HE0780 Biotechnology Research and Development

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CLUSTER
Health Science Education
CONCENTRATION
Biotechnology Research and Development
WEVIS CODE
HE0780
National Consortium for Health Science Education Health Care Standards and Accountability Criteria
http://www.healthscienceconsortium.org/docs/biotech_pathway.pdf
Sample of reported job titles upon completion of the Biotechnology Research and Development cluster:
Certified Phlebotomy Technician, Laboratory Aide
Sample of reported job titles upon completion of additional education: Biochemist, Bioinformatics
Scientist, Biomedical Chemist, Biomedical Manufacturing Technician, Biostatistician, Cancer Registrar, Cell
Biologist, Clinical Data Management Specialist, Clinical Pharmacologist, Crime Scene Investigator, Diagnostic
Molecular Scientist, Forensic Biologist, Forensic Chemist, Forensic Odontologist, Forensic Pathologist, Genetic
Counselor, Geneticist-Lab Assistant, Lab Technician, Medical Editor/Writer, Microbiologist, Molecular
Biologist, Nurse Researcher, Packaging Technician, Patent Lawyer, Pharmaceutical Sales Representative,
Pharmacologist, Processing Technician, Quality Assurance Technician, Quality Control Technician, Regulatory
Affairs Specialist, Research Assistant, Research Scientist, Toxicologist
INDUSTRY CREDENTIALS
Certified Phlebotomy Technician, CPR/AED Healthcare Provider or Professional Rescuer, First Aid,
Bloodborne Pathogens Training: Preventing Disease Transmission
REQUIRED COURSES (Required Sequence)
Note: A minimum course completion score of 80% is required to progress to next course.
WVEIS Code
0711
0715
0707
0708
Course
Foundations of Health Science
Advanced Principles of Health Science
Biomedical Applications
Biomedical Innovation
ELECTIVE COURSES
0716
0721
0725
0730
0739
1060
Body Structures and Functions
Medical Terminology
Understanding Human Behavior
Health Science Clinical Experience
Nutrition and Wellness
Essentials of Addiction and Prevention
SKILL SETS
Career Preparation Skills
Safety Practices
Leadership Development
Patient/Client Customer Service
Literacy and Numeracy
Academic Foundation
Communications
Systems
1
Legal Responsibilities
Ethics
Health Maintenance Practices
Technical Skills
Teamwork
Information Technology Applications
Contributions of Biotechnology to Health and the Human Condition
Introduction to Biotechnology Knowledge Areas and Techniques
Laboratory Protocols and Procedures
Product Design and Development
Bioethics/Biomedical Research and Development
Follow Regulatory Guidelines
Quality Assurance and Safety Practices
Demonstrate Problem Solving and Decision Making Skills
Utilize and Maintain Equipment and Supplies Specific to Bio-medical Labs
Phlebotomy Certification/Clinical Experience
2
Career Preparation, Safety, Leadership Development, Customer Service and Literacy and Numeracy skill sets should be
integrated throughout the concentration as remaining skill sets are delivered.
Skill Set
Knowledge Objectives
HE.1
Career Preparation Skills
Students will demonstrate knowledge of
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career paths.
goal development and achievement.
attitudes and work habits that support career retention and advancement.
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personal qualities and abilities needed to be effective as a healthcare provider.
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Performance Objectives
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Skill Set
Knowledge Objectives
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Performance Objectives
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Skill Set
Knowledge Objectives
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Performance Objectives
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communication in varied contexts.
Students will
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relate skills and abilities to possible career pathways.
explain methods of goal development.
discuss methods of time management and task coordination.
practice professionalism in punctuality, appropriate dress, task completion, etc.
investigate methods of supervision such as giving and receiving feedback and
instruction.
 develop and present a statement of their personal work ethic beliefs.
 prepare an application, cover letter, resume and thank you letter.
 create a personal portfolio for use when applying for employment.
 practice simulated job interviews.
Safety Practices
Students will demonstrate knowledge of
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infection control.
controlling the growth and spread of microorganisms.
Students will
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explain principles of infection control.
perform hand washing according to Centers for Disease Control regulations.
don and remove non-sterile gloves.
