The Commission on Accreditation in Clinical Chemistry (COMACC) is an independent non-profit organization that accredits training programs in clinical chemistry at the masters, doctoral, and postdoctoral level. The purpose of granting accreditation to training programs is to foster their excellence, to provide recognition to accredited programs, and to attract qualified individuals to training centers of excellence. This process is intended to assure the trainee that the standards of education and training are consistent with the progress in medicine and clinical laboratory sciences.
Standards and associated guidelines have been established that define the conditions under which these goals may reasonably be achieved at each level of training. These guidelines are provided for the benefit of institutions to help them to achieve a level of excellence in their educational efforts. The Commission expects the institution to have flexibility in developing programs of quality. It does however consider the program director to be a key to the success of any program and will strive to assure that excellence begins with the program leadership.
This document is intended as a guideline for program directors who provide the leadership in organizing local resources for training in clinical chemistry and to assist them in assuring that their programs meet the standards and requirements for accreditation by COMACC.
Clinical chemistry is a broad field that includes general chemistry, endocrinology, toxicology, therapeutic drug monitoring, nutrition, serology and immunology, urinalysis, pharmacogenomics, and molecular diagnostics. The types of clinical chemists vary. The principal professional opportunities range from Director, Associate/Assistant Director of clinical laboratories in an assortment of medical centers and hospitals, to Director or Associate staff in Research and Development departments in pharmaceutical and/or diagnostics industrial firms. Another career path is Director/Associate or Assistant Director of a reference laboratory.
The principal objective of a training program should be to educate and train clinical chemists who will be able to provide leadership in the field of clinical chemistry and other areas of clinical laboratory science, who will be active in research, and who will serve the needs of physicians and patients. The training program should be of sufficiently broad scope that it provides the essentials necessary for the clinical chemist to sit for the American Board of Clinical Chemistry Board examination in chemistry and toxicology or molecular diagnostics and to have career mobility and to be able to succeed in the professional environment. Therefore, in order to prepare the clinical chemist for these various professional opportunities, the well-balanced program deals with research, education, service, and administration.
A. STANDARD I. FACULTY
Educational programs in clinical chemistry must be staffed with adequate, qualified faculty (e.g., clinical chemists and/or chemical pathologists) to assure program quality consistent with program objectives and effective student learning.
GUIDELINES
1. PROGRAM DIRECTOR
- The program should have an "on site" director who has continuing responsibility for the operation of the entire program.
- The Program Director must be a clinical chemist who holds a faculty position in the sponsoring institution and who is certified as a Diplomate by the American Board of Clinical Chemistry (ABCC). The program director may be certified by another board that is acceptable to COMACC if the program is administered jointly with a co-director who is certified by ABCC. The program director must be active academically in clinical chemistry research, education, service, and administration at the sponsoring institution. Ideally the program director will have at least five years of academic and service experience in the field, and will have demonstrated teaching expertise at the graduate and postdoctoral level. Individuals who have completed formal postdoctoral training in clinical chemistry will be particularly well suited to function as directors of training programs.
- Currently accredited programs whose program directors do not meet these qualification requirements will retain their accreditation. All programs will be expected to comply with these requirements by the year 2010.
2. TEACHING FACULTY
- Faculty associated with a training program should meet the same qualifications as specified by the Commission for the program director.
- The ratio of postdoctoral trainees to full time clinical chemistry faculty should, as a general rule, not exceed one to three.
B. STANDARD II. INSTITUTIONAL SUPPORT
The parent institution of an accredited educational program in clinical chemistry shall provide adequate space as well as administrative and logistical support to facilitate the effective, efficient operation of the training activity.
GUIDELINES
1. SALARY/BENEFITS
It is recommended that a postdoctoral trainee has the same salary and benefits as that provided for a first year resident in laboratory medicine (clinical pathology).
2. LABORATORY FACILITIES
- It is essential that postdoctoral training in clinical chemistry is associated with a broad based clinical laboratory, with rotations in many specialty areas such as general chemistry, endocrinology, toxicology, therapeutic drug monitoring, nutrition, serology and immunology, urinalysis, pharmacogenomics and molecular diagnostics being available to the trainees.
- It is highly recommended that postdoctoral trainees have the opportunity to spend some time at institutions with special patient populations such as children's hospitals and/or veterans administration medical centers. An opportunity for decision-making responsibility must be available to the trainees, as their proficiency increases.
