Clinical Laboratory Sciences Syllabi


Syllabus for CLLS 4310
Clinical Chemistry II
Instructor:Muneeza Esani, Ph.D., MPH, MT(ASCP)
Contact Information:Office: SHP 4.426
Phone: 409-772-9456
Course Description:The student will be given the opportunity to demonstrate the ability to: 1) discuss the interrelated human metabolic functions in both normal and disease states; 2) describe the principles and significance of clinical chemistry laboratory procedures employed in patient evaluation; 3) utilize quality control techniques in evaluating the validity and reliability of laboratory data; 4) describe the relationship of accuracy and precision in laboratory work; and 5) discuss the principles of mathematical calculations and laboratory instruments as applied to electrolytes and acid/base physiology, therapeutic drug monitoring, toxicology, hypothalamus, pituitary, adrenal cortical and medullary, reproductive and thyroid endocrinology, parathyroid glands and calcium/phosphate metabolism, gastrointestinal and pancreatic function, nutritional assessment, and advanced methods evaluation.
Course Objectives:

Cognitive Terminal Objective:
Throughout this course and upon its completion the student will learn to be able to prepare and implement laboratory procedures for the analysis of clinically significant chemicals for evaluation of normal organic functioning, monitoring therapeutic or abuse drugs or detection of cellular indications of disease. The student will be able to interpret results and identify additional testing needs as required to function as an integral part of the health care team, with competency, integrity and the high level accountability as necessary for a clinical laboratory scientist.

Cognitive Enabling Objectives:
Throughout this course and upon its completion the student will be expected to:

Acid Base/Blood Gas Unit

  1. Explain the role of an acid-base buffer, listing three key examples in human body fluids.
  2. Relate the combined gas laws as they apply to measuring arterial blood gases.
  3. Describe the exchange of gases in the lungs including the role of alveoli, venous and arterial circulation (and the hemoglobin molecule) as they relate to gases in ambient air, and provided by a ventilator.
  4. Define hypoxia, cyanosis and hypercapnia in terms of main causes and their typical effects.
  5. Explain hypoventilation in terms of several common causes and their main effects.
  6. Discuss the role of the isohydric shift and chloride shift at a cellular level and the renal system and respiratory system in helping to maintain or compensate to normal pH.
  7. Calculate and transcribe accurately, total carbon dioxide, H2CO3, HCO3, pH and oxygen capacity given Henderson-Hasselbalch and related formulas.
  8. Classify accurately a patient’s acid base status, in terms of metabolic acidosis or alkalosis or respiratory acidosis or alkalosis, given arterial blood gas and electrolyte results, predicting how compensation will affect these results.
  9. Evaluate the acceptability of arterial blood gas and oxygen saturation results based on quality control and quality assurance issues including specimen collection and handling and analytic errors.
  10. Describe the principle of oximetry and amperometry for oxygen analysis and potentiometry for pH and carbon dioxide analysis taking into consideration validation mechanisms and limitations.
  11. Describe briefly characteristics, one cause, prognosis and typical arterial blood gas findings of common obstructive and restrictive respiratory disorders including: COPD illness such as emphysema and chronic bronchitis, severe pneumonia, acute asthma, respiratory failure, and in some extra-pulmonary respiratory diseases.
  12. Prepare and transcribe protocols for specimen collection of arterial blood gases, venous pH and electrolytes, and analysis of arterial blood gases, pH and electrolytes, including all necessary components as required for CLIA regulations and NCCLS standards.
  13. Evaluate or validate new methodology for collection and analysis of blood gases, pH and electrolytes.
  14. Exemplify integrity and a sense of responsibility as they relate to confidentiality and timeliness of specimen collection, analytic validation, and reporting of results.

Therapeutic Drug Monitoring/Toxicology Unit

  1. List the four major classes of toxic substances and state common examples in each class.
  2. Describe the seven major classes of therapeutic drugs listing two common examples in each category.
  3. Define the following terms as they relate to therapeutic or toxicologic drug monitoring: volume of distribution, route of administration, metabolism, excretion, forensic, chain-of-evidence, chain-of-custody and permissive exposure limit (PEL).
  4. Describe from an illustration the following terms: peak, trough, therapeutic index, minimum effective concentration (MEC), minimum toxic concentration (MTC), half-life, steady-state and dose-response curve.
  5. Describe the commonly recognized principle of analysis of therapeutic drugs, salicylates, acetaminophen, alcohol and carbon monoxide taking into consideration validation mechanisms and limitations.
  6. Interpret patient, control and standard results from chromatograms obtained in thin-layer chromatography, gas chromatography-mass spectrometry and high-performance (pressure) liquid chromatography for the detection and quantitation of drugs and volatile substances, as they relate to principles of analysis.
  7. Differentiate between screening and confirmatory testing, qualitative and quantitative methods for toxicology in terms of analytic sensitivity, specificity, turn-around time, medical or forensic applications, presumptive and definitive results.
  8. Describe principle methodology, limitations, specimen collection and handling techniques and clinical correlation of heavy metal toxicology, including lead and mercury.
  9. Demonstrate the highest level of confidentiality when dealing with patient results.
  10. Prepare and transcribe protocols for specimen collection of therapeutic and abused drugs and analysis of therapeutic drugs, non-pharmacologic toxins and abused drugs, including all necessary components as required for CLIA regulations and NCCLS standards.
  11. Evaluate or validate new methodology for collection and analysis of toxins and drugs.
  12. Demonstrate the highest level of integrity when dealing with known or potential samples for forensic toxicology, maintaining strict adherence to protocols for chain-of-custody.

