MLAB 2401 - Clinical Chemistry MLAB 2401.401 Course Syllabus

After studying all materials and resources presented in the course, the student will be able to:

1. Chapter 1-Laboratory Basics
   (1a-iii, b-ii, iii, iv, v, vi. 2a-i,ii,iii. 2c-i, iii..)
   1. Select appropriate method of water purification: distilled, deionized, reverse osmosis.
   2. Explain types of (CLSI) reagent grade water.
   3. Identify attributes, advantages, advantages and disadvantages of specific type of glassware
   4. Define:
      1. units of systems of measurement (Metric and SI)
      2. dilutions (serial and ratio),
   5. Describe basic mechanisms and types of balances.
   6. Define balancing terminology: capacity, sensitivity, precision, readability, tare
   7. Operate balances: leveling, handling weights, pan and/or beam arrest, weight paper or boats have cleanliness, temperature, elimination of drafts, vibrations, etc
   8. Calibrate balances following established laboratory procedure.
   9. Perform routine maintenance checks on all balances.
   10. Perform basic calculations:
       1. Exponents
       2. Molarity
       3. Percentage
       4. ratios and proportions
       5. unit conversions (concentration relationships)
       6. percent to molarity
       7. molarity to percent
       8. standard solutions
   11. Perform temperature conversion (F⁰ to C⁰), (C⁰ to F⁰).
   12. Perform conversion between and among systems of measurement- metric to SI and SI to metric.
   13. Calculate and perform dilutions (serial and ratio)
   14. Explain basic concepts of centrifugation- principles of centrifugal force, tachometer, relative centrifugal force
   15. Identify basic components of a centrifuge
       1. head/rotor
       2. bowl and cover
       3. shields/cups
       4. brushes
       5. cushion
   16. Describe operation of centrifuge- function controls, balancing
   17. Operate centrifuges- load and balance, lock head, select appropriate speed and temp, follow safety precautions.
   18. Perform routine maintenance checks on all centrifuges.
   19. Perform routine maintenance checks on heating units following established laboratory procedure.
   20. Check/calibrate temperature setting of heating units.
   21. Correct malfunction according manufacturer's manual.
2. Chapter 2- Safety in the Clinical Chemistry Laboratory
   (1a-i,ii. b-ii,iv,v. 2c-i,iii, d-i.)
   1. Apply OSHA Standards
   2. Outline fire safety guidelines: Fire protocol (RACE), Classes of fire extinguishers, Fire evacuation plan, Fire Extinguisher protocol (PASS)
   3. Identify potential sources of lab hazards (Biological/Bioterrorism)
   4. List five examples of personal protective equipment (PPE) and engineered controls used to protect laboratory staff
   5. Identify elements of an exposure control plan.
   6. Describe the purpose of a chemical hygiene plan.
   7. Apply ergonomic practices to laboratory tasks
   8. Follow a disaster preparedness program
3. Chapter 3- Laboratory Statistics, Method Development, and Quality Control
   (1ai,ii. 1b-ii, iv. 2c-iii, d-i.)
   1. Define statistical data for quality control and statistical analyses
   2. Define type of laboratory errors and biases: Preanalytical, Analytical (Random, Systematic) have Postanalytical.
   3. Assess pre-analytic and analytic factors that can affect patient results:
      1. Sample integrity
      2. draw time
      3. preservation or storage
      4. Age
      5. Gender
      6. Ethnicity
      7. Diet have viii. nutritional status
      8. fasting
      9. post prandial
      10. Exercise
      11. Position
      12. Posture
      13. Sample processing
      14. identification
      15. Method
      16. interfering substances/sources of error
      17. Recording of results
   4. Report results according to laboratory protocol: Routine, STAT, Action limits (critical values)
   5. Correlate all patient test data for acceptability: Review normal physiology and function (liver have cardiac, kidney, etc.)
