Title: Describe state/local/industry/professional regulations.
Course: Biomedical Technician (14900) > Section: Exploring Foundations in Biomedical Technology

Description should include

- the definition of regulations
- the importance of regulations
- the roles of regulatory government agencies that influence the biomedical field, such as
  - U.S. Department of Transportation (DOT)
  - U.S. Department of Health and Human Services (HHS)
  - Occupational Safety and Health Administration (OSHA)
  - U.S. Department of Agriculture (USDA)
  - U.S. Food and Drug Administration (FDA)
  - U.S. Environmental Protection Agency (EPA)
  - Virginia Department of Health (VDH)
  - College of American Pathologists
  - Center for Disease Control and Prevention (CDC)
  - institutional review committees (i.e., Institutional Biosafety Committee [IBC], Institutional Review Boards [IRB] for Human Subjects Research, Institutional Animal Care and Use Committee ([IACUC])
  - peer-nonpeer reviews   (i.e., governmental and nongovernmental)
- the purpose of Clinical Laboratory Improvement Amendments (CLIA)
- major regulated areas (e.g., packaging, handling, shipping, and disposal of biological materials)
- the purpose of each regulatory organization.

Process/Skill Questions:

- Why do government regulations exist?
- What resources are available for locating information on government agencies and their respective regulations?
- Why are government regulations in place for the packaging, handling, and shipping of biological materials? What other government regulations may pertain to biomedical labs?