111/2013 Coll.
DECREE
Dated 22 April 2013
Establishing requirements for the creation of procedures to ensure
system of quality and safety of human organs intended for transplantation
Change: 6/2014 Coll.
Ministry of Health, pursuant to § 25 par. 4 Act no.
285/2002 Coll., On donation, drafts and transplantation of tissues and organs and
amending certain acts (Transplantation Act), as amended by Act no.
44/2013 Coll .:
§ 1
Subject Matter
This Decree implements the relevant regulations of the European Union ^ 1) and
adjusts in order to protect the health of donors and recipients set of requirements
create a workflow system to ensure the quality and safety
human organs intended for transplantation.
§ 2
Procurement, preservation, packaging, labeling and transportation
(1) Working procedures to ensure quality and safety of organs
(hereinafter "Working Procedures"), for the removal of organs, should be
designed to
A) are suitable for living and deceased donors and organ donation;
Case of a living donor must also ensure these procedures
donor safety and protect their health and privacy
B) that the required biological, or physical properties
organs that are required for their use for transplantation, while
minimize the risk of microbial contamination throughout
process
C) the place of collection was recorded from a deceased donor and the time that has elapsed since
proof of death of the deceased donor to donate and
D) organ harvesting was done in operating rooms that meet the requirements
pursuant to regulations on technical requirements and
material equipment of health facilities ^ 2).
(2) For the collection and preservation must be created such working practices
ensuring the use of sterile, well-maintained and regularly
instruments and medical devices.
(3) packaging and labeling of removed organs must be created such
workflows that
A) ensure the packaging method that minimizes the risk of contamination
,
B) ensure that each pack authorities at the time of collection marked;
on the package body shall number generated during registration in donor transplants
Coordination Centre (hereinafter "the unique identification number
donation"), type of institution, the date, time and place of organ donation, identifying the person
that body wrapped in the name, or
name, surname and signature, and the information on the package body, and
C) ensure that wrapped bodies are transported in a container that
is suitable for the transport of biological materials and which maintains
quality and safety of organs transported.
(4) For transportation removed organs must be created such working
procedures to ensure that
A) will maintain the integrity of the organs during transport and a suitable transport time,
B) the shipping containers used for transporting organs will include
First identification information healthcare providers with which he was
sampling procedures, to the extent the name, address and contact telephone number,
Second identification of the transplantation center, which is the authority designated in
range name, address and contact telephone number,
Third a statement that the package contains an organ, specifying the type of authority and
or its location in the donor's body to the left or right with inscription
"HANDLE WITH CARE" and
Fourth the recommended conditions of transport, including instructions for keeping the container
at an appropriate temperature and position, and
C) the organs transported report will be accompanied on the organ and donor
.
(5) The requirements referred to in Subsection 4. b) need not be met where the transportation is carried
within the same hospital.
§ 3
Traceability
(1) Working procedures for ensuring traceability
must be created so that all organs procured, allocated and transplanted
could be traced from the donor to the recipient and vice versa.
(2) To ensure traceability must be created such working
procedures that ensure the use of the identification of donors and recipients
and within the leadership and recordkeeping
A) allowing at least
First donor identification in the name, or names, year of birth and
number
Second identification of organ donation in the range name, address and contact telephone number
transplant center that conducted sampling, data
type and number of removed organs, unique identification number
donation, the date and time of collection, site collection, the species donation, especially
case of a donation from a living or deceased donor
Third identification of the body in the range of anatomical description, anatomical name
authority, or its location in the body to the left or right, and whether it comes
a whole organ or part of an organ, specifying lobe or segment of organ
Fourth identify the recipient of the name, or names, surname and date of birth and
Fifth identification of the transplantation center, which was carried
transplant, to the extent the name, address and contact telephone number and date of transplantation and
B) recording devices from which records are available and readable
throughout their conservation, including the protection of personal records; if
ensure compliance with this condition, it can store data in electronic form
.
(3) To ensure traceability, in case the exchange of organs between
Member States must set up the working procedures for the transfer
information referred to in paragraphs 1 and 2. Coordination Centre transplants at
transfer this information to the competent authority or authorized
entity of a Member State with which the organ is exchanged, as well as provide information about
unique identification number of the donation or unique identification number
recipient, which means the number generated during registration
recipient in the Coordination Centre transplants. Unless
organ used for transplantation, also transmit information about its end use.
For the purpose of exchange of organs between Member States with the personal identification number of the donor
does.
§ 4
Serious adverse events and serious adverse reactions
(1) Working procedures for the reporting of serious adverse effects
or serious adverse reactions and their solutions must be
created so that a system for reporting, investigation
register and transmit relevant and necessary information
A) serious adverse events which may affect the quality and safety of organs and
which may be caused by the investigation,
characterization, procurement, preservation and transport of organs,
B) any serious adverse reaction observed during
or after transplantation which may affect the quality and safety of organs and
which may be related to the investigation, characterization, procurement, preservation
or transport of organs and
C) provide interconnection system for reporting adverse reactions and events
for tissues and cells pursuant to regulations
requirements for ensuring the quality and safety of human tissues and cells
^ 3).
(2) In case of detection of serious adverse events or serious adverse reactions
must be created such workflows that
ensure
A) any identified serious adverse events or serious adverse reactions were
promptly reported to the Coordination Centre transplants and
appropriate transplant center, and provided for in Part A
Annex hereto,
B) serious adverse events or serious adverse reactions were
assessed and evaluated and have been identified and their causes have been taken
measures to address them and
C) measures to deal with serious adverse events and serious adverse reactions
was immediately reported to the Coordination Centre
transplantation and the appropriate transplant center, and to the extent
under Part B of the Annex hereto.
