Act No. 44 / 2013 Coll.
Act amending Act No. 285 / 2002 Coll., on Donation, Collection and Transplantation of Tissue and Organs and on the Amendment of Certain Laws (Transplant Act), as amended, and other related laws
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Effective from 01.04.2013
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44
THE LAW
of 31 January 2013
amending Act No 285 / 2002 Coll., on the Donation, Collection and Transplantation of Tissue and Organ and on the Amendment of Certain Laws (Transplant Act), as amended, and other related laws
Parliament has decided on this law of the Czech Republic:
Change of transplant law
Act No. 285 / 2002 Coll., on donation, collection and transplantation of tissues and organs and on the amendment of certain laws (Transplant Act), as amended by Act No. 228 / 2005 Coll., Act No. 296 / 2008 Coll., Act No. 129 / 2008 Coll., Act No. 41 / 2009 Coll., Act No. 281 / 2009 Coll. and Act No. 375 / 2011 Coll., is amended as follows:
1. Paragraph 1, including the title and footnotes No 21 and No 1, reads as follows:
Subject matter
(1) This Act implements the relevant provisions of the European Union21 and lays down rules for ensuring the quality and safety of human organs (hereinafter referred to as the "Authority") intended for human body transplantation in order to ensure a high level of human health protection, in their donation, investigation, characterisation, collection, preservation, transport and transplantation.
(2) This law further regulates the conditions of donation, collection and transplantation of tissues, cells and organs carried out solely for the provision of medical services (1). When it comes to the quality and safety of tissues and cells, the law governing human tissues and cells7a is followed.
21) 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.
1) Act No. 372 / 2011 Coll., on health services and the conditions for their provision (Health Services Act). '.
2. In Article 2, at the end of the text in point (a), the words "; part of the body shall also be considered to serve the same purpose as the whole body, while maintaining the requirements for structure and vascular supply ';
3. in Article 2 (d):
"(d) by donor, the person who donates the organ or tissue, whether the donation takes place during or after the life of the person."
4. In Section 2, at the end of the text in point (e), the words "or irreversible arrest of blood circulation 'are added.
5. in Article 2 (g):
"(g) the recipient of the person receiving the transplanted organ or tissue,"
6. In Article 2 (h), the words "human consumption 'are replaced by the words" acquisition'.
7. in Article 2 (i) and (j):
"(i) donation of organ or tissue for transplantation,
(j) transplantation process to restore specific functions of the human organism by transferring the organ or tissue from the donor to the recipient's body, '.
8. in Article 2, the following points (k) to (r) are added:
"(k) the characterisation of the donor by the collection of relevant information on the characteristic characteristics of the donor required to assess its medical fitness for organ or tissue donation in order to carry out appropriate assessment and risk minimisation for the recipient and optimisation of organ allocation;
(l) characterisation of the organ by collecting relevant information on the organ characteristics needed to assess its suitability for transplantation in order to assess and minimise the risk to the recipient and optimise the organ allocation;
(m) preserving the use of chemicals, changes in ambient conditions or other means to prevent or slow down biological or physical damage to the organ during the period from collection to transplantation;
(n) a serious adverse reaction of any adverse and unexpected event related to the donation, investigation, characterisation, collection, preservation or transport of an organ for transplantation and transplantation of an organ that could lead to the transmission of a communicable disease, to death or to life-threatening, harm to health or limitation of the ability of the patient, or which could cause or prolong its hospitalisation or disease;
(o) a serious adverse reaction of an unexpected response by a living donor or recipient, including a communicable disease that could be related to the donation, investigation, characterisation, collection, preservation or transport of an organ intended for transplantation and the transplantation of an organ that results in death, life hazard, health damage or impairment of abilities, or results in or prolong its hospitalisation or disease;
(p) working procedures, written instructions describing the stages of the process from donation to organ transplantation, including materials and methods to be used, and the expected overall result;
(q) traceability possibility
1. identify the place where the authority is located and identify it during each stage of treatment and identify the place of its liquidation,
2. identify the living or deceased donor;
3. identify the health service provider that has performed the organ procurement;
4. identify the recipient in the transplant centre; and
5. find and identify all necessary data concerning products and materials that come into contact with the authority;
(r) a close relative in a direct line, a spouse, a registered partner, a sibling or a married person. ';
9. footnote 3 is deleted, including the footnote references.