Endocrinology Unit

  1. Describe steroid and protein hormones (breaking out proteins, modified amino acids and thyroid hormones into separate groupings) in terms of general chemical makeup, speed of action and half-life, type of receptor, typical intracellular response (mechanism of action), general functions including regulation of metabolism, temperature, growth and development and common transport mechanism and aspects of metabolism.
  2. List the main organs in the endocrine system and major hormones from each, including target of those hormones.
  3. Diagram the interaction of the hypothalamus, pituitary, primary endocrine organ axis, using examples discussed in class.
  4. Define and illustrate positive and negative feedback using specific examples.
  5. Describe growth hormone, anti-diuretic hormone, prolactin and oxytocin, in terms of conditions of over- or under-secretion, the usual systemic effects and the typical methodology of analysis.
  6. Describe the main hormones produced by the adrenal medulla and parathyroid, including conditions of over- or under-secretion, typical systemic effects and common methodology of analysis.
  7. Explain the role of LH, prolactin, estradiol or other estrogens, progesterone, testosterone and FSH in reproductive medicine, common methods of analysis and physiologic, pre-analytic and post-analytic factors to be considered.
  8. Discuss the main hormones produced by the thyroid and adrenal cortex, the secondary and tertiary stimulatory hormones that effect them, general metabolism and typical systemic effects.
  9. Explain the value and expected interpretation of thyroid uptake (T3U), reverse T3 (rT3), thyroid-binding proteins, and thyroid antibody values.
  10. Describe Grave’s disease, Hashimoto’s thyroiditis, Cushing’s disease or syndrome, Addison’s disease or syndrome and primary and secondary hypothyroidism states in terms of typical etiology, signs and symptoms, typical diagnostic laboratory findings and prognosis.
  11. Calculate and interpret THBR and FT4 I, in relationship to euthyroid (in conjunction with chronic illness and hyperproteinemic states), hyperthyroid and hypothyroid states.
  12. Describe the commonly recognized principle of analysis of total thyroxine, sTSH, free thyroxine, and cortisol taking into consideration validation mechanisms and limitations.
  13. Evaluate the acceptability of thyroid panel or adrenal cortex results based on quality control and quality assurance issues including specimen collection and handling and analytic errors.
  14. Explain the value and usual interpretation of timed cortisol, ACTH, urinary free cortisol and dexamethasone or metyraprone effects on these values.
  15. Discuss the action of renin, angiotensin, aldosterone and serotonin and their role in endocrinopathies.
  16. Interpret LH, FSH, progesterone, estradiol and estriol results based on the female reproductive cycle in regards to ovulation, fertilization, states of anovulation and in menopause.
  17. Evaluate results of estriol, hCG, AFT and sufactant phospholipids in terms of fetal viability or fetal distress given gestational age.
  18. Demonstrate empathy for patients and their families by maintaining the highest level of sensibility and reliability.
  19. Prepare and transcribe protocols for specimen collection of hormones, and analysis of hormones including all necessary components as required for CLIA regulations and NCCLS standards.
  20. Evaluate or validate new methodology for collection and analysis of hormones.

Vitamin/Mineral/Nutrition Unit

  1. Evaluate vitamin and nutritional status based on clinical characteristics including laboratory findings.
  2. Describe the principle methodology, methods of validation and sources of pre-analytic variation and analytic interferences for serum carotene, folate, vitamin B12, retinol-binding protein and prealbumin (TBPA).
  3. Classify vitamins based on their general chemical characteristics and specific roles in human physiology.
  4. Discuss conditions related to and laboratory indicators of generalized nutritional deficiency, specific vitamin and trace metal deficiencies and carbohydrate status.
  5. Considering the following laboratory tests, explain the diagnostic importance, main testing method and principle and clinical correlation of results: gastric analysis, lactose tolerance or H breath test, d-Xylose absorption, fecal fat, occult blood, serum gastrin, and sweat chloride.
  6. Prepare and transcribe protocols for specimen collection of and analysis of vitamins, trace minerals, other chemicals for nutritional assessment and gastrointestinal functioning, including all necessary components as required for CLIA regulations and NCCLS standards.
  7. Evaluate or validate new methodology for collection and analysis of vitamins, minerals and gastrointestinal functioning.

