Which federal law requires that the competency of laboratory personnel be documented?

The correct answer is rooted in the requirements established by the Clinical Laboratory Improvement Amendments (CLIA). CLIA was enacted to ensure high standards in laboratory testing, including the necessity for laboratories to demonstrate that their personnel are competent to perform tests. This competency must be documented as part of the quality assurance and quality control measures in laboratories. The law outlines specific requirements for both training and proficiency assessments, emphasizing the need for laboratories to regularly evaluate the performance of their personnel to maintain accuracy and reliability in laboratory results.

Other laws mentioned, such as the Occupational Safety and Health Act, focus primarily on workplace safety and health standards, while the Health Insurance Portability and Accountability Act (HIPAA) addresses the protection and privacy of patient information. The Food and Drug Administration (FDA) regulations pertain to the approval and regulation of medical devices and drugs rather than directly addressing the competency documentation of laboratory personnel.