Description should include
- the definition of regulations
- the importance of regulations
- the roles of regulatory government agencies that influence the biomedical field, such as
- 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?