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.

Actividades de integración de conocimientos en el Grado de Farmacia. Aplicación en la asignatura de toxicología / Knowledge Integration Activities in the Pharmacy Degree. Application in the Toxicology Subject

Objetivos. Durante los últimos años, los profesores del Departamento de Farmacología, Toxicología y Química Terapéutica hemos puesto en marcha un conjunto de acciones docentes con el objetivo de promover en los alumnos del grado de Farmacia la mejora de capacidades de integración de los conocimientos de las materias impartidas, así como un modelo de evaluación continuada multidisciplinar y retroactivo que nos permita objetivar su consecución. Métodos. Para desarrollar estas acciones de integración y la posterior evaluación de las mismas, diversas asignaturas del Departamento se han coordinado y se han analizado los conocimientos necesarios para la comprensión de contenidos que se desarrollan en cursos posteriores. Dentro de la asignatura de Toxicología hemos desarrollado un conjunto de acciones que se han concretado fundamentalmente en el diseño, aplicación y, en algunos casos, evaluación de unas actividades de tipología diversa. Resultados. A fin de valorar el éxito de estas acciones, se han comparado los resultados obtenidos en un test de preguntas de integración a principio de curso con los resultados de otro test a final de curso. Los resultados obtenidos en los cuatro ítems comparados muestran una mejora significativa en una pregunta, una mejora relativa no significativa en otras dos y resultados similares en la última. Conclusiones. Podemos concluir que las acciones desarrolladas han conseguido parcialmente los objetivos propuestos. Consideramos que esta herramienta puede ser muy útil para promover una mayor coordinación entre los profesores, en el diseño de material didáctico conjunto y transversal y en modelos integrados de evaluación

Aim. During the last years the professors of the Department of Pharmacology, Toxicology and Therapeutic Chemistry have initiated a set of teaching actions with the aim of promoting the improvement of knowledge integration capacities corresponding to the subjects taught to students of Pharmacy degree; as well as a multidisciplinary and retroactive continuous evaluation model allowing to objectify its achievement. Methods. In order to develop these integration actions and their subsequent evaluation, several subjects of the Department have been coordinated and the knowledge necessary for understanding the contents of following courses have been analyzed. Within the subject of Toxicology, we have developed a set of actions based on the design, application and, in some cases, evaluation of a variety of activities. Results. In order to assess the success of these actions, we have compared the results obtained in a test of integration questions at the beginning of the course with the results of another test at the end of the course. The results obtained in the four items compared show a significant improvement in one question, a maintenance of results in another, and a non-significant relative improvement in the other two. Conclusions. We can conclude that the actions developed have partially achieved the proposed objectives. We consider that this tool can be very useful to promote greater coordination among teachers in the design of joint and transversal teaching materials and in integrated evaluation models

Attitudes and Beliefs of Pathology Residents Regarding the Subspecialty of Clinical Chemistry: Results of a Survey.

CONTEXT: -Previous studies suggest that training in pathology residency programs does not adequately prepare pathology residents to become competent in clinical chemistry. OBJECTIVES: -To define the beliefs of pathology residents in the United States regarding their preparation for practicing clinical chemistry in their career, their attitude toward the discipline, and the attractiveness of clinical chemistry as a career. DESIGN: -The residents of all pathology residency programs in the United States were given the opportunity to participate in an online survey. RESULTS: -Three hundred thirty-six pathology residents responded to the survey. Analysis of the survey results indicates that pathology residents are more likely to believe that their income may be lower if they select a career that has a clinical chemistry focus and that their faculty do not value clinical chemistry as much as the anatomic pathology part of the residency. Residents also report that clinical chemistry is not as enjoyable as anatomic pathology rotations during residency or preferable as a sole career path. A large proportion of residents also believe that they will be slightly prepared or not prepared to practice clinical chemistry by the end of their residency and that they do not have enough background and/or time to learn clinical chemistry during their residency programs to be able to practice this specialty effectively post graduation. CONCLUSIONS: -Our survey results suggest that many pathology residents do not have a positive attitude toward clinical chemistry and do not experience a supportive learning environment with an expectation that they will become competent in clinical chemistry with a residency alone.

The reliability of the pass/fail decision for assessments comprised of multiple components.

OBJECTIVE: The decision having the most serious consequences for a student taking an assessment is the one to pass or fail that student. For this reason, the reliability of the pass/fail decision must be determined for high quality assessments, just as the measurement reliability of the point values. Assessments in a particular subject (graded course credit) are often composed of multiple components that must be passed independently of each other. When "conjunctively" combining separate pass/fail decisions, as with other complex decision rules for passing, adequate methods of analysis are necessary for estimating the accuracy and consistency of these classifications. To date, very few papers have addressed this issue; a generally applicable procedure was published by Douglas and Mislevy in 2010. Using the example of an assessment comprised of several parts that must be passed separately, this study analyzes the reliability underlying the decision to pass or fail students and discusses the impact of an improved method for identifying those who do not fulfill the minimum requirements. METHOD: The accuracy and consistency of the decision to pass or fail an examinee in the subject cluster Internal Medicine/General Medicine/Clinical Chemistry at the University of Heidelberg's Faculty of Medicine was investigated. This cluster requires students to separately pass three components (two written exams and an OSCE), whereby students may reattempt to pass each component twice. Our analysis was carried out using the method described by Douglas and Mislevy. RESULTS: Frequently, when complex logical connections exist between the individual pass/fail decisions in the case of low failure rates, only a very low reliability for the overall decision to grant graded course credit can be achieved, even if high reliabilities exist for the various components. For the example analyzed here, the classification accuracy and consistency when conjunctively combining the three individual parts is relatively low with κ=0.49 or κ=0.47, despite the good reliability of over 0.75 for each of the three components. The option to repeat each component twice leads to a situation in which only about half of the candidates who do not satisfy the minimum requirements would fail the overall assessment, while the other half is able to continue their studies despite having deficient knowledge and skills. CONCLUSION: The method put forth by Douglas and Mislevy allows the analysis of the decision accuracy and consistency for complex combinations of scores from different components. Even in the case of highly reliable components, it is not necessarily so that a reliable pass/fail decision has been reached - for instance in the case of low failure rates. Assessments must be administered with the explicit goal of identifying examinees that do not fulfill the minimum requirements.

