Clinical Labs: CMS and Survey Organization Oversight Is Not Sufficient to Ensure Lab Quality

Today's hearing focuses on oversight of clinical labs. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) strengthened quality requirements for labs that perform tests to diagnose or treat disease. About 36,000 labs that perform certain complex tests must be surveyed biennially by a state survey agency, a state CLIA-exempt program, or a private accrediting organization. CMS oversees implementation of CLIA requirements, which includes determining the CLIA equivalency of the inspection requirements used by exempt states and accrediting organizations. GAO was asked to discuss (1) the quality of lab testing and (2) the adequacy of CLIA oversight. To examine these issues, GAO analyzed data on lab performance and reviewed the procedures used by CMS and survey organizations to implement CLIA and oversee lab performance. This testimony is based on the GAO report, Clinical Lab Quality: CMS and Survey Organization Oversight Should Be Strengthened, GAO-06-416 (June 16, 2006).