Effects of calcium dobesilate (CaD) interference on serum creatinine measurements: a national External Quality Assessment (EQA)-based educational survey of drug-laboratory test interactions.

Objectives: Drug-laboratory test interactions (DLTIs) are one of the major sources of laboratory errors. Calcium dobesilate (CaD) interference on serum creatinine testing is a widespread problem that has long been ignored in China. A national EQA-based survey was launched to investigate the current status of CaD interference on creatinine routine methods used in China and enhance the education of CaD interference in clinical laboratories. Methods: A descriptive survey was developed to characterize the status quo of Chinese laboratory professionals' cognition to CaD interference. Four of survey samples which were spiked with/without interference additive were shipped to 175 participant laboratories. The target reference values from a reference measurement procedure were compared against the results from participating laboratories to evaluate the CaD interference on serum creatinine measurements using enzymatic method or Jaffé method. Results: The lack of knowledge of DLTIs and the barriers to collect information from pharmacological and laboratory data systems had become the main problems on implementing DLTIs education in China. A significant negative influence of CaD on enzymatic method was observed regardless of measurement platforms. Jaffé method was generally free from interaction with CaD but showed poor precision and accuracy at low creatinine concentrations. Conclusions: More efforts should be made to enhance the education of DLTIs in clinical laboratories in China.

Practice in financial support of third party organised conferences and courses at a national level for health care professionals in Europe.

Background Ethical MedTech prescribes high standards for the participation of the in vitro diagnostics (IVD) industry in third-party organised educational events in terms of charitable donations, educational grants, scholarships and fellowships. We planned a survey to investigate the previous and current practice in terms of cooperation between professionals or professional societies and the IVD industry, as well as plans under the incorporation of the MedTech Europe Code. Methods Different questions, from general information to specific questions related to the practice and knowledge of the new Ethical MedTech Code, were included in two different surveys; for European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) National Societies' (NSs) representatives, and for their (NSs) individual members. Results Twenty-five out of 40 EFLM NS representatives replied; more than half declared that all different types of financial resources were available for supporting the continuing professional education of health care professionals (HCPs). In addition, 322 individual responses collected from 31 NSs, answered that the institutional director (50.3%) or laboratory chief (70.1%) made generally made a decision, without specific criteria. Conclusions The MedTech Europe Code is already adopted or is about to be adopted in numerous EFLM NSs, but most of them have not implemented it as yet. The use of the Code and better communication between IVD companies and HCPs are necessary to guarantee an improved and fair use of financial support, as well as better choices for the organisation and attendance at scientific events.

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

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.

Survey of national guidelines, education and training on phlebotomy in 28 European countries: an original report by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PA).

BACKGROUND: European questionnaire survey was conducted by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PA) to assess how phlebotomy is performed in EFLM countries, including differences in personnel, level of education and skills, and to investigate the presence and compliance of national phlebotomy guidelines on this matter. METHODS: A questionnaire was constructed containing questions elucidating different aspects of the organization behind the phlebotomy praxis on a national basis, including questions on the staff performing phlebotomy, the education of these staff members, and the existence of and adherence to national guidelines. All 39 EFLM member countries were invited to participate. RESULTS: In total 28/39 (72%) EFLM member countries responded. Seven out of the 28 (25%) have national phlebotomy guidelines and five have implemented other guidelines. The estimated compliance with phlebotomy guidance for the laboratories in the countries that have national guidelines available is poor, regardless to whether the phlebotomy was under the laboratory control or not. Most countries were interested in EFLM guidelines and to participate in a pilot EFLM preanalytical phase external quality assessment (EQA) scheme. In the responding EFLM member countries, the majority of phlebotomy is performed by nurses and laboratory technicians. Their basic education is generally 4-5 years of high school, followed by 2-5 years of colleague or university studies. Only a third (10/28; 36%) of the participating member countries has any specific training available as a continuous educational resource. A specific training for phlebotomy is not part of the education required to become qualified in 6/28 (21%) and 9/28 (32%) of countries for nurses and laboratory technicians, respectively. In countries and professions where training is required, most require more than 5 h of training. CONCLUSIONS: Based on the results of this survey we conclude the following: 1) There is a need to assess the quality of current practices, compliance to the CLSI H3-A6 guidelines and to identify some most critical steps which occur during phlebotomy, in different healthcare settings, across Europe; 2) Existing CLSI H3-A6 phlebotomy guidelines should be adapted and used locally in all European countries which do not have their own guidelines; 3) National EFLM societies need to be engaged in basic training program development and continuous education of healthcare phlebotomy staff (implementing the certification of competence).

The EC4 European syllabus for post-graduate training in clinical chemistry and laboratory medicine: version 4--2012.

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.

The Greek way to the Register: the establishment and operation of the Register for Clinical Chemists-Clinical Biochemists in Greece.

