Several federal agencies share responsibilities for oversight of the healthcare industry in the United States:
- U.S. Department of Health and Human Services, including
- Centers for Medicare and Medicaid Services- Responsible for regulating clinical laboratory testing through the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
- Food and Drug Administration (FDA)- Responsible for protecting public health through regulation of food, drugs, vaccines, blood and blood products, medical devices, and more
- U.S. Department of Labor, including
- Occupational Safety and Health Administration (OSHA)- Ensures safe working conditions in healthcare as well as other industries
Some of the federal laws/regulations that affect clinical laboratories in the United States and relate either directly or indirectly to risk management include
- Clinical Laboratory Improvement Amendments of 1988 (CLIA).
- Health Insurance Portability and Accountability Act of 1996 (HIPAA).
- OSHA standards for hazard communication, chemical hygiene, and blood-borne pathogens.
- Safe Medical Devices Act of 1990 (SMDA).
- The Patient Safety and Quality Improvement Act of 2005.
