Federal Regulations Laboratory Operations Review 5
STANDARD SUMMARY
Hazard Communication Standard (OSHA 1983)
“Right-to-Know Law”
Clinical Laboratory Improvement Amendments of 1988
“CLIA ‘88”
Occupational Exposure to Hazardous Chemicals in Laboratories
(OSHA 1990)
“Laboratory Standard”
Bloodborne Pathogens Standard (OSHA 1991)
Formaldehyde Standard (OSHA 1992)
Health Insurance Portability and Accountability Act of 1996
“HIPAA”
Requires employers to inform employees about hazardous sub-
stances in workplace & educate them in safe handling.Regulates all lab testing (except research) performed on humans in
U.S. Requirements for personnel & quality assurance determined by
test complexity. Administered by CMS.Requires chemical hygiene plan to minimize personnel exposure to
hazardous chemicals in labs.Mandates work practices & procedures to minimize worker exposure
to bloodborne pathogens.Requires monitoring of formaldehyde exposure.Regulates use & disclosure of protected health information (PHI).