Is laboratory medicine ready for the era of personalized medicine? A survey addressed to laboratory directors of hospitals/academic schools of medicine in Europe.

Developments in "-omics" are creating a paradigm shift in laboratory medicine leading to personalized medicine. This allows the increase in diagnostics and therapeutics focused on individuals rather than populations. In order to investigate whether laboratory medicine is ready to play a key role in the integration of personalized medicine in routine health care and set the state-of-the-art knowledge about personalized medicine and laboratory medicine in Europe, a questionnaire was constructed under the auspices of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and the European Society of Pharmacogenomics and Personalised Therapy (ESPT). The answers of the participating laboratory medicine professionals indicate that they are aware that personalized medicine can represent a new and promising health model, and that laboratory medicine should play a key role in supporting the implementation of personalized medicine in the clinical setting. Participants think that the current organization of laboratory medicine needs additional/relevant implementations such as (i) new technological facilities in -omics; (ii) additional training for the current personnel focused on the new methodologies; (iii) incorporation in the laboratory of new competencies in data interpretation and counseling; and (iv) cooperation and collaboration among professionals of different disciplines to integrate information according to a personalized medicine approach.

IFCC educational materials on selected analytical and clinical applications of high sensitivity cardiac troponin assays.

In 2011, the IFCC Task Force on Clinical Applications of Cardiac Bio-Markers (TF-CB) was formed, with the purpose of providing evidence based educational materials to assist all biomarker users, i.e. laboratorians, clinicians, researchers, in-vitro diagnostics and regulatory agencies, in better understanding important analytical and clinical aspects of established and novel cardiac biomarkers for use in clinical practice and research. The goal of the task force was to promulgate the same information conjointly through the in vitro diagnostic industry to the laboratory, emergency department and cardiologists. The initial undertaking of the TF-CB, which is comprised of laboratory medicine scientists, emergency medicine physicians and cardiologists, was to address two key issues pertaining to implementing high-sensitivity cardiac troponin (hs-cTn) assays in clinical practice: the 99th percentile upper reference limit (URL) and calculating serial change values in accord with the Universal Definition of AMI. The highlights of both concepts from IFCC statements are described.

Development and initial validation of a project-based rubric to assess the systems-based practice competency of residents in the clinical chemistry rotation of a pathology residency.

CONTEXT: Systems-based practice (SBP) is 1 of 6 core competencies required in all resident training programs accredited by the Accreditation Council for Graduate Medical Education. Reliable methods of assessing resident competency in SBP have not been described in the medical literature. OBJECTIVE: To develop and validate an analytic grading rubric to assess pathology residents' analyses of SBP problems in clinical chemistry. DESIGN: Residents were assigned an SBP project based upon unmet clinical needs in the clinical chemistry laboratories. Using an iterative method, we created an analytic grading rubric based on critical thinking principles. Four faculty raters used the SBP project evaluation rubric to independently grade 11 residents' projects during their clinical chemistry rotations. Interrater reliability and Cronbach α were calculated to determine the reliability and validity of the rubric. Project mean scores and range were also assessed to determine whether the rubric differentiated resident critical thinking skills related to the SBP projects. RESULTS: Overall project scores ranged from 6.56 to 16.50 out of a possible 20 points. Cronbach α ranged from 0.91 to 0.96, indicating that the 4 rubric categories were internally consistent without significant overlap. Intraclass correlation coefficients ranged from 0.63 to 0.81, indicating moderate to strong interrater reliability. CONCLUSIONS: We report development and statistical analysis of a novel SBP project evaluation rubric. The results indicate the rubric can be used to reliably assess pathology residents' critical thinking skills in SBP.

An analysis of clinical consultation activities in clinical chemistry: implications for transformation and resident training in chemical pathology.

CONTEXT: Clinical consultation is a key role of pathologists. Many have advocated that pathologists expand their consulting activities to improve laboratory utilization. Although many have suggested that residency programs need to provide experience in clinical consultation, little has been written on the nature of consultation or on the methods of training. OBJECTIVE: To characterize the content of consultations and to describe training in consultation in chemical pathology within the residency program at the University of Utah, Salt Lake City. DESIGN: Retrospective review of the consultation database for the period between July 2011 and July 2012. RESULTS: Residents performed an average of 159 consultations a month covering 276 topics during the course of a year. Each topic involved 1 or more specific tests. Eighty percent of the topics received fewer than 12 calls. The most common topics involved virus testing (eg, hepatitis B virus, hepatitis C virus, human immunodeficiency virus). Consultations most often involved test interpretation (53%), selection (38%), and performance characteristics (21%). Twenty-seven percent of consultations involved 2 or more consultation categories (eg, interpretation and performance). CONCLUSIONS: Consultation calls in chemical pathology are widely distributed across topics. Consultations most often involve test interpretation and selection. Methods to assess the effectiveness of consultations and resident teaching should be devised.