   6. Interpret patient test results using reference intervals and previous patient data
   7. Recognize pathophysiology of abnormal results
   8. Define:
      1. Mean
      2. Mode
      3. Median
      4. Standard Deviation
      5. Coefficient of variation
      6. Reference intervals
      7. Variance
      8. linear regression
      9. correlation coefficient
      10. Gaussian distribution
      11. scales/graphs/charts
      12. Levey-Jennings charts
      13. Westgard Multirule system
4. Chapter 4- Instrumentation, Laboratory Automation, and Informatics
   (1a-i, ii, b-i, ii, v. 2c-i, iii)
   1. State basic concepts of atomic absorption spectrophotometry: Principles of light absorption have Generation of atoms from molecules
   2. Describe unique components relative to Osmometry:
      1. Principles of osmolality (colligative properties)
      2. Definition
      3. Calculations
   3. Identify basic concepts of spectrophotometry:
      1. Principles of light absorption
      2. Wavelength
      3. Spectrum
      4. Beer’s law
      5. Complementary spectra
   4. Identify spectrophotometer components:
      1. Light Source
      2. Monochromator
      3. Cuvettes
      4. Light Detectors
      5. Read-out systems
   5. State basic concepts of fluorometry:
      1. Principles of light absorption and emission by molecules
      2. Absorption and emission spectrum
   6. State basic concepts of turbidimetry and nephelometry:
      1. Principles of absorption
      2. light scatter
      3. Reflectance
   7. State basic concepts of mass spectrophotometry
   8. State basic concepts of chromatography:
      1. Separation mechanisms (partition, absorption)
   9. Define basic chromatography techniques:
      1. Column
      2. Thin layer (TLC)
      3. Liquid (HPLC)
      4. Gas (GLC)
   10. Describe the basic components of a chromatography system:
       1. Flow regulation
       2. Mobile phase
       3. Stationary phase
       4. Column Detectors
   11. Explain basic concepts of electrochemistry:
       1. Principles of electrochemistry
       2. Potentiometry
       3. Electrodes
   12. Describe the basic concepts of Ion-selective electrodes:
       1. Glass
       2. Solid state
       3. Liquid membrane
   13. Describe the basic components of electrochemistry:
       1. Reference electrode
       2. Indicator electrode
       3. Salt bridge
   14. State basic concepts of luminescence.
   15. Describe the basic components of an automated system:
       1. Sample/reagent pick-up/dilution
       2. Transfer module/mechanism
       3. Spectrophotometer module
       4. Control/calibration module
       5. Readout/recorder
       6. Operation/calibration
       7. Maintenance/quality assurance
       8. Troubleshooting
   16. Describe operations and principles of the automated systems.
   17. State basic concepts of automated analyzers:
       1. Discrete sample systems
       2. self-contained
       3. special purpose (POC)
5. Chapter 6- Molecular Diagnostics
   (1a-i, ii, b-i, ii, v. 2c-i, iii)
   1. Discuss Mendelian and non-Mendelian genetics
   2. Define mutation and polymorphism
   3. Discuss the basic functions of DNA
   4. Discuss Nucleic acid electrophoresis:
      1. Role of size
      2. Charge
      3. shape
      4. conformation in migration/movement
   5. Discuss PCR:
      1. Amplification Reaction
      2. the cycle (denature, anneal, extend)