Leadership Development
Students will demonstrate knowledge of
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public speaking.
parliamentary law.
leadership concepts.
characteristics of effective teams and organizations.
Students will
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develop and deliver speeches.
participate in meetings using parliamentary procedure.
attend leadership conferences and training (local, state and/or national).
volunteer in community service opportunities.
participate in career development events.
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Skill Set
Knowledge Objectives
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Performance Objectives
Patient/Client Customer Service
Students will demonstrate knowledge of
 customer service.
 patient/client satisfaction.
 patient/client needs assessment.
 quality for services.
Students will
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Skill Set
Knowledge objectives
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Performance Objectives
demonstrate respectful and empathetic treatment of all patients/clients.
hear and work to resolve complaints from patients/clients or the public.
check completed work for spelling, punctuation and format.
greet visitors or callers and handle their inquiries or direct them to the
appropriate persons according to their needs.
answer inquiries pertaining to patient care policies and services and work to
resolve patient/client complaints.
measure and assess patient/client and employee satisfaction.
confer with patients/clients by telephone or in person to provide information
about health care or services, take orders from superiors, obtain details of
complaints and forward to instructor/supervisor.
keep records of patient/client interactions, recording details of inquiries,
complaints or comments, as well as actions taken per health care institution
guidelines.
check to ensure that appropriate changes were made to resolve patient/client
problems.
describe points of patient safety and respond to questions.
investigate and work to resolve complaints regarding food quality, service or
patient care within your scope of practice.
identify the characteristics of each health care industry’s target market.
Literacy and Numeracy
Students will demonstrate knowledge of
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literacy and numeracy skills required to solve complex.
real-world problems associated with their career/technical content area.
improve their thinking and reasoning skills.
Students will
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utilize a variety of technical sources (e.g., Internet, manuals, journals,
directions, reports, etc.) to complete career/technical assignments and projects.
demonstrate writing skills required to complete career/technical assignments
and projects.
demonstrate accuracy in calculating and measuring graphical work required to
complete career/technical assignments and projects.
analyze tables, charts, graphs and multiple data sources to complete
career/technical assignments and projects.
4
Foundations of Health Science
WVEIS 0711
* Foundations of Health Science (0711) is a prerequisite for Advanced Principles of Health Science (0715).
These two courses provide the introductory core for all Health Science Concentrations.
*Admission to Advanced Principles of Health Science requires a minimum course completion score of 80% in
Foundations of Health Science.
Skill Set
Knowledge Objectives
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Performance Objectives
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Skill Set
Knowledge Objectives
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Performance Objectives
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Skill Set
Knowledge Objectives
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Performance Objectives
Academic Foundation
Students will demonstrate knowledge of
 human growth and development.
 nutrition.
Students will
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explain the four main areas of growth and development in each of the
seven life stages.
 examine Maslow’s Hierarchy of Needs theory.
 discuss key issues surrounding end-of-life care.
 create scenarios to analyze the five stages of grief.
 identify the six essential nutrients.
 examine the basic food groups.
 compare therapeutic diets.
Communications
Students will demonstrate knowledge of
 medical terminology.
 concepts of effective communication skills.
 written communication skills.
Students will
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use roots, prefixes and suffixes to communicate information.
interpret verbal and nonverbal communication.
recognize barriers to communication.
recognize the elements of communication using a sender-receiver model.
apply speaking and active listening skills.
recognize elements of written and electronic communication (spelling,
grammar and formatting).
Systems
Students will demonstrate knowledge of
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health care delivery systems.
Students will
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discuss the health care delivery system (public, private, government and nonprofit).
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describe the responsibilities of consumers within the health care system.
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Skill Set
Knowledge Objectives
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Performance Objectives
Teamwork
Students will demonstrate knowledge of
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health care teams.
team member participation.
Students will
 recognize characteristics of effective teams.
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 recognize methods for building positive team relationships.
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 analyze attributes and attitudes of an effective leader.
Skill Set
Health Maintenance Practices
Knowledge Objectives Students will demonstrate knowledge of
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 healthy behaviors.
Performance Objectives Students will
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apply behaviors that promote health and wellness.
describe strategies for the prevention of diseases including health screenings
and examinations.