In Greece, there is no officially organized training in clinical chemistry for scientists. The Greek Society of Clinical Chemistry-Clinical Biochemistry (GSCC-CB), following the encouragement of the EC4/RC decided to organize a voluntary Register for specialists in clinical chemistry. The following criteria for registration were defined: 1) University degree in Chemistry, Biochemistry, Biology, Medicine, Pharmacy or other relevant subject. 2) A total of 9 years of university studies and postgraduate specialization in clinical chemistry-clinical biochemistry. 3) A minimum of 4 years of postgraduate specialization in clinical chemistry-clinical biochemistry on the job. 4) The candidate must be practicing clinical chemistry-clinical biochemistry in a laboratory in a medical environment in Greece. The postgraduate specialization in clinical chemistry-clinical biochemistry includes the laboratory training and the theoretical education. The laboratory training is organized by the GSCC-CB according to the Professional Training Dossier. The theoretical education was organized in a series of 18 "Seminars" which was the content of the "Educational program" of the GSCC-CB. Successful completion of the Educational program leads to a Certificate of Competence. The Greek Register has gained equivalence with the EC4 Register and it has 218 members, more than 80 of whom are European clinical chemists.

Studies of biochemistry and clinical biochemistry. Studies at sample medical schools in 13 EU countries regarding biochemistry and clinical biochemistry teaching.

The study summarizes the results obtained during personal visits to 53 medical schools in the 13 original EU countries during 2004--2006. Data from the Czech Republic is shown for comparison. The possibilities of acquiring information from the websites of the medical schools in the local language and English are assessed. The admission process to medical schools and the organization of studies of medicine, dentistry, and non-medical healthcare fields are briefly characterized. Significant attention is paid to the forms of education in biochemistry and clinical (bio)chemistry in the medical study field. The position of these subjects in the studies of dentistry and non-medical healthcare fields is also noted. In addition, the course of subject exams is described. The methods of funding and postgraduate studies at the medical schools are also briefly addressed.

Clinical biochemistry education, training and continuing professional development in the United Kingdom.

Education and training to become a senior professional in UK clinical biochemistry is coordinated at national level and is largely dependent upon completion of the MRCPath examination. The number of training commissions is regulated to accord with workforce planning requirements. Both medical and science graduates are eligible to undertake this training and the core curriculum is similar for both groups. Medical trainees have the option of including additional clinical training in metabolic medicine. Increasingly, with the introduction of new methods of assessment, the MRCPath examination is becoming a measure of competence rather than knowledge. Structured CPD is mandatory for career grade doctors and scientists as part of the requirements for them to maintain their individual licence to practice and in order that the laboratory in which they work may be accredited. The education, training and assessment of trainees in clinical biochemistry enable the production of a flexible workforce that is competent and designed to be fit for purpose. The requirement for structured CPD is one part of maintaining competence.

Improving training in laboratory medicine.

Recent advances in medicine and technology, combined with an ever-growing workload, have increased the demand for skilled professionals in laboratory medicine. The specific need for trained physicians and scientists raises important questions about the content of training programs and about the ideal characteristics of the human products of the training programs. Excellent recent publications in several countries have addressed the scientific and technical components of training and the competencies that trainees are expected to develop. These publications will provide important guidance for training programs and for trainees for the foreseeable future. An additional goal of training is to produce members of a profession. These professionals will 1) aspire to meeting the challenges of the field with creativity, 2) be involved with the profession and the world and 3) function in a manner informed by their thorough grounding in professional and medical ethics. In the promising future of laboratory medicine, a focus on professional aspects is essential to meeting the potential of the field to contribute to health of the patients we serve.

The holistic approach to teach laboratory medicine.

Laboratory diagnostics has undergone relevant changes in organization and complexity, providing new opportunities and risks. The skill and expertise required for laboratory professionals to fulfil the need of a continuously evolving scenario in diagnostics embrace now a variety of scientific, managerial and organizational issues. Translating into clinical practice new insights from basic science, particularly regarding omics, requires construction of a new and complex core curriculum for laboratory professionals. In addition, the integration of different areas of diagnostics within the same laboratory service is expected to improve efficiency and effectiveness.

The changing scenario in laboratory medicine and the role of laboratory professionals in translational medicine.

