20050397.110_120.tp

Clin Chem Lab Med 2006;44(1):110–120 ᮊ 2006 by Walter de Gruyter • Berlin • New York. DOI 10.1515/CCLM.2006.021 2006/397
EC4 European Syllabus for Post-Graduate Training in Clinical
Chemistry and Laboratory Medicine: version 3 – 2005
Simone Zerah1,*, Janet McMurray2, Bernard
18 Laboratoire National, Luxembourg, Luxembourg Bousquet3, Hannsjorg Baum4, Graham H.
19 Department of Clinical Pathophysiology, Clinical Beastall5, Vic Blaton6, Marie-Jose`phe Cals7,
Danielle Duchassaing8, Marie-Francoise
20 Hospital de la Santa Creu i Sant Pau, Servei de Gaudeau-Toussaint8, Aimo Harmoinen9, Hans
Hoffmann10, Rob T. Jansen11, Desmond
21 R. de Cedofeita 347 18 Esq, Porto, Portugal Kenny12, Klaus P. Kohse13, Ursula Ko¨ller14,
Jean-Ge´rard Gobert15, Christine Linget8, Erik
23 General Hospital Vienna, Wien, Austria Lund16, Giuseppe Nubile17, Matthias Opp18,
Mario Pazzagli19, Georges Pinon8, Jose´ M.
25 Department of Clinical Chemistry, Medialab AB, Queralto20, Henrique Reguengo21, Demetrios
Rizos22, Thomas Szekeres23, Michel Vidaud24
and Hans Wallinder25 (European Communities
of Clinical Chemistry, EC4 Register
Abstract
Commission)
1 Laboratoire d’analyses de biologie me´dicale,
The EC4 Syllabus for Postgraduate Training is the Bagnolet, France, SFBC, EC4 Register Committee basis for the European Register of Specialists in Clin- 2 Hope Hospital, Clinical Biochemistry Department, ical Chemistry and Laboratory Medicine.
3 Hoˆpital Saint-Louis, Service de Biochimie A et • Indicates the level of requirements in postgraduate training to harmonise the postgraduate education 4 Institut fu¨r Klinische Chemie und Pathobiochemie, • Indicates the level of content of national training 5 Royal Infirmary, Department of Clinical programmes to obtain adequate knowledge and 6 AZ Sint Jan Hospital, Department of Clinical • Is approved by all EU societies for clinical chem- 7 Hoˆpital Corentin Celton, Issy-Les-Moulineaux,France The syllabus is not primarily meant to be a training guide, but on the basis of the overview given (com- Syndicat National des Biologistes des Hoˆpitaux, mon minimal programme), national societies should formulate programmes that indicate where knowl- 9 Savonlinnan keskussairaala, Savolinna, Finland 10 Department of Clinical Chemistry Catharine Hospital, Eindhoven, The Netherlands11 St. Anna Hospital, Department of Clinical • Knowledge in biochemistry, haematology, immu- 12 Our Lady’s Hospital for Sick Children, Department of Clinical Biochemistry, Crumlin, Dublin, Ireland 13 Sta¨dtische Kliniken Oldenburg, Institut fu¨r • Interpretations (post-analytical phase); 14 Institute for Medical and Chemical Laboratory The aim of this version of the syllabus is to be in accordance with the Directive of Professional Qualifi- 15 G.H. Pitie´-Salpe´trie`re, Paris, France cations published on 30 September 2005.
16 Vejle County Hospital, Department of Clinical To prepare the common platforms planned in this directive, the disciplines are divided into four 17 Laboratorio Analisi Ospedale G. Bernabeo di • General chemistry, encompassing biochemistry, *Corresponding author: Dr. Simone Zerah, Laboratoire endocrinology, chemical (humoral), immunology, d’analyses de biologie me´dicale, 7 rue Raymond Lefebvre, toxicology, and therapeutic drug monitoring; 93170 Bagnolet, France, SFBC, EC4 Register Committee, • Haematology, covering cells, transfusion serology, Zerah et al.: EC4 European Syllabus for Post-Graduate Training in CCLM 111 • Microbiology, involving bacteriology, virology, reported to provide information; and, most impor- tantly, interpretation of the significance and conse- quences of the laboratory data obtained (clinicalauthorisation).
As the results of laboratory investigations and con- Keywords: clinical chemistry and laboratory medi-
sultations of the clinical chemist1) have a direct and cine; postgraduate education; professional qualifica- important influence on treatment of the patient, it is to the benefit of the public that the profession of theclinical chemist1) is duly regulated.