- The clinical chemistry laboratory used for training shall meet the requirements for local, state or Federal licensure or, where no such requirements exist, be approved by an organization acceptable to the Commission (such as the College of American Pathologists). Exceptions to this rule may be made on the basis of the Commission's own findings upon a site visit by its inspection team.
3. LIBRARY
Training institutions will have library and/or other services that provide an adequate, readily available basic collection of reference books as well as books in the sciences fundamental to clinical chemistry and medicine. In addition, the library should provide access to a wide range of on-line medical/biochemical journals in the fields of clinical chemistry.
4. COMPUTER SERVICES
The institution will provide the trainee with full access to a personal computer and on-line services. Postdoctoral trainees must have an electronic mail address and access to Medline or similar on-line literature search function.
5. RECORDS
The institution shall maintain, and have available for inspection by the Commission upon request, the records of faculty, students, and postdoctoral trainees' curriculum offerings, and program activities. The records should be prepared in a manner consistent with Federal right to privacy legislation. Records should include, but are not limited to:
- Recruitment/selection documentation
- Rotation/course schedules and activity logs
- Documentation for clinical consultation i.e., on-call experience
- Trainee performance evaluations
- Program evaluations (by trainees)
- List of past trainees, including certification status and current position
C. STANDARD III. CURRICULUM AND INSTRUCTION
The curriculum and instruction, both didactic and clinical, of an accredited training program in clinical chemistry, shall demonstrate a pursuit toward excellence and the achievement of preset educational objectives. The curriculum and instruction shall demonstrate, but not be restricted to, compliance with minimum requirements defined by the Commission.
1. PROGRAM OBJECTIVES
The major goal of training at the postdoctoral level is to prepare a clinical chemist trainee with sufficient clinical and practical experience to be an assistant/associate director or director of a clinical chemistry laboratory. A trained clinical chemist should be able to demonstrate competency in directing clinical services and proficiency for initiating independent (or collaborative) research projects. Teaching is an important part of a clinical chemist's responsibilities and a trained clinical chemist must be able to teach others (residents, graduate students, medical students, medical technologists, etc). Finally, a trained clinical chemist should have administrative skills. Most training programs devote part of the program to supervised managerial training, in which a trainee will manage the laboratory as an “acting director”. During that period, the trainee will have interaction with staff and administration and learn to handle related issues. The clinical chemist must serve effectively as a consultant to physicians in the interpretation of reported laboratory values and in the relationship of biochemical and genetic findings of disease. A clinical chemist should be familiar and up to date with the newest tests, disease markers and technologies in the field of clinical chemistry. He/she should have a cordial relationship with medical staff. Also, a clinical chemist should be a source of information in his/her field and educate his/her colleagues about the most recent findings in clinical chemistry by speaking at Grand Rounds, staff meetings, etc. The latter approach can result in an excellent collegial relationship between the laboratory and the medical staff. The trainee must be thoroughly grounded in the theory, operation, and maintenance of instrumentation, methodology, and the quality control measures applicable to the modern clinical laboratory. As an administrator, the clinical chemist must be a competent manager of people, capital equipment, budgetary resources, and have a working knowledge of the ethics of medicine and science. As the training proceeds, the postdoctoral trainee should be given increasing responsibility, preferably during the second year of training, for management and supervisory duties.
2. ADMISSION
Postdoctoral trainees in clinical chemistry should have an earned doctoral degree in clinical chemistry, biochemistry, chemistry, or other related biological science or a doctorate in a medical discipline. Sufficient courses in chemistry, biochemistry or other acceptable subjects should have been completed to qualify the student for certification eligibility with the American Board of Clinical Chemistry. Students with limited coursework in chemistry and biochemistry should have an opportunity to take graduate level courses in the discipline while participating in postdoctoral training.
3. CURRICULUM
Postdoctoral training should be sufficient to allow the trainee to assume immediate responsibility for the clinical chemistry laboratory in a medium sized hospital or to direct a laboratory subject to regulations governing interstate commerce. Although the training may duplicate coverage of certain subject areas outlined in the standards for the doctoral program, the postdoctoral trainee must acquire a competency for independent decision-making and assume a responsible role in providing the most accurate laboratory results and interpretation to his/her medical colleagues. The postdoctoral training period for a graduate with a doctorate (Ph.D.) in chemistry, biochemistry and related fields or a doctorate of medicine degree should be a minimum of two years in duration. Previous training in pathology/clinical pathology may be substituted for one year of training. This time usually is required to teach trainees the fundamentals of clinical chemistry, pathobiology of human diseases, biostatistics, quality assessment, principles of instrumentation from basic (e.g., photometry) to sophisticated (e.g., tandem mass spectrometry), as well as to provide sufficient exposure to the management and supervisory aspects of a broad based clinical chemistry laboratory. Accordingly, training will consist of didactic and hands on laboratory teaching, supervised decision making responsibilities, design of clinically oriented research projects and development of presentation skills.