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 discuss complementary (alternative) health practices as they relate to wellness
and disease prevention.
Skill Set
Technical Skills
Knowledge Objectives Students will demonstrate knowledge of
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 medical emergency response procedures.
Performance Objectives Students will
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apply skills to obtain training and/or certification in Health Care Provider or
Professional Rescuer CPR, AED and FBAO.
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apply skills to obtain training and/or certification in First Aid.
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Skill Set
Information Technology Applications
Knowledge Objectives Students will demonstrate knowledge of
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 information technology.
Performance Objectives Students will
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communicate using technology to access and distribute data and other
information.
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Advanced Principles of Health Science
WVEIS 0715
* Foundations of Health Science (0711) is a prerequisite for Advanced Principles of Health Science (0715).
These two courses provide the introductory core for all Health Science Concentrations.
*Admission to Advanced Principles of Health Science requires a minimum course completion score of 80% in
Foundations of Health Science.
Skill Set
Knowledge Objectives
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Performance Objectives
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Skill Set
Knowledge Objectives
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Performance Objectives
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Skill Set
Knowledge Objectives
Academic Foundation
Students will demonstrate knowledge of
 human structure and function.
 diseases and disorders.
 medical mathematics.
Students will
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classify the basic structural and functional organization of the human body
(tissue, organ and system).
 recognize body planes, directional terms, quadrants and cavities.
 analyze the basic structure and function of the human body.
 describe common diseases and disorders of each body system (prevention,
pathology, diagnosis and treatment).
 recognize emerging diseases and disorders.
 investigate biomedical therapies as they relate to the prevention, pathology
and treatment of disease.
 apply mathematical computations related to healthcare procedures (metric and
household, conversions and measurements).
 analyze diagrams, charts, graphs and tables to interpret healthcare results.
 record time using the 24-hour clock.
Communications
Students will demonstrate knowledge of
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concepts of effective communication.
medical terminology.
Students will
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report subjective and objective information.
use roots, prefixes and suffixes to communicate information.
use medical abbreviations to communicate information.
Systems
Students will demonstrate knowledge of
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 health care delivery systems.
Performance Objectives Students will
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explain factors influencing the health care delivery system.
explain the impact of emerging issues such as technology, epidemiology,
bioethics and socioeconomics on healthcare delivery systems.
discuss common methods of payment for healthcare.
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Skill Set
Knowledge Objectives
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Performance Objectives
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Skill Set
Knowledge Objectives
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Performance Objectives
Legal Responsibilities
Students will demonstrate knowledge of
 legal implications.
 legal practices.
Students will
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analyze legal responsibilities.
apply procedures for accurate documentation and record keeping.
apply for Health Insurance Portability and Accountability Act (HIPAA).
describe advance directives.
summarize the Patient’s Bill of Rights.
discuss informed consent.
explain laws governing harassment, labor and scope of practice.
Ethics
Students will demonstrate knowledge of
 ethical boundaries.
 ethical practice.
 cultural, social and ethnic diversity.
Students will
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differentiate between ethical and legal issues impacting healthcare.
recognize ethical issues and their implications related to healthcare.
apply procedures for reporting activities and behaviors that affect the health,
safety and welfare of others.
 understand religious and cultural values as they impact healthcare.
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 demonstrate respectful and empathetic treatment of ALL patients/clients
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(customer service).
Skill Set
Safety Practices
Knowledge Objectives Students will demonstrate knowledge of
infection control.
personal safety.
environmental safety.
common safety hazards.
emergency procedures and protocols.
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Performance Objectives
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Skill Set
Knowledge Objectives
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Performance Objectives
Students will
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explain principles of infection control.
describe methods of controlling the spread and growth of microorganisms.
apply personal safety procedures based on Occupational Safety and Health
Administration (OSHA) and Centers for Disease Control (CDC) regulations.
 apply skills to obtain training and/or certification in Bloodborne Pathogens –
Preventing Disease Transmission (American Red Cross).
 demonstrate principles of body mechanics.
 demonstrate safety techniques in the laboratory setting.
 comply with safety signs, symbols and labels.
 recognize types of hazardous materials.
 explain fire safety in a healthcare setting.
 apply principles of basic emergency response in natural disasters and other
emergencies.
