A description includes the following:
- The meaning of the term regulations
- The importance of regulations
- The roles of regulatory government agencies that impact 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), Center for Disease Control and Prevention (CDC), and others.
- The purpose of Clinical Laboratory Improvement Amendments (CLIA)
- Major regulated areas, such as packaging, handling, and shipping 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 regulating the packaging, handling, and shipping of biological materials? What other government regulations may pertain to biomedical laboratories?