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LAW OF UKRAINE

of September 30, 2020 No. 931-IX

About safety and quality of donor blood and components of blood

(as amended of the Law of Ukraine of 15.12.2021 No. 1962-IX)

This Law determines legal and organizational basis of state policy by the organization of procurement, testing, conversion, storage, distribution, transportation and realization of donor blood and components of blood, functioning of system of blood, determines standards of safety and quality of donor blood and components of blood for the purpose of ensuring equal access of the population of Ukraine to high-quality and safe components of donor blood in necessary amount, the organization of the address of donor blood and components of blood, safety and health of blood donors and components of blood, and also their recipients, protection of their rights and legitimate interests.

This Law is drafted for the purpose of adaptation of the legislation of Ukraine to acquis of the European Union in pursuance of the Agreement on association between Ukraine, on the one hand, and the European Union, European Atomic Energy Community and their state members, on the other hand.

Section I General provisions

Article 1. Determination of terms

1. In this Law the stated below terms are used in such value:

1) autologichny donation - donation of blood and components of blood which are prepared from one person and are intended only for the subsequent autologichny transfusion or other application to this person;

2) autologichny transfusion - transfusion in case of which the donor and the recipient are one person, for which in advance prepared blood and components of blood are used;

3) aferez - method of receipt of components of blood by means of machine conversion of whole blood in case of which residual components of blood return to the donor to time or at the end of process;

4) validation - establishment of the objective and documented proofs of that certain requirements to specially intended application to fulfill perhaps consistently;

5) the responsible person - person, authorized and specially appointed the subject of system of blood which is responsible for safety issues and qualities of donor blood and components of blood within activities of appropriate subject;

6) tracking - process of studying of the report on the suspect, adverse reaction at the recipient connected with transfusion for identification of potentially involved donor;

7) discharge from donorship - the permanent or temporary termination of the admission of physical person to donorship of blood or components of blood;

8) haemo supervision - enrollment of procedures of organized supervision and the control connected with serious adverse or adverse cases or reactions at donors or recipients and also further epidemiological observation of donors and recipients;

9) voluntary non-paid donorship - implementation by the donor of donation of blood and/or components of blood voluntarily and without receipt of the monetary reward for such donation (in the form of cash or in any other form which can be considered as equivalent of money), except small souvenirs, light meals and cost recovery on the road;

10) donorship of blood and components of blood - the voluntary act of the person which consists in donation of blood and/or components of blood for their further use for transfusion, production of medicines, medical products or use in scientific research;

11) quality assurance - activities at all stages - from procurement of blood and components of blood before their distribution which is performed for providing the quality level of blood and components of blood necessary for their target use;

12) inspection (inspection) - official and objective event of the state supervision (control) which is held by authorized body in accordance with the established procedure for check of compliance to the requirements established by this Law and other regulatory legal acts and for detection of discrepancies;

13) qualification - component of validation which consists in check of correctness of work and provision of the expected results by any personnel, rooms, the equipment or materials;

14) blood component - therapeutic component of blood (erythrocytes, leukocytes, platelets, plasma) which can be prepared by different methods;

15) quality control - constituting quality systems, oriented to ensuring compliance on quality of blood and components of blood;

16) blood - the whole blood prepared from the donor, processed and intended for transfusion or for further use as initial material (raw materials) in the production purposes;

17) laboratory of transfusion immunology - the structural division of the subject of managing providing services in transfusion of blood and/or components of blood as a part of hospital bank of blood or clinical laboratory which conducts isoserological and immunohematologic researches before transfusions;

18) hospital bank of blood - the division of the subject of the managing providing services in transfusion of components of blood (healthcare institution) which stores distributes and can carry out tests for compatibility of blood and components of blood for use exclusive by such subject of managing for transfusion of blood and/or components of blood to recipients;

19) hospital transfuziologichesky committee - the advisory (coordination) collegiate organ created by the subject of managing, providing services in transfusion of components of blood, determining the organization and the procedure for rendering the transfusion help ensuring and controlling its quality and safety for the patient in cooperation with subjects of system of blood, hospital bank of blood, laboratory of transfusion immunology and health workers;

20) proper practice - all elements of the established practice which use provides compliance of blood and components of blood to previously determined specifications and regulations;

21) No. 1962-IX Is excluded according to the Law of Ukraine of 15.12.2021

22) National transfuziologichesky committee - advisory collegiate organ which is formed for provision of professional consultations and the help with questions of realization of state policy in the sphere of donorship of blood and components of blood, procurement, testing, conversion, storage, distribution and realization of donor blood and components of blood, the solution of technical issues at the nation-wide level, project developments of regulatory legal acts of the Cabinet of Ministers of Ukraine and the central executive body which provides forming and realizes state policy in health sector, orders of the National transfuziologichesky center, strategic plans of development, actions for development of system of blood, and also instructions, education guidances, methodical recommendations, etc.;

23) the National transfuziologichesky center - the legal entity of the public law created by the central executive body which provides forming also realizes state policy in health sector, or structural division of the central executive body which provides forming and realizes state policy in health sector which promotes realization of state policy in the sphere of donorship of blood and components of blood, regarding coordination of activities of subjects of system of blood, management and monitoring of execution of state programs by such subjects, and also provides methodical management in the sphere of donorship of blood and components of blood;

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