Alternate site testing. The regulatory perspective

This article provides a high-level overview of federal, state, and accrediting body requirements for laboratory testing outside the traditional laboratory environment. The Clinical Laboratory Improvement Amendments of 1988 provide a framework for most state and accrediting-body regulations. The stand taken by all regulators at this point is that testing wherever it is performed must conform to the same standards. The most variety in regulation is seen at the state level in the area of who can perform what tests and under what circumstances. All regulation focuses on the training and competency of the staff, adequate direction and supervision of the testing, and mechanisms for assessing the reliability of test results.