A revolution is now expected to occur in the ever-changing scenario of laboratory medicine thanks to the introduction of "omics" into clinical practice. However, our awareness of the divide between knowledge and practice, and the understandable assumption that omics research will be riddled with difficulties, has led to the concepts of knowledge translation, translational research and translational medicine. The interchangeable terms, translational research or translational medicine (hereafter referred to as translational research), currently underline the pressing need to gain practical benefit from the enormous investments made in biomedical research by the private and public sector. From the viewpoint of physicians, clinical laboratory professionals and patients, who are more directly involved in clinical practice, translational research responds to the need to obtain benefit from research, thus closing the gap between what we know and what we practice. This means transferring diagnostic and therapeutic advances that have proven effective in large well-conducted trials (and are therefore evidenced-based,) to daily medical practice. Translational research should be regarded as a two-way road: bench to bedside, and bedside to bench. However, to achieve a more effective translation process, a new road map should be implemented through interaction and cooperation between basic researchers, clinicians, laboratory professionals and manufacturers. Some examples of recent developments in clinical laboratory testing, including markers of cardiovascular diseases, clinical proteomics and recombinant allergens, attest to the importance of a careful evaluation of all variables allowing the introduction of such new insights into clinical practice in order to assure better clinical outcomes. The ability of laboratory medicine to deliver safer and more effective health care calls for a more careful evaluation not only of analytical characteristics but also of any other variables that may affect the clinical usefulness and diagnostic performances of laboratory tests thus enabling a more accurate interpretation and utilization of laboratory information.

The new Italian course of post-graduate education in laboratory medicine.

Clinical biochemistry has undergone a dramatic transformation in the last decade, with the introduction of new technologies, instrumentation and methodologies. The educational program of the postgraduate training should allow the students to achieve knowledge and skills to work and supervise a laboratory department in a hospital or health service institution. Here we describe the proposed revision of the postgraduate training in the Italian system, focusing on educational goals as well as mandatory professional activities.

Undergraduate education in Laboratory Medicine.

The graduation of medicine is a title necessary but not sufficient to practice the medical profession. In Italy, as in other countries, Laboratory Medicine teaching is an educational area integrated with relevant pre-clinical disciplines, supporting the main medical processes of patient diagnosis, prognosis, treatment monitoring, evolution following-up, risk screening and hidden/latent condition finding. In the modern concept of core curriculum of medical students, some cardinal aspects of Laboratory Medicine should be included and precisely: test ordering, preanalytical and analytical issues, test interpreting. Such learning objectives would ultimately contribute, by a procedural/methodological approach, to the process of either correctly diagnosing or proper decision making, at the patient's benefit. The present article provides an overview of Laboratory Medicine teaching in the core curriculum of medical students in Italy, and highlights specific tasks of laboratory competencies and skills required to optimize the learning abilities of the students.

Learning needs in clinical biochemistry for doctors in foundation years.

BACKGROUND: Most medical school curricula have reduced the amount of time available for teaching in pathology despite the fact that junior staff in the early stages of their training were responsible for requesting the majority of pathology tests on acutely ill hospital patients. So, the lack of specific training in this area means that test requesting may be poorly performed and the results ill understood by these staff. This paper describes a questionnaire, which was designed to assist laboratory staff providing targeted teaching in this area. METHODS: Doctors in Foundation year 1 (F1) and Foundation year 2 (F2) in Sheffield teaching hospitals were given a questionnaire to ascertain how confident they were in requesting and interpreting the results of clinical biochemistry tests. The doctors were also asked about which areas of laboratory medicine they would like to be taught. RESULTS: Responses were received from 82 doctors, about half those in F1 and F2. The survey revealed areas where juniors are less confident in requesting tests and interpreting results. Despite lack of confidence in interpreting the result, 18% were confident about requesting tests. Doctors were also unsure of the effects of common problems like haemolysis on the interpretation of results. More than 70% of the doctors requested specific teaching in these areas. CONCLUSIONS: Foundation doctors have learning needs in clinical biochemistry, addressing which would assist them in patient care. While better training in medical school may help in future, there are specific needs for those on the wards now that require targeted teaching.

A survey of scholarly literature databases for clinical laboratory science.

This article reviews the use of journal literature databases including CINAHL, EMBASE, and Web of Science; summarizing databases including Cochrane Database of Systematic Reviews, online textbooks, and clinical decision-support tools; and the Internet search engines Google and Google Scholar. The series closes with a practical example employing a cross-section of the knowledge and skills gained from all three articles.

Teaching method validation in the clinical laboratory science curriculum.

With the Clinical Laboratory Improvement Amendment's (CLIA) final rule, the ability of the Clinical Laboratory Scientist (CLS) to perform method validation has become increasingly important. Knowledge of the statistical methods and procedures used in method validation is imperative for clinical laboratory scientists. However, incorporating these concepts in a CLS curriculum can be challenging, especially at a time of limited resources. This paper provides an outline of one approach to addressing these topics in lecture courses and integrating them in the student laboratory and the clinical practicum for direct application.

Education of the PhD in laboratory medicine.

Throughout the history of laboratory medicine, the PhD scientist has played a role in developing new methods and algorithms that have contributed significantly to the field. Although the number of formally trained PhDs in laboratory medicine is currently small, they continue to play an important role in large, primarily academic, clinical laboratories and departments and in the in vitro diagnostics industry. This article discusses the importance of the formally trained PhD in today's laboratory medicine environment and the necessary training process, and approach for training PhDs at the postdoctoral level to have successful careers in laboratory medicine.