New Graduate Program Proposal
Master of Science in Clinical Molecular Genetics
School of Clinical Sciences: Clinical Laboratory Sciences Programs
Rationale
The Clinical Laboratory Sciences (CLS) programs propose to offer a graduate program leading to a
Master of Science Degree in Clinical Molecular Genetics. There has been profound growth in the
molecular diagnostics market in healthcare. Molecular tests are utilized with increasing frequency in
areas of medicine including genetic disorders, infectious diseases, detection and monitoring of cancer,
pharmacogenomics, and identity testing. The future of healthcare will rely on genomic medicine for
diagnosis, prognosis, monitoring the course of disease, and selecting optimal treatment strategies.
Diagnostic molecular scientists require specialized training and the demand for these professionals is
great. NMU is one of eight universities nationwide that offers an accredited program in Diagnostic
Molecular Science at the baccalaureate level. The accredited program by the National Accrediting
Agency for Clinical Laboratory Sciences (NAACLS), coupled with the fact that Molecular Diagnostics is the
fastest growing area of the clinical laboratory, provides the framework and opportunity to expand our
program to the Master’s level.
The proposed MS program will be offered through online coursework with an on-campus laboratory
experience. There will be two tracks. The professional, project-based, track will appeal to working
professionals. Molecular assay development and validation projects can be completed at their place of
employment under the tutelage of NMU faculty. A research, thesis-based, track will be appropriate for
those seeking research positions in industry including pharmaceuticals, biotechnology, government, and
academe.
The MS degree program will be highly desirable to Biology and CLS BS graduates as it will provide
professional growth opportunities in health care and related industries. The program will bring
increased national visibility to NMU which will likely result in enrollment increases at both
undergraduate and graduate levels.
Description of Curriculum
The Master of Science degree program in Clinical Molecular Genetics will provide coursework and
training in molecular-based clinical diagnostics. Graduates will perform and interpret molecular
diagnostic testing and explain the clinical utility to health care professionals. Coursework for the Clinical
Molecular Genetics program will be offered online allowing working professionals’ flexibility in
scheduling. A one week experience in the Molecular Diagnostics laboratory on campus will be included.
Students will have the option of choosing the professional project-based track which involves method
verification and validation, or a clinical research track with the completion of a thesis.
Program Goal: The Master’s degree in Clinical Molecular Genetics will prepare graduates for
professional roles as practitioners, researchers, and educators in clinical molecular diagnostics.
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School Mission Statement: The mission of the School of Clinical Sciences is to educate future clinicians.
We seek to engage students in innovative, problem-based learning, preparing them to serve the regional
and global community with skill and compassion.
The proposed program is in congruence with the mission statement by providing a graduate curriculum
that is relevant to current healthcare trends. The School fosters innovative ways to provide instruction
as exemplified by the online nature of the proposed program.
Program Objectives: Graduates of the program will
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Select, interpret, and implement molecular-based clinical assays
Communicate the appropriate clinical use and significance of molecular-based tests to other
health care professionals and the public
Establish and validate novel molecular methods for clinical use
Interpret, implement, and comply with laws, regulations and accrediting standards of
governmental and non-governmental agencies
Apply principles of management to biomedical laboratories
Job Opportunities for Graduates
Job opportunities for graduates are found nationwide in healthcare including hospitals and public health
departments, reference laboratories, state and federal law enforcement agencies, biotechnology
industries, pharmaceutical companies, research institutions and academe.
The US Bureau of Labor Statistics data identify a 13% increase in the need for clinical laboratory
scientists between 2010 and 2020. The specific data regarding personnel trained in Clinical Molecular
Genetics is not cited as this is a relatively new and emerging diagnostic field. The rapid growth in
Molecular Diagnostic testing is exemplified by the number of molecular genetic tests currently available
at Mayo Clinic (NMU affiliate in the accredited Diagnostic Molecular Science BS program). The Mayo
Clinic website (www.mayomedicallaboratories.com/test-catalog) currently lists 422 types of molecularbased clinical assays available with the menu of diagnostic test growing each month (Mayo Clinic
Communique). The large menu of diagnostic tests coupled with the lack of qualified graduates
exponentially increases the need for trained personnel according to the American Society for Clinical
Pathology.
Reports from laboratories performing clinical molecular testing indicate that it is difficult to find
personnel to fill current position. Job postings for graduates trained in Molecular Genetics can be found
on websites for the following organizations: Association for Molecular Pathology, Association of Genetic
Technologists, American Society for Clinical Pathology, American Society for Microbiology, and American
Society for Hematology.