(3) When you create a workflow if it was carried
exchange of organs between Member States, with
A) for the detection of serious adverse events or serious adverse reactions
paragraph 2 shall apply mutatis mutandis, or
B) in the event of serious adverse events or serious adverse reactions
for the purpose of transmitting information
Coordination Centre transplants competent authority or body responsible
Member State with which the exchange implemented, will ensure such
procedures that
First report on these effects or reactions contained in the data range
Under Part A and Part C, Section I of the Annex hereto and
Second Final reports on these events or reactions contained data in a range
under paragraph II of the Annex hereto.
§ 4a
Joint working practices to ensure traceability and reporting
serious adverse events and serious adverse reactions in case
exchange of organs between Member States
Joint working practices to ensure traceability and reporting
serious adverse events and serious adverse reactions
must be designed so that in case of exchange of organs between Member States
A) the information was transmitted
First without delay,
Second in writing, electronically or by fax
Third in urgent cases, an oral form that will subsequently be forwarded
in writing
B) information
First They were written in a language understood by the sender and the addressee,
unless such language, the language mutually agreed or, unless
out in English,
Second They are recorded and can be provided on request and
Third addressee received were confirmed by the sender,
C) information contained
First date and time of delivery,
Second contact information for the person responsible for the transmission and
Third warning: "contains personal information. They must be protected against
unauthorized disclosure or access. "And
D) Coordination Centre transplants were able to continuously deal
emergency and promptly receive and transmit the necessary information.
§ 5
Efficiency
This Decree shall take effect on 1 October 2013.
Minister
:
Doc. MD. Heger, CSc.
Notes
Serious adverse events and serious adverse reactions
PART
A
Reporting serious adverse event or serious adverse reactions
First Notifying the transplant center (name, address, contact:
phone, e-mail or fax)
Second The identification number of the notice issued by the Coordination Centre transplants
Third Date and time announcement (year / month / day / hour / minute)
Fourth The affected person (indicate whether the recipient or donor)
Fifth Date of collection (year / month / day) and place of removal of organs, if it is a response by the donor
6th Filing date (year / month / day) and site of administration bodies, in the case of a reaction in the recipient
7th Unique identification number of donation
8th Date and time of serious adverse reactions or effects
(year / month / day / hour / minute)
9th Type of organs that are related to the announcement, and country of origin, in the case of foreign authorities
10th Type of serious adverse reactions or effect, and their description
11th Responsible person healthcare providers (name, surname,
title, phone and e-mail)
PART B
Reporting measures for addressing serious adverse event or serious adverse reactions
First Notifying the transplant center (name, address)
Second Identification number notice (consistent with the notification of serious adverse reactions or effects
)
Third Date of confirmation of serious adverse reactions or effects (year / month / day)
Fourth The date when the evaluation of serious adverse reactions or effects
closed (year / month / day)
Fifth Date of serious adverse reactions or effects (year / month / day)
6th Unique identification number of donation
7th Confirmation of serious adverse reactions or effects (yes / no)
8th Changing the type of serious adverse reactions or effects (yes / no, if yes, please
change)
9th Other changes to the data specified in the notification of serious adverse reactions or
effect (if yes, please change)
10th The number of disabled beneficiaries in case of a serious adverse reaction or
effect on the recipient
11th Analysis of the main causes of adverse reactions or effects
12th Preventive and remedial measures including implementation date specified
13th Responsible person healthcare providers (name, surname,
title, phone and e-mail)
PART C
I. Where organs are exchanged between Member States contains
reporting of serious adverse events or serious adverse reactions and reporting
measures for their solution in addition to the requirements mentioned in Part A of this information
:
First Member State reporting,
Second the identification number of the message: the country (ISO) and national identification number of the message
Coordination Centre transplants
Third contact information Coordination Centre transplants:
telephone number, e-mail and possibly fax
Fourth transplant center reporting, his telephone number,
e-mail or fax,
Fifth Member State in which the body is removed,
6th Unique identification number of the donation,
7th All Member States in which the bodies were sent, if known,
8th Unique identification number of the recipient
9th date and time of onset of serious adverse event or serious adverse reaction
(year / month / day / hour / minute) and
10th immediate measures taken or proposed.
Reporting to the competent authority or body responsible Member State
with which the exchange implemented, forward forthwith;
if you were after a handover report revealed other related information are also
information is transmitted immediately.
II. Where organs are exchanged between Member States contains the final report
serious adverse events or serious adverse reactions following information
:
First Member State reporting,
Second the identification number of the message: the country (ISO) and national identification number of the message
Coordination Centre transplants
Third contact information Coordination Centre transplants:
telephone number, e-mail or fax,
Fourth date and time of reporting,
Fifth the identification number of the first report,
6th description of the case,
7th Member States concerned
8th the outcome of the investigation and the final conclusion
9th adopt preventive and corrective measures
10th Finally, including follow-up actions, if required.
Final report to the competent authority or body responsible
Member State with which the exchange was made, passes
after gathering relevant information from all the Member States, usually within 3 months after the first
reporting serious adverse event or
serious adverse reactions to the competent authorities of the Member States.
1) Directive of the European Parliament and Council Directive 2010/53 / EU of 7 July 2010 on
quality and safety of human organs intended for transplantation
.
Implementing Commission Directive 2012/25 / EU of 9 October 2012 laying down
information procedures for exchange of human organs intended for transplantation
between Member States.
2) Decree no. 92/2012 Coll., On requirements for minimum
technical and material equipment of health facilities and contact centers
home care.
3) Decree no. 422/2008 Coll., On down detailed requirements for
ensure the quality and safety of human tissues and cells intended for human application
, as amended by Decree no. 339/2012 Coll.
