Decree No. 111 / 2013 Coll.
Decree on laying down requirements for the establishment of working procedures to ensure the quality and safety of human organs intended for transplantation
Valid
Order
Effective from 01.10.2013
111
DECLARATION
of 22 April 2013
laying down requirements for the establishment of working procedures to ensure 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.:
Subject matter
This decree implements the relevant European Union1 regulations and regulates a set of requirements for the development of working procedures to ensure the quality and safety of human organs intended for transplantation in order to protect the health of donors and recipients.
Collection, preservation, packaging, labelling and transport
(1) The working procedures for ensuring the quality and safety of the institutions (hereinafter referred to as "working procedures") for the collection of organs must be established in such a way that:
(a) are suitable for both living and deceased donors and the type of organs donated; if there is a living donor, the donor's safety and health and privacy must also be ensured by these procedures;
(b) the biological and, where appropriate, physical characteristics of the organs required for their use for transplantation are maintained while minimising the risk of microbial contamination throughout the whole process;
(c) the place of collection from the deceased donor and the time elapsed since proof of death of the deceased donor until collection; and
(d) the procurement of organs has been carried out in operating rooms which meet the requirements of the legislation governing the requirements for technical and physical equipment2).
(2) The use of sterile, quality and regularly maintained tools and medical devices must be developed for the collection and preservation.
(3) For the packaging and labelling of the organs collected, working procedures shall be established to:
(a) the method of packaging is ensured which minimises the risk of contamination;
(b) ensure that each package of organs is marked at the time of collection; the organ packaging shall bear the number generated at the time of the donor registration at the Coordination Centre of Transplants (hereinafter the "unique donation identification number '), the type of organ, the date, time and place of collection of the organ, the identification of the person who packed the organ, to the extent of the name and, where applicable, the name, surname and signature, and the particulars of the organ packaging; and
(c) it is ensured that the packaged authorities are transported in a container suitable for the transport of biological material which ensures the quality and safety of the transported authorities.
(4) Work procedures shall be established for the transport of the organs collected to ensure that:
(a) the integrity of the organ during transport and the appropriate time of transport shall be maintained;
(b) the transport vessels used to transport the organs shall contain:
1. identification details of the health service provider for which the collection has been carried out, within the scope of the name, address and contact telephone number,
2. the identification of the transplant centre to which the authority is addressed, within the scope of the name, address and contact telephone number;
3. a statement that the pack contains an organ indicating the type of organ and, where appropriate, its location in the donor body to the left or to the right and bearing the words "MANIPULATE INTRA"; and
4. the recommended transport conditions, including instructions for keeping the container at appropriate temperature and position; and
(c) the transported organs will be accompanied by a report on the characterisation of the organ and donor.
(5) The requirements referred to in paragraph 4 (b) need not be met if the transport is carried out within the same medical establishment.
Traceability
(1) The working procedures to ensure traceability must be established in such a way that all organs collected, allocated and transplanted can be traced from donor to recipient and vice versa.
(2) In order to ensure traceability, working procedures shall be established to ensure the use of and keeping records of donor and recipient identification systems
(a) enabling at least:
1. identification of the donor within the scope of the name, name, surname, year of birth and birth number,
2. identification of organ donation to the extent of the name, address and contact telephone number of the transplant centre that has performed the procurement, the type and number of organs collected, the unique identification number of the donation, the date and time of collection, the place of collection, the type of donation, in particular if there is a donation from a living or deceased donor;
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 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;
4. identification of the recipient within the scope of the name, name, surname and year of birth, and
5. identification of the transplant centre in which the transplantation took place, within the scope of the name, address and contact telephone number and date of the transplantation; and
(b) means of recording from which records are available and legible throughout their retention, including the protection of personal records; Where compliance with this condition is ensured, the data may also be stored electronically.
(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 birth number shall not be entered.
