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The page below is a sample from the LabCE course Risk Management in the Clinical Laboratory. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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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.