AIMS FELLOWSHIP CURRICULUM GENERAL II

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1 AIMS FELLOWSHIP CURRICULUM GENERAL II Module Code: GENERAL II (Compulsory Module) Module Title: Routine and Acute Clinical Chemistry Module Convener: Mr David Condie, B. app.sci (QUT), FAIMS, MASM, MBA Senior Scientist Pathology Queensland Mackay West Mackay Mail Centre, QLD 4740 Phone E.mail (H) Discipline Committee: Mr David Condie Ms Dianne Zurcher Mr Richard Hanlon Data Module Outline last reviewed: May 10, 2007 Data Module Outline last modified: July 30, 2013 Other Modules in this Discipline: Module General I Microbiology Module General III Transfusion Science Module General IV Haematology

2 A Objectives The objective for this module is to explore the candidate s knowledge in routine and acute clinical chemistry. There will be a mix of short answer questions, case based scenarios, and essays questions to thoroughly test the candidate. It assumed that the candidate has studied clinical chemistry at an undergraduate level, and that they have been employed in a clinical laboratory, including clinical chemistry, for at least two years. This plus the other three disciplines make up the four compulsory subjects of the general fellowship. On successful completion of this module candidates should be well equipped to manage the clinical chemistry section in a routine multidisciplinary laboratory and core laboratory. B. Interrelationship of the Module to Other Modules This module provides the basic knowledge needed to underpin both the normal routine testing, and critical care analytes. Module Routine and Acute Clinical Chemistry is a compulsory module that includes both critical care analytes as well as routine clinical chemistry. The other modules represent distinct disciplines, which comprise the major disciplines represented in most clinical laboratories. Module General I Module General III Module General IV Microbiology Transfusion Science Haematology C. Brief Description This module will provide a broad working knowledge of the basic concepts in clinical chemistry. The candidate will need to have at least two years experience in a clinical chemistry laboratory before attempting this module. It is also recognised that areas in laboratory medicine have experienced significant changes over the past decade, and that all scientists need to recognize these changes. It is up to each of us to remain competent in our chosen profession and successful completion of this module will help to maintain these high standards.

3 D. Content Part A 1. Basic laboratory Techniques and Preanalytical variation. 2. Instrumentation and Analytical Techniques 2.1 understand the principles of photometric measurements such as spectrophotometry 2.2 recognise the components in a spectrophotometer and how they work 2.3 be able to list the various photometers 2.4 understand Beer s law and Beer-Lambert law 2.5 understand, reflectance spectrophotometry, densitometry and fluorometric assays. 2.6 Recognise the value of potentiometry and ion selective electrodes and the principals that they use. 2.7 Point of care testing. Objective: to be fully conversant with the principles of various analysers such as spectrophotometry, ion selective electrodes, densitometry and fluorometric assays. 3. Immunoassays 3.1 understand the use of antibodies in the diagnose of a number of disorders 3.2 know the concepts of direct and indirect immunoassay 3.3 know the principles in enzyme-linked immunosorbent assay (ELISA), enzyme-multiplied immunoassay technique (EMIT) chemiluminescent immunoassays 3.4 understand the difference between polyclonal and monoclonal antibodies 3.5 know what is meant by the terms heterogeneous and homogeneous assays 3.6 recognise potential errors due to high-dose hook effect and take action that will eliminate errors from this source 3.7 know the problems that may arise due to heterophilic antibodies and how to correct these 3.8 differentiate between antibody specificity and avidity and be able to define the term hapten and know when haptens are mainly used in assays. 3.9 understand what is meant by the term sandwich assays Objective: to know the principles of various immunoassay methods that are available currently available, to recognise causes that may invalidate the result, and to know how to correct this. Part B Critical care analytes On completion of this module the candidate would be expected to have a complete and thorough knowledge of the following: 1. Electrolytes and Blood Gases 1.1 the importance of serum osmolality as an indicator of water balance 1.2 recognise the importance of water balance and the kidney 1.3 have a detailed knowledge of electrolytes and in particular sodium 1.4 understand the causes of hypernatremia and hyponatremia and their relationship to chloride and potassium 1.5 understand the significance of: euvolaemia, hypovolaemia, hypervolaemia. 1.6 understand the importance of the residual anion concentration 1.7 know the significance of the anion gap to electrolytes and to blood gases 1.8 understand the function and importance of potassium ions and their effect on acidosis