Serious adverse reactions and serious adverse reactions
(1) The working procedures for reporting and addressing serious adverse reactions or serious adverse reactions must be established in order to establish a system for notification, investigation, registration and transmission of relevant and necessary information
(a) serious adverse reactions which may affect the quality and safety of the organs and which may be caused by an examination, characterisation, collection, preservation or transport of the organs;
(b) any serious adverse reactions observed during or after the transplantation which may affect the quality and safety of the organs and which may be related to the examination, characterisation, collection, preservation or transport of the organs; and
(c) ensuring links to the system for reporting adverse reactions and events for tissues and cells under the legislation governing the requirements for ensuring the quality and safety of human tissues and cells3).
(2) In the event of serious adverse reactions or serious adverse reactions, working procedures shall be established to ensure that:
(a) any serious adverse reaction or serious adverse reaction detected has been reported without delay to the Coordination Centre and to the appropriate transplantation centre, to the extent specified in Part A of the Annex to this Decision;
(b) serious adverse reactions or serious adverse reactions have been assessed, evaluated and their causes have been identified and measures taken to address them; and
(c) measures to address serious adverse reactions and serious adverse reactions have been reported without delay to the Coordination Centre of Transplants and to the appropriate transplantation centre, to the extent specified in Part B of the Annex to this Decision.
(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.
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.
Efficacy
This Decree shall take effect on 1 October 2013.
Minister:
Doc. MUDr. Heger, CSc., v. r.
Annex to Decree No 111 / 2013 Coll.
Serious adverse reactions and serious adverse reactions
Reporting of a serious adverse event or serious adverse reaction
1. Notification transplant centre (name, address, contact details: telephone, e-mail or fax)
2. Identification number of the notification granted by the Coordination Centre for Transplants
3. Date and time of notification (year / month / day / hour / minute)
4. Person affected (please indicate whether the recipient or donor)
5. Date of collection (year / month / day) and place of collection of organs if there is a response in the donor
6. Date of administration (year / month / day) and place of administration of the organs if there is a reaction with the recipient
7. Unique Donation Identification Number
8. Date and time of serious adverse reaction or effect (year / month / day / hour / minute)
9. Type of authority related to notification and country of origin if the authorities are foreign
10. Type of serious adverse reaction or effect and their description
11. Responsible person of the health service provider (name, surname, title, phone and e-mail)
Reporting of measures to address a serious adverse event or serious adverse reaction
1. Notification transplant centre (name, address)
2. Notification Identification Number (consistent with notification of a serious adverse reaction or effect)
3. Date of confirmation of a serious adverse reaction or effect (year / month / day)
4. Date on which the assessment of a serious adverse reaction or effect was concluded (year / month / day)
5. Date of severe adverse reaction or effect (year / month / day)
6. Unique Donation Identification Number
7. Confirmation of a serious adverse reaction or effect (yes / no)
8. Change in type of serious adverse reaction or effect (yes / no; if yes, indicate change)
9. Further changes against data reported in the notification of a serious adverse reaction or effect (if yes, indicate changes)
10. Number of beneficiaries affected if there is a serious adverse reaction or effect on the beneficiary
11. Analysis of major causes of adverse reaction or effect
12. Preventive and corrective measures including the specified implementation date
13. Person responsible for the health service provider (name, surname, title, phone and e-mail)
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, as a general rule, be transmitted to the competent authority or delegated body of the Member State with which the exchange was made after the collection of the relevant information from all Member States concerned 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.
1) Directive 2010 / 53 / EU of the European Parliament and of the Council of 7 July 2010 on quality and safety standards for human organs intended for transplantation. Commission Implementing Directive 2012 / 25 / EU of 9 October 2012 laying down the information procedures for the exchange of human organs for transplantation between Member States.
2) Decree No. 92 / 2012 Coll., on the requirements for minimum technical and material equipment of health care facilities and home care contact centres.
3) Decree No. 422 / 2008 Coll., establishing closer requirements to ensure the quality and safety of human tissues and cells intended for human use, as amended by Decree No. 339 / 2012 Coll.
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Decree No. 111 / 2013 Coll., laying down requirements for the establishment of working procedures to ensure the quality and safety of human organs intended for transplantation |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.04.2013 |
|---|---|
| Effective from | 01.10.2013 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
Comments 0