Introduction
Clinical Chemistry and Laboratory Medicine
In modern medicine the undeniable value and indis-pensability of scientific investigations are now uni- Definition
versally recognised both for diagnostic purposes andmonitoring of disease and in basic epidemiology. The Clinical Chemistry and Laboratory Medicine is a direct treatment of patients is an undeniable task of scientific discipline within medicine. It includes the doctors in medicine. Progress in laboratory science is analysis of body fluids, cells and tissues, and inter- largely the result of contributions by scientists (gen- pretation of the results in relation to health and eral meaning) with an appropriate education and spe- cialisation in the field, i.e., by specialists in clinical The exact content of the specialty of clinical chem- chemistry and laboratory medicine1). Clinical labora- istry varies considerably from country to country and tory science has developed on a broad front through- a modular approach appears essential for suitable out the European Union, resulting in significant integration into the national contexts.
differences in what constitutes a national clinical lab- The discipline encompasses fundamental and oratory service in each state. Clinical chemistry is the applied research into the biological and physiological medical discipline devoted to obtaining, exploring processes of human and animal life, and application and employing biological knowledge and methods of of the resulting knowledge and understanding to the investigation to obtain knowledge about normal and diagnosis, treatment and prevention of disease.
abnormal biological processes in man. These pro-cesses are studied on a general level to obtain an Syllabus
insight into human health and disease, and on apatient-specific level for diagnostic or monitoring pur- This syllabus provides a short description of the pro- poses. The delineation of clinical chemistry varies fession of clinical chemistry. The name clinical chem- from country to country, since there is no sharp ist1) is used throughout, although it is realised that boundary to biochemistry, haematology, immunolo- different names exist in different countries to describe gy, microbiology, genetics and the biology of repro- the profession according to the definitions of the International Federation of Clinical Chemistry and One of the main tasks of the clinical chemist1) is the direction and supervision of a laboratory department The scope of clinical chemistry is not solely con- in a hospital or health service (public or private), fined to laboratory activities as such, but in daily prac- where his or her role involves bridging the gap tice is strongly interrelated with patient care and between rapidly developing laboratory science and treatment. Moreover, medical laboratory activities are technology and growing knowledge on the character- not purely of a chemical nature, but also involve the istics of disease. He or she must possess fundamental practice and study of biochemistry and molecular biological knowledge and have the ability to use this biology, haematology, immunology, microbiology knowledge most appropriately as applied to clinical (bacteriology and virology), parasitology (including requirements, i.e., diagnosis of disease, and planning mycology), genetics and the biology of reproductive and monitoring of therapy. Apart from providing a competent laboratory service, the clinical chemist1) This syllabus does not consider the different struc- must be able to function as a consultant to his or her tures of medical laboratories as developed in their clinical colleagues and liaise with them in the inter- national environments. It is meant to describe the pretation of laboratory results. His or her advice and minimum scientific content for professional knowl- professional consultations have at least three aspects: edge and training, appreciating the national authority choosing the most appropriate laboratory investiga- and responsibility of each member state to organise tion in a particular case; ensuring that analyses are laboratory medicine within in its own national health- performed in the best possible way and correctly Although significant differences exist in the devel- opment of clinical chemistry throughout the European 1) Abbreviated in this paper to clinical chemist: i.e., Specialist Union, in all cases there are some core elements. As in Clinical Analysis (polyvalent) or Specialist in Clinical Bio-chemistry (monovalent) in Spain, Specialist in Medical Bio- well as these core elements, knowledge of biochem- chemistry in Slovenia, Clinical Biologist in Luxembourg or istry, haematology, microbiology, parasitology and immunology, genetics and the biology of reproduc- 112 Zerah et al.: EC4 European Syllabus for Post-Graduate Training in CCLM tive medicine are necessary in the training of clinical opean Union. Post-graduate study should provide an in-depth knowledge of the biology of disease and the Detailed knowledge on the application of chemistry procedures and analytical techniques used in a med- and molecular biology in diagnostic medicine, moni- ical laboratory. It is important that there should be a toring of therapy and in pathophysiology is indispen- commitment to research and development, which will sable. Although cytology and medical microbiology often be in association with clinical colleagues. The are sometimes considered as distinct specialities in objective is to produce a person competent in labor- laboratory medicine, many mutual interfaces in the atory procedures with a sound knowledge of the sub- investigation of biological samples at the molecular ject, who is able to interpret and impart laboratory biology level require general knowledge of infectious findings and their implications to clinical colleagues.
