CLINICAL LAB SCIENCES (CLS) ASSOCIATES DEGREE PROGRAM

Transcription

1 CLINICAL LAB SCIENCES (CLS) ASSOCIATES DEGREE PROGRAM This curriculum was developed by Bunker Hill Community College through a Workforce Competitiveness Trust Fund grant awarded to Beth Israel Deaconess Medical Center. These8 new courses were developed to create a Clinical Lab Science Program at Bunker Hill Community College. Introduction to Clinical Laboratory Science Urinalysis Hematology and Hemostasis Medical Microbology Immunology and Serology Immunohematology Clinical Chemistry Clinical Lab Sciences Practicum

2 It is the intent of the CLS Program to provide local employers with a course of study which will train individuals for a position that will soon experience a critical shortage and to enable students to acquire skills and knowledge essential for working in the clinical laboratory. The general knowledge and skills of the graduates will include the ability to: Collect and prepare clinical specimens for analysis in an efficient and timely manner. Demonstrate knowledge of laboratory tests and standards. Operate laboratory instrumentation. Prepare diagnostic reagents according to prescribed methodology. Monitor and assess the quality of data generated. Recognize and correct problems that may occur during the analytical process. Disseminate laboratory data to clinicians in a timely manner. Describe the principles, reactions, and reagents for each method studied. Relate test results to other patient information, to the extent required, for understanding the analyses and correlating the results obtained to the stated diagnosis. Demonstrate behavior and attitudes consistent with those of laboratory professionals. Demonstrate basic knowledge of professional ethics, laws, and regulations. Participate in continuing education, and maintain membership in professional organizations. Graduates will be eligible to take a national certifying exam for Clinical Laboratory Technicians administered by one of the national certifying agencies; NCA National Certifying Agency for Medical Laboratory Personnel, or ASCP American Society for Clinical Pathology. Sixty six credits are required to complete the Clinical Laboratory Sciences degree program, including a prerequisite of a four - credit Human Biology course, twenty - seven credits of CLS major courses, and twenty credits of science courses. The remaining fifteen credits are in general education. The science courses provide the foundation in anatomy and physiology, chemistry, clinical chemistry, and microbiology that is essential to the more specific application of the didactic and clinical practice courses required for the field. The general education courses provide students with knowledge in mathematics, psychology, and history. These courses also provide students with an opportunity to develop writing and critical thinking skills. Curriculum Requirements Courses in the Bunker Hill Community College Clinical Laboratory Sciences Program are taught in a cooperative venture between the clinical affiliates and the College. Didactic instruction is provided by the College with associated practice and demonstration activity occurring in the student laboratory. Advanced skills, instrumentation and practice to proficiency are obtained at the clinical affiliate laboratories. Year one is an introduction to the various clinical disciplines: Chemistry, Hematology, Immunohematology, Microbiology, Serology and Immunology, Coagulation and Urinalysis. Quality assurance, regulatory requirements, organizational structure of the laboratory and health care industry, lab safety, and specimen collection and storage are introduced with further reinforcement of principals in other courses as appropriate. Second year courses revisit the subjects covered during the first year but at a more advanced level. An introductory session in Phlebotomy is held in the student laboratory with further reinforcement when students enter the Practicum.

3 The student laboratory is equipped to perform manual methods and some basic instrumentation: microscopes, hematology analyzer, point of care coagulation instruments, spectrophotometers, and a soon to be acquired bench-top chemistry analyzer. Prior to admission to the Program, students must take or test out of courses in English, math and reading. A human biology course must also be taken before admission. As part of the curriculum, students also take courses in college math, statistics, anatomy and physiology, microbiology, chemistry as well as a number of general education courses.