      3. components
   6. Explain florescence in situ hybridization (FISH)
   7. Describe DNA:
      1. Central dogma
      2. Transcription
      3. Translation (codons/anticodons, ribosomes, genetic code/degeneration)
      4. Extrachromosomal (plasmid, mitochondrial transmission)
   8. Describe nucleic acid extraction/isolation/quantitation/purification techniques:
      1. Purpose of technique
      2. Reagents and purpose
      3. Acceptable sample types
   9. Differentiate PCR modifications techniques:
      1. Real time PCR
      2. nested PCR
      3. Multiplex PCR
      4. Reverse Transcriptionase PCR.
   10. Define the basic principles of restriction endonucleases.
   11. List the different types of amplification assays.
   12. Compare blotting techniques: Western, Northern, Southern
   13. Consider the following variables with performing various blotting techniques:
       1. RFLP
       2. Stringency
       3. Hybridization
6. Chapter 7- Carbohydrates
   (1a-i, ii, b-i, ii, v. 2c-i, iii)
   1. Define the following terms:
      1. Monosaccharide
      2. Disaccharide
      3. Polysaccharide
      4. Glycosidic linkage
      5. Aldose
      6. Ketose
      7. Hexose
      8. Pentose
      9. Isomer
   2. State the components of the disaccharides:
      1. Lactose
      2. Maltose
      3. Sucrose
   3. State the composition and function of each of the following polysaccharides:
      1. Starch
      2. Glycogen
   4. Discuss carbohydrate metabolism:
      1. State the purpose of digestion and absorption of dietary carbohydrates
      2. State how glucose is transported in the blood
      3. State the main physiologic functions of carbohydrates
      4. State the purpose of the following glucose pathways:
         1. Glycolysis
         2. Gluconeogenesis
         3. Glycogenesis
         4. Glycogenolysis
   5. State whether the following hormones increase or decrease blood glucose levels:
      1. Insulin
      2. Glucagon Cortisol
      3. Adrenocorticotropic hormone (ACTH)
      4. Epinephrine
      5. Thyroxine
      6. Growth hormone (GH)
      7. Human placental lactogen (HPL)
   6. Discuss the maintenance of blood glucose levels in the fed state (parenteral) and the fasting state
   7. List disease states and disorders associated with carbohydrate metabolism
   8. Explain etiology, symptoms, and effects of GDM
   9. Explain etiology, symptoms, and effects of Type 1 and Type 2 Diabetes
   10. Explain etiology, symptoms, and effects of Cushing's Syndrome
   11. Explain the diagnostic criteria for Type 1, 2 (impaired glucose tolerance and provisional diabetes mellitus), and GDM
   12. Explain etiology, symptoms, and effects of hypoglycemia:
       1. Induced
       2. Fasting Reactive
   13. State the principle of the chemical reaction, sample types required, reference interval, most common interfering substances/sources of error, and the usefulness of each:
       1. Glucose oxidase
       2. Hexokinase
       3. Glycated hemoglobin (A1C)
   14. State the qualitative or quantitative method used for detection:
       1. Other reducing substances
       2. Ketones
       3. Urinary sugars
       4. Cerebrospinal fluid (CSF) glucose
   15. Explain the usefulness of, patient preparation, and the procedure for a glucose tolerance test; include normal and diagnostic levels
   16. Correlate all patient results and patient outcomes with disease state or disorder
   17. Explain the usefulness of insulin and C-peptide
   18. State the usefulness of bedside or at-home glucose monitoring devices; compare results to non-POC analyzer results.
7. Chapter 8- Lipids and Lipoproteins
   (1a-i, ii, v, b-i, ii, v, vi, c-ii, iii, v. 2c-i, ii, iii)
   1. Define the lipid associated terminology:
      1. Lipid / Lipase
      2. Simple /Complex lipid
      3. Lipemia
      4. Lecithin
      5. Sphingomyelin
      6. Glycolipid
      7. Lipoprotein
      8. Apoprotein
      9. Esterification
      10. Saturated/Unsaturated
   2. State structural characteristics of lipids:
      1. Cholesterol
      2. Fatty Acids T
      3. Triglycerides
      4. Phospholipids
   3. Discuss lipid metabolism
   4. State the main physiologic functions of lipids
   5. State the main transport route of dietary lipids
   6. State the origin, main function of each lipoprotein; include apoprotein(s) required for normal function
   7. Explain the lipid pathways; include exogenous, endogenous, reverse
   8. Compare the lipoproteins using the difference in lipid and protein composition:
      1. Chylomicron
      2. Very low density lipoproteins (VLDL)
      3. Low density lipoproteins (LDL)
      4. High density lipoproteins (HDL)
   9. Correlate disease states and disorders associated with hyperlipidemias: Hyperglycemia/ Hypoglycemia
   10. List methodologies for lipid determinations, state the principle of the chemical reaction, reference interval, most common interfering substances/sources of error, and the usefulness:
       1. Cholesterol
       2. Triglycerides
       3. LDL
       4. HDL
   11. Explain the calculation for LDL
   12. List the usefulness of apolipoprotein measurements
   13. List the lipid levels associated with hereditary disorders:
       1. abetalipoproteinemia
       2. hypobetalipoproteinemia
       3. Tangier disease
   14. Explain recommended patient preparation protocol, specimen requirements, and abnormal serum appearance when collecting or handling specimens for lipid analysis
   15. Correlate patient results with disease state or disorder
   16. State the disorders/conditions associated with lipid imbalances:
       1. Atherosclerosis
       2. Malabsorption states
       3. Biliary obstruction
       4. Pregnancy
       5. Post menopause
       6. Ketosis
       7. Fatty liver
       8. Lipid storage diseases
       9. Hyaline membrane disease/Respiratory Distress Syndrome
8. Chapter 9- Amino Acids and Proteins
   (1a-i, ii, b-i, ii, v. 2c-i, iii)