diseases and medical microbiology, even in the prac- The interpretation of laboratory data is an essential tice of clinical chemistry and immunochemistry. This part of the professional task of the clinical chemist1), is even more the case for haematology and immu- for which he should be trained adequately. The post- nohaematology; laboratory investigations in haema- graduate study and training must meet national requi- tology are rapidly developing towards molecular rements, but in formulating the courses, conside- biology and instrumental analysis, which are both ration should be given as to how such requirements based on detailed knowledge of basic chemistry and might meet those of the European Union as a whole so as not to restrict opportunities for their nationals There are important physiological, analytical and who might wish to practise in other member states.
technical developments in cellular and molecular biol-ogy that demonstrate the importance of scientific European Syllabus
investigations in the understanding of disease pro-cesses, and consequently in the diagnosis and The European Syllabus for post-graduate training in monitoring of disease. Obviously techniques and clinical chemistry affords an overview of the fields technology will change, but basic biological and sci- within the discipline in which the clinical chemist1) entific principles will not, and research and develop- should be able to demonstrate knowledge and expe- ment at the scientific level are indispensable for good rience with regard to scientific, clinical and manage- ment aspects of the subject. This is a programme forknowledge in the field, indicating the level of requi- Quality assurance
rements in post-graduate training in clinical bio-chemistry, haematology, immunology, microbiology, Safeguarding and protecting the public against mis- parasitology, genetics and the biology of reproductive use of medical laboratory investigations are impor- tant features of good laboratory practice and reliable The exact content of clinical chemistry varies con- laboratory diagnostics. Appropriate laboratory man- siderably from country to country. Therefore, the agement and scientifically based quality assurance training requirements may best be satisfied by a mod- procedures must be incorporated into the production ular system enabling the clinical chemist1) to adjust and management of data in medical laboratories.
his or her competence to the demands of the author- These elements of good laboratory practice appear to be increasingly important with the growing possibility The syllabus is not primarily meant to be a training of laboratory investigations in medical laboratory guide, but on the basis of the overview given, national societies should formulate programmes, indicatingwhat knowledge and experience is needed, appropri- The clinical chemist1)
ate to the national service requirements in differentcountries.
Training as a clinical chemist1) must involve dedicated The breadth of work to be found in clinical chem- post-graduate study of at least 4 years, following a istry across the whole European Union gives a clear comprehensive and appropriate university education indication that an appropriate description of the field is necessary for all the disciplines.
Clinical chemists1) and specialist medical consult- This general basis is applicable to the whole of lab- ants operate at the same professional level and must oratory medicine and helps to unify the scientific and use their complementary knowledge to the benefit of clinical principles on which it is based and demon- the patients and institutions they serve. The complex- strates the unity of concepts underlying the diversity ity and scope of currently obtainable laboratory infor- of practice (which is more apparent than real). Dis- mation inevitably requires professional interpretation ease is due to metabolic, genetic, infectious or other disturbances of homeostasis. The study, diagnosis This interpretation is an essential task of the clinical and therapy of disease require clinical chemistry, cell chemist1), for which he should be trained appro- and molecular biology to identify such changes. The classical subdivisions of laboratory medicine are The principal subject of the undergraduate educa- becoming blurred by developments in science and tion will usually be chemistry/biochemistry or medi- technology, and particularly as a result of the rapid cine or pharmacy, but the specific subjects acceptable advances in biochemical, cellular and molecular biol- in a particular member state will vary across the Eur- ogy. It is essential that the European Syllabus for clin- Zerah et al.: EC4 European Syllabus for Post-Graduate Training in CCLM 113 ical chemistry should not only recognise its current V. Case-related medical evaluation of laboratory
strength, but should also provide a framework within tests and methods
which all member states can develop their ownapproaches towards this model. This should facilitate The clinical chemist1) in a consultative role requires a not only the mutual recognition of national syllabus- working knowledge of the subject underlying the es, but also the maintenance and enhancement of choice of tests and interpretation of results.
1. Evaluation (recognition of possible fluctuations in comparison to previous values, patterns of abnor- Syllabus
2. Use of reference values: influences of age, sex, This syllabus affords an overview of the fields within way of life, etc., and decision values and limits.
the discipline in which the clinical chemist1) should be 3. Longitudinal evaluation of disease course and able to demonstrate knowledge and experience with therapy monitoring; critical differences.
regard to scientific, clinical, management and quality 4. Recognition of combinations of findings typical of assurance aspects of the subject. This is a programme for knowledge in the field, indicating the level of 5. Testing strategies applied to clinical questions.
requirements in post-graduate training in clinical biol- 6. The laboratory report with evaluation of data.
ogy. This syllabus is not meant to be a training guide, 7. Independent performance or suggestions for fur- but on the basis of the overview given, national soci- eties should formulate programmes indicating whereknowledge and experience is needed appropriate to VI. Clinical training
the national service requirements in the differentcountries.