Teamwork
Students will demonstrate knowledge of
 health care teams.
 team member participation.
Students will
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 understand roles and responsibilities of team members.
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 apply effective techniques for managing team conflict.
Skill Set
Technical Skills
Knowledge Objectives Students will demonstrate knowledge of
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 vital signs.
Performance Objectives Students will
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Skill Set
Knowledge Objectives
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apply procedures for measuring and recording vital signs including
normal ranges.
Information Technology Applications
Students will demonstrate knowledge of
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 information technology.
Performance Objectives Students will
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utilize current computer hardware and software.
identify records, files and technology applications common to healthcare.
enter data into computer files using reference tools to ensure accuracy.
maintain security and confidentiality of electronic patient information adhering
to workplace policies.
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Biomedical Applications
WVEIS HE0707
* Foundations of Health Science (0711) and Advanced Principles of Health Science (0715) provide the
introductory core for all Health Science Concentrations and require a minimum course completion score of
80% in order to advance to Biomedical Applications (0707).
Skill Set
Knowledge Objectives
0707.1
Contributions of Biotechnology to Health and the Human Condition
Students will demonstrate knowledge of
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Performance Objectives
Students will
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Skill Set
Knowledge Objectives
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molecular biology of disease and health.
biotechnology products.
quality of life related to finding cures for genetic, environmental and
behavioral diseases, chronic conditions and industrial enzymes.
new diagnostic tools.
legal and ethical issues with emphasis on social and diversity issues.
propose an industrial enzyme that could contribute to the quality of life.
generate a list of environmental diseases or chronic conditions that have been
or could be treated with biotechnology products.
assess a current biotechnology-related ethical issue and how it may affect
quality of life.
Academic Foundations/Biomedical Research and Development
Students will demonstrate knowledge of
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fundamentals of:
o mathematical concepts.
o statistics.
o genetics.
o organic chemistry.
o biochemistry.
o cell biology.
o molecular biology.
o microbiology.
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Performance Objectives
Students will
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Skill Set
Knowledge Objectives
0707.30
illustrate the concepts of percentages and ratios using a biotechnology
application.
contract weight-to-weight and weight-to-volume calculations for solutions.
explain scientific notation.
compare the deviation and the mean of efficacy testing data of two
biotechnology products.
graphically illustrate a set of biotech data in an format/illustration that a
layman would understand.
describe the basic structure of a chromosome.
construct a karyotype with human chromosomes.
differentiate the genetic inheritance of a lethal dominant homozygous trait (e.g.
dwarfism) from a heterozygous disease (e.g., sickle cell anemia).
construct a molecule of a compound with three or more carbon atoms.
create an equation of two organic substrates leading to a product.
describe atomic number, atomic mass and orbitals.
contrast covalent, ionic and hydrogen bonding.
diagram six chemical side groups that could be in a biotechnology product.
categorize all amino acids into essential and non-essential.
describe the relationship between biochemistry and biotechnology product
development.
compare the underlying reasons why some molecules are hydrophilic and
some are hydrophobic.
describe the basic structures and functions of cells and how this knowledge is
used in biotechnology.
select cellular barriers to be overcome for a biotechnology product to work
inside a cell.
diagram the structure of the nucleic acid DNA.
demonstrate DNA replication graphically and its importance to biotechnology
product development.
describe the central dogma of molecular biology and how understanding this
process impacts biotechnology research and development.
analyze how microorganisms are used in mass producing recombinant
proteins.
compare and contrast bacterial, fungal and animal cells and how their
similarities and differences affect biotechnology product development and
production decisions.
compare and contrast the use of plasmids in bacterial transformation and the
process of plasmid DNA isolation.
Introduction to Biotechnology Knowledge Areas and Techniques
Students will demonstrate knowledge of
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recombinant DNA and genetic engineering, bioprocessing (producing
recombinant DNA products on a large scale for profit), monoclonal antibody
production, separation and purification of biotechnology products,
nanotechnology, bioinformatics, genomics, proteomics and transcriptomics.
