Clinical Laboratory Sciences Syllabi


Syllabus for CLLS 5327
Laboratory Validation Studies
Instructor:Miriam Corti, PhD, MS, MLS(ASCP)SBB
Contact Information:Office: SHP 4.439
Phone: (409) 772-3034
Course Description:The student will be given the opportunity to 1) develop skill in the use of Excel program in performing necessary statistical calculations and graphs for various required validation studies; 2) apply method evaluation principles, statistics, and experiments to judge the performance of a selected method for clinical laboratory use; 3) identify the potential sources of error; 4) identify advantages and limitations of the method in terms of cost, time, and adaptability to the clinical laboratory; 5) become familiar with regulatory requirements for accredited laboratories in regard to validation of patient testing methods; and 6) given actual testing data and lab background be able to determine the acceptability or non-acceptability of a clinical testing method.
Cognitive & Psychomotor Objectives:Upon completion of this course the student will be able to:

1. judge the acceptability of a selected method

2. utilize statistical tools to identify descriptive and inferential information

3. identify internal and external validity and applications to the clinical laboratory

4. perform a method evaluation by organizing and analyzing a body of presented data

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 and the outcome of this evaluation will be reflected in the your course grade as part of your participation grade.. You will have the opportunity to develop these attributes in classroom assignments and activities. You will be placed in different work groups or assigned different partners for exercises. You will also be given opportunities to demonstrate your ability to work independently, follow instructions and be creative.
Methods of Evaluation:

Students should refer to the Department's Academic Policies for general information regarding the Attendance, Methods of Evaluation, and Academic Dishonesty. Those general policies apply to this course.
Students are required to complete all units, projects, and Internet discussion sessions for this course. 

Learning Activities

Method of Grading

Unit Projects

35 %

Method Evaluation Semester Project

45 %

Final Exam

20 %


100 %


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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