FeaturesA Review and Analysis of the Clinical Laboratory Improvement Amendment of 1988: Compliance Plans and Enforcement PolicyRivers, Patrick A.; Dobalian, Aram; Germinario, Francesco A.Author Information Patrick A. Rivers, PhD, MBA, is Associate Professor and Director, Health Management Program, College of Applied Sciences and Arts, Southern Illinois University, Carbondale. E-mail: email@example.com. Aram Dobalian, PhD, MPH, JD, is Research Health Scientist, VA Greater Los Angeles Healthcare System, HSR&D Center of Excellence for the Study of Healthcare Provider Behavior, Sepulveda, CA. E-mail: firstname.lastname@example.org.; and is Visiting Assistant Professor, Department of Health Services, UCLA School of Public Health. Francesco A. Germinario, DC, MBA, MHSA, School of Health Administration and Policy, College of Business, Arizona State University, P.O. Box 874506, Tempe. E-mail: email@example.com. Health Care Management Review: April-June 2005 - Volume 30 - Issue 2 - p 93-102 Buy Abstract 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. § 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 objectives. © 2005 Lippincott Williams & Wilkins, Inc.