4 and alkalosis. 1.9 know the methods and their principles, in determining electrolytes and blood gases 1.10 have a detailed knowledge of blood gases, and the ability to interpret the results understand the value of chemical buffers 1.12 understand the importance of obtaining a blood specimen that has been collected properly and sent to the laboratory promptly 1.13 identify mechanisms that the kidney uses to maintain homeostasis Objective: To understand the significant homeostatic role carried out by electrolytes and the water, and their relationship with blood gases 2. Markers of Cardiac Function and Injury: 2.0 know the criteria for the diagnosis of a myocardial infarction 2.1 have a detailed knowledge of the pit-falls that may effect the various analytical methods 2.2 be able to compare the value CK-MB mass assays to Troponin T or I 2.3 understand the value of Myoglobulin 2.4 to be able to identify reperfusion and re-infarction 2.5 identify the active binding sites on the Troponin complex Objective: to be able to carry out appropriate tests to assist in the diagnosis of a myocardial infarction 3. Carbohydrates and Diabetes: 3.0 know the role of the following hormones in glucose metabolism: insulin, glucagon, epinephrine, thyroxine, ACTH, cortisol, and growth hormone 3.1 understand the metabolism of carbohydrates in humans 3.2 identify diabetes mellitus type 1 and 2, and gestational diabetes mellitus 3.3 know the value of testing and monitoring for hypo or hyperglycaemia 3.4 know the use of haemoglobin A1c and its measurement 3.5 recognise the role of self monitoring for glucose 3.6 understand the value of glucose tolerance testing in diabetic diagnosis 3.7 know the complications that diabetics suffer from 3.8 be able to evaluate of the levels of ketoacidosis and micro-albuminuria 3.9 know the role of potassium when monitoring treatment Objective: to understand the importance of maintaining blood glucose levels within normal limits and know the consequences if they are not. Routine analytes: 4. Lipids and lipoproteins: 4.0 know the general chemical structure and biological functions of lipids 4.1 understand the significance of the following: fatty acids, triglycerides, phospholipids, cholesterol and HDL-cholesterol 4.2 identify the important role that the liver plays 4.3 identify the two lipid pathways and their functions 4.4 understand the causes that lead to atherosclerosis 4.5 identify individuals at risk for atherosclerosis 4.6 have a sound knowledge of diseases that result from deficiencies in lipid metabolism 4.7 have the analytical ability to be able to test for the various lipids and to understand the principles underpinning these Objective: to recognise the importance of identifying an abnormal lipid result, and if abnormal, treating and monitoring these levels

5 5. Metabolic Analytes: 5.0 recognise the value of measuring both urea and creatinine 5.1 note sources of error, particularly, when measuring creatinine 5.2 recognise the many functions that the kidney performs 5.3 carry out creatinine clearance testing as well as concentration and dilution tests 5.4 understand the metabolic pathways leading to the elimination of uric acid. 5.5 know the causes and treatment of gout 5.6. a sound knowledge of various uric acid methods is essential as interfering substances, in some methods, can significantly affect the results Objective: to understand the importance of the kidney in removing waste products, and to recognise the endocrine of the kidney. To know the pitfalls in laboratory testing, in particular for creatinine and uric acid 6. Bone Metabolism and Calcium: 6.0 understand the hormones that control calcium absorption 6.1 identify the homeostatic functions of calcium 6.2 know the various analytical test methods for calcium, phosphate, and magnesium 6.3 understand the complexities of measuring calcium 6.4 understand why albumin is also measured 6.5 know the value of measuring ionised calcium as compared to total calcium 6.6 be aware of the errors in these tests and also recognise and identify the diagnostic value when measuring calcium, magnesium and phosphates 6.7 be able to interpret these results for the clinician Objective: to know that calcium and magnesium are difficult tests to carry out, and the accuracy is often poor. Yet recognise that these are some of the most important tests in a number of critical conditions. 7. Proteins: 7.1 understand the structure and function of proteins 7.2 measurement of total protein and albumin 7.3 know the diagnostic value of measuring proteins 7.4 understand the diagnostic value of various proteins: Examples are α1-antitrypsin, α1- fetoprotein, haptoglobin, ceruloplasmin, transferrin, fibrinogen, C-reactive protein, C3 component, and immunoglobulins 7.5 understand the principles of protein electrophoresis and understand the significance of Bence Jones protein. Objective: to be able to identify proteins from an electrophoresis strip and recognize the clinical significance of these. 8. Liver Function and Enzyme Testing: 8.1 understand the difference between mass and activity enzyme reactions. 8.2 identify abnormal liver function using a variety of enzyme tests. 8.3 understand the value of measuring bilirubin. Identify the value of measuring both conjugated and unconjugated bilirubin. 8.4 understand the molecular structure of bilirubin and identify the value of blue light in a jaundiced neonate. 8.5 know the main causes of incorrect bilirubin testing. 8.6 understand the pit-falls of the various methods in use. 8.7 know what delta bilirubin is and understand the diagnostic significance of this. 8.8 many liver function tests rely on enzymatic tests.