GUIDELINES
a. The specific content of the training program curriculum is left largely up to the Program Director and Teaching Faculty. However, the curriculum for an effective training of clinical chemists should provide the necessary education, training, and practice in the essential areas of clinical chemistry and laboratory practice that are outlined in appendices I (Fundamental concepts and procedures), II (Principles of analysis and techniques used in clinical chemistry), III (Instrumentation in clinical chemistry) and IV (Principles of laboratory medicine).
b. Additional guidance for development of a training program curriculum may be found in the Syllabus for a Postgraduate Training Program in Clinical Biochemistry , prepared by the Canadian Academy of Clinical Biochemistry of the Canadian Society of Clinical Biochemists ( www.cscc.ca ), and the EC4 European Syllabus for Post-Graduate Training in Clinical Chemistry and Laboratory Medicine: version 3 – 2005 [S Zerah et al ., Clin Chem Lab Med 2006;44(1):110-20].
c. Applicable competencies for clinical pathology based on the six areas of competency defined by the Accreditation Council for Graduate Medical Education (ACGME) – patient care, medical knowledge, practice-based learning and improvement, interpersonal and communication skills, professionalism, and systems-based practice - have been developed by the Academy of Clinical Laboratory Physicians and Scientists [BR Smith et al. , Curriculum Content and Evaluation of Resident Competency in Clinical Pathology (Laboratory Medicine): A Proposal . Clin Chem 2006;52(6):917-49]. This document includes curricula for rotations in relevant subdisciplines (chemical pathology, molecular diagnostics, and management and informatics) and suggestions for means of assessing trainee competency. The Royal College of Pathologists of Australasia (RCPA) publishes a Trainee Handbook that includes a checklist of basic laboratory procedures and tests in chemical pathology and a table of suggested learning activities designed to achieve specific learning outcomes. Potential methods for assessing trainee performance are provided for each task. The handbook can be downloaded from the RCPA website ( www.rcpa.edu.au ).
Appendix I, II, III, and IV (see below)
APPENDICES
APPENDIX I. FUNDAMENTAL CONCEPTS AND PROCEDURES
LABORATORY MANAGEMENT, ORGANIZATION AND OPERATION
1) Principles of leadership and organization
2) Laboratory facilities and design
3) Centralized versus Point-of-Care Testing
4) Laboratory test ordering and reporting systems
5) Medico-legal requirements (confidentiality, record keeping)
6) Accreditation requirements
7) Workload reporting and cost accounting
8) Billing and reimbursement concepts and issues
9) Preparation and maintenance of proper laboratory manuals
10) Quality management
LABORATORY SAFETY
1) Fire, chemical, radiation and infection control
2) Waste disposal regulations
3) Blood and body fluid precautions
4) Applicable OSHA/JCAHO regulations and requirements
5) Material Safety Data Sheets (MSDS) interpretation
6) Any other laboratory or institutional safety practices and policies in effect
BASIC STATISTICS
1) Descriptive statistical measures, e.g., mean, median, mode and standard deviation
2) Comparative statistics, e.g., confidence limits, t-test, F-test, analysis of variance, Chi-square, linear and other regression and difference plots
3) Concepts of parametric and non-parametric statistics
APPENDIX II. PRINCIPLES OF ANALYSIS AND TECHNIQUES USED IN CLINICAL CHEMISTRY
SPECIMEN COLLECTION AND PROCESSING
1) Specimen collection, identification, transport, delivery, preparation and preservation
2) Patient preparation for tests
3) Special collection requirements, e.g., neonates
4) Anticoagulants, preservatives and gel separators
5) Regulations and precautions regarding transport of biological specimens
6) Pre-analytical errors
PRINCIPLES OF ANALYSIS
1) Solute/solvent concepts and calculations
2) Units of measurement – Conventional, SI, and unit conversions
3) Basic laboratory techniques, e.g., pipetting, weighing, filtering, centrifugation
4) Fundamental analytic concepts such as spectrophotometry and other optical techniques, electrochemistry, electrophoresis, chromatography, mass spectrometry, enzymology, immunochemistry, radioimmunoassay, etc. (See Appendix I)
5) Chemicals, water, primary and secondary standards; reference materials (International reference materials) and reference methods
6) Internal and external quality control concepts and procedures
i. Control charts (e.g. Levey-Jennings)
ii. QC rules (e.g. Westgard) 7) Proficiency testing – external, internal
8) Principles of analytic error assessment, evaluation of methods, and method validation (assessment of accuracy, precision, interferences, sensitivity and limits of detection, method bias, total allowable error, etc.)
