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Federal Regulations for Risk Management

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.