4 Curriculum Structure Course Title Prerequisites Course number Eng 095 or placement ESL 098 or RDG 095 or placement MAT 195 or placement BIO 108 Semester Taken Prior to admission Prior to admission Prior to admission Credits Prior to 3 admission Admission to Program Prerequisites/Corequisites Intro to Clinical 1 2 Admission to program Laboratory Science Urinalysis 1 1 Corequisite: Into to CLS College Writing I ENG ENG 095 and ESL098 or RDG095 or placement Statistics MAT MAT 195 or placement Chem Science I/Lab CHM ENG095 and MAT195 or placement World View From Area College Writing II ENG ENG111 Anatomy and BIO BIO195 Physiology I/Lab Immunology and 2 3 Intro to CLS Serology Chem Science II/Lab CHM CHM110 Microbiology BIO205 Summer 4 BIO 195 or BIO 203 Anatomy and BIO 204 Summer 4 BIO203 Physiology II/Lab Principles of PSY101 Summer 3 ESL098 or RDG095 or placement Psychology Clinical Chemistry 3 3 Intro to CLS, CHM 112, Immunology and Serology Medical Micro 3 4 Into to CLS, BIO205 Immunohematology 3 3 Immuno &Serology Hematology and 3 3 Into to CLS Hemostasis CLS Practicum CLS Successful completion of CLS coursework Total 66

5 Introduction to Clinical Laboratory Science This course explores the nature and scope of clinical laboratory work. The primary focus will be on the role of the laboratory in delivery of health care in various settings, emphasizing historical background, types of health care facilities, regulatory agencies affecting laboratory operations, responsibilities, duties and professional conduct expected of clinical laboratory technicians, safety in the laboratory, laboratory mathematics and quality control. A phlebotomy workshop will develop the fundamental skills required to procure and prepare blood specimens for testing. A field trip will be scheduled to an area hospital laboratory. Prerequisite: Admission to CLS Program Learning Objectives: Describe the organizational structure of a generalized health care organization (i.e. hospital), and be able to discuss the working relationship each department has with the other departments. Name the departments of a clinical laboratory. Compare and contrast the users of various sites for laboratory testing: central laboratory, point of care, physician s office laboratory, and reference Laboratory. Describe the importance of federal, state, and institutional regulations concerning the quality and reliability of laboratory work. Define the acronyms OSHA, CLIA 88, CMS, CLSI, NAACLS, and CAP. Briefly explain the CLIA 88 regulations and the classification of laboratory tests by complexity. Describe the purpose of participation in CLIA 88 mandated proficiency testing, and how they are used as an aid to maintaining quality in the clinical laboratory. Explain the general safety regulations governing the clinical laboratory, including OSHA mandated components for chemical hygiene, and occupational exposure to blood borne pathogens. Describe the principles and applications of Standard Precautions. Describe what is contained in the MSDS manual, and be able to discuss the various components of the Clinical Laboratory Sciences program safety requirements. Describe the basic aspects of infection control policies, including how and when to use personal protective equipment or devices, and the reasons for using Standard Precautions. Demonstrate how to take the necessary precautions to avoid exposure to the many potentially hazardous situations in the clinical laboratory. Demonstrate the proper decontamination of a work area at the beginning and end of a work/lab session. Explain the process of properly segregating and disposing of various types of waste products generated in the clinical laboratory, including the use of sharps containers for used needles and lancets. Demonstrate and describe the skills needed to interact with patients in the collection of specimens. Describe the equipment used for venous blood collection. Explain and demonstrate the proper collection technique for venous blood collection. Compare common anticoagulants and additives used to preserve blood specimens and the general use of each type of anticoagulant. Identify the major potential type of error in specimen collection.

