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.     

Clinical chemistry and laboratory medicine in Croatia: regulation of the profession

Heterogeneity exists across Europe in the definition of the profession of clinical chemistry and laboratory medicine and also in academic background of specialists in this discipline. This article provides an overview of the standards of education and training of laboratory professionals and quality regulations in Croatia. Clinical chemistry in Croatia is almost exclusively practiced by medical biochemists. Although term Medical biochemist often relates to medical doctors in other European countries, in Croatia medical biochemists are not medical doctors, but university degree professionals who are qualified scientifically. Practicing the medical biochemistry is regulated by The Health Care Law, The Law of the Medical Biochemistry Profession and The Law of the State and Private Health Insurance. According to the law, only medical biochemists are entitled to run and work in the medical biochemistry laboratory. University degree is earned after the 5 years of the studies. Register for medical biochemists is kept by the Croatian Chamber of Medical Biochemists. Licensing is mandatory, valid for 6 years and regulated by the government (Law on the Health Care, 1993). Vocational training for medical biochemists lasts 44 months and is regulated by the national regulatory document issued by the Ministry of Health. Accreditation is not mandatory and is provided by an independent, non-commercial national accreditation body. The profession has interdisciplinary character and a level of required competence and skills comparable to other European countries.     

Laboratory medicine education in Lithuania

In Lithuania there are two types of specialists working in medical laboratories and having a university degree: laboratory medicine physicians and medical biologists. Both types of specialists are officially being recognized and regulated by the Ministry of Health of Lithuania. Laboratory medicine physicians become specialists in laboratory medicine after an accredited 4-year multidisciplinary residency study program in Laboratory Medicine. The residency program curriculum for laboratory medicine physicians is presented. On December 9, 2009 the Equivalence of Standards for medical specialists was accepted and Lithuanian medical specialists in Clinical Chemistry and Laboratory Medicine can now apply for EC4 registration. Medical biologists become specialists in laboratory medicine after an accredited 2-year master degree multidisciplinary study program in Medical Biology, consisting of 80 credits. Various postgraduate advanced training courses for the continuous education of specialists in laboratory medicine were first introduced in 1966. Today it covers 1-2-week courses in different subspecialties of laboratory medicine. They are obligatory for laboratory medicine physicians for the renewal of their license. It is not compulsory for medical biologists to participate in these courses. The Centre of Laboratory Diagnostics represents a place for the synthesis and application of the basic sciences, the performance of research in various fields of laboratory medicine, as well as performance of thousands of procedures daily and provision of specific teaching programs.     

Harmonization of pre-analytical quality indicators

Quality indicators (QIs) measure the extent to which set targets are attained and provide a quantitative basis for achieving improvement in care and, in particular, laboratory services. A body of evidence collected in recent years has demonstrated that most errors fall outside the analytical phase, while the pre- and post-analytical steps have been found to be more vulnerable to the risk of error. However, the current lack of attention to extra-laboratory factors and related QIs prevent clinical laboratories from effectively improving total quality and reducing errors. Errors in the pre-analytical phase, which account for 50% to 75% of all laboratory errors, have long been included in the ‘identification and sample problems’ category. However, according to the International Standard for medical laboratory accreditation and a patient-centered view, some additional QIs are needed. In particular, there is a need to measure the appropriateness of all test request and request forms, as well as the quality of sample transportation. The QIs model developed by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is a valuable starting point for promoting the harmonization of available QIs, but further efforts should be made to achieve a consensus on the road map for harmonization.     

The state and the problems of the education in the sphere of clinical laboratory diagnostics in Ukraine