   1. State the reference range for serum total protein and albumin
   2. Define protein-associated terminology:
      1. Isoelectric point
      2. Amino acid
      3. Peptide bond
      4. Complex or conjugated protein
   3. State protein structures and classifications
   4. Contrast protein structures:
      1. Primary
      2. Secondary
      3. Tertiary
      4. Quaternary.
   5. State protein metabolism
   6. State the main transport route of dietary amino acids
   7. State the main physiologic functions of plasma proteins
   8. Discuss synthesis:
      1. Non-essential amino acids
      2. Cellular proteins; include DNA and RNA
   9. State the main site of synthesis for plasma proteins
   10. State the principle of the chemical reaction, sample types required, reference interval, most common interfering substances/sources of error, and the usefulness:
       1. Biuret
       2. Turbidimetry/nephelometry
       3. Dye binding
       4. Protein electrophoresis
   11. List the cause for elevated urine levels:
       1. Albumin (microalbumin)
       2. Immunoglobulin
       3. Immunoglobulin light chains (Bence-Jones protein)
       4. Beta-2-microglobulin
   12. Correlate disease states and disorders associated with total protein levels and other test results:
       1. Dehydration
       2. Multiple myeloma
       3. Nephrotic syndrome
       4. Malabsorption
       5. Liver disease
       6. Hemolytic anemia
       7. Acute phase reaction
       8. Hypogammaglobinemia
       9. Congestive heart failure (beta-natriuretic peptide)
   13. Discuss methodologies for protein determinations
   14. State the property of proteins that allows separation or classification:
       1. Electrophoresis
       2. Isoelectric focusing
       3. Ion exchange chromatography
       4. Ultracentrifugation
       5. Immunochemical assay
   15. State the electrophoretic fraction in which each is located, the normal function, and disease states associated with abnormal levels:
       1. Albumin
       2. Alpha-1-antitrypsin
       3. Fetal fibronectin
       4. Alpha-2-macroglobulin
       5. Haptoglobin
       6. Ceruloplasmin
       7. Transferrin
       8. Fibrinogen
       9. C-reactive protein Immunoglobulins
   16. Correlate the serum protein electrophoresis pattern with disorders:
       1. Nephrotic syndrome
       2. Monoclonal gammopathy
       3. Hypogammaglobinemia L
       4. liver cirrhosis
       5. Acute phase reaction
       6. Polyclonal gammopathy/inflammation
   17. State the regulation of Copper:
       1. Absorption
       2. Ceruloplasmin
9. Chapter 10- Enzymes
   (1a-ii, iii, b-iii. 2c-i, ii, iii)
   1. State the chemical composition of an enzyme
   2. Give the basic function of Ligases
   3. List types of inhibitors (reversible/ irreversible)
   4. Define enzyme-associated terminology:
      1. Enzyme
      2. Catalyst
      3. Cofactor
      4. Apoenzyme
      5. Coenzyme
      6. Prosthetic Group
      7. Active Site
      8. Substrate
      9. Product I
      10. inhibitor
      11. Kinetic
      12. International Unit
      13. Isoenzyme
      14. Vmax
      15. Km
      16. Energy of Activation (EA)
      17. Michaelis-Menten Constant
      18. First-Order Kinetics
      19. Zero-Order Kinetics
   5. Discuss the usefulness of measuring enzymes
   6. State enzyme classification, nomenclature, and structure
   7. List types of activators
   8. State the most common physiologic functions of enzymes
   9. Explain theories of substrate binding by enzymes:
      1. Lock and key
      2. Induced fit
   10. State the kinetic measurement (first order, zero order) that is preferred for use in an analytical method
   11. List factors affecting enzyme reaction rates:
       1. Temperature
       2. Substrate
       3. concentration
       4. pH
       5. Enzyme concentration
       6. Time
       7. Isoenzymes
       8. Substrate specificity
   12. Contrast endpoint and continuous monitoring kinetic methods
   13. List clinically significant enzymes:
       1. Lactate dehydrogenase (LD)
       2. Creatine kinase (CK)
       3. CK-MB
       4. Aspartate amino transferase (AST)
       5. Alanine amino transferase (ALT)
       6. Gamma glutamyl transferase (GGT)
       7. Alkaline phosphatase (ALP)
       8. Amylase (AMY)
       9. Lipase (LIP)
       10. Cholinesterase/pseudocholinesterase
   14. State the primary tissue source(s) of clinically significant enzymes
   15. Explain the significance of abnormal serum levels and correlate with specific disease states or disorders:
       1. Myocardial infarction
       2. Liver disease
       3. Muscle disease
       4. Bone disease
       5. Malignancy
       6. Hematological disorders
       7. Pancreatitis
   16. List examples of the use of enzymes as analytical reagents
   17. State the chemical principle and reaction of the most commonly used methods for determining levels of the clinically significant enzymes
10. Chapter 11- Nonprotein Nitrogen and Renal Function
    (1a-ii, iii, b-iii. 2c-i, ii, iii)
    1. Describe renal function tests:
       1. Creatinine Clearance
       2. Estimated Glomerular Filtration
       3. Cystatin C
       4. Beta2Microglobulin
    2. List methodologies for urea nitrogen: State the principle of the chemical reaction, sample types required, reference interval, most common interfering substances/sources of error, and the usefulness.