The results of the 2012 Advance Laboratory salary survey for laboratory professionals offered insight to
professional opportunities in clinical molecular genetics. The average salary of those that specialize in
Molecular Diagnostics/Genetics was $80,760. The Pacific region (AK, HI, CA, OR, WA) offers the highest
salaries, followed by the Middle Atlantic (NJ, PA, NY) and New England (VT, NH, CT, MA, RI, ME).
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Related Programs at NMU
The CLS programs offer a BS program with a concentration in Diagnostic Genetics: Diagnostic Molecular
Science. This NAACLS accredited program continues to have excellent outcomes for the BS graduate.
The proposed master’s program will provide the opportunity to earn the Master’s degree in the rapidly
expanding field of Clinical Molecular Genetics.
Comparison to Other Universities
Several universities in the region offer MS degree programs in Cell and Molecular Biology that prepare
students for research careers. These programs are offered as traditional, on- campus programs that
typically include a thesis. The proposed program is unique in its focus on the clinical application of
Molecular Genetics. The online program will appeal to both working professionals as well as traditional
students interested in earning a Master’s degree. The employment opportunities in a variety of venues
will be highly valued. The MS degree will also give students unique training for those pursuing doctoral
degrees.
Accreditation
The proposed degree program will not be subject to professional accreditation standards. Graduates of
the program will be eligible for national certification in Molecular Biology from the American Society for
Clinical Pathology with six months of experience in a clinical molecular genetics laboratory.
Graduate Bulletin Listing
The Master of Science in Clinical Molecular Genetics is offered to those interested in professional
opportunities in clinical molecular diagnostics for healthcare, biotechnology, pharmaceuticals, forensics,
research and academe. Students complete online graduate courses and one week in a molecular
diagnostic lab experience on campus. Students will perform research or a method verification and
validation which will culminate in a Thesis or Project, respectively. The Thesis or Project will be
presented as a seminar at the conclusion of the program.
Students will take the following courses.
CLS 520
Principles of Clinical Molecular Genetics
3 credits
CLS 526
Clinical Molecular Diagnostic Techniques
4 credits
CLS 536
Clinical Genetics
3 credits
CLS 541
Clinical Applications of Genomic Medicine
3 credits
CLS 543
Molecular Diagnostics in Identity Testing
2 credits
CLS 544
Molecular Diagnosis of Infectious Disease
3 credits
CLS 560
Biomedical Laboratory Operations
3 credits
CLS 563
Research Design and Methods
3 credits
CLS 570
Method Verification and Validation
4 credits
3
CLS 580
Project in Clinical Molecular Genetics
4 credits
CLS 599
Thesis in Clinical Molecular Genetics
4 credits
Total Credits: 32
Admission Requirements
Applicants are required to comply with the regular admission requirements of the Office of Graduate
Education and Research, which includes an undergraduate grade point average of 3.0. In addition,
students must have a Bachelor’s degree in Clinical Laboratory Science or Biology. Transcripts of
applicants will be evaluated on an individual basis.
In cases where the undergraduate GPA is below 3.0, additional factors, including 2 years of clinical
laboratory experience or performance in the last 60 hours of course work, may be weighted more
heavily in the assessment for admissions.
Applicants should have coursework in genetics, hematology, microbiology, immunology, molecular
biology, chemistry, and statistics. Laboratory experience is required. This requirement can be met by
documenting one year of clinical laboratory experience or 16 credits of courses accompanied by a lab.
Students may be admitted with deficient backgrounds if coursework is met in a defined period of time.
Applicants are required to comply with the regular admission requirements of the Office of Graduate
Education and Research. In addition:
1. Applicants must submit three letters of recommendation from instructors or professional
references. Letters should address the applicant’s academic and professional abilities and
preparation for graduate study.
2. A statement of intent must be included which describes the applicant’s laboratory skills and
experiences, and reasons for pursuing graduate education.
Graduation Requirements
Students must complete all courses listed and a Project or Thesis.
New Course Descriptions
All courses in the program are new. The description for each new course, course number, name, credit
hours, prerequisites, rationale, grading, outline, goals and student outcomes are provided on pages 7 –
26.
Projected Enrollment
We anticipate enrollment in year one would be 10 students with 20 students in year two. Enrollment in
each subsequent year is projected at 15 – 20 per year for a total enrollment of 30 – 40 per academic
year.
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Costs
Staff
All of the courses in the program are new and will be offered online. Compensation for online course
development for initial offering would be as additional assignments.