10. in Article 5 (2), the words "medical establishments" are replaced by the words "health service providers."
11. in Article 5 (5) of the final part of the provision, the words "the person intending to donate the organ or tissue" shall be inserted after the words "the medical file."
12. In Article 5, at the end of paragraph 5, the sentence "The Ethics Commission shall send a copy of the instrument to the Coordination Centre of Transplants within 7 days of its consent or of its opposition. 'shall be added.
13. In Article 6, at the end of paragraph 1, the sentence "An integral part of the donor medical assessment is the characterisation of the donor and the characterisation of the organ."
14. In Article 6, at the end of paragraph 3, the sentence "The assessor shall, within 7 days of the assessment of the donor's medical fitness, transmit an extract of the medical file to the extent of the record according to the sentence of the first Coordination Centre of Transplants."
15. in Article 6 (5), "a" is replaced by "comma," and after "organ donor," the words "and the extent of the data needed to characterise this donor and to characterize the organs from that donor" are inserted.
16. in Article 7 (7), the words "Medical equipment" shall be replaced by the words "Health service provider" and the words "medical equipment" shall be replaced by the words "health service provider."
17. Paragraph 10 (2) reads:
"(2) The detection of the death of a potential donor shall always be carried out by at least two doctors with appropriate specialised competence who examined the donor independently of each other. The detection of the death of a potential donor shall be recorded in the protocol, which is an integral part of the donor's medical documentation, in the case of anticipated collection before 2 hours after that finding. The death report shall be signed by doctors who have discovered death."
18. in Article 10 (3) (a), the word "or" shall be inserted after the word "circulation."
19. In Paragraph 10 (4) (b), the words "which have failed to restore or support effectively, by a doctor for at least 30 minutes; resuscitation is carried out simultaneously by artificial breathing and by heart massage '.
20. In Paragraph 10 (6), "No 2 'is replaced by" To this Act'.
21. Paragraph 10 (7) reads as follows:
"(7) The Ministry shall determine the extent of the data needed to characterise the deceased donor and to characterise the organs from the deceased donor, the nature and model of the death report and the specialised competence of the medical practitioners investigating death and of the medical examiners carrying out the tests confirming the irreversible death by decree. The Ministry may lay down detailed conditions on the manner in which the examination of evidence of death, the examination of the irreparability of the pauses of blood circulation or brain death and the conditions under which they are carried out by decree. '
22. The following Section 10a is inserted after Section 10:
Acceptance of collection from a deceased donor who is a stranger
(1) Aliens 9) which may be expected to collect tissues or organs under this Act may be collected if the alien holds a valid document of consent to donate tissues or organs to be donated to him by the competent authority of the State of which the alien is a citizen (the donor card).
(2) If there is a stranger who does not hold a donor card and who can be expected to collect tissues or organs under this law, the Coordination Centre of Transplants shall, at the initiative of the health service provider, make a written enquiry to the competent authority of the State of which the alien is a citizen,
(a) did not express the will to oppose the post-mortem collection of tissues or organs; or
(b) agree to the donation of tissues or organs, if the principle of presumed opposition is applied in the State of which the alien is a citizen.
(3) When establishing contact with a person close to a stranger in order to fulfil his obligation under Paragraph 15 (1), the Coordination Centre of Transplants shall, at the initiative of the health service provider, make a written request to the competent authority of the State of which the alien is a citizen.
(4) If the health service provider does not receive within 72 hours information on the facts referred to in paragraph 2 or if it is unable to inform a person close to a stranger pursuant to Paragraph 15 (1), the conditions for withdrawal shall be deemed not to be met. ';
23. Paragraph 11 (4) is deleted.
24. in Article 12 (2) and (3):
"(2) Health service providers involved in the collection and transplantation of organs or tissues from a deceased donor shall inform each other without delay of the additional detection of the medical incompetence of the deceased donor, as well as of the Coordination Centre for Transplants to the same extent.
