Federal Regulatory Agencies Laboratory Operations Review 4
AGENCY AUTHORITY
Centers for Medicare & Medicaid Services (CMS)
Department of Health & Human Services (HHS)
Department of Transportation (DOT)
Environmental Protection Agency (EPA)
Food & Drug Administration (FDA)
Nuclear Regulatory Commission (NRC)
Occupational Safety & Health Administration (OSHA)
Substance Abuse and Mental Health Services Administration
(SAMHSA)
Writes regulations for & enforces Clinical Laboratory Improvement
Amendments of 1988 (CLIA ‘88).
Interprets & implements federal regulations related to health care.
Oversees CDC, CMS, FDA, SAMSHA.
Regulates packaging, labeling, & transportation of biological products.
Regulates disposal of toxic chemical & biohazardous wastes.
Regulates market entry of instruments/reagents & production of
donor blood & components. Licenses blood banks.
Licenses labs that use radionucleotides.
Regulates employee safety in the workplace.
Certifies laboratories to conduct forensic drug testing for federal
agencies.