Provost Lang has approved an enhancement position for the CLS programs with a national search
currently underway. It is expected that the new faculty position will teach courses in the graduate
program according to background and experience. Current faculty, Dr. Mary Stunkard, Dr. Linda Riipi
and Assistant Professor Catherine Bammert, have qualifications to develop and teach courses in the
proposed graduate program. Current faculty with the addition of the enhancement position are
adequate for the initial offering of the graduate program.
Two courses for a total of six credits will be offered in the Summer semester. Costs associated with
summer staffing will be in accordance with the guidelines in the Agreement.
Equipment
Equipment that will be needed to accommodate ten students in year one of the program are detailed
below. This is in addition to the equipment currently available in the CLS Molecular Diagnostics
Laboratory (Appendix A).
Roche Light Cycler 2
$25000
LightCycler Centrifuge
$3,500
Inverted Microscope
$15,000
ELP “Mini-Sub” Chamber (10)
$3176
ELP “Wide-Sub” Chamber (10)
$4024
Nucleic Acid Workstation (2)
$8000
Micropipettes (set of 24 of 4 volumes) $11,050
Microtome
$10,000
Supplies
Yearly supplies for the on campus experience in the Molecular Diagnostics Laboratory are estimated to
be $4500. An additional $750 (per student) will be needed for consumables for students choosing the
on campus research and thesis track.
Library
Current library resources are adequate for this online program.
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Space
All courses will be online with the exception of CLS 526 which includes a one week experience in the
Molecular Diagnostic Laboratory on campus. Current laboratory space can accommodate up to ten
students.
Staffing Plan
The approved enhancement position for the CLS programs along with current faculty will be adequate to
staff the courses for the proposed program in Year 1. In Year 2 of the program, additional adjunct
faculty may be needed dependent on enrollment. The total additional credit hours of courses offered in
Year 2 is 13 credits per semester. The summer course offerings will require additional summer salary.
Equipment
Current equipment that is available for the proposed program is described in Appendix A. Additional
equipment needs are outlined above under ‘Costs’/’Equipment’.
Library Usage
Given that the courses in the proposed program are offered online, library usage will likely be through
online resources. In addition to online journals and books, the Library Distance Education Services
provide photocopying of print journal articles not available online. The Clinical Sciences library liaison,
Mike Strahan, has been consulted regarding the library resources needed.
Space
The online program requires space for the one week laboratory experience in the CLS Molecular
Laboratory which is adequate for ten students. This area may also be utilized by students choosing the
research track. Occasionally there may be a working professional who is unable to complete the
required scholarly project at their place of employment. We anticipate adequate space for these
activities.
Program Delivery
Fall Year 1
CLS 520 Principles
of Clinical
Molecular
Diagnostics – 3 cr
CLS 536 Clinical
Genetics – 3 cr
Winter Year 1
CLS 541 Clinical
Applications of
Genomic
Medicine – 3 cr
CLS 544 Molecular
Diagnosis of
Infectious Disease
– 3 cr
Summer Year 1
CLS 526 Clinical
Molecular
Diagnostic
Techniques – 4 cr
CLS 543 Molecular
Diagnostics in
Identity Testing –
2 cr
6
Fall Year 2
CLS 563 Research
Design and
Methods – 3 cr
CLS 570 Method
Verification and
Validation – 4 cr
Winter Year 2
CLS 560
Biomedical
Laboratory
Operations – 3 cr
CLS 580 Project in
Clinical Molecular
Genetics – 4 cr
OR
CLS 599 Thesis in
Clinical Molecular
Genetics – 4 cr
The program will be offered with online courses with the exception of the one week campus laboratory
experience in CLS 526. Students opting for the research track will conduct their research on campus
while working professionals will likely complete the scholarly project at their place of employment.
The table above provides the opportunity for program completion in two academic years with the
required summer semester enrollment. The program also allows for part-time enrollment.
Implementation Date
The goal is to offer the program beginning in Fall 2014.
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New Course Proposal
Bulletin Description
CLS 520 Principles of Clinical Molecular Diagnostics, 3 credits, online
Concepts and principles of current molecular technologies will be examined with applications to clinical
diagnostics.
Prerequisites: Admission to MS program in Clinical Molecular Genetics
Grading: Letter grade (A-F)
Rationale: Course is a foundation course for subsequent courses in the degree program. This is a
required course for both project and thesis tracks.