(3) The tissues collected under the law governing the treatment of human tissues and cells which have not been used for transplantation can only be passed on to the tissue bank for further examination, processing, preparation, preservation, storage and distribution. "
25. In Paragraph 13, the following paragraph 2 is inserted after paragraph 1:
"(2) The autopsy of the deceased who has been sampled shall be carried out as short as possible so that, in the event of an additional finding that the deceased has suffered from a disease or condition likely to endanger the health or life of the recipient, the conclusion on the medical incompetence of the deceased may be reached."
Paragraph 2 shall become paragraph 3.
26. In Article 13, the following paragraph 4 is added:
"(4) If, on the basis of the results of that autopsy, a doctor who has performed an autopsy finds that the deceased has suffered from a disease or condition which could endanger the life or health of the recipient, he shall immediately notify the health service provider who carried out the collection of the tissue or organ. Where an additional finding of medical incompetence of a deceased donor has been made on the basis of an autopsy and the organ or tissue collected from that donor has already been transplanted, the provider of the health services that carried out the transplant shall without delay take precautionary measures to prevent the life or health of the recipient and, where appropriate, ensure that the recipient receives the necessary health care and shall notify the Coordination Centre of the transplantation without delay. ';
27. in Article 15 (2), the words "if the deceased is a minor or a person deprived of competence, the instruction shall also be" shall be replaced by "if the deceased is also a minor or a person deprived of competence."
28. In Article 18 (1), the words "or, where appropriate, other registries intended for the registration of organ donation data 'are deleted.
29. Footnote 12 reads:
"12) § 70 of Act No. 372 / 2011 Coll. '.
30. In Paragraph 18 (3), "with operation 'is replaced by" with administration'.
31. in Paragraph 18 (4), the word "address" shall be inserted after the words "birth number and";
32. in Paragraph 18, the following paragraph 5 is added:
"(5) For the purpose of carrying out the tasks
(a) the national organ donor registry is also understood as the donor of the tissue;
(b) the national register of persons waiting for organ transplantation shall also mean the person waiting for the transplant;
(c) The national register of transplants of organs shall be the one carried out by the transplantation of tissue. ';
33.
Cooperation in the provision of data from basic registers and other public administration information systems
(1) The Coordination Centre for Transplants and the Coordination Centre for the Department for Health Information Systems uses the following reference data from the basic population register for the purpose of carrying out tasks in the management of national health registers under this Act:
(a) surname;
(b) the name and, where appropriate, the names,
(c) the address of the place of stay and, where applicable, the address to which the documents are to be served under a special legislation;
(d) the date, place and district of birth of the data subject who was born abroad, the date, place and state where he was born;
(e) the date, place and district of death, if the death of the data subject is outside the territory of the Czech Republic, the date of death, the place and the State in whose territory the death occurred; if the court's decision on the declaration of death is given, the date indicated in the decision as the date of death or, where appropriate, as the day on which it did not survive, and the date on which the decision was acquired.
(2) The Coordination Centre for Transplants and the Coordination Centre for the Department for Health Information Systems use the following reference data from the information system of the population register for the purpose of carrying out tasks in the management of national health registers under this Act:
(a) the name and / or the names, surnames and surnames,
(b) the date of birth;
(c) sex;
(d) the place and district of birth and the place and state where the citizen was born,
(e) birth number,
(f) the address of the place of permanent residence and, where appropriate, the address to which the documents are to be served under a special legislation;
(g) the beginning of the permanent residence or, where applicable, the date of cancellation of the permanent residence or the date of termination of the permanent residence in the Czech Republic;
(h) the date, place and district of death; if the death of a citizen is outside the territory of the Czech Republic, the date of death, the place and the State in whose territory the death occurred,
(i) the date indicated in the court's decision on the death declaration as the day of death or, where applicable, as the day on which he did not survive, and the date on which the court's decision on the death declaration became final.
(3) The Coordination Centre for Transplants and the Coordination Centre for the Department for Health Information Systems uses the following reference data from the information system of foreigners to carry out tasks in the management of national health registers under this Act:
(a) the name and / or the names, surnames and surnames,
(b) the date of birth;
(c) sex;
(d) the place and state where the alien was born; where he was born in the territory of the Czech Republic, the place and district of birth,
(e) birth number,
(f) the type and address of the place of residence in the Czech Republic or, where applicable, the address to which the documents are to be served under a special legislation;
(g) date, place and district of death; if there is a death of a stranger outside the Czech Republic, the State in which the death occurred or the date of death,
(h) the date given in the court's decision on the declaration of death as the day of death, or as the day that the alien declared dead did not survive.
