Education and Recognition of Professional Qualifications in the Field of Medical Biochemistry in Serbia
Medical biochemistry is the usual name for clinical biochemistry or clinical chemistry in Serbia, and medical biochemist is the official name for the clinical chemist (or clinical biochemist). This is the largest sub-discipline of the laboratory medicine in Serbia. It includes all aspects of clinical chemistry, and also laboratory hematology with coagulation, immunology, etc. Medical biochemistry laboratories in Serbia and medical biochemists as a profession are part of Health Care System and their activities are regulated through: the Health Care Law and rules issued by the Chamber of Medical Biochemists of Serbia. The first continuous and organized education for Medical Biochemists (Clinical Chemists) in Serbia dates from 1945, when the Department of Medical Biochemistry was established at the Pharmaceutical Faculty in Belgrade. In 1987 at the same Faculty a five years undergraduate branch was established, educating Medical Biochemists under a special program. Since school-year 2006/2007 the new five year undergraduate (according to Bologna Declaration) and postgraduate program of four-year specialization according to EC4 European Syllabus for Post-Gradate Training in Clinical Chemistry and Laboratory Medicine has been established. The Ministry of Education and Ministry of Public Health accredits the programs. There are four requirements for practicing medical biochemistry in the Health Care System: University Diploma of the Faculty of Pharmacy (Study of Medical Biochemistry), successful completion of the profession exam at the Ministry of Health after completion of one additional year of obligatory practical training in the medical biochemistry laboratories, membership in the Serbian Chamber of Medical Biochemists and licence for skilled work issued by the Serbian Chamber of Medical Biochemists. The process of recognition of a foreign higher education document for field of medical biochemistry is initiated on request by Candidate. The process of recognition of foreign higher education documents is performed by the University. In the process of recognition in Serbia national legislations are applied as well as international legal documents of varying legal importance.
What is a Biomarker? From its Discovery to Clinical Application
The term biomarker in medicine most often stands for a protein measured in the circulation (blood) whose concentration indicates a normal or a pathological response of the organism, as well as a pharmacological response to the applied therapy. From a wider perspective, a biomarker is any indicator that is used as an index of the intensity of a disease or other physiological state in the organism. This means that biomarkers have a very important role in medical research and practice providing insight into the mechanism and course of a disease. Since a large number of biomarkers exist today that are used for different purposes, they have been classified into: 1) antecedent biomarkers, indicating risk of disease occurrence, 2) screening biomarkers, used to determine a subclinical form of disease, 3) diagnostic biomarkers, revealing an existing disease, 4) staging biomarkers, that define the stage and severity of a disease, and 5) prognostic biomarkers, that confirm the course of disease, including treatment response. Regardless of their role, their clinical significance depends on their sensitivity, specificity, predictive value, and also precision, reliability, reproducibility, and the possibility of easy and wide application. For a biomarker to become successful, it must undergo the process of validation, depending on the level of use. It is very important for every suggested biomarker, according to its purpose or its nature, to possess certain characteristics and to meet the strict requirements related to sensitivity, accuracy and precision, in order for the proper outcome to be produced in the estimation of the state for which it is intended. Finally, the development of guidelines for biomarker application is very important, based on well defined and properly conducted assessments of biomarker determination, providing the means by which research is translated into practice and allowing evidence based on facts to promote the clinical application of new biomarkers.
During 15th Belgrade Symposium for Balkan Region (April 11 and 12, 2019, Belgrade, www.dmbj.org.rs) Society of Medical Biochemists of Serbia organized scientific and professional program with aim to discuss laboratory medicine topics of mutual interest for all the countries of the Region, such as:
Laboratory Medicine Planning and Organization
Type of Medical Laboratory and Strategy
Laboratory Medicine Management
Accreditation and Competences
Environmental Health and Safety
Laboratory Standards in Balkan Countries
Experiences of Young Scientists
Together with the countries from Balkan Region the countries from our neighborhood as Italy, Austria, Hungary, Cyprus and Israel have been invited to discuss this important topics and exchange the mutual experiances with aim to improve the laboratory medicine in our countries and to help our colleagues to improve daily laboratory practice in our countries. Also participation in the Symposium took colleagues from France and Belgium.
As one of the leading causes of death within both the developed and developing world, stroke is a world-wide problem. About 80% of strokes are ischemic. It is caused by multiple genetic factors, environmental factors, and interactions among these factors. There is a long list of candidate genes that have been studied for a possible association with ischemic stroke. Among the most widely investigated genes are those involved in haemostasis, inflammation, nitric oxide production, homocysteine and lipid metabolism, renin-angiotensin-aldosterone system. Combined link-age/association studies have demonstrated that genes encoding PDE4D and ALOX5AP confer risk for stroke. We review the studies of these genes which may have potential application on the early diagnosis, prevention and treatment ischemic stroke patients.
Myeloperoxidase (MPO) is a member of the heme peroxidase-cyclooxygenase superfamily. It is abundantly expressed in neutrophils and monocytes. During inflammation MPO is released from leukocytes and catalyzes the formation of several reactive species and tissue damage. In this article we present state of the art knowledge on the general properties, biosynthesis and processing and trafficking of MPO. The basic functions of MPO in inflammation and oxidative stress are discussed in detail. This article also summarizes the studies that investigated the relationship between MPO and cardiovascular disease. An overview of the assays for determination of MPO, the sample type and preanalytical procedures is given. Future studies are needed before this marker is introduced into routine clinical practice.
