MCCCD Official Course Competencies:

HCE249  2006 Spring – 2011 Summer II

Practicum: Clinical Chemistry

1.

Practices clinical chemistry including reagents, units of measure, supplies, and equipment. (I)

2.

Apply and differentiate specimen collection techniques, preanalytical variables, and quality assurance principles. (II)

3.

Assess mathematical calculations used in clinical chemistry. (III)

4.

Use statistical analysis to compare and evaluate methods and determine reference intervals. (IV)

5.

Analyze quality control and use quality control systems. (V)

6.

Apply the principles of spectrophotometry and the application of Beer's Law. (VI)

7.

Use chemical analytical techniques and applications. (VII)

8.

Assess the characteristics of immunoassays and the use of nucleic acid probe applications. (VIII)

9.

Apply the automation principles of the analytical process and operations. (IX)

10.

Apply principles of point-of-care testing and instrumentation. (X)

11.

Assess and correlate the metabolism and regulation of glucose in the body with associated disease states and laboratory testing. (XI)

12.

Assess and correlate lipid metabolism and analysis with coronary disease and current standards of practice. (XII)

13.

Assess protein properties, protein metabolism, and the significance and laboratory analysis of normal and abnormal serum proteins. (XIII)

14.

Assess the properties of enzymes including kinetics, and evaluate patient serum enzyme levels in relation to disease states. (XIV)

15.

Analyze the clinical conditions associated with non-protein nitrogen compounds. (XV)

16.

Apply laboratory measurements of electrolytes, water balance, and trace elements with associated disease states. (XVI)

17.

Apply acid base balance and the principles of blood gas testing. (XVII)

18.

Assess the practices for therapeutic drug monitoring including the therapeutic classes and toxicity of drugs measured in the laboratory. (XVIII)

19.

Perform the testing for drugs of abuse and toxicology. (XIX)

20.

Apply concepts relating to the clinical significance of bilirubin and disease of the liver with analytic methods. (XX)

21.

Analyze hormones and endocrine function with correlation to laboratory testing for thyroid function. (XXI)

22.

Perform the laboratory testing used in the assessment of cardiac function and disease. (XXII)

23.

Apply the clinical application of tumor markers. (XXIII)

24.

Assess laboratory testing for genetic disease and inborn errors of metabolism. (XXIV)

MCCCD Official Course Outline:

