A Review and Analysis of the Clinical Laboratory Improvement Amendment of 1988: Compliance Plans and Enforcement Policy

Abstract

In 1988, Congress passed the Clinical Laboratory Improvement Amendment (CLIA), thereby extending coverage of the Clinical Laboratory Improvement Act of 1967 to include quality standards for all laboratory-based testing. The CLIA was enacted to ensure the accuracy, reliability, and timeliness of patient test results, regardless of the location where the tests were performed. This article assessed trends in the enforcement policy of the CLIA through an examination of the Laboratory Registry, an annual publication of those individuals or entities that have had sanctions imposed on them by the Centers for Medicare and Medicaid Services. We reviewed the CLIA, including its oversight, regulations that were promulgated based on it, and its enforcement procedures. We obtained the Laboratory Registries for 1993-2001. Sanctions were categorized into groups per the enforcement regulations (42 C.F.R. section sign 493.2 2000). The data indicated an increasing use of more lenient sanctions from 1997 to 2001, and a gradual increase in fraudulent activity for that same period. One possible explanation for this finding is that implementation of compliance plans by participating clinical laboratories had a mitigating effect on enforcement policy. Compliance plan guidance from the OIG provides an opportunity for laboratory service providers to be proactive in their attempts to decrease errors, and thus improve accuracy and reliability by documenting laboratory policies, procedures, and objectiv…