Clinical laboratory improvement amendments of 1988 (CLIA '88): A review

On February 28, 1992, the Secretary of the Department of Health and Human Services (DHHS) published the final rules that implemented CLIA '88. (The word “final” here is somewhat of a misnomer as several modifications of the February 28 rules have since been published.) CLIA '88 is the federal law that sets standards for almost all laboratories in this country. Although individual states and private accrediting agencies may implement clinical laboratory regulations, these rules must be at least as strict as CLIA '88 (they may in fact be more stringent than CLIA '88). CLIA '88 is specific in its definition of what constitutes a “laboratory” (see below). This chapter will provide an overview of the rules and regulations that make up CLIA '88.