The regulation of clinical chemistry in Slovenia

The practice of medical biochemistry in Slovenia includes clinical biochemistry (including toxicology, therapeutic drug monitoring, endocrinology, molecular diagnostics, immunology), hematology and coagulation. To start the vocational medical biochemistry training programme it’s necessary to have a completed university degree (second cycle) in pharmacy, chemistry, biochemistry, medicine or other relevant university study and 1 year supervised practical training in medical laboratories, completed with mandatory state exam at Ministry of Health. The duration of vocational training programme is 4 years and is completed with final exam. The title after passed final examination is Medical biochemistry specialist. In October 2005 EC4 (Communities Confederation of Clinical Chemistry and Laboratory Medicine) approved Equivalence of standards of Slovenian national standards for medical biochemistry specialists. Since 2006 it is mandatory to be registered and to have valid license for medical biochemistry specialists and other professionals in laboratory medicine with at least university degree (second cycle) of education.

Laboratory medicine in Slovenia is regulated globally through the Law of health-care activity and particularly through the Bylaw of laboratory medicine. The latter is based on standard ISO 15189, ratified in 2004. The Bylaw envisages granting working license to laboratories, valid for 5 years period. Granting of working licenses is ongoing process and first licenses have been granted in 2009. Important improvement toward the quality requirements for medical laboratories can be observed in the last 5 years. Parallel with the Bylaw of medical laboratories, Slovenian Accreditation (SA), the legal national accreditation body, started the initiative for accreditation of medical laboratories according to ISO 15189. It is in the implementation phase.