    3. Differentiate the advantage and disadvantages of substances for determination of renal clearance:
       1. Creatinine
       2. Inulin
       3. Cystatin
    4. State the usefulness of creatinine measurement
    5. Explain creatinine synthesis and mode of excretion
    6. List methodologies for creatinine: For the most common methods, state the principle of the chemical reaction, sample type, reference interval, most common interfering substances/sources of error.
    7. Discuss disease states and disorders associated with creatinine measurement:
       1. Renal disease
       2. Muscle wasting disease
    8. State the reference range and explain the usefulness of the BUN/creatinine ratio
    9. Explain uric acid synthesis of and mode of excretion
    10. List methodologies for uric acid
    11. List disease states and disorders associated with uric acid measurement:
        1. Renal disease
        2. Gout
        3. Increased cell turnover (Leukemia, Chemotherapy)
        4. Liver Disease I
        5. inborn Errors of metabolism
    12. List factors that can influence creatinine clearance results (timing, complete collection, body size)
    13. Differentiate eGFR and GFR
    14. Calculate creatinine clearance results using body surface area normalization
    15. List disease states and disorders associated with urea measurement:
        1. Pre-renal causes
        2. Renal causes
        3. Post-renal causes
           1. Decreased formation (liver disease)
           2. Over-hydration; dilution
        4. End stage renal disease
11. Chapter 12
    (1b-ii, iv. 2c-iii, d-i.)
    1. Define electrolyte-associated terminology:
       1. Electrolyte
       2. Anion
       3. Cation
       4. Intracellular/extracellular
       5. Anion Gap
       6. Trace element
    2. State the significance of results: Reflection of electrolyte-fluid balance Assessment of renal concentrating ability
    3. Discuss electrolyte metabolism
    4. State the physiologic function and distribution of the following electrolytes:
       1. Sodium
       2. Potassium
       3. Chloride
       4. Bicarbonate
       5. Calcium
       6. Magnesium
       7. Phosphate
    5. Define and explain the usefulness of the Anion Gap
    6. Given electrolyte data, calculate the Anion gap
    7. Correlate an increased or decreased Anion gap with specific disorders or conditions
    8. Utilize the Anion gap as a quality control measure when performing electrolyte analyses
    9. Describe water regulation:
       1. Anti-diuretic hormone (ADH) (vasopressin)
       2. Renin-angiotensin-aldosterone system
       3. Thirst center
    10. Explain water movement and metabolism:
        1. Intracellular
        2. Extracellular
        3. Osmosis
        4. Maintenance of electrical equilibrium
        5. Effect of macromolecules
    11. State the regulation of Bicarbonate:
        1. Blood
        2. pH
        3. Kidney function
    12. State the regulation of Potassium:
        1. Dietary intake
        2. Blood
        3. pH
        4. Kidney function
    13. State the regulation of Sodium:
        1. Dietary intake
        2. Aldosterone
        3. Renin
        4. Kidney function
    14. State the regulation of Chloride:
        1. Follows sodium
        2. Blood pH
    15. State the difference between a direct and indirect ISE: State electrolyte specimen requirements and most common sources of error
    16. State the basic concepts in the measurement of osmolality:
        1. Definition
        2. Colligative properties of solutions
    17. Discuss disease states and disorders associated with electrolyte metabolism
    18. State reference intervals and critical values:
        1. Sodium
        2. Potassium
        3. Chloride
        4. Bicarbonate
    19. Define by including the diagnostic level and list causes and symptoms:
        1. Hyponatremia
        2. Hypernatremia
        3. Hypokalemia
        4. Hyperkalemia
        5. Hypochloremia
        6. Hyperchloremia
        7. Increased levels of bicarbonate Decreased levels of bicarbonate
12. Chapter 13- Blood Gases, pH, and Acid–Base Balance
    (1b-ii, iv. 2c-iii, d-i.)
