Decree No 351 / 2010 Coll.
Decree amending Decree No. 143 / 2008 Coll., on the establishment of closer requirements to ensure the quality and safety of human blood and its components (Ordinance on human blood)
Valid
Order
Effective from 01.01.2011
Text versions:
01.01.2011
10.12.2010
351
DECLARATION
of 2 December 2010
amending Decree No. 143 / 2008 Coll., laying down closer requirements to ensure the quality and safety of human blood and its components (Decree on human blood)
According to § 114 (1) of Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), the Ministry of Health provides:
Decree No. 143 / 2008 Coll., on the establishment of closer requirements to ensure the quality and safety of human blood and its components (Human Blood Ordinance) is amended as follows:
1. In Article 12, at the end of paragraph 2, the dot is replaced by a comma and the following point (d) is added:
"(d) a declaration that the distribution, import or export of transfusion products and plasma for the production of blood derivatives will only be made from blood or plasma withdrawals from voluntary unpaid donors (7).
7) Article 2 (1) of the Guide to the preparation, use and quality assurance of blood components, as amended. ';
2. In Annex 1, point 5.2 (5):
"5. Part of the records is a report on the operation of the transfusion service for the previous year, including:
(a) number of donors,
1. the total number of donors, provided that the preponderants who have repeatedly donated blood in the reference period, are only listed once in the total number of donors,
2. the total number of multiple donors,
3. the total number of primary producers,
(b) the total number of individual types of sampling and the sum of all samples;
(c) an updated list of blood banks supplied by the blood services facility during the reference period;
(d) the total number of whole withdrawals not used;
(e) number of processed individual types of sampling;
(f) the quantities of transfusible preparations and raw materials produced and distributed for further production, the name of which is given in Annex 4, Part A;
(g) incidence and prevalence of indicators for individual transfusions communicable infections and the total number of repeat donors or primary donors tested;
(h) the number of packages of withdrawn transfusions or raw materials for further production;
(i) the number of serious adverse reactions and events reported.
The data in points (b), (d) and (e) shall be reported separately for each type of sampling, in particular full blood or plasmapheresis or cytaferesis. The data in point (f) shall be presented separately in the appropriate units for whole blood, erythrocytes, platelets, plasma and any other product types to be given. The report on the activities of the previous year in electronic form shall be transmitted to the Ministry of Health by 31 January of the following year in a way enabling remote access. ';
3. In Annex 1, point 7.1 of the final part of the provision, the first words "and (h) 'are replaced by" and (i)'.
4. In Annex 1, point 7.2, the following sentence is added at the end of sub-point 2: "Where a validated method of inactivation of the plasma pathogens authorised by the Institute in accordance with Section 67 (2) of the Act is used by the Transfusion Service, no repeated testing shall be carried out. '
5. In Annex 1, point 9 (1) of the final part of the provision, "(a) 'is replaced by" (b)'.
6. In Annex 1, point 9 (2), "(a) (2) 'is replaced by" (1) (b)';
7. In point 2.3 of Part A of Annex 3, at the end of sub-point 2, the sentence "The minimum interval between two instrumentation samples of plasma is 14 days."
8. In Annex 3, Part C, point 3, at the end of the first sentence, the words "in the State Health Constitution (8) 'shall be added.
footnote 8:
"8) Paragraph 74 (1) of Act No. 258 / 2000 Coll., on Public Health Protection, as amended by Act No. 320 / 2002 Coll. '.
9. In Annex No 4, Part A, under the heading "Full blood ', in the column" Quality measurement results received', the word "than 'is deleted.
10. In Annex 6, point 1, at the end of sub-point 1.1, the words "where the package size is indicated in the relevant quantitative units' shall be inserted after the words" Number of packages of transfusion products issued '.
11. In Annex 6, point 2, the words "listed in the relevant quantitative units' shall be inserted after the words" Total number of blood units and blood components processed '.
Efficacy
This Decree shall take effect on 1 January 2011.
Minister:
Doc. MUDr. Heger, CSc., v. r.
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Regulation Information
| Citation | Decree No. 351 / 2010 Coll., amending Decree No. 143 / 2008 Coll., on the establishment of closer requirements to ensure the quality and safety of human blood and its components (Human Blood Decree) |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 10.12.2010 |
|---|---|
| Effective from | 01.01.2011 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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