HCE249  2006 Spring – 2011 Summer II

Practicum: Clinical Chemistry

I. Clinical Practices

A. Basic concepts

1. Reagent grade

a. Water

b. Chemicals

2. Units of measure

B. Laboratory

1. Supplies

2. Operations

a. Centrifuges

b. Balances

c. Thermometers

d. Other

II. Specimens

A. Collection

1. Venipuncture tube types

2. Other specimens

3. Specimen handling

4. Testing profiles

B. Preanalytical variables

C. Quality assurance

III. Mathematical Calculations

A. Conversions

B. Concentrations

1. Percent solution

2. Molarity

3. Normality

C. Dilutions

1. Standard

2. Serial

IV. Statistical Analysis

A. Standard deviation (SD)

1. Mean, median; mode

2. Coefficient of variation

B. Comparison of methods

1. Linear regression

2. t-test; f-test

C. Reference intervals

D. Diagnostic efficacy

1. Predictive value

2. Sensitivity and specificity

3. Interference studies

E. Method selection and evaluation

V. Quality Control

A. Systems

1. Gaussian (normal) frequency distribution

2. Material

B. Stages

1. Levey-Jennings control system

2. Westgard multi-rule system

3. External

4. Proficiency testing

VI. Spectrophotometry

A. Electromagnetic spectrum

1. Properties of light

2. Transmittance versus absorbance

B. Beer's law

C. Spectrophotometric instruments

1. Components

2. Performance parameters

3. Atomic absorption spectrophotometry

VII. Other Clinical Techniques and Instrumentation

A. Light emission and scattering techniques

1. Fluorometry

2. Chemiluminescence

3. Nephelometry

B. Chromatography

C. Electrochemistry

1. Potentiometry

2. Coulometry

3. Electrodes

4. pH meters

VIII. Immunoassays and Nucleic Acid Probes

A. Labeled immunoassays

1. Definition of terms

2. Labels

3. Assay design

4. Assay application

B. Nucleic acid probes

1. Molecular testing applications

2. Hybridization techniques, PCR (Polymerase Chain Reaction)

IX. Automated Principles

A. Advantages

1. Common features

2. Other

B. Analytical process

1. Sample preparation and identification

2. Specimen measurement and delivery

3. Reagent systems and delivery

4. Chemical reaction phase

5. Measurement phase

6. Signal processing and data handling

7. Other

C. Calibration

D. Controls

E. Maintenance and troubleshooting

X. Point-of-Care

A. Program components

B. Requirements

C. Applications

1. Glucose meters

2. Chemistry

3. Connectivity

XI. Metabolism and Regulation of Glucose

A. Classification of carbohydrates

1. Monosaccharide

2. Disaccharide

3. Polysaccharide

B. Physiological function of glucose

1. Cellular metabolism

2. Other

C. Metabolic processes

1. Glycolysis

2. Gluconeogenesis

3. Glycogenolysis

4. Glycogenesis

D. Regulation of blood glucose

1. Insulin

2. Glucagon

3. Adrenal gland hormones, epinephrine, and cortisol

4. Pituitary hormones, growth hormones, and ACTH (Adrenocorticotropic Hormone)

E. Hyperglycemia

1. Type 1 diabetes mellitus

2. Type 2 diabetes mellitus

3. Gestational diabetes mellitus

4. Laboratory findings in hyperglycemia

5. Criteria for diagnosis of diabetes

6. Acute and long-term complications of diabetes mellitus

F. Hypoglycemia

1. Causes

2. Symptoms

3. Laboratory findings

G. Inborn errors of metabolism

1. Glucose-6-phosphate deficiency

2. Galactosemia

H. Glucose measurement

1. Whole blood versus serum or plasma

2. Preservation of glucose in blood draws

3. Glucose oxidase method, oxygen electrode, or spectrophotometry

4. Hexokinase method

5. Self-monitoring of blood glucose

I. Glucose tolerance and 2-hour postprandial tests

J. Glycosylated hemoglobin

K. Ketones