    1. State basic concepts of blood gas analyzers
    2. Describe basic components of blood gas analyzers:
       1. pCO2 electrode
       2. pO2 electrode
       3. pH electrode
       4. ISE electrode
       5. Cooximetry
       6. Sample chamber
    3. Describe operation of blood gas analyzers:
       1. Function controls
       2. Sample handling
    4. Define blood gas analysis terminology:
       1. Acid
       2. Acidosis
       3. acidemia
       4. Base
       5. Alkalosis
       6. Alkalemia
       7. base excess
       8. Buffer
       9. pH
       10. Partial pressure
       11. Oxygen saturation
       12. P50
       13. oxygen capacity
       14. Hypoxia
       15. hypoxemia
       16. Henderson-Hasselbalch equation
    5. List the mechanisms of bicarbonate reabsorption by the renal tubules:
       1. Sodium-hydrogen exchange/H+ secretion
       2. Sodium-potassium exchange/secretion of K+
       3. Secretion of ammonia
    6. Explain the application of the Henderson-Hasselbalch equation
    7. Explain compensatory mechanisms:
       1. Pulmonary compensation with primary metabolic change (change in HCO3)
       2. Hypoventilation if bicarbonate increased (increased pCO2 if increased HCO3)
       3. Hyperventilation if bicarbonate decreased (decreased pCO2 if decreased HCO3)
       4. Renal compensation with primary respiratory change (change in CO2)
       5. Retention of bicarbonate, if CO2 is retained
       6. Excretion of bicarbonate, if CO2 is blown off
    8. Identify the four major body buffer systems.
    9. State the mechanisms of carbon dioxide excretion via the lungs:
       1. Mechanism for expiration of CO2
       2. Factors affecting pCO2 or H2CO3
    10. Perform routine maintenance/quality assurance of blood gas analyzers:
        1. Standard gases
        2. Electrode and membrane care
        3. Interference
    11. Perform test procedures on standards, controls, and unknowns:
        1. Evaluate quality control data (QC)
        2. Accept/reject results
        3. Take appropriate corrective action, if necessary
        4. Report results, if acceptable
    12. Correlate test results with other laboratory tests and patient diagnosis.
    13. Discuss blood gas analysis.
    14. List causes for:
        1. metabolic acidosis (= bicarbonate deficit)
        2. metabolic alkalosis (= bicarbonate excess)
        3. respiratory alkalosis (= decreased carbonic acid)
        4. respiratory acidosis (= increased carbonic acid)
    15. Evaluate blood gas results to determine defect.
    16. Discuss oxygen metabolism.
    17. Define hemoglobin oxygen saturation.
    18. List factors that affect oxygen dissociation from hemoglobin:
        1. 2,3-diphosphoglycerate (DPG)
        2. pH
        3. Temperature
        4. Carbon monoxide (CO)
    19. State causes of:
        1. shift to the left
        2. shift to the right
13. Chapter 14- Mineral and Bone Metabolism
    (1a-i, ii, v, b-v. 2c-i, iii. d-i)
    1. State the regulation of Calcium:
       1. Parathyroid hormone (PTH)
       2. Calcitonin
       3. Protein affects
       4. total calcium
       5. Blood pH
       6. Vitamin D
    2. State the regulation of Magnesium: Aldosterone PTH
    3. State the regulation of Phosphate:
       1. PTH
       2. Calcitonin
       3. Vitamin D
    4. Define by including the diagnostic level and list causes and symptoms:
       1. Hypocalcemia
       2. Hypercalcemia
    5. Define by including the diagnostic level and list causes and symptoms:
       1. Hypophosphatemia
       2. Hyperphosphatemia
14. Chapter 15- The Endocrine System
    (1b-ii, iv. 2c-iii, d-i.)
    1. List factors that affect hormone levels other than endocrine diseases:
       1. Emotional stress
       2. Time of day
       3. Menstrual cycle
       4. Menopause
       5. Food intake/diet
       6. Hormone therapy
       7. Drugs
    2. Define endocrinology associated terminology:
       1. Hormone
       2. Endocrine
       3. Releasing factor/hormone
       4. Tropic hormone
       5. Effector (non-Tropic) hormone
       6. Glucocorticoid
       7. Mineralocorticoid
       8. Diurnal variation
    3. State the most common screening and diagnostic testing for hyperthyroid disorders: Grave's disease
    4. List relevant hormone and/or metabolite determinations in Thyroid Testing:
       1. TSH
       2. Free T4
       3. free T3
       4. reverse T3
       5. TBG
       6. Antithyroid antibodies
    5. List relevant hormone and/or metabolite determinations in Adrenal Testing:
       1. Cortisol
       2. Urinary/primary free cortisol
       3. ACTH
       4. DHEA-S
       5. Aldosterone
       6. Renin
       7. Catecholamines
       8. Vanillylmandelic acid (VMA)
       9. metanephrines
    6. List relevant hormone and/or metabolite determinations in Infertility Testing:
       1. FSH
       2. LH
       3. Testosterone
       4. Progesterone
       5. Estrogens
    7. State the most common screening and diagnostic testing for hypothyroid disorders:
       1. Hashimoto's thyroiditis
       2. Myxedema
       3. Congenital
    8. State the source and intended effect of protein hormones: Growth hormone
       1. Adrenocorticotropic hormone (ACTH)
       2. Thyroid stimulating hormone (TSH)
       3. Follicle stimulating hormone (FSH)
       4. Luteinizing hormone (LH)
       5. Prolactin (PRL)
       6. Antidiuretic hormone (ADH)/vasopressin
       7. Calcitonin
       8. Parathyroid hormone (PTH)
       9. Insulin
       10. Glucagon
       11. Human chorionic gonadotropin (HCG)
    9. State the source and intended effect of steroid hormones:
       1. Cortisol
       2. Aldosterone
       3. Androgens
       4. Testosterone
       5. Dehydroepiandrosterone (DHEA)
       6. Dehydroepiandrosterone-sulfate (DHEA-S)
       7. Progesterone
       8. Estrogens/estradiol/estriol
    10. State the source and intended effect of amine hormones:
        1. Catecholamines
        2. Thyroxine (T4)
        3. Triiodothyronine (T3)
        4. Serotonin/5-hydroxyindolacetic acid (5-HIAA)
    11. List disease states and disorders associated with endocrine metabolism
15. Chapter 17- Pancreas
    (1a-i, ii, v, b-v. 2c-i, iii)
    1. Summarize the most common noninvasive tests for assessing pancreatic exocrine insufficiency:
       1. pancreatic elastase-1
       2. pancreatic chymotrypsin
       3. pancreatic serum enzymes
       4. breath test (C-mixed triglyceride test)
       5. urinary amylase
       6. fecal fat
       7. phospholipase A2
       8. NBT-PABA
       9. fecal elastase.
