A physician office plans to start doing fingerstick hemoglobin A1c testing on site. Which federal program sets the quality standards and certification requirements that apply to this testing?
Show answer & explanation
Answer: A
The Clinical Laboratory Improvement Amendments (CLIA): Correct. CLIA, administered by CMS, regulates all US laboratory testing on human specimens, including waived tests, which require a CLIA Certificate of Waiver.
The Occupational Safety and Health Administration (OSHA): OSHA protects worker safety (for example, bloodborne pathogens) but does not certify laboratory testing quality.
The Clinical and Laboratory Standards Institute (CLSI): CLSI publishes voluntary consensus standards, such as order of draw, but it is not a federal regulatory program.
The Health Insurance Portability and Accountability Act (HIPAA): HIPAA governs privacy and security of health information, not test quality.
CLIA (run by CMS) = lab testing quality and certification; OSHA = worker safety; HIPAA = privacy; CLSI = voluntary technical standards.