L. Urine microalbumin

M. Lactic acid

XII. Lipoproteins

A. Clinical lipids

1. Fatty acids

2. Triglyceride

3. Cholesterol

B. Classifications

1. Chylomicrons

2. VLDL (Very Low Density Lipoprotein)

3. LDL (Low Density Lipoprotein)

4. HDL (High Density Lipoprotein)

5. Other

C. Physiology and metabolism

1. Arteriosclerosis

2. Other

D. NCEP (National Cholesterol Education Program) Adult Treatment Panels

1. CHD (Coronary Heart Disease) risk factors

2. Treatment, diet, and drug therapy

E. Dyslipidemias

F. Analysis

1. Reference ranges

2. Analytical performance goals

3. Cholesterol

4. HDL

5. LDL, calculated and measured

6. Specimen collection and pre-analytical variables

XIII. Proteins

A. Properties

1. Composition

2. Charge and isoelectric point (pI)

3. Immunogenicity

B. Synthesis

1. Dietary proteins and amino acids

2. Nucleus, DNA, mRNA (messenger ribonucleic acid), cytoplasm, tRNA (transfer ribonucleic acid), ribosomes

3. Hormone stimulation

4. Protein anabolism and catabolism

5. Classification

C. General functions

D. Plasma proteins

1. Albumin

2. Alpha-1-antitrypsin

3. Alpha-2-macroglobulin

4. Haptoglobin

5. Ceruloplasmin

6. Transferrin

7. Fibrinogen

8. Immunoglobulins

9. C-reactive protein

E. Total protein abnormalities

1. Specimen requirements and reference ranges

2. Total protein analysis

3. Albumin analysis

F. Serum Protein Electrophoresis

1. Principles of electrophoresis

2. Densitometry

3. Electrophoretic patterns

4. Isoelectric focusing

G. Urinary protein/CSF (Cerebral Spinal Fluid) protein

XIV. Enzymes

A. General properties and definitions

1. Enzyme, catalyst, cofactor

2. Catalytic mechanism

3. Zero-order kinetics; enzyme reactions

B. Enzyme activity measurement

1. Measurement by activity; mass

2. Enzymes as reagents

C. Clinically significant enzymes and associated disease/conditions

1. Creatine kinase

2. Lactate dehydrogenase

3. Aspartate aminotransferase (AST)

4. Alanine aminotransferase (ALT)

5. Gamma-glutamyl transferase (GGT)

6. Amylase; lipase

7. Acid phosphatase

XV. Non-Protein Nitrogen Compounds

A. Definition and significance

B. Renal system function

C. Analytes, disease states, and disorders

1. Urea

2. Creatinine/creatine

3. Uric acid

4. Ammonia

XVI. Electrolytes, Water Balance, Trace Elements, and Disease States

A. Osmolality

1. Colligative properties

2. Regulation of water and blood volume

3. Determination of osmolality

4. Significance

B. Electrolytes

1. Significance

2. Renal function

C. Sodium

1. Function

2. Regulation

3. Measurement

4. Hyponatremia and hypernatremia

D. Potassium

1. Function

2. Regulation

3. Measurement

4. Hypokalemia and hyperkalemia

E. Chloride

1. Function

2. Regulation

3. Measurement

F. Bicarbonate (CO2)

1. Function

2. Regulation

3. Measurement

4. Acidosis and alkalosis

G. Anion Gap

1. Calculation

2. Significance

H. Magnesium

1. Function

2. Regulation

3. Measurement

4. Hypomagnesemia and hypermagnesemia

I. Calcium

1. Function

2. Regulation

3. Measurement

4. Hypocalcemia and hypercalcemia

5. Measurement of calcium

J. Phosphorous

K. Lactic acid

L. Critical values

M. Trace elements

N. Iron

1. Function, regulation; measurement

2. Clinical disorders of iron

XVII. Acid-Base Balance and Blood Gas Testing

A. Definitions

B. Acid base balance

1. Maintenance of pH (H+)

2. Buffer systems

3. Regulation of acid-base balance

a. Lungs

b. Kidneys

4. Assessment of acid-base balance

a. Henderson-Hasselbalch equation; calculation of HCO3-(bicarb)

b. pH of 7.4; ratio of HCO3-(bicarb) to H2CO3 (carbonic acid)

