Strengthening the capability of the Romanian blood transfusion system to comply with EU re-quirements for quality and safety of human blood and blood components


To strengthen the Romanian health authorities through capacity building for the implementation of the EU Directive 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC, in the Romanian Blood Transfusion System.

Specific objectives:

  • To develop and implement a national quality management system based on the principles of good practice and in compliance with EU Directive 2002/98/EC;
  • To set up a National register of voluntary non-remunerated regular donors in compliance with the provisions of Article 20 of Directive 2002/98/EC;
  • To design, develop and deploy to pilot operation an ITC System (Blood and Blood Products Processing and Distribution Information Management System) of limited scale and scope, to:
  1. support and facilitate the national quality system and management (update of QMS rule base as part of the information management system);
  2. ensure a cost effective transition from the current non quality managed Romanian Blood Transfusion Network to an EC directives compliant environment;
  3. deliver a sustainable ITC solution, which may cost-effectively evolve in time to a full scale and scope national Blood Transfusion Network (BTN) ITC solution;
  • To develop and implement technical requirements for an adequate storage, transport and distribution system to allow proper preservation of blood and blood components.
  • Proposal development
  • Provided M&E expert
  • Planning support to the team leader during initial situation analysis
  • Preparation and facilitation of the project planning workshop
  • Support to the team leader in the development of a M&E system
  • Support to the development and submission of the project reports
  • Continuous follow up of project progress
  • Preparation of the final conference