(4) The Coordination Centre for Transplants and the Coordination Centre for Resorts Health Information Systems use the following reference data from the register of birth numbers for the performance of tasks in the management of national health registers under this Act:
(a) the birth number,
(b) in the case of a change in the birth number of the original birth number,
(c) the name and / or surname, surname and / or maiden name of the carrier of the birth number;
(d) the date, place and district of birth and, in the case of the carrier of the birth number born abroad, the place and State in whose territory he was born.
(5) From the data referred to in paragraphs 1 to 4, only such data as is necessary to fulfil the task may be used in a particular case. Data which are kept as reference data in the population base register shall be used from the population registration or alien information system only if they are in the form preceding the current situation. ';
34. In Paragraph 20, the following paragraph 2 is inserted after paragraph 1:
"(2) The provider of the tissue collection and transplantation services, the transplant centre and the Coordination Centre of Transplants shall record and maintain a birth number for donor identification. To that end, the health service provider shall be entitled to require the production of the document in which the birth number is indicated. The donor's birth number shall be retained for traceability purposes. ';
Paragraph 2 shall become paragraph 3.
35. in Paragraph 20 (3), the word "nearest" shall be replaced by "relevant."
36. Sections 21 and 22, including the headings and footnotes No 15 and 22, read:
Provider of tissue collection and transplantation services
In addition to the obligations arising from the special legislation15, the provider of tissue collection and transplantation services, which is not a transplant centre (§ 22), is also obliged to:
(a) report to the persons who have been sampled into the National Register of Organ Donors;
(b) report transplants to the National Register of Organ Transplants,
(c) if tissues are involved, provide data required by the Coordination Centre for Transplants;
(d) to gather information from the National Register of Persons not in agreement with post-mortem tissue and organ sampling for the purpose of performing withdrawals from deceased donors and to respect the disapproval thus expressed;
(e) verify other means of proving non-compliance with the post-mortem sampling provided for by this Act and respect the dissent thus expressed;
(f) keep documentation of the sampling and transplantation carried out and the management of the tissues or organs collected in the report on the final determination of the tissues or organs collected;
(g) to monitor the health of living donors and recipients;
(h) have an import or export permit for import or export (§ 26a to 26g).
Transplant Centre
(1) Transplant centre means a health service provider which has been granted the status of a centre of highly specialised care (22) and which can on this basis carry out collection and transplantation of haematopoietic cells, organs and tissues which have not been transmitted to a tissue bank pursuant to § 12 (3). The Transplant Centre shall fulfil its obligations under Paragraph 21 and shall be subject to:
(a) report persons indicated for tissue and organ transplantation to the National Register of Organ Transplants,
(b) perform a tissue and organ transplantation exclusively to recipients registered in the National Register of Organ Transplants;
(c) cooperate with the Coordination Centre for transplantation in the selection of the most suitable organ recipients;
(d) upon receipt of the information referred to in Article 20 (3), determine whether the conditions for collection are met (Sections 10 to 11);
(e) inform the potential donor of the Coordination Centre for Transplants upon compliance with the conditions for collection;
(f) verify that a donor medical assessment has been carried out and recorded, including completion of organ and donor characterisation;
(g) verify that the conditions of preservation and transport have been complied with for the authorities delivered;
(h) keep documentation on the sampling and transplantation carried out and the handling of the organs collected in the final determination report of the organs collected;
(i) report any serious adverse reactions and serious adverse reactions to the Coordination Centre for Transplants and to the tissue collection and transplantation health service providers or any other transplantation centre;
(j) report the measures taken to address serious adverse reactions and reactions to the Coordination Centre of Transplants.