Training in clinical chemistry requires participation inward rounds as a member of the clinical team andother contact with the users of the laboratory service, Contents
for example, seminars and case discussions.
Study in the following areas will provide a general I. Core knowledge
basic knowledge of clinical chemistry from which con-sultative skills can be developed.
II. Indications for clinical chemistry procedures
1. Organ function, anatomy and physiology.
2. Metabolism.
1. In the early detection of disease, and in epidemi- 3. Biochemical exploration and testing.
2. In disease-related diagnosis.
3. In organ-related diagnosis.
4. In monitoring vital functions.
VII. Research and development
5. In monitoring response to therapy.
6. In the field of drug monitoring.
As laboratory medicine is continually and rapidly 7. Indications for subsequent specialised exami- evolving, research and development of both the lab- oratory aspects and their clinical application are in- 8. Indications for functional tests.
dispensable. The clinical chemist1) must maintainup-to-date knowledge in all relevant diagnostic pro-cedures. Special attention must be paid to the III. Influence of collection and storage of specimens
1. Place and time of sample collection, preservation, 1. Developments and improvements in methods and influence of nutrition, drugs, posture, etc.
techniques; special emphasis on new develop- 2. Choice and correct use of anticoagulants and ments in areas such as molecular biology.
2. Procedures to test and evaluate the steps of a 3. Care of specimens, identification, transport, stor- method and the components of an instrument.
age, influence of temperature, freezing/thawing.
3. Evaluation of laboratory-based and clinical re- 4. Analyses and documentation of results obtained IV. Methodological evaluation of analytical methods
through research and development, with statisti-cal and scientific presentation of data.
5. Collaborative planning of clinical research based 2. Reference methods and statistical comparison of on the liaison function of the clinical chemist1) as methods (statistical methods to develop).
an essential specialist for interpretation of labor- 3. Internal quality assurance and external quality 6. Publication of papers reporting new or improved 4. Analytical specificity and analytical sensitivity.
laboratory methods and of clinical research 114 Zerah et al.: EC4 European Syllabus for Post-Graduate Training in CCLM VIII. Laboratory management and quality assurance
3.1 Structure and function of the human body, 1. Laboratory organisation and quality management.
laws on the distribution of substances in thebody.
• Work procedure, work load measurements, emergency laboratory, laboratory planning, selection of equipment and methods, cost-bene- 3.3 Pathobiochemistry, pathophysiology and 4. Basic knowledge of statistics and biostatistics.
• Statistical applications in the clinical laboratory: interpretation of statistical laboratory and popu-lation data, biological variation, establishment of Clinical assessment of laboratory analyses
reference intervals, method comparison.
1. Reference intervals and biological variability.
• Data management: medical informatics, data processing and telecommunications, presenta- • Genetic influences, environmental influences, tion and communication of results of investiga- age, sex, nutrition, season and time of day, influ- tion (choice of units, design and content of 2. Predictive value of analytical methods, diagnostic 3. Education of laboratory personnel and writing and 3. Diagnostic strategies and analytical goals in the 4. Basic knowledge of clinical epidemiology.
5. Laboratory safety.
Analytical principles and techniques
• Handling of potentially infectious samples (e.g., HIV and hepatitis), handling of noxious chemi-cals and isotopes, mechanical and electrical safe- 1. Separation techniques including gas and liquid chromatography, electrophoresis and dialysis.
ty, fire precautions, dealing with an accident.
2. Standard analytical techniques such as titrimetry • Laws, guidelines and recommendations on work 3. Photometric methods: spectrophotometry (UV, in clinical laboratories: in particular, accident pre- visible) atomic absorption, turbidimetry, nephe- vention and hygiene regulations, handling of iso- lometry, spectrofluorimetry, flame emission, etc.
topes, calibration law, quality control, education 4. Spectrometric methods: mass spectrometry, regulations, labour laws and occupational dis- nuclear magnetic resonance, infra-red.
5. Electrochemical techniques: ion-selective elect- • Ethical aspects and conventions on production, interpretation, reporting and use of medical lab- 6. Techniques for protein analysis and other molec- ular separation: electrophoresis, chromatogra- 7. Medical laboratory accreditation.