Course Outline:
Separation and Detection Techniques
Gel and Capillary Electrophoresis
Probe Hybridization
Nucleic Acid Purification
Probe Structure
Nucleic Acid Amplification
Polymerase Chain Reaction (PCR)
PCR Variations (real-time, nested, multiplex, arrays, reverse transcriptase)
Branched DNA Technology (bDNA)
Sequence Based (NASBA)
Transcription-Mediated Technology (TMA)
Strand Displacement Amplification (SDA)
Loop - Mediated Isothermal Amplification (LAMP)
DNA Sequence Analysis
Sanger Sequencing
Next Generation Sequencing
Automated Sequence Analyzer
Melt Curves Analysis
In-situ Hybridization
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Restriction Fragment Length Polymorphism
Multiplex Ligation-Dependent Probe Amplification (MLPA)
Quality Assurance and Control
Course Objectives:
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Compare and contrast major molecular technologies
Discuss the theory for each molecular technology
Apply the theories to the clinical assays used
Describe quality control for molecular-based assays
Diagnose clinical assay failures
Evaluation Methodologies: Evaluations include online assignments that will be submitted individually
or by group participation. Assignments may be given in a variety of formats such as short papers, case
studies, and laboratory problems. Exams will be administered online consistent with the course
objectives.
Staffing: Course can be taught by current faculty with Molecular Biology (MB) certification by the
American Society for Clinical Pathology (ASCP) or enhancement faculty position (approved).
Equipment and Supplies: Online course so no equipment and supplies needed.
Library Holdings: Current library resources are adequate.
Costs: Faculty course load.
Effects on Other Departments: No effects on other departments are anticipated.
Implementation Date: Fall 2014
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New Course Proposal
CLS 526 Clinical Molecular Diagnostic Techniques, 4 credits, online and one week (40 hours) campus
molecular laboratory
The techniques course will provide students with clinical molecular decision making strategies required
for diagnosis, prognosis and management of human disease.
Prerequisites: CLS 520
Grading: Letter grade (A-F)
Rationale: Under the direct supervision of experienced and certified molecular biology technologists,
students will learn to perform procedures using analytical methodology in a clinical molecular
laboratory. The course will link to the principles learned in CLS 520 to clinical molecular techniques. The
course will utilize online tutorials prior to the campus laboratory experience to maximize
learning. Course will be required in both project and thesis tracks.
Course Outline: The course will provide participants with hands-on laboratory experience in performing
molecular techniques such as DNA extraction, purification and quantification; preparing and viewing
PCR products; interpreting DNA fingerprints via gel and capillary electrophoresis. Students will also
perform advanced molecular methodologies such as cell culture techniques, melting curve analysis,
Southern blot analysis, and fluorescent in-situ hybridization.
Tutorial sessions will be completed prior to the campus laboratory experience to prepare students for
intense hands-on training. Online topics will include: RNA isolation, analysis of expression, PCR,
preparation of DNA, RNA and probes, cDNA synthesis (RT-PCR) and analysis, Southern, Western and
Northern Blots, microarrays and gene chips, and Real-Time-PCR.
Course Objectives: Upon completion of the course, students will be able to:
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Perform DNA and RNA extraction and purification methods on a variety of specimens, including
blood, tissue cultures, and formalin-fixed, paraffin-embedded tissue. Quantify products
mathematically and using the Nanodrop instrument.
Demonstrate proper storage and retrieval of tissue cultures and extracted nucleic acids.
Perform micro-dissection of formalin-fixed, paraffin-embedded tissue prior to performing DNA
extraction and discuss the rationale for doing so.
Utilize restriction enzymes to perform RFLP-PCR and analyze the DNA fingerprint following
agarose gel ELP.
Prepare and perform PCR reactions and explain ways to optimize the reaction.
Perform Real-Time PCR using FRET probes and capillary electrophoresis.
Perform melting curve analyses.
Perform FISH and interpret fluorescent imaging
Comply with the essential elements of a QA/QC program for the Molecular Lab and CAP/Joint
Commission standards required for accreditation.
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Evaluation Methodologies: Evaluations will include online assignments that may include short papers,
case studies and laboratory problems. Laboratory evaluations assess accuracy, efficiency, problemsolving, and organization.
Staffing: Course can be taught by current faculty with Molecular Biology certification or enhancement
faculty position (approved).
Equipment and Supplies: Equipment needed for the laboratory experience is outlined in the ‘Costs’
section of the proposal. Consumables for a laboratory of ten students would be approximately $4500 in
total.
Library Holdings: Current library resources are adequate.