6 8.9 know the principles of these and the pit-falls that can happen know what zero order and first order kinetics are in an enzymatic reaction understand the terminology of enzyme assays know the causes of error in enzyme reactions and how to rectify them identify linear phase and lag phase of the reaction be able to synthesis the results together to indicate a diagnosis recognise that most enzyme reactions are measured at 340nm and know the reasons for this understand the reasons why ph, temperature, substrate, enzyme concentration, are so important in these reactions that have to be tightly controlled recognise the importance of storage, transport and handling of specimens prior to their assay. Objective: to be able to carry out enzyme tests with accuracy and to recognise situations where substrate depletion is occurring; to be able to identify cytoplasmic and mitochondrial enzymes and know the diagnostic value of these. 9. Pregnancy 9.1 know that human chorionic gonadotrophin (HCG) is one of the first hormones to become elevated in pregnancy 9.2 recognise the similar structure of HCG to LH, FSH, and TSH 9.3 understand the value of monitoring human chorionic gonadotrophin in pregnancy 9.4 be aware of the very diverse range of results obtained 9.5 know that if an HCG result is in the millions, then further investigations must be made, and the diagnosis identified. 9.6 recognise the value of the HCG tests for monitoring patient progress and the conditions that may result in a miscarriage 9.7 list the major source of error when measuring HCG. Objective: Recognise that human chorionic gonadotrophin (HCG) is used to detect, or monitor, pregnancy and know that HCG has a similar structure to FSH, LH, and TSH. Know that the major function of HCG is to maintain the progesterone level to permit the developing conceptus to implant. Sudden decreases in HCG levels can indicate pending miscarriage. 10. Miscellaneous analytes 10.1 recognise the urgency in measuring paracetamol 10.2 know that paracetamol can cause hepatic failure, and recognise the effective antidote that is available 10.3 understand the Rumack-Matthew nomogram 10.4 know the meaning of the terms, TDM, and therapeutic range 10.5 be able to list the drugs that are commonly measured, such as Gentamicin, Vancomycin, Phenytoin, Theophylline, Digoxin understand the key principles for interpretation of plasma drug concentration 10.7 recognise the importance of peak and trough measurements and their use in TBA 10.8 know the concept of the half-life, steady-state concentration, when measuring concentrations of drugs 10.9 understand the special care that must be taken in the measurement of digoxin Objective: To recognise that the measurement of drugs is quite different to other tests. Therapeutic drug monitoring requires knowledge of when the drug was taken, its various half-lives, binding to albumin, and other binding proteins, and its absorption by the body. 11. Quality Assurance: 11.1 understand the components of a quality assurance program know the Westgard Multirule system in regard to quality control data.

7 11.3 differentiate between a warning rule and a rejection rule recognise the value of external quality control programs understand matrix effects recognise that there are pre-analytical, analytical and post analytical factors that can cause errors. Objective: to have a sound knowledge in all aspects of quality assurance, and to recognize erroneous results do to pre-analytical errors. E. Rationale for Content A comprehensive knowledge of routine clinical chemistry testing for a wide range of analytes, and an understanding of the clinical urgency surrounding the measurement of some analytes compared with others, is important in determining the appropriate management and quality assurance of the testing process. F. Examination Under the Fellowship Regulations, a 3-hour written examination will be held at the completion of each Module. Each examination will contain a mixture of short answer questions and essay style questions. In some examinations, clinical and laboratory management case based scenarios will be included in the question mix. Examination for this Module will focus on an overall understanding of the principal concepts and regulatory mechanisms across the major topic themes. G. Texts and Supporting Material The following texts all provide an excellent resource for this module. It is suggested that you glance through the texts and select one that appeals to you and you purchase that text. You should, from time to time, consult the other texts in the library to broaden your reading. 1 Kaplan L. A., Pesce J.P. and Kazmierczak C. K., Clinical Chemistry: Theory, Analysis, Correlation, Mosby, 5 th Edition, Burtis C.A., Ashwood E. R., Bruns D., Tietz Textbook of Clinical Chemistry and Molecular Diagnostics Saunders, 5 th Edition, Marshall W.J., Bangert S.K., Clinical Chemistry, Mosby, 5 th Edition, Gaw A., Murphy, M.J., Cowan A.C., O Reilly D,J, Stewart, M.J.Shepherd., Clinical Biochemistry, Churchill Livingstone, 3rd Edition, 2004 H. Appointment of a Mentor Candidates are strongly advised to nominate a mentor for the Module at the time of application for entry and into the Fellowship Program. If a candidate is unable to nominate a mentor then the candidate should contact the Module Convenor for assistance. The appointment of a mentor is made by the Examinations Council.

8 I. Module Communications Module Convener: Mr David Condie, B. app. Sci (QUT), FAIMS,MASM, MBA Senior Scientist Pathology Queensland Mackay West Mackay Mail Centre 5580, QLD 4740 Phone E.mail (H) (W) Discipline Committee: Mr David Condie Ms Dianne Zurcher Mr Richard Hanlon J. Candidate Feedback Immediately following notification of the examination result each candidate will be asked to complete a feedback questionnaire on the Module. However, feedback at anytime during the study of the Module is encouraged through the mentor or directly to the Module Convener.

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