6 Identify eight typical phlebotomy problems and describe the solution to each problem. Describe special considerations for pediatric and geriatric patients in the collection of blood. Demonstrate and describe the proper technique for the collection of a capillary blood specimen. Identify and compare the carious urine specimen requirements for routine urinalysis, including preservation and storage requirements. Briefly explain collection procedures for other body fluid specimens, including cerebrospinal fluid, pleural fluid, and synovial fluid. Collect and explain the proper procedure for collecting a throat swab specimen for culture. Describe relevant medical-legal issues related to specimen collection. Describe the various types of and uses for laboratory volumetric glassware, the techniques for their use, and the various types of glass used to manufacture them. Describe how Laboratory volumetric glassware is calibrated and how the calibration markings are indicated on the glassware. Explain how to properly clean laboratory glassware and plastic ware. Describe the operation and uses of common laboratory balances. Describe types and uses of laboratory centrifuges. Compare various forms and grades of water used in the laboratory and how each is prepared. Compare various grades of chemicals used in the laboratory, including their levels of quality and purpose. Demonstrate how to properly label a container used to store a laboratory reagent or solution. Discuss and properly demonstrate the use of various calculations used in the clinical laboratory: o Convert metric units of measure for weight, length, volume, and temperature to English Units and metric units to English units. o Use the fundamental units of the Système International (SI) in making measurements and doing calculations. o Convert temperatures form degrees Celsius to degrees Fahrenheit, and vice versa. o Define the basic terms and concepts related to common laboratory measurements, including volume, mass, and weights. o Properly round any calculations involving measurements by using the rules for significant figures. o Explain and apply the rules for rounding off numbers and for the use of significant figures. o Describe the use of exponents. o Calculate proportions and ratios. o Define the terms density and specific gravity. o Define the basic terms and concepts related to preparing solutions of various concentrations, including part-to-part, percent, molarity normality, and specific gravity. o Calculate the requirements for solutions of a given volume and molarity. o Describe the procedures for making a single dilution and a serial dilution. o Calculate the amount of one solution needed to make a solution of a lesser concentration. o Differentiate the expressions of a solution concentration weight per unit weight and weight per unit volume. o Prepare a percent solution.

7 o Mathematically correct results using a dilution correction factor. o Calculate logarithms and antilogarithms. o Given data, construct graphs by plotting the independent variable vs. the dependent variable on linear graph paper. o Correctly graph data on semi log paper. o Construct a standard curve for a laboratory measurement using known concentrations vs. percent transmittance (%T) or absorbance (A). o Mathematically convert percent transmittance to absorbance. o Calculate the concentration of unknown solutions using the absorbance/concentration equation. o Given a set of data, calculate: mean, standard deviation, and coefficient of variation. Discuss and interpret the use of mean, standard deviation and coefficient of variation in maintaining the quality of laboratory testing and how it is used as part of a laboratory s quality assurance program. Required Textbooks: Clinical Laboratory Science, Mary Louise Turgeon, 5 th ed., Mosby, 2007 Mathematics for Medical and Clinical Laboratory Professionals, Joel R. Helms, Delmar/ Cengage Learning, Computer Assisted Learning: Medical Training Solutions Inc. medtraining.org. A library of over 30 courses for laboratory students on a wide variety of topics. Library Resources: Journals Clinical Laboratory Science, Journal of the American Society of Clinical Laboratory Science Laboratory Medicine, American Society of Clinical Pathologists Medical Laboratory Observer, The Management Source for Lab Professionals Clinical Laboratory News, The American Association for Clinical Chemistry Advance for Medical Laboratory Professionals, The Nation s Medical Laboratory Biweekly Reference Books Clinical and Laboratory Standards Institute (CLSI formerly NCCLS) Various Documents concerning all aspects of approved laboratory standards. Clinical Chemistry Principles, Procedures, and Correlation, Michael Bishop, 5 th

8 ed., Lippincott, Williams & Wilkins,2004 Clinical Hematology, Mary L. Turgeon, 4 th ed., Lippincott, Williams, & Wilkins, 2004 Koneman s Color Atlas & Testbook of Diagnostic Microbiology, Alan, Winn, Janda, Koneman, Schreckenberger, Procop, Woods, 6 th ed., Lippincott, Williams, & Wilkins 2005 Tietz, Fundamentals of Clinical Chemistry, Burtis, Ashwood, & Burns, 6 th ed., Elsevier, Mosby/Saunders, 2007 Bailey & Scott s Diagnostic Microbiology, Forbes, Sahm, & Weissfeld, 12 th ed., Elsevier, Mosby/Sunders, 2007 Basic and Applied Concepts of Immunohematology, Blaney & Howard, 2 nd ed., Elsevier, Mosby/Saunders, 2008 Phlebotomy Essentials, Ruth E. McCall, Cathee M. Tankersley, 4 th ed., Lippincott, Williams and Wilkins, 2008