    2. Summarize briefly diabetes mellitus, the major endocrine pancreatic disease.
    3. Outline Ranson’s indicators of severity in acute pancreatitis.
    4. Summarize the etiology of cystic fibrosis.
16. Chapter 18- Cardiac Function
    (1a-i, ii, v, b-v. 2c-i, iii)
    1. Identify a normal CK isoenzyme pattern and the typical pattern following a myocardial infarction (MI).
    2. List five factors that define an ideal cardiac biomarker.
    3. Define hs-CRP relative to cardiac usefulness.
    4. Discuss the advantages of point-of-care testing (POCT) for cardiac biomarkers.
    5. State the origin and the usefulness in the detection of and risk assessment for a MI:
       1. CK/MB
       2. Myoglobin
       3. Troponin
       4. hs-CRP
       5. Lp(a)
       6. Homocysteine
17. Chapter 19- Liver Function
    (1a-i,ii. 1b-ii, iv. 2c-iii, d-i.)
    1. List diseases associated with bilirubin metabolism:
       1. Prehepatic jaundice (neonatal/hemolytic anemia):
          1. Dubin-Johnson syndrome
          2. Rotor’s
          3. Crigler-Najjar
       2. Hepatitis
       3. Cirrhosis
       4. Posthepatic jaundice
    2. State basic concepts relating to the significance of bilirubin:
       1. Heme catabolism
       2. Bilirubin conjugation
    3. State methods of analysis for total/direct bilirubin
    4. State the usefulness of ammonia measurement
    5. Explain ammonia synthesis and mode of excretion
    6. List methodologies for ammonia; For the most common methods, state the principle of the chemical reaction, sample type, reference interval, most common interfering substances/sources of error.
18. Chapter 20- Iron, Porphyrins, and Hemoglobin
    (1a-i, ii, v, b-v. 2c-i, iii)
    1. State the physiologic function and distribution of Iron
    2. State the regulation of Iron:
       1. Iron Intestinal absorption
       2. Transferrin
       3. Serum iron Ferritin
19. Chapter 21- Therapeutic Drug Monitoring
    (1a-i, ii, v, b-v. 2c-i, iii.d-i)
    1. Define the TDM-associated terminology:
       1. Therapeutic drug monitoring
       2. Toxicology
       3. Steady State
       4. Half-life (t1/2)
       5. Therapeutic range
       6. Peak and trough
       7. Drugs of abuse
       8. Emergency toxicology
       9. Chronic poisoning
    2. List factors that influence toxicity
    3. Contrast chemical, generic, and trade name nomenclature for drugs.
    4. Explain and demonstrate proper specimen collection: Time of blood draw relative to last dose.
20. Chapter 22- Toxic Substances
    (1b-ii, iv. 2c-iii, d-i.)