7. Techniques for nucleic acid analysis: amplifica- tion, investigation of mutations and gene ex-pression.
A. General chemistry, covering biochemistry,
endocrinology, chemical (humoral),
• Immunochemical protein analysis: immuno- immunology, toxicology, and therapeutic drug
electrophoresis, immunofixation, immunon- monitoring
• Immunological and other binding analyses Basic knowledge
using different labels. Homogeneous and non-homogeneous immunoassays.
9. Techniques using radioactive isotopes.
10. Enzyme analyses and substrate determination • Homogeneous and heterogeneous systems, dis- tribution and absorption with regard to analyti- 11. Knowledge of analytical instrumentation and cal separation methods. Study of atoms and molecules, especially with regard to stoichiom- 12. Knowledge of electronic data processing.
• Knowledge of thermodynamic laws and their Knowledge and experience in applications in the
application in analysis and biological systems.
biochemical, endocrinology, chemical (humoral)
Reaction kinetics with regard to catalysed reac- immunology, toxicology, and therapeutic drug
monitoring fields
• Molecular structure of the body; metabolism, enzymes, metabolites, molecular biology of 1.1 Glucose metabolism and regulation.
genetics, biological macromolecules, lipids, 1.2 Metabolism and regulation of other carbo- hydrates (e.g., galactose, lactose, glycogen).
Zerah et al.: EC4 European Syllabus for Post-Graduate Training in CCLM 115 1.3 Type 1 and type 2 diabetes mellitus.
1.4 Other hereditary and acquired metabolic 12.1 Induction, synthesis and elimination.
disorders (e.g., lactose intolerance, galacto- 12.2 Enzyme patterns in various tissues and 2.2 Hereditary and acquired disorders; storage diseases; hypercholesterolaemia; hypo- and hyperlipoproteinaemia; characterisation by 13.3 Hereditary and acquired disorders of CSF 14.1 Digestive enzymes in the various sections of the digestive system, including the exo- 3.2 Important plasma proteins (albumin, immu- crine functions of the liver and pancreas.
noglobulin, haptoglobin, transferrin, C-reac- 14.2 Hydrochloric acid, bicarbonate and bile 14.3 Fluid and electrolyte secretion.
3.3 Dysproteinaemia, monoclonal components.
3.5 Hereditary and acquired disorders of amino 14.6 Hereditary and acquired disorders of the 3.6 Urine proteins and proteinurias.
14.7 Malabsorption, including vitamin mal- 15. Exocrine functions of the pancreas.
4.3 Other hereditary and acquired disorders of 16.1 Physiology; normal and disturbed func- tions of the liver; metabolism, synthesis, 16.2 Enterohepatic circulation; metabolism of 6.2 Catecholamines, serotonin and their break- 16.3 Hepatitis, cirrhosis, cholestasis, necrosis.
17.1 Physiology; normal and disturbed renal 17.2 Excretory substances in the plasma and 7.2 Sodium, potassium, chloride abnormalities.
urine; glomerular filtration rate and clear- ance; activity and effects of diuretics; free 8.1 Acid-base balance and disorders; buffer systems (bicarbonate, phosphate, protein); 17.4 Acute and chronic renal insufficiency, 18.1 Normal and disturbed circulation.
8.3 Pulmonary gas exchange; oxygen metabo- 18.2 Myocardial infarction and shock; enzyme patterns and marker proteins; fluid balance.
11.1 Functions of the humoral and cellular bones, cartilage, synovial and connective immune systems and their regulation; cyto- kines; inflammation; acute phase proteins.
19.2 Hereditary and acquired disorders, espe- 11.3 Hereditary and acquired disorders.
lism, vitamin D, collagen and proteopoly- 11.4 Immunoglobulin deficiency and overpro- 20.1 Physiology, biosynthesis and catabolism of 11.5 Major histocompatibility complex.
20.2 Hormonal regulation, hormone transport, 116 Zerah et al.: EC4 European Syllabus for Post-Graduate Training in CCLM 20.3 Functional disorders of the thyroid gland, the parathyroid glands, the adrenal cortex, the adrenal medulla, the endocrine part of 2.2 Determination of coagulation factors; control the pancreas, the gonads, the placenta, and of anticoagulation factors, supervision of all 21. Pregnancy, perinatal laboratory analysis.
21.1 Hormone analyses; in vitro fertilisation.
21.2 Molecular biology of hereditary disorders.
3.1 Blood group typing, ABO and Rh(D); D-variant 22.1 Pharmokinetics, pharmacodynamics and bioavailability of drugs, pharmacogenetics.
