Which organization is responsible for setting laboratory practice standards?

The organization responsible for setting laboratory practice standards is the Clinical Laboratory Improvement Amendments (CLIA). CLIA establishes quality standards for laboratory testing in the United States, ensuring that laboratories meet a minimum level of quality for the tests they perform. These regulations apply to all types of laboratory testing, including those performed in hospitals, clinics, and private laboratories.

CLIA's main goal is to improve the quality of laboratory testing, which directly affects patient care and outcomes. It sets forth guidelines on the operation of laboratories, the qualifications of personnel, and the accuracy and reliability of test results.

While other organizations, such as the International Organization for Standardization (ISO), also develop standards that can apply to laboratories, CLIA specifically focuses on clinical laboratory testing regulations within the U.S. The Joint Commission primarily accredits and certifies healthcare organizations, overseeing quality and safety in a broader healthcare context but not solely focused on laboratories. The Food and Drug Administration (FDA) is involved in the regulation of medical devices, including devices used in laboratories, but it does not set the specific standards for laboratory practices themselves.