Costs: Faculty course load and consumable costs as indicated above.
Effects on Other Departments: No effects on other departments are anticipated.
Implementation Date: Summer 2015
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New Course Proposal
Bulletin Description
CLS 536 Clinical Genetics, 3 credits, online
Principles of human molecular genetics will be studied. The emphasis of the course will be on the
molecular mechanisms operative in human disease.
Prerequisites: Admission to MS program in Clinical Molecular Genetics or Doctor of Nursing Practice
program.
Grading: Letter grade (A-F)
Rationale: The study of molecular genetics is important in the diagnosis, prognosis, and monitoring of
treatment in human disease. This course will explore the fundamental concepts that are critical in
understanding the genetic basis of inherited and acquired human disease. The course will be required for
both project and thesis tracks.
The CLS programs were asked by the Graduate Program Coordinator in the School of Nursing to develop
a course to meet the requirements of the American Association of Colleges of Nursing (AACN) to achieve
the curricular elements and competencies for the Doctor of Nursing Practice (DNP) degree program. The
course will be required for all students in the DNP program.
Course Outline:
Principles of Molecular Genetics
Clinical Cytogenetics
Genetic Diversity in Individuals and Populations
Genetic Disorders and Inheritance
Molecular Basis of Genetic Disease
Developmental Genetics
Treatment of Genetic Diseases
Pharmacogenomics
Genetic Counseling and Risk Assessment
Course Objectives:
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Develop knowledge in human genetics and genomics in order to integrate recent advances into
health care delivery. This includes developing a detailed understanding of strategies to identify
and evaluate treatment outcomes. (Essential I)*
Develop skills to critically evaluate existing literature in the field of clinical genetics with the aim
of translating research into practice for the improvement of health care practice. (Essential III)*
Develop a greater understanding of the ethical issues related to human genetic testing and
delivery of health care. (Essential V)*
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Analyze genetic data in order to provide clinical prevention and health promotion strategies at
the individual and population levels. (Essential VII)*
*Objectives meet AACN foundational competencies for the DNP degree.
Evaluation Methodologies: Evaluations include online assignments that will be submitted individually
or by group participation. Assignments may be given in a variety of formats such as short papers and
clinical case studies. Exams will be administered online consistent with the course objectives.
Staffing: Course can be taught by current faculty with Medical Laboratory Science (MLS) or MB ASCP
certification or enhancement faculty enhancement position (approved).
Equipment and Supplies: Online course so no equipment or supplies needed.
Library Holdings: Current library resources are adequate.
Costs: Faculty course load
Effects on Other Departments: The School of Nursing will incorporate this course in the Doctor of
Nursing Practice curriculum. No effects on other departments are anticipated when this course is
implemented.
Implementation Date: Fall 2014
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New Course Proposal
Bulletin Description
CLS 541 Clinical Applications of Genomic Medicine, 3 credits, online
Course will cover clinical applications of molecular techniques used in diagnostic testing. Diseasespecific applications include molecular oncology and inherited genetic disorders.
Prerequisites: CLS 520
Grading: Letter grade (A-F)
Rationale: Clinical molecular testing is used in the diagnosis, prognosis, treatments and monitoring
response to therapy. This course provides the link from principles and techniques of molecular
diagnostics to the application in human disorders. The course will be required in both the project and
thesis tracks.
Course Outline:
Oncology
Leukemias
Lymphomas
Solid tumors
Hereditary cancer syndromes
Inherited Genetic Disorders
Hemoglobinopathies
Coagulopathies
Trinucleotide repeat disorders
Single gene disorders
Epigenetic disorders
Pharmacogenomics
Herceptin
Warfarin
Plavix
Course Objectives:
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Identify diagnostic aspects of molecular medicine
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Describe the molecular basis and diagnosis of clinical disorders
Discuss pertinent and innovative aspects of molecular technologies related to clinical applications
Assess advanced methods employed for clinical molecular testing
Appraise future considerations and issues based on clinical needs
Evaluation Methodologies: Evaluations include online assignments that will be submitted individually
or by group participation. Assignments may be given in a variety of formats such as short papers, case
studies, and laboratory problems. Exams will be administered online consistent with the course
objectives.
Staffing: Course can be taught by faculty with MLS or MB ASCP certification or enhancement faculty
position (approved).
Equipment and Supplies: Online course so no equipment or supplies needed.
Library Holdings: Current library resources are adequate.
Costs: Faculty course load.
Effects on Other Departments: No effects on other departments anticipated.