9 Week Date (W/O) Topic 1. 1/5 Introduction to the Clinical Laboratory Health Care Organizations Organizational Structure of the Clinical Laboratory Regulatory Bodies and Accrediting Agencies CLIA 88 NAACLS Potential Places of Employment Medical Legal Considerations (HIPAA) Lab Safety Assignment: Turgeon Chapters 1, 2, 3 Review Questions; p19-20 p /12 Collection and Processing of Blood and Body Fluids Venous anatomy Safety Issues Blood Collection Variables Collection Tube Additives Tube Draw Order Blood Drawing Apparatuses Special Phlebotomy Considerations Collection of Other Types of Lab Specimens Assignment: Turgeon Chapter 4 Helms Chapters 2, /19 Systems of Measurement, Lab Math, Reagents, and Equipment Metric System and SI Units Laboratory Glassware Pipettes Balances Centrifuges Reagent Grade Water Reagent Prep Basic Laboratory Mathematics (part 1) Assignment: Turgeon Chapter 7 Helms Chapter 4, 5, 6 Practice Problems 2.1, 1-11 odd 2.3, 1 7 odd 2.4, 1-8 odd

10 11 14 odd 3.1, 1 8 odd 3.4, 1 9 odd 4. 1/26 Laboratory Math, Continued Solutions Molarity Equivalent Weight Working Solutions From Stock Solutions Titers Serial Dilutions ph, Logarithms and Ionic Solutions Graphs and Graphing Assignment: Helms Practice Problems 4.1 # 1, 5, 9, 21, 27,37, 39 Practice Problems 4.2 # 1, 3 Practice Problems 6.2 # 1, 7, 11 Practice Problems 6.3 # 1, 9, 11 Turgeon Chapter 8 Review Material to Date in Preparation for Exam 5. 2/2 Exam Weeks 1-4(1 hour) Quality Control Overview of Statistics Control Charts and Westgard Rules Rules for Handling Out of Control Results Assignment: Turgeon Chapter 9 Helms Chapters 11, /9 Central Lab Automation and Point of Care Testing Automation Overview Types of Common Automated Analyzers o Chemistry o Immunochemistry o Hematology o Urinalysis o Coagulation o Molecular Testing Point of Care Testing o Waived o Non - Automated o Automated

11 Assignment: Turgeon Chapter 10, Turgeon Chapter 5 Review Questions p /16 Laboratory Information Systems Component of an LIS Networking Applications Privacy Issues Review of Topics to Date Assignment: Review of Material in Preparation for Exam Turgeon Chapter /23 Exam 2 Weeks 5-7(1 hour) Renal Anatomy and Physiology Composition of Urine Physical Properties of Urine Chemical Tests in Routine Urinalysis Assignment: Review Questions p Questions /2 Microscopic Analysis of Urine Cellular Constituents Crystals Casts Other Constituents Artifacts and Contaminants Review of Urinalysis Case Studies Assignment: Turgeon Chapter 15 Review Questions p Questions /9 Examination of Other Body Fluids and Misc. Specimens Occult Blood Semen Analysis Fecal Leukocytes Synovial Fluid Serous Fluid Case Studies Assignment: Turgeon Chapter 12 p Review Questions p

12 Review Material for Exam 12. 3/23 Exam 3 Weeks 8-11 (1 hour) Introduction to Hematology Cell Maturation and Function o White Cell o Red Cell Assignment: Turgeon Chapter 12 p Review Questions p Questions /30 Clinical Hematology Anticoagulants Processing and Testing of Specimens Hemoglobin Hemoglobin Variants Hemoglobin and Hematocrit Indices WBC and RBC counts Assignment: Turgeon Chapter 12 p Review Questions p 323 Questions /6 Examination of Peripheral Blood Film Preparation of Blood Film Staining Microscopic Examination RBC and WBC Morphology Other fluids Assignment: Turgeon Chapter 12 p Review Questions p Review Material for Exam Review Hematology Case Studies 15 4/13 General Review of course 16. 4/20 Final Exam (Weeks 12 14)

