LEGAL AND REGULATORY FRAMEWORK OF BLOOD ESTABLISHMENTS OF UKRAINE
Keywords:
legal and regulatory framework, blood service, statistical reporting forms, haemovigilance system, legislation of the European Union.Abstract
Purpose: to determine the status of legal and regulatory that regulates activities of blood service establishments of Ukraine as of 01.01.2013.
Materials and methods. Operating documents that regulated activity of blood service in Ukraine were studied.
Results. It is established that the activities of blood service establishments in Ukraine regulating 107 legal acts, including 15 Laws of Ukraine, 2 Decrees of the President of Ukraine, 16 Resolutions of the Cabinet of Ministers of Ukraine, 37 Orders of Ministry of Health of Ukraine, 14 intergovernmental orders, 9 Orders of Ministry of Health of USSR and Ukrainian SSR, 1 Resolution of the USSR State Committee on standards and 10 guidelines of Ministry of Health and National Academy of Medical Sciences of Ukraine. Have limitation period up to 5 years 19 acts, from 5–10 years – 25 documents, from 10 to 15 years – 35 certificates, from 15 to 20 years – 13 acts, from 20 to 25 years – 8 acts and 25–40 years have 7 legal and regulatory acts.
Conclusions. The standard base of blood service of Ukraine demands harmonisation with recommendations and resolutions WHO and the Council of Europe, Guidelines on production, use and quality assurance of blood components.
References
Moskalenko V. F. Pryntsypy pobudovy optymalʹnoyi systemy okhorony zdorovʺya. Ukrayinsʹkyy kontekst / V. F. Moskalenko. – K. : Knyha plyus, 2008. – S. 10.
Pro zahalʹnoderzhavnu prohramu adaptatsiyi zakonodavstva Ukrayiny do zakonodavstva Yevropeysʹkoho Soyuzu : Zakon Ukrayiny № 1620-IV vid 18 bereznya 2004 r. // Vidomosti Verkhovnoyi Rady Ukrayiny. – 2004. – № 29. – S. 367.
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