Course Descriptions

Course Descriptions

CLSC 610 – Clinical Laboratory Methods (3) Summer Session I

This course covers the basic knowledge and laboratory skills specific to the practice of clinical laboratory science. The information covered provides the student with the fundamental skills to solve common laboratory mathematical problems and to interpret quality assessment. Topics include: laboratory calculations, specimen processing, quality control, pipetting, spectrophotometry, assay performance, microscopy, and laboratory safety. The week-long laboratory session covers basic laboratory skills necessary for performance of clinical diagnostic testing. These include laboratory safety, specimen processing, pipetting, standard curve and control range development as well a practicum assay.

CLSC 710 Principles of Molecular Diagnostics (3) Summer Sessions I and II

This course covers the fundamental principles of molecular technology and techniques used in clinical and research laboratories. Topics include: nucleic acid chemistry, nucleic acid extraction and hybridization; target, signal and probe amplification; microarrays and in-situ hybridization. Quality assurance and control issues used to monitor molecular tests are addressed. The course covers the development and validation of “home brew” assays.

CLSC 720 Applications of Molecular Diagnostics (3) Fall

This course focuses on the clinical applications of the various molecular techniques used in diagnostic testing. The course covers molecular methods used for the detection of disease mutations, gene-targeted therapy, infectious disease testing, leukemia and lymphoma testing, monitoring response to therapy, and for solid tumor testing. Identity testing both for forensic purposes and transplant uses is addressed.

CLSC 720 L Molecular Diagnostic Techniques Laboratory (3) Fall

This course covers the performance of basic techniques used in molecular testing to include nucleic acid extraction, quantitation, digestion, hybridization, amplification by polymerase chain reaction, and electrophoresis. Students also perform real time PCR to compare to end-point PCR. Interpretation of results and quality control techniques are emphasized.

Bios 600 Biostatistics 600 (3) Fall

This course is an introductory course in probability and statistical inference offered by the Biostatistics Department in the School of Public Health. MMDS students have special permission to take this course. This course serves as an introduction to the collection, summarization, analysis and presentation of data. Topics include sampling, experimentation, measurement, descriptive statistics, correlation, probability, confidence intervals, test of hypotheses, 2-way tables and a simple linear regression. Bios 600 is deliberately broad and not intended to give students an in-depth understanding of statistical testing, analysis of categorical data or regression analysis. Rather, its intent is to provide an overview of some of the main areas of probability and statistics and a working knowledge of basic summary statistics, graphs and simple statistical tests for hypothesis testing. At the end of the course a student should be able to evaluate straight-forward statistical usage in everyday life and their own discipline, especially in relevant research publications; and interact knowledgeably with statisticians in planning, conducting, analyzing and reporting research

CLSC 730: Research Methods (3) Spring

This course provides students with an overview of the knowledge of research design and methods commonly used in the clinical research arena.  It prepares students to be critical consumers of published research and potential investigators in research activities.  Major topic areas to be addressed include:  the concept of research and how theory and ethics impact choices, measurement issues that affect research and clinical practice, the broad scope of experimental, exploratory and descriptive research designs, the application of statistical procedures using a conceptual approach, and the communication issues of research, from the inception of a research project to the dissemination of results.  A primary aim of this course is to equip students with the knowledge and skills necessary to critically examine professional literature, as well as the methodical and ethical considerations that influence research design.

CLSC 735 Method Evaluation (3) Spring

This course provides students with the information and tools necessary to determine whether a particular molecular test is useful in a clinical diagnostic setting and if so, the steps that must then be followed to bring a new assay into the molecular diagnostic laboratory. Students will learn how to evaluate the diagnostic accuracy of a new test as well as the clinical value of that test. The economics evaluation of a new test will also be discussed. Students will learn to write up procedures for laboratory procedure manuals following guidelines specified by various accrediting agencies and organizations.

CLSC 740 Clinical Rotation in Molecular Diagnostics I (4) Spring

This course is supervised rotation in a clinical molecular laboratory. The student will perform molecular assays, apply quality control, interpret results and correlate results with the clinical condition. The rotation will include preventive and corrective maintenance on instruments and equipment used in the molecular laboratory.

CLSC 650 Clinical Laboratory Administration (3) Summer Session I

This course provides a foundation in the technical and non-technical aspects of supervising and managing clinical laboratory testing services within the current health care delivery system. Topics covered in this course include: clinical laboratory testing within the context of the current health care delivery system, the influence of other aspects of society, financing of clinical laboratory testing, regulation of clinical laboratories, accreditation of laboratories, financial management, information systems management, management of the quality of clinical laboratory testing, the role and responsibilities of a supervisor, personnel management, leadership and communication skills, and ethics in the clinical laboratory testing environment. The emphasis of the course is on the knowledge, skill, and attitudes needed to work successfully in a health care setting at the entry-level and beyond. The primary goal of this course is the development of awareness of non-technical issues and functions important to the oversight of clinical laboratory services in the current health care delivery system.

CLSC 750 Clinical Rotation in Molecular Diagnostics II (2) Summer Session I

This course is a second supervised rotation in a clinical molecular laboratory. The student will perform molecular assays, apply quality control, interpret results and correlate results with the clinical condition. Students will acquire the additional clinical skills and experience needed for entry-level competence and for national certification examinations.

CLSC 760 Molecular Diagnostics in the Corporate Setting (3) Summer Session II

This course covers the development of in vitro diagnostic molecular methods with clinical applications in infectious disease, oncology, and other areas. Major topics include an overview of the research and development process, technical documentation, product commercialization, and IVD regulatory issues.

CLSC 770: Educational Methods and Applications. (3) Fall

This course provides an overview of educational issues and methods in order to prepare students for future roles as educators in the clinical laboratory profession. Course topics and assignments address the major educational responsibilities of clinical laboratory professionals including continuing education, competency assurance, certification and accreditation. Students will use the educational methods to prepare, present, and evaluate a continuing education presentation.

CLSC 780: Capstone Seminar (3) Fall

In this course, students will use the knowledge and clinical skills they have acquired in their MMDS courses to prepare a written manuscript that is suitable for publication. The manuscript will describe the student’s method validation study performed in the clinical setting. The paper will include relevant literature review and include the following: abstract, introduction, methods and materials, statistics, results, discussion, conclusion and references. Students will present the method evaluation study to MMDS students and faculty on-campus at the conclusion of the program.

Capstone Seminar

The Capstone seminar serves as the culminating educational experience in the MMDS program. During the clinical rotations, students use the knowledge they have gained in MMDS courses to complete two method evaluation projects. These types of projects are most appropriate for the MMDS program, because graduates working in clinical laboratories will be called upon to establish the need for and validity of new tests at their institutions. This process requires an in-depth knowledge of the science of molecular diagnostic science as well as an understanding of the federal regulations governing the use of molecular tests in clinical settings, method validation and research design. At the end of the last semester of the MMDS program, students will return to Chapel Hill to present one of their method evaluation projects. They will also submit manuscripts describing their projects that are suitable for submission to a peer-reviewed journal.