Impact of CLIA 88 on the clinical microbiology laboratory

The Clinical Laboratory Improvement Amendments (CLIA 88) to the Clinical Laboratory Improvement Act of 1967 continues to undergo transformation since its implementation more than 2 years ago. The law and its subsequent regulatory modifications were intended to promote high quality in and accurate results from laboratory testing procedures, regardless of the site at which testing occurred. A number of federal regulatory agencies and committees such as the Healthcare Financing Administration, the Clinical Improved Amendments Committee, and the Commission on Laboratory Accreditation, as well as numerous new or modified regulations and requirements have gained importance since CLIA 88 was enacted. In this discussion, components of CLIA 88 that have the greatest impact on clinical microbiology laboratories are presented. In addition, the potential future significance of CLIA 88 are outlined.