3.2 Detection of irregular antibodies.
3.3 Cross-matching of blood samples for trans- 22.3 Individual determinations for the most fusion; indirect antiglobin test, direct antiglo- anticonvulsants, immunosuppressants.
4. Haematological biochemistry of erythrocytes.
23.1 Pathomechanisms of the most important 4.1 Detection and measurement of variant and 23.2 Knowledge of the preparation and preser- vation of specimens, regulations for exam- 5. Theoretical and clinical background.
5.1 Haemoglobinopathies and thalassemias.
5.2 Vitamin B12 and folic acid deficiencies; iron 23.3 Knowledge of strategies for group recog- nition of poisons by extraction, isolation 5.3 Kinetics of blood cells and platelets.
5.4 Enzymology of blood cells and platelets.
23.4 Individual determinations for the most 5.5 Haematooncological abnormalities (leukae- important types of poisoning, e.g., ethyl benzodiazepines, tricyclic antidepressants, 5.7 Immunological determination of coagulation glycol, benzene, toluene, etc.; cholinester- factors and knowledge of coagulation abnor- ase in the case of organic phosphate intoxi- malities (factor deficiency, increased fibri- nolytic activity) and regulation and monit- oring of thrombosis and disseminated intra- 23.6 Radioactive isotope toxicology.
vascular coagulation; use of anticoagulant 23.7 Toxicology: LSD, entactogenic drugs, opi- 5.8 Blood group antigens and other antigen sys- 23.8 Professional and environmental toxicology.
24. Molecular biology investigations of non-infec- (including genetics); selection criteria for donors for blood transfusion; several types 24.1 Prenatal diagnosis of inborn errors of 5.9 Medical applications, clinical relevance and indications for the administration of bloodand blood components.
5.10 Haematopoiesis and haemostasis physiol- B. Haematology, including cells, transfusion
serology, coagulation, and cellular
immunology
Extended haematology
Basic haematology
1.1 Morphological investigation of bone marrow 1. General morphology and blood cell counting.
smears, including different staining proce- 1.1 Determination of erythrocyte sedimentation dures; PAS staining for intracellular glycogen; rate; determination of haemoglobin concen- Sudan black staining for lipids; iron staining; tration, haematocrit, cell counts and knowl- acid phosphatase; esterase and peroxidase 1.2 Investigation of cellular characteristics and 1.2 Preparation and staining of blood smears, 1.3 Haemoglobinopathies; haemoglobin electro- phoresis on cellulose acetate, in agar gel; 1.4 Flow cytometry and leukocyte sub-grouping.
Zerah et al.: EC4 European Syllabus for Post-Graduate Training in CCLM 117 1.4 Investigation of anaemias, both congenital and acquired; Ham test and sucrose test.
2.1 Specimen selection and collection (blood, 1.5 Detection of abnormal haemoglobin deriva- 2.2 Specimen processing: smears, staining, cul- tures including cell cultures, susceptibility 2.3 Usual techniques for microbe and virus iden- tification (including principal differential 2.1 Investigation of platelet function; influence on 2.4 Molecular biology techniques for characteris- platelet aggregation by ADP-adrenaline, col- lagen, ristocetin, ADP, ATP; determination of 2.5 Bacteriological and viral serology.
retraction; platelet factor III determination, Succinct description of responsible bacteria and viruses in bacteriological and viral syndromes or 2.2 Use of chromogenic substrates for the deter- diseases (including principal differential character- 2.3 Detection of circulating inhibitors, thrombo 3.1 Bacteria: Neisseria gonorrhoeae and N. test diluted curve, cephalin dilution curve.
meningitidis, Staphylococcus aureus, Strep- tococcus pyogenes (especially S. agalactiae 2.5 Theoretical background and clinical back- and S. pneumoniae), Escherichia coli, Sal- ground and knowledge of the following sub- monella, Shigella and other Enterobacteria- jects: prekallikrein, high molecular kininogen aeruginosa, Haemophilus influenzae, Clos- tridium perfringens, C. tetani, Bacteroides 3. Immunohaematology and blood banking.
spp, Listeria monocytogenes, Legionella, 3.1 Typing of irregular (auto) antibodies; deter- Mycobacterium tuberculosis and others, Treponema pallidum, Chlamydiae, Mycoplas- 3.2 Extended blood group typing (beyond ABO, 3.2 Viruses: herpes (herpes simplex, herpes vari- 3.3 Investigation of transfusion reactions.
cellae, cytomegalovirus, Epstein Barr virus); hepatitis A, B, C, D, E; human immunodefi- ciency virus; enteroviruses (poliovirus); rubel- myxovirus, rhinovirus, coronavirus, adenovi- rus, rotavirus, papillomavirus, rabies, etc.
