After a law is enacted by the federal government, a regulatory agency is responsible for creating and enforcing regulations outlined in that law.
Laboratories and healthcare facilities are governed by regulations based on the relevant laws passed by Congress, which are enforced by the responsible agencies of the federal government. Many states have their own laws and regulations governing laboratories, but discussion of state laws and regulations is beyond the scope of this introductory course.
The most important federal laws affecting the clinical laboratory are as follows:
- Occupational Safety and Health (OSH) Act, passed in 1970 and enforced by:
- Occupational Safety and Health Administration (OSHA)
- Clinical Laboratory Improvement Amendments (CLIA), passed in 1988 and enforced by:
- Centers for Medicare and Medicaid Services (CMS)
- Food and Drug Administration (FDA)
- Centers for Disease Control and Prevention (CDC)
- Health Insurance Portability and Accountability Act (HIPAA), passed in 1996 and enforced by:
- Department of Health and Human Services, the Office of Civil Rights
For more information on how a bill becomes a law, please refer to the attached resource.