Implementation Date: Winter 2015
15
New Course Proposal
Bulletin Description
CLS 543 Molecular Diagnostics in Identity Testing, 2 credits, online
Course will cover applications of molecular testing in genomic medicine related to genetic identification.
This will include paternity testing, identification of DNA in transplantation medicine, and analyzing crime
scene evidence.
Prerequisites: CLS 520
Grading: Letter grade (A-F)
Rationale: A significant portion of molecular genetic testing is related to identity testing. This course
covers those areas. Course will be required for both project and thesis tracks.
Course Outline:
Histocompatibility
Genetic identity
Parentage
Specimen identification
Forensic
Engraftment and Transplantation
Course Objectives:
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Discuss the significance of HLA
Defend molecular techniques in paternity testing
Analyze molecular techniques to identify specimens
Apply appropriate molecular diagnostic techniques in forensic medicine
Discuss the utility of molecular genetic testing in engraftment
Evaluation Methodologies: Evaluations include online assignments that will be submitted individually
or by group participation. Assignments may be given in a variety of formats such as short papers, case
studies, and laboratory problems. Exams will be administered online consistent with the course
objectives.
Staffing: Course can be taught by current faculty with MLS or MB ASCP certification or enhancement
faculty position (approved).
Equipment and Supplies: Online course so no equipment and supplies needed.
Library Holdings: Current library resources are adequate.
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Costs: Faculty work load.
Effects on Other Departments: No effects on other departments are anticipated.
Implementation Date: Summer 2015
17
New Course Proposal
Bulletin Description
CLS 544 Molecular Diagnosis of Infectious Disease, 3 credits, online
Course will cover molecular techniques utilized in the diagnosis and prognosis of infectious disease.
Prerequisites: CLS 520
Grading: Letter grade (A-F)
Rationale: Applications of molecular diagnostics in the detection of microbial pathogens are numerous
and growing. Molecular methods are used for pathogen detection, identification and quantitation.
Required course in both project and thesis tracks.
Course Outline:
Qualitative Analysis
Methicillin resistant S. aureus
Clostridium difficile
Respiratory pathogens
Urogenital Tract Pathogens
Viral pathogens
Fungi and Parasites
Quantitative Analysis
Viral load
Genotypic Characterization
Molecular epidemiology
Viral typing
Resistance testing
Pharmacogenomics
Carbemazepine
Course Objectives:
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Discuss molecular-based assays as related to infectious disease testing
Compare and contrast qualitative and quantitative molecular assays
Assess advanced methods utilized for clinical molecular microbiology testing
Evaluate new clinical molecular assays for infectious disease diagnosis
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Justify the utility of molecular testing for prognosis and monitoring treatment of infectious
disease
Evaluation Methodologies: Evaluations include online assignments that will be submitted individually
or by group participation. Assignments may be given in a variety of formats such as short papers, case
studies, and laboratory problems. Exams will be administered online consistent with the course
objectives.
Staffing: Course can be taught by current faculty with MLS or MB ASCP certification or enhancement
faculty position (approved).
Equipment and Supplies: Online course so no equipment and supplies needed.
Library Holdings: Current library resources are adequate.
Costs: Faculty course load.
Effects on Other Departments: No effects on other departments are anticipated.
Implementation Date: Winter 2015
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New Course Proposal
Bulletin Description
CLS 560 Biomedical Laboratory Operations, 3 credits, online
Overview of management principles and how they apply to the biomedical laboratory. Financial
management, personnel management, regulation and accreditation of the clinical laboratory will be
addressed.
Prerequisites: Admission to MS program in Clinical Molecular Genetics
Grading: Letter grade (A-F)
Rationale: Graduates of the MS program in Molecular Genetics will be eligible for positions that will
require the ability to manage personnel and budgets; ensure quality assurance; assess regulatory and
reimbursement issues; and comply with accreditation requirements. The course will cover issues critical
to the oversight of a biomedical laboratory. Course will be required in both project and research tracks.
Course Outline:
Financial Planning
Cost Containment
Reimbursement
Personnel Management and Leadership
Laboratory Benchmarking
Laboratory Informatics
Regulatory Requirements
Accreditation Requirements
Course Objectives:
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Justify budget allocations in relation to resources
Compare and contrast reimbursement models
Defend laboratory test utilization
Compare and contrast methods for effective communication
Apply principles of management to the evaluation of information systems
Discuss the reasons for undertaking benchmarking
Discuss the impact of regulatory requirements in the diagnostic laboratory
Comply with accreditation requirements
Evaluation Methodologies: Evaluations include online assignments that will be submitted individually
or by group participation. Assignments may be given in a variety of formats such as short papers and
laboratory problems. Exams will be administered online consistent with course objectives.