The question of the medical laboratories staff training is currently in the focus of attention in Ukraine. Laboratory technicians with a college degree are prepared in the medical colleges for two or four years depending on school educational level. During their practice they are assessed every five years on completing the additional improving course. The position and their job responsibilities are defined by the Ministry of Health Protection. Bachelors of clinical laboratory diagnostics (CLD) are trained in medical universities obtaining the appropriate license. The position and their job responsibilities are similar to laboratory technicians' ones. The CLD specialists are prepared by the CLD departments in the medical academies of postgraduate education or medical universities' faculties of postgraduate studies. Those graduates, who have already acquired a degree in Medicine or Biology are eligible for the training program. Biologists pass courses of specialization for five month whereas doctors pass the specialization for ten month including four month practice. If the doctors wish, they can do the masters degree program within doing the specialization. However, because their position and job responsibilities are not determined by the Ministry of Health Protection of Ukraine, masters are allowed to practice their profession at the level of specialists. The specialists that practice clinical biochemistry, laboratory immunology, microbiology and medical genetics have to take the additional appropriate two-three month specialization courses. During their practice, specialists are assessed every five years. For assessment the commission takes into account the quantity of credits that a specialist has received within five years. Credits are earned for attending the scientific conferences, publishing scientific works, books or handbooks, professional training and pre-assessment module courses. The position and their responsibilities are defined by the Ministry of Health Protection of Ukraine. Currently there is no system in Ukraine for higher academic education for professionals in clinical laboratory diagnostics. We are aware of this fact and are committed to the improvement of the Ukrainian teaching clinical laboratory diagnostics system.     

Croatian Society of Medical Biochemistry and Laboratory Medicine: national recommendations for venous blood sampling

Phlebotomy is one of the most complex medical procedures in the diagnosis, management and treatment of patients in healthcare. Since laboratory test results are the basis for a large proportion (60–80%) of medical decisions, any error in the phlebotomy process could have serious consequences. In order to minimize the possibility of errors, phlebotomy procedures should be standardised, well-documented and written instructions should be available at every workstation. Croatia is one of the few European countries that have national guidelines for phlebotomy, besides the universally used CLSI (Clinical Laboratory Standards Institute) H3-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; approved Standard-Sixth Edition (CLSI, 2007) and WHO (World Health Organization) guidelines on drawing blood: best practices in phlebotomy (WHO, 2010). However, the growing body of evidence in importance of preanalytical phase management resulted in a need for evidence based revision and expansion of existing recommendations.The Croatian Society for Medical Biochemistry and Laboratory Medicine, Working Group for the Preanalytical Phase issued this recommendation. This document is based on the CLSI guideline H3-A6, with significant differences and additional information.     

Reference intervals: current status,recent developments and future considerations

Reliable and accurate reference intervals (RIs) for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations. Since the 1980s, the International Federation of Clinical Chemistry (IFCC) has been proactive in establishing recommendations to clarify the true significance of the term ‘RIs, to select the appropriate reference population and statistically analyse the data. The C28-A3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of reference in this area. In recent years, protocols additional to the Guideline have been published by the IFCC, Committee on Reference Intervals and Decision Limits (C-RIDL), including all details of multicenter studies on RIs to meet the requirements in this area. Multicentric RIs studies are the most important development in the area of RIs. Recently, the C-RIDL has performed many multicentric studies to obtain common RIs. Confusion of RIs and clinical decision limits (CDLs) remains an issue and pediatric and geriatric age groups are a significant problem. For future studies of RIs, the genetic effect would seem to be the most challenging area.
The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs.Key words: multicenter study, common reference intervals, reference values, clinical decision limits, genetic information     

基于培养“具有创新能力医学生”生物化学实验课程改革的探索与实践

医学院校应积极探索培养高素质创新型人才的途径和方法,以培养“具有创新能力医学生”为己任,为国家培养优秀的医学人才。生物化学是医学重要的基础课程和核心课程,生物化学实验课更具直观性、实践性和创新性,在加强学生综合素质教育与能力培养方面具有举足轻重的作用。本实验室经过三年的探索与实践,初步建立起一套培养学生创新能力的生物化学实验课程,旨在能全方位、多层次地锻炼学生的综合创新意识,培养创新能力。     

Continuing professional development crediting system for specialists in laboratory medicine within 28 EFLM national societies

Introduction:

Continuing professional development (CPD) with corresponding crediting system is recognized as essential for the laboratory medicine specialists to provide optimal service for the patients. Article presents results of the survey evaluating current CPD crediting practice among members of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).

Materials and methods:

A questionnaire had been forwarded to presidents/national representatives of all EFLM members, with invitation to provide information about CPD programmes and crediting policies, as well as feedback on individual CPD categories, through scoring their relevance.

