Office Administrative Assistant Practice Exam

Which legislation primarily affects the quality of laboratory reports and results?

1. HIPAA

2. CLIA

3. ARRA

4. FDA

The correct answer is: CLIA

The legislation that primarily affects the quality of laboratory reports and results is the Clinical Laboratory Improvement Amendments (CLIA). CLIA was established to regulate laboratory testing and ensure that laboratory results are accurate, reliable, and timely. This legislation applies to all clinical laboratories, regardless of whether they are in hospitals, private practices, or other healthcare settings. The main focus of CLIA is to set forth standards that laboratories must meet to ensure the quality of laboratory testing. This includes personnel qualifications, proficiency testing, quality control, and quality assurance processes. By ensuring these standards are met, CLIA directly impacts the integrity of laboratory reports and results, making it an essential framework for laboratory operations. While other options such as HIPAA, ARRA, and FDA have important roles in healthcare and laboratory practices, they do not primarily focus on the quality of laboratory reports. HIPAA is concerned with patient privacy and information security, ARRA involves health information technology and stimulus funding, and the FDA regulates drugs and medical devices rather than the quality of laboratory testing itself. Thus, CLIA is the legislation specifically dedicated to maintaining and improving laboratory quality standards.