13 Demonstration and Practice Schedule Lab Date Topic 1 1/17 Phlebotomy techniques through the use of Vacutainer, Microtainer, butterfly, and capillary. Collection of other types of specimens 2 1/31 Pipetting techniques Pipettes (manual and automated) Serial Dilution Exercise Using the Analytical Balance 3 2/14 Use and maintenance of the Microscope Parts Care and Cleaning Use of Microscope Other Types of Microscope Illumination Systems 4 2/28 Chemical and Physical analysis of Urine Microscopic analysis of Urine 5 3/14 Other body fluids 6 3/28 The Complete Blood Count (CBC): White Cell Count, Red Count, Platelet Count, Hemoglobin and Hematocrit 7 4/11 Peripheral Blood Smear Differential 8 4/18 (optional) Skills Review

14 Urinalysis This course explores the principles and procedures of the routine urinalysis as well as the normal and abnormal physiological functions of the renal system. The course consists of didactic sessions and laboratory sessions where normal and abnormal cellular constituents will be reviewed. Corequisite: Introduction to Clinical Laboratory Science Learning Objectives Define routine urinalysis, and describe its three main components. Explain the critical usefulness of urinalysis, and classify tests pertaining to diseases or conditions affecting the kidney or urinary track and metabolic disease. Describe the basic anatomic components of the urinary system and the function of each. Discuss the chemical composition of normal urine. Describe a suitable urine specimen for routine urinalysis, including storage and preservation. Identify and describe normal and abnormal physical properties (especially color and transparency) that might be encountered in urine specimens, and correlate physical findings with chemical and microscopic findings. Discuss the relationship between urine volume and specific gravity. Define the term specific gravity. Test a urine specimen by using a multiple reagent strip, and demonstrate correct technique. For each analyte discussed, describe the following: principle of the test, specificity and sensitivity, interferences, and additional considerations. Discuss the pathophysiology and significance of proteinuria, and consistent microalbuminuria. Compare the pathophysiology of hematuria, hemoglobinuria, and myoglobinuria, and explain how to differentiate among the respective analytes when a positive reagent strip test for blood is seen. Discuss the pathophysiology and clinical importance of tests for nitrite and leukocyte esterase and how they relate to each other. Discuss the pathophysiology and clinical importance of bilirubin, urobininogen, and identify the laboratory findings in various types of jaundice. Describe the conditions when urine should be examined microscopically. Perform a microscopic examination of the urine sediment. Identify and discuss the various urine sediment constituents that might be encountered including pathophysiology and clinical importance. Describe the formation and significance of casts and how they are classified and reported. List the normal crystals encountered in acid and alkaline urine, and describe the most frequently encountered forms of each. List the abnormal crystals of metabolic and iatrogenic origin, and describe the most frequently encountered forms of each. Discuss the relationships among sediment, chemical, and physical findings in the urine. Recognize discrepant results when reviewing urinalysis findings (physical, chemical, and sediment), before results are reported. Analyze case studies in terms of the relevance of the laboratory findings to the clinical condition. Define cerebrospinal fluid and describe the components of routine examination, including gross examination, cell counts, morphologic examination, and common chemical tests.

15 Differentiate a traumatic tap from a hemorrhage on the basis of gross appearance of the spinal fluid. Identify the serous fluids and describe the components of their routine examination. Define the term effusion, and differentiate a transudate from an exudate. Define synovial fluid and describe the components of its routine examination. Describe the microscopic examination of synovial fluid for gout and pseudogout, using compensated polarizing microscopy for the identification of crystals. Discuss the clinical significance of tests for occult blood. Describe the common interferences in tests for occult blood and special dietary considerations necessary for specimen collection. Explain the chemical principle of the common slide tests for occult blood..discuss the significance of testing for the presence of fecal leukocytes, and describe the procedure for slide preparation. Describe the components of a semen analysis.

