The National Institute for Transfusion Medicine (NITM) is the major institution in Macedonia responsible for transfusion service and comprises of 3 regional centres and 18 hospital units. The existing variations in the use of blood and blood products between hospitals impose the need for implementing internationally accepted optimal standards defining quality in terms of appropriate use of blood resources. The reorganisation of the blood transfusion system that has already taken place in a new organisational set up is targeted to enable implementation of EU standards and norms of quality and safety, during the process of collection, testing, processing, storage, and distribution into daily practice.
This project was envisaged to improve the quality of transfusion service and its health professionals with a focus on the improvement of common policies and training of health professionals. Henceforth, this project will serve as a basis for further strengthening and capacity building of the blood transfusion system in Macedonia.
Analysis of existing guidelines and Standard Operating Procedures (SOP); selection of existing reviewed guides and essential guidelines of the Council of Europe (CoE), which were carefully reviewed for harmonization with NITM capacities to utilize resources in line with EU guidelines and subsequently translated in Macedonian language. After approval of the beneficiary, the translation was published and used for capacity building and for the planned training sessions for quality management. During the training, experts have learned how to convert existing SOPs and guidelines into EU accepted format.
Training of 12 transfusion specialists in quality management in Slovenia for 10 days; training of 30 transfusion specialists for 3 days in Skopje; training of 150 employees of the NITM and 30 State sanitary and health inspectors of the Ministry of Health in quality management in Skopje. Pre- and post-assessments indicated significant improvement of knowledge of the participants of the courses. Also the courses were highly appreciated by the participants, as indicated by anonymized questioning.
Two essential books on Quality Management (QM), i.e. a book with SOP containing 54 current SOP according to EUBIS format and a book with 50 Guidelines on safety and quality of blood and blood components have been produced. All SOP and guidelines are also registered in a web-based document management system (DMS) and accessible online for employees of the blood transfusion organization (BTO) in the whole of Macedonia.
The Guide to the preparation, use and quality assurance of blood components of the CoE 17th edition 2013 was translated in Macedonian language and published in hard cover as well as on the website of the NITM. In the Guide all regulations according to EU standards are formulated, necessary to comply with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
Software for DMS was provided by NITM, and it was further customized to serve the needs of the NITM. A web-based DMS was established according to user requirement specifications (URS). The DMS was validated and accepted by the NITM. All documents related to quality (SOPs, regulations, audit results etc.) can be registered in the DMS. All employees at NITM, regional and hospital centers can have access to the DMS. 52 NITM personnel were trained on proper use of DMS.
A master plan was established, in which the project team gave its vision how the Macedonian BTO should proceed in the next years to benefit optimally from the unified system and how a quality system, including hemovigilance, should be further implemented, with the aim to comply with GMP, GLP and GCP, as required by EU standards.