Tumor Marker Unit

  1. Explain the meaning of each term listing specific examples when applicable: malignancy, tumor, cancer, benign, neoplasm, and tumor marker.
  2. Categorize tumor markers based on a five item classification system, relating to chemical makeup and general methodology of analysis.
  3. Define the following terms as they relate to tumor markers: diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, receiver operator curve (ROC), diagnostic limit (cut-off) and tumor load.
  4. Discuss the differences between screening for cancer in asymptomatic general population, in symptomatic patients within high-risk groups, in diagnostic or confirmatory tests and in monitoring for success of treatment or recurrence of malignancy based on tumor marker levels, citing specific examples.
  5. Explain the value of specific tumor markers for diagnostic and treatment of patients with gastrointestinal, breast, prostatic, uterine, testicular and leukemic malignancies.
  6. Prepare and validate protocols for specimen collection of tumor markers and analysis of tumor markers, including all necessary components as required for CLIA regulations and NCCLS standards.
  7. Evaluate or validate new methodology for collection and analysis of tumor markers.

Affective Objectives:

"Students will be given the opportunity to demonstrate the development of behaviors and attitudes consistent with those of the profession. Evaluation of these behaviors will be performed using the Affective Objectives and Evaluation checklist in the Orientation Handbook."

The student should successfully meet these objectives a minimum of 70% of the time for satisfactory completion of this course. Certain criteria on the checklist are more specific. Students must meet those criteria at the level indicated on the checklist.

Required Course Materials:Textbooks:
  1. Clinical Chemistry: Principles, Procedures, Correlations. Bishop, Fody & Schoeff. Lippincott Williams & Wilkins Publishers, 2005, ISBN 0-7817-4611-6
  2. Clinical Laboratory Science: The Basics, Linne & Ringsrud. C.V. Mosby, Co Publishers., 1999, IBSN 0-323-00759-7
Methods of Evaluation:

Students should refer to the Department Academic Policies for general information regarding the Attendance, Methods of Evaluation, and Academic Dishonesty. Those general Policies apply to this course.

Course Activities & WeightingGrading Scale
Lecture Exams/Exercises95%90 - 100%A
Class Attendance/Participation5%80 - 89%B
Laboratory Practical Exams0%70 - 79%C
Laboratory/Small Group Activities0%60 - 69%D
Total100%59% and belowF

Exams are not cumulative; that is, the exam covers only that material from the last exam.

Course Policies:

STUDENT RESPONSIBILITY: Students will be expected to attend class, take notes, and participate in class discussions. All classes require participation on one form or another. You are expected to come to class on time and ready to participate in designated activities. If a student misses a class, it is their responsibility to get handouts and notes from a fellow classmate. Makeup tests will be given only if prior approval has been acquired from the instructor. Faculty will follow the CLS Attendance and Participation policy found in the Orientation Handbook.

Attendance is expected in lecture sessions. In the event of an unavoidable absence, the student must notify the instructor. Students not attending will have points deducted from their attendance and participation grade. In addition, small group activities will be completed in class. There will be no makeup for these projects without prior approval in the instructor. It is expected that assignments will be turned in at the beginning of the class period on the due date. Late assignments will have points deducted from them.


General Policies of the School of Health Professions

Academic Progress:Information regarding the Student's academic progress in this course will be shared with their Academic Advisor and/or Department Chair. Student's making unsatisfactory progress will be referred to the Office of Student Affairs for assistance.
Academic Integrity:Academic dishonesty includes, but is not limited to, cheating, plagiarism, collusion, the submission for credit of any work or materials that are attributable in whole or in part to another person, taking an examination for another person, and any act designed to give unfair advantage to a student or the attempt to commit such an act. Procedures to be followed in the event of alleged academic dishonesty are described in the Rules and Regulations of the Board of Regents of The University of Texas System, and the SAHS Student Handbook. Alleged academic dishonesty issues should be reported to the Student Affairs Officer.
Professional Behavior:As a part of a professional program, you are expected to conduct yourselves in a manner consistent with the level of trust and responsibility that will be placed on you when you are part of a health care team. You are expected to be honest in your dealings with your instructor and your peers. You are also expected to be able to follow instructions, to act with the utmost integrity, to follow safety protocols while in laboratory, to perform laboratory work with care, and to act in accordance with those standards characteristic of those we call "professionals."
Behavior during examinations, written and practical, will be monitored. Inappropriate behavior may result in pursuance of disciplinary action.
University Statement on Equality, Tolerance, and Affirmative Action:Please indicate by the end of the second week of the semester if you will need accommodations under the Americans with Disabilities Act (Public Law 101-336). If the need for ADA accommodations should arise during the semester you will need to make your request within one week of returning to classes. You may contact your Instructor or the Office of Student Affairs.
Course Evaluation:Students will be given the opportunity to evaluate the instructor and course near the end of the course/semester. When submitting course evaluations students must follow the guidelines provided by the course instructor or the department.
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