9) Point-of-Care testing concepts
10) Principles of instrumentation and automation and strategies to select appropriate instruments (See Appendix III)
TECHNIQUES USED IN CLINICAL CHEMISTRY
1) General Techniques: Volumetric techniques, weighing, filtration, liquid-liquid and solid-phase extractions, partition coefficients; selection and preparation of buffers; freeze drying; dialysis; concentration, desalting, ultra-filtration; preparation of derivatives; calibration techniques
2) Spectrophotometric Techniques: Molar absorptivity, reflectance, absorbance, transmittance, fluorometry, fluorescence polarization, bioluminescence, chemiluminescence, electroluminescence, nephelometry and turbidimetry
3) Electrochemistry: Potentiometry, ion-selective electrodes, voltammetry and amperometry, conductometry, coulometry and biosensors
4) Electrophoresis: Conventional, capillary, microchip, polyacrylamide, capillary zone, isotachophoresis, isoelectric focusing, immunofixation, two dimensional (2D)
5) Chromatography: Planar vs. column, gas vs. liquid, adsorption, affinity, ion-exchange, partition and size-exclusion techniques, direct and reverse phase liquid chromatography, highperformance liquid chromatography, solid phase extraction techniques, gas chromatography
6) Mass spectrometry: GC-MS, LC-MS, LC-MS-MS, MALDI-TOF, SELDI, ICP-MS
7) Clinical Enzymology: Enzyme kinetics, enzymes as reagents, coupled enzymatic reactions, zero-order (enzyme) assays, first-order (substrate) assays
8) Immunoassay techniques: Preparation, assessment and storage of antisera, methods of assessing analytical sensitivity and specificity, standardization issues, isotopic and non-isotopic, liquid or solid-phase, competitive, non-competitive or immunometric, specific techniques (radioreceptor, immunodiffusion, immunoelectrophoresis, immunoblotting and immunofixation, enzyme-linked immunoassays, nephelometric, turbidimetric and fluorometric immunoassays
9) Isotope Techniques: Physical principles and types of radioactive isotopes, counting techniques and their statistical evaluation, half-life and specific activity concepts and calculations, units of radioactivity, radioimmunoassay techniques, radiation safety and legal requirements for storage and disposal
10) Molecular Diagnostics: Principles and methods of DNA and RNA isolation, purification, polymerase chain reaction (PCR); DNA probes (radioactive and non-radioactive labels), hybridization, restriction fragment length polymorphism (RFLP), blotting techniques, DNA chips/microarrays, sequencing, Real Time PCR, fluorescent in situ Hybridization (FISH), other methods of genomic analysis
11) Proteomics and Protein Arrays: Qualitative and quantitative methods for proteome characterization such as 2-D gel electrophoresis, SELDI-TOF MS, MALDI-TOF MS, protein profiling, fluorescence resonance energy transfer (FRET), and surface plasmon resonance (SPR)
APPENDIX III. INSTRUMENTATION IN CLINICAL CHEMISTRY
The following are examples of the array of instruments often found in a clinical laboratory and with which the trainee should be familiar. For those programs not possessing a broad array of instrumentation, trainees are nevertheless expected to develop an understanding of the principles and potential uses for the instruments listed below. In addition, program directors should provide opportunities for trainees to visit other laboratories in order to broaden their instrumentation/automation exposure and experience.
1) Amino-acid analyzer
2) Atomic absorption spectrophotometers
3) Automated and semi-automated analyzers for general chemistry, automatic sampling and pipetting devices, immunologic techniques, chemiluminescence, fluorescence polarization; random access and batch analyzers; reagent cassette and thin film analyzers
4) Blood gas apparatus and co-oximeters
5) Capillary zone electrophoresis and immuno-fixation electrophoresis
6) Electrophoresis and densitometer equipment
7) Flow cytometers
8) Fluorometers
9) Gas chromatographs with FID, NPD and mass detection
10) General laboratory equipment such as centrifuges, dry and water baths, balances, microscopes, pH meters, shakers, thermometers, vortex mixers, etc.