Quality indicators are tools that allow the quantification of quality in each of the segments of health care in comparison with selected criteria. They can be defined as an objective measure used to assess the critical health care segments such as, for instance, patient safety, effectiveness, impartiality, timeliness, efficiency, etc. In laboratory medicine it is possible to develop quality indicators or the measure of feasibility for any stage of the total testing process. The total process or cycle of investigation has traditionally been separated into three phases, the pre-analytical, analytical and post-analytical phase. Some authors also include a »pre-pre« and a »post-post« analytical phase, in a manner that allows to separate them from the activities of sample collection and transportation (pre-analytical phase) and reporting (post-analytical phase). In the year 2008 the IFCC formed within its Education and Management Division (EMD) a task force called Laboratory Errors and Patient Safety (WG-LEPS) with the aim of promoting the investigation of errors in laboratory data, collecting data and developing a strategy to improve patient safety. This task force came up with the Model of Quality Indicators (MQI) for the total testing process (TTP) including the pre-, intra- and post-analytical phases of work. The pre-analytical phase includes a set of procedures that are difficult to define because they take place at different locations and at different times. Errors that occur at this stage often become obvious later in the analytical and post-analytical phases. For these reasons the identification of quality indicators is necessary in order to avoid potential errors in all the steps of the pre-analytical phase.
The effect of Hyperglycemia and Oxidative Stress on the Development and Progress of Vascular Complications in Type 2 Diabetes
Oxidative stress is the result of increased production of free radicals, which impair the cell function and cause many pathological conditions and diseases. The development of diabetes, its course and complications are closely associated with an imbalance in pro-antioxidative cell state and change of redox potential. Prolonged exposure to hyperglycemia is currently considered the major factor of the pathogenesis of atherosclerosis in diabetes. Atherosclerosis is the cause of about 80% of mortality in diabetics, and over 75% of all hospitalized diabetic patients have associated cardiovascular complications. Hyperglycemia induces different vascular tissue damage at the cellular level, which potentially accelerates the atherosclerotic processes. The most significant mechanisms responsible for acceleration of atherosclerotic processes in diabetic patients are: a) non-enzymatic protein and lipid glycosylation which interferes with normal function, in the way that it deranges molecular conformation, impairs enzymatic function, reduces the capacity of breakdown and interferes with recognition of protein structures by receptors; b) interaction of glycosylated proteins with their receptors resulting in induction of oxidative stress and pro-inflammatory reactions; c) polyol pathway; d) hexosamine pathway and e) activation of protein kinase C and impaired growth factor expression.
Primena »Six Sigma« U Kontroli Kvaliteta Zdravstvenih Laboratorija
Cilj svakog postupka ili proizvodnog sistema je dobijanje dobrog proizvoda. Većina metoda kontrole kvaliteta je inicijalno razvijena da pomogne industrijsku proizvodnju. Ovo ne predstavlja iznenađenje s obzirom da masovna proizvodnja tipično zahteva mnogo ponavljanja koje uključuju kontrolisani redosled operacija. Nisu svi prilazi kontroli kvaliteta podjednako efikasni. Neusaglašenosti koje postoje u laboratorijskom određivanju su u osnovi uzrokovane kako prekomernim varijacijama u procesu, tako i greškama. Ključni nedostatak u primeni metoda statističke kontrole kvaliteta ležKi u činjenici da su neefikasne u detekciji i kontroli grešaka, a one danas predstavljaju najdominatniji uzrok neusaglašenosti većine organizacionih procesa. Statističkom kontrolom kvaliteta mogu efikasno da se kontrolišu varijacije u procesu, ali ne mogu da se detektuju ili spreče greške. »Six Sigma« pripada statističkoj kontroli kvaliteta koja pružKa novu metodologiju za merenje karakteristika procesa, a takođe usavršava prethodne metodologije čime dolazi do unapređenja procesa. MenadžKment zasnovan na »Six Sigma« kvalitetu polako ulazi u zdravstvene organizacije pri čemu nudi realnu nadu za unapređenje razmišljanja i procesa menadžKmenta kvaliteta. Jedan od razloga je što se »Six Sigma« fokusira na defekte koji za uzvrat zahtevaju da ciljevi za dobar kvalitet budu definisani. »Six Sigma» pružKa univerzalnu metodologiju kojom se meri kvalitet time što se broje defektni proizvodi, pri čemu se određuje stopa defektnih proizvoda kao »defekti na milion» (»defects per million» ili »DPM»), a koji se zatim konvertuju u »Sigma metriku» uz korišćenje standradnih tabela koje su dostupne u svakom tekstu vezanom za »Six Sigma». »Sigma metrikom» se »Six Sigma» pojednostavljuje i dobija univerzalni »reper» koji govori o karakteristikama procesa. Na ovaj način svi procesi mogu da se okarakterišu na »Sigma skali.« Tipično se vrednosti nalaze između 2 i 6, pri čemu je cilj postizanje »svets- ke klase kvaliteta» koja iznosi 6. Na osnovu podataka koji potiču iz stvarnog sveta zdravstvenih laboratorija očigledno se možKe zaključiti da je izvođenje operacija na današnjim instrumentima dobro. Nova generacija kliničkih analizatora je postigla jako visoku «Sigma metriku«. Korisnici zdravstvene zaštite mogu da užKivaju u novoj eri napretka sa instrumentima i metodama nivoa 6 Sigma ili višim.