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Performance Objectives
Students will
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Skill Set
Knowledge Objectives
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Performance Objectives
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describe the following techniques:
o recombinant DNA.
o genetic engineering.
o monoclonal antibody production.
o separation and purification of biotechnology products and
bioprocessing.
predict how nanotechnology, bioinformatics, proteomics, genomics and
transcriptomics will create new career opportunities.
Laboratory Protocols and Procedures
Students will demonstrate knowledge of
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principles of solution preparation such as molarity, pH, and dilution.
sterile techniques such as inoculum development and transfer.
contamination control.
measurement and calibration of instruments such as micropipettes and pH
meters.
 maintaining a sanitary, safe and hazard free laboratory environment.
 teamwork, oral and written communication skills, problem solving, emergency
lab response and biosafety protocols.
Students will
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describe how molarity relates to solution preparation.
calculate the molarity of a given solution and measure the pH of this solution.
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prepare a serial dilution of a microbial culture starting with 10 going to 10
and plate onto nutrient agar petri dishes.
 determine the original concentration of the microbial culture.
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 distinguish the requirements of sterile techniques.
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 respond to a hypothetical laboratory accident appropriately as a member of a
laboratory team.
Skill Set
Product Design and Development
Knowledge Objectives Students will demonstrate knowledge of

how the product is designed.
what is involved in the development of the product..
subsequent production, including the laboratory procedures and regulatory
requirements.
how their scope of work contributes to the resulting Research & Development
at the lab bench level including pre-clinical trials, clinical trials (3 phases),
product license application, regulatory process for clinical trials (current Good
Manufacturing Practices [cGMPs] and Good Laboratory Practices [GLPs]) for
production (cGMPs, GLPs).
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Performance Objectives
Students will
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Skill Set
Knowledge Objectives
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Performance Objectives
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Skill Set
Knowledge Objectives
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Performance Objectives
diagram the process involved in making one biotech product in an industrial
setting.
analyze the role of pre-clinical and clinical trials in biotechnology product
development.
examine the role of a Quality Assurance person in this process.
define cGMP and explain why it is important in biotech production.
Bioethics/ Biomedical Research and Development
Students will demonstrate knowledge of
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the interdependence of science, technology and society.
ethical, moral and legal issues related to biotech research, and product
development/use in society.
Students will
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differentiate between morality and ethics and the relationship of each to
biotechnology health care product development.
 discuss bioethical issues related to recombinant products.
 contrast personal, professional and organizational ethics.
 comply with policies and requirements for documentation and record keeping.
 comply with institutional ethical policies and procedures.
Safety Practices/Biomedical Research and Development
Students will demonstrate knowledge of
 infection control.
 personal safety.
 environmental safety.
 common safety hazards.
 emergency procedures and protocols.
Students will
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explain principles of infection control.
describe methods of controlling the spread and growth of microorganisms.
apply personal safety procedures based on Occupational Safety and Health
Administration (OSHA) and Centers for Disease Control (CDC) regulations.
apply skills to obtain training and/or certification in Bloodborne Pathogen –
Preventing Disease Transmission (American Red Cross).
apply principles of body mechanics.
apply safety techniques in the work environment.
comply with safety signs, symbols and labels.
understand implications of hazardous materials.
practice fire safety in a healthcare setting.
apply principles of basic emergency response in natural disasters and other
emergencies.
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Biomedical Innovations
WVEIS HE0708
* Foundations of Health Science (0711) and Advanced Principles of Health Science (0715) provide the
introductory core for all Health Science Concentrations and require a minimum course completion score
of 80%.
*Biomedical Applications (0707) is a prerequisite for Biomedical Innovations (0708) and requires a minimum
course completion score of 80%.
Skill Set
Follow Regulatory Guidelines
Knowledge Objectives Students will demonstrate knowledge of
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Performance Objectives
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basic concepts and techniques necessary to work effectively in a biotechnology
laboratory.
Students will
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discuss the nature of science, lab work and the role of the biological technician.
discuss basic microbiology with emphasis on the role of bacteria, viruses
and fungi in human health and disease.
discuss FD&C Act.
discuss and follow OSHA guidelines.
discuss and follow other national guidelines including, but not limited to: NIH,
DOT, EPA, FDA and CDC.
discuss and follow state and local regulations.
