Decree No. 369 / 2023 Coll.
Decree amending Decree No. 114 / 2013 Coll., on determining the closer conditions for the assessment of medical fitness and the extent of examination of a living or deceased donor of tissues or organs for transplantation purposes (Ordinance on the medical fitness of a donor of tissues and organs for transplantation purposes), as amended by Decree No. 7 / 2014 Coll.
Valid
Order
Effective from 01.01.2024
Text versions:
01.01.2024
20.12.2023
369
DECLARATION
of 12 December 2023
amending Decree No 114 / 2013 Coll., laying down the conditions for the assessment of medical fitness and the extent of the examination of a living or deceased donor of tissues or organs for the purpose of transplantation (Ordinance on the medical fitness of a donor of tissues and organs for the purpose of transplantation), as amended by Decree No 7 / 2014 Coll.
The Ministry of Health provides, pursuant to § 6 (5), § 10 (7) and § 11 (3) of 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 by Act No. 296 / 2008 Coll. and Act No. 44 / 2013 Coll.:
Decree No. 114 / 2013 Coll., on the determination of the closer medical assessment conditions and the extent of the examination of a living or deceased donor of tissues or organs for transplantation purposes (Ordinance on the medical fitness of a donor of tissues and organs for transplantation purposes), as amended by Decree No. 7 / 2014 Coll., is amended as follows:
1. In the title of the Decree, the title of § 1, § 1 (1), § 1 (2) of the Introductory Part of the provision, § 1 (2) (d), § 1 (4), § 1 (5), § 1 (6), § 1 (7), § 1 (8) of the Introductory Part of the provision, § 2 (2) of the Introductory Part of the provision, § 5 of the Introductory Part of the provision, § 6 (a) and § 7 of the words "tissue or" are deleted. "
2. In the title of the decree, the words "tissues and 'are deleted.
3. in Article 1 (2) (a):
"(a) a history with a targeted focus on identifying risk-related circumstances for the recipient of the institution, in particular:
1. the occurrence of infectious diseases, including those acquired in endemic risk areas;
2. the incidence of cancer,
3. risk behaviour, which means in particular intravenous application of addictive substances and risk sexual behaviour,
4. the occurrence or suspected occurrence of prion diseases, particularly in the treatment of natural growth hormone or in cases where the donor has been transplanted with a graft of brain, corneal or sclera denim,
5. the occurrence of chronic or other diseases which may endanger the health or life of the donor at the time of collection, the health or life of the recipient after transplantation or the quality of the organs intended for transplantation;
6. prior exposure to harmful substances or ionising radiation;
7. Information on current and previous use of medicinal products,
8. information on immunisation with live vaccines in the previous 6 months; and
9. Information on blood transfusions over the past 12 months. "
footnotes 1 and 2 are deleted.
4. in Article 1 (3) (b) and (c):
"(b) comprehensive pre-operative examination;
(c) examination of the size, condition and function of the body to be collected. ';
5. in Article 1 (3), point (d) shall be deleted;
6. in Articles 1 (5) (b) and (c), 1 (6), 1 (7), 2 (1) (b), 2 (2) (d), (e) and (f), 2 (3) of the introductory part of the provisions, 6 (a) and (b), the words "tissues" shall be deleted;
7. In Paragraph 1 (5), at the end of point (b), the word "a 'is replaced by a comma.
8. In Article 1, at the end of paragraph 5, the dot is replaced by "a 'and the following point (d) is added:
"(d) the long-term expected development of the donor's state of health after the collection of the organ."
9. in Paragraph 1 (8), point (a) is deleted;
Points (b) and (c) shall become points (a) and (b).
10. in Article 1 (8) (a), the words "tissue taken or" shall be replaced by ";
11. in Paragraph 2 (2) (e), the word "theirs" is replaced by the word "his."
12. in Article 2 (2) (f), the words "tissue taken or" are replaced by the words "collected" and the words "evaluate rapid biopsy" shall be replaced by the words "histological examination."
13. in Article 2 (3), the word "or" shall be added at the end of point (b).
14. in Article 2 (3), point (c) is deleted;
Point (d) shall be renumbered (c).
15. in Article 2 (3) (c), the words "tissue taken or" shall be replaced by ";
16. in Article 2 (4), the words "life saving transplantation" are replaced by the words "with the overall benefit of transplantation."
17. in Article 4 (1) (a), the words "and secondary diagnosis" shall be replaced by the words "diagnosis."
18. in Paragraph 4 (1) (c), the word "clinical" shall be inserted after the word "results."
19. In Paragraph 4 (1) (e), the words "and medical practitioners carrying out tests confirming the irreversible death of the brain" shall be deleted.
20. in Article 5, point (a) is deleted;
Points (b) and (c) shall become points (a) and (b).
21. In Section 6 of the final part of the provision, the words "tissue taken or 'are replaced by the words" collected'.
22. in Article 7, the second sentence is deleted;
23. In Annex 1, point 1, the words "or behaviour increasing the risk of HIV infection 'are deleted.
24. In Annex 1, point 2 is deleted.
Points 3 to 12 shall become points 2 to 11.
25. In Annex 1, point 3, the words "histologically verified 'are deleted.
26. In Annex 1, point 4, the words "with expressed 'are replaced by the words" with tissue';
27. In Annex 1, points 6 to 8 are deleted.
Points 9 to 11 shall become points 6 to 8.
28. In Annex 1, point 6, the words "in respect of organ procurement 'are deleted.
29. In Annex 1, point 7:
"7. other diseases, defects or conditions that, according to current knowledge of science and clinical medicine, could exclude donation."
30. In Annex 1, point 8 is deleted.
31. Annex 3 shall read as follows:
"Annex No 3 to Decree No 114 / 2013 Coll.
"
Efficacy
This Decree shall take effect on 1 January 2024.
Minister:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
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Regulation Information
| Citation | Decree No. 369 / 2023 Coll., amending Decree No. 114 / 2013 Coll., on determining the closer conditions for the assessment of medical fitness and the extent of the examination of a living or deceased donor of tissues or organs for transplantation purposes (Decree on the medical fitness of a donor of tissues and organs for transplantation purposes), as amended by Decree No. 7 / 2014 Coll. |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 20.12.2023 |
|---|---|
| Effective from | 01.01.2024 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
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