C. Disorders

1. Respiratory disorders versus non-respiratory disorders

2. Compensation

3. Acidosis

a. Non-respiratory acidosis

b. Respiratory acidosis

4. Alkalosis

a. Non-respiratory

b. Respiratory

D. Oxygen and gas exchange

1. Hypoxia; hypoxemia

2. Oxygen status assessment

3. PO2, SO2; Co-oximeter

E. Blood gas measurement

1. Reporting

2. Specimen collection and handling

3. Sources of error

XVIII. Therapeutic Drug Monitoring

A. Clinical usefulness of serum drug levels

B. Drug metabolism

1. Half life; steady state

2. Therapeutic range; peak and trough

3. Time of draw; specimen collection

C. Drug classes/drugs monitored, therapeutic ranges; toxicity

1. Digoxin

2. Antibiotics

a. Gentamicin

b. Tobramycin

c. Vancomycin

d. Other

3. Antiepileptic drugs

a. Phenytoin

b. Phenobarbital

c. Valproic acid

d. Carbamazepine

e. Other

4. Lithium

5. Theophylline

6. Other

D. Analytical methods

XIX. Toxicology and Drug of Abuse

A. Alcohol

B. Lead poisoning

C. Salicylate/Acetaminophen

D. Drugs of abuse

1. Medical versus legal testing

2. Analytical methods

3. Screening versus confirmation

4. Amphematines

5. Barbiturates

6. Benzodiazepines

7. Cocaine

8. Opiates

9. Tetrahydrocannabinol (THC)

10. Tricyclic Antidepressants (TCA)

11. Other

XX. Clinical Significance

A. Liver

1. Function

a. Composition

b. Acids

c. Salts

2. Bile excretion

a. Composition

b. Acids

c. Salts

3. Disorders

a. Cirrhosis

b. Tumors

c. Reye's syndrome

d. Drugs

e. Alcohol

4. Hepatitis A

5. Hepatitis B

a. Hepatitis B Surface Ag (HBsAg)

b. Hepatitis B Core Antigen (HBcAg)

c. Hepatitis B Surface Antibody (HBsAb)

6. Hepatitis C Virus (HCV)

a. Polymerase Chain Reaction (PCR) testing

b. Other

7. Human Immunodeficiency Virus (HIV)

a. Antibody screening

(1). Western blot confirmation

(2). Other

b. Consent laws

c. Rapid HIV testing

B. Bilirubin

1. Degradation

2. Conjugation

3. Analysis

a. Malloy and Evelyn

b. Jendrassik and Grof

c. Spectrophotometry

d. Total bilirubin, direct (conjugated); indirect (unconjugated)

e. Sample stability and interferences

C. Jaundice

1. Prehepatic

a. Hemolytic anemias

b. Neonatal

c. Unconjugated bilirubin

2. Hepatic

a. Gilbert's syndrome

b. Crigler-Najjar

3. Posthepatic

a. Bile obstruction

b. Conjugated bilirubin

XXI. Endocrinology and Thyroid

A. Endocrine system

1. Definitions

2. Actions of hormones

3. Biorhythms

B. Hormones

1. Pituitary

2. Adrenal

a. Glucocorticoids

b. Mineralcorticoids

c. Adrenal insufficiency - Addison's disease

d. Excess glucocorticoid production - Cushing's Syndrome

3. Commonly measured

a. Pregnancy

b. Cortisol

c. Prolactin

d. Reproductive hormones

C. Thyroid function

1. Hormone synthesis

2. Active hormones

a. Triiodothyronine (T3)

b. Thyroxine (T4)

3. Hypothalamic-pituitary-thyroid axis

4. Hypothyroidism

5. Hyperthyroidism

6. Grave's disease

7. Laboratory measurements

XXII. Cardiac Function and Disease

A. Acute coronary syndrome

B. Myocardial infarction (MI)

1. World Health Organization (WHO) Criteria

2. Other

C. Laboratory diagnosis

1. Creatine kinase (CK)

2. Creatine kinase-muscle-brain (CK-MB)

3. Index

4. Myoglobin

5. Troponin

6. Cardiac marker turn around time (TAT)

7. Thrombolytic agents

8. Other

D. Congestive heart failure

XXIII. Tumor Markers

A. Clinical utility

1. Screening

2. Monitoring disease course during treatment

3. Detection of recurrence following surgery

B. Individual tumor markers

1. Alpha fetoprotein (AFP)

2. Prostate Specific Antigen (PSA)

3. Carcinoembryonic antigen (CEA)

4. Cancer antigen (CA 125, CA 15-3, and CA 19-9)

5. Other

XXIV. Genetic Disorders

A. Inheritance patterns

B. Autosomal recessive mode

1. Galactosemia

2. Cystic fibrosis

3. Other

C. Inborn errors of metabolism

1. Newborn screening

2. Other

D. Aminoacidopathies

1. Phenylketonuria (PKU)

2. Maple Syrup Urine Disease (MSUD)