16 Hematology This course consists exploring the theory and practice of routine hematology. Topics include the collection and handling of clinical specimens, the origin, development, and function of human blood cells in health and disease, hemostasis, and coagulation, automation, and quality control. Routine hematology and coagulation testing will be emphasized. Prerequisite: Introduction to Clinical Laboratory Science Summarize the process of hematopoiesis. Describe the formation of erythrocytes, leukocytes, and thrombocytes, Identify the types of mature leukocytes found in the circulating blood and describe the characteristics of each. Describe the organs used for hematopoiesis throughout fetal and adult life. Define the microenvironment and the factors affecting differentiation of the pluripotent stem cell. Discuss four functions of the spleen. Differentiate between intramedullary and extramedullary hematopoiesis. Define the myeloid erythroid ration. Describe leukopoiesis and the steps leading from immature forms to maturation. List the maturation sequence of the granulocytic series. Name four morphologic features that are helpful in differentiating the cells of the granulocytic series. Describe the physiology and function of granulocytes. Describe the features that differentiate the granules of the neutrophilic, eosinophilic, and basophilic cell lines. Describe the lymphocytic system and its relationship to lymphocyte production. Discuss the mode and use for the three types of anticoagulants used for hematology assays. Explain the proper processing and testing of specimens. Identify at least three types of unsuitable blood specimens and the effect of each on tests results. Compare the effects of isotonic, hypotonic, and hypertonic solutions on blood cells. Briefly explain the hemoglobin procedures for normal hemoglobin and for abnormal hemoglobin S. Describe the principle and procedure of the microhematocrit determination. Define and calculate red blood cell indices of mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCV), mean corpuscular hemoglobin concentration (MCHC). Explain the formula and application of the red cell distribution width (RDW). Describe the procedure for counting and calculating erythrocytes, leukocytes, and platelets. Calculate a corrected cell count. Describe the performance, calculation, and applications of a reticulocyte count. Describe the performance and applications of the erythrocyte sedimentation count (ESR). Explain the proper preparation and examination of a peripheral blood film. Compare the three categories based on morphology. Identify and describe the morphologic alterations of size, shape, color, inclusions, and abnormal distribution pattern in erythrocytes.

17 Identify and describe leukocyte alterations. Describe the changes observed when white cells respond to infections. Define the probable causes for an increased leukocyte count. Recall the reactive symptoms of infectious mononucleosis and cytomegalovirus. Define white cell related terms such as leukocytosis, left shift, leukomoid reaction, and leukoerythroblastic reaction..compare and contrast acute versus chronic leukemia with respect to age of onset, presenting symptoms. Classify the acute nonlymphocytic leukemias according to the French-American-British (FAB), and the World Health Organization (WHO) classification systems. Correlate the various leukemias between the FAB and WHO classification systems. Identify and describe the three components of the hemostatic system. Explain the role of platelets in hemostasis. Describe the three major steps of the mechanism of coagulation. Summarize the activity of the extrinsic pathway of coagulation. Summarize the activity of the intrinsic pathway of coagulation. List and describe the role of the various coagulation factors. Identify and describe the process involved in the coagulation cascade from activation to stable clot formation. Describe the common laboratory tests used for coagulation and hemostasis. Describe the use of coagulation point of-care tests. Describe the various bleeding disorders, compare and contrasting those due to platelet disorders verses those due to factor deficiencies. Identify the components of the fibrinolytic system. Describe laboratory testing for fibrinolytic disorders.

