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Regulation of the Minister for Health, Welfare and Sport of 31 January 2005, No GMT/MT2551254 containing rules on the blood supply (Rules on Blood Supply)
The Minister for Health, Welfare and Sport,
Having regard to Directive 2002 /98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of blood and blood components of human origin and amending Directive 2001 /38/EC (PbEU L 33) and on the Article 3, third paragraph , 5, second paragraph , and 9, second paragraph, of the Law on Blood ;
Decision:
The following definitions shall apply:
a. blood: whole blood taken from a donor and treated for the purpose of transfusion or further processing;
b. blood component: a therapeutic substance of blood, namely red blood cells, white blood cells, platelets, plasma, which can be prepared by means of various methods;
c. Hospital blood bank: a hospital unit providing blood and blood components, intended for use only in hospitals, including for transfusion activities in a hospital, stores and distributes, and may carry out compatibility tests on that.
d. serious adverse event: an undesired occurrence in connection with the collection, testing, processing, storage and distribution of blood and blood components which may result in death, danger of life, disability or incapacity for work have, or leads to hospitalisation, or prolongs the duration of the disease;
e. serious adverse reaction: an unintended response to the donor or the patient in connection with the collection or transfusion of blood or blood components, which is fatal, life-threatening, disability or incapacity for work, or leads to hospitalisation or prolong the duration of the disease;
f. release of a blood component: a process leading to the elimination of the quarantine status of a blood component through the use of systems and procedures to ensure that the final product complies with the requirements of the specifications for release;
g. exclusion: permanent or temporary suspension of a person's suitability for the donation of blood or blood components;
h. distribution: the supply of blood and blood components to producers of blood and plasma obtained products. The issuance of blood or blood components for transfusion shall not be included here;
(i) autologous transfusion: a transfusion where the donor is also the recipient and where previously issued blood and blood components are used;
j. Directive: Directive 2002 /98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of blood and blood components of human origin and amending Directive 2001 /83/EC of the Council (PbEU L 33).
2 This scheme does not apply to blood stem cells.
1 The Blood Supply Organisation shall inform the Minister of the data referred to in Annex I .
2 The Blood Supply Agency shall require the written consent of the Minister for a major change in its activities.
1 The Blood Supply Organisation shall ensure that:
-in the collection and testing of each unit of blood or blood components, whatever the intended use, and in the processing, storage and distribution of the unit, if they are intended for transfusion, compliance with the applicable rules;
-the Minister responsible for the designation procedure, Article 3 of the Law on Blood , receives the necessary information;
-the requirements of the Articles 4 to 8 are applied to the Blood Supply Organisation.
2 The Blood Supply Organisation shall carry out the performance of the duties referred to in paragraph 1 to a person who is at least:
a. The holder of a diploma, certificate or other evidence of evidence at the conclusion of a university course in the field of medicine, biology or pharmacy, or of a training course recognised by the Minister as equivalent;
b. after having obtained the diploma at least two years of practical experience in relevant fields has acquired in one or more of the institutions which may carry out activities relating to the collection or testing of blood and blood components of human origin or the processing, storage and distribution of human origin.
3 The person referred to in paragraph 2 may delegate his or her duties to any person who is qualified by their training or experience to carry out those tasks.
4 The Blood Supply Organisation shall inform the Minister of the name of the person referred to in paragraph 2 and of the persons referred to in paragraph 3, and of the specific tasks with which they are responsible.
5 If the persons referred to in the second or third paragraph are replaced either temporarily or permanently, the Blood Supply Agency shall immediately inform the Minister of the name of the new person and the date of his entry.
Personnel directly involved in the collection, testing, processing, storage and distribution of blood and blood components of human origin, shall have the necessary qualifications to perform those tasks and shall be given a timely appropriate training and regular refresher training.
The quality system referred to in Article 6 of the Law on Blood , it is applied based on the principles of good practice. In doing so, the Blood Supply Organisation shall respect the standards and specifications referred to in Article 29 (h) of the Directive.
1 The Blood Supply Organisation shall maintain documentation on operational procedures, guidelines, manuals and manuals, as well as reporting forms.
2 The Blood Supply Agency keeps records of the data, named in the Annex II and IV and in Article 29 (b), (c) and (d) of the Directive. This information shall be kept for a period of at least 15 years.
1 In order to trace blood and blood components collected, tested, edited, stored, released or distributed from the donor to the recipient and vice versa, the Blood Supply Agency applies a system for the identification of each blood donation and each individual blood unit and its components. The system must uniquely identify each unique donation and each unique type of blood component. The system shall be established in accordance with the rules referred to in Article 29 (a) of the Directive.
2 In respect of blood and blood components imported from third countries, the Blood Supply Organisation shall apply a donor identification system which allows for an equivalent level of traceability.
3 The system which uses the Blood Supply Organisation for the labelling of blood and blood components collected, tested, processed, stored, released or distributed by it shall comply with the system referred to in paragraph 1. identification system and the Annex III labelling requirements.
4 Data necessary for complete traceability in accordance with this Article shall be kept for at least 30 years.
1 The Blood Supply Agency reports on the Regulatory Compliance of the Blood supply law officer in charge of serious adverse events related to the collection, testing, processing, storage and distribution of blood and blood components which can affect its quality and safety, as well as serious adverse reactions which are detected during or after transfusion and which can be attributed to the quality and safety of the blood and blood components. The notification shall take place in accordance with the procedure referred to in Article 29 (i) of the Directive and in the manner provided for therein.
