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Clinical Chemistry in Croatia: Regulation of the Profession

There is already a great deal of common regulation in clinical chemistry respective to the undergraduate and postgraduate education as well as the vocational training programs. However, the situation in some other non-EU countries is less well known. The purpose of this lecture is to review the current status of the standards of education and training of laboratory professionals as well as laboratory quality regulations and accreditation standards in Croatia. Clinical chemistry in Croatia is almost exclusively practiced by medical biochemists. There are 190 laboratories in Croatia and 536 registered medical biochemists. Clinical chemistry in Croatia comprises clinical chemistry, hematology and coagulation, immunology, toxicology and therapeutic drug monitoring, endocrinology and transfusion serology. Blood-banking, microbiology and cytogenetics are out of the scope of the clinical chemistry. Practicing the medical biochemistry is regulated through The Health Care Law, The Law of the Medical Biochemistry Profession and The Law of the State and Private Health Insurance. There are also some other regulatory documents issued by the Croatian Chamber of Medical Biochemists. The Law of the Medical Biochemistry Profession defines our profession and its scope, competencies and responsibilities. It furthermore explicitly defines responsibility and scope of activities for Croatian Chamber of Medical Biochemists. According to that law, only medical biochemists are entitled to run and work in the medical biochemistry laboratory. University degree (Master of Science) is earned after the 5 years of the studies. ECTS credits are assigned to all subjects and are fully transmittable among other universities in Croatia as well as across Europe. Faculty of Pharmacy and Biochemistry also provides the postgraduate education within the four year of Doctoral studies. Register for medical biochemists is kept by the Croatian Chamber of Medical Biochemists (CCMB). Upon graduation, medical biochemists enter the one year program of supervised practical training in laboratory. After completion of that training, a State exam has to be taken. Exam is organized by the Croatian Ministry of Health and is mandatory. After completed training and exam, medical biochemist becomes registered as a member of CCMB and gets the license for independent work. License is valid for 6 years. During that period credits are earned within the program of continuous education provided by the CCMB. Licensing is regulated by the government (Law on the Health Care, 1993) and is mandatory. Vocational training (44 months) for medical biochemists is regulated by the national regulatory document issued by the Ministry of Health. Training program consists of 1 year postgraduate study and 4 years of obligatory vocational training in designated hospitals and fully matches the European Syllabus. Final examination after vocational training is obligatory and is under the responsibility of the Ministry of Health. Accreditation is not mandatory in Croatia. There are only two medical biochemistry laboratories so far accredited according to ISO 15189. Accreditation is provided by the Croatian Accreditation Agency, an independent, non-commercial national accreditation institution. Being the candidate country for joining the European Union, Croatia has invested a lot of efforts to be prepared for the common platform for clinical chemists in terms of their education and training, everyday practices and other relevant issues.

Clinical Chemistry; Croatia: Regulation of the Professio

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