18 Medical Microbiology This course is a comprehensive study of both theory and practical aspects of clinical microbiology. Emphasis will be placed on the collection and handling of clinical specimens as well as the primary isolation and identification of the most frequently encountered bacterial, pathogenic to humans. Other topics discussed include antimicrobial chemotherapy and host resistance. Other organisms examined include fungi and parasites. Prerequisites: Introduction to Clinical Laboratory Science, BIO 205 Learning Objectives Define normal flora. Compare and contrast Prokaryotic and Eukaryotic cells. Describe the system for the classification of microorganisms, taxonomy and nomenclature. Describe the different biosafety levels employed in the microbiology laboratory. Discuss the different procedures used to protect workers in the microbiology laboratory. Discuss the importance of collection requirements for the various specimen used in microbiological studies. Discuss the storage requirements for specimens, media, and reagents. Describe the procedures for performing Gram stain and acid-fast staining procedures. Describe the various Gram stain reactions of various common bacteria. Identify the appropriate media for frequently collected specimens: urine, throat swabs, genitourinary exudates, and blood. Describe the basic tools used to process specimens in the microbiology laboratory. Identify the various media used in the microbiology laboratory for the growth and identification of various bacterial pathogens. Describe the proper dilution streak technique for the planting of bacteria on media. Describe the various colony characteristics seen with various microorganisms. List the various growth requirements for bacterial cultivation. List and define the various types of media used in the microbiology laboratory. Describe the Quality Control requirement of the microbiology laboratory. Demonstrate the ability to analyze patient or specimen information and outline procedures to be followed. Demonstrate the ability to recognize technical problems and suggest possible corrective actions. Describe the lifecycles of various pathogenic human parasites. Discuss the sources and growth patterns of various pathogenic fungi.

19 Immunology and Serology This course introduces the theoretical principles of immunology which involve the structure, function, and interactions of the immune system. The serological techniques useful in the diagnosis of many diseases will be reviewed and performed. Prerequisites: Introduction to Clinical Laboratory Science Definition of the term immunology. Describe the first line of defense against infection. Describe the components and general function of natural immunity. Explain the function of adaptive immunity. Compare the cellular and humoral components of adaptive immunity. Name the three immunologically functional groups of leukocytes. Describe the five steps and general activities in phagocytosis. Name the various types of lymphocytes and explain the function of each type. Define the terms antigen and antibody. Describe the general characteristics of antigens. Explain the general characteristics of antibodies. Identify and compare the five classes of antibodies. Explain the general configuration of an IgG antibody molecule. List and discuss characteristics of the five major classes of immunoglobulins. Illustrate and explain the characteristics of the four phases of an immune response. Define the term immune complex. Compare the terms monoclonal and polyclonal. Describe the production of monoclonal antibodies. Describe the characteristics of agglutination. Explain the mechanism of particle agglutination. Compare the grading of agglutination reactions. Name and compare the principles of latex agglutination, coagglutination, liposome mediated agglutination, direct bacterial agglutination, and hemagglutination. Compare the characteristics of precipitation versus flocculation. Explain the action and application of lysis in serologic reaction. Name and compare immunofluorescent assays. Identify and compare various enzyme immunoassays. Briefly describe the application of polymerase chain reaction (PCR), Southern blot, Northern blot, Western blot, and DNA chip technology. Compare the two phases of testing for antibody levels. Define the term antibody titer and explain the procedure for the serial dilution of serum. Explain the principles of immunologic tests for pregnancy. Describe the pathophysiology and immunologic testing in infectious mononucleosis. Describe the pathophysiology and screening tests for antinuclear antibody (ANA) in systemic lupus erythematisus (SLE). Describe the pathophysiology and laboratory testing for rheumatoid factor (RF) in patients with rheumatoid arthritis (RA). Explain the rationale and outcomes of syphilis testing.

20 Immunohematology This course consists of the study of the genetic basis and immunological interaction of the mayor blood group antigens and antibodies. Topics will include compatibility testing, antibody screening and identification techniques, blood donation, transfusion therapy, record keeping, and quality control techniques. Prerequisite: Introduction to Clinical Laboratory Science, Immunology and Serology Define the following terms: Immunohematology Blood banking Transfusion medicine Explain the role of antigens and antibodies in Immunohematology. Define: isoantibodies and immune antibodies. Describe the means of detecting antigen-antibody reactions in transfusion medicine, including the role of complement. Describe the preparation and requirements of antisera. Define genotype and phenotype as used in Immunohematology. Describe the procedure for ABO typing of red blood cells both front typing and back typing. Explain Landsteiner s rule and how it applies to transfusion medicine procedures. Explain the concept of universal donor and universal recipient. Explain the terms Rh negative and Rh positive. Discuss CDE and Rh-Hr terminology and inheritance. Describe and compare the direct and indirect antihuman globulin reaction (Coombs test). Discuss hemolytic disease of the newborn, including detection and prevention. List and explain the components of compatibility testing, including identification, ABO and Rh typing, screening for unexpected antibodies, and crossmatching. Identify and compare various types of transfusion reactions. Identify and describe the various red blood cell components and derivatives used for transfusion, including platelets, and explain the reasons for transfusion of each. Describe the procedures for quality assurance as practiced in transfusion medicine.

