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United States Government Accountability Office (GAO) Targets Laboratory Quality

Once again, the quality of services provided by clinical laboratories across the nation is under the scrutiny of the federal government. CLIA '88 was implemented in 1992 to ensure that all laboratories meet the same minimal standards, based on the complexity of testing performed rather than by location. However, laboratory quality problems recently surfaced in several locations, prompting proposed federal legislation and a study of clinical laboratory quality by the US Government Accountability Office (GAO) to assess: the quality of laboratory testing, the effectiveness of surveys, complaint investigations, and enforcement actions in detecting problems and ensuring compliance, and the adequacy of the oversight provided by the Centers for Medicare and Medicaid Services (CMS) to the CLIA program. The study, presented to Congress in June 2006, focused on oversight by CMS, state CLIA-exempt programs, and laboratory accrediting agencies including the College of American Pathologists (CAP), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and COLA. Principal findings cited by GAO in the study include: Insufficient data exists to identify the extent of the problem. CMS state survey data prior to 2004 is not available. When inspection guidelines changed in 2004, the prior data was purged. GAO is concerned that potential quality problems are masked. Announced inspections are problematic. Laboratories prepare specifically for inspection so announced inspections fail to provide a true picture of the laboratory's quality. CAP and JCAHO inspections have since begun announced inspections. All agree that physician office laboratory inspections should be announced due to disruption of patient care,…