11) High performance liquid chromatographs and associated detection systems
12) Infrared spectrophotometers
13) Ion specific electrodes (electrolyte measurement and other applications
14) Isoelectric focusing
15) Liquid scintillation and gamma counters
16) Mass spectrometers (quadrupole and tandem)
17) Nuclear magnetic resonance
18) Osmometers
19) Polymerase chain reaction cyclers and other amplification instruments
20) Refractometers
21) Small instruments for satellite and point-of-care testing
22) Spectrophotometers, reflectometers and nephelometers
23) Tonometers
24) Ultracentrifuge
25) Water purification systems, stills, de-ionizers, reverse osmosis units
26) Laboratory automation (Trainees should understand the principles of front- and back-end and full automation. They should be familiar with advantages and shortcomings associated with automation and be able to assess the appropriateness and feasibility of adapting automation for a given laboratory.)
APPENDIX IV. PRINCIPLES OF LABORATORY MEDICINE
RELATIONSHIP OF THE LABORATORY TO MEDICAL PRACTICE
1) Understand the roles (screening, diagnosis, monitoring) and limitations for laboratory testing in clinical practice
2) Understand the structure, use and limitations of the medical record (paper or electronic); develop proficiency in extracting and interpreting laboratory and medical information
3) Be able to design studies and appropriately analyze and interpret data related to determination of diagnostic performance:
a) Design and performance of outcome studies
b) Sensitivity, specificity, predictive value, odds ratio, hazard ratios, and ROC studies
c) Economic evaluation of diagnostic testing and application of principles of evidence-based medicine
4) Understand the principles and application of evidence-based medicine in test implementation and patient evaluation
INTERPRETATION OF LABORATORY TEST RESULTS
1) Understand the establishment and appropriate use of reference ranges and critical values
2) Understand the sources and effects of analytic variables on laboratory tests
3) Understand the sources and effects of physiological variables (diurnal and individual variations, rest, exercise, age, gender, fasting and the pharmacologic effects) on test results
4) Understand the effects of disease on test results and recognize typical disease patterns
5) Recognize the use and limitations of current disease-related testing strategies/algorithms, e.g., use of cardiac markers for AMI and ACS, lipid screening, for CHD, diabetes screening, PSA screening, etc.
6) Develop and demonstrate (via activity logs) application of the above skills through liaison and consultative interaction with medical staff and other laboratory professionals; participate in service rounds, autopsy reports and related seminars and case reports
CLINICAL PATHOLOGY AND LABORATORY EVALUATION OF DISEASE
Understand basic human biochemistry and physiology, specific biochemical alterations and laboratory tests and testing strategies for the following:
1) Cardiovascular and related diseases
a) Biochemistry and physiology of normal circulatory function
b) Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of acute myocardial infarction, acute coronary syndromes and congestive heart failure
c) Role of the laboratory in diagnosis and management of primary and secondary hypertension
2) Endocrine disorders
a) Biochemistry and physiology of endocrine hormones, including:
i) Pituitary- hypothalamic
ii) Adrenal
iii) Thyroid
iv) Parathyroid
v) Pancreatic endocrine
vi) Ovarian, placental and testicular hormones
b) Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of disorders of the above listed systems
c) The use of stimulation/suppression tests in the assessment of endocrine function
3) Gastro-intestinal and exocrine pancreatic disease
a) Biochemistry and physiology of GI metabolites and hormones, including:
i) Pancreatic digestive enzymes
ii) Hydrochloric acid and bicarbonate
iii) Gastro-intestinal hormones
b) Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of gastro-intestinal and exocrine pancreatic disease, including:
i) Malabsorption
ii) Secretory disorders (neoplastic and non-neoplastic)
iii) Immunologic disorders (e.g. celiac disease)
c) The use of stimulation/suppression tests in the assessment of gastric function/disease
4) Genetic diseases
a) Gene structure, mechanisms of damage and repair and phenotypic manifestations
b) Specific genetic defects, inheritance patterns and biochemical, cytogenetic, and molecular diagnostic approaches for genetic diseases
c) Recommended tests and newborn screening strategies for inherited disorders
5) Hematologic/coagulation disorders
a) Principles of blood homeostasis and morphology and function of cellular elements of blood
b) Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of hematologic diseases and disordered hemostasis with biochemical implications including:
i) Hemolysis, hemoglobinopathies and thalassemias
ii) Coagulopathies, primary and secondary causes
iii) Porphyrias
iv) Isoimmunization (Rh/ABO)
v) Anemias and disordered iron metabolism
6) Hepatobiliary diseases
a) Hepatic structure, physiology and biochemistry
b) Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of hepatobiliary diseases, including:
i) Hepatocellular diseases
ii) Cholestatic disorders
iii) Immunologic and neoplastic liver diseases
7) Immune system disorders
a) Immunoglobulin production, structure and function
b) Principles of cellular and humoral immune reactions
c) Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of immunologic diseases/alterations in immune function, including:
i) Immunoglobulin deficiency/overproduction (e.g. immune deficiency syndromes, monoclonal gammopathies, cryoglobulinemia)
ii) Immunologic impact of transplantation
iii) Autoimmune diseases
iv) Allergy testing
d) Interpretive skills for evaluation of electrophoretic and immunofixation results in serum, urine and CSF for monoclonal and/or oligoclonal gammopathies.