21 Clinical Chemistry The primary focus of the course is the biochemical analysis of blood and body fluids in health and disease. Topics include routine manual and automated testing methods, electrophoresis, molecular techniques, safety practices and quality control. Prerequisite: Introduction to Clinical Laboratory Science, CHM 112, Immunology and Serology Compare the pathophysiology of types 1 and 2 diabetes. Describe the symptoms of diabetes. Identify and explain other causes of hyperglycemia. Describe the characteristics of hypoglycemia. Compare point-of-care testing to traditional testing methods for glucose. Describe the methods for quantitative and semiquantitative determination of glucose. Describe the Clinical Practice Guidelines of the American Diabetes Association for classification, diagnosis and assessment of diabetes mellitus. Describe the principles of glucose, ketones, and glycated hemoglobin analyses, including commonly encountered sources of analytical interferences. Identify the four major electrolytes found in blood and body fluids. Describe the anion gap. Discuss the principle of analysis of Na, K, Cl and total CO 2 in terms of electronic components, reagents, and endpoint detection. Provide appropriate criteria for interpreting electrolyte laboratory tests. Identify the four major electrolytes found in blood and body fluids. Describe the anion gap. Explain the role of acid-base balance and blood gases in the body. Name and compare renal function assays. Describe the methodology and clinical significance of uric acid analysis. Explain the clinical significance of ammonia analysis. Compare the biochemical and physiological characteristics of cholesterol, triglycerides, and lipoprotein. Identify and compare the various types of hyperlipidemia. Describe specimen sampling in cardiac disease. Name the cardiac markers associated with acute myocardial infarction. Describe liver and pancreatic assays and their clinical significance. Identify at least two hormone assays and describe the clinical application of each. Compare the clinical significance of various types of tumor markers. Describe therapeutic drug assays and identify drugs of abuse

22 Standard 22C: Curriculum Requirements During year one of the Clinical Laboratory Sciences Program, students are introduced to the disciplines that comprise the body of knowledge of Clinical Laboratory Science. Topics covered include: Lab safety (incorporated into all courses) Lab regulations (incorporated into all courses) Health care industry organization Laboratory mathematics Measuring devices (glassware, pipettes, balances, spectrophotometers) Microscopy Clinical Chemistry Hematology Coagulation Immunology and Serology (includes waived and Point of Care Testing) Immunohematology (basic techniques) Urinalysis Microbiology (basic principles in General Micro and introduction to Medical Micro) Laboratory experiences during Year - 1 are designed to introduce students to basic laboratory procedures and principals (cell count, calibration curves, etc). Building on the knowledge gained in Year - 1, the subjects are reintroduced, -but the treatment of the subject matter is delivered at a higher level. Year - 1 deals with mostly facts. During Year - 2 the material introduced in Year - 1 is presented in a higher level of detail, and employing the higher domains of learning (i.e. case studies. etc.). Students are introduced to instrumentation and the principles of troubleshooting in the student lab. During the last half of Year - 2, students enter a Practicum at the various affiliate hospitals. During the Practicum, students rotate among the various laboratory departments. Students practice the techniques of those departments, and are evaluated to ensure a level of entry level proficiency. At the end of the Practicum, students have achieved a level of proficiency suitable to an entry level MLT. To ensure that the clinical experience is equivalent at each institution, representatives from each affiliate met with the Program Director, working in committee, to cooperatively developed the Practicum Guide. A basic menu of leaning activities, where test menus, and methods of evaluation are listed in detail. Affiliates have the option of also including specialty items over and above the core curriculum, but have agreed to follow the curriculum as listed in the Practicum guide.