    1. State the physiologic function and distribution of copper.
    2. Explain the usefulness of screening methods.
    3. Requirements for legal samples, Requirements for forensic samples
21. Chapter 23- Nutrition and Vitamins
    (1a-i, ii, v, b-v. 2c-i, iii)
    1. List the fat-soluble vitamins.
    2. Correlate disease states with vitamin deficiencies.
22. Chapter 24- Tumor Markers
    (1a-i, ii, v, b-v. 2c-i, iii)
    1. Describe the purpose and function of the immunosurveillance system for tumor recognition.
    2. List and discuss antigens that are associated with human tumors:
       1. Carcinoembryonic antigen (CEA)
       2. Alpha-fetoprotein (AFP)
       3. Prostate-specific antigen (PSA)
       4. Beta-2-microglobulin
       5. HCG
       6. CA 125
       7. CA 19-9)
23. Chapter 26- Pediatrics
    (1a-i, ii, v, b-v. 2c-i, iii)
    1. Define genetic disease
    2. Categorize and list examples of genetic diseases:
       1. Chromosomal aberration
       2. Inborn errors of metabolism
24. Lab #1
    (1a-i, ii, v, b-v. 2c-i, iii)
    1. Define mean, standard deviation, coefficient of variation.
    2. Distinguish between assayed and unassayed controls.
    3. Read Levy-Jennings graphs to determine the analyte and the value of the mean.
    4. Read Levy-Jennings graphs and be able to determine values outside of 2SD and 3SD.
    5. Define precision and accuracy.
    6. Define statistical data for quality control and statistical analyses
    7. Calculate and utilize statistical data for quality control and statistical analyses:
       1. Mean
       2. Median
       3. Mode
       4. Standard Deviation
       5. Coefficient of Variation
       6. Confidence Limits
    8. Describe the proper labeling when a reagent or control is opened and/or reconstituted in the lab.
    9. Describe why controls are important is the clinical lab.
    10. Evaluate quality control data:
        1. Select control materials for use
        2. Analyze data for acceptability
        3. If data unacceptable, identify problems or causes
        4. Follow corrective action to resolve problem and document
    11. Verify or establish reference intervals (Normal ranges)
    12. List reference intervals for major analytes.
25. Lab #2
    (1a-i, ii, v, b-v. 2c-i, iii)
    1. Perform routine maintenance checks on all spectrophotometers
    2. Describe the operation of a spectrophotometer:
       1. Function controls
       2. Standard curves
    3. Perform test procedures on standards, controls, and unknowns:
       1. Calculate, if necessary, and record quality control (QC) data
       2. Evaluate quality control data (QC)
       3. Accept/reject results
       4. Take appropriate corrective action, if necessary
       5. Report results, if acceptable
       6. Correlate test results with other laboratory test and patient diagnosis.
    4. Perform test procedures on standards, controls, and unknowns:
       1. Evaluate quality control data (QC)
       2. Accept/reject results
       3. Take appropriate corrective action, if necessary
       4. Report results, if acceptable
    5. Perform carbohydrate analyses according to established laboratory protocol:
       1. Determine acceptability of results
       2. Report results according to laboratory protocol
       3. Perform, document, and evaluate quality control
    6. Explain the purpose of the blank in spectrophotometry.
    7. Discuss the importance and the reason we are required to run controls.
    8. Explain Beer's law as it relates to the activity performed today. (How the intensity of the observed color relates to concentration)
    9. Explain the difference in wavelengths used on spectrophotometer. List the wavelength used in today's procedures.
    10. Identify all parts of the spectrophotometer we used today (light source, monochromater, cuvette have photodetector, output).
    11. Discuss PHYSICAL factors of the patient that have an effect on the concentration of cholesterol in the blood.
    12. Discuss where cholesterol is found in the body.
    13. List common mistakes that can be made in spectrophotometry testing.
    14. Explain maintenance/quality assurance of instrumentation:
        1. Stray light
        2. Sensitivity
        3. Linearity
        4. Wavelength calibration
26. Lab #3
    (1a-i, ii, v, b-v. 2c-i, iii)
    1. Explain the concept of electrophoresis.
    2. Describe the results of an electrophoresis gel, including what each band represents.
    3. State the function of the buffer in an electrophoresis system.
    4. List the different Hemoglobin fractions found in humans.
    5. Describe the purpose of staining electrophoresis gels.
    6. Explain tests that can be done using electrophoresis.
    7. Outline the symptoms of Sickle Cell Anemia.
    8. Interpret a completed electrophoresis gel.
    9. Describe the basic components of electrophoresis:
       1. Support media: cellulose acetate/gel/agarose
       2. Chamber Buffer
       3. Electrodes
       4. Power supply
       5. Densitometer
    10. State basic concepts of electrophoresis:
        1. Principles of electrophoresis Voltage
        2. current
        3. pH
        4. Ionic strength
        5. Buffers
        6. Temperature
    11. Describe the operation of electrophoresis:
        1. Sample application
        2. Time
        3. Temperature Voltage
        4. current
        5. Stains
    12. Perform analyses according to laboratory procedure:
        1. Accept/reject results
        2. Evaluate and record quality control data
        3. Report results, if acceptable