Results:

Complete or partial answers were received from 28 of 38 members. In 23 countries, CPD programmes exist and earn credits, with 19 of them offering access to non-medical scientists. CPD activities are evaluated in all participating countries, regardless to the existence of an official CPD programme. Among participating members with mandatory specialists’ licensing (22/28), CPD is a prerequisite for relicensing in 13 countries. Main categories recognized as CPD are: continuing education (24 countries), article/book (17/14 countries) authorship and distance learning (14 countries). The highest median score of relevance (20) is allocated to professional training, editor/authorship and official activities in professional organizations, with the first category showing the least variation among scores.

Conclusions:

Majority of EFLM members have developed CPD programmes, regularly evaluated and accompanied by crediting systems. Programmes differ in accessibility for non-medical scientists and impact on relicensing eligibility. Continuing education, authorship and e-learning are mainly recognized as CPD activities, although the professional training is appreciated as the most important individual CPD category.     

Defining laboratory medicine,or squaring the circle?

In the August 2020 issue of Clinical Chemistry and Laboratory Medicine, Giuseppe Lippi and Mario Plebani proposed a definition of laboratory medicine, which ends with this sentence: “The results of these measurements are translated into actionable information for improving the care and/or maintaining the wellness of both a single individual and an entire population”. Nevertheless, the selfishness of individuals may, sometimes, jeopardize the interest of whole populations. The virtue of justice being within the reach of the entire human community more than of single individuals, the final sentence in the definition proposed by Giuseppe Lippi and Mario Plebani, should therefore, in our view, be rewritten, less selfishly, for example like this: “For a given investment, these measurements are preferably made when they bring as much beneficence, and non-maleficence, as possible to the whole population”.     

中国第一位诺贝尔科学奖提名人与被提名人

本文考察了中国第一位诺贝尔科学奖的提名人与被提名人的情况。中国本土第一位诺贝尔科学奖提名人为国际著名生物化学家吴宪(1893-1959),他于1932年提名了约翰·诺斯罗普(John H Northrop)和詹姆士·萨姆纳(James B Sumner)为诺贝尔生理学或医学奖候选人。而最早获得诺贝尔科学奖提名的中国人乃中国检疫和防疫事业先驱,公共卫生学家、中华医学会首任会长伍连德(1879-1960)博士,他因在肺鼠疫方面的工作尤其是发现土拨鼠在鼠疫传播过程中的作用而被提名角逐1935年诺贝尔生理学或医学奖。     

Validation of a laboratory and hospital information system in a medical laboratory accredited according to ISO 15189

Introduction

The aim of the study was to present a protocol for laboratory information system (LIS) and hospital information system (HIS) validation at the Institute of Clinical Chemistry and Laboratory Medicine of the Merkur University Hospital, Zagreb, Croatia.

Materials and methods:

Validity of data traceability was checked by entering all test requests for virtual patient into HIS/LIS and printing corresponding barcoded labels that provided laboratory analyzers with the information on requested tests. The original printouts of the test results from laboratory analyzer(s) were compared with the data obtained from LIS and entered into the provided template. Transfer of data from LIS to HIS was examined by requesting all tests in HIS and creating real data in a finding generated in LIS. Data obtained from LIS and HIS were entered into a corresponding template. The main outcome measure was the accuracy of transfer obtained from laboratory analyzers and results transferred from LIS and HIS expressed as percentage (%).

Results:

The accuracy of data transfer from laboratory analyzers to LIS was 99.5% and of that from LIS to HIS 100%.

Conclusion:

We presented our established validation protocol for laboratory information system and demonstrated that a system meets its intended purpose.     

Assessment of antinuclear antibodies (ANA): National recommendations on behalf of the Croatian society of medical biochemistry and laboratory medicine

Antinuclear antibodies (ANA) represent a family of autoantibodies targeting ubiquitous cellular constituents and are a hallmark of systemic inflammatory autoimmune rheumatic diseases named connective tissue diseases (CTD). The gold standard method for ANA determination is indirect immunofluorescence (IIF) on the human laryngeal epidermoid carcinoma cell line type 2 substrate (HEp-2), but with increasing demand for ANA testing, novel methods eased for automation emerged, which allows testing by staff less experienced in this specific field of laboratory diagnostic. In 2016 The working group (WG) for laboratory diagnostics of autoimmune diseases as part of the Committee for the Scientific Professional Development of the Croatian Society of Medical Biochemistry and Laboratory Medicine (CSMBLM) published the data of a survey regarding general practice in laboratory diagnostics of autoimmune diseases in Croatia. Results indicated high diversity in the performance of autoantibody testing as well as reporting of the results and indicated the need of creating recommendations for the assessment of ANA that would help harmonize diagnostics of systemic autoimmune rheumatic diseases in Croatia. This document encompasses twenty-seven recommendations for ANA testing created concerning indications for ANA testing, preanalytical, analytical, and postanalytical issues, including rational algorithm and quality control assurance. These recommendations are based on the relevant international recommendations and guidelines for the assessment of ANA testing and relevant literature search and should help to harmonize the approach in ANA testing and clarify differences in interpretation of the results obtained using different methods of determination.     

