body or part of the body with lobe or segment

the authority ".



3. In article 3, paragraph 3. 2 at the end of subparagraph (a)) the following point 5 is added:



"5. the identification of transplant centers, in which it was carried out

transplantation, in the scope of the name, address and a contact telephone number and

the date of transplantation and ".



4. in article 3, the following paragraph 3 is added:



"(3) to ensure traceability in the case of the exchange of organs between

the Member States must be created working procedures for the transmission

the information referred to in paragraphs 1 and 2. When you transplant coordination centre

transmission of such information to the competent authority or authorized body

the Member State to which the authority of the Exchange, provide information about the

the unique identification number of a donation or a unique identification

number of the recipient, which means the number generated when you register

the recipient in the Coordinating Center of transplantation. If the authority was not used

for transplantation, shall supply the information on its final use.

For the purposes of the exchange of organs between Member States, the social security number giver

not to be ".



5. In section 4, paragraph 3 is added:



"(3) when you create the workflow, if the Exchange was carried out

organs between Member States,



and findings) in case of serious adverse reactions or serious

adverse reactions, paragraph 2 shall apply mutatis mutandis, or



(b)) in the event of serious adverse reactions or serious

adverse reactions for the purposes of the transmission of information Coordination

the Centre of transplantation to the competent authority or authorized body

the Member State with which it was carried out, the replacement shall ensure such

procedures to ensure that



1. reporting on these events or reactions include data in the range

under part A and part C, point 1 of the annex to this Decree and



2. the final reports on these events or reactions include details

to the extent referred to in part C, point II of the annex to this Ordinance. ".



6. in paragraph 4, the following new paragraph 4a, which including the title:



"§ 4a



Joint working procedures to ensure traceability and reporting of

serious adverse events and serious adverse reactions in

the case of the exchange of organs between Member States



Joint working procedures to ensure traceability and reporting of

serious adverse events and serious adverse reactions shall

be created so that, in the case of the exchange of organs between Member States



the information was passed)



1. without delay,



2. in writing, electronically or by fax, and



3. in urgent cases the oral form that subsequently will be passed

in written form,



(b))



1. they were written in a language comprehensible to the sender and addressee,

If there is no such language in the language mutually agreed or, unless

in the English language,



2. have been recorded and can be made available upon request and



3. received by the addressee to the sender were committed,



(c) the information contained)



1. date and time of transmission,



2. the contact details of the person responsible for the transfer and



3. warning: "contains personal data. Must be protected against

unauthorized disclosure, or access. "



d) transplant coordination centre was able to continuously address the

emergency and immediately receive and transmit the necessary

information. ".



7. In the annex, part A, point 3 is added:



"3. notification of the date and time (year/month/day/hour/minute)".



8. In the annex, part A, point 8 is added:



"8. The date and time of serious adverse reaction or effect

(year/month/day/hour/minute) ".



9. At the end of the annex shall be added to part (C), to read as follows:



"(C)



I. in the exchange of organs between Member States contains reports on the serious

adverse reactions or serious adverse reactions and reporting

the measures for their solution in addition to requirements referred to in part A of this

information:



1. Member State reporting,



2. the identification number for the message: the country (ISO) and national identification

report number granted by the transplant coordination centre,



3. contact details: phone transplant coordination centre

number, e-mail and, where applicable, fax,



4. the transplant center reporting, its telephone number,

e-mail or fax,



5. the Member State in which the body is removed,



6. the unique identification number of the donation,



7. all Member States, which have been sent to the authorities, if known,



8. unique identification number of the recipient,



9. date and time of the onset of a serious adverse reaction or serious

adverse reaction (year/month/day/hour/minute) and



10. immediate measures which have been adopted or proposed.



Reporting to the competent authority or to the designated body of the Member State,

with which it was carried out, Exchange passes without delay; If you were after

transmission of the report identified other related information, these

information passed to also immediately.



II. In the exchange of organs between Member States includes the final reports on the

serious adverse reactions or serious adverse reactions such

information:



1. Member State reporting,



2. the identification number for the message: the country (ISO) and national identification

report number granted by the transplant coordination centre,



3. contact details: phone transplant coordination centre

number, e-mail, or fax,



4. the date and time of the message,



5. identification number of the first message,



6. Description of the case,



7. the Member States concerned,



8. the outcome of the investigation and the final conclusion,



9. preventive and remedial measures taken and



10. conclusion, including follow-up measures are required.



Final report to the competent authority or authorized body

the Member State with which it was carried out, passes replacement after gathering

relevant information from all the Member States concerned usually within 3

months after the first reports of serious adverse reaction or serious

adverse reactions to the competent authorities of the concerned Member States. '.



Article. (II)



The effectiveness of the



This Decree shall enter into force on 10 July 2004. April 2014.



Minister:



Mudr. Holcat, MBA, in r.