Final answer:
The US Federal regulatory standards that apply to all clinical laboratory testing performed on humans in the US, except clinical trials and basic research, are known as Clinical Laboratory Standards Institute (CLSI) guidelines. These guidelines provide a framework for ensuring accurate and reliable laboratory testing and help maintain quality control and patient safety.
Step-by-step explanation:
The US Federal regulatory standards that apply to all clinical laboratory testing performed on humans in the US, except clinical trials and basic research, are known as Clinical Laboratory Standards Institute (CLSI) guidelines. These guidelines provide a framework for ensuring accurate and reliable laboratory testing and help maintain quality control and patient safety. The CLSI guidelines cover various aspects of laboratory testing, such as specimen collection and handling, test method validation, proficiency testing, and quality management.
These guidelines are developed by the Clinical Laboratory Standards Institute, which is a globally recognized organization that sets standards for laboratory testing. The CLSI guidelines are widely used in the United States and are considered the gold standard for clinical laboratory testing practices.