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Staffing: Course can be taught by current faculty with clinical management experience or enhancement
faculty position (approved).
Equipment and Supplies: Online course requires no supplies or equipment needed.
Library Holdings: Current library resources are adequate.
Costs: Faculty course load.
Effects on Other Departments: No effects on other departments are anticipated.
Implementation Date: Fall 2015
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New Course Proposal
Bulletin Description
CLS 563 Research Design and Methods, 3 credits, online
Overview of the research design and methods employed in clinical research. Students will learn to
critically evaluate published scientific literature and identify theoretical and ethical considerations in
research design.
Prerequisites: Admission to the MS program in Clinical Molecular Genetics, completion of a statistics
course.
Grading: Letter grade (A-F)
Rationale: Evidence-based health care ensures that clinical services are based on the best available
scientific reasoning. Graduates of the program will be analyzing literature and data with clinical
applications of molecular genetic testing. Course will be required in both project and research tracks.
Course Outline:
Research Design and Planning
Biostatistics in Molecular Diagnostics
Interpretation of Research Evidence
Qualitative Research in Health Sciences
Critical Evaluation of Published Research
Communication of Health Science Research
Ethical Considerations Influencing Research Design
Clinical Trials and Evidence-Based Medicine
Course Objectives:
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Compare quantitative and qualitative forms of research
Justify statistical methods for data analysis
Assess validity of professional literature
Evaluate research findings
Describe communication issues of research
Demonstrate how evidence produced through research is applied to solving problems in
health care
Evaluation Methodologies: Evaluations include online assignments that will be submitted individually
or by group participation. Assignments may be given in a variety of formats such as short papers or case
studies designed to assess the ability to critically examine professional literature.
Staffing: Course can be taught by current faculty with MLS or MB ASCP certification or enhancement
faculty position (approved).
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Equipment and Supplies: Online course with no equipment or supplies needed.
Library Holdings: Current library resources are adequate.
Costs: Faculty course load.
Effects on Other Departments: No effects on other departments are anticipated.
Implementation Date: Fall 2015
23
New Course Proposal
Bulletin Description
CLS 570 Method Verification and Validation in Molecular Diagnostics, 4 credits, online
The process of method verification and validation is an integral component in the implementation of
molecular-based clinical assays. Course will provide guidelines for the development and validation of
new types of molecular diagnostic assays.
Prerequisites: CLS 520 and CLS 526
Grading: Letter grade (A-F)
Rationale: Introduction of new clinical assays require that performance characteristics are verified, US
Food and Drug Administration (FDA) – approved or FDA – cleared test, or validated, if it is laboratory –
developed (“home brew”) assay. This course will examine the process of test verification and validation
for molecular diagnostic assays. Course will be required for both project and thesis tracks.
Course Outline:
Federal and State Regulations
In vitro Diagnostics (IVDs) and Laboratory Developed Tests (LDTs)
Performance Characteristics
Clinical Validity and Utility
CLSI Guidelines
Test Implementation
Quality Control and Assurance
Proficiency Testing
Course Objectives:
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Verify and validate high complexity clinical molecular diagnostic tests
Monitor all aspects of test performance
Develop standard operating procedures (SOPs)
Evaluate protocols governed by SOPs
Implement quality control and assurance processes
Direct troubleshooting and implement process improvements
Analyze molecular testing and data review
Evaluate current relevant scientific literature and technologies
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Evaluation Methodologies: Evaluation will be based on a written paper that describes the
implementation of a new molecular assay into the diagnostic laboratory. The paper must include the
required processes, diagnostic accuracy and clinical value, operating procedures, and quality assurance.
Staffing: Course can be taught by current faculty with MLS or MB ASCP certification or enhancement
faculty position (approved).
Equipment and Supplies: Online course so no equipment or supplies needed.
Library Holdings: Current library resources are adequate.
Costs: Faculty course load.
Effects on Other Departments: No effects on other departments are anticipated.
Implementation Date: Winter 2016
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New Course Proposal
Bulletin Description
CLS 580 Project in Molecular Genetics, 4 credits
Student will complete a method verification and validation study that will incorporate the knowledge
and analytical skills learned in the graduate program. The project culminates in a written manuscript
suitable for submission to a peer-reviewed journal. Selection of a validation study must be approved by
the faculty advisor who will supervise the project. Appropriate forms must be completed prior to
enrollment. The student should consult with the School of Clinical Sciences and the College of Graduate
Studies for specific requirements.