Skill Set
Knowledge Objectives
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Performance Objectives
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Quality Assurance and Safety Practices
Students will demonstrate knowledge of
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appropriate safety procedure.
hazardous materials.
MSDS.
safety symbols and signs.
safety equipment.
Precautions.
aseptic techniques.
quality control.
Students will
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identify first aid supplies, personnel and emergency protection areas.
use appropriate safety procedures and guidelines.
monitor, use, store and dispose of hazardous materials properly.
follow Material Safety Data Sheets (MSDS).
identify safety symbols and signs.
demonstrate an ability to utilize safety equipment.
follow Precautions.
maintain a clean work area.
practice aseptic techniques as required.
discuss quality control in relation to inspection procedures, testing methods and
internal audits.
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Skill Set
Knowledge Objectives
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Performance Objectives
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Skill Set
Knowledge Objectives
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Performance Objectives
Demonstrate Problem Solving and Decision Making Skills
Students will demonstrate knowledge of
 problem solving techniques.
 decision making techniques.
 algebraic equations.
 computation of angles and lengths.
 conversion between measurement systems.
 interpreting tables and graphs.
Students will
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apply problem solving techniques in the workplace utilizing the scientific
method.
 apply decision making techniques in the workplace utilizing the scientific
method.
 solve basic shop problems using elementary math.
 solve single/variable algebraic equations.
 calculate geometric parameters such as area, circumference, perimeter and
volume.
 compute angles and lengths using basic trigonometry.
 convert between measurement systems including metric.
 convert decimals and fractions.
 express ratios as percentages.
 interpret tables and graphs.
Utilize and Maintain Equipment and Supplies Specific to Bio-medical Labs
Students will demonstrate knowledge of
 utilization and maintenance of equipment.
 utilization and maintenance of supplies specific to bio-medical laboratories.
 safety measures.
Students will
0708.31
0708.32


0708.33
0708.34
0708.35
0708.36




practice aseptic technique.
recognize and describe the use of laboratory equipment including, but not limited
to the following: thermocycler, microscope, fluorometer, hoods, centrifuge,
polarimeter, pH meter, chart recorder, stirs, balance, mixers, conductivity
meters, autoclaves, shakers, power supplies, dry heat, ovens, incubators, Bunsen
burners and Geiger counters.
check and maintain equipment and logs.
clean, organize and sterilize materials.
order and maintain inventory of supplies.
handle and store biological and hazardous materials.
15
Skill Set
Knowledge Objectives
0708.37
Performance Objectives
0708.38
0708.39
0708.40
0708.41
0708.42
0708.43
0708.44
0708.45
0708.46
0708.47
0708.48
Skill Set
Knowledge Objectives
0708.49
Performance Objectives
0708.50
0708.51
Technical Skills/Biomedical Research and Development
Students will demonstrate knowledge of










solutions and reagents.
physical properties of reagent, buffers and media solutions.
laboratory tests.
basic microbiology skills.
basic immunological skills.
genetic skills.
chemical assays.
sterilization of supplies and equipment.
packaging of sterile products.
bio-compatibility tests.
Students will











prepare solutions and reagents for laboratory use.
monitor physical properties of reagents, buffers, media and solutions.
set up laboratory tests.
describe and/or perform basic microbiology skills.
describe and/or perform basic cell biology skills.
describe and/or perform basic immunological skills.
describe and/or perform basic genetic skills.
describe and/or perform chemical assays.
sterilize supplies and equipment.
package sterile products.
demonstrate an understanding of bio-compatibility tests.
Teamwork/ Biomedical Research and Development
Students will demonstrate knowledge of
 health care teams.
 team member participation.
Students will


understand roles and responsibilities of team members.
apply effective techniques for managing team conflict.
Skill Set
Knowledge Objectives
0708.52
Performance Objectives
0708.53
Phlebotomy Certification/Clinical Experience
Students will demonstrate knowledge of

phlebotomy technician training requirements. (WVEIS 0825)
Students will

complete requirements for phlebotomy technician certification. (WVEIS 0825)
16
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