4. Bacteriological and viral syndromes or diseases: 3.8 Typing of leukocytes and tissue antigens.
epidemiology, main clinical signs, basis for biolog- 3.9 Recognition of cell markers using monoclo- 3.10 The application of plasmapheresis, both in 4.3 Urinary and genital infections.
4.4 Bacteriological and viral diarrhoeas.
4.5 Respiratory infections.
4.6 Human acquired immunodeficiency syn- C. Microbiology, covering bacteriology,
virology, parasitology, and mycology
4.8 Hepatic virus infections.
4.9 Cytomegalovirus infections.
5.1 Basic knowledge of antibiotics and antimicro- The investigation of biological samples in infec- tious diseases is different from the other speciali- 5.2 Antibiotic and antiviral sensitivity test.
ties in that it requires general knowledge of 5.3 Antibiotic and antiviral resistant mechanisms.
pathogenic agents (bacteria or viruses) and of hostreaction.
1.1 Definition of infection and infectious disease: Medical parasitology (including mycology)
1.2 Pathogenicity of bacteria and viruses; 1. Epidemiology, main clinical signs, basis for biolog- ical diagnosis (including a succinct description of 1.3 General epidemiology of infection and infec- parasites and fungi without biochemical character- 118 Zerah et al.: EC4 European Syllabus for Post-Graduate Training in CCLM 1.1 Amoebiasis: Entamoeba histolytica.
• To appreciate the validity criteria of chromo- 1.2 Giardiasis, cryptosporidiosis and uro-genital • To know how to perform in situ hybridisation fluorescent techniques: centromeric probe, 1.5 Intestinal, hepatic and urinary helminthiasis: chromosome painting probe, specific probe of strongyloidiasis, ancylostomiasis, enterobi- asis, ascariasis, schistosomiasis (Schis- • To acquire the necessary knowledge to per- tosoma mansoni and S. haematobium), form comparative genomic hybridisation on fascioliasis (Fasciola hepatica) and taeniasis • To appreciate the validity criteria of molecular 1.6 Fungal infections (Candida albicans, Cryp- 1.3 To be able to describe the analysis strategy for 1.7 Aspergillus infections (Aspergillus fumiga- the abnormalities listed below and to recognise their diagnostic, prognosis and/or therapeutic canis, Epidermophyton floccosum, Tricho- • Chromosome number abnormalities.
phyton rubrum, Trichophyton mentagro- • Structure abnormalities in equilibrium and • Identification of a chromosomal marker.
• Identification of chromosomal variants.
2. Usual techniques for parasite and fungus identi- • Chromosome fragility and chromosome break- 3. Immunological and molecular diagnosis of para- 2. Molecular genetics
At the end of his training, the clinical chemist must D. Genetics and IVF
be able to appreciate the prescription relevance, eval-uate the cohesiveness of the results, perform and Biological genetics includes cytogenetics and molec- supervise the carrying out of, molecular genetics 1. Cytogenetics
• To perform the different procedures of nucleic At the end of his training, the clinical chemist1) must be able to appreciate the relevance of the prescrip- tion, evaluate the cohesiveness of the results, and to • To perform the different identification methods perform and supervise the realisation of a karyotype • To perform the different identification methods • To perform the different methods of study of • To know the different analysable materials and DNA polymorphisms (SNP, microsatellites).
• To know the culture conditions according to • To perform the different methods of gene the sample and indications (medium, support, • To acquire the necessary principles to perform • To perform chromosomal preparations as • To master acquisition of the principal types of • To appreciate the validity criteria for molecular • To perform high-resolution karyotypes (repli- 2.2 To be able to describe the analysis strategy of the following pathological types and to recog- • To perform microscopic examination, display nise their diagnostic, prognosis and/or therapeu- capture on analyser and karyotype classi- • Monogenic disorders (autosomal dominant, • To know how to supervise and critically ana- autosomal recessive, X-linked recessive, X- lyse the quality of the chromosomal prepara- tions and the resolution level of the chromo- Zerah et al.: EC4 European Syllabus for Post-Graduate Training in CCLM 119 3. Reproductive medicine
1.11 Young DS, editor. Effects of drugs on clinical laboratory tests. Washington, DC: AACC Press, Basic knowledge
1.12 Young DS, editor. Effects of preanalytical variables on clinical laboratory tests. Washing- • Huner test and in vitro penetration.
1.13 Richard-Lee GL, Foerster J, Lukens J, Wintrobe MM, editors. Wintrobe’s clinical haematology.
Philadelphia, PA: Lea and Febiger, 1998.