Prerequisite: CLS 570 and consent of the advisor.
Grading: S/U
Rationale: The graduate program is designed to provide the student with the appropriate knowledge
and skill set to select, validate and implement a new molecular-based clinical assay. The protocol
developed is intended to be used by a clinical healthcare agency. This type of project is appropriate for
the Clinical Molecular Genetics program because graduates working in clinical facilities will be expected
to establish the clinical utility and validity of new molecular-based tests. Course will be required for
those in the Project track.
Course Outline: NA
Course Objectives: NA
Staffing: Current faculty with MLS or MB certification or enhancement faculty position (approved).
Equipment and Supplies: Professionals that are currently employed will likely complete the project at
their institutions at no cost to the program. If the student is not able to utilize the resources at their
employment site the estimated consumable budget for the project is $750 per student.
Library Holdings: Current library resources are adequate.
Costs: Faculty course load.
Effects on Other Departments: No effects on other departments are anticipated.
Implementation Date: Winter 2016
26
New Course Proposal
Bulletin Description
CLS 599 Thesis in Clinical Molecular Genetics, 4 credits
Student will develop a thesis with the help of a thesis committee. Appropriate thesis forms must be
completed prior to enrollment. The thesis must be approved by the thesis committee and the College of
Graduate Studies. The student should consult the department and the College of Graduate Studies for
specific requirements.
Prerequisites: Consent of the thesis committee.
Grading: S/U
Rationale: Knowledge and skills gained in the graduate program will be applied to research in molecular
genetics. Course will be required for those in the Thesis track.
Course Outline: NA
Course Objectives: NA
Staffing: Current faculty with MLS or MB ASCP certification or enhancement faculty position
(approved).
Equipment and Supplies: Students completing research will utilize supplies and equipment in the
Clinical Molecular Diagnostics Laboratory. Professionals working in a clinical facility may arrange the use
of equipment and supplies at that facility. Consumable cost per student is estimated at $750 per
student.
Library Holdings: Current library resources are adequate.
Costs: Faculty supervision and supply cost as indicated above.
Effects on Other Departments: No effects on other departments are anticipated.
Implementation Date: Winter 2016
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APPENDIX A
CLS Molecular Diagnostics Lab Equipment List ( v083011)
Air Cadet vacuum
BioRad Molecular Imager * Gel Dock XR (gel documentation system; image capture, cutting gel)
BioRad 16K Microcentrifuge
BioRad MJ Mini Personal Thermal Cycler
BioRad Smart Spec Plus Spectrophotometer
BioRad Ultra Rocker
BioRad 6l water bath
Electrophoresis Equipment:
BioRad Mini-Protean Tetra Cell 4-gel Vertical Electrophoresis System (quantity of 3);
including BiroRad Power Pac (quantity of 3)
BioRad Sub-cell-GT Agarose Gel Electorphoresis System
Gibco BRL Sequencing Gel Electrophoresis System, Model S2 (quantity of 4); including
BioRad 583 Gel Dryer (quantity of 4) and BIoRad Vacuum Pumps (quantity of 2)
Eppendorf Research Pippettes (10ul, 100ul, 300ul, 1000ul and 10ml)
Fisher Accumet pH Meter
2 sets of Eppendorfer Research plus pipettes (10, 20, 200 and 1000 ul)
Fisher Low speed minicentrifuge with strip rotors
2 @ Fisher Vortex mixers with 48 hole microtube rack
Grossing Microscope
Haier Mini-refrigerator
Metler Analytical Balance
Metler Precision Balance
Nanodrop 2000c spectrophotometer
Precision Scientific Water Bath (dual wells)
Sunrise Tecan Absorbance (and turbidimetry ) 96-well microplate reader & Megellan Software
Package
Sysbron / Thermolyne Nova II Stirrer
2 @ USA Scientific 24” Nucleic Acid Workstations
2 @ VWR Digital Heat Blocks with Block holders
VWR mini incubating Shaker
Thelco Double Water Bath
Dell Desktop for Biorad Gel Imaging Station
AO Microscope
Sharp Carousel microwave
VWR Clinic Centrifuge 120V
VWR Block 2.0ML tube
VWR Tip 100 ul lowbind ST
VWR Tip 1000 ul lowbind ST
Fisher Clean Room Tacky Mat
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