Організація та державне регулювання діяльності служби крові в Україні

Problem setting. Transfusion medicine is one of strategic elements of national health service system in Ukraine, which has extremely significant importance in almost all spheres of medical care. The principal task of transfusion medicine is providing health care institutions with quality, safe and effective blood components and blood preparations in sufficient amount, which, in its turn, directly effects life saving of millions of patients.In Ukraine effective state policy and organizational structure of blood supply service is absent, which renders impossible centralized management and unified supervision (control) in this sphere. The immediacy of the problem is emphasized by the fact that during war conflict in Eastern Ukraine, from 12.03.2020 for already five months quarantine is established at all Ukrainian territory to prevent the spread of acute respiratory disease COVID-19, caused by virus SARS-CoV-2. As the result, donors are lacking, and it is impossible to manage the transfusion remedies stocks.Considering the above said and taking into consideration state priorities for providing equal and timely patients access to quality and safe donor blood components in sufficient amount, it is necessary to create effective organizational structure of blood supply service, as an integral part of health care system.Recent research and publications analysis. The performed analysis of scientific, analytical and regulatory documentation showed that in Ukraine the issue of blood supply service reformation was studied by such researchers, as: Perekhrestenko P.M., 2008; Chugriev А.M., 2011; Tereshchiuk Т.О., 2012; Liubchak V.О. Tymchenko А.S., Liuvchak V.V., 2014; Novak V.L., 2014. At the same time, considering high importance if this problem the scientific research from the position of state policy is virtually absent. Whereas in world practice the governments are paying significant attention to the processes of organization of stocking of high-quality donor plasma, and focus on creation of global standards (norms and recommendations of World Health Organization, Council of Europe, European Pharmacopeia and European Commission).Therefore, implementation of European standards and recommendations for creation and securing of quality blood components and blood preparations in the practice of blood supply service institutions should become the basis of successful reforms and approaching of our country to international community. Besides, reformation of blood donor system in Ukraine is one of the requirements of EU to Ukraine, mentioned in the Agreement on Association between Ukraine, on the one part, and European Union, European Atomic Energy Society and respective member-states, on the other part.The paper objective – to analyze the acting structure of Ukraine blood supply service in respect of provision of population with quality, safe and effective blood components and blood preparations, determine the unsolved problems in this sphere, and propose the ways of their resolution.The paper main body. The performed analysis of structure and organization of donor services of blood and blood components in Ukraine shows that the organizational structure of blood supply service in Ukraine is decentralized by institutional and territorial parameters and characterized by permanent lacking of such important recourses, as finances, material-technical base and personnel. As the result, the blood supply system elements are functioning inappropriately; it is impossible to secure the proper condition of infectious and immunological safety, and impossible to guarantee equal and timely access of citizens to quality and safe donor blood components in sufficient amount.The analysis of legal and regulatory bases, regulating blood products trade in Ukraine shows that in Ukraine actual legislative and normative-regulatory basis is absent. Thus, the state uncertainty towards implementing general program of voluntary chargless blood donor services, non-implementation of requirements to licensing of blood supply service institutions in Ukraine, absence of unified surveillance (control) over the activities of blood supply service institutions, inappropriate material-technical basis and lack of qualified personnel negatively affect the development of the industry in general and, again, cause the decrease of the number of donors in all regions of Ukraine.The problem of lack of donors and absence of state organizational policies on their rapid involvement is particularly acute for the restrictions, introduced in Ukraine due to spread of acute respiratory viral disease COVID-19, caused by coronavirus  SARS-CoV-2 (further referred to as - COVID-19). Even active donors refuse to perform planned donations.The experience of other world countries was studied on provision of permanent safety and availability of blood supply, as well as principal standards of quality and safety for stocking, testing, processing, storage and distribution of human blood and blood components. The mentioned analysis allows systematizing strong areas of modern transfusion practice, which is based on the principle of voluntary donor services.Conclusions of the research. After analyzing state policies and modern condition of the trade with blood preparations in Ukraine, organizational structure and regulatory basis of Ukrainian blood supply service, the conclusion can be made that the current organizational structure of blood supply service does not correspond to world standards on quality and safety of stocking, testing, processing, storage and distribution of human blood and its components. This, further, causes inappropriate medical provision of Ukrainian citizens with blood components and blood preparations, impossibility to secure the appropriate level of infectious and immune-biological safety, absence of unified supervision (control), inefficiency of the industry financing and lack of material-technical and human recourses.In order to secure equal and timely patients’ access to quality and safe donor blood components in sufficient amount, the following principal directions of improvement of blood supply service organizational structure and donor services in Ukraine are proposed:- creating effective organizational structure of blood supply service, as an integral part of health care system, which should secure at the state level the trade of blood components and blood preparations in Ukraine, namely: organization of donor services, stocking, processing, testing, storage, use, disposal, distribution, sale, transportation, import to Ukrainian territory, export from Ukrainian territory, transit through Ukrainian territory, along with appropriate use of blood components and blood preparations for medical purposes;- creating authorized central organ of executive power, securing clear division of functions, responsibilities and obligations at all organizational levels;- approving at the country level organization of proper blood donor services in Ukraine and creating the prerequisites for the development of voluntary nd chargless donor movement;- creating appropriate regulatory base, implementing personnel policy, providing adequate financing.