医学留学生“实验诊断学”临床见习教学体会

实验诊断学是一门联系基础医学与临床医学的桥梁学科。本教研室针对实验诊断学的实践教学性很强的特点,结合医学留学生的实际情况,开设实验诊断学临床见习课程,对实验诊断学课程的教学内容和临床实践模式等方面进行了一些改进和探索。本文通过总结温州医学院留学生实验诊断学临床实习的实践,分析和探讨医学留学生临床实习的若干问题。     

新医科背景下药学专业人才培养方案的修订与探索——以新疆医科大学药学院为例

在新医科建设背景下,传统的药学专业需要进行升级改造,对人才培养方案也提出了新的要求。以新疆医科大学药学院为例,在分析了药学专业现有人才培养方案与新医科建设要求的差距后,通过合理制定培养目标,科学设计课程体系,增大实验实践课程比重,选修课程模块化,增设先修课、研讨课和一体化课程等,主动适应新医科建设的要求,努力为社会培养在药学领域能够从事各方面工作的高素质药学专业人才。     

Effects of specimen haemolysis on complete blood count results by Abbott Alinity hq System

IntroductionThe current study aimed to assess the interference of in vitro haemolysis on complete blood count (CBC) using Abbott Alinity hq system, and to determine which haemolysis levels affect the reliability of sample results.Materials and methodsBlood samples obtained from 25 volunteers in K3-EDTA tubes were divided into four aliquots. The first aliquot was not subjected to any intervention. The second, third and fourth aliquots were passed through a fine needle 2, 4 and 6 times, respectively. Complete blood count was performed by multi-angle polarized scatter separation technology and haemolysis index (HI) was assessed from the plasma samples separated by centrifugation. Five groups were formed according to the HI values. The percentage biases between the results of non-haemolysed and haemolysed groups were compared with the desirable bias limits from The European Federation of Clinical Chemistry and Laboratory Medicine database and reference change values (RCVs).ResultsIn groups 1 to 4, the effects of haemolysis on CBC parameters were acceptable comparing to the analytical bias except for lymphocytes (7.26%-7.42%), MCH (2.59%), and MCHC (0.47%-2.81%). Results of group 5 (gross haemolysis) showed decreases in HCT(- 4.56%), RBC (- 4.07%) count and increase in lymphocyte (11.60%) count higher than the analytical performance specifications. Moreover, variations in MCH (4.65%) and MCHC (5.24%) were exceeding the RCVs.ConclusionsGross haemolysis (haemoglobin concentration > 10 g/L) is likely to produce unreliable CBC results on non-pathological samples. Further studies including pathological specimens are needed.     

中医方剂领域本体建模和语义推理实现

针对目前中医领域知识共享的现状,结合对中医方剂领域知识特点的分析,采用骨架法构建基于OWL语言的方剂本体模型。并以中医诊断和开方为应用场景,提出基于SWRL规则结合Jess推理引擎的方法,尝试中医领域本体的语义推理。     

现代高校实验室建设和管理初探

新时期高校实验室建设与管理存在诸多问题,加强高校实验室建设与管理工作十分重要,它已成为高校教学管理工作不可缺少的重要组成部分。加强实验室建设与管理对于提高教学质量、培养创新人才起着举足轻重的作用。要不断探索和研究实验室建设与管理新模式,努力为教学、科研服务。     

关于临床实习生病历书写培训模式的研究进展

病历在临床医疗、科研及医疗纠纷中均承担着重要的角色。病历书写是每一个从事医疗工作人员必须严肃对待的工作,而对于进入临床的学生来说,病历书写更是临床学习的重要课程,还是医学生成长为合格临床医师的重要必备技能之一。本文就近几年关于临床实习生病历书写培养模式方面等问题展开论述。