1.14 Dacie JV, Lewis SM. Practical haematology.
Extended knowledge
London: Churchill Livingstone, 1995.
1.15 Spivak JL, Eichner ER. The fundamentals of clinical hematology. Cambridge: Harper and • Sperm preparation for fertilisation with frozen 1.16 Bloom AL, Forbes CD, Thomas DD. Haemos- • Fertilisation by the ICSI technique.
tasis and thrombosis. London: Churchill Living- • Embryo preparation for transfer.
1.17 Engelfriet CP, Contreras M, Mollison PL. Blood transfusion in clinical medicine. Oxford: Black- • Cryopreservation of gametes and embryos.
1.18 Babior BM, Stossel TP. Haematology: ‘‘a patho- physiological approach’’. New York: ChurchillLivingstone, 1994.
1.19 Hall R, Malia RG, editors. Medical laboratory Examples of scientific and medical literature
haematology. London: Butterworths, 1991.
1.20 Colman RW, Hirsh J, Marder VJ, Salzman EW, 1. Textbooks
editors. Hemostasis and thrombosis; basicprinciples and clinical practice. Philadelphia, Note: As new editions of textbooks appear regularly the following list only serves as an example and is 1.21 Stiene-Martin EA, Lotspeich-Steininger ChA, certainly not exhaustive; frequent updating is Koepke JA, editors. Clinical hematology: prin- ciples, procedures, correlations. Philadelphia,PA: JB Lippincott Company, 1998.
1.1 Burtis CA, Ashwood ER, editors, and Tietz NW.
1.22 Harmening DM, editor. Clinical hematology Tietz textbook of clinical chemistry. Philadel- and fundamentals of hemostasis. Philadelphia, phia, PA: WB Saunders Company, 1998.
1.2 Greiling H, Gressner AM, editors. Lehrbuch der 1.23 Hoffbrand AV, Petit JE. Essential haematology, Klinischen Chemie und Pathobiochemie. 3.
Oxford: Blackwell Scientific Publications, 1993.
Auflage. Stuttgart: FK Schattauer Verlag, 1995.
1.24 Adelberg EA, Jawetz E, Melnick JL. Review of 1.3 Thomas L, editor. Clinical laboratory diagnos- medical microbiology. Los Altos, CA: Lange tics. Frankfurt am Main: T-H Books, 1998.
1.4 Johnstone A, Thorpe R, editors. Immunochem- 1.25 Murray PR, Baron EJ, Pfaller MA, editors. Man- istry in practice. Oxford: Blackwell Scientific ual of clinical microbiology. Washington, DC: American Society for Microbiology, 1999.
1.5 Rose BD, Post T, Narins R. Clinical physiology 1.26 Bangert SK, Marshall WJ, editors. Clinical bio- of acid-base and electrolyte disorders. New chemistry: metabolic and clinical aspects. Lon- York: McGraw-Hill Book Company, 1994.
1.6 Greenspan FS, Strewler GJ, editors. Basic & clinical endocrinology. Los Altos, CA: Appleton& Lange Medical Publications, 1997.
2. Scientific and medical journals
1.7 Felig P, Baxter JD, Frohman LA, editors. Endo- 2.1 Annals of Clinical Biochemistry.
2.2 Antimicrobial Agents and Chemotherapy.
1.8 Sackett DL, Haynes RB, Tugwell P, editors.
Clinical epidemiology, a basic science for clin- ical medicine. Boston, MA: Little, Brown and 2.5 Clinical Chemistry and Laboratory Medicine.
1.9 Stites DP, Terr AI, Parslow TG, editors. Medical 2.7 Current Advances in Clinical Chemistry.
immunology. London: Appleton & Lange, 1997.
1.10 Friedman RB, Young DS, editors. Effects of dis- 2.9 European Journal of Clinical Microbiology ease on clinical laboratory tests. Washington, 2.10 Journal of Biological Chemistry.
120 Zerah et al.: EC4 European Syllabus for Post-Graduate Training in CCLM 2.11 Journal of Clinical Endocrinology and Meta- 3. Primary literature
2.12 Journal of Clinical Microbiology.
It must be stressed that reading primary literature (articles, surveys, etc.) is of utmost importance to 2.14 New England Journal of Medicine.
keep informed on the ‘‘state of the art’’ in clinical biol- 2.15 Scandinavian Journal of Clinical & Labora- ogy. For this reason, students should adopt a system for themselves of keeping constantly informed on developments in the field of laboratory medicine and

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