8) Kidney and urinary tract diseases
a) Biochemistry and physiology of normal kidney function
b) Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of acute and chronic kidney diseases, including:
i) Glomerular dysfunction
ii) Renal tubular disease
iii) Diseases of renal endocrine dysfunction
iv) Diabetic nephropathy
c) The physiologic basis and limitations of various renal clearance tests and estimates of glomerular filtration rate
9) Lipid and lipoprotein disorders
a) Structure, synthesis and metabolism of the various lipoprotein classes
b) Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of primary and secondary lipid disorders
c) Pathophysiology and utility of various testing modalities (e.g., lipid panel, apolipoproteins, lipoprotein subfractions) for risk stratification and management of coronary heart disease
10) Mineral and bone disorders
a) Biochemistry of calcium, phosphorus and vitamin D metabolism and of bone formation/resorption
b) Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of primary and secondary bone diseases (e.g. osteoporosis, Paget's disease, lytic bone diseases)
11) Nutrition and protein disorders
a) Biochemistry of plasma proteins and amino acids
b) Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of:
i) Dysproteinemias and dysproteinurias
ii) Malnutrition
iii) Genetic and acquired amino acid disorders
c) Interpretive skills for evaluating plasma protein patterns from electrophoretic testing of serum and urine
12) Pregnancy and reproductive disorders
a) Biochemistry and physiology of normal pregnancy
b) Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of obstetrical complications and diseases of the prenatal and perinatal period
c) Recommended laboratory screening tests and testing strategies for prenatal diagnosis of inherited disease (e.g., trisomy 21)
d) Recommended laboratory tests and testing strategies for fetal lung maturation
13) Toxicology and clinical pharmacology
a) Classification of major classes of drugs and toxins and their biochemical/physiologic effects
b) Appropriate sample collection, laboratory test methods, testing sequence and interpretive guidelines for workup of suspected poisoning or toxic exposures by various classes of toxins
c) Understanding of pharmacokinetics and pharmacodynamics
d) Pharmacogenetics
e) Appropriate sample collection and timing, laboratory test methods, testing sequence and interpretive guidelines for therapeutic drug monitoring
14) Water, electrolyte and acid-base disorders
a) Basic intracellular and extracellular fluid and electrolyte homeostasis
b) Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of fluid and electrolyte disorders, including:
i) Dehydration (e.g. fluid deprivation, diabetes insipidus)
ii) Water excess (e.g., SIADH)
iii) Hyper-/hyponatremia; hyper-/hypokalemia
iv) Oncotic disorders (e.g., edema and ascites)
c) The physiologic basis, use and limitations of various fluids/electrolytes formulae (e.g., anion gap, osmolar gap, serum/urine electrolyte ratios) for detection and differentiation of various fluid and electrolyte abnormalities)
15) Pediatric Clinical Chemistry
a) Considerations and requirements for pediatric testing as related to:
i) Sample collection requirements and limitations
ii) Reference ranges
b) Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of diseases of childhood (e.g., respiratory distress syndrome, hyperbilirubinemia, neuroblastoma, congenital hypothyroidism)
c) Develop interpretive skills for evaluating urine/plasma amino acid and organic acid patterns characteristic of inherited pediatric metabolic disorders
16) Laboratory evaluation of neoplasia
a) Etiology and clinical manifestations of cancer
b) Recommended laboratory tests for screening, diagnosis, staging and management of specific human cancers, including:
i) Biochemical markers
ii) Biogenic amines
iii) Oncofetal tumor markers
iv) Enzymes
v) Cellular markers
vi) Genetic screening
c) Clinical performance and limitations of tumor markers
02/19/07
COMACC Curriculum Committee