2 The Blood Supply Organisation shall have an accurate, rapid and verifiable procedure for extracting the blood and blood components associated with a notification referred to in paragraph 1.
1 The blood supply organisation provides prospective donors with the data referred to in Article 29 (b) of the Directive.
2 The blood supply organisation shall require donors after they have declared their willingness to donate blood or blood components, the data referred to in Article 29 (c) of the Directive.
1 The Blood Supply Agency shall ensure that there are verification procedures for all donors of blood and blood components, and that the criteria set out in Article 29 (d) of the Directive are met.
2 The results of the donor assessment and the tests carried out shall be recorded and the donor shall be informed of any relevant dissenting findings.
Any donation of blood or blood components shall be preceded by an examination of the donor, which includes a conversation. A certified health professional is in particular responsible for providing, and gaining in, the donor of information necessary to judge whether the donor is suitable for donation and decides on that basis or the donor. may be allowed.
1 The Blood Supply Agency ensures that all donations of blood and blood components are tested according to the rules of Annex IV .
2 Imported blood and imported blood components are tested according to the requirements of Annex IV .
1 The Blood Supply Organisation shall ensure that the way in which blood and blood components are stored, transported and distributed complies with the requirements referred to in Article 29 (e) of the Directive.
2 The Blood Supply Organisation shall ensure that the quality and safety requirements for blood and blood components comply with the requirements referred to in Article 29 (f) of the Directive.
3 The blood supply organisation shall ensure that autologous transfusion complies with the requirements referred to in Article 29 (g) of the Directive.
The Blood Supply Organisation shall ensure that the data collected under this scheme, which may be consulted by third parties, including genetic information, have been anonymised in order to ensure that the donor is no longer identifiable. To:
-take measures for the purpose of data security and create guarantees against unauthorised addition, deletion or alteration of donors ' files or exclusions and against the transfer of information;
-it shall establish procedures to eliminate discrepancies between data;
-prevents unauthorised disclosure of such information, but the donations must remain traceable.
The Minister of Defence takes part in the performance of the tasks Article 11a of the Law on Blood 'Blood supply organisation' means the organisation in charge of military blood supply:
a. It is the case of or under the Article 2, first paragraph , 4 , 6, first paragraph , 7 , 8 and 13, first and second members , certain;
b. At or under the 3, first part, first part, second, third, fourth and fifth members , and 5 certain, with the exception of the requirements relating to the collection of blood; and
c. In the case of Article 2, second paragraph , as far as amendments affecting the quality and safety of blood and intermediate products are concerned.
An amendment to the Directive and EU Directives adopted for the implementation of the Directive shall apply to the implementation of this Regulation as from the day on which the relevant amendment or EU Directive has to be implemented.
The Rules on blood supply rules -of 21 December 2004, published in the Official Gazette, no. 251 is hereby repealed.
This arrangement shall enter into force on 8 February 2005.
This arrangement is cited as: Rules on blood supply.
This arrangement will be set out in the Official Journal of the European Union and in the annexes and the explanatory notes.
TheMinister
of Public Health, Welfare and Sport,J.F. Hoogervorst
Part A: General information
-Identity of the Blood Supply Organization.
-Name, qualification and contact details of the responsible persons.
-A list of hospital blood banks which are supplied by the Blood Supply Agency.
Part B: Description of the quality management system, including
-documentation (for example, an organisation chart), including the tasks of the persons responsible and the hierarchical structure;
-documentation (e.g. documentation such as a Site Master File or a quality manual describing the quality assurance system of Article 6 of the Blood Supply Act);
-number of staff members and their qualifications;
-hygiene requirements;
-locations and equipment;
-list of Standard Operating Procedures for the recruitment, maintenance and evaluation of donors and for the processing, testing, distribution and recall of blood and blood components, and for reporting and registering serious adverse events and reactions.
This annual report shall contain:
-the total number of donors of blood and blood components,
-the total number of donations,
-an updated list of hospital blood banks which are supplied by the Blood Supply Organisation;
-the total number of unused total donations,
-the number of units of each component produced and distributed;
-the incidence and prevalence of infectious markers of blood and blood components transmitted by transfusion,
-the number of recalls,
-the number of reported serious adverse events and adverse reactions.
The label on the component shall contain the following information:
-Official name of the ingredient.
-Volume or weight or number of cells of the component (as the case may be).
-Unique numerical or alphanumeric donation identification.
-Name of the producing blood institution.
-ABO group (not required for plasma solely for fractionation).
-Rh D-group, indicated as 'Rh D-positive' or 'Rh D-negative' (not required for plasma solely for fractionation).
-Expiry date or period of time (as appropriate).
-Storage Temperature.
-Name, composition and volume of anticoagulant and/or storage fluid (if present).
The following tests shall be carried out for whole blood and end-of-life donations, including autologous donations, which have been deposited in advance:
-ABO group (not required for plasma solely for fractionation).
-Rh D-group (not required for plasma solely for fractionation).
-Testing for the presence of the following infectious diseases among donors:
• Hepatitis B (HBs-Ag);
• Hepatitis C (Anti-HCV);
• HIV 1/2 (Anti-HIV 1/ 2).
Additional testing may be required for specific constituents or donors, or epidemiological situations.
