Dalius Vitkus

Accreditation of medical laboratories in the European Union

Abstract Background: Using a questionnaire, the EC4 (European Communities Confederation of Clinical Chemistry and Laboratory Medicine) has collated an inventory of the accreditation procedures for medical laboratories in the EU. Results and discussion: Accreditation of medical laboratories in the countries of the EU is mostly carried out in cooperation with national accreditation bodies. These national accreditation bodies work together in a regional cooperation, the European Cooperation for Accreditation (EA). Professionals are trained to become assessors and play a prominent role in the accreditation process. The extent of the training is diverse, but assessors are kept informed and up-to-date by annual meetings. The frequency of assessments and surveillance visits differs from country to country and ranges from 1 to 4 years. More harmonisation is needed in this respect, based on a frequency that can be pragmatically handled by laboratory professionals. In the majority of EA bodies, accreditation is carried out on a test-by-test basis. Many professionals would prefer accreditation of the entire service provided within the actual field of testing (i.e., haematology, immunology, etc.), with accreditation granted if the majority of tests offered within a service field fulfil the requirements of the ISO 15189 standard. The scope of accreditation is a major point of discussions between the EC4 Working Group on Accreditation and representatives of accreditation bodies in the EA Medical Laboratory Committee. Clin Chem Lab Med 2007;45:268–75.

The EC4 European Syllabus for Post-Graduate Training in Clinical Chemistry and Laboratory Medicine: version 4 - 2012

Abstract Laboratory medicine’s practitioners across the European community include medical, scientific and pharmacy trained specialists whose contributions to health and healthcare is in the application of diagnostic tests for screening and early detection of disease, differential diagnosis, monitoring, management and treatment of patients, and their prognostic assessment. In submitting a revised common syllabus for post-graduate education and training across the 27 member states an expectation is set for harmonised, high quality, safe practice. In this regard an extended ‘Core knowledge, skills and competencies’ division embracing all laboratory medicine disciplines is described. For the first time the syllabus identifies the competencies required to meet clinical leadership demands for defining, directing and assuring the efficiency and effectiveness of laboratory services as well as expectations in translating knowledge and skills into ability to practice. In a ‘Specialist knowledge’ division, the expectations from the individual disciplines of Clinical Chemistry/Immunology, Haematology/Blood Transfusion, Microbiology/ Virology, Genetics and In Vitro Fertilisation are described. Beyond providing a common platform of knowledge, skills and competency, the syllabus supports the aims of the European Commission in providing safeguards to increasing professional mobility across European borders at a time when demand for highly qualified professionals is increasing and the labour force is declining. It continues to act as a guide for the formulation of national programmes supplemented by the needs of individual country priorities.

Development of a functional whey beverage, containing calcium, vitamin D, and prebiotic dietary fiber, and its influence on human health

This study describes the development of a beverage made from curd whey with the addition of functional ingredients such as calcium, vitamin D3, prebiotic dietary fiber, and its influence on human health. Samples of beverages with added calcium phosphate or calcium lactate were analyzed for the selection of optimal calcium preparation. Quality attributes of beverages were evaluated in their fresh state and during storage at intervals of 15, 30, and 45 days. The beverage with calcium lactate was chosen as the one with most stable quality indices for evaluation of the effect on health status of volunteers (n=30). Five hundred milliliters of beverage were consumed daily by the volunteers over a period of 21 days. A significant decrease in low density lipoprotein (LDL)-cholesterol (P<0.01) and triglycerides (P<0.01) concentrations after consumption of functional whey beverage with calcium lactate, vitamin D3, and prebiotic dietary fiber was determined.

Patient’s knowledge and awareness about the effect of the over-the-counter (OTC) drugs and dietary supplements on laboratory test results: a survey in 18 European countries

Abstract Background Nowadays over-the-counter (OTC) drugs and dietary supplements are widely used. Their use can have a significant impact on the validity of laboratory results. The aim of this multicenter European study was to determine the frequency of consumption of various dietary products and OTC drugs among patients and explore their level of knowledge and awareness about the potential impact of various products on laboratory test results. Methods Eighteen European countries participated in this study. The survey was carried out anonymously on a subsequent series of outpatients (n=200) in each participating country. Included were patients who were referred to the laboratory for blood sampling and who voluntarily agreed to participate in the study. The survey included questions about the frequency of consumption of various products, awareness of the importance of informing physicians and laboratory staff about it and information about influence of preanalytical factors in general on laboratory test results. Results In total, 68% of patients were regularly taking at least one OTC drug or dietary supplement. The frequency of patients consuming at least one OTC drug or dietary supplement differed between countries (p=0.001). Vitamins (38%), minerals (34%), cranberry juice (20%), acetylsalicylic acid (ASA) (17%) and omega fatty acids (17%) were the most commonly used in our study. Conclusions The use of various OTC drugs and dietary supplements is highly prevalent in Europe and patients are often not willing to disclose this information to the laboratory staff and ordering physician. The education of both patients and healthcare staff is needed.

The European Federation of Clinical Chemistry and Laboratory Medicine syllabus for postgraduate education and training for Specialists in Laboratory Medicine: version 5 – 2018

Abstract Although laboratory medicine practise varies across the European Union’s (EU) member states, the extent of overlap in scope is such that a common syllabus describing the education and training associated with high-quality, specialist practise can be identified. In turn, such a syllabus can help define the common set of skills, knowledge and competence in a Common Training Framework (CTF) for non-medical Specialists in Laboratory Medicine under EU Directive 2013/55/EU (The recognition of Professional Qualifications). In meeting the requirements of the directive’s CTF patient safety is particularly enhanced when specialists seek to capitalise on opportunities for free professional migration across EU borders. In updating the fourth syllabus, the fifth expands on individual discipline requirements, new analytical techniques and use of statistics. An outline structure for a training programme is proposed together with expected responsibilities of trainees and trainers; reference is provided to a trainee’s log book. In updating the syllabus, it continues to support national programmes and the aims of EU Directive 2013/55/EU in providing safeguards to professional mobility across European borders at a time when the demand for highly qualified professionals is increasing in the face of a disparity in their distribution across Europe. In support of achieving a CTF, the syllabus represents EFLM’s position statement for the education and training that underpins the framework.

Fermented Buttermilk-Based Beverage: Impact on Young Volunteers' Health Parameters

Liutkevicius A., Speicienė V., Alencikienė G., Mieželienė A., Narkevicius R., Kaminskas A., Abaravicius J.A., Vitkus D., Jablonskienė V., Sekmokienė D. (2016): Fermented buttermilk-based beverage: impact on young volunteers’ health parameters. Czech J. Food Sci., 34: 143–148. The technology of a functional fermented buttermilk-based beverage was developed and the impact of beverage con sumption on the health parameters of young volunteers was studied. Three functional beverages were made on the basis of buttermilk, which differed in the composition. The beverage containing the buttermilk-skimmed milk-milk protein concentrate (0.3%) as a product with the preferred quality characteristics (synaeresis, viscosity, sensory properties, and acceptability) was used for further studies regarding the impact on human health. The medical nutrition experi ments did not show any statistically significant effect on the biochemical blood parameters of 25 young volunteers after a 21-day period of the consumption of fermented buttermilk beverage with milk protein concentrate, although some of them (e.g. total, low- and high-density cholesterol, triacylglycerol concentrations, etc.) slightly decreased. The anthropometric and body composition, arterial blood pressure, and pulse evaluation indicators of recipients did not change significantly.