Which document governs the validity and quality requirements for laboratory testing in many U.S. labs?

• A. The Clinical Laboratory Improvement Amendments (CLIA) and applicable state regulations.
• B. HIPAA
• C. OSHA
• D. FDA

Answer: (A)

Quality and validity of laboratory test results in many U.S. labs are governed by CLIA, which establishes federal standards for clinical testing. CLIA requires properly trained personnel, validated testing methods, ongoing quality control and quality assurance programs, participation in proficiency testing, regular instrument calibration and maintenance, accurate recordkeeping, and periodic inspections to ensure reliable results no matter where the test is performed. In addition, states regulate labs at the local level and may impose extra requirements, so facilities typically operate under both CLIA and state regulations. HIPAA is about protecting patient privacy, OSHA focuses on workplace safety, and the FDA oversees certain tests and devices, but the routine quality framework for clinical lab testing is provided by CLIA together with applicable state regulations.