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.