(2) The Transplant Centre is further required
(a) process and maintain an internal quality and safety assurance system for all phases of the process from donation to transplantation;
(b) use, for traceability purposes, the identification system of donors and recipients through which each donation, each associated authority and each associated recipient can be identified; the data necessary to ensure traceability of the transplantation centre shall be kept for at least 30 years;
(c) to apply working procedures for the collection, preservation, packaging and labelling of organs;
(d) to apply working procedures for the notification, investigation, registration and transmission of information on serious adverse reactions which may affect the quality and safety of the organs and which may be caused by investigations, characterisation, collection, preservation and transport of organs, as well as information on any adverse reactions observed during or after the transplantation which may be related to such activities;
(e) ensure the application of working procedures ensuring the integrity of the authority during transport and the appropriate time for transport;
(f) ensure that health professionals directly involved in the process from donation to transplantation or destruction of the organ or tissue have appropriate qualifications or training, are competent to pursue the profession and are adequately trained.
(3) The transplantation centre performing haematopoietic cell transplantation fulfils the obligations set out in Sections 21 (c) and (g), and it is also obliged to cooperate with the haematopoietic cell donor centres (Section 24) in selecting the most appropriate indirect potential haematopoietic cell donors and to make the final selection of a suitable haematopoietic cell donor for a specific recipient.
15) For example, Act No. 372 / 2011 Coll., Act No. 296 / 2008 Coll., as amended, Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended.
22) § 112 of Act No. 372 / 2011 Coll. '.
(37) footnotes 14 and 16 are deleted, including the footnotes.
38. The following Section 22a is inserted after Section 22:
Protocol on tissue management and organs
Medical personnel involved in the collection or transplantation of tissues and organs shall record the treatment of tissues or organs collected in a protocol accompanying the tissue or organ collected. In particular, the date and place of collection and the final destination of the tissue or organ collected shall be recorded in this Protocol. If the tissue or organ collected is used for the transplant, the date, place and person to whom the transplant was carried out shall be recorded in the protocol. If it has been decided that the tissues and organs collected are unfit for transplantation, the protocol shall include the reason why they were found inappropriate and the way in which they are handled. The health service provider shall ensure that the Protocol is sent to the Coordination Centre by transplantation within 7 days of the date on which the tissue or organ collected has been definitively identified. ';
39. in Article 23 (2) (a), the words "health care establishments" are replaced by the words "health service providers" and the words "health care establishments" are replaced by the words "health service providers."
40. In Article 24, at the end of paragraph 2, the dot is replaced by a comma and the following points (e) to (i) are added:
"(e) ensure public awareness of the importance and possibilities of donating haematopoietic cells in the context of the acquisition of new donors and provide guidance to potential voluntary donors of haematopoietic cells on the facts related to voluntary donation;
(f) ensure that a medical assessment of potential donors is carried out prior to their inclusion in the registry of potential haematopoietic cell donors;
(g) seek in the registry of potential haematopoietic cell donors suitable for the recipient;
(h) ensure monitoring of the health status of unrelated donors after collection;
(i) ensure the release of an unrelated donor for further investigations. ';
41.In Article 24, paragraphs 3 and 4 are added:
"(3) The haematopoietic cell donor centre for the maintenance of the registry referred to in paragraph 2 (b) shall establish and maintain an information system allowing the search for potential haematopoietic cell donors. Data on potential donors shall be kept in the registry for the duration of donor records, but at least 30 years from the date of collection of haematopoietic cells. The consent of a potential donor to the management of data on his or her person in the registry shall be written.
(4) The haematopoietic cell donor centre shall, by 1 March each year, prepare an annual report on the activities of the haematopoietic cell donor centre for the previous calendar year. The annual report shall be published by that date at the latest in a way that allows remote access and submitted to the Coordination Centre for transplantation. ';
42. In Paragraph 25 (1), the first sentence is replaced by the following: "The Ministry of Health shall establish a Coordination Centre for Transplants for the performance of the tasks referred to in paragraph 2 'and the last sentence shall be deleted.
43. In Paragraph 25 (2), the words "on the basis of a written pre-defined allocation algorithm" shall be added at the end of the text of point (e).
44. in Article 25 (2), point (f) is deleted;
Points (g) to (i) shall be renumbered as points (f) to (h).
45. in Paragraph 25 (2), the following points (h) to (k) are inserted after point (g):
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Regulation Information
| Citation | Act No. 44 / 2013 Coll., amending 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, and other related laws |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 25